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298 views279 pages

Prevent

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andini
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© © All Rights Reserved
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You are on page 1/ 279

Marvin F.

Kraushar Editor

Risk Prevention in
Ophthalmology
Risk Prevention in Ophthalmology
Marvin F. Kraushar, MD
Editor

Risk Prevention
in Ophthalmology
Marvin F. Kraushar, MD
Clinical Professor of Ophthalmology
University of Medicine and Dentistry of New Jersey
Newark, NJ
and
Clinical Associate Professor of Ophthalmology
The Mount Sinai School of Medicine
New York, NY
USA

ISBN: 978-0-387-73340-1 e-ISBN: 978-0-387-73341-8

DOI: 10.1007/978-0-387-73341-8

Library of Congress Control Number: 2007932967

© 2008 Springer Science+Business Media, LLC


All rights reserved. This work may not be translated or copied in whole or in part without the written
permission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street, New York,
NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in
connection with any form of information storage and retrieval, electronic adaptation, computer software,
or by similar or dissimilar methodology now known or hereafter developed is forbidden.
The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are
not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject
to proprietary rights.
While the advice and information in this book are believed to be true and accurate at the date of going
to press, neither the authors nor the editors nor the publisher can accept any legal responsibility for any
errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect
to the material contained herein.

Printed on acid-free paper.

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Preface

Just as patients do not come to a medical office with the intention of suing the phy-
sician, physicians have no intention of harming their patients. The extensive train-
ing physicians undertake and the nature of the services they provide make them
dedicated to doing their best for the well being of their patients. Medical training
itself inculcates physicians with the philosophy of not making mistakes. The crite-
rion for establishing medical malpractice is negligence on the part of the physician
that is the proximate cause of an injury suffered by the patient. The definition of
negligence refers to “an unintentional act or failure to act.” If a physician acts in a
negligent manner regardless of whether he or she causes harm to a patient, it is an
unintentional error. Allegations of negligence are thus not simply a legal challenge
for physicians but are also a professional and psychological affront. It is very unset-
tling for the physician who acts with the best of intentions to face the allegation that
his or her care was negligent.
For physicians, who are trained to search for the truth, the process of litigation is
antithetical to their manner of reasoning. The adversarial system of the law is not
necessarily a search for the truth but rather the selective presentation of only that evi-
dence that is favorable to the plaintiff or to the defendant. Physicians are usually
uncomfortable and unfamiliar with this process in much the same way as are patients
in a medical office or in the operating room. The natural desire of the physician is to
devote his or her time and effort to the practice of good medicine and to spend as little
time as possible considering the possibility of litigation. As a result, most physicians
know relatively little about medical malpractice litigation, and unfortunately many
view this lack of knowledge as a badge of honor. For these physicians, contemplation
of litigation is an unnecessary burden on the practice of medicine, and many regard
with disdain those physicians who participate in malpractice litigation as defense or
plaintiff experts. The average physician discounts the importance of modeling
the practice of medicine in order to minimize the risk of litigation and also to maxi-
mize the opportunities for successfully defending lawsuits. Failure to implement
these modalities can increase the tendency for a patient to sue and/or compromise the
defense of a lawsuit.1 Paradoxically, many of these suggested practice patterns are
identical to the advice of practice management consultants whose job it is to grow
practices and to whom physicians listen attentively.

v
vi Preface

The frequency and severity of claims against physicians have multiplied many
times during the past few decades. This has been referred to as a “malpractice cri-
sis,” a misnomer implying that malpractice is the problem. There is, however, no
demonstrable actual increase in malpractice. There has been a significant change in
the physician–patient relationship. Advances in medicine have proved to be a dou-
ble-edged sword. Although they have greatly improved the quality of medicine, the
advances have also increased patient expectations. Unfortunately, many patients
not only want to be cured but they also expect to be cured, and anything less than
a complete cure will be unsatisfactory.2 During the course of physician–patient
encounters there is something the physician does or fails to do that leads the patient
to consider a lawsuit. Thus, in many instances, the problem is not necessarily the
litigious patient but rather the lawsuit-causing physician.
As an in-house reviewer for medical malpractice insurance companies and as an
expert witness, I have reviewed over 900 medical malpractice claims for the purposes
of collecting data for publications. This experience has revealed specific recurrent
patterns of physician behavior and patient management that encourage litigation and
others that discourage it. Fear of the unknown can be unpleasant for both the patients
contemplating their prognosis and the physicians involved in medical malpractice
litigation. It is the purpose of this book to provide sufficient enlightenment about
medical malpractice litigation to allay the anxieties of physicians regarding lawsuits,
thus maximizing their performance and enjoyment of the practice of medicine.
This book presents, in a clinical, nondidactic manner, the basic elements of the
law regarding medical malpractice litigation as they apply to the practice of medi-
cine in order that the physician can understand that which is required for more
effective risk prevention. The presentation is unique in that material is presented
almost exclusively by physicians and from the physician’s point of view rather than
by attorneys as a treatise on the law in order that it can be more easily incorporated
into the routine practice of medicine. The concept of informed consent is presented
from the physician’s point of view in order to stress that it can be a powerful risk
prevention measure instead of merely a legal encumbrance. Discussion of the
sequence of events in a medical malpractice lawsuit is presented by a physician
rather than by an attorney in order to be more physician friendly. It is designed to
help the physician navigate the journey more easily by means of simplification of
the facts and with suggestions that have stood the test of time
The chapters by the defense’s and plaintiff’s attorneys and the judge are designed
to avoid legal terminology wherever possible and will familiarize the physician with
“secrets of the trade” and how best to manage the litigation process, discovery, trial
testimony, and especially cross examination. The chapter on expert witnesses is
important for those who may act as an expert and even more important for anyone
who is a defendant in order to understand the preeminent role an expert plays on
behalf of a plaintiff or a defendant. The chapters on the ophthalmic subspecialties and
related fields are intended to cover those problems that most commonly lead to
litigation and the means by which to maximize risk management.
Being sued for malpractice is a significant psychological trauma for any
physician no matter the circumstance or the outcome. It will definitely alter the
Preface vii

physician’s self-image and the way he or she regards patients and enjoys the
practice of medicine. Following any lawsuit, even if it is dropped without payment
or successfully defended, it will be difficult thereafter not to view patients as poten-
tial adversaries. To this end a chapter has been included to assist physicians in cop-
ing with the psychological effects of litigation. Furthermore, because most
physicians are not trained businessmen, a chapter is devoted to simplifying the
evaluation and selection of medical malpractice insurance policies and companies,
which can be a daunting process to the uninformed physician. Duplication of effort
in discussing some subjects has been minimized wherever possible, but it is diffi-
cult to avoid completely because of the multiplicity of authors and the overlap of
some subjects. Therefore, some topics (i.e., informed consent) are appropriately
discussed in more than one chapter.
The current system of malpractice litigation is at best inadequate, inefficient,
unfair, and wasteful. “Canadian physicians are only one-fifth as likely to be sued
as are American doctors.”3 Does this mean that American doctors are only 20% as
caring or competent as their Canadian counterparts? Too many frivolous claims are
initiated in the United States. “Eighty-three percent of the 2,827 claims closed in
the United States in 2005 resulted in no payments.”4 These nonmeritorious claims
cost the physicians’ insurance companies money to defend whether they were even-
tually dropped by the plaintiff or successfully defended in court by the physician,
and it is the physician who must unfairly bear this financial burden, which would
seem more appropriately placed on the plaintiff. On occasion, a nonmeritorious
claim may need to be settled because the medical details are too complicated for a
jury to comprehend. “The use of malpractice awards for social justice is frequently
prominent in the thinking of juries. This is a most inefficient method of accom-
plishing … redistribution of wealth. Much of this wealth is redistributed to the legal
profession.”5 Only a fraction of the money awarded in meritorious claims goes to
patients. Although the number of medical liability lawsuits is stabilizing the sever-
ity of claims and the cost of defending them continues to rise (17% in 2005).4
The trial bar avers that the jury is the best and most impartial judge of evidence.
If juries are in fact the most impartial “triers of fact,” why do attorneys “venue shop”
for locations with jury pools that are notoriously more favorable to one side or the
other? Does the fact that malpractice insurance premiums in those venues that are
currently hotbeds of litigation, such as South Florida, West Virginia, parts of Texas,
and three counties in Illinois,6 can be over 26 times more expensive than premiums
in other less litigious parts of the country mean that those local physicians are less
competent? General surgeons in Dade County, Florida, paid an average of $299,420
for malpractice insurance in 2006, while the average premium in Minnesota was
$11,306.7 “Furthermore, in litigated cases, it is the severity of the patient’s disability,
not the occurrence of an adverse event due to negligence, which best predicts the
payment of claims to plaintiffs.”8 Government and private insurers are presently con-
sidering “pay for performance” incentive systems in which the quality of care by
physicians is evaluated through physician clinical performance assessment (PCPA).
“There is concern that PCPA may increase litigation risks if plaintiff attorneys are
able to use the data as evidence to bolster malpractice claims.”9
viii Preface

“According to a new nationwide survey, six in ten doctors have considered leav-
ing medicine because they are discouraged by the health care system. The medical
liability environment is one of the top six reasons.”10 The outcome options for a
physician defendant in medical malpractice litigation are uniformly poor. In today’s
hyperlitigious environment, insurance companies tend to add every lawsuit to the
physician’s claim total and increase the premium for coverage accordingly. This is
usually the case not only in the event of a jury verdict for the plaintiff but even if
the claim is voluntarily dropped, dismissed by the court, or after a defense verdict,
because in each instance the insurance company incurs expenses. The net result is,
therefore, if the physician is sued he or she loses regardless of the outcome. It is
truly a no-win situation. Attorneys often file “shotgun” lawsuits aimed at every
physician who provided any services to a patient. This is to protect the attorney
as well as the patient. If an attorney fails to name the appropriate physician prior
to expiration of the statute of limitations, that physician can theoretically never
be sued for the malpractice. This puts the attorney at risk for a malpractice lawsuit
by the patient. If one or more physician defendants are later dropped from the suit,
the claim will still be added to their lawsuit total by the insurance company, thus
affecting their premium. Thus the physician has literally paid the price of protecting
the attorney.
Another bias of legislation that is prejudiced against physicians is the statute of
limitations for filing a medical malpractice lawsuit on behalf of a minor. In many
states the statute runs until the child’s twenty-first birthday and even a year or two
beyond. For example, in the 1960s, the only ophthalmologist practicing in a subur-
ban city volunteered to evaluate the retinas of premature newborns before discharge
from the hospital. The service was essentially pro bono, because at that time it was
not the rule for newborns to be covered by medical insurance. In 1981, the ophthal-
mologist was sued by the parents of a child he had seen 20 years earlier and who
was blind from retrolental fibroplasia (as it was called at the time). The limits of
the ophthalmologist’s malpractice insurance policy in 1961, the year he saw the
patient, were the typical $10,000/20,000 that practically every physician had at that
time. The 1981 lawsuit was for $3 million, and the ophthalmologist, aged 62 years
and near retirement, was concerned about depleting his financial resources. Two
years later the lawsuit was dismissed by the court. Unfortunately, the physician had
already lost 30 pounds and practically all of his hair. Jury awards have escalated at
an alarming rate in recent years. It is not difficult to imagine an award for retinopa-
thy of prematurity 20 years from now to be in the range of $30 million, thus threat-
ening the retirement funds of today’s ophthalmologists, who are typically covered
by $2–$5 million. This threat explains why so many vitreoretinal specialists are
presently unwilling to see premature infants.
In 2007, the President of the American Medical Association wrote11:
Medical liability is one area in which we seem to make little progress as long as we “soldier
on” and live with the terror of the tort system. There is no question that as long as we con-
tinue to allow ourselves to be subjected to the inequities of this system, we will never see
meaningful change. It is clearly time that we face this undeniable fact. The day will most
certainly come when we must say ENOUGH.
Preface ix

The questions are when do we say it, and in what manner do we express this
sentiment? The unfortunate situation is presently that among any 100 physicians in
a room there will be 200 opinions. Until and unless we are willing to act as one, we
have no choice but to suffer and endure. In the current political setting any chance
physicians have for favorable, meaningful reform of the tort system in the near or
intermediate term is remote at best. Although political activism for tort reform
presents hope for the future, under the present circumstances it is essential that
physicians recognize the inequities and limitations of the system and learn how best
to deal with them. The optimal solution is effective risk prevention, enabling the
physician to stay out of court and avoid putting his or her fate in the hands of any
jury. To this end I offer the following chapters.

Marvin F. Kraushar, MD

References

1. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little, Brown;
1977:xiii.
2. Kraushar MF. Practical and philosophical considerations of the physician-patient relationship.
Ann Ophthalmol 1987;19:83–84.
3. Professional issues: quickview. JAMA, September 11, 2006, p.13.
4. Reports assess liability situation. In brief. Am Med News, December 25, 2006.
5. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham,
AL: Aesculapius; 1984:7.
6. Rose JR. Is your state a haven for “litigation tourists”? Med Econ 2006;Feb:10.
7. Sorrel AL. Liability insurance rates mostly hold steady or drop this year. Am Med News,
December 11, 2006:1–2.
8. Spicer J. Professional liability insurance II. The legal environment. NJ Med (Suppl) 2002;
99:23–28.
9. Kesselheim AS, Ferris TG, Studdert DM. Will physician-level measures of clinical perform-
ance be used in medical malpractice litigation? JAMA 2006;295:1831–1834.
10. Adams D. Doctor morale shaky as practice stressors surge. Am Med News, January 15,
2007:1–2.
11. Plested WG III. Starting the new year with our priorities set realistically. Am Med News,
January 22, 2007:20–21.
Contents

Preface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv

Part 1 General Considerations

Chapter 1 Basic Medical Malpractice Terminology . . . . . . . . . . . . . . . . 3


Marvin F. Kraushar

Chapter 2 The Defense Attorney . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7


E. Burke Giblin

Chapter 3 The Plaintiff’s Attorney . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27


Lee S. Goldsmith

Chapter 4 The Trial Judge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37


David S. Cramp

Chapter 5 The Medical Expert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41


Edward L. Raab

Chapter 6 Sequence of Events in a Medical Malpractice Lawsuit. . . . . 47


Marvin F. Kraushar

Chapter 7 Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65


Marvin F. Kraushar

Chapter 8 The Five Most Effective Risk Prevention Strategies . . . . . . . 77


Marvin F. Kraushar

Chapter 9 Revelation of Adverse Events and the Conundrum


of an Apology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Peter H. Morse and Marvin F. Kraushar

xi
xii Contents

Part 2 Risk Management in the Ophthalmic Subspecialties


and Related Fields

Chapter 10 Anesthesia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Peter H. Morse and Marvin F. Kraushar

Chapter 11 Cataract Surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103


Stephen A. Kamenetzky

Chapter 12 Cornea: External Disease and Contact Lenses . . . . . . . . . . 119


Peter R. Laibson

Chapter 13 Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131


Simon K. Law

Chapter 14 Emergencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149


Peter H. Morse

Chapter 15 Glaucoma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163


Robert F. Sanke and Paul P. Lee

Chapter 16 Neuroophthalmology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171


Andrew G. Lee

Chapter 17 Oncology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181


Devron H. Char

Chapter 18 Ophthalmic Plastic Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . 187


Tanuj Nakra and Norman Shorr

Chapter 19 Pediatric Ophthalmology . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201


Edward L. Raab

Chapter 20 Refractive Corneal Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . 209


James J. Salz and Anne M. Menke

Chapter 21 Retina and Vitreous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225


Marvin F. Kraushar and Peter H. Morse

Chapter 22 Uveitis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237


C. Stephen Foster
Contents xiii

Part 3 Personal and Business Considerations

Chapter 23 Physician and Defendant: Living and


Coping with a Double Life . . . . . . . . . . . . . . . . . . . . . . . . . . . 249
Sara Charles

Chapter 24 Medical Malpractice Insurance: Selection


of Companies and Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
Eric S. Poe

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269
Contributors

Devron H. Char, MD
Clinical Professor of Ophthalmology, Stanford University School of Medicine,
Director, The Tumor Foundation, San Francisco, CA, USA

Sara Charles, MD
Professor of Psychiatry, Emerita, University of Illinois School of Medicine,
Chicago, IL, USA

David S. Cramp
Judge of the Superior Court, Trenton, NJ, USA

C. Stephen Foster, MD, FACS, FACR


Clinical Professor of Ophthalmology, Harvard Medical School, Cambridge,
MA, USA

E. Burke Giblin, Esq.


Certified Civil Trial Attorney, Supreme Court of New Jersey, Morristown,
NJ, USA

Lee S. Goldsmith, MD, JD


Goldsmith, Richman & Harz, LLP, Englewood Cliffs, NJ, USA

Stephen A. Kamenetzky, MD
Clinical Professor of Ophthalmology and Visual Sciences, Washington University
School of Medicine, St. Louis, MO, USA

Marvin F. Kraushar, MD
Clinical Professor of Ophthalmology, University of Medicine and Dentistry
of New Jersey, Newark, NJ; Clinical Associate Professor of Ophthalmology,
The Mount Sinai School of Medicine, New York, NY, USA

xv
xvi Contributors

Peter R. Laibson, MD
Professor of Ophthalmology, Thomas Jefferson University of Medicine,
Philadelphia, PA; Attending Surgeon and Director Emeritus Cornea Service,
Wills Eye Hospital, Philadelphia, PA, USA

Simon K. Law, MD, PharmD


Associate Professor of Ophthalmology, Jules Stein Eye Institute,
David Geffen School of Medicine, UCLA, Los Angeles, CA, USA

Andrew G. Lee, MD
Professor of Ophthalmology, Neurology and Neurosurgery,
University of Iowa Hospitals and Clinics, Iowa City, IA, USA

Paul P. Lee, MD, JD


James P. Gill, III, M.D., and Joy Gillis Professor of Ophthalmology,
Department of Ophthalmology, Duke University Eye Center,
Duke University School of Medicine, Durham, NC, USA

Anne M. Menke, RN, PhD


Risk Manager, Ophthalmic Mutual Insurance Company, San Francisco, CA, USA

Peter H. Morse, MD
Clinical Professor of Surgery, Department of Ophthalmology, Sanford School
of Medicine, University of South Dakota, Sioux Falls, SD, USA

Tanuj Nakra, MD
Visiting Assistant Professor of Ophthalmology, Division of Orbital
and Ophthalmic Plastic Surgery, Jules Stein Eye Institute,
David Geffen School of Medicine, UCLA, Los Angeles, CA, USA

Eric S. Poe, Esq., CPA, JD


Vice President of Marketing & Business Development, New Jersey PURE,
Princeton, NJ, USA

Edward L. Raab, MD, JD


Professor of Ophthalmology, Professor of Pediatrics, The Mount Sinai School
of Medicine, New York, NY, USA

James J. Salz, MD
Clinical Professor of Ophthalmology, University of Southern California,
Los Angeles, CA, USA
Contributors xvii

Robert F. Sanke, MD, JD


Clinical Associate Professor of Ophthalmology, University of North Dakota,
Trinity Medical Center, Minot, ND, USA

Norman Shorr, MD
Clinical Professor of Ophthalmology, Director, Fellowship in Orbital
and Ophthalmic Plastic Surgery, Jules Stein Eye Institute,
David Geffen School of Medicine, UCLA, Los Angeles, CA, USA
Part 1
General Considerations
Chapter 1
Basic Medical Malpractice Terminology

Marvin F. Kraushar

Introduction

There are several basic terms and phrases that bear on the process of medical
malpractice litigation. Familiarization with them will facilitate the understanding of
the development and conduct of a lawsuit.

Standard of Care

Physicians are expected to provide care that falls within a certain level of quality.
This level is referred to as the standard of care. The standard is defined as that level
of care provided by the average physician in the same specialty, in the same commu-
nity, during the same period of time. This definition can cause a false sense of secu-
rity for the physician who may mistakenly feel comfortable in being compared to the
“average” physician and not to the “best” physician. The phrase “average physician”
is a nebulous concept and does not truly refer to the physician in the 50th percentile.
In fact, it refers to practically every physician because practically all medical care is
within the accepted standard. Generally, the law recognizes that medicine is not an
exact science. A poor result may occur even though the physician followed the
accepted standard of care. Therefore, whether the doctor was negligent is not deter-
mined solely by the outcome but by whether he or she followed the accepted standard
of care. By this standard, missing a retinal break in a symptomatic patient may not
constitute negligence if the jury concludes that the doctor’s evaluation met the stan-
dard of care. Nonetheless, it is essential that the appropriate method for detecting the
break, namely, performing a dilated fundus examination, was used and that the physi-
cian has the appropriate level of expertise with the instruments in order for the care
to be within the “standard.” The community is usually the entire country now that
dissemination of knowledge is widespread and basic equipment is readily available.
The standard of care is not always a firm, black and white concept. It is defined for
the jury by the experts for the plaintiff and the defense, and this is often accomplished
by the selective presentation of information that is favorable to the side of the presenter.

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 3


doi: 10.1007/978-0-387-73341-8; © Springer 2008
4 M.F. Kraushar

Both experts will review the same facts and come to diametrically opposed conclu-
sions. It is commonly this testimony on which the jurors, who typically have no
knowledge of their own regarding the facts, will depend during deliberations. The bot-
tom line is that an error by a physician may be excusable provided he or she made a
competent attempt to do the right thing.

Tort

A tort is a private or civil wrongful act as opposed to a public or criminal wrongful


act. The law seeks to restore the injured party to the status he or she enjoyed prior
to the injury. Because the injured or lost body part cannot be completely physically
restored, the manner of restitution (making the plaintiff whole) is in the form of
compensatory damages (monetary indemnification).

Negligence

Negligence is the tort of an unintentional act or omission. The level of care that
“breaches” or falls below the standard of care is judged negligent. Negligence
occurs when the physician does or fails to do something that the average physician
in the same specialty under the same circumstances would not have done or failed
to do and has thus “deviated from,” “breached,” or “fallen below” the standard of
care. Negligence in and of itself does not constitute malpractice unless it is the
proximate cause of an injury suffered by the patient (see next section).

Proximate Cause

To prevail in a medical malpractice lawsuit, the plaintiff has the burden of proving he
or she suffered an injury that was caused by the physician’s negligence. This is the
concept of proximate cause. When an ophthalmologist fails to use povidone iodine prior
to cataract surgery and endophthalmitis occurs, it is reasonable to assume there was
negligence that was a substantial factor in the causation of an injury to the patient. These
facts meet the criteria for the determination of medical malpractice. Failure to use povi-
done iodine is a deviation from the standard of care that increased the risk of infection.
Suppose an ophthalmologist fails to use povidone iodine prior to cataract surgery that
is uneventful and uncomplicated. Suppose further that endophthalmitis does not
develop, but 3 weeks following surgery a rhegmatogenous retinal detachment occurs.
The surgeon was negligent in failing to use povidone iodine and there was an injury
suffered by the patient, but the negligence was not the proximate cause of the retinal
detachment. These facts would not meet the criteria for medical malpractice. A final
Chapter 1. Terminology 5

example is that of an ophthalmologist who fails to use povidone iodine prior to cataract
surgery that is uncomplicated and no postoperative complication occurs. The ophthal-
mologist deviated from the standard of care and was thus negligent, but there was no
injury suffered by the patient and thus there was no medical malpractice.

Allegations

When a patient initiates a lawsuit, he or she alleges deviations by the physician


from the standard of care. The allegations are failure or delay in diagnosis, failure
or delay in treatment, negligent treatment, and/or problems relating to informed
consent. The plaintiff alleges that one or more of these deviations from the standard
of care decreased the chance for a more favorable result. This “doctrine of loss of
chance” is the basis of lawsuits in most jurisdictions.

Maloccurrence

Maloccurrence is not a legal term. It is often used by physicians to describe “what


went wrong” as bad luck and not the result of malpractice.

Medical Misadventure

Medical misadventure is a nonmedical and nonlegal term used by insurance com-


panies to describe “what went wrong” in the management of a patient.

Respected Minority

The type of treatment rendered to a patient need not be the choice of most physicians in the
same specialty in order to be within the standard of care. However, the care rendered must
be respected as a reasonable alternative by at least a substantial minority of colleagues.

Vicarious Liability

Physicians can be sued because of responsibility for the acts of someone else. The obvi-
ous example is the negligence of a nurse/technician, fellow, and so forth, employed in
the physician’s office. Lawsuits have been brought against ophthalmologists who
6 M.F. Kraushar

caused injuries to patients in the operating room by using improper medications without
checking to see whether the nurse gave the physician the correct medication. Retinal
toxicity caused by too high a concentration of an intravitreal antibiotic during pars plana
vitrectomy for endophthalmitis would be the responsibility of the pharmacist and the
hospital for whom he or she works. The surgeon would most likely be named in the
lawsuit initially.
The performance of a “covering physician” is of paramount importance. It is
essential that whoever sees a physician’s patients in his or her absence is competent
and responsible. This applies to those persons over whom we have some control
(partners, fellows, etc.) and thus for whose negligence we may have legal responsibil-
ity and also to those persons over whom we have little or no control (house staff, col-
leagues, etc.) and for whose negligence we are not legally responsible. Conversely,
we must treat the patients of other physicians as we would treat our own. Make sure
to document the facts of phone calls from patients of those physicians for whom you
are covering and pass along the appropriate information the next day. Create a sepa-
rate dedicated file in which you keep this information as well as the documentation
that you transmitted it. This will be powerful exculpatory evidence if you are eventu-
ally named in a lawsuit.
Chapter 2
The Defense Attorney

E. Burke Giblin

Helping Your Defense

As I reflected on cases our firm has successfully defended for physicians, it


occurred to me that two of the most important elements that helped us to achieve a
successful outcome were, first of all, extensive preparation, and, second, teamwork
between the defendant physician and the defense attorney. I will outline some of
the techniques that we provide to our clients to help them toward a successful out-
come at trial and will discuss how physicians have helped us to successfully pre-
pare their cases.

Preparation for Your Deposition Is Essential

Any discussion about how a physician can assist defense counsel in achieving a favo-
rable outcome must, of necessity, start with a discussion about preparation for the
physician’s deposition. Once a physician has placed his position on the record at his
deposition, it becomes extremely difficult to alter that position at the time of trial. In
some jurisdictions, depositions may be videotaped and the videotaped deposition may
be used at trial. Naturally, this makes deposition preparation even more important.
Generally, prior to the deposition, the physician should review all relevant
records, depositions, and expert reports that are available. The data should be
reviewed self-critically, as if the physician were serving as the expert witness for
the opposing side. If there are any weaknesses identified, the physician should dis-
cuss this with the defense attorney prior to the deposition in order that these “prob-
lem” areas may be handled as effectively as possible.
The physician should be extremely well versed in the medical issues involved in
the case. I typically suggest to my clients that they should go over the medicine as
if they were going to be asked to present the case during a board certification
examination. In some cases, if there is uncertainty regarding certain medical issues,
an early expert review may be recommended to obtain early guidance regarding
these issues.

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 7


doi: 10.1007/978-0-387-73341-8; © Springer 2008
8 E.B. Giblin

It is important that physicians meet with their attorney prior to their deposition, at
which time the attorney will go over general techniques for testifying at a deposition
and will also discuss the specific issues involved in the case. The defense attorney
should also discuss with the defendant physician the specific issues germane to the
particular case prior to the deposition.
I have learned that it is often helpful that there be some role playing wherein
the defense attorney questions the physician as if the defense attorney were the
opposing attorney. Some physicians have found it helpful to have this role playing
videotaped so that they can see how they appeared when answering difficult ques-
tions and thereby potentially improve their performance at the actual deposition.
Whether or not videotape is used in the deposition preparation process, some role
playing is usually very helpful because it is often easier to answer difficult ques-
tions for the second time at the actual deposition rather than for the first time at
the deposition.
In some jurisdictions, there are rules that make preparation for the deposition
particularly crucial. These are rules that limit the ability of the defense attorney to
direct a defendant physician not to answer a question at a deposition. Accordingly,
the preparation session is extremely important because the defense attorney has
limited capability to direct a physician not to answer even improper questions. For
example, without proper preparation, a physician may not know, if asked, whether
to criticize the care of a codefendant physician.

Working with Codefendants

As a general proposition, it is usually preferable from the defense perspective to


avoid “fingerpointing” among codefendants. Once fingerpointing begins, it typi-
cally accelerates, and the plaintiff almost invariably wins such cases.
There may be rare instances, however, when fingerpointing among defendant
physicians is unavoidable. In these circumstances, it is important for the defense
attorneys to try to work together to attempt to minimize the fingerpointing to the
extent the factual scenario allows.
In certain jurisdictions, physicians cannot be forced to provide their “opinions”
against their will. In this instance, a physician does not have to offer an opinion
critical of another physician unless that opinion was one that was formed as a part
of treatment of the patient. In other words, opinions formed in order to provide
treatment may be considered factual, and therefore the physician may have to state
his or her opinion if it is asked. However, if the physician is simply reflecting back,
after the litigation has started, as to whether another physician’s conduct was appro-
priate, a physician may choose not to offer such an opinion.
It is extremely important that any opinions critical of another physician be dis-
cussed with defense counsel prior to providing the opinion at a deposition or trial.
This will ensure that the defense attorney is aware of the opinion and can deal with
the issue in the best way possible given the circumstances.
Chapter 2. The Defense Attorney 9

Questions Physicians Frequently Ask About Testifying

Our clients have frequently asked whether they can be forced to answer questions with
merely “yes” or “no” at the time of deposition or trial. Many judges will give the wit-
ness the following options. The witness can answer either “yes” or “no,” or he may tell
the attorney asking the question, “I cannot answer the question ‘yes’ or ‘no.’ ”
We typically advise our clients that if a simple “yes” or “no” does not fairly
explain their position, they should explain and not limit their answer to just one
word. If the opposing attorney insists on a “yes” or “no” answer and the judge allows
this, the witness should state, when appropriate, that he is not able to fairly answer the
question “yes” or “no.” In the event the physician is ultimately forced to answer with
only a “yes” or “no,” he will have a chance to explain when the defense counsel gets
the opportunity to ask questions following cross-examination.
Clients also often ask whether they should be their own expert witness. Again,
this is something that must be decided on a case-by-case basis. Theoretically, if the
physician is serving as his own expert, the scope of cross-examination is broader.
However, in my experience, most judges allow a very broad scope of cross-
examination of a defendant physician regardless of whether the physician is serving
as his own expert. Accordingly, I often have the defendant physician serve in the
role of an expert on certain issues, because I have found that the scope of cross-
examination usually is not much different.
However, there may be times when it is extremely important to limit the scope of
the defendant physician on a particular issue. Therefore, the physician should be
sure to discuss this issue with his attorney because this is something that must be
decided on a case-by-case and issue-by-issue basis.

General Differences Between Deposition and Trial

It is helpful to have an understanding of the differences between deposition testimony


and trial testimony. In general, a deposition gives the opposing counsel the opportunity
to learn what a witness may say at the time of trial. Opposing counsel is seeking to obtain
information that will assist him in cross-examining the witness at trial. Accordingly, it is
usually the role of the physician at his or her deposition to attempt not to educate oppos-
ing counsel more than is absolutely required. Certainly, if a specific question is asked,
the physician must answer it completely. However, as previously discussed, physicians
should generally not volunteer additional information beyond what is specifically asked.
As with any general rule, however, there may be exceptional circumstances in which the
defense attorney may want the physician to bring out certain points during the deposition
even if the opposing attorney does not inquire about these points.
In contrast to the deposition, trial testimony is the physician’s opportunity to
explain facts that are favorable and to expound upon his theory of the case.
Accordingly, when your attorney questions you during direct testimony, you will be
trying to educate the jury. Your answers will likely be much more detailed and easy
10 E.B. Giblin

to understand when you are testifying at trial than when you were testifying at a
deposition. This is not to suggest that any fact or theory should be unfairly covered
up at a deposition even though inquired about in an effort to surprise the opposing
attorney at trial. It simply means that at a deposition answers should generally be
limited to exactly what is inquired about and nothing more.

A Judge or a Jury?

Many physicians jump to the conclusion that it would be better to have their case
decided by a judge rather than by a jury. In reality, this is not always true. In any
event, the defendant physician often has no option in this regard. In many jurisdic-
tions, if the plaintiff requests a trial by a jury, which plaintiff’s attorneys almost
invariably do, then the law provides that the trial will be decided by a jury rather
than by a judge regardless of the defendant’s wishes.
In defending doctors in malpractice cases for over 30 years, I have encountered
only four or five situations in which defendants have had the option of a trial by a
judge rather than by a jury. Interestingly, in each instance, the insurance carriers for
the physicians decided that they would not agree to allow the case to proceed to a
trial by a judge rather than by a jury. The rationale for this decision was that the car-
rier’s experience with judges deciding medical malpractice cases had not been good.
The carriers believed that judges tend to want to make everyone happy and to come
up with a compromise verdict, whereas jurors tend to be more decisive and more
willing to turn away a sympathetic plaintiff if the treatment was proper.
The greater decisiveness of the jury may be a function of the fact that six or more
individuals are making the decision rather than just one individual, as in the case of a
judge trial, and that none of the jurors knows any of the attorneys. In contrast, the judge
often knows the attorney for the plaintiff and the attorney for the defendant and is fre-
quently focused, as part of his daily routine, on settling cases for a compromise amount.
As juries typically find in favor of the defendant in the great majority of cases when the
treatment is proper, this probably accounts for the decision of the insurance companies
to go with a jury in those rare cases when there has been an option. Obviously, insur-
ance carriers may make a different decision based on the circumstances of any individ-
ual case. For example, if the particular venue is known for having poor jurors or if the
injuries are particularly severe or the proposed judge is well respected.
In the event that a case involves poor treatment and the plaintiff has significant
damages, it would likely be to the advantage of the defendant physician to have a
judge determine his case rather than a jury. However, the only cases, in my experi-
ence, when the option of a judge trial has been presented to the defense have been
those that were medically defensible and the plaintiff’s attorney felt that he could
get the case resolved more quickly and efficiently, and with the possibility of a
compromise verdict, by agreeing to proceed to trial with a judge. In one such case,
the plaintiff’s attorney appeared to have had a longstanding, and apparently very
friendly, relationship with the proposed judge. Of course, the option of having the
case decided by this particular judge was declined.
Chapter 2. The Defense Attorney 11

The Roles of the Judge and the Jury

As noted, medical malpractice cases are almost invariably tried before a jury. In a
jury trial, the judge will explain to the jury that they will be the sole judges of the
facts. Jurors alone have the responsibility of deciding the factual issues in the case.
The determination of the jury as to the facts must be based solely on the evidence
admitted during the course of the trial. The evidence will consist, generally, of the
testimony of witnesses who appear in court and testify as well as any depositions
or answers to interrogatories that are read to the jury. Also, exhibits, which in a
medical negligence case typically involve medical records, may also be admitted
into evidence and go with the jury into the jury room.
When it comes to the facts, it is the recollection and evaluation of the evidence
by the jury that controls. Indeed, the judge will instruct the jury that if the attorneys,
or even the judge, say anything about the facts in the case that disagrees with the
recollection of the evidence by the jury, it is the jurors’ recollection that controls.
The jury is instructed that they must decide the case based on the instructions as to
the law given to them by the judge and applied to the facts as found by the jury.
In contrast, the judge rules on the admission or rejection of evidence and passes
upon questions of law that may arise. At the end of the case, the judge charges the
jury as to the law that applies.
There is much debate in legal circles as to how much consideration the jury gives
to the instructions of law given by the judge. Based on my observations, most jurors
certainly try to listen carefully to the judge’s instructions regarding the law, but
hearing the law read only one time may be confusing to even the most attentive
juror. In some instances a judge will provide the jury with a written transcript of his
charge on the law, or repeat the charge, to assist the jury in following the law.
I will not attempt to discuss herein everything that is covered in the charge. In gen-
eral, however, the judge will define the standard of care to which a physician is held
based on the applicable law of the state in which the case is being tried. The judge will
also typically discuss the legal concepts relating to proximate causation and damages.
I generally provide my clients with either a written or an oral outline of the
judge’s charge. I believe it helps the physician to be aware, in advance of his testi-
mony, of the standard of care to which he or she is held as well as the concept of
proximate causation.

Jury Selection

I will now turn to the various aspects of a trial and discuss some of the ways that
physicians can assist in their own defense at trial. I will start with jury selection. I
recommend that our physician clients be present during jury selection. In most
cases, the jurors, not the judge, will ultimately decide the case. Accordingly, it is
important that the physician provides the attorney any input that he may have about
any particular juror.
12 E.B. Giblin

Usually the questions that are asked by the judge or counsel eliminate most
jurors who are obviously biased toward one party or the other. After the jurors are
questioned, each attorney typically gets a number of opportunities to excuse jurors
with or without cause. If there is any juror in the jury box with whom you are not
comfortable, let your attorney know. Your attorney may or may not follow your
recommendation, but at least your attorney will have your input before making the
ultimate decision.
As your attorney uses up his or her available challenges of jurors, your attorney
will probably frequently be studying the jurors who remain available for selection.
In a recent case, I had used up five of my six available challenges. My physician cli-
ent indicated he was somewhat concerned about one of the potential jurors in the
jury box and suggested I might wish to use my last challenge to excuse him. I looked
at the panel of jurors who remained available to replace this juror, which consisted
of three more potential jurors, and then suggested that my client do likewise. After
looking at the three remaining potential jurors, my client and I agreed that the chance
that any of those who remained would be better was probably slim, so we did not
exercise the final challenge.

Opening Statements

I have listened to opening statements that have lasted anywhere from ten minutes
to three hours. Every case differs in terms of complexity, and, accordingly, there is
often significant variation in the lengths of the opening statements. However, in my
experience, I would estimate that opening statements in medical malpractice cases
average between 20 and 40 minutes.
The opening statement is a summary of the facts and theories each attorney
intends to prove. Typically, each attorney will identify the witnesses whom he
intends to call during the case. The defense attorney will usually provide a sum-
mary of the defense theory, typically including comments indicating that the treat-
ment complied with accepted standards of care as well as any defense theories on
proximate causation.
Many legal commentators believe that the opening statement is more impor-
tant than the summation. It is thought that the opening statement provides jurors
with their first impression of the case, and, once an impression is formed, it is
thought that it tends to become fixed and difficult to change. In addition, when
summations are given, the jurors have already heard all of the evidence and
hence are more likely to have already made up their minds once and for all.
Therefore, the summations may not be as important in many cases as the open-
ing statements. However, summations should never be taken lightly, and, par-
ticularly in close or very complicated cases, the summations may be extremely
important to tie together key pieces of evidence and theories that may not be
readily apparent to a lay jury.
Chapter 2. The Defense Attorney 13

The Plaintiff’s Case

In a medical malpractice case the attorney for the plaintiff usually presents his
witnesses before the testimony of the defendant physician. However, in some
cases, the defendant physician is called by the attorney for the plaintiff as the first
witness. In my experience, this often helps the defendant, particularly if the phy-
sician has been well prepared. A well-prepared defendant can defuse many of the
arguments of the plaintiff early in the case and cause the jury to have an early
impression favorable to the defense. Therefore, unless the plaintiff scores signifi-
cant points during his examination of the defendant physician, the strategy of
calling the defendant first often may turn out to be better for the defense than for
the plaintiff.
In many cases, the plaintiff’s attorney will not call the defendant during the
plaintiff’s case but instead will read portions of the defendant physician’s deposi-
tion during the plaintiff’s case. The plaintiff’s attorney will typically “cherry pick”
those portions of the defendant physician’s deposition that are thought to be favo-
rable to the plaintiff’s case or that provide testimony that the plaintiff’s expert
intends to rely on for his opinion. The fact that the defendant physician’s deposi-
tion is frequently read to the jury once again reinforces the importance of prepara-
tion by the physician prior to his or her deposition.
In typical medical negligence cases, the plaintiff’s attorney will be calling wit-
nesses who may include the plaintiff, relevant family members, and the plaintiff’s
medical and/or economic expert witnesses. It is important that the defendant physi-
cian read over the depositions of both the plaintiff and the plaintiff’s expert(s). The
defendant should advise his attorney of any thoughts that might be useful for cross-
examination of either the plaintiff or the plaintiff’s expert(s). Possible examples of
helpful suggestions for cross-examination include factual inaccuracies, conflicts
with the medical records, conflicts with the medical literature, or weaknesses in the
expert’s curriculum vitae such as limited experience in performing the treatment in
question or lack of board certification.
The defense attorney will often depose the plaintiff’s expert(s) prior to trial to
elicit information that may be useful for cross-examination. Areas of inquiry may
include the expert’s training and experience, any literature that the expert relies on
or that contradicts the expert, whether the expert’s factual assumptions are accurate,
and any weaknesses of logic in the expert’s theory of the case. In addition to taking
a deposition of the plaintiff’s expert, there are services available that can provide
information regarding testimony given by the plaintiff’s expert(s) in other cases.
Transcripts of previous testimony may be obtained and reviewed by your attorney
to determine whether there are any conflicting statements in the prior testimony that
may be helpful to your case.
Defense attorneys often hire private detectives in appropriate cases to perform
surveillance of the plaintiff. A decision whether to perform surveillance is often
made based on the index of suspicion of the defense attorney that the plaintiff may
be misrepresenting his injuries based on the plaintiff’s deposition testimony and on
14 E.B. Giblin

comments by treating physicians that may suggest that the disability claimed in the
lawsuit may be disproportionate to the findings on examination. Over the years, my
firm has obtained some remarkable surveillance videos. For example, a plaintiff
who was allegedly unable to walk without assistance was filmed climbing up and
down ladders to work on the roof of his house. If the defendant physician suspects
that the plaintiff is exaggerating his injuries, the physician should recommend to his
attorney that surveillance be considered.

The Defendant’s Case

In a typical medical negligence case, after the plaintiff’s attorney has presented all
his witnesses and exhibits, the plaintiff’s attorney rests his case. The defense attor-
ney will then typically move to dismiss any aspect of the plaintiff’s case that was
not sufficiently proven. The standard to have a case dismissed by the judge is
extremely difficult to meet, and in most competently presented plaintiff’s cases,
very little of the plaintiff’s case will be dismissed.
After motions presented at the end of the plaintiff’s case have been decided, the
defense will begin presenting evidence. The defendant physician’s case typically
involves the testimony of the defendant physician himself together with the testi-
mony of any defense experts. In some cases, there may be factual disputes between
the plaintiff and the defendant rather than merely different medical opinions based
on the same facts, and in these cases there may be fact witnesses called by the
defense to rebut the plaintiff’s factual evidence.
In most cases, the testimony of the defendant physician will be more important
than that of any other witness, including experts, called by the defense. Jurors look
upon the case as a dispute between the plaintiff and the defendant, and hence the
jurors often consider the testimony of the parties to be the most important.
Obviously, if the jurors like and believe one party more than the other, that party is
highly likely to receive a favorable verdict.
Because the defendant physician’s testimony is so crucial, it is extremely impor-
tant for the defendant to be well prepared. The defendant physician should read as
much available information about the case as possible, including the depositions of
the parties and experts. Most important, the physician should carefully study his
own deposition. If there are any errors in the transcript, the physician should advise
his attorney, preferably well in advance of trial.
Before the trial begins, the defendant physician should meet with his attorney
and begin the trial preparation process. The physician should plan to attend as much
of the trial as possible. The more the defendant physician sees of the plaintiff’s
witnesses, the better prepared the defendant will be to rebut what these witnesses
have told the jury.
Defendant physicians should naturally dress appropriately for trial. Generally, I
recommend that health care professionals dress conservatively, for example, wear-
ing a blue or gray suit without any ostentatious jewelry. In addition, I advise clients
Chapter 2. The Defense Attorney 15

against reacting to the testimony provided by plaintiff’s witnesses, for example,


making gestures such as shaking the head or rolling the eyes. I suggest that the
defendant physician always remain very professional while the plaintiff’s witnesses
are testifying. I also remind the defendant that he or she will have ample opportunity
to set forth his or her side of the story when the defendant’s turn to testify comes.

Defendant Physician’s Testimony at Trial

I recommend that the defendant physician speak to the jury as if he or she were
explaining the medicine, and his or her thinking about the treatment, to a patient or
to a friend. I have often suggested that the physician speak to the jury as if he or
she were talking to a few friends in their living room, explaining why the treatment
that was rendered was appropriate.
It is important that the defendant physician appear to be helpful. For example,
he or she should explain any medical terms that might be difficult for a lay juror to
understand. Naturally, this should never be done in a condescending manner but
only with an attitude of being helpful. If there are any points that can be made
clearer by using a diagram or an anatomic model, the defendant physician should
attempt to do so. It is advisable to go over any proposed drawings or models with
the defense attorney prior to presenting them to the jury.
When I am questioning my client during the trial, I typically stand in a location
in the court room so that the witness is facing both me and the jury. This permits
the defendant physician to easily include the jury in the discussion. In other words,
the defendant physician will be able to look at me when responding to questions
but also speak to the jury and include them in the discussion. I do not recommend
that the physician speak only to the jury but rather that the physician speak to me
and then frequently turn to the jurors to include them in the discussion.
It is essential that the defendant physician never be arrogant or condescending.
Likewise, the physician should never lose his temper. A little righteous indignation
may be appropriate if the opposing attorney is being difficult, but the physician
should never lose his or her composure. Defendants who appear professional and
reasonable usually win.
Many years ago I advised a physician that he should attempt to explain medical
terms to the jury during his testimony. Unfortunately, he prefaced each explanation
with the condescending statement, “You probably will never be able to understand
this, but this part of the surgery involves.…” Naturally, he eliminated this preface
to his explanations after I had a chance to speak with him during the first break, and
he went on to be a good witness.
In some cases, it may be appropriate to express sympathy for the plaintiff.
Physicians are often concerned whether an expression of sympathy will be miscon-
strued as an admission of negligence. If properly done, an expression of sympathy for
the injuries of the plaintiff can actually be very helpful to the defense as long as it is
made clear that this does not constitute an admission of negligence. For example, in
16 E.B. Giblin

a case involving the loss of a child, a defendant physician recently indicated that he
felt badly for his patient’s loss. His testimony went roughly as follows: “I feel very
badly for Marge, as it is always very difficult to lose a child. However, we did every-
thing in our power to help her child.”
A defendant physician should acknowledge the limits of his or her expertise. For
example, if a defendant physician is a family doctor and is asked a highly technical
surgical question, it may be appropriate to state as follows: “This is a surgical issue
on which I would defer to my consulting surgeon.”
The defendant physician should try to avoid exaggerating or “sugar coating” his
case. Weaknesses should generally be brought out and dealt with while the defense
attorney is doing the questioning and before cross-examination. Naturally, it is not
favorable when the opposing attorney is the one who exposes all of the weaknesses
in the defendant’s case.
Deposition testimony may be used by the opposing counsel to impeach the
defendant physician if there is any difference between what the doctor said in his
deposition and what the doctor says on the witness stand. If possible, the defendant
physician should try to clarify any inconsistencies between the deposition testi-
mony and the trial testimony when confronted with the prior testimony at trial.
However, there may be times when you definitely misspoke in your deposition,
and, of necessity, you have to change your testimony at the trial. Any need to
change your deposition testimony should be thoroughly discussed with your attor-
ney long before trial to give him the best opportunity to deal with this issue.
Physicians should be willing to disagree with so-called authorities or commonly
used texts if convinced that the literature is wrong. Hopefully, you or your expert
witness can emphasize that the particular literature used by the plaintiff does not
apply to the treatment in question or emphasize that there is other literature that
supports your treatment choices.
Physicians should attempt to appear confident. Take each question one at a time
and answer it as best as you can, trying not to concern yourself with how you are
doing. In other words, by doing your best on each question it is likely that the over-
all impression that you will make will be as good as possible.
Do not hesitate to ask the cross-examining attorney to clarify any question. If it
will leave the wrong impression, try not to answer questions simply “yes” or “no.”
Likewise, if a question assumes improper facts, try to point out the error in the
question’s assumptions when you answer.
In a recent case, the theory of the plaintiff was that there was a purported delay
in diagnosis of a blood infection that led to the patient becoming septic and dying.
The attorney for the plaintiff wanted to get the defendant on cross-examination to
sound as if he agreed with the theory of the plaintiff, that is, that the patient died
from sepsis, which actually was not true. The attorney for the plaintiff engaged in
the following series of questions: “Certainly sepsis causes death, true doctor?” If the
physician answered this question simply by saying “yes” it would have sounded as
if he agreed that sepsis was the cause of the death in this particular case. Fortunately
the physician provided a better answer than just “yes” by stating, “In some cases
sepsis may cause death, but it definitely did not in this case.”
Chapter 2. The Defense Attorney 17

The plaintiff also attempted to cross-examine the defendant physician for an


alleged delay in diagnosis during the night before the patient died by asking the
following question: “That evening, you left the hospital without giving the decedent
any treatment whatsoever and then you went home, isn’t that true doctor?” In real-
ity, no treatment had been given because it was not indicated at that time. If the
physician answered only “yes” it would sound as if he improperly failed to give
indicated treatment and went home. Fortunately, the physician gave a better answer
by stating, “After evaluating the patient and determining that no treatment was
indicated, based on his condition at the time, I went home, that is correct.”
In the event that the opposing attorney does not allow the defendant physician
to answer questions completely, or to clarify improper assumptions, it is important
that the physician be patient and not appear fazed. The physician should remember
that his attorney will have an opportunity to ask additional questions following the
completion of cross-examination to clarify any misimpressions created by the
cross-examination.
Physicians should keep trying their best, no matter what. Over the years, I have
had many physicians indicate to me, after they finished testifying, that they felt they
had not done well on cross-examination, when, in fact, I was able to tell them that
they had done an outstanding job. Physicians should remember that cases are not
typically won by l00 points to 0 points. Most competent plaintiff’s attorneys are
able to score at least some points on cross-examination, and it should be kept in
mind that, even if the final score is 5l to 49 in favor of the physician, it is reported
only as a physician win.
Most surveys indicate that when assessing the performance of professionals, the
criterion which the public feels is most important is whether the professional “tried
his best.” Indeed, whether the professional “tried his best” was generally thought to
be even more important than the outcome. Therefore, if a physician appears to the
jury as having tried his best in the circumstances, it is extremely likely that the
physician will have a favorable outcome at trial.
In concluding my discussion of the defendant’s physicians presentation at trial,
I can state that I have almost never seen a well-prepared physician do poorly in his
testimony. Although not every physician will have the ability to articulate his position
the way Clarence Darrow might, well-prepared physicians virtually always provide
their testimony in at least a satisfactory manner. Real estate agents say that the three
most important factors in residential home sales are location, location, location.
For physicians going to trial, the three most important factors are preparation,
preparation, preparation.

Cross-Examination Styles

Over the years I have seen many different cross-examination styles used by plain-
tiff’s attorneys. One style I categorize as the “dramatic questioner.” This attorney
will often use a booming voice with “pregnant pauses” when he believes he has
18 E.B. Giblin

scored a point. The goal of this style of cross-examination obviously is to intimi-


date the witness. This type of plaintiff’s attorney is trying to upset the physician,
and accordingly the physician should just keep trying to do his best to answer each
question as reasonably as possible without allowing the histrionics of the questioner
to bother him or her. Frankly, jurors generally do not like an attorney who comes
across as a bully, so if the physician keeps answering questions calmly and reason-
ably, in the face of this style of questioner, the physician will probably end up doing
very well.
Another style of cross-examination is what I categorize as the “ingratiating
questioner.” This type of attorney will attempt to get the physician to say “yes” to
many innocuous questions, thereby trying to give the impression to the jury that the
physician’s repeated answer of “yes” suggests that this attorney is actually scoring
points. This attorney often will move gradually from innocuous questions to more
difficult questions with the hope that the physician will continue to give “yes”
answers. If the physician does not, this questioner will quickly return to the innocu-
ous questions, once again getting the physician to repeatedly state “yes.” This
approach is often used when the plaintiff’s attorney has very little merit to his case
and therefore is not able to challenge the defendant physician with questions that
go to the true merits of the case.
The most dangerous type of plaintiff’s attorney is the one I categorize as the
“prepared questioner.” This type of attorney usually has taken an effective deposi-
tion and knows in advance, based on the deposition, medical records, medical liter-
ature, or other sources, the answer to each question that he asks at trial. The
“prepared questioner” is the most dangerous type because he or she will always
have something to back up whatever question is asked.

The Defense Expert’s Testimony

In the typical professional negligence case, the defense expert will testify after the
defendant physician. It is important that the defense attorney bring the defense
expert up to speed regarding what occurred during the testimony of the defendant
physician. It is likely that many of the questions that the plaintiff’s attorney asked
the defendant will also be asked of the defense expert. Accordingly, if time allows
between the testimony of the defendant physician and the defense expert, this is an
excellent opportunity for the expert witness to be prepared for the type of question-
ing to expect from the opposing attorney.
The decision regarding which expert to use is a very important one. An expert
witness for the defendant physician should have a good curriculum vitae. However,
it is equally, if not more, important that an expert have the ability to communicate
effectively with lay jurors. Some physicians may be extremely well qualified but
nevertheless have a hard time communicating to lay jurors in a trial setting. Defense
experts should have the ability to make difficult medical concepts understandable
to a lay jury. Experts who use complex, technical, medical language, which may
Chapter 2. The Defense Attorney 19

fascinate a group of physicians, may be too technical for a lay jury and leave them
confused and unconvinced.

Summations

Once the testimony is complete and all nontestimonial evidence has been offered, each
attorney has the opportunity to argue on summation why his or her client should prevail.
The summations tend to be much more argumentative than the opening statements.
Demonstrative evidence, such as enlarged views of important records or diagrams, can
be particularly helpful to accentuate favorable points during summation.
I have listened to summations ranging in length from 15 minutes to 6 hours. The
length of the summation is often a function of the complexity of the case. However,
in the typical medical negligence case I have found that summations usually range
from 30 minutes to an hour and a half. In my opinion, it is very unlikely that the
attention of the jury will be held after about 90 minutes. Many attorneys attempt
not to speak much longer than this during their summations because they believe
that the jurors’ attention span will be exceeded.

Settlement Negotiations

A certain percentage of cases do involve professional negligence, and usually these


cases are settled prior to trial. Typically, the defense attorney will obtain expert review(s)
that provide the defense attorney with an opinion as to whether the treatment rendered
was proper. If multiple experts report that the treatment rendered was not proper, the
attorney will typically recommend that the case be settled. Expert opinions may still be
obtained that focus on weaknesses in the plaintiff’s case and help your defense attorney
attain a settlement which is as favorable as possible in the circumstances.
Typically after the weaknesses in the plaintiff’s case have been highlighted to the
plaintiff’s counsel, settlement negotiations will begin, using the weaknesses in the
plaintiff’s case as leverage to try to get the case settled at as reasonable a level as is
possible. Physicians should advise their attorney of any weaknesses in the plaintiff’s
case that can be emphasized in an effort to reduce the settlement value of the case.

Statute of Limitations

The statute of limitations is the time period within which a case must be filed or
else it is barred from being pursued. Physicians should discuss with their attorney
whether any claim brought against them might be time barred by this statute in the
jurisdiction in which the case is filed.
20 E.B. Giblin

The purpose of the statute of limitations is to require that cases be brought


within a time period when witnesses are still available, memories have not grown
dim, and evidence has not been lost. The goals of the statute are to achieve security
and stability in human affairs and to ensure that cases are not tried on the basis of
stale evidence.
Such statutes determine the time period during which a claim must be brought.
However, many state courts have concluded that because the statute of limitations
is intended to be equitable in nature, the time period set forth should not be applied
mechanically. These courts consider whether the plaintiff was unable to “discover”
the fact that there was medical malpractice and whether the plaintiff brought the
suit in a reasonably timely fashion after the plaintiff was able to “discover” that
there was malpractice. Also, the defendant may be required to demonstrate preju-
dice due to the delayed notice of the claim in order to have a case dismissed on the
basis of the statute of limitations.
The classic case for extending the time within which a claim may be brought based
on the so-called discovery rule involves situations in which a foreign body is left
within a patient at the time of surgery and the patient does not discover the presence
of the foreign body until after the time period set forth in the statute. In these “foreign
body” cases, the courts stress that the patient is ignorant of the foreign body during the
customary period of limitations. Accordingly, if the patient acts in a reasonably expe-
ditious fashion after discovery of the foreign body, the claim should not be barred.
In some jurisdictions, the discovery rule has been extended beyond “foreign
body” cases to other types of medical malpractice matters. In some jurisdictions,
defense attorneys joke that the courts have so attenuated the statute of limitations
by liberal application of the discovery rule that the original intent of the legislature
to have a statute of repose has been vitiated and there really is no such statute. For
example, in a case in New Jersey it was concluded that a cause of action did not
accrue until a patient was aware not only that he had been injured by a doctor but
also that he suffered the injury because of the doctor’s fault. Even though years
went by after the period set by the statute of limitations had passed while plaintiff
searched for an expert willing to support his preferred theory of liability, the case
was held not to be barred by the statute. The statute of limitations is also fre-
quently extended for infants as well as for patients who are deemed to be
incompetent.
For a physician involved in a medical malpractice case, the defense attorney
should handle all issues related to the statute of limitations, and hence it is not cru-
cial to know all the nuances of the law of your state. However, if an extended time
period has passed before you receive notice of a claim against you, it would be wise
to discuss with your attorney whether there is a basis to have the case dismissed
based on the statute of limitations.
Generally, we advise taking the deposition of the plaintiff before filing a motion
to dismiss based on the statute of limitations. In this way, the defense attorney can
question the plaintiff in a way that will establish whether there is a basis upon
which the plaintiff can claim application of the “discovery rule”. Once the motion
to dismiss based on the statute is brought, the plaintiff will have an opportunity to
Chapter 2. The Defense Attorney 21

think about reasons why he allegedly was unable to “discover” that there was a
basis to bring the claim. If questions relating to “discovery” of the claim are asked
at the deposition before any motion has been filed and thus at a time when the
plaintiff may not be prepared, the plaintiff may be locked into answers that prevent
the plaintiff from subsequently arguing that the time set forth in the statute should
be extended based on the “discovery rule.”

When to Hire Your Own Attorney

In a typical medical malpractice case, the insurance carrier will assign a defense
attorney to defend you. It is important that the physician confirm that the attorney
who has been assigned is someone who devotes a significant percentage of his or her
practice to defending medical malpractice cases. The defense of medical malpractice
cases is a highly specialized area, and insurance companies usually select attorneys
who specialize in this area. It is certainly reasonable for the physician to inquire about
the background of the assigned attorney to determine the attorney’s level of experi-
ence. Many insurance companies will respect a request for a particular attorney, at
least among attorneys a company has preapproved as malpractice specialists.
There may be occasions when a physician has to consider whether to hire his own
attorney, for example, when a theory for damages is raised by the plaintiff which is not
covered by the insurance policy. One such situation may be, if the plaintiff is claiming
that a physician did something intentionally wrong, as opposed to merely being
negligent. In these circumstances, a letter from the insurance company is usually
sent to notify the physician that he will not be covered for any awards for damages
arising out of theories premised upon intentional acts. In this case, the physician
should consider retaining his own counsel.
Another situation that will typically trigger a letter from an insurance company
suggesting that the physician consider retaining his own counsel occurs when the
plaintiff makes a demand in excess of the insurance coverage. The initial demands
made by the plaintiff are often unrealistically high, but a demand in excess of
the policy still triggers a duty on the part of the insurance company to notify the
defendant physician that the demand exceeds the coverage. The carrier will typi-
cally recommend that the insured physician consider retaining personal counsel to
protect himself regarding any amounts claimed in excess of the policy limits.
The physician should discuss any situation involving the potential for exposure not
covered by insurance with the defense attorney assigned to his cases as well as with personal
counsel. In many instances, the assigned defense attorney will be able to resolve the
issues raised by an unrealistic demand or a claim that there was an intentional action on
the physician’s part, by merely speaking with the plaintiff’s counsel and asking him to
drop such a claim if it is without merit, thereby helping the physician to avoid expending
a great amount of money dealing with personal counsel. Also, a discussion with the
assigned defense counsel and personal counsel may lead the physician to conclude
that the demand made by the plaintiff is extremely excessive and unrealistic in the
22 E.B. Giblin

circumstances and the likelihood of any verdict in excess of the insurance coverage is
so remote that there is no need on a cost/ benefit analysis for personal counsel to become
actively involved. In some instances, there may be very little that personal counsel can
add to the preparation of the case beyond what is already being done by the attorney
assigned by the insurance carrier. Accordingly, there is a cost/benefit analysis that the
physician must undertake to determine whether it would be beneficial to engage personal
counsel to become actively involved simply because a plaintiff makes an excessive and
unrealistic demand.
Likewise, a plaintiff’s claims of intentional actions by a physician may be frivo-
lous and the physician may be reassured by the assigned defense counsel and personal
counsel that these claims will almost certainly be dropped voluntarily by the plaintiff;
if they are not, a motion will be made to strike such claims. In this instance, once
again, a cost/benefit analysis must be undertaken to determine whether it is necessary
to expend significant amount of money on personal counsel to become actively
involved when it is extremely likely that the count will be dropped or stricken before
the case goes to trial. To a great extent, the decision as to how active personal counsel
should be is often a function of the level of confidence that the physician has in the
defense attorney assigned by the insurance company and the likelihood that any
counts that are not covered by insurance will be dismissed before trial.
Personal counsel is frequently needed when there is a conflict between the physi-
cian’s desire to settle a case and the insurance company’s desire to try the case. For
example, a physician may have $1 million in coverage in a case where the value of the
case, if tried and lost, is in the range of $5 to $10 million. A physician may determine
that he wishes to protect himself from personal exposure by having the case settled,
while the insurance company may feel that the case is medically defensible and there-
fore one that should be tried. In these circumstances, personal counsel’s involvement is
extremely important. Some states provide protection to the physician in the event that
the insurance company insists upon trying the case against the wishes of the insured
physician and a verdict in excess of the policy limits is obtained by the plaintiff. The
courts will look at the “good faith” of the insurance company in proceeding to trial in a
case where they knew that a verdict would likely be in excess of the insurance coverage
if the case was lost and the physician demanded that the case be settled prior to trial.
Personal counsel can provide guidance to the physician prior to trial if a situation
arises where the desire of the physician regarding settlement is in conflict with the
desire of the insurance company. Indeed, in any situation where there is a conflict
between the physician’s desire and the desire of the insurance company regarding
how the case is being handled, personal counsel should be consulted.

Physician–Patient Relationship: When Does it Start?


When Should it End?

Once a physician undertakes to treat a patient, the physician may not abandon the
patient. Generally, abandonment consists of a failure by the physician to continue
to treat when treatment is still needed in a situation in which the physician has
assumed responsibility and from which he has not been properly relieved.
Chapter 2. The Defense Attorney 23

In general, the courts are very liberal in establishing a physician–patient rela-


tionship. Accordingly, once a physician undertakes treatment of any nature, it is
important to know that the physician may risk a claim of abandonment if the physi-
cian does not provide the patient with reasonable notice that he or she is withdraw-
ing from the care of the patient so as to permit the patient to obtain care from
another physician.
Although a physician who has been employed to treat a patient is generally
under no duty to continue treatment forever, many courts have concluded that it
would be unfair to the patient for the physician to withdraw from treatment without
giving the patient a reasonable opportunity to obtain care elsewhere. When physi-
cians contact us regarding withdrawing as a treating doctor, we generally provide
them with the following procedure.
We recommend that physicians notify the patient in writing that they intend to
withdraw from providing further care. In the written statement (which should be
sent certified mail, return receipt requested), the physician should advise the patient
that he can no longer continue to provide treatment and expects that the patient will
therefore seek care elsewhere. The physician should indicate that while the patient
is in the process of seeking care elsewhere, if there is any emergent circumstance,
of course the physician will help the patient. However, the physician expects that
the patient will actively seek other care and will obtain other care in the near
future.
We also recommend that the physician include the names of other qualified
physicians in the same geographic area as the patient. The physician can further
remind the patient that he or she can consult with the local medical society, the
local hospital, or other reference sources in order to find someone of his or her
own choosing. We generally recommend that the physician include a statement
that it will be expected that the patient will be under the care of another physician
within a set period of time, often a month (although this can vary with the circum-
stances), and it will be presumed that after this time the patient has obtained alter-
nate care, barring some extraordinary circumstances that the patient should bring
to the physician’s attention.

Good Samaritan Laws

Good Samaritan laws have been enacted in an effort to encourage the rendering of
medical care to those who need it, but otherwise might not receive it, by persons
who come upon such victims by chance. If you have provided care to a patient vol-
untarily in a circumstance that you believe might put you in the position of a “good
Samaritan,” you should discuss with your defense attorney whether there is a good
Samaritan statute in your state that might immunize you from a lawsuit.
Unfortunately, the scope of good Samaritan statues is often not as broad as physicians
would like. For example, at least one court has determined that a good Samaritan act in
that jurisdiction cannot be invoked to immunize a hospital physician who assists a patient
at a hospital during a medical emergency. The theory of the court was that the physician
24 E.B. Giblin

rendered aid in a fully equipped and staffed hospital to a patient who had been admitted
for the purpose of receiving medical care, and therefore the good Samaritan act did not
apply to immunize the physician from the patient’s medical malpractice suit. The point,
however, is that if the circumstances in which you treated a patient who has brought a
suit against you were such that you think that there is even a possibility that a good
Samaritan act might apply, this issue should be raised with your defense attorney.

Damages

In the typical medical malpractice claim, the plaintiff will be seeking compensatory
damages for alleged acts of negligence. Compensatory damages are damages that are
designed to reimburse the plaintiff, to the extent money is able to do so, for injuries
that are proximately caused by the defendant physician’s negligence. Compensatory
damages can include pain and suffering, lost wages, medical expenses, emotional
distress, and other theories for damages that vary from state to state.
In some cases, there may be a claim made for punitive damages. Punitive damages
are damages that are intended to punish the wrongdoer in an effort to prevent the wrong-
doer from repeating the offending act. Punitive damages typically flow from actions that
were intentional, wanton, willful, or grossly negligent, not merely negligent.
When punitive damages are claimed, they typically will not be covered by the
insurance policy. As discussed earlier, this will typically trigger a letter from the
insurance carrier advising that it will not indemnify the physician for any award of
punitive damages, and hence the physician should consult personal counsel.
As an aside, there are many attorneys who hold themselves out as experts in “asset
protection.” These attorneys will work with the physician to situate his or her assets in
a manner that it will be more difficult for a plaintiff’s attorney to get to. Generally, this
asset protection plan must already be in effect before the claim is brought in order to
be effective. To our knowledge, these asset protection plans have not been completely
tested so their effectiveness is not entirely clear. In practice, many plaintiffs’ attorneys
usually accept the insurance coverage as payment in full for any claims and do not
typically go after personal assets of a physician. However, particularly when a physi-
cian is in a very high-risk specialty or jurisdiction, it may be worthwhile to meet with
an attorney who specializes in asset protection. Even if these programs are not l00%
effective, the more difficult it is for any plaintiff to get to personal assets, the better.

Joint and Several Liability

Joint and several liability simply means that when several defendants are found
liable, each is liable for the entire amount recovered. The plaintiff can select from
whom to try to collect. For example, if three physicians are found liable, the plain-
tiff could choose to collect the entire amount from one of the three physicians. The
Chapter 2. The Defense Attorney 25

theory is that it should be made easy for the innocent victim to collect from the
culpable parties, and hence the plaintiff can choose to collect the entire award from
any one of the three physicians found to be liable.
This principle of law has led to outcomes in which a party who was found to be only
one percent responsible was forced to pay for all or most of the damages. Some states
have modified these harsh rules by statute. It is recommended that physicians consult
with their defense attorney to determine what rules are applied in their jurisdiction.

Comparative Versus Contributory Negligence

In some cases, a plaintiff may bring suit against a physician claiming that the actions
of the physician were not reasonable in the circumstances. In reality, however, the
patient may have acted unreasonably and this is the reason for the patient’s injuries.
Contributory negligence means that the plaintiff did not act reasonably in the
circumstances for his own protection and safety. In some jurisdictions, contributory
negligence by the plaintiff may bar all recovery. However, other jurisdictions use
comparative negligence, which means that the fault of the physician and the fault
of the plaintiff will be apportioned. In other words, the negligence of the patient
will not be a complete bar to recovery, but the recovery will be reduced to the extent
that the plaintiff’s own actions contributed to the harm.
Your defense attorney should be fully familiar with the comparative negligence
or contributory negligence law in the jurisdiction in which your case arises. In the
event that there was any negligence on the part of the plaintiff, you should alert your
attorney in order to allow him to take any legal actions that are indicated.
One of the difficult decisions that defense attorneys often have to make is
whether to claim that a severely injured plaintiff is responsible for his own injuries.
For example, if a plaintiff is paralyzed from the neck down and his contribution to
these injuries is minor, your defense attorney may decide that the jury would be
alienated if it is actively argued that the patient contributed in a small way to the
ultimate injuries. Hence, a decision as to whether to argue comparative negligence
at trial is often a very difficult judgment. In some cases, a defense attorney may
decide to bring the negligence of the plaintiff to the attention of the jury as part of
the overall factual situation but not ask the court to charge the jury that the defense
is claiming comparative negligence by the plaintiff.

Note

“The material contained in this publication is for educational purposes only and is not
intended to serve as a substitute for the professional services an attorney would nor-
mally provide to a client, including up to the minute legal research. Accordingly, this
material should not be relied upon as legal advice for any individual legal action.
Chapter 3
The Plaintiff’s Attorney

Lee S. Goldsmith

Introduction

As is often the case, perception and reality, when associated with a given set of cir-
cumstances, have no common ground. This appears to be especially true when
applied to medical negligence litigation. The physician’s perception of the problem
differs from that of the attorney and most certainly differs from that of the
patient.
No patient enters into a physician–patient relationship with thoughts of future
litigation. There is a condition that is a problem or a perceived problem that war-
rants medical care and attention. The patient is seeking care from a professional in
whom he will place his trust, even if there has been no past relationship. The need
for care is present, and the trust is given. However, not all patients enter into the
relationship blindly, and some assert their right to question decisions, especially as
problems and levels of anxiety rise. The responses that the patient receives from the
physician often determine the ensuing events.
The patient and often family enter into the relationship with a level of anxiety
independent of the level of education, the nature of the problem, and prior informa-
tion that has been obtained or given. Notwithstanding the amount of research the
patient and family have done or the amount of information that they have received
from prior practitioners, the patient and family want answers and have questions. This
need for information will compete with the amount of time that the physician has
available or wants to give to the situation, and the resolution should be patient
dependent. A patient with a cataract to be removed might demand an hour of time to
obtain an explanation and then come back with additional questions. Another patient
with glaucoma might require 15 minutes for an explanation, although an hour has
been set aside. Indeed, the situation might be reversed. However, if the patient
demanding an hour is only given 15 minutes, the seeds of discontent may have been
sown. Each patient has to be treated individually, but consideration must be given to
individual differences and needs and they cannot be dismissed casually.
Studies have indicated that the degree of patient recall is limited after an informed
consent is given. Because of anxiety, the memory lapses are understandable and this
may well occur with members of the family, but certain facts remain. How long will

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 27


doi: 10.1007/978-0-387-73341-8; © Springer 2008
28 L.S. Goldsmith

the surgery take? The time may be 1 hour and this is the information given to the
family. However, the family is sitting outside the operating suite. When the 1 hour
passes and there is a second or a third with no information being given, anxiety rises
and questions will be asked and need to be answered. A “disappearing act” never
works. Sending an assistant, a nurse, or a resident is never satisfactory. The person
with whom they had the discussion has to show up and answer questions. If that does
not occur, another seed is planted and discontent rises.
Any physician who starts the day thinking about prospective patients bringing
suit should probably not be practicing medicine. This negativity and hostility will
be passed to the patient and create an environment that will encourage litigation.
A physician who overbooks, does not keep appointment times, and rushes patients
in and out of the office is potentially creating problems. The patients will forget
these problems if the outcome is successful but will remember every slight and
every inconsiderate action if there is a problem. Physicians should answer ques-
tions and be responsive even with the difficult patient and especially if there has
been a problem. Good medicine avoids litigation. Good communication averts
litigation.
As a result of the changes in medical practice over the past 15 years, less time is
being spent with the individual patient. Getting authorizations to provide care may be
difficult, and delays in treatment lead to patient frustrations. The patients or family
members cannot take out their grief with the insurance company so the physician will
become suspect. Care not being given because the physician will not be paid can be
perceived as care not being given because the physician is only interested in money.
In addition, as the patient reads about physicians in the press relating to Medicare or
Medicaid fraud and physicians read about malpractice lawsuits, the physician–patient
relationship may be affected. Physicians state that they would never respond at the
time of an accident because they may be sued, but they either forgot or do not know
that physicians are not sued when they are good Samaritans. We as lawyers know that
we will not win. Every time a physician does act as a good Samaritan, the good press
that is engendered helps every other physician in every situation.
A typical situation in which an attorney is called is when a combination of events
occurs, that is, an untoward event or a patient or family member becomes upset, and
these events are combined with an unresponsive or hostile physician. The physician
has the initial relationship with the patient and family and can usually control the
actions of the patient and family, but when physicians do not fulfill their obligations
it leaves a vacuum to be filled by the attorney to the attorney’s benefit. Fact patterns
seem to indicate that one of the physicians involved in a case either directly or indi-
rectly goads the patient or the family to seek legal advice. The attorney is no more
than the receptacle for the ill will and anger that has escaped the physician’s control.
When the patient is no longer in the hands of the physician and is in the hands of the
attorney, the attorney becomes the decision maker.
In the Veterans Administration hospital system and in some states there is now
the requirement that the physician tell the patient or the patient’s family if there has
been a medical error. It is always important to speak to the patient and/or family
after an incident. If the truth is not possible, tell them what you can but do not lie.
Chapter 3. The Plaintiff’s Attorney 29

Patients and their families are not stupid, and with the Internet available they can
check on the information they have been given. When a physician does not talk to
the patient or family, it is disastrous. When the patient and family are lied to it is
even worse and will ensure legal intervention.
An example, although unrelated to ophthalmology is as follows: a patient slipped
and fell at home and suffered a subdural hematoma. The treating physicians concerned
about potential seizures after surgery prescribed intravenous Dilantin. Intravenous
Dilantin comes in two forms: Dilantin dissolved in alcohol or in propylphenylhydan-
toin. The latter costs about six times the former but is absolutely safe intravenously.
The former is dangerous. If the mixture extravasates, there is the potential to lose a
limb. The patient lost her hand, and the family was told it was due to an allergic reac-
tion. Both of the patient’s daughters have their PhDs. The hospital and doctor now
have a major lawsuit exacerbated by their lying to the family coupled with the phar-
macy problems. This was a family who might well have never consulted an attorney
had they been told the truth in the first place. They truly do not believe in litigation.

Case Analysis

The experienced attorney is probably the potential defendant’s best friend. The attorney
is interested in two things and in the following order. First, the attorney is interested in
the nature and extent of the injury. The extent of the potential damages will determine
whether any consideration is given to potential liability. The handling of medical mal-
practice cases is extremely costly. Money has to be expended to obtain records, to have
experts review those records, and to hire court reporters for depositions, life care plan-
ners, and other potential damage witnesses. The basic case cost will run between
$20,000 and $100,000. Unless a potential case can ultimately achieve damages in
excess of at least $300,000, the patient’s claim will often not be considered.
Second, the attorney is interested in the issue of liability. How clear is the poten-
tial for liability? How difficult will it be to prove liability in the particular case? The
degree of difficulty in proving liability will be factored against the potential damages
when the firm decides whether or not to accept the case. The greater the damages,
the cloudier the potential liability can be, and, the smaller the potential damages, the
clearer the potential liability must appear to the reviewer and ultimately the jury.
Experienced lawyers know how to evaluate the damages in the individual case.
What is an eye worth? What are two eyes worth?

Client Intake—History and Damages

The initial client interview is done in two phases. The first intake will generally be
done by a paralegal. The purpose is to get the basic information in the shortest
period of time.
30 L.S. Goldsmith

Who is involved? Who are the potential defendants, and are there any potential con-
flicts of interest? If a name is raised that can create a conflict of interest, the conversa-
tion with the potential client will probably end. A conflict of interest is present if the
firm has represented the physician in the past or if the firm has worked with the physi-
cian as an expert in the past. An ancillary question is, who is the individual seeking
counsel? Is the potential defendant a world-renowned physician whom every juror will
know, or is he someone whom the potential jurors might not care to see as a patient?
What does the individual state is the problem? For example, “My husband
underwent cataract surgery in the doctor’s office and died on the table.” This
response will lead to follow-up questions.
What are the damages? The ultimate answer might vary with the state (jurisdic-
tion), but the follow-up questions will be the same. “How old was your husband?
Was he 40 or 80? Was he employed, or was he retired?” In most states, the 80-year-
old retired male would not create sufficient damages to warrant litigation regardless
of how clear the liability might ultimately be.
The information from the initial intake is then passed on to an attorney for a deci-
sion. The attorney will be looking at the record from two perspectives. Was there an
act of omission? Was there an act of commission? An act of omission is a failure to
act when action should be taken. Failure to order an eye examination for a premature
infant receiving oxygen in a neonatal intensive care unit or failing to order antibiot-
ics in the presence of an obvious infection would be acts of omission. An act of
commission would include ordering the wrong antibiotics for an infection or taking
a patient to the operating room when the procedure might be contraindicated.
If the information obtained in the initial intake warrants follow up, a formal
interview will take place. This will be conducted by an attorney with the purpose
of fleshing out the information gathered initially. This will also allow the attorney
to evaluate the client to determine the client’s ultimate ability to testify and the
impression he will make. It would be nice to say that ancillary factors do not influ-
ence case selection, but they must. What is the attitude toward malpractice cases in
a given county? The attorney might consider the fact that the case would be tried
in a rural and conservative county and the potential plaintiff is a drug using ex-
convict with tattoos over obvious portions of his body (e.g., “kill” on his knuckles
and a skull on his forearm). Proving a case for this individual would be extremely
difficult. The jurors would recoil from his presence only a few feet from them while
they are in the jury box. It would be a very courageous attorney who would take on
such a case in a conservative county. However, if the case involves a mother with
minor children and she is permanently injured, the damages would be evident and
she would be a very presentable witness.

Medical Records—Collection and Review

Based on the interviews and determinations, authorizations will have been obtained
from the client. With these authorizations, the relevant medical records will be
Chapter 3. The Plaintiff’s Attorney 31

obtained. These are the records that surround the incident of initial concern. The
initial materials will be used to focus in on the main events, and ultimately all of
the medical records will have to be obtained. For example, if eye surgery was per-
formed in a surgicenter or in a hospital, the records of the institution as well as the
records of the treating physician and all of the subsequent treating physicians are
obtained. The records of the subsequent physicians are important for the purposes
of evaluating the nature and extent of the damages suffered.
Once the records are obtained, they will be analyzed. This can be a relatively com-
plex process. A patient might be in the hospital for months, and the records may amount
to hundreds of pages. The largest record obtained in my firm was 4000 pages thick. No
matter how long the record, the issue of malpractice will amount to only a few pages
involving acts of commission. If a problem arose during surgery, attention would be
focused on the day of the surgery and all of the notes and forms prepared for that day.

Internal Analysis

The internal analysis will start with the numbering of the pages. This may be done
through the copier if the records are scanned. Numbering the records allows for a
thorough review and retrieval of specific pages at a later time. Concurrently the
medical literature will be reviewed and a decision made as to whether the attorney
believes there was negligence. If the answer is in the affirmative, the records will
be sent to a medical expert for further review.

External Analysis

The attempt is usually made to find an expert who has specific knowledge in the
area in question. Does the surgeon use a laser to treat patients? Is the potential
defendant a neuroophthalmologist? The attempt is made to find an expert with
knowledge of the specific area and who has had some experience in reviewing
cases and testifying so that he or she would be expected to be able to handle and
withstand cross-examination. Some practitioners, while very good in their profes-
sion, do not have the added skills needed to be an expert. The selection of the expert
is the second most important decision after the decision to accept the case.

Decision to Proceed

Once an expert has agreed to testify, the decision will be made to proceed with the
litigation. The complaint will be drafted and served on the physician(s). Defendants
have many complaints about the process. Why is it that so many individuals are
32 L.S. Goldsmith

named as defendants? The easiest case for the plaintiff’s attorney is bringing into
the case only one defendant. However, in a given set of circumstances, more than
one physician may have seen the patient, and from the records no one can deter-
mine who did what with the patient or what the potential communications were
among the defendants. Not knowing what will be said, or who may point the finger
at a colleague, it is often necessary to name all involved physicians. If physician A
is named and not physician B and the statute of limitations runs so that physician
B cannot be included in the litigation and thereafter physician A blames physician
B for the problems, then the plaintiff’s attorney could theoretically be liable for
legal malpractice. Early in my career, I was assisting an attorney in a case in which
an individual had a laminectomy and the vena cava was perforated from behind.
The team realized the problem, a general surgeon was called in, and the patient was
turned and opened. Despite the efforts of the general surgeon, the patient died on
the table. The original attorney, wanting to be just and basing his case on the opin-
ion of his expert, sued only the spine surgeon. The defense at the trial, through their
expert, indicated that there was an error but had the general surgeon, who was not
a defendant, done appropriate work the patient would not have died. The lawyer
had committed malpractice by not naming and including the general surgeon in the
lawsuit. At the time of the trial the statute of limitations had run so the general sur-
geon could not have been named a defendant. If the general surgeon had been sued
he would have obviously felt abused, but under the circumstances of the state laws
there would be no alternative. Therefore, the tendency among lawyers is to sue
everybody and let the defendants fight it out among themselves.
The second major gripe that physician’s have is the manner in which they are
served the summons and complaint. This often is the physician’s fault. The process
server wants only to serve the summons and move on to serve the next one, day in
and day out. Every summons served earns a fee. Therefore, the easier it is to serve
a summons, the less time the server will spend on any individual summons. If the
server enters a doctor’s office during office hours it is because a call has been made
and the process server knows that the doctor will be there and will theoretically be
able to accept the summons quietly and professionally. However, if the physician
is unwilling to come out of his office or tries to avoid the process server, the process
server will use whatever means necessary to accomplish the task. Our process serv-
ers are always instructed to speak to the receptionist and quietly ask to speak to the
physician after explaining why he or she is there. However, if the physician does
not come out after a reasonable period of time or tries to sneak out the back door,
the server is allowed to use his or her own judgment.

Interrogatories

In most states, prepared sets of interrogatories will be served on both the plaintiff
and defendant. Interrogatories are a series of questions that are prepared to give the
opposing side some insight as to facts of the case. The interrogatories will often
Chapter 3. The Plaintiff’s Attorney 33

request additional information, and copies of the physician’s curriculum vitae will
be attached as well as an additional copy of the records.
There is a tendency to review the materials requested prior to turning them over to the
attorney for attachment. During this review there can be a tendency to make a curriculum
vitae look better or to “amend” the records. Resist all temptations, and never ever “amend”
the records. As a physician, you make notes in patient records, and this may be your total
physical involvement with those records. You may be unaware that an insurance com-
pany has previously requested a copy of the records. In one case we obtained the copy of
the records obtained by the insurance company and they were different from the original
records. In another case, a subsequent treating physician requested the records, and we
obtained a complete copy of that physician’s records as well as the records of the first
physician. When compared with the originals, they were different. In a third case, the
patient obtained a copy of the records; when this occurs, we always re-request the records
and then compare. Sometimes physicians’ egos make them believe that they are brighter
and know more than anyone else, and, no matter how often they are told not to change,
alter, or amend records, they cannot control the impulse to exhibit superiority and proceed
to amend the records with disastrous results for them and great results for us.
Another approach to the medical records comes with obtaining all the medical
records as well as the billing records. The medical records are looked at carefully,
and the billing records will be compared with the visits, pharmacy records will be
compared with prescriptions, and when necessary the original records and their
inks will be analyzed. The next best thing to finding changed records is to find
charges to Medicare that are unrelated to treatment rendered. Getting an assist from
either the state or federal government with insurance fraud is always advantageous.
Although it may not have anything to do with quality of care, it does have a great
deal to do with honesty and telling the truth.
Similar statements can be made regarding the curriculum vitae. The curriculum vitae
might be brought up to date, but the document should not be embellished. As attorneys,
while we might not have access to the National Practitioner Data Bank, there are alter-
nate ways to get information. We can access the websites of the state boards of medical
examiners and of the National Board of Medical Examiners. Two other easy sources of
information are the physician’s own website and the website associated with the hospi-
tal where the physician has privileges. As a routine practice during the first visit by the
client to our office, we access and copy information from the client’s the website to
obtain a snapshot of the physician at a given point in time. A quick search will be made
to determine whether the physician has written any articles that are not included in the
curriculum vitae. Finally, we Google the physician’s name.
Prior to the depositions, the attorney has two goals. The first is to learn as much
about the client as possible from as many sources as possible. In one case the defend-
ant had written and submitted an article on the events involved in the case. The case
was of interest, and the problems were worthy of publication. However, the article
treated the situation in a manner that was directly opposite to the defendant’s subse-
quent medical testimony. In another case, the defendant basically set the standards in
an article written on the subject matter of the lawsuit. Second and probably more
important for the attorney is learning the medicine of the case as well as the defendant
34 L.S. Goldsmith

physician. The intelligent attorney will always be working with an expert. The attor-
ney will start by reading the literature and relevant text materials. Then the attorney
will sit down with the expert and spend the time reviewing the areas of negligence
and discussing approaches to the deposition. By the time the deposition is taken, the
attorney should be able to foresee every step in the procedure and be fully conversant
with all of the records necessary for the deposition as well as the relevant literature.

Depositions

Many attorneys believe that the deposition is the most crucial part of the case and requires
maximum preparation. Attorneys may join their experts in reviewing surgeries or video-
tapes of the type of surgery performed, reading the relevant literature, and discussing the
case at length with the expert who has agreed to testify on behalf of the plaintiff.
The deposition questions will often be outlined in advance. How the deposition
will be taken and the areas to be covered will vary depending on the rules of the
particular jurisdiction and on the purpose for which the deposition is being taken.
Ultimately, the process will be up to the individual attorney taking the deposition
and on that individual’s techniques. I like to start a deposition with a question that
I do not think will be anticipated for the purpose of getting the overly prepared
witness flustered and more open to follow-up questions.
A rule that some attorneys follow is to ask every question they can think of and
then additional questions. The problem with this technique is that questions that
should be asked will often be omitted. Questions that should be asked include the
following circumstances:
● All conversations between the witness and all other relevant witnesses
● Pertinent portions or questions in the curriculum vitae (including questions
about failing the boards, retaking the boards, or articles written)
● The interpretation of laboratory tests and their relationship to the particular problem
● Areas of medicine not only directly pertinent to the theories of liability but also
potentially relevant to any defense that might be raised
In our office, we will generally videotape the deposition so that the deposition can
be reviewed and analyzed in the office after it has been completed. In addition,
being on camera is something most individuals have not experienced and will often
cause nervousness and agitation. This tape will be used for trial.

Trial Preparation

Trial preparation will vary depending on the jurisdiction and on the relative rules in
that jurisdiction. There is only minimal cross-state uniformity. In the state of New
York, the attorneys do not exchange expert reports or even the names of the experts
Chapter 3. The Plaintiff’s Attorney 35

being used. What is supplied is a general outline of the credentials of the expert, which
is generally sufficient to identify the individual. In Pennsylvania, expert reports have
to be exchanged and have to be detailed so that each side will have a clear picture of
what their opponent will say and the context in which it will be said. In New Jersey,
not only are expert reports exchanged but also each side will have the opportunity to
take the deposition or oral testimony, under oath of the opposing expert; therefore,
prior to encountering the witness on the stand, attorneys can test the opinions of the
expert. Depending on the state, or jurisdiction, the nature and degree of pretrial discov-
ery will affect trial preparation. As a plaintiff’s attorney, I always assume that every
case that I take will have to be tried, and I prepare each case from that point of view.
As the date of the trial is set and approaches and there is no settlement, final trial
preparations will begin. The following steps are likely to be included in the trial
preparation.
Models will be obtained and reviewed. We have models of many anatomic parts
in the office. These represent the normal and will always be accepted by the court
as part of the evidence. These are to be reviewed with the expert who will use them
as part of the testimony prepared for the direct examination. They also help the
expert to explain the anatomy as a basis for discussion of the errors that occurred.
Charts will be prepared. These anatomic charts do not depict the normal, and
they are prepared by a medical illustrator. The purpose of these charts is to show
the abnormality that was present and the errors that occurred. They are used by the
medical expert on direct testimony. However, when preparing these charts we
know that they can be used by the defendant’s attorney not only in cross-examining
our expert but also with his expert on direct examination. Therefore the illustrations
must be carefully prepared so that when used by the defense they do not become
damaging. Some years ago we were involved in a nonmalpractice case involving a
young child who received trauma to his eye. The position of the plaintiff was that
the blindness in the eye was caused by the trauma. The position of the defense was
that the blindness in the eye was a result of Coats’ disease. The plaintiff had
kodachromes taken of the retina and showed these to the jury. The defense’s expert
brought to the jury colored photos in a text to demonstrate that it was not trauma
but Coats’ disease that caused the blindness. During summation the plaintiff’s attor-
ney showed the kodachrome slides and held up the book next to the slides. The jury
was asked to compare the two. The two pictures did not look alike. The boy had
been traumatized, and the jury found for the plaintiff.
Some documents will be enlarged. There are usually portions of the records, be
they hospital records, office records, or insurance records, that become important.
The intention is to use these enlargements during the entire trial. They could be
used by the experts. In one case that did not come to trial, the enlargement, which
was a note in a hospital record written by a resident, was used by the plaintiff at a
settlement conference. The patient had undergone a cataract operation that had
gone badly. A week later when seen in the clinic the resident wrote: “This patient
one week post butcherotomy.…” Obviously, it was an inappropriate note but
caused the case to be resolved. This page would have been blown up and placed
before the jury at every opportunity.
36 L.S. Goldsmith

The expert designated by the defendant will be investigated. The name of the
individual would be sent out on various professional Internet list serves and prior
reports, depositions, and trial transcripts would be obtained. There will be a litera-
ture search to determine what the defense expert has written and whether any of the
prior testimony, prior reports, or literature conflict with the testimony expected to
be given at the trial. These materials would be prepared for cross-examination dur-
ing the trial.
Depending on the case, we often subject the case to a pretrial mock trial. This is
done by hiring a consultant, preparing the case as it would be presented during the
actual trial, and then presenting the case to a “jury.” We tend to obtain the potential
“jurors” from the county in which the case is to be tried. Questionnaires are given
to the jurors before they hear the testimony. The entire case presentation is video-
taped for review, as are the jurors’ deliberations. At the end of the case presentation
and prior to deliberation, the jurors are presented with an additional questionnaire.
We are looking for juror biases, weaknesses in the case, how the jurors react to
particular witnesses, and how the presentation of the case should be changed. The
changes are made in order to maximize the potential likelihood of obtaining a
plaintiff’s verdict and a potential verdict that will be sizeable.
After the mock trial is completed, final preparations begin. The opening to the
jury will be revised, and the witnesses will be prepared for their direct examination.
Potential cross examinations of witnesses will also be prepared.
If appropriate, special questions will be briefed for discussion with the judge
prior to jury selection. For example, suppose it is known that the plaintiff had con-
tracted a venereal disease and that fact is in one of the hospital records. A motion
may be made to have that fact excluded from mention at the time of trial as being
irrelevant to the facts and the issues in the case. The only reason it might be men-
tioned is to do damage to the plaintiff’s reputation.
After the trial presentation, a jury consultant may be hired. The consultant, who
specializes in jury selection, will work with trial counsel at the time the jury is
selected to sift juror information, assist in the determination of the type of questions
to be asked during jury selection, and advise counsel on which jurors should be
selected or rejected from the jury.

Conclusion

● For a plaintiff’s attorney to be successful in handling a medical malpractice case,


the first step, the evaluation and decision to accept a potential case, is the most
crucial.
● Every potential juror is going to be a patient at some time in the future. Jurors
like physicians and need physicians for their own care. We rely on the arrogance
of the defendant physicians not only in assisting us in obtaining clients but also
in helping us prove the case once the case is initiated.
Chapter 4
The Trial Judge

David S. Cramp

The U.S. Supreme Court has said in Daubert v. Merrill Dow Pharmaceuticals, 509
U.S. 579 (1993), that trial judges have a gatekeeper role to play in determining the
qualification of expert witnesses and whether the opinions of the experts are suffi-
cient to send to a jury. Thus, in virtually every case in which a proximate cause
between the event and damage to the plaintiff is alleged, a hearing would be
required before the trial judge to determine three things:
1. Whether expert testimony is required
2. The qualifications of the expert
3. Whether the opinion is scientifically reliable
It is the third question that is most vexing to trial judges. There are three means by
which the proponent of expert testimony of scientific results can prove the reliabil-
ity of the testimony:
1. The testimony of knowledgeable experts
2. Authoritative scientific literature
3. Pervasive judicial decisions that acknowledge such general acceptance of expert
testimony
The third circumstance almost never occurs in our jurisprudence, nor is there any
requirement that an expert witness’s theory has achieved general acceptance within
the scientific community. Rather, the test is whether the opinion is based on scien-
tific principles and methodologies of the type reasonably relied on by experts in the
scientific field.
In most jurisdictions, the rule in most cases is that if a substantial minority of the
applicable scientific community accepts a particular theory, it is admissible in evi-
dence. To illustrate how far this theory may lead, the New Jersey Supreme Court
recently held that the differential diagnosis methodology was reliable, and testi-
mony about the methodology would be received by a jury.
In reviewing the gatekeeper role as set forth in Daubert, lawyers will have to be
particularly sensitive to the varying interpretation by the state’s Supreme Courts.
For example, in New Jersey, Rule 702 governs the admissibility of expert testi-
mony, and New Jersey has not yet fully adopted the decision in Daubert. These
technicalities aside, the test (or standard) of Frye v. United States, 293 F. 1013

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 37


doi: 10.1007/978-0-387-73341-8; © Springer 2008
38 D.S. Cramp

(D.C. Cir. 1923) is almost unanimously accepted as the three-part standard in dem-
onstrating reliability. These three methods have survived since 1923. General
acceptance in the scientific community is not an end in itself. It is reliability that
must be ensured. Consequently, unanimous belief or universal acceptance is not
required, because there can always be some detractors to any scientific theory.
The function of a trial judge is complicated in a field such as ophthalmology
because it is complex, permitting a number of treatment modalities (often implicat-
ing surgery) that are all generally supportable. It is the task of the trial judge to
determine whether an opinion of an expert commands sufficient respect in the field
of ophthalmology that it should go to a jury with all of the other relevant evidence.
It is particularly vexing for trial judges because, generally, they do not understand
enough about ophthalmology to recognize that an opinion by an expert does not
attract sufficient respect among practitioners. How would it be expected that a trial
judge would have familiarity with the technical details of a field as wide-ranging
as ophthalmology? How would a judge know about anterior segment surgery, cata-
ract surgery, corneas, glaucoma, neuroophthalmology, ocular oncology, oculoplas-
tics, refractive surgery, retina and vitreous, immunology, or even the basics of these
so-called subspecialties? In each, there are technical requirements that would over-
whelm the most avid student of scientific requirements—an attribute that most trial
judges do not possess. Consequently, a hearing on the issues is of crucial impor-
tance. It is essential that a trial judge be supplied with enough information to make
an informed judgment. To argue that an opinion by an expert requires no less than
inclusion in a peer-reviewed medical journal may not carry the day if the peer-
reviewed material is weak or not on point or if the literature (any literature) con-
tains an opinion that is strong enough but has not yet appeared in a peer-reviewed
journal. The trial judge’s view is always subject to the prospect that an appellate
court may disagree that the trial judge’s findings of fact are sufficient. The gate-
keeper role is not one to which trial judges are accustomed. Junk science is a diffi-
cult concept that presents enormous problems for the trial judge trying to make a
determination that is fair for everyone. Most judges simply do not know enough
about the subject matter to make a reasonable determination.
In a further example, in State v. Cavallo, 88 N.J. 508 (1982), the New Jersey
Supreme Court stated, “The Frye test recognizes that most judges are experts in
few, if any, fields of scientific endeavor … [and that] judges are not well-suited to
determine the inherent reliability of expert evidence …” (Id. at 521). However, the
Court said that judges “can decide whether the proffered evidence has gained gen-
eral acceptance” in the scientific community (Ibid). Yet, the stakes are high. Trial
judges instinctively know that scientific evidence may be viewed as conclusive by
jurors. In United States v. Addison, 498 F.2d 741 (D.C. Cir 1994), the Court (after
applying the Frye test) said: “Since scientific proof may in some instances assume
a posture of mystic infallibility in the eyes of a jury of laymen, the ability to
produce rebuttal experts, equally conversant with the mechanics and methods of a
particular technique, may prove to be essential” (Id. at 744).
Because ophthalmologists perform operations on eyes and are generally classi-
fied as surgeons, it becomes more than essential at a hearing on the subject of
Chapter 4. The Trial Judge 39

expert qualifications and proximate cause that all relevant information be brought
forward to assist the trial judge in performing the “gatekeeper” function. The func-
tion is there. Use the opportunity.
What may seem odd for a judge to say, and may seem idiosyncratic, is that, in
my experience, jurors simply do not like expert witnesses. Jurors recognize that
expert witnesses are paid, and jurors look hard at other areas, such as appearances,
evidence of prevarication, and other incidents to make determinations. To some
extent, jurors decide cases on facts that cannot be anticipated and on factors that
cannot be foretold. Often, a show of arrogance by the defendant will be enough. I
was once involved in a case in which the defendant appeared to display some arro-
gance about his being a defendant in the case. My Court Clerk hated him; the jury,
as it turned out, hated him. My staff hated him. I would not have agreed. Yet, the
jury decided the case against him. In one case, jurors waited and waited for the
defense expert to testify. He arrived very late, and the defense attorney asked why
he was late. He said, “I have to make a living.” The jury did not listen to a word he
said and decided the case against the defendant. I am convinced that the jury held
the expert’s remark against the defendant.
I have tried many medical malpractice cases and am convinced that if a physi-
cian does his best to treat a patient properly, using his best skill and training, that
doctor will prevail. It does take an enormous effort in court to be polite, to not
betray any impatience, and to act vitally interested throughout the trial, but it is well
worth it. I liked it when a physician defendant (openly) helped his attorney. The
best cases I was involved in from the point of view of the defendant were those in
which the defendant was respectful, helpful, and then explained in detail the theo-
ries and methodologies that he or she utilized in treating the defendant. In most
states, the charge to the jury is very favorable to the defendant and can easily carry
the day. However, there cannot be any slip ups such as a lackadaisically prepared
defense. The most effective defense is when a physician can take the stand, effec-
tively educate a jury, and steer the jury to the physician’s point of view. This, in my
opinion, is worth all the expert witnesses who can be called.
Here is one last thought. In a hospital setting, there is a tendency to let the resi-
dent complete the discharge summary. Often, the resident’s knowledge is incom-
plete. Why any physician would ever allow a resident to complete the discharge
summary is incomprehensible to me. I guess that the practice has grown popular
because of time constraints. However, beware, because a jury may believe that a
physician who does not have time to do his own discharge summary does not
deserve much time of the jury.
Remember, when you get six people together as a jury, they become the most
difficult people. They are impatient, cranky, and believe that their time is to be
protected at all costs. They are often wrong, but they are the system. Learning to
play the system is crucial. An intelligent defendant, actively involved in his or her
case, is of the utmost importance.
Chapter 5
The Medical Expert

Edward L. Raab

Introduction

“Doctor, I need an expert witness. Will you help?”


Note that this is a request, not a command, unlike a subpoena for jury duty. If
you react with instant aversion, then say “no.” However, a positive response prob-
ably will lead to an interesting professional experience.
Most physicians are unfamiliar with legal procedure. We are accustomed to
being “in charge” in our usual environment, but the legal arena is unknown terri-
tory. This chapter, based on my own participation, presents an overview of the
role of the medical expert and how it is fulfilled, particularly in malpractice
litigation.

Why Are Experts Needed?

The medical malpractice plaintiff must prove that the defendant physician’s acts or
failures to act did not follow the applicable standard of care and that these were the
direct and substantial cause of whatever harm the plaintiff has suffered. The jury
(occasionally the judge) is responsible for determining whether this has occurred.
Some conclusions can come from one’s own education and life experience. However,
nonphysician jurors cannot call upon their own backgrounds to resolve questions
involving medical care standards. An expert is required to inform and educate the jury
through special knowledge and experience about the unfamiliar subject matter of the
dispute. The unique feature of expert testimony is that it consists of opinions on mat-
ters in the case and that the jury will employ these opinions prominently in its
findings.

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 41


doi: 10.1007/978-0-387-73341-8; © Springer 2008
42 E.L. Raab

Who May Be a Medical Expert?

The judge is the gatekeeper who determines whether the proffered expert is legally
competent to serve as such after hearing the physician’s responses to questions
about his or her education, residency, and possible fellowship training. In actual
practice, the requirements usually are easily met by the holding of the pertinent
professional licenses and specialty board or equivalent certification.
A distinction should be made between competence to provide expert opinions and
the weight that the jury will give to such testimony. Relevant experience in the field
and publications are persuasive indicators of expertise. The court may not require
practice in the ophthalmic subspecialty involved in the dispute, but a request to serve
as an expert in an unfamiliar field is an invitation to courtroom disaster for both the
expert and the case. I have seen this occur when a general ophthalmologist testifying
on behalf of a plaintiff claimed it was malpractice not to have made strabismus meas-
urements in nine positions, ignoring every other detail of a thorough analysis that led
to an intelligent decision on treatment. The defense expert made short work of this
textbook argument, which constituted the plaintiff’s entire case. In this instance, “will
you help?” would have been better interpreted as “should I help?”

Basis for Expert Opinion

The special qualifications (education, training, and experience) of the medical expert
allow the expression of opinion, but the court will allow the jury to consider only opin-
ions that are appropriately reached. Reliability of expert testimony depends on whether
it is based on the kind of information a member of that discipline would ordinarily use
to form a professional judgment and whether the foundation for that information is
generally accepted within that professional discipline. Perhaps unduly, courts regard
peer-reviewed publication as a prominent hallmark of validity. In any event, “junk
science” derived from unproven, unaccepted methodology is disfavored, and you can
be certain that the opposing attorney will explore this question of your sources.

The Process

In deciding to serve, the physician undertakes certain obligations to the engaging


attorney, who is fulfilling his or her own legal and ethical professional responsibili-
ties of vigorous advocacy for the client. Doctors typically disparage attorneys for
not comporting themselves “above the fray,” but this is an unfortunate misunder-
standing of the lawyer’s role. If a potential expert will not actively assist the attor-
ney in advocating for the client irrespective of whether plaintiff or defendant,
including testifying if necessary, the assignment should be declined.
Chapter 5. The Medical Expert 43

The expert will be asked to review the case file, typically consisting of the plead-
ings (why and for what relief the plaintiff is suing and the answer to these allegations
by the defendant), medical and hospital records, various documents from which each
party learns the merits of the other’s case (“discovery”), depositions (examinations
before trial of the parties and often of other individuals with personal knowledge of
the circumstances), reports of the opponent’s experts and perhaps their depositions,
and reports of economic experts on the extent of the plaintiff’s financial harm. Often
some photocopies are illegible, and replacements should be requested.
To protect the credibility of his testimony, the expert should require inspection of all
available medical documents in the case. I have personally observed the extreme embar-
rassment of a witness whose opinion was given with no knowledge of convincing con-
trary information in a portion of the medical record with which he was never supplied.
I find it helpful to do an initial general reading in order to learn what each side
says about the case. This should be followed by a more detailed line-by-line analy-
sis, particularly of the medical and associated records, which can consume much
time. The first goal should be to address the most important issues. The expert’s
analysis may cast matters in a different order of priority than that of the attorney,
whose strategy will depend on knowledge of the medical facts and on how to have
them presented in the most favorable light possible.
The objectives are to point out the strengths as well as the weaknesses of the
case and to identify any good argument for the other side. The attorney benefits
most from being able to see, through the expert’s assistance, the case from both
opposing perspectives. As part of a thorough attempt to assist, the expert should
offer to read the day-by-day transcript of the trial, if one later takes place, to point
out additional opportunities or problems.
When the medical review indicates an unwinnable case, should the expert rec-
ommend settlement? My practice is to avoid direct suggestions on legal strategy.
The advice can be conveyed indirectly by offering an estimate of the likelihood of
prevailing based on the medical assessment. One way or another, the expert should
deliver the message despite the probability of the loss of a witness fee.
The element of surprise is not a part of litigation, which explains the discovery
process and the requirement for exchange of information between the opposing par-
ties. However, for valid strategic reasons, such as a decision that expert testimony
on one or more issues will not be introduced or that a different expertise is required,
a formal written report should not be prepared unless requested. If made, it should
include a listing of every document reviewed, and it is proper to include a statement
reserving the right to amend the opinion on the basis of later-received information.

Testifying

Juries are inevitably influenced in one direction or another by a comparison, the


so-called battle of the experts. For this reason, an attorney chooses an expert not only
on the basis of the required qualifications but also for whether the expert will project
44 E.L. Raab

an impression of knowledge and confidence. These latter qualities are assessed by


the opposing lawyer as well in evaluating the expert’s effect on his client’s case.
Trial procedure calls for the expert’s willingness to be flexible about dates and
times for appearing. Delays because of revision of the trial schedule, juror prob-
lems, the intervention of other court business preempting the judge’s time, unex-
pectedly prolonged testimony of other witnesses, and other factors should be
expected and accommodated, as these are generally outside of the attorney’s con-
trol. The compensation agreement should reflect a reasonable figure for time spent
that includes such delays.
The expert should appear punctually for the deposition or trial and treat the
adversaries courteously at all times. Dress should be conservative. Depositions
are most often conducted in a setting other than a courtroom, typically in the
office of the attorney for one of the parties. This does not diminish the formal
nature of the exercise. At depositions while temporarily off the record, confine
conversation to “small talk.” During the trial, be extremely careful to avoid even
informal interaction with the jurors or the attorneys for other parties, even extending
to the courthouse elevators.
Courtrooms generally are arranged so that the witness stand is just to one side
of the judge’s bench, facing the “well,” which is where the parties’ attorneys have
their tables. The jury box typically is along the side wall nearest the witness stand.
Although attorneys ask the questions, testimony should be directed at the jury, in
keeping with the expert’s role of educator and informer. Directly facing the jurors
irrespective of the location of the questioning lawyer accomplishes this objective.
Be prepared also for questions from the judge, who has the discretion to assist in
clarifying the jury’s understanding of the issues. If your testimony involves a dem-
onstration requiring you to step off the stand, ask the judge’s permission to do so.
Answer only the questions asked; additional information can be inadvertently
damaging. When you do not know an answer, this should be stated, but when appli-
cable, point out that you do not know because nobody does. Pause before replying
to the opponent’s question; this gives an opportunity for objection by the attorney
engaging you if the question is improper.
There should be no discussion of the case with uninvolved persons, colleagues
who also may actually become witnesses themselves, and above all with the party
for whom the expert is testifying. This last is because of the importance of avoiding
even the appearance of collusion. The expert must be able to state under oath that
no such collaboration has occurred. This does not preclude casual greeting or tem-
porary intermingling provided that no substantive discussion of the case occurs.

“Minefields” for the Expert

The appropriate goal of the opposing attorney during cross-examination is to dis-


credit the testimony of the expert. Do not be intimidated by the questioner’s possi-
bly brusque manner. Remember that it is not personal; on occasion my services
Chapter 5. The Medical Expert 45

have been solicited by a lawyer by whom I have been vigorously cross-examined


in a prior lawsuit.
One attempt at discrediting is to have the expert admit to no personal publica-
tions on the subject of the case. I counter this by indicating the extent of my hands-
on clinical care experience and any unpublished lectures and pointing out that other
subject areas in my field have taken priority for my literary efforts and have resulted
in numerous publications.
An additional point of attack is to ask how often the expert has testified in medical
malpractice cases and whether it is always for the same side. The opposing attorney
hopes to convince the jury that you are a “hired gun” and a biased one at that. Your
answer must be truthful; to the extent that it presents a credibility problem, this was
or should have been evaluated by the attorney who requested your participation.
It is common to inquire about on what literature sources the expert relied. The
opposing attorney hopes to raise the inference that the expert has been less than dili-
gent and not up to date on the necessary information. An effective reply, if truthful,
is that the expert did read not in order to form an opinion but to test the reasonableness
of that opinion against those of knowledgeable colleagues concerning similar facts.
Another minefield is whether a certain published work (usually professing an
opinion other than the expert’s own) is considered an authority. This depends entirely
on the definition of “authority.” If the witness believes that any opinion from that
source ought to be followed without question or hesitation, the point must be con-
ceded, but it is far more likely that an expert chosen for his or her qualifications can
reply that while the opinions detailed in the suggested authority are worth consider-
ing, they do not necessarily apply to this particular case and in any event must be fil-
tered through and reconciled with the expert’s own knowledge and experience.
You might be asked whether your testimony is based on personal examination
of the patient. This actually is irrelevant, because, as noted earlier, experts may rely
in forming their opinion on the kinds of information customarily relied on by simi-
larly situated practitioners of the discipline. The medical and associated records
clearly fall under that criterion. Your best reply is a simple “no”; if necessary, the
attorney who engaged you is probably able to elicit the same response from the
opposing expert.
An issue whose importance is usually overemphasized is whether and how much
the expert is to be compensated for testifying. The correct characterization is that
compensation is for time lost from income-producing activities, not for the testimony
itself. This explanation will be entirely truthful if the hourly rate charged is reasona-
bly related to that of the expert’s usual charges for medically related efforts.

More Advice

Do not underestimate the abilities of the attorneys on both sides of the case, many
of whom have specialized in this area of the law for a long period. Their lawyering
skills and preparation for trial are likely to be considerable, and they are functioning
46 E.L. Raab

in their own arena, to which the physician is essentially a stranger. Most important,
the physician expert should understand that while the attorneys may seek to intimidate
as part of trial strategy (risky in many instances), they are merely adversaries, not
enemies.
Learn the outcome of the case, and take the opportunity to hear the jury’s evalu-
ation of your testimony, as may have been revealed in the customary postverdict
interview. This and the attorney’s own evaluation of your efforts are very instruc-
tive for the further development of your interest and effectiveness.
Chapter 6
Sequence of Events in a Medical
Malpractice Lawsuit

Marvin F. Kraushar

Why Patients Sue

We tend to overlook the fact that patients do not come to a medical office with the
prior intent to sue. They come hoping to be cured. Something occurs during the
course of the physician–patient relationship to cause the patient to seek an attorney
to “find out why.” This is very often due to the unavailability of the physician to
answer questions about a problem. It can also be the occurrence of an unexpected
event (anything other than a perfect result). The problem is frequently the “lawsuit-
causing physician” and not necessarily the “litigious patient.”
The best means of risk prevention in these situations is for the physician and all
members of the staff to demonstrate caring and compassion at all times. Patients tend
to forgive a suboptimal result if they feel they were treated with understanding. While
patients may not have the knowledge to judge their level of medical care, everyone
knows when they are treated with respect. Patients who experience repeated rudeness
in their encounters with the physician and/or staff will want retribution:
Whenever one person treats another person shabbily, the human tendency is for the injured
party to want redress for that shabby treatment. Patients are often moved by vengeance to
sue their physician and they do not do such a thing hastily. It is not one mistake that angers
patients but rather repeated insults that grate upon the patient until a mistake occurs that
breaks the camel’s back. The frustrated patient needs only for damage to occur to complete
the foundation for a lawsuit. It is not necessarily the money that patients who have been
mistreated want. Suing is the only means to vengeance that is available to the patient.1

Most plaintiff attorneys agree that their angriest clients are patients suing for medi-
cal malpractice.

Prelawsuit Activities

The physician is not part of a lawsuit until he or she is served with a summons. Prior
to that moment many other actions will have been taken, and knowledge of these
activities may alert the physician to the possibility of pending litigation. The patient

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 47


doi: 10.1007/978-0-387-73341-8; © Springer 2008
48 M.F. Kraushar

has, for whatever reason, become dissatisfied with the level of care and/or compassion
he or she has received and is no longer keeping appointments at the physician’s
office. Thus the physician–patient relationship has been terminated, and the patient
has spoken with someone, such as a family member, friend, or another physician,
following which a decision was made to consult an attorney. The attorney has
assessed the facts provided by the patient and decided there may be a worthwhile
financial opportunity in a lawsuit (without which practically no case will be accepted).
Larger law firms are typically more stringent in their financial assessment of potential
suits and often turn over weaker and/or less lucrative claims to smaller firms or solo
practitioners. Next, the attorney who accepts the case, with the written permission of
the patient, has requested from your office a copy of the patient’s medical record. You
may also have been advised by the medical records department of the institution at
which you performed surgery that a copy of the records has been requested. By now
the plaintiff’s case has evolved over a considerable period of time.
At such time as the physician becomes aware of any of these developments it is
imperative that the medical malpractice insurance company is contacted and
brought up to date in order that it may begin its process so the plaintiff will not get
even further ahead. The insurance company will not add this incident to the total of
claims against the physician if no claim is filed.
The medical records are the property of the physician. You must comply with
the request for a copy of the patient’s record provided the request was accompanied
by a release signed by the patient. Be certain not to send the original of the chart or
any other information until you have contacted the insurance company. Avoid any
temptation to alter the record, because the consequences of such an action can be
devastating to the defense as is discussed in detail in another chapter. By no means
should you hide or throw away the file in anticipation of claiming it was lost. A lost
file is not only a sign of sloppy office management, it suggests intent to conceal
unfavorable facts. Most requests for records are for matters other than a malpractice
lawsuit (relocation to another part of the country, a second opinion, accident, insur-
ance, claims for disability, etc.) Do not contact the patient or the patient’s attorney
to inquire as to the reason for the request for records.
Beware of a request for medical records by means of a “subpoena duces tecum.”
This can be used by an agency investigating a physician (State Board of Medical
Examiners, hospital credentials committee, etc.) or by an attorney for a patient who
has a problem with someone other than the physician from whom the records are
requested. The subpoena has an official appearance, which can be intimidating to
physicians. The format of the document creates the assumption it is an order of the
court, no release from the patient thus being necessary. In reality, nothing could be
further from the truth. The natural tendency of the physician is to forward the
requested material. Complying with the subpoena if no release is provided is a vio-
lation of federal Health Insurance Portability and Accountability Act (HIPAA)
regulations, with the possibility of penalties and litigation for release of unauthor-
ized information for which physicians have been successfully sued. Although it
seems grossly unfair that physicians are held liable for compliance with these
arcane documents in the absence of a properly executed release from the patient,
Chapter 6. Sequence of Events in a Lawsuit 49

the courts have ruled in these cases that ignorance of the law is not an excuse.
Consult your insurance company for assistance before considering any response.
The plaintiff’s attorney will also have obtained (and probably paid a retainer to)
an expert medical witness for a review and opinion. Many states have a law requiring
a “certificate of merit” to be executed and signed by a physician attesting to the likeli-
hood of malpractice before a lawsuit can actually be brought. These certificates are
hailed by the trial attorneys’ bar associations as a means of preventing frivolous suits.
While a small number of suits may be avoided by this means, the criteria for the alle-
gations in these certificates are intentionally vague and so broadly worded that any
physician can sign one without fear of contradiction or retribution. A sample from
one state reads, “I have read the materials presented to me regarding the treatment of
this patient and it is my belief that there exists a reasonable probability that the care,
skill or knowledge exercised or exhibited in the treatment of —— by the defendant
fell outside acceptable professional standards or treatment practices.”
The next step in many states is for the plaintiff attorney to venue shop for a
jurisdiction with a reputation for jurors sympathetic toward plaintiffs. The choices
are often limited to those counties where the patient resides, where the physician
resides or practices, or where the alleged negligent treatment was given. Some
states are more liberal than others in granting discretion for choice of venue. Larger
urban centers are renowned for juries sympathetic to plaintiffs.

The Summons

Once the claim is filed, the next step is service of the summons on the physician
defendant. The summons contains the location of the court, the names of the plaintiff,
the plaintiff’s attorney, the defendant, and the reason for instituting the suit. The phy-
sician should contact the insurance company as soon as possible. Although the sum-
mons is required to be served personally, it is often left with the physician’s
receptionist or even mailed without a return receipt. The natural tendency for the
physician if served in such a manner may be to indulge in wishful thinking and to
disregard the summons because of apparent “improper service.” This is a mistake in
practically every instance, because the law allows a great deal of latitude to plaintiffs
in many phases of a lawsuit lest they be deprived of “their day in court.” Furthermore,
by this stage, the plaintiff’s attorney has already spent a significant amount of time
and money and is certain not to allow the statute of limitations expire for fear of being
sued for malpractice by the patient. Further delay by the physician allows the plaintiff
an even greater head start in the process, thus putting the defense further behind.
The best course of action is never to make any decision regarding the lawsuit on
your own. The insurance company should be called immediately, because there is
generally a finite period of time within which the defendant’s attorney must answer
the summons. The summons having been served, the physician is now, short of tender-
ing a premature offer to settle, inextricably a defendant in a high stakes situation and
must do whatever is possible to be in the most advantageous a position at all times.
50 M.F. Kraushar

Selection of an Attorney

The insurance company will assign an attorney to you. Although the insurance
company also has a stake in the attorney’s management of the suit and doubtless
feels the attorney is competent, you should try to find out something about him
or her before agreeing to the assignment. Your personal attorney can do the
appropriate research as to whether the assigned attorney is a relatively senior
member of the law firm and can also get an idea of his or her track record because
these facts are public and easily obtainable to those who are familiar with the
procedures.
It is rarely necessary for the physician to hire an attorney in addition to the
one assigned by the insurance company. An attorney in whom you cannot feel
confident or with whom you have difficulty relating should be replaced by the
insurance company, which also has a stake in the best defense possible. You
should also ask for a different attorney if there is more than one defendant and
the attorney or his office represents a codefendant. If you are convinced there
is a significant chance that your case is weak and the verdict may exceed your
coverage (unusual in almost all cases), retaining a personal attorney is a good
idea.

The Physician–Attorney–Insurance Company Relationship

Complete cooperation with the attorney and the insurance company is essential to a
successful defense. It is critically important that the physician educate his or her
attorney regarding the medical facts of the lawsuit not only so that the attorney can
provide a better defense but also for the attorney to be able to ask more relevant and
probing questions of the plaintiff’s witnesses. To this end, it is imperative that the
physician defendant critically review all the plaintiff’s and plaintiff’s expert witness’
allegations as well as any exculpatory evidence for the defense. This should be
accomplished by a line-by-line review of all documents as well as a search of the
pertinent literature. This exhaustive search usually results in penetrating questions
with which the defense attorney can confront the opposition. By no means should
this daunting task be left solely to the defense expert, who may be capable and well
intentioned but who does not have nearly as much riding on the outcome of the law-
suit as the defendant.
Of the utmost importance is a truly dispassionate personal review of the claim
by the physician defendant. Any possible weakness no matter how personal or
embarrassing should be divulged to the attorney in order to avoid damaging sur-
prises at a later date such as during the deposition or in the courtroom. This infor-
mation may also aid your attorney in counseling whether to consider settling the
claim. No mention of the claim should be made to anyone outside the circle of the
physician’s immediate family and the defense team.
Chapter 6. Sequence of Events in a Lawsuit 51

The Complaint

The complaint document is served with the summons in some states or may be sent to
the defendant’s attorney at a date after service of the summons and the response by your
attorney. The nature of the allegations is usually a combination of several accusations.
These include failure or delay in diagnosis, failure or delay to treat, negligent treatment,
and/or informed consent problems. Lawsuits can also involve vicarious liability for the
acts of others, such as operating room nurses or technicians covering physicians.
The complaint is difficult and emotional reading for a defendant for two main rea-
sons. First, it is a shotgun list of practically every possible manner in which the physi-
cian may have improperly managed the patient’s care. If the plaintiff’s attorney were
to list only those alleged deviations readily apparent in the records and the expert’s
report and the statute of limitations were thereafter to expire, the plaintiff might be
precluded from alleging anything further should new information become available at
a later date. This would not only harm the patient’s claim but it would also put the
patient’s attorney at risk for a malpractice suit by the patient. This is also why practi-
cally any physician who interacted with the patient during the period of allegedly neg-
ligent treatment is also named as a codefendant. The unfortunate problem associated
with this practice is that many medical malpractice insurance companies will count
this as a lawsuit, and it can affect the codefendant’s future premiums even though the
claim against him or her is eventually dropped because the insurance company will
have incurred expenses involved with defending this claim no matter how short its
lifespan. The second upsetting part of reading this document, if you practice in one of
those states that allow it, is the “ad damnum” clause. Herein the plaintiff names the
amount of money he or she is seeking as damages. This amount is usually extremely
high for a couple of reasons. First, just as when you are negotiating the sale of a house,
you can always come down in price but it is difficult to go up. Second, a large mone-
tary demand can be intimidating to the physician defendant especially if it exceeds the
limits of the malpractice insurance coverage, thus tending to encourage a settlement.
In this document it is not unusual for the plaintiff’s spouse to ask for additional
monetary indemnification because of “loss of consortium.” The allegation is that the
injury suffered by his or her spouse because of the defendant’s negligence has pre-
vented the plaintiff from fulfilling his or her spousal role. More recently some states
have expanded the law to also permit children to make a similar claim. A nightmar-
ish possibility is future expansion of the law allowing this same privilege to children
and/or grandchildren not conceived at the time of the alleged negligent act.

The Narrative Summary

At this point, many medical malpractice companies will send a representative to the
physician’s office to obtain a summary in the physician’s words as to exactly what
is on every line of the chart and related documents from the first to the last visit.
52 M.F. Kraushar

The purpose of this is to create a document for a physician in the same specialty to
do an in-house review for the insurance company. The reviewer will assess the
strengths and weaknesses of the claim in order that the insurance company will
have a clear-cut opinion of whether the claim is defensible and to determine how
much money to put in reserve for the defense and any likely patient indemnifica-
tion. The physician is often asked to meet with the reviewer and the claim manager
from the insurance company to provide details for this purpose.

Selecting the Expert Witness

The quality of expert testimony is one of the most important considerations regarding
malpractice litigation. The plaintiff’s expert will state the defendant’s management
was below the standard of care, and the defendant’s expert will state it was within the
standard of care. The jury will deliberate as to whose opinion they believe. It can be a
great help for the physician to recommend one or more possible experts to the attorney
who may not be familiar with ophthalmologist expert witnesses. Although impressive
expert credentials may make the jury accord more credence to the testimony, the
choice should not be made purely on the basis of academic rank, high volume practice,
number of publications, and so forth. The expert must be someone who can make a
convincing, authoritative presentation and think on his or her feet (especially under
cross-examination). More will be said about this in another chapter. Frequently an
experienced attorney will suggest an ophthalmologist with a proven track record. To
avoid the appearance of a conflict of interest, it should not be a personal friend or
someone with whom you have worked closely in any medical or personal manner.

Discovery: The Process

Once the battle is engaged, both sides have proscribed opportunities for fact find-
ing. A great deal of patience is required on the part of the physician because the
process is agonizingly slow. Discovery is accomplished mainly by review of
records, reports by experts, interrogatories, and examination before trial.

Review of Records

The plaintiff will request a complete copy of the patient’s record, with any additions
since the original request was made. There may also be a request for a typewritten
copy of the office record if the original record is not sufficiently legible. Everything
in the record is usually requested, including billing, laboratory results, and reports
to other physicians. The office medical records are the property of the physician.
Chapter 6. Sequence of Events in a Lawsuit 53

A request for a copy of the records, if accompanied by a release signed by the


patient, must be forwarded to the requesting party but only after consultation with
the physician’s malpractice insurance company.

The Expert’s Report

It is the job of the defendant’s expert witness to establish the standard of care. He
or she must then, based on review of the facts of the case, be able to state that the
defendant provided treatment within the standard of care. The expert must also
successfully undergo what is certain to be a rigorous cross-examination by the plain-
tiff’s attorney at the deposition and at the trial. This is why selection of the expert
is such an important process. The same applies to the responsibility of the plain-
tiff’s expert who must be able to state the defendant’s performance was “below the
standard of care.” The crux of the lawsuit is the manner in which, after reviewing
the same materials, both the plaintiff’s expert and that of the defendant can, by the
selective presentation of those facts that are corroborative to their respective side,
state that the performance of the defendant physician was within or below the
accepted standard of care. “In effect, then, your treatment is being measured not
against what you know to be the accepted standards in the community, but against
the testimony of the plaintiff’s hired expert as to these standards.”2 Both sides may
retain the same or separate experts to determine whether “within a reasonable
degree of medical probability” the alleged negligence was a cause of harm to the
patient.

Interrogatories

Interrogatories are a series of written questions sent by each side to the other to be
responded to in writing. Some of the questions may seem absurd (“Name every
course you have taken and every article you have read on the subject of . . . ”). The
physician’s attorney will ease the pain of responding to questions of this type with
appropriate legal jargon. The preparation of the responses is a joint effort between
the physician and the attorney.

Examination Before Trial (Depositions)

The importance of the deposition stage of a lawsuit cannot be overemphasized.


This is the taking of sworn testimony from the person being deposed (the deponent).
Each side has the opportunity to obtain testimony from persons on the other side.
The depositions of the plaintiff and parties on his or her side usually precede those
54 M.F. Kraushar

of the defendant. Some states allow deposition of the expert(s), and others do not.
Those present at the proceedings include the deponent (plaintiff or defendant),
attorney(s) from each side, and a court reporter who records the proceedings and
produces a transcript. The defendant may attend the deposition of the plaintiff and/
or plaintiff’s witnesses and vice versa. Hearing what the plaintiff and his or her
expert have to say prior to being deposed yourself can increase your understanding
of their case and help in preparing for your deposition. You may also be helpful to
your attorney during the deposition by suggesting questions during a break. Your
presence may have some intimidating effect on the plaintiff who may thus be a little
less likely to exaggerate. At the very least you should familiarize yourself com-
pletely with the transcripts of these proceedings regardless of whether you were
present.
The choice of location for the deposition is agreed to by both sides. It may be an
attorney’s office, the physician’s office, or a neutral site. Although it may be con-
venient for the physician to be deposed in his or her office, it is not a good idea for
the physician to give the plaintiff’s attorney the opportunity to learn any more
information than is absolutely necessary. A predeposition conference between the
physician and his or her attorney is always advisable to review the strengths and
weaknesses and to frame responses to expected questions.
The warm, jocular, casual, friendly demeanor of the opposing attorney is a
smokescreen designed to make the deponent dangerously relaxed and off guard.
Never forget that this is a high stakes situation, and both sides are looking for what-
ever edge can be exploited. Before the deposition begins, the court reporter will
swear in the deponent. The end result of the deposition will be a transcript of the
testimony sworn to, corrected by, and approved by the deponent upon which the
opposing attorney will rely as a bible in the courtroom from which to cross-examine
the witness.
The opposing attorney is looking for information of two different types. First,
there is a search for factual information regarding the medical nature of the claim.
This may include references to nurses’ notes, the anesthesia record, drug interac-
tions, and so forth. This can be a daunting experience for the physician deponent
who must also be maximally prepared regarding the basis for the differential diag-
nosis and management, as well as the rationale for rejecting alternatives. Knowledge
of pertinent literature will usually be helpful. The second thing for which the
opposing attorney will be looking is how good a witness the physician will be in
court. Personal appearance and demeanor are of paramount importance. Haughtiness
and/or a short temper can and will be exploited in front of the jury to the detriment
of the witness. At the deposition the opposing attorney may purposely attempt to
frustrate or anger the physician by repeating questions, asking a series of questions
that are obviously not germane, making derisive remarks, or being combative.
Physicians sometimes make the colossal mistake of supposing they can be so
knowledgeable and persuasive at the deposition that they will convince the oppos-
ing attorney there was no malpractice and the case will be dropped. This is usually
a calamitous error because experience shows it is far easier to lose a case at the
deposition than it is to win it. By the time the deposition occurs the plaintiff’s attorney
Chapter 6. Sequence of Events in a Lawsuit 55

has carefully vetted the lawsuit for the probability of success. He or she has spent
a great deal of time and has spent money for an expert’s opinion. The plaintiff’s
attorney is usually not taking the deposition to see whether the case is winnable. At
this point he or she feels there is a good chance for success and is at the deposition
to find out how good a witness the defendant will be and how best to exploit
defense weaknesses. The physician defendant would be wise to deal with the reality
of the situation and realize that, having come this far in the sequence of events, he
or she will most likely be going to court.
Because the transcript of the deposition will be used by the opposing attorney as
part of your cross-examination to try to impeach your testimony, it is essential to
give as little information as possible during the deposition. If you do not wish to
hear opposing counsel say in court, “Doctor, on page two hundred fifteen, on line
twenty of your deposition you said …” do your best not create two hundred fifteen
pages of testimony. “The more you commit yourself, the more likely you are to
contradict yourself in the deposition and in the trial.”3 An effective technique to
employ is one that is advised when taking the oral examination for the American
Board of Ophthalmology. After the question is asked, pause before answering. This
serves three purposes. First, it allows your attorney to object if he or she feels the
question is improper. Second, it gives you time to form a better response. Third, it
takes more time. There is only so much time the opposing attorney usually allots
for the deposition. An extra hour or so is one thing but with few exceptions attor-
neys are not anxious to come back another day. If you do not understand the ques-
tion ask for it to be repeated by the court reporter. If you still do not understand,
say so again and ask the attorney to rephrase it. If you can answer sufficiently by
saying only “yes” or “no,” by all means do so and take advantage of the opportunity
to add nothing further. If you are asked to answer with only a “yes” or “no” and
you feel that this would not accurately represent your opinion, say, “I will be happy
to answer the question but I cannot accurately respond with a yes or no.” If possi-
ble, in a reasonable manner, it is good to show some spine and stand up to unrea-
sonable questioning by the attorney. Do not allow opposing counsel to put words
in your mouth. “Isn’t it true, Doctor, that you do not necessarily always use povi-
done iodine in the preoperative prep prior to cataract surgery?” Do not fall for the
trick of agreeing with opposing counsel that a particularly noteworthy physician,
medical text, or publication is “authoritative.” Consult with your attorney if you are
not certain as to the proper response to this type of question, which is asked fre-
quently. Be certain not to ramble or to give information for which no question is
asked. Rambling is not a characteristic of a good witness and may provide the
opposition with information about which they were not previously aware and
would not have requested. If information you feel is crucial is not asked for by
opposing counsel, your attorney may choose to question you on the record about
this information or may reserve such information until trial. “If you leave the depo-
sition with the feeling that you did not get a chance to tell your story, you were a
great success. The other side failed.”4
A transcript of the deposition will be sent to you for your signature. Prior to
signing it you must read it completely and thoroughly to correct transcription
56 M.F. Kraushar

errors. Although it is still possible to amend a material misstatement at this stage,


you may be compelled to explain “this change” in your testimony in a second depo-
sition or at trial. As any change in your testimony may damage your credibility, it
is important to answer correctly the first time.

Settlement

Some policies restrict the decision of whether to settle entirely to the insurance com-
pany. Physician-owned insurance companies typically leave the decision to the physi-
cian with the caveat that if the company advises settlement and the physician refuses
there may be financial liability on the part of the physician in the event of a plaintiff
verdict. Consideration of settlement should be preceded by a totally honest analysis
of any weaknesses in the defense as well as strengths in the plaintiff’s case.
Stubbornness and ego must be set aside. “A likely penalty for being dishonest in your
self-assessment, is to be stunned by the size of the financial penalty assessed against
you by the jury in a trial.”5 A lawsuit can be settled at any time from the earliest days
of the discovery process, during the trial, and even during jury deliberations. A plain-
tiff’s attorney who feels his case may have been received less than optimally by the
jury may approach the defense attorney during jury deliberations and say, “You can
never know how a jury will vote. Suppose we settle before they reach a verdict.”
Plaintiffs consider settlement to ensure a monetary reward. Defendants settle for
several reasons. Some physicians wish to avoid the courtroom at almost any cost.
A study of ophthalmic malpractice lawsuits showed the most frequent factors influ-
encing the decision to seek a settlement included altered records, poor documenta-
tion, informed consent problems, failure to see a patient promptly, and failure to
obtain or follow the advice of a consultant.6 Lawsuits may be settled for fear that
the jury award might exceed the upper limit of the malpractice policy. “When dis-
cussing settlement, you have to take into consideration that the plaintiff does not
yet know a certain fact damaging to the defense, and that the emergence of that fact
will drive the price of the settlement sky-high.”6 In fact, when a “runaway jury”
awards an amount in excess of the upper limit of the physician’s coverage, the
judge may adjust the award to within the limits of coverage in some instances
except those rare cases in which there are particularly egregious circumstances.
Occasionally even in a strongly defensible lawsuit, settlement may be the optimal
course of action if the exculpatory medical facts are beyond the comprehension of
a jury. Another consideration for settling a lawsuit might be the sympathetic
appearance of the plaintiff, such as a small child with poor vision or an adult whose
eye has a poor cosmetic appearance following postoperative endophthalmitis. One
case involved a patient with an unsuccessful repair of a retinal detachment whose
wife had multiple sclerosis and claimed her husband could no longer button her
blouse because he had only monocular vision and poor depth perception.
The documents drawn in a settlement state there is no admission of liability on
the part of either side. The decision is a draw. Settlements also include an agree-
Chapter 6. Sequence of Events in a Lawsuit 57

ment that the amount of the settlement and the facts of the lawsuit must remain
confidential. This protection from publicity, which is not available after a jury ver-
dict for or against the physician, is often an important consideration in the physi-
cian’s decision to settle. Unfortunately this freedom from publicity is not guaranteed.
Recently a newspaper in New Jersey was able to take advantage of the state’s sun-
shine law to force the courts to reveal medical malpractice settlement information
regarding the state’s physicians (the paper never asked for permission to reveal
similar information for attorneys, businessmen, accountants, etc.). The rationale for
revealing the data was the interpretation that the provisions of the settlement agree-
ments prevent only the parties in the suit (plaintiff and defendant) from disclosing
the facts, and, because the court is not a party to the lawsuit, the court documents
such as the transcript of the proceedings may be revealed. To further compound the
problem, revelation of the settlements was allowed not only for prospective settle-
ments that had not yet materialized but also retroactively for those lawsuits that had
been previously settled and in which the physicians had a reasonable expectation
of confidentiality. This development has naturally had a chilling effect on physician
decisions regarding settlement. Before considering a settlement it is advisable that
the physician investigate the sunshine laws in his or her state.
Settlement of a lawsuit can in some circumstances affect the physician’s future
insurance premiums and insurability. The insurance company usually takes into
consideration the specific circumstances of the case before making a decision to
raise the premium. The physician should be familiar with the practices of the insur-
ance company prior to making a decision. This is discussed in greater detail in
another chapter.

The Trial

Attendance

Optimal preparation is essential for all parties. This is the ultimate high stakes situ-
ation, and any edge that can be obtained must be sought. Consider the world class
competitive swimmer to whom hundredths of a second can be the difference
between winning and losing, who shaves his or her arms, legs, and torso to reduce
drag in the water in order to get every possible advantage. The physician must be
thoroughly familiar with all pretrial testimony in the form of depositions, expert
reports, documents, hospital records, test results, and so forth. In all probability the
plaintiff and his or her spouse will be present at all times.
The physician should optimally be present throughout the entire trial to demon-
strate similar interest. “If you come to court only to testify you give the impression
that you do not care very much about the result. The jury may conclude that you do
not care because you have a large insurance policy, and may use such reasoning to
justify awarding the plaintiff a large verdict.”7 The presence of the physician’s
58 M.F. Kraushar

spouse is likewise desirable. Rather than sit in the audience chairs, it is advanta-
geous for the physician to sit at or near the table with the defense attorney in order
to offer information when appropriate.

Courthouse Conduct

You never know when you will be in the presence of one of your potential jurors.
Your appearance, demeanor, and presentation should be such that any juror with
whom you come in contact will feel, “I would like to have him as my doctor.” It is
an accepted reality that patients are less likely to sue physicians they like (see
Chapter 8). This also applies to jurors when deliberating, and it should not be over-
looked. “The attorney is under no such constraining image regarding demeanor,
etc. His television personality is often portrayed as one who is tricky, argumenta-
tive.… The jury expects and accepts these characteristics in an attorney, but not in
a physician.”8 If you have a choice, do not drive to court in an ostentatious car. Be
well dressed in a suit or jacket and tie, but nothing flashy, and with shoes polished.
Do not talk loudly in the parking lot, elevator, hallways, and elsewhere. Hold the
door for those persons behind you. Courtesy is the order of the day. Do not in any
way interact with any witnesses or jurors.

Selection of the Jury

Because medical malpractice litigation is a civil suit, only six jurors plus alternates
are selected. Jury candidates are called and questioned (voir dire) by both attorneys.
Each side has a limited number of peremptory challenges that permit them to
excuse jurors without an explanation. Otherwise jurors may be excused only if the
judge is shown good cause to believe the juror cannot be fair and impartial.
Occasionally a juror might lie because he or she wants to be on the jury. “Jury
selection is mostly guesswork based on the attorney’s feelings about the individual
juror.”9 A potential juror in my trial mentioned her father had undergone retinal
detachment surgery. My attorney suggested perhaps we should accept her. I sug-
gested he ask whether the surgery was successful. When she answered in the nega-
tive my attorney requested that she be excused.
The original concept of a jury was that it be composed of “peers.” This is often
an awkward criterion in today’s multifaceted society in which many members of
the jury pool are scientifically and intellectually unqualified to comprehend the
facts of the case. Yet it is these citizens upon whom our system of jurisprudence
depends. “The forte of a jury is its ability to sense when someone is lying. . . . This
ability, based on the collective experiences of the many different kinds of people
who comprise a jury, allows the jury the inside track on reaching the correct
conclusion.”9
Chapter 6. Sequence of Events in a Lawsuit 59

Opening Statements

The judge will begin with instructions to the jury. This is a civil trial and not a
criminal proceeding, and thus there is no requirement that the jury reach a verdict
unanimously and “beyond reasonable doubt.” Only a majority is required, and the
criterion is “the preponderance of evidence.” This means, is it more likely than not?
In other words, a verdict for the plaintiff depends on whether there is at least a 51%
probability of the evidence in his or her favor. Each attorney then presents what is
essentially an outline of what he or she intends to establish with evidence and testi-
mony. Because the plaintiff has the burden of proof, his or her side of the case is
presented first. This gives an advantage to the plaintiff because first impressions
tend to be more lasting. This may be balanced by the fact that the defendant goes
last and his or her comments are more recent and fresher in the jury’s memory.

Testimony of Others

Be prepared for gut-wrenching delays throughout the day. Often the judge will not
enter the courtroom to start the morning for over an hour while he or she listens to
motions in chambers from attorneys who may be involved in other cases. On occa-
sion the judge may decide not to have a court session on a given day. Either attor-
ney can ask to stop testimony to approach the judge with lengthy off-the-record
arguments. When testimony begins, the plaintiff presents his or her side of the case
first. The testimonies of the plaintiff and the plaintiff’s expert witness often consist
of nonstop criticism of the defendant, which is not easy listening for the defendant.
Understandably and with the exception of cross-examination, only that selected
evidence that is favorable to the plaintiff will be presented, usually with exaggera-
tion and sometimes with little consideration for the truth and occasionally by out-
right lies and unbelievable fabrication.
Consider this example: A patient was seen in the morning by an ophthalmologist
and was diagnosed with a condition that required surgery that day. She was told to
go home and remain abstinent from food or liquids and that she would be called
later in the day when the operating room was available. The surgical result was
unfavorable, and the patient sued. At trial she attempted to make the surgeon look
as bad as possible and stated that when she was called at home to go to the hospital
she told the ophthalmologist she had lunch and claimed the physician instructed her
to go to the hospital and say she had not eaten. To make the situation seem as bad
as possible, she claimed she told the physician she had eaten onion soup, garlic
bread, pork chops with sauerkraut, and three cups of coffee.
Jurors will look at the physician during the testimony of others, and it is best not
to show excess emotion. If the plaintiff or his or her expert exaggerates while testi-
fying and you quietly turn your head slightly left-to-right-to-left, it may convey
your disagreement to an observant juror.
60 M.F. Kraushar

Expert witnesses, especially those testifying for the plaintiff, have been known
to stretch the truth and occasionally to knowingly go beyond the boundaries of the
truth. If the expert testifying against you is presenting obviously false testimony,
there is little that can be done during the trial other than effective cross-examination
and/or rebuttal by the defense expert. False testimony can be dealt with after the
trial by reporting the expert to the specialty society for sanctions and/or for use by
the attorneys of future defendants for cross-examination. The manner in which I
dealt with a plaintiff expert who fabricated facts in his testimony against me (the
jury verdict was in my favor) was to purchase a copy of his trial testimony and send
it to the state board of medical examiners, which suspended his license.

Testimony of the Physician Defendant

The courtroom can be as intimidating and unfamiliar to the physician defendant as


the operating room is to the patient. If you have never testified, it is a good idea to
find some time during the day during a period of inactivity when the jury is not
present to sit in the witness chair and accustom yourself to the setting. On the day
of your testimony, in order to get whatever edge possible, it can be helpful to pay
attention to the smallest details of personal attire. Psychological studies have shown
that the most persuasive combination of clothing is black shoes, a white shirt, navy
blue suit, and a red tie. If you do not believe that this combination provides an edge,
look at what the President or any member of congress wears when giving an impor-
tant speech or interview. There is even a classic “power tie,” which is red with diag-
onal narrow stripes of white within black. The same studies show the least persuasive
tie color is green. This is not to imply that if you dress this way a jury will believe
everything you say, but you can bet successful politicians get an edge with it and so
should you. In the final analysis, “The most effective witness is a doctor who has
humility, compassion and conveys the impression that he did the best he could.”8
“No matter how correct one’s testimony is, it only counts if the jury believes it.”10
When you testify as a defendant you are only a fact witness. You are asked what
you did and why you did it. Establishment of the standard of care or the breaching of
it is the responsibility of the expert witnesses. Occasionally the plaintiff’s attorney
will feel it appropriate to call you as the opening witness and begin with his “cross-
examination” of you. For this reason it is helpful to meet with your attorney prior to
trial to discuss both your direct examination and your cross-examination. Whenever
your testimony occurs it is advisable to take with you to the witness stand any docu-
ments or records to which you may want to refer. Do not be macho and feel you appear
more in command if you speak without looking at records. No one can remember
everything, and jurors do not subtract points for consulting records. There is no substi-
tute for accuracy. Consulting records will impress upon the jury your desire for hard
evidence as opposed to saying, “I don’t know but I suppose it was. . . .”
Remember that it is the jury who will decide the case and not the judge, attorneys,
and so forth. Therefore, your testimony should be directed to the jury. Before you
Chapter 6. Sequence of Events in a Lawsuit 61

sit down, make a point of angling the witness chair toward the jury so you are facing
them as much as possible (hopefully the jury will notice this action). It is a good rule
of thumb to maintain eye contact with the jury, especially on direct examination
when you are explaining your side of the case. When your attorney asks you a ques-
tion be sure you turn to the jury before responding. Ask your attorney whether to
face the jury or the opposing attorney during cross-examination. This advice can be
easy to forget during contentious cross-examination. Generally, looking jurors in the
eye as you speak makes them feel like your patient and enhances your credibility.
As your testimony goes on and you tire it is easy to lose total concentration espe-
cially during the cross-examination and thus be caught off guard. If you feel yourself
tiring it is perfectly permissible to turn to the judge and ask politely for a brief recess.
In order to remain “politically correct,” wait for a lull in the questioning before mak-
ing this request, and do not do it in the middle of or directly after a challenging set
of questions. On cross-examination the opposing attorney is trying to invalidate the
testimony of the witness on the direct examination. The court allows the attorney
more freedom from restraint during cross-examination, and the witness must pay
extra attention to questions before answering. “The basic principle is that a truthful
witness will be able to weather cross-examination.”9
Remember, it is the jury whom you must convince, not the attorneys or the judge.
Despite the fact that the jury pool is drawn from the entire local population, the makeup
of the jury is controlled by the attorneys during the selection process. Naturally attor-
neys prefer someone who will be sympathetic to their side. With few exceptions they
try to get jurors who are neither too dumb nor too smart. The ideal juror is one who can
comprehend the material and still be persuaded by the attorney. For this reason, physi-
cians, attorneys, corporate officers, and so forth are usually not selected. Typical jurors
are merchants, laborers, retired persons, civil service employees, high school graduates,
and lower level executives. Intellectuals and their ilk generally need not apply.
Consideration to the above should be applied to framing responses to questions.
Your demeanor should be calm and confident and your responses unhurried. Verbal
jousting with opposing council on cross-examination is inappropriate. Although
there may be great personal satisfaction with a clever riposte to an accusatory ques-
tion, it will most likely not be understood by the average juror, and it may have the
additional undesired effect of making the physician appear arrogant and, most
important, unsympathetic. A calm, reasonable response will be better received and
may even create sympathy for the “victim.”

Summations

Once both sides state that they have presented all of their testimony, the defendant’s
attorney makes a summation followed by that of the plaintiff’s attorney. Each attorney
has the opportunity to explain to the jury how the evidence supports his or her side. The
defense attorney goes first and the plaintiff’s attorney has the last word, which is
another advantage for the plaintiff because it is he or she who has the burden of proof.
62 M.F. Kraushar

The Charge to the Jury

The judge has the obligation to explain to the jurors the specifics of the law as they
apply to the case and by what means the jury should attempt to apply them. There
is usually some advice on how to evaluate the facts and testimony and how to
decide whether there is liability on the part of the defendant (negligence that is the
proximate cause of an injury suffered by the patient).
The judge explains to the jurors that if they find liability they are next to consider dam-
ages and the basic principles by which to ascertain monetary indemnification for expenses,
loss of income, and pain and suffering. The jury is then excused to begin deliberations.

Jury Deliberations and the Verdict

Jury deliberations are yet another opportunity for an agonizing wait. Because juries
are typically unpredictable, you should disregard the fable that “a quick verdict
favors the defendant,” and do not get depressed if the deliberations are lengthy.
There are stories of bailiffs overhearing jurors who are eating and joking when they
are supposed to be deliberating.
A defense verdict brings a feeling of exhilaration to the physician. Unfortunately
the process creates scars no matter the result, and it cannot change the way he or she
will experience the future practice of medicine. Despite “winning,” the physician
cannot avoid a sense of some loss of ego and self-confidence. The situation, on a
personal level, is analogous to that of Mr. Raymond Donovan, a former presidential
cabinet secretary who was acquitted in a corruption lawsuit and following the ver-
dict asked a questioning reporter, “Now where do I go to get back my reputation?”
A verdict for the plaintiff is a stunning shock to the physician’s psyche even if it
was somewhat expected. There is also the additional problem of a newspaper article.
Plaintiff’s attorneys will frequently call the local newspaper to report the verdict in
order to get free publicity, which is powerful advertising. Many attorneys proudly
frame and display the articles on their office wall. Peer and patient knowledge of the
result is a natural embarrassment for the physician and can be difficult to manage. The
psychological effects of litigation are discussed in greater detail in another chapter.

Appeal

The attorney for the losing side can make a motion for a new trial or file an appeal
if he or she feels errors in procedure have occurred that may have influenced the
jury’s verdict. This is usually a difficult goal to achieve because appellate courts
tend not to interfere with the decisions of lower courts and accord great weight to
the opinions of the lower court judge who tried the lawsuit and who obviously saw
no reason to prevent the case from concluding as it did.
Chapter 6. Sequence of Events in a Lawsuit 63

Countersuits

The countersuit lawsuit, against the patient, the patient’s attorney, or both, is almost
always “the impossible dream.” The burden of proof for the physician is to show
that the plaintiff or his attorney acted with malicious intent in a malicious prosecu-
tion case. In a frivolous litigation case one must show the plaintiff and/or his attor-
ney knew or reasonably should have known there was no basis to file the case. The
law in this respect is stacked heavily in favor of the plaintiff and attorneys.
Attorneys freely admit that the threat of a countersuit might discourage plaintiffs
from litigation and would thus deprive them of their day in court (does “them” refer
to the patient’s day or the attorney’s day?). The laws are constructed to make it dif-
ficult for anyone to prevail in a countersuit for any type of litigation because of
society’s preference for resolving disputes through the court system. When a plain-
tiff and/or the plaintiff’s attorney have obtained a certificate of merit from a quali-
fied expert, this will usually be sufficient to protect them from any defense
countersuit.
The first criterion for being able to countersue is discontinuing the suit by the
plaintiff, dismissal of the suit by the court, or successfully defending the lawsuit in
court. The next hurdle is to prove malice, which, in the absence of an admission, is
very difficult. The physician must next prove that the publicity of the suit was the
proximate cause of a decrease in income from the practice of medicine—a difficult
task at best. This loss of income is the only indemnification the physician can
recover. There is no recovery for pain and suffering despite the number of sleepless
nights, episodes of heartburn, and anxiety attacks the physician has suffered. The
physician cannot recover any of the cost for time away from the practice that was
devoted to trial preparation, meetings with the attorney, the deposition, or the trial.
Spending this time is considered one’s civic responsibility and is not reimbursable.
The physician cannot even recover the cost of bringing the countersuit. Except in
unusual situations, the best course of action for the physician is to sublimate any
feelings of hostility and rejoice in the admittedly insufficient vindication of the
verdict.

Retribution for an Unethical Plaintiff’s Expert Witness

Unfortunately, as in any field of endeavor, there are unethical physicians who will
bend the truth or even present outright junk science to make a frivolous claim
appear meritorious in order to generate an expert’s fee. Although attorneys typi-
cally familiarize themselves with medical information from textbooks, they are
nonetheless to a significant degree dependent on the opinion of their expert.
Similarly, while judges who preside over medical malpractice cases may also read
appropriate medical texts, they too are dependent on the facts presented by experts
on both sides. This dependence can alter the decisions of a judge during the trial
regarding what testimony and what evidence is presented to the jury.
64 M.F. Kraushar

Unless the defense’s expert is able to effectively counter the false statements of
an unethical plaintiff’s expert with his or her own trial testimony there is little else
that a physician can do. In the event of a verdict unfavorable to the physician the
option is an appeal. Appeals are generally based on problems with the conduct of
the trial and are not specifically concerned with the accuracy of the evidence pre-
sented. If the verdict is favorable to the physician the option is a countersuit. As
stated earlier, countersuing is a daunting task.
Regardless of whether the jury verdict is favorable to the physician defendant he
or she still has the opportunity to stain the reputation of the unethical plaintiff
expert witness, thus reducing the possibility of future unethical testimony. The first
option is reporting the facts to the specialty board that can censure or withdraw
certification. This information will be available to attorneys looking for experts,
thus making it more difficult for the physician to secure future expert witness
opportunities. A stronger course of action is available to any physician defendant
who is willing to spend a few hundred dollars plus significant additional time and
effort. This involves obtaining copies of the deposition and trial testimony of the
plaintiff expert and sending them to the state’s board of medical examiners along
with a detailed letter noting where the unethical expert deviated from the medical
facts. These documents will usually be submitted by the board to one or more phy-
sicians in your specialty for review. The process may take as long as a year or two.
I have personally done this twice following favorable jury verdicts and the board
suspended the licenses of the experts one of whom retired shortly thereafter.

References

1. Davis GG. Pathology and the Law: A Practical Guide for the Pathologist. New York: Springer;
2005:82.
2. Alton WG Jr. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little Brown;
1977:4.
3. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham, AL:
Aesculapius; 1984:48.
4. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham, AL:
Aesculapius; 1984:49.
5. Davis GG. Pathology and the Law: A Practical Guide for the Pathologist. New York: Springer;
2005:111.
6. Kraushar MF. Ophthalmic malpractice lawsuits with large monetary awards. Arch Ophthalmol
1996;114:333–337.
7. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little Brown;
1977:177.
8. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham, AL:
Aesculapius; 1984:60.
9. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little Brown;
1977:180.
10. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham, AL:
Aesculapius; 1984:57.
Chapter 7
Informed Consent

Marvin F. Kraushar

History

A brief review of the evolution of informed consent law will provide an under-
standing of the current status of the physician’s duties with respect to disclosure.
The writings of Hippocrates, one of the earliest to discuss professional conduct,1
include phrases such as “concealing most things from the patient” and “revealing
nothing of the patient’s future or present condition.”2 In that authoritarian age
patients were expected to be obeisant, and the purpose of physician–patient com-
munication was solely to persuade the patient to accept therapy. de Mondeville, a
medieval physician, believed hope to be of sufficient therapeutic benefit to justify
avoiding the truth. He advised, “Promise a cure to the patient but tell parents or
friends of any danger.”3 In the nineteenth century, Benjamin Rush wrote, “Educate
the patient about his condition.”4 His purpose for patient education was to motivate
compliance with the advice of the physician. Although Rush thus proposed an
informed patient decision, he was not an advocate of consent.
“Courts very much tend to rule on the basis of precedent or previous decisions.
This is called ‘stare decisis.’ Generally it takes either a most unusual case or a
growing amount of social dissatisfaction with existing law for courts to consider
overruling the present law.”5 Actual legal doctrine evolving from court cases per-
taining to present day informed consent requirements occurred mainly in the twen-
tieth century. A patient consented to an examination under anesthesia and requested
no surgery be performed. The physician found a fibroid tumor of the uterus and
removed it. In 1914 the patient sued (Schloendorff v. Society of New York Hospitals)
and Justice Benjamin Cardozo wrote in his opinion, “Every human being of adult
years and sound mind has a right to determine what shall be done with his own
body; and a surgeon who performs an operation without his patient’s consent com-
mits an assault, for which he is liable in damages.”6 As of this date the law required
consent but not informed consent. There was an additional problem for physicians
in this ruling insofar as assault is a criminal offense as opposed to a civil offense.
A patient undergoing translumbar aortography was left with a permanent paralysis.
He sued his physicians (Salgo v. Leland Stanford Jr. University Board of Trustees7)
and claimed they failed to warn him of the risk of paralysis, and had he known of

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 65


doi: 10.1007/978-0-387-73341-8; © Springer 2008
66 M.F. Kraushar

this risk he would not have consented to the procedure. In 1957, the court ruled that
“physicians have the duty to disclose any facts which are necessary to form the
basis of an intelligent consent by the patient to proposed treatment” and thus cre-
ated the doctrine of informed consent.
A patient sued her physician (Natanson v. Kline8) because of severe burns from
radiation therapy and claimed she had not been informed of this risk. In 1960 the
court ruled in her behalf and, fortunately for physicians, also established that
informed consent liability was negligence, a civil offense rather than battery, a
criminal offense. A patient sued his physician (Canterbury v. Spence9) after suffer-
ing paralysis following a laminectomy and claimed he had not been warned of the
possibility of this risk and would not have consented to the procedure had he been
so warned. In 1972, the court ruled it is the physician’s duty to warn patients of
“risks and alternatives” to treatment. This phrase, “risks and alternatives,” should
be part of the vocabulary of any physician with knowledge of risk prevention. The
children of a woman who died from cervical cancer sued her physician (Truman v.
Thomas10). She had refused a Pap smear more than once and claimed she would
have consented to the test if she had been warned of the risks of not having it. In
1980, the court found in her behalf and ruled the patient must be warned of “the
risks of a decision not to undergo the treatment.” This is the doctrine of informed
refusal.
According to Faden and Beauchamp,11
It was case law that introduced the concept of informed consent to medicine in the twenti-
eth century using the language of “self-determination.” Shortly thereafter informed consent
was transformed into a social context beyond the law from a malpractice issue to a moral
duty incumbent on physicians.

Definition

Performing an invasive diagnostic or surgical procedure with improper consent or


no consent in most instances is actually battery. Battery is intentional (not acciden-
tal or careless) physical contact for which the patient has not given permission. It
is a criminal offense that can be punishable by incarceration, although incarceration
is extremely rare. However, an intentional tort such as battery may allow plaintiffs
to recover punitive damages that are not covered by malpractice insurance.
Negligence is an unintentional act or omission and is a tort, a civil offense for
which there may be monetary consideration.
Patients rarely sue for only informed consent problems, but allegations regarding
improper informed consent are included in almost every medical malpractice claim.
“Courts are allowing consent cases to go forward in cases where they are suspicious
that there really was negligence but it can’t be proven.”12 Members of the medical
and legal professions are faced with many problems when considering the critical
question of whether the appropriate legal standard has been satisfied in any given
Chapter 7. Informed Consent 67

instance. The inherent difficulty of securing a definition of “informed consent” that


satisfies both legal and medical requirements is but one of these. It is no longer
enough to equate consent with the mere completion of a form; rather, it is the proc-
ess of communication between health care provider and patient upon which subse-
quent judgments as to the extent and validity of consent must be made.13 Informed
consent is a continuum and not a single event and should be viewed by the patient
and the physician as collaborative and not paternalistic. The process begins at the
first encounter and continues through treatment and follow up.
Physicians tend to regard the process as a legal requirement to protect them-
selves rather than as an ethical process to involve the patient. Consideration must
be given to the fact that patients and physicians often have different models of ill-
ness. While physicians may think of diabetes as a disease of blood vessels, many
patients regard it as simply a lot of injections. Likewise, patients and physicians
may have different treatment goals. It is common for patients to expect a cure with
as little of their own input as possible, and it thus falls to the physician to encourage
the patient to be an active participant.
The criteria for truly “informed” consent include the fact that there must be
understanding by the patient of relevant information. This is often idealistic in
those instances of patients with a language problem regardless of whether an inter-
preter is present or in the case of many elderly patients with early dementia as well
as in other circumstances. The consent must be autonomous with no coercion,
manipulation, or persuasion. The patient must understand the process as giving of
permission. The consent is not truly “informed” unless the patient understands it as
an act of authorization regardless of how well he or she understands the medical
information, risks, benefits, alternatives, and so forth.

Purposes

There are four purposes to obtaining informed consent.


1. The informed consent process enables the physician to comply with the legal
requirement to “disclose sufficient facts and information which are necessary to
form the basis of an intelligent consent by the patient” (Salgo v. Leland Stanford
Jr. University Board of Trustees7). Unfortunately this is too often the only reason
physicians become involved with informed consent.
2. Many studies have shown that patient involvement in decision making improves
patient compliance, thus increasing the chance for a better result.
3. Patient education regarding risks is perhaps the most powerful risk prevention tool
available to physicians. The typical patient comes to the physician expecting a cure.
Patient expectations in our society are so high that to most people anything less than a
perfect cure will be an unexpected event. “Surprise produces anger and anger produces
lawsuits.”14 Negligence attorneys agree that their angriest clients are medical malprac-
tice plaintiffs. Studies in several specialties have shown that explaining the possibility
68 M.F. Kraushar

of complications reduces patient expectations and results in greater satisfaction with


whatever result is achieved. There are also studies in several specialties that show that
patient retention of facts is less than optimal. Priluk et al.15 had a 15-minute prepared
preoperative informed consent discussion with detached retina patients on admission
to the hospital and tested their recall prior to their discharge from their inpatient hospi-
tal stay (range 2–11 days). Forty-three percent of the patients, none of whom had yet
been discharged, were unable to recall all the material in the preoperative informed
consent discussion. Furthermore, 54% of the patients with incomplete recall actually
denied they were ever given the information. The authors’ conclusion was that patients
understandably tend to remember favorable facts and suppress threatening facts. A
more recent study16 of cataract patients questioned as early as the first postoperative
day had similar results. Studies in cardiovascular surgery17 and plastic surgery18 were
equally discouraging. Despite the results of these studies, it still makes good sense that
physicians do their best to educate patients regarding the possibility of complications
and less than perfect results for the purpose of risk prevention and to document these
efforts. There are both videotape and computer website services available to help phy-
sicians document that they have obtained an informed consent.
4. Going through the process of informed consent gives the physician the opportu-
nity to document having done so. Although patients have certainly been known
to lie or exaggerate on the witness stand, on occasion some may honestly lose
recall of the conversation. To refute the allegations of the plaintiff it becomes
the responsibility of the physician to establish that the process did in fact occur.
The options for documentation are discussed later in this chapter.

Indications

The indications for informed consent include any diagnostic, therapeutic, or surgi-
cal procedure with an element of risk. As a rule the more elective the nature of the
procedure (e.g., LASIK) the greater is the indication for informed consent.

Exceptions

In specific circumstances it may be permissible to intentionally disregard the


requirement for informed consent.19
1. Public health emergency actions such as quarantine or vaccination are often
required by law.
2. Medical emergencies in which delay might be harmful are also an exception
provided there is no evidence to indicate the patient would refuse the procedure
(e.g., blood transfusion for a Jehovah’s Witness).
Chapter 7. Informed Consent 69

3. An incompetent person, such as a minor when no parent or legal guardian is


available or a person with diminished capacity, can in the appropriate circum-
stances receive treatment without informed consent.
4. The concept of therapeutic privilege enables a physician to withhold all or part
of the informed consent discussion if it is judged that there would be harmful
effects from the disclosure. This is a nebulous concept that presents a slippery
slope and should be avoided whenever possible.
5. Waiver of informed consent by the patient can release the physician from the
requirement of informed consent. Such a patient may say, “I trust you and I
don’t need to have you explain it to me.” This situation is a “catch 22” because
this waiver is in and of itself an actual consent and must also be informed. The
physician should not allow the patient to waive the process for two reasons.
First, defending this admittedly unclear concept in court is a tenuous situation at
best. Second, failure to use the informed consent process deprives the physician
of the opportunity for patient education regarding risks, one of the strongest risk
prevention tools available.

The Standard for a Lawsuit

To recover damages for lack of informed consent the patient must prove the treat-
ment carried a known risk of which he or she was not advised, the risk occurred as
the result of the treatment, and a reasonable person in the patient’s place would not
have undergone the treatment if advised of the risk.

The Process

Presentation of Consent Material

The environment for the discussion should be leisurely and unhurried, and privacy
should be respected. The concerns of the patient should be elicited, and he or she
should be encouraged to ask questions. The discussion should occur within “rea-
sonable proximity to the procedure” (an admittedly nebulous phrase). Problems
include balancing information overload versus underdisclosure. When in doubt it is
advisable to give more rather than less information. The material should be well
organized, unfamiliar terms should be avoided, and lay terms should be used when
possible. It is easy to lose sight of the reality that information that is too complex
and not easily understandable will not have the desired impact on the patient’s deci-
sion making. It may also cause the patient to feel that his or her participation is not
truly desired by the physician. This may lead the patient to feel that the purpose of
the consent form is solely to protect the physician. Early in my medical practice I
70 M.F. Kraushar

completed what I felt was a superb informed consent discussion only to have the
patient’s husband say, “Okay Doctor, that takes care of you, now how about us?”
Printed materials and/or audiovisual materials can not only save time but also
increase patient comprehension. Distractions such as anxiety, fear, or pain should
be recognized and dealt with as the situation requires.

Setting

The patient should be invited to ask any interested party accompanying him or her
to be present in the room during the discussion. This has the added benefit of not
having to repeat all of part of the process to an interested party who may have gone
outdoors for a smoke. The names and relationships of all those accompanying the
patient in the room where the discussion is held should be recorded. In addition, the
same information for anyone who accompanied the patient to the office but is not
in the room should also be recorded (e.g., brother George in waiting room).
Recording this information precludes any credible testimony on behalf of the plain-
tiff as to what material was covered by person(s) who were not actually present at
the discussion.

Discussant and Discussion

The discussant should optimally be the physician who will perform the procedure
and not a fellow, resident, nurse, technician, or other staff. It is preferable not to
delegate this task. The physician is the most qualified person and will be the one
charged with the responsibility of defending any lawsuit in the courtroom. If the
presentation is made by a video of the physician, by other audiovisual aids, and/or
by someone else, the physician should be present at the end of the presentation to
answer any questions the patient may wish to ask of a medical nature. Lay vocabu-
lary should be used to increase patient comprehension. The nature of the problem
and why it is of concern should be covered. The technique of the procedure should
be described as simply as possible. The patient must be informed who will be per-
forming the procedure and what parts, if any, will be done by someone else.

Risks, Benefits, and Alternatives

The discussion of risks is of paramount importance because of the opportunity for


patient education. Patients rarely refuse a procedure even after learning of serious
risks. Fear that a patient will refuse a necessary procedure after hearing of a serious
risk is not usually a sufficient defense for withholding full disclosure. Do not make
Chapter 7. Informed Consent 71

the mistake of assuming just because you tell the patient he or she might die or lose
an eye it is not necessary to make full disclosure of lesser risks. This will not usu-
ally impress a jury favorably. Furthermore, incomplete disclosure deprives the
physician of the opportunity for better risk prevention by means of patient educa-
tion regarding risks.
Until recently the criterion for which risks should be disclosed was any risk that
a “reasonable physician” judged significant. With the passing of the authoritarian
age of medicine into the present day environment of self-determination, the stand-
ard has shifted in most states to any risk that would affect the decision of the “pru-
dent patient.” Despite the evolution of the informed consent doctrine over the years
there is presently no definitive legal guideline as to what risks or what type of risk
must be disclosed. A continuing conundrum is the lack of a workable definition of
a “material” risk. The courts have stated that a material risk is one that the average
patient would feel is significant when deciding whether to agree to a diagnostic,
therapeutic, or surgical procedure. Exactly how the courts expect physicians to
know what specific risk will affect the decision of a given patient in a given situa-
tion is unclear. Basically, the more remote a risk is, the less likely a patient will
consider it material. Likewise, the more severe the risk, the more likely a patient
will consider it material even if it is remote. It is neither necessary nor possible to
include every risk in the discussion. The physician must convince the jury that
he or she made a bona fide attempt to include those risks that would influence the
decision of a “prudent patient.” When it is applicable, do not forget to include the risks
of failure to improve vision as well as decreased or total loss of vision.
Frankness and complete honesty are essential to the discussion of benefits. Be
certain not to say anything that might be considered a guarantee. Angry patients
frequently claim a better result was guaranteed. I recall a plaintiff who swore he
was guaranteed to improve from 20/400 to 20/20 vision following panretinal pho-
tocoagulation for neovascular glaucoma secondary to a severely ischemic central
retinal vein obstruction.
The discussion of reasonable alternatives should include those choices that
might affect the decision of the “prudent patient” with an explanation of your opin-
ion of the appropriateness of each and why you have chosen the procedure you are
recommending. The alternative of no treatment must be included with mention of
the likely consequences.

Questions for and by the Patient

Presentation of all the above material by the physician is optimal. At this point of
the process, regardless of whether the physician has personally made the presenta-
tion, it is essential that he or she be present to ask whether the patient has under-
stood the presentation and to answer any questions of a medical nature. Even if
there are no questions for the physician, his or her presence adds the personal touch
and demonstrates caring. It is the physician’s responsibility to answer if asked how
72 M.F. Kraushar

many times he or she has performed the procedure. When physicians misrepresent
their experience or success rates with new or established procedures, many states
view this as a “deceptive and unconscionable act” and allow patients to sue under
their consumer protection laws.
There is no obligation for the physician to volunteer information regarding his
or her malpractice litigation history. If asked, the physician may decline to answer.
However, if there is a complication and the physician had lawsuits arising from a
similar complication, the patient may claim the physician deprived them of
informed consent because disclosure of this information would have caused them
to choose another physician. If the physician chooses to answer he or she may not
misrepresent their claims history. Questions of a nonmedical nature such as time of
surgery, place, and so forth, can be answered by a nurse, technician, or other
staff.

The Consent Form

At such time as the patient and anyone else in attendance with him or her have no
further questions it is time to present the consent form. There are three types of writ-
ten consent documentation.20 The first is the long, detailed consent form, which is the
traditional means. The short form states that the patient has been informed but does
not list specific risks, benefits, and so forth. The third method is a detailed note in the
patient’s record. There is still controversy as to the relative values of each type. The
long form and the detailed note in the record are basically the most appropriate. Many
physicians make their own forms with or without consulting an attorney or medical
society. Some states, such as Texas, have mandatory forms that if executed properly
are a very strong defense for physicians. The American Academy of Ophthalmology
has consent forms that are excellent, and several are procedure specific.
By no means should a physician rely on only the consent form given to patients
on arrival at the hospital or ambulatory surgery center registration desk. Any jury
can rightfully be expected to feel sympathy toward a patient who claims, “The clerk
didn’t explain much to me and I was so nervous about the procedure I signed the
form in order not to make trouble.” After the patient has had sufficient time to read
the consent form and after all his or her additional questions have been answered,
it is time for the signature. The signature can be witnessed by a patient’s family
member. I prefer to also have someone from my staff act as a witness. I do not have
any of my staff in the room during the informed consent conversation. My staff
witness is called in at the time the form is to be signed by the patient. It will not be
the responsibility of my witness to testify as to what was or was not discussed. If
litigation ensues I want someone loyal to me to be able to testify only that it was
the patient who signed the form and it was signed on the date written on the form
and not 3 months after the complication had already occurred, as I have seen
patients allege. After the consent form is signed and witnessed, I impress upon the
patient that “what you have just signed is permission for me to do the procedure. It
Chapter 7. Informed Consent 73

is not an irrevocable contract and you can change your mind at any time.” This is
intended to reinforce the concept of patient authorization.

Documentation

At this point the consent has been documented. “Any number of experts can testify as
to the competency of whatever medical of surgical treatment may be in question.
However no-one who was not actually present in the room throughout the discussion
can testify accurately in behalf of either the physician or the patient as to exactly what
was or was not discussed.”21 For this reason I have tape recorded all my informed con-
sent conversations in my offices since 1980. I keep the recorder on the desk in the room
where the discussion occurs. Before starting the discussion I say to the patient, “The
conversation we are about to have is rather lengthy and instead of having someone take
notes I am going to make a recording so I have a copy.” I have not had a single patient
ever refuse the recording. I use a double-sided 2-hour tape on which I can typically
record a dozen or more conversations per side (the average time is approximately 7–10
minutes). The name and date are written in a small spiral notebook kept on the recorder.
I store the tapes and notebook pages with my yearly income tax returns. The act of
recording takes practically no extra time. Begin the recording by stating, “This is (date)
and this is Dr. (name) explaining informed consent to (the patient and the name and
relationship to the patient of anyone else present in the room).”
While the process of recording may appear cumbersome and/or over the top
(some physicians use videotaping) it can be a powerful and effective defense tool.
If the plaintiff has in fact suffered a bad result, regardless of whether there has been
malpractice, a jury will often be more prone to accord greater credibility to his tes-
timony. I strongly urge that you seriously consider the following rationale of an
experienced negligence attorney22:
The key to understanding what must be done to defeat a claim for lack of informed consent
is this: The injured plaintiff need only testify that you did not tell him about the risk of the
terrible complication that happened to him and that, if you had done so, he never would
have agreed to the treatment; in order to defeat the claim, you cannot merely take the stand
and assert the contrary. It will merely be your word against his—and he has the injuries,
not you. You must produce corroboration of your testimony that you disclosed the risk.
Your evidence must be as strong as possible, since the plaintiff is saying that the injuries
from which he is suffering would never have occurred if you had disclosed everything to
him, because he would never have agreed to the treatment. When you produce a tape
recording of your explanation of the risk to the patient and the patient’s statement that he
understands all the risks you have explained and agrees to the treatment, you destroy the
plaintiff’s claim of lack of informed consent and go a long way toward destroying any
other claims of malpractice he may be making.

A recording would have been powerful support for the physician alleged to have
promised return of 20/20 vision following panretinal laser to the patient with
20/400 vision from neovascular glaucoma secondary to severely ischemic central
retinal vein obstruction.
74 M.F. Kraushar

Informed Refusal

In 1980, Truman v. Thomas10 established the doctrine of informed refusal. Unfortunately


relatively few physicians are familiar with this concept, and the need for appropri-
ate action is usually overlooked. The court holds the position that the physician is
the expert and the patient is ignorant with respect to most medical situations. When
a patient refuses any recommended diagnostic, therapeutic, or surgical procedure,
the physician may not assume the refusal was an informed decision. The patient
must be warned of the risks of refusal. Most physicians are unaware of the many
situations to which this concept can be applicable. In the average medical practice
informed refusal situations arise far more frequently than do situations involving
informed consent. Failure to keep a postoperative appointment, missing a follow-
up appointment for continuing treatment, or a glaucoma patient missing an appoint-
ment for a visual field examination requires documented notification of the patient
with mention of the risk of delayed examination or treatment. A patient you have
never seen calls complaining of the recent onset of flashes and floaters. The recep-
tionist gives the patient an appointment for the same day but the patient fails to
appear and 3 weeks later is diagnosed with a retinal detachment by another ophthal-
mologist. Technically your office has not established a relationship with the patient
but under some circumstances a clever attorney can bring a lawsuit claiming your
office failed to warn the patient of the risk of not being seen promptly. Other exam-
ples include refusal of routine tonometry, bilateral pupillary dilation, and poor
compliance in taking glaucoma medication.
To provide adequate protection for the physician, the conversation regarding
risks of refusal should be documented and signed by the patient with a witness as it
would be for informed consent. This situation can involve anxiety for the patient and
occasionally resentment or anger as well and may thus make the atmosphere inap-
propriate for suggesting a formal discussion with tape recording. This is nonetheless
a potentially litigious situation and should not be taken lightly. The physician must
sublimate any personal feelings of anger or resentment toward the patient who has
questioned and/or disregarded his or her judgment and advice. Physician demeanor
should be calm and understanding in order to maintain a good physician–patient
relationship in the hope that the patient will eventually acquiesce. If the problem
arises without a physician–patient encounter (e.g., missed appointment), a return
receipt letter is called for as is chart documentation of any phone calls.

Conclusion

Although it the physician’s duty to inform, it is the patient’s right to consent. The
process can be neither complete nor utilitarian unless both parties recognize and
comprehend their respective obligations. “Professionals would do well to end their
traditional preoccupation with disclosure and instead ask questions, elicit the
Chapter 7. Informed Consent 75

concerns and interests of the patient, and establish a climate that encourages the
patient to ask questions.”23

References

1. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford
University Press; 1986:61.
2. Jones WHS: Hippocrates. Cambridge: Harvard University Press; 1923:297–299.
3. de Mondeville H. On the morals and etiquette of surgeons. In: Rieser SJ, Dyck AJ, Curran WJ,
eds. Ethics in Medicine: Historical Perspectives and Contemporary Concerns. Cambridge:
MIT Press, 1977.
4. Rush B. On the vices and virtues of physicians. A lecture delivered November 2, 1801. In:
Sixteen Introductory Lectures. Philadelphia: Bradford and Innskeep; 1811:123–125.
5. Rosenberg AR, Goldsmith LS. Malpractice Made Easy. New York: Magazines for Industry;
1976:12.
6. Schloendorff v. Society of New York Hospitals, 211 N.Y. 128, 105 N.E. 93.
7. Salgo v. Leland Stanford Jr. University Board of Trustees, 317 P.2d 170, 181 (1957).
8. Natanson v. Kline, 186 Kan. 393, 350 P.2d at 1104.
9. Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).
10. Truman v. Thomas, 165 Cal. Rptr. 308, 611 P.2d at 10.
11. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford
University Press; 1986:101.
12. Curren W. Consent law leaves physicians in limbo. AMA Medical News May 10, 1985:10.
13. Rozofsky FA. Consent to Treatment: A Practical Guide. Boston: Little, Brown; 1984:xxxv.
14. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham, AL:
Aesculapius; 1984.
15. Priluk IA, Robertson DM, Buettner H. What patients recall of the preoperative discussion after
retinal detachment surgery. Am J Ophthalmol 1797;87:620–623.
16. Robinson G, Merav A. Informed consent: recall by patients tested preoperatively. Ann Thorac
Surg 1976;22:209–212.
17. Leeb D, Bowers DG Jr, Lynch JB. Observations on the myth of “informed consent.” J Plast
Reconstr Surg 1976;58:280–282.
18. Rozofsky JD. Consent to Treatment: A Practical Guide. Boston: Little, Brown; 1984:634.
19. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford
University Press; 1986:35–39
20. Rozofsky JD. Consent to Treatment: A Practical Guide. Boston: Little, Brown;
1984:634–642.
21. Kraushar MF, Steinberg JA. Informed Consent: Surrender or Salvation? Arch Ophthalmol
1986;104:352–355.
22. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little Brown;
1977:180.
23. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford
University Press; 1986:307.
Chapter 8
The Five Most Effective Risk
Prevention Strategies

Marvin F. Kraushar

Introduction

Although the choice of the strategies discussed in this chapter may seem obvious,
physicians commonly have misconceptions about each, which causes them not to
accord these tools their rightful value in risk prevention. The unfortunate result
is improper or underutilization and greater exposure to medical malpractice
litigation.
By taking a novel approach to the value, understanding, and implementation of
each of these strategies, physicians will be encouraged to avail themselves of their
maximum benefits. What is needed is a contrarian view toward these processes and
a 180 degree shift in physicians’ perspective of them as purely legal responsibili-
ties. These strategies must be considered not as legal encumbrances but rather as
opportunities for risk prevention. In this way they can work for the physician
instead of against the physician. This is a classic example of, “when life gives you
lemons, make lemonade.”

Good Result

Experience shows that patients usually sue for a bad result and not for a good result.
The problem is that patients and physicians often have differing opinions of what
constitutes a good result. An example is a patient with 20/20 vision after uncompli-
cated cataract surgery who develops postoperative endophthalmitis following cata-
ract surgery in the second eye. The diagnosis is made in a timely manner, and,
following treatment with pars plana vitrectomy and intravitreal antibiotics, the
patient regains 20/50 visual acuity. While the surgeons feel this is a superb visual
result under the circumstances, the patient, who sees 20/20 in the first eye, may be
less than completely happy.
Fortunately, physicians have the opportunity to influence the patient’s opinion of the
result prior to treatment by means of the discussion of risks during the process of
informed consent. Advances in medical technology have resulted in higher patient

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 77


doi: 10.1007/978-0-387-73341-8; © Springer 2008
78 M.F. Kraushar

expectations. For many patients anything less than a perfect result will be an unexpected
event. Education of the patient regarding the fact that complications can and do happen
will decrease expectations and achieve greater patient satisfaction with the eventual
result. Realization of the possibility of a complication makes its occurrence less of a
surprise. The patient will be less angry, and the risk of litigation will be reduced.

The Physician–Patient Relationship

Breakdown of the physician–patient relationship is a sine qua non for almost every
case of medical malpractice litigation. Patients do not visit the medical office with the
intention of suing. Rather, they come with the hope of being cured. There is some-
thing that the physician does or fails to do during the course of treatment that makes
the patient consider a lawsuit. The establishment and continued nurturing of the
physician–patient relationship can overcome almost any problem that arises. The opti-
mal means by which to accomplish this is to establish a feeling of collaboration with
the patient through shared decision making.1 Understanding, caring, and compassion
for the patient must be evident in the demeanor of everyone in the physician’s office.
“A patient who cannot find a physician who will listen can probably find an attorney
who will. As the physician–patient relationship falters, the attorney–client grows.”2
It is not rare for a patient consulting an attorney in regard to a possible lawsuit to
be so fond of the treating physician whose care may have been negligent that he or
she asks that the suit be directed only against anyone else who participated in the care.
A classic example of good “bedside manners” is an internist I encountered during my
internship who was widely regarded as greatly deficient in medical knowledge and
skills. His practice was very large, and his patients revered him. During my emer-
gency room rotation I assisted a resident for 2 hours just after midnight in stabilizing
one of this physician’s patients who was on the verge of exsanguination from a rup-
tured esophageal varix. At 3:00 AM the physician, who had avoided appearing, called
the emergency room and was brought up to date by the resident. Fifteen minutes later
he entered through the back door, removed his jacket, loosened his tie, and rolled up
his shirtsleeves. He went into the writing room and told the family, “We saved her.”
I am certain the family never forgot this experience.
Patients tend to be quick to forgive if they feel the physician cares. A superbly
qualified ophthalmologist colleague of mine has built a successful practice and has
the firm belief that, “Ya gotta make ‘em love ya.” The optimal aim of every patient
encounter is to make the patients so pleased with their management that they will
refer another patient to you. The means by which to accomplish a good relationship
is part of the presentation of every successful practice management consultant. It
basically relies on good communication. An excellent example is a study3 in which
physicians were divided into two groups and asked to solicit the chief complaint of a
new patient. One group was instructed not to interrupt the patient until he or she fin-
ished responding. Seventy percent of these patients took less than a minute to com-
plete their statement. Seventy-seven percent of the patients in the other group were
Chapter 8. Risk Prevention Strategies 79

interrupted by the physician after an average of only 18 seconds, and 98% of them
never got to complete their statement. Those patients who were interrupted had a
lower opinion of the quality of their care than those who were allowed to speak with-
out interruption. This is one of many studies proving that patients generally have a
lower opinion of the quality of care received if they feel the physician communicated
poorly. This can be a double-edged sword for the physician. These patients are less
likely to refer other patients to the practice, and they are more likely to sue.
Another study demonstrated that providing empathy and support to a concerned
patient4 by means of “active listening” added only 1 minute to the length of patient
visit, thus disproving the theory that empathy and relationship building are too time
consuming to be worthwhile. Active listening involves using phrases such as,
“I can see why you’re concerned. I’m sorry to hear that. It must be very difficult
for you.” Listening in this manner encourages patients to be more actively involved
in the treatment process, and their compliance leads to better results. Patients who
are encouraged to express their concerns early in the treatment process are less
likely to express concerns later.
A physician examining a patient who is dissatisfied with the diagnostic or thera-
peutic result of another physician must be extremely cautious about comments.1
A history obtained from a dissatisfied patient can understandably be inaccurate.
Without knowing the circumstances under which a suboptimal result occurred, it is
difficult to assign blame. Medical malpractice suits have been intentionally or unwit-
tingly instigated by deprecation of another physician to an already dissatisfied patient.5,6

Informed Consent

Most physicians regard the process of informed consent as mainly a legal encum-
brance. In reality, the discussion of risks is arguably the most effective means of risk
prevention available. As has been noted in a separate chapter, educating patients to
the fact that complications can and do occur and being as certain as possible of their
acceptance of this fact is a very strong defense. Those physicians who fail to make
optimal use of informed consent are losing a valuable opportunity to get a big edge
in risk prevention. The importance of informed refusal, discussed in the chapter on
informed consent, cannot be overemphasized. Too many physicians are unfamiliar
with this concept, which occurs far more frequently than is realized. Physician
vulnerability to this problem is equally as serious as that from informed consent.

Documentation and Medical Records

Medical record keeping is viewed by physicians as mainly a legal encumbrance.


What physician has not heard the warning, “Every time you write in a chart, medi-
cal record, operative report, etc., you create a legal document that can be used
80 M.F. Kraushar

against you in court?” There are countless stories of physicians whose court testi-
mony was impeached by a contradiction in the medical record.
Conversely, an accurate and complete medical record is not only a strong
defense strategy, it is also a very powerful risk prevention tool for the physician.
The keys to good documentation are legibility, consistency, completeness, accu-
racy, and timeliness. Medical records tell a lot about the person who produced
them. A thorough, organized, neat record indicates that the physician and his or her
treatment are also thorough and organized.7 During the prelawsuit activities (see
Chapter 6), before an attorney decides whether to accept a case, he or she will go
over the written materials and will pay attention to the smallest details. So also will
the physician who is selected as the expert witness for the plaintiff. If the attorney
or the expert can find anything in the records that appears to be an error, he or she
will be encouraged to go pursue the claim. If there is any deviation from an uncom-
plicated, perfect course and the exculpatory facts have been clearly noted, it will
tend to discourage the initiation of a lawsuit. If a diagnosis has been missed and the
appropriate facts are clearly present to excuse the mistake, litigation is far less
likely to occur. The bottom line is to consider the questions, “Whom am I trying to
convince?” and “How will this look to a jury or a plaintiff’s expert?”
A typical example is the allegation of a missed retinal break. Because the stand-
ard of care requires only that the physician perform as well as the average physician
in his or her circumstance, mistakes are permissible provided that the appropriate
means were used to avoid them. Therefore, a retina drawing showing that the ocular
fundus was examined is essential to include for support. Evidence that the anterior
vitreous was examined for the presence of retinal pigment is also helpful. It is also
appropriate to indicate the patient was advised to return if the symptoms worsened.
All of the above steps are exculpatory in the event of a missed retinal break, but
merely telling a jury you did the examination is usually insufficient. Juries tend to
believe, “If it isn’t written in the chart, it wasn’t done.” This also applies to includ-
ing pertinent negative findings. An example is failing to include denial of symp-
toms of cranial arteritis by an elderly patient with a central retinal artery obstruction.
If the patient actually has the disease and suffers additional problems because of
delay or failure to treat, a jury will not be favorably impressed by the physician’s
explanation that he or she does not record pertinent negatives.
One of the first documents the expert will read if there is a surgical problem is
the operative report, which is the bottom line as far as evidence is concerned in a
lawsuit involving surgery. The operative report should be dictated within 24 hours,
because, if it is dictated a significant time after the operation, it may give the
appearance of being contrived. When dictating the report the physician must antici-
pate it will be read by an expert in the same specialty. Therefore, it is essential that
if a complication occurs the operative report must include information to show that
the appropriate steps were taken to avoid the complication, the complication was
diagnosed in a timely manner, and the complication was managed appropriately.
This information can be essential in preventing or defending a lawsuit.
Documentation that is also contemporaneous is a very strong defense. An oph-
thalmologist does an intravenous fluorescein angiogram on a patient at 2 PM. That
Chapter 8. Risk Prevention Strategies 81

evening the patient’s wife calls while the doctor is at the arena watching a basket-
ball game and reports that her husband has chest pain, shortness of breath, and pain
radiating to the left arm and asks whether it is related to the angiogram. The oph-
thalmologist says it sounds like a heart attack and tells the wife to call the emer-
gency squad as soon as possible. The doctor forgets about the call and makes no
note of the conversation in the office record the next day. The patient actually
refused to call the emergency squad, remained at home, and died 12 hours later.
A lawsuit for wrongful death followed in which the patient’s wife claimed the oph-
thalmologist had never suggested the possibility of a heart condition and said it was
probably a transient reaction to the angiogram. The ophthalmologist eventually
settled the claim. A note in the medical record entered the morning after the phone
call would have been difficult to refute. Similar precautions should be taken when
the ophthalmologist is on call for other physicians.
I have encountered the following scenario on several occasions. An ophthal-
mologist performs uneventful cataract surgery and sees the patient on the first
postoperative day. The corrected vision is 20/30, and everything looks fine. Two
nights later, the patient calls after office hours with vague symptoms of mild dis-
comfort and an itching feeling around the eye. The cataract surgeon (or a covering
on-call ophthalmologist) decides it is not endophthalmitis and tells the patient to go
to the office the first thing in the morning. On examination the next morning there
is clearly endophthalmitis, and after appropriate treatment the best corrected vision
is hand motions. Several weeks later the ophthalmologist (surgeon or covering
ophthalmologist) writes a long note describing the questions he asked the patient
during the evening phone call along with the patient’s responses, which he now
adds to the chart as exculpatory evidence. This document, written long after the
event, will certainly make a different impression on a jury than if it had been written
in the record during or immediately after the examination the morning following
the phone conversation.
In my experience, the above scenario occurs more frequently in lawsuits involv-
ing the covering on-call physician than the operating surgeon. This may be because
of unfamiliarity with the patient or the fact that we may on occasion be less con-
cerned with the patients of others than with our own. When covering the practice
of other physicians, it goes without saying that we should be as diligent as we
would be with our own patients. To this end it is a good idea to keep a dedicated
file of on-call encounters with patients of other physicians wherein information
such as disposition of phone call messages and their contents are stored. It is good
medical practice to entrust the care of your patients during your absence to only
those physicians whom you know to be caring and competent.
Alteration of records can be the most damaging evidence possible to the defense
of litigation. Some malpractice insurance policies include a stipulation that alteration
of the record may be grounds for the company to revoke responsibility for coverage of
the insured. Analysis of ink, paper, watermarks, and so forth can enable an expert in
document analysis to detect that part or all of a record was rewritten. If review of the
record indicates there is an inaccuracy or omission, the best way to manage it is to
draw a line through the problematic part of the chart in such a manner as to maintain
82 M.F. Kraushar

the legibility of the original material and add the changes with the date of the change
and the writer’s initials. Corrections of hospital chart entries by house staff, nurses, and
other staff should be made as a separate dated note. Adding a change in the margin
even though it is signed and dated can appear suspicious.
Even the most minimal alteration of a medical record can cause a problem. A cata-
ract surgeon operated on the eye of a patient with bilateral cornea guttata and brunes-
cent cataracts. The patient was properly informed of the risk of postoperative corneal
decompensation. The surgeon dictated the operative note as if everything went per-
fectly with no problems, when in fact the phacoemulsification time was greatly pro-
longed. The recovery room record showed the patient did not arrive until 1 hour and
15 minutes after the surgery started. In the anesthesia record one digit of the time when
the operation was completed was altered in an obvious manner to indicate the surgery
took 15 minutes instead of over an hour. The patient eventually developed bullous
keratopathy, and the surgeon wrote in the office record that it was “probably due to
the prolonged phaco time.” An eventual corneal transplant was unsuccessful.
Approximately 1 year later the patient contacted an attorney to investigate the possibil-
ity of negligent surgery. The combination of the “perfect surgical procedure” in the
operative note plus the office record note of “prolonged phaco time” in addition to the
altered time of the duration of the surgery appeared suspicious to the ophthalmologist
who was retained as a plaintiff expert. The statute of limitations was about to expire,
so the attorney, after getting a “certificate of merit” from the expert, instituted a lawsuit
to protect the patient’s right to sue. After reviewing all the documents and deposition
testimony the plaintiff’s expert found no negligence and the claim was dropped. The
process cost the physician’s insurance company money for in-office expenses (secre-
tarial, attorney, medical expert, etc.). The claim was added to the physician’s record,
and the cost of his subsequent premiums was raised significantly.

Identifying and Managing the Litigious Patient

There is no accurate demographic profile of those patients who are likely to sue.
One study8 indicated that attorneys are 10 times more likely to sue than the general
population. Unfortunately, there is a mythical profile suggesting that patients who
are chronic complainers, poorly compliant, and/or cynical or angry are more likely
to sue.9 Although these patients can be more of a challenge to manage, studies have
shown that they are no more likely to sue. However, according to Bradford,10
[If] a new patient looks like trouble, the best strategy is to tell him that you and he are not a good
match and he’d best be served by another physician. Once you embark on a treatment plan it
will become much more difficult to terminate him later on even if you do it by the book.

Even the most loyal-appearing patients sue. An example is a young physician’s


widow with no insurance who was treated gratis for years and who bought the oph-
thalmologist a tie every Christmas. After developing a postoperative pseudophakic
retinal detachment, she initiated a nonmeritorious lawsuit.
Chapter 8. Risk Prevention Strategies 83

The only reliable constant element regarding a patient’s likelihood of suing is


that patients usually sue only for a bad result (or for a result that they feel is bad).
It is important to alert office staff to report to the physician any patient behavior
that is demonstrative of dissatisfaction with anything about their experiences in the
office. Insufficiently trained office staff typically hesitate to report such informa-
tion for fear the physician will affix blame to them. Practice management consult-
ants advise that informing the physician of patient dissatisfaction is essential to
improving the atmosphere in a way that pleases patients and makes their opinion of
care received more favorable. This also alerts the physician to the fact that what he
or she feels is a good result may not be viewed as favorably by the patient.
Patients who achieve a bad result require a different pattern of management. These
patients often harbor feelings of resentment and even hostility toward the treating
physician. It is a good idea to flag the chart so all the staff is aware of the situation.
Every possible effort should be made to maintain the physician–patient relationship
through continuing patient visits. The patient should be seen twice as often as other
patients would be in the same situation. If an appointment is missed the patient should
be contacted by the staff member who can provide the most tender, loving care. If
necessary, the office should offer to send and pay for a cab. The staff and the physician
should be patient and solicitous and elicit the patient’s concerns while spending as
much time as is required to assuage them. At the first sign of deterioration of the physician–
patient relationship, the physician should consider referring the patient for a second
opinion to a trusted, qualified colleague who has been advised of the situation.
Mrs. Jones, I sense you are not happy with your result and that makes me unhappy also.
Perhaps another ophthalmologist can come up with a fresh idea to help you. I would like
to have my office to make an appointment for you to be seen by Dr.…

The aim of this referral is to prevent the patient from doctor/lawyer shopping on his
or her own and to reduce patient–physician hostility. The second opinion physician
can calm such patients’ anxieties by assuring them that everything was done prop-
erly and may even be able to assume the continuing care. In this manner the treating
physician can maintain control of the physician–patient relationship. At the begin-
ning of the series of events in a lawsuit (see Chapter 6) many insurance companies
send a representative to the physician’s office to obtain a narrative summary of the
records from the first day to the last visit. The typical narrative ends with the doctor
saying, “And that’s the last time I saw the patient.” That is actually when the physi-
cian lost control of the physician–patient relationship and that is specifically what
this patient management pattern is designed to avoid.

Risk Prevention Opportunities for Perceptive Ophthalmologists

All ophthalmologists have occasion to see in the office patients who are dissatisfied
with the treatment of another physician. Sometimes these patients harbor anxiety
and resentment toward the treating physician. Because only the patient’s side of the
84 M.F. Kraushar

situation is available, it is usually difficult to make a fair judgment of the treatment


rendered. The criterion to which an expert witness is held is whether he or she can
make a decision “within reasonable medical probability.” In this situation a dispas-
sionate review of the available facts is essential. If it appears likely that the treat-
ment was appropriate, the second ophthalmologist has a unique opportunity for risk
prevention. He or she can reinforce the “treating physician–patient relationship” by
saying something such as, “I would have done it the same way.” It may be appro-
priate to repeat all or part of the informed consent discussion as it applies to the
treatment rendered. In this manner the patient’s anxiety and resentment toward the
treating physician can be resolved and possible litigation avoided.

References

1. Saba GW, Wong ST, Schillinger D, et al. Shared decision making and the experience of part-
nership in primary care. Ann Fam Med 2006;4:56–62.
2. Kraushar MF. Practical and philosophical considerations of the physician–patient relationship.
Ann Ophthalmol 1987;19:83–84.
3. Beckman HB, Frankel RM. The effect of physician behavior in the collection of data. Ann
Intern Med 1984;101:692–696.
4. Frankel RM, Morse DS, Suchman A, Bechmen HD. Can I really improve my listening skills
with only 15 minutes to see my patients? HMO Pract 1991;5:114–120.
5. Jacobsen HL, Tucker RD. How to defend yourself in an ophthalmic malpractice suit. Arch
Ophthalmol 1985;103:1793–1794.
6. Bradford EW. Big mouths cause malpractice suits. Med Econ 1986;3:310–313.
7. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little, Brown &
Co.; 1977:60.
8. Kraushar MF. Medical malpractice experiences of vitreoretinal specialists. Retina
2003;23:523–529.
9. Kraushar MF. Recognizing and managing the litigious patient. Surv Ophthalmol
1992;37:54–56.
10. Bradford EW. Can you spot potential plaintiffs? Med Economics December 16, 2005:62–68.
Chapter 9
Revelation of Adverse Events
and the Conundrum of an Apology

Peter H. Morse and Marvin F. Kraushar

Introduction

Disclosure of error and apology in the practice of medicine is an evolving concept


and procedure. Currently, a few institutions have policies for disclosure of error
that often include an apology.1 Approximately 30 states have passed legislation
making physician’s apologies, including admission of fault, subsequently inadmis-
sible in malpractice litigation. Not all these statutes are equally protective of physi-
cians. Other states have laws allowing expression of regret, caring, and consolation
without admitting fault.1
Recently, prompt disclosure of medical error to the patient in a timely manner
has been endorsed as ethically proper by the American Medical Association
(AMA). Furthermore, honest dialogue is regarded as a means of strengthening the
relationship between a physician and a patient, thereby enhancing the prevention of
litigation.2,3 No action should be taken by a physician or a member of his or her
office staff before a thorough investigation of the case, circumstances, results, and
possible attendant damages have been discussed with the insurance company and
the appropriate lawyers. However, some states require that the patient or the
patient’s family be advised of the adverse event during the episode of care or, if
discovered afterward, in a timely fashion. Therefore, prompt investigation and
evaluation on the physician’s part is recommended.

Modification of Behavior

The spectrum of conventional social intercourse includes interaction among


physicians, patients, and attorneys. Within the structure of civil behavior, apol-
ogy is an integral category of demeanor. Because of the phantom of malpractice
litigation with the accompanying anxiety and fear, a collapse of normal accepta-
ble human behavior often occurs. The result is frequently manifest in ways rang-
ing from inexcusable discourtesy to barbaric incivility between and among
individuals.

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 85


doi: 10.1007/978-0-387-73341-8; © Springer 2008
86 P.H. Morse and M.F. Kraushar

Ordinary Courtesies

To avoid or mollify offense, an apology may be appropriate in many patient


encounters. Common examples are apologies for a prolonged waiting time at an
appointment, addressing a patient by his or her Christian name rather than surname,
failing to allow a patient to complete a statement, and forgetting to fully and clearly
explain a diagnosis and treatment plan.
Circumstances become more complicated and threatening when there is patient
dissatisfaction or mistrust and the feeling that a mistake in medical or surgical judg-
ment may have been committed. Many physicians have a self-image of invincibil-
ity and devotion to perfectionism that renders a suspicion or admission of fallibility
difficult or unachievable.1 Furthermore, physicians have an understandable ten-
dency to resist both disclosure and apology because of the fear of potential litiga-
tion or of being reported by the patient to the hospital or to the state board of
medical examiners.1

Gravity of the Offense

An error in evaluation and treatment must be distinguished from an unfortunate


result. Failure of treatment in complicated situations or diseases with a low
expectation of improvement or cure is ordinarily not considered an offense
requiring an apology.1 An unfavorable outcome often creates a feeling of guilt in
the physician; however, consolation rather than an apology is a more appropriate
response.

Prevention of Risk

If disclosure to the patient is to be made, it should be done as soon as possible after


the occurrence for which it is required. The physician having the greatest rapport
with the patient and family should be the spokesperson. Complete information
should be provided along with plans for further analysis and treatment.
Additional assurances that plans have been made to prevent recurrence of adverse
events are also advisable. Many failures occur because of a defect in systems or
processes. The responsible people must attempt to correct errors and if necessary
initiate changes in procedures to preclude similar mistakes in the future.
The patient and family should be advised as the situation evolves. Complete
honesty is important because the patient’s medical records are available to him or
her and to involved attorneys. Statements made to a patient may be discoverable in
a lawsuit, and care must be taken that the statements made are objective and factual.
Chapter 9. Adverse Events and Apology 87

Explanations must be given without blame. If an attempt is made to conceal an


error or injury to a patient, one might be guilty of “fraudulent concealment.”3
Disclosure and apology may be coincident but are not identical. Apology is
appropriate when facts and evidence reveal a preventable error.3 An apology is not
an admission of fault. However, protection against an admission of fault is not
invariable, and one must be knowledgeable with respect to the situation in a partic-
ular jurisdiction. No statement by a physician or any health care personnel should
be made without this information and counsel.

Structure and Effect of Apology

An apology may be defined as an acknowledgment of responsibility for an offense


or error that is coupled with an expression of remorse.1 The four components in the
structure of an apology are acknowledgment of the offense; explanation or reason
for the commission of the offense; expression of remorse, shame, forbearance,
humility; and reparation.1
The following are several salutary mechanisms in apology. If the patient feels
humiliated, an apology may restore dignity and self-respect. Concern for the well-
being of the patient and the patient’s family may be communicated through apol-
ogy. Patients often feel powerless after an offense, but the knowledge that changes
are being made to correct the error and prevent future errors may restore a sense of
power to the patient.
Some patients and their families are vindictive and wish to witness suffering by
those whom they view as the offenders. A physician’s appearance and manner dur-
ing an apology may help to mitigate this desire on the part of the patient.
Some patients require validation that the offense occurred and that it has become
part of his or her history and identity. Especially when infants or children are
injured, parents feel variable intensities of guilt and are comforted by the assurance
that they are not at fault.
Confirmation of shared values is important for continuing trust in a patient’s
relationship with a physician. The patient must know that what he or she feels to be
an error is also the opinion shared by those involved in his or her health care. An
injured party also desires to feel some hope or promise for the future with knowl-
edge that individuals or institutions responsible for the alleged offense are taking
or have taken corrective and preventive measures.
Emotions commonly felt by patients in adverse situations are anger, frustration,
helplessness, abandonment, and fear. Physicians must be aware of this and be avail-
able and willing to have appropriate and empathic dialogue about the concerns of
the patient and the patient’s family.
Reparations may also be a therapeutic part of an apology and do not always require
legal intervention. Reparations may take many forms, including facilitating subsequent
appointments with physicians, canceling bills, and making a financial settlement.1
88 P.H. Morse and M.F. Kraushar

Inadequate Apology

The fact that an apology has been made is insufficient. In fact, an inadequate or
cursory apology may worsen a situation. A peremptory “I am sorry” is not enough.
Often apologies fail to acknowledge responsibility or attempt to make an excuse or
partial excuse in the apologetic statement. Many vague, tangential, or oblique
impersonal phrases are invoked in an apology. Examples include such phrases as
“I am sorry for what happened” or “mistakes were made.” Conditional statements,
such as “if there was an error” or “a mistake was made but” or “these things happen
to the best of people,” should not be used. Unacceptable explanations, arrogance,
or inadequate reparation may also degrade or negate the effect of an apology.1

Conclusion

An apology when indicated may be regarded as a therapeutic intervention. All too


often psychological aspects, which are part of complete patient care, are disregarded.
A cleansing or catharsis for both physician and patient may be effected by a proper
apology. Previous satisfactory relationships may be enhanced, and damaged relation-
ships may be repaired. Rendering an apology by the physician may provide atone-
ment by diminishing the feeling of guilt and shame and apprehension of retaliation.
For the offended patient, receiving an apology may expunge a grudge and abate ine-
luctable corrosive anger, thereby facilitating forgiveness and reconciliation.1
Despite some evidence that apologies seem to decrease the prevalence of malprac-
tice litigation, there is an understandable hesitancy and lack of certitude on the part
of physicans.1,4 This aspect of medical practice should be further explored in that it
may ameliorate heretofore insoluble aspects of patient care and medical–legal con-
flicts. It is a conceivable manner for negotiation between a physician and an injured
patient. Furthermore, initiation or enhancement of cooperation between physicians
and attorneys may be possible. Even if no formal method or procedure evolves, a
greater comprehension of the psychology involved in the perception of injury by the
patient may help to modify a physician’s interpersonal behavior and relationships.

References

1. Lazare A. Apology in medical practice: an emerging clinical skill. JAMA 2006;296:1401–1404.


2. Joint Commission on Accreditation of Healthcare Organizations. Standard R1.1.2.2, July 1,
2001. Available at: http://www.jointcommission.org/.
3. Perspectives on Prevention. Minneapolis: Midwest Medical Insurance Company, August 2006,
pp. 1–4.
4. Zimmerman R. Doctors’ new tool to fight lawsuits: saying “I’m sorry.” Wall Street Journal
May 18, 2004, A1.
Part 2
Risk Management in the Ophthalmic
Subspecialties and Related Fields

The 13 chapters in Part 2 are not intended to be comprehensive recapitulations of


“how to do it” with respect to the clinical management of patients with ophthalmic
disease. The authors discuss only those problems that arise in the management of
diseases in their field that, in their experience as consultants and experts, most com-
monly lead to litigation, and they offer opinions on how best to maximize risk
management. For example, because presbyopia surgery is in its developmental
infancy and the optimal procedure for specific candidates has not yet been deter-
mined, there is presently no significant track record regarding the malpractice
litigation experience. The suggestions offered are not in any way intended to be
regarded as establishing a standard of care.
Because some diseases can appropriately be categorized in more than one field
there is some overlap of discussion within chapters. While there is variation within
these chapters with respect to the spectrum of diseases, there are also similarities in
risk management modalities, such as establishing a good physician–patient rela-
tionship, having an effective discussion of informed consent, and maintaining ade-
quate documentation. Additionally, many of these chapters have their own unique
indications for these same modalities. For example, while informed consent is
essential for all fields, it is of even greater importance for elective procedures such
as clear lens exchange, cosmetic surgery, or LASIK. Although establishing a good
physician–patient relationship can be relatively easily accomplished during the
management of long-term problems such as glaucoma and strabismus, it is a more
challenging task in the management of acute problems such as trauma and retinal
detachment. The concept of documentation is of particular importance in the preop-
erative evaluation of cosmetic surgical patients.
Based on the advice of noted ophthalmic pathologists, no specific chapter is
devoted to the subspecialty of pathology because lawsuits of this nature are uncom-
mon and are typically brought against the ophthalmologist managing the care of the
patient, that is, the generalist, retinavitreous surgeon, pediatric ophthalmologist,
ophthalmic plastic surgeon, ophthalmic oncologist, and so forth. The discussion of
these problems is included in the appropriate subspecialty chapters.
Chapter 10
Anesthesia

Peter H. Morse and Marvin F. Kraushar

Sixty percent of the total indemnity paid to a group of patients who brought
lawsuits against ophthalmologists for complications related to the management of
cataract was for claims involving anesthesia.1 In this study, complications of
anesthesia had the highest ratio of indemnification per claim of any category. An
analysis of claims of eye injury associated with anesthesia showed 30% were char-
acterized by patient movement during ophthalmic surgery. Blindness occurred in all
these cases, most during general anesthesia, but in one of four cases, under moni-
tored anesthesia.2 Complications from the administration of anesthesia for ophthalmic
surgery are relatively uncommon; however, the losses from these claims are more
expensive because the most severe injuries involve significant loss of vision, serious
physical disability, or death.
Ophthalmologists traditionally administer topical and local (regional) anesthesia.
An anesthesiologist or Certified Registered Nurse Anesthetist (CRNA) typically
monitors regional anesthesia and administers general anesthesia. In many jurisdictions,
regional blocks are given by anesthesiologists and CRNAs. This may create anxiety
on the part of a patient unfamiliar with the person giving the anesthesia. In addition,
a lawsuit arising from the actions of nonophthalmologic practitioners providing
anesthesia to one’s patient may cause one to be sued for vicarious liability even
though the practitioner is not in one’s employ. It is therefore imperative that the
ophthalmic surgeon be familiar with the training, experience, and other pertinent
credentials of personnel administering local anesthesia to his or her patients.
Anyone giving anesthesia should pay meticulous attention to detail and be
thoroughly familiar with ocular and orbital anatomy, physiology, and the pharmacology
of the agents used.
While anesthesia problems involving litigation usually involve permanent injury
to a patient, they are not necessarily the result of a deviation from the acceptable
standard of care expected of an ordinary, well-qualified practitioner. Because
patients do not anticipate difficulties from anesthesia, practically any problem may
elicit investigation for possible litigation.

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 91


doi: 10.1007/978-0-387-73341-8; © Springer 2008
92 P.H. Morse and M.F. Kraushar

Topical Anesthesia

Some topical anesthetics, especially cocaine, may cause clouding of the corneal
epithelium. Idiosyncratic reactions are rare. Cocaine blocks the re-uptake of norepine-
phrine at nerve terminals causing a sympathomimetic effect. Ocular instillation, even
with very low plasma levels, may create severe bradycardia.2,3
Bupivacaine, lidocaine, proparacaine and tetracaine have all been used topically
and intracamerally for cataract extraction. Some claim this route of anesthesia is
insufficient. Although it lacks akinesia and requires a cooperative patient, it is the
method of choice for a large number of cataract surgeons. It is imperative that
patients are carefully selected and appropriately counseled for this type of anesthesia,
including a thorough discussion of informed consent. Additional sedation is
generally required.4

Local Anesthesia

General Considerations

There is greater patient awareness in anticipation of and during procedures per-


formed under local anesthesia than with general anesthesia. Therefore, critical and
prolonged preparation is required. No haste should be evident and thorough
informed consent should be obtained. If an anesthesiologist is involved, either in
the administration or monitoring of anesthesia, he or she should spend time with
the patient. Oversedation should be carefully avoided to facilitate patient cooperation.
Often, hearing aids and dentures should be left in place for patient comfort.
Attention is given to patient transport and positioning. Equipment for and personnel
experienced with emergency resuscitation must be readily available.
Risk factors for regional anesthesia include inadequate sedation, a communi-
cation barrier, lack of patient cooperation or desire, and patients with spontane-
ous chronic coughing, shortness of breath while recumbent, a recently operated
or inflamed eye, prolonged operations, Parkinsonian head tremor, Alzheimer’s
disease, and/or claustrophobia.4 General anesthesia should be considered for such
patients.
Complications following injection of local anesthetics are rare and estimated at
1 in 500. Awareness of possible interactions of a patient’s medications and anes-
thetic agents is paramount. Most reactions occur within 15 minutes of injection and
are usually the result of apprehension, pain, oversedation, local anesthetic toxicity,
method of needle placement, or injection of local anesthetic. Hypotension, brady-
cardia, diaphoresis, nausea, and cardiac arrest are usually elicited by fear, pain, or
manipulation of the globe. True allergic reactions occur in less than 1% of local
injections and are characterized by wheezing, urticaria, and respiratory distress.5-8
With the Nadbath block of the stylomastoid foramen for facial akinesia, the
Chapter 10. Anesthesia 93

anesthetic may spread to the vagus, glossopharyngeal, or spinal accessory nerves,


causing respiratory distress and dysphagia.
Systemic complications may follow an overdose or intravascular injection of
adrenline, which is often combined with the anesthetic to extend the duration of
the local block. Hyaluronidase, used to hasten the onset and quality of the block,
rarely causes an allergic reaction.9 Respiratory arrest may occur after intravenous
sedation.7
Systemic toxicity from local peribulbar 4% xylocaine injection leads to toxic
central nervous system dysfunction and cardiac depression. For a 70 kg patient, a
total volume of 7.5 mL of 4% xylocaine is safe. For a smaller patient, no more than
5 mL should be given.4

Retrobulbar Hemorrhage

Retrobulbar hemorrhage is estimated to occur in 1 of 700 retrobulbar blocks. Other


citations of prevalence range from 0.1% to 1.7% of patients. Predisposing factors
are elderly patients and those receiving corticosteroids, aspirin, nonsteroidal anti-
inflammatory medications, and anticoagulants.4
The mechanical tamponade of the hemorrhage causes increased intraocular pres-
sure (IOP), which may cause central retinal artery compression or occlusion
(CRAO). Osmotic diuresis, anterior chamber paracentesis, lateral canthotomy, and
decompressive surgery may be required. The IOP should be measured and the optic
nerve should be observed for arterial pulsation and pallor. Similar complications
may occur following the injection of an excessive volume of anesthesia in the orbit.
If the lack of clarity of the ocular media precludes adequate visualization of the
optic nerve, an empirical lateral canthotomy may be advisable.10

Penetration or Perforation of the Globe

Whenever any medication is injected near the outside of the eyeball and the tip of
the needle cannot be visualized, maximal care must be taken to be as certain as
possible that the needle tip is in the desired location prior to injection. Unintended
insertion of a needle into the globe (penetration) or through the globe with an entry
wound and an exit wound (perforation) is a rare complication. Myopic eyes, often
longer than 26 mm, are at greater risk because of the posterior, staphylomatous
bulge and the relative thinness of equatorial myopic sclera. Other estimates place
high risk eyes at 23.5 mm or greater length. Perforation may occur with either ret-
robulbar or peribulbar (periconal) blocks. Direct damage by the needle to the fovea
or optic nerve may occur. A retinal tear or detachment is also possible. Referral to
a retinavitreous specialist is advisable if there is any difficulty completing a thor-
ough examination of the ocular fundus.
94 P.H. Morse and M.F. Kraushar

Although pain at the time of the block is typical when a needle enters the globe,
many patients experience no pain, thus making a timely diagnosis more difficult.
Penetration of the globe as opposed to a through and through perforation carries the
additional risk of accidental injection of anesthetic into the eye. This will raise the
IOP and the person administering the block will sense back pressure on the plunger
of the syringe. Even a minimal amount of fluid injection into the eye can increase
IOP sufficiently to cause partial or complete CRAO in which case the patient may
complain of loss of vision. Another clue may be loss of the red reflex due to a vitre-
ous hemorrhage from a choroidal or a retinal vessel. On withdrawal of the needle,
there may be leakage of vitreous from the entry site with attendant hypotony. Every
patient who receives medication of any kind by periocular injection in whom a
postinjection vitreous hemorrhage is diagnosed should have a prompt, thorough
examination of the ocular fundus to rule out the possibility of accidental intrusion
of the needle. If the hemorrhage precludes adequate visualization and fails to clear
rapidly, serious consideration must be given to the need for pars plana vitrectomy.
The risk of this complication may be minimized by having the patient look in
the primary (neutral) position of gaze rather than upward and nasally during retro-
bulbar injection. When giving peribulbar or retrobulbar injections, it is often forgot-
ten that the globe curves outward in the orbit. Especially with peribulbar anesthesisa,
the risk of perforation is enhanced because the injections are often given with the
needle inserted straight backward rather than angled away from the globe toward
the orbital wall. To avoid unintended intraocular injection of anesthetic, it has been
recommended11 that once the practitioner thinks the needle tip is in the proper loca-
tion and prior to injecting anywhere in the immediate vicinity of the outside of the
eyeball, the syringe should be moved in and out as well as circumferentially. An
experienced practitioner will be able to discern the difference between motion of
the globe caused by traction on Tenon’s capsule as opposed to motion due to traction
from an intrascleral needle. The risk of causing a retrobulbar hemorrhage with this
maneuver is negligible and the usual consequences are far less dangerous than
those of accidental intraocular injection of anesthetic.
An example of this is a twenty-eight year-old male who presented with a tem-
poral pterygium and vision of 20/20 in his right eye (OD). The visual acuity in his
left eye (OS) was 20/200 because of amblyopia. The patient underwent removal of
the pterygium following a subconjunctival injection of xylocaine 2%. The adminis-
tration of local anesthesia and surgery were believed to be uneventful. When the
patch was removed the following morning, the patient had hand motions vision OD.
There was no evidence of retrobulbar hemorrhage, there was no proptosis of the
eye, and there was a full range of motion. Examination of the ocular fundus
revealed a cherry-red fovea with a pale retina secondary to CRAO from undetected
accidental intraocular injection of the anesthetic. Despite immediate referral to a
retinavitreous specialist and extensive therapeutic efforts, the visual acuity never
improved. At trial there was a multimillion dollar award by the jury.
Because an eye is anesthetized, it does not diminish the risk of inadvertent
penetration and a number of cases involving intraocular injection of antibiotic or corti-
costeroid have occurred. Intraocular Gentamycin may cause irreparable loss of vision.
Chapter 10. Anesthesia 95

One situation involved gross misdirection of the needle with tearing of the retina
and subretinal injection of corticosteroid beneath the macula. Vision was lost and
the claim was settled.

Amaurosis

Temporary loss of vision may occur from anesthetic blocking the optic nerve or
being accidentally injected into the eye. Patients having regional blocks, especially
retrobulbar, should be warned of loss of vision up to perception of light and, if some
vision is retained, it does not mean that the block is ineffective. Patients may also
be aware of the microscope light and some movement during surgery.

Atrophy of the Optic Nerve

In the 1950s and 1960s, there were numerous reports in the literature12 of optic atro-
phy of unknown origin developing six to twelve weeks after cataract surgery. At the
time it was commonplace for the ophthalmic surgeon to stand at the contralateral
shoulder of the supine patient and direct the patient to look superonasally at him dur-
ing retrobulbar insertion of the anesthetic needle at the inferotemporal aspect of the
orbit. In this manner the upward-inward gaze of the patient brought the posterior part
of the globe and the optic nerve inferotemporally to facilitate the location of the nee-
dle tip as close to the optic nerve as possible for maximal anesthetic effect. In retro-
spect, this maneuver increased the risk of needle trauma to the optic nerve and the
central retinal artery. This is an additional indication for the patient’s eye to be in the
primary (neutral) position of gaze during the insertion of the needle.
Another practice of anesthetic delivery, which has been discontinued, is intraconal
injection. It was the aim of this technique to pierce the muscle cone with the needle
in order to inject the anesthetic closer to the optic nerve and the ciliary ganglion. This
technique had the added putative advantage of requiring a smaller volume of anes-
thetic and achieving the anesthetic effect faster without having to wait for diffusion
of the anesthetic through the muscle cone. However, this technique carried the unde-
sirable risk of placing the needle tip dangerously close to the optic nerve.
Optic atrophy or central retinal artery occlusion may be caused by direct needle
tip damage to the optic nerve or the central retinal artery or by injection into or
hemorrhage within the optic nerve sheath. The fundus may resemble Purtscher’s
retinopathy. If this is suspected, an urgent MRI might identify the problem and
optic nerve sheath decompression can be performed. Celerity is essential for effec-
tive treatment.
The standard needle provided in most operating rooms is 1.50 inches in length. It
has been suggested13 that to avoid the risk of damaging the optic nerve the needle
for retrobulbar injection should be no longer than 31 mm or 1.25 inches in length.
96 P.H. Morse and M.F. Kraushar

Since the difference between a 1.25 inch needle and a 1.50 inch needle may not be
readily apparent, it is a good idea for anyone who requests a 1.25 inch needle to check
the label on the wrapper prior to injecting. In peribulbar injection, a 5/8 inch needle
is sufficient. Needles should never be inserted beyond 25 mm of the orbital rim.
While length of the needle is often emphasized, it is knowledge of the anatomy of the
orbit and careful attention to technique of injection that is critical.
Damage to the optic nerve may also occur following retrobulbar hemorrhage
with or without acute retinal vascular occlusion. The increased orbital pressure may
occlude the small nutrient vessels to the optic nerve without signs of retinal vascular
occlusion. This complication may lead to late optic atrophy and result in partial to
complete visual loss.

Penetration of the Optic Nerve Sheath

The optic nerve has a complete dural cuff extending to the sclera. An injection of an
anesthetic agent into this cuff leads to direct spread to the central nervous system via the
subarachnoid space. This can lead to protean symptoms and signs, including increased
or decreased cardiovascular vital signs, pulmonary edema, drowsiness, vomiting, and
contralateral blindness because of reflux of the drug to the optic chiasm or an air bubble
in the sheath. Contralateral oculomotor paralysis, facial palsy, deafness, vertigo, aphasia,
loss of neck muscle power, vagolysis, shivering, convulsions, respiratory depression or
arrest (apnea), neurological deficits, hyperreflexia, hemiplegia, paraplegia, quadriple-
gia, and cardiac arrest may be seen. If the diagnosis is made in a timely manner and if
appropriate life support is instituted promptly and continued until the anesthetic is
metabolized, permanent deleterious complications can be avoided.4,5,14

Brainstem Anesthesia

Manifestations of brainstem anesthesia have interconnections with those of injec-


tion into the optic nerve sheath. The symptoms usually appear within 8 minutes but
vary from immediate to 40 minutes. This complication occurs with either retrobulbar
or peribulbar anesthesia. Symptoms and signs of this potentially fatal complication
may be amaurosis, gaze palsy (ductional defects), dysphagia, shivering, tachycardia,
hypertension, loss of consciousness, dilation of the contralateral pupil, apnea, and
cardiac arrest4,5,14 Resuscitation equipment and personnel trained in its use must be
available. Alertness and cognizance of this possible complication with institution
of early therapy usually leads to full recovery.
An an example, A CRNA administered a retrobulbar block to the right eye of a
cataract patient. Within ten minutes, the patient noted bilateral amaurosis and shortly
thereafter became apneic and lost consciousness. Following prompt recognition of
the problem by the ophthalmologist, the patient was intubated and maintained on life
support. When the patient regained consciousness and was extubated, she described
Chapter 10. Anesthesia 97

the return of vision in only the left eye. The vision in the right eye was hand motions
and never improved. A few weeks later the right optic nerve was noted to be
atrophic. A lawsuit ensued alleging improper technique in administering the retrob-
ulbar block causing irreversible damage to the right optic nerve and other temporary
injuries due to injection of anesthetic into the subarachnoid space. The ophthalmolo-
gist was included in the suit with the CRNA. The defense claimed that the injury
occurred because the patient suddenly lifted her head as the retrobulbar needle was
inserted thus driving the needle tip farther posterior than was intended. The jury
found for the defense.

Accidental Intravenous Injection

Symptoms of accidental intravenous injection include cutaneous numbness, confu-


sion, dizziness, drowsiness, twitching, unconsciousness, convulsions, coma, apnea,
hypoxia, hypotension, bradycardia, ventricular fibrillation, cardiac arrest, and
death. Routine withdrawal of the plunger of the syringe prior to injecting can help
avoid this problem.14

Accidental Intra-arterial Injection

As a result of accidental intra-arterial injection, acute grand mal convulsion may


occur. This can be avoided by routine withdrawal of the plunger of the syringe prior
to injection.14

Oculocardiac Reflex

This trigeminal-vagal reflex is caused by traction on the extraocular muscles, pain,


and pressure on or manipulation of the globe. A local anesthetic block usually
ablates this reflex. The person administering the anesthetic should be aware that the
injection may occasionally provoke an oculocardiac reflex at the time of injection
because of rapid distention of the tissues by the fluid injected or hemorrhage.
Symptoms and signs are bradycardia, nausea, arrhythmias, hypertension, loss of
consciousness, or cardiac arrest.4,14

Myotoxicity

Extraocular muscle palsies, most frequently involving the inferior rectus, have
been described. The superior oblique, medial rectus, superior rectus, and levator
98 P.H. Morse and M.F. Kraushar

palpebrae superioris have also been affected. Spontaneous recovery is usual but
not guaranteed. The highest concentrations of local anesthetics should not be
employed as they have been shown to be myotoxic. Caution must be used to avoid
extraocular muscles during injection. Ophthalmologists have been successfully
sued for this complication.14

General Anesthesia

Complications arising during the administration of general anesthesia are not nec-
essarily directly attributable to substandard technique. Some may be coincidental,
and others may not be as likely without general anesthesia. It is common for sur-
geons to be named for vicarious liability in lawsuits regarding general anesthesia
problems involving their patients.
For example, a patient undergoing cataract extraction, bucked on the endotra-
cheal tube during surgery and developed a choroidal hemorrhage and retinal
detachment. The surgeon was included in the suit but the claim against her was
dropped after a year of discovery. The anesthesiologist settled the claim because of
an insufficient level of anesthesia. The claim against the ophthalmologist was added
to the total of claims against her by the insurance company and her premium was
increased the following year.
The most common injury is corneal abrasion and, although it seldom has serious
complications, insurance payments have been made for this problem.
Patients in the cataract age group generally have a higher incidence of signifi-
cant systemic disease, which can lead to problems in the use of general anesthesia.1
Most medical complications of general anesthesia in ophthalmology patients are
from coexisting disease, mostly cardiac. For this reason, the ophthalmologist must
be familiar with the patient’s medical history. It is strongly advisable to obtain pre-
operative medical clearance for patients with significant medical problems.
Documentation of these reports should be kept in the patient’s medical record.
Communication between the surgeon and the internist-consultant should include a
discussion of the expected duration of the surgery and the medications to be used
before, during and after the operation.1
As an example, an eighty-two year old woman with no significant medical
history was admitted to the hospital for outpatient scleral buckle surgery under
general anesthesia for a pseudophakic macula-on retinal detachment. An
internist examined her at the hospital for preoperative medical clearance and
noted a bruit over the left carotid artery. He advised the vitreoretinal surgeon
report this finding to the patient’s family physician in order that Doppler studies
could be scheduled a few days after the surgery. In the recovery room, the
patient was noted to have suffered a stroke. It was postulated that an embolus
had broken off the carotid atheroma as a result of extension of the neck during
anesthetic intubation (Beauty Parlor Stroke Syndrome15). A lawsuit was brought
against the anesthesiologist, the ophthalmologist, and the internist. After fifteen
Chapter 10. Anesthesia 99

months of discovery, the suit was dropped on the recommendation of the plain-
tiff’s second expert.
The anesthesiologist should also be thoroughly familiar with the patient’s gen-
eral health, laboratory values, EKG, and chest X-ray, as well as current medica-
tions. Although the ophthalmologist is not primarily responsible, he or she should
discuss concerns with the anesthesiologist prior to beginning the surgery. During
surgery the ophthalmologist may be first to notice darkening of the patient’s blood
indicating hypoxia. When exerting traction on a rectus muscle and an oculocardiac
reflex occurs, the ophthalmologist must not only release the traction but may also
give a retrobulbar anesthetic injection to block the reflex from recurring.

Intraocular Pressure

If a patient has an intraocular gas bubble of sulphur hexafluoride (SF6) or perfluoro-


propane (C3F8) preoperatively or if the surgeon is considering using one of these
gases, the use of nitrous oxide by the anesthesiologist is contraindicated because of
the risk of absorption into the gas bubble and attendant critical increase in intraocu-
lar pressure (IOP). An example of a typical claim involving this problem is described
in Chapter 21.
Prolonged significant elevation of IOP with ischemic optic neuropathy or CRAO
can occur in patients undergoing surgery in the prone position. In many patients,
the mechanism is unknown. Increased intraorbital pressure is alleged as a possible
etiology. Other patients have suffered CRAO because of improper head position
with direct compression of the eye. Practically every occurrence of this prob-
lem is diagnosed when the patient awakens in the recovery room and complains of
amaurosis in one or both eyes. Ophthalmologists are typically called for consulta-
tion in the recovery room. If the cause was not direct compression of the eye, urgent
orbital decompression may be beneficial.

Malignant Hyperthermia

Malignant hyperthermia (MH) is characterized by intracellular hypercalcemia. This


problem is of clinical significance to ophthalmologists because there is a possible
greater prevalence in patients with strabismus.4,5,16

Summary

Little serious permanent disability is encountered from any form of anesthesia for
ocular surgery. Most complications, even penetration of the globe during retrobulbar
anesthesia, have no deleterious sequelae if managed appropriately.
100 P.H. Morse and M.F. Kraushar

Because serious complications from anesthesia may cause blindness or death, it


is not surprising that analyses previously cited reveal a significant risk of high
indemnification for infelicitous results. Not all complications are manifestations of
negligence. There will be differences of opinion regarding the use of local or gen-
eral anesthesia, the agents used and the gauge, and the sharpness and length of nee-
dles used for local injection. These will depend upon the choice of the surgeon and
the patient, as well as mitigating or jeopardizing circumstances.
While the ophthalmic surgeon may be named in the lawsuit if his or her patient
suffers a complication from general or local anesthesia administered by another
person, the primary responsibility for the defense will rest with the anesthesiologist
or CRNA. In this circumstance, the ophthalmologist’s defense will be stronger if he
or she can document preoperative medical clearance if there was a preexisting
medical problem that may have played a part in the complication. Familiarity of the
credentials and experience of the nonophthalmic person administering a local anes-
thetic will enable the ophthalmologist to make a more informed decision regarding
the capability of this practitioner.
Awareness of possible hazards and meticulous attention to detail with obviate
most local anesthesia problems. In the event of a complication from local anesthesia
administered by the ophthalmic surgeon it is of paramount importance that he or
she to dictate a contemporaneous operative note. The content should state that the
appropriate means were used to minimize the risk of the complication, the fact that
the problem was diagnosed in a timely manner and that it was managed properly.
These facts will tend to dissuade a plaintiff’s attorney from advising litigation and
will strengthen the defense of any subsequent litigation. Advanced preparation for
rare emergencies, such as apnea and cardiac arrest, may well avert disaster.
In recent years the specialty of ophthalmology has experienced myriad improve-
ments in diagnostic capability, medical technology and surgical expertise all of
which have decreased operating time, patient morbidity and dramatically improved
outcomes. Ophthalmologists must guard against taking the possibility of complica-
tions too lightly and remember that most of their surgical patients are of advanced
age and are likely to have significant medical conditions. There is always a risk that
even a ten minute cataract operation with topical or local anesthesia on a patient in
this age group still carries the threat of serious injury.1

References

1. Kraushar, M.F., Turner, M.F. Medical malpractice litigation in cataract surgery. Arch
Ophthalmol 1987;105:1339–1343.
2. Gild, W.M., Posner, K.L., Caplan, R.A., Cheney, F.W. Eye injuries associated with anesthesia.
Anesthesiology 1992;76:204–208.
3. Wilson, F.M. II. Adverse external ocular effects of topical ophthalmic medications. Survey of
Ophthalmology 1979;24:57–58.
4. Smith, G.B., Hamilton, R.C., Carr, C.A. Ophthalmic Anesthesia, A practical handbook, 2nd
edition, London, Sydney, Auckland. Arnold, 1996, pp 139–140.
Chapter 10. Anesthesia 101

5. Donlon, J.V., Jr., Doyle, D.J., and Feldman, M.A. Anesthesia for Eye, Ear, Nose and Throat
Surgery, in R.D. Miller (ed), Miller’s Anesthesia, 6th ed., volume 2, Philadelphia, Elsevier,
Churchill, Livingstone, 2005, Chapter 65, 2527–2537.
6. Hamilton, R.C. Complications of ophthalmic regional anesthesia, In Kumar, C.M., Dodds, C.,
Fanning, G.L. (eds). Ophthalmic Anesthesia, Lisse, Netherlands, Swets & Zeitlinger, 2002,
pp. 181–196.
7. Rubin, A.P. Complications of local anaesthesia for ophthalmic surgery. British Journal of
Anaesthesia 1995;75:93–96.
8. Kay, M.C., Kay, J. Complications of Anesthesia for Ocular Surgery, in Charlton, J.F.,
Weinstein, G.W. (eds). Ophthalmic Surgery, Complications, Prevention and Management,
Philadelphia, J.B. Lippincott Company, 1995, pp. 87–93.
9. Watson, D. Hyaluronidase, British Journal of Anaesthesia 1993;71:422–425.
10. Kraushar, M.F., Seelenfreund, M.H., Freilich, D.B. Central retinal artery closure during orbital
hemorrhage from retrobulbar anesthesia. Trans Amer Acad Ophthalmol and Otolaryngol 1974;
78:65–70.
11. Kraushar, M.F., Cangemi, F.E., Morse, P.H. Prevention of accidental intraocular injection fol-
lowing inadvertent needle perforation of the eyeball. Ophthal Surg 1996;27:405–406.
12. Reese, A.B., Carroll, F.D. Optic neuritis following cataract extraction. Arch Ophthalmol
1958;45: 659–662.
13. Katsev, D.A., Drews, R.C., Rose, B.T. An anatomic study of retrobulbar needle path length.
Ophthalmology 1989;96:1221–1224.
14. Smith, G.B., Hamilton, R.C., Carr, C.A., op. cit. pp. 148–180.
15. Weintraub, M.I. Stroke after visit to the hairdresser. Lancet 1997;350:1777-1778.
16. Smith, G.B., Hamilton, R.C., Carr, C.A., op. cit. p. 226.
Chapter 11
Cataract Surgery

Stephen A. Kamenetzky

Introduction

There are well over 2 million cataract operations performed yearly in the United
States, making it the most commonly performed major surgical procedure in the
Medicare population. Ophthalmologists have developed techniques and technologies
over the years that make it one of the safest surgical procedures for patients, with an
overall complication rate of less than 10%. Serious complications, such as loss of
vision or infection, are even less frequent. The surgical advances have changed the
procedure from one for which several days of hospitalization with sandbags to restrict
head movement were required to an outpatient procedure with an initial recovery
period measured in hours. Visual outcomes have improved, and patient satisfaction
remains high.
Despite this great progress and an enviable safety record (or perhaps because of
them), lawsuits related to cataract surgery remain the number one cause of malprac-
tice litigation against ophthalmologists. Ophthalmic Mutual Insurance Company
(OMIC), the American Academy of Ophthalmology (AAO)–sponsored professional
liability insurance company, which insures more ophthalmologists (about 3,700) than
any other single carrier, has opened an average of 65 cataract-related cases yearly for
the past 5 years. This incidence is twice that of any other ophthalmic subspecialty.
There are many reasons for this frequency. The most important is the sheer
volume of cataract operations performed. Also important, however, is the high
expectation level present in patients undergoing the procedure. Largely through the
fault of ophthalmologists themselves, the surgical skills required to achieve these
exceptional results have been trivialized, creating a public perception of the proce-
dure as being foolproof—a simple “no shots, no stitch, no pain” experience that
will reliably restore the vision to the way it used to be. Naturally each patient
absorbs this message and is always disappointed and often angry if this is not the
outcome in his or her case. Patients have the impression that if the result is not per-
fect, someone must have made a “mistake” and legal action often is threatened.
The risk of complications is inherent in all medical procedures, and their occur-
rence is not necessarily an indication of medical malpractice. Ophthalmologists have
developed excellent techniques to deal with the inevitable issues that occur from time

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 103


doi: 10.1007/978-0-387-73341-8; © Springer 2008
104 S.A. Kamenetzky

to time—how to handle a posterior capsular break, a small pupil, vitreous loss, or a


dropped nucleus—and these refinements have allowed good visual results even when
these situations or others like them arise. Even in cases with a poor visual outcome,
a good physician–patient relationship can often prevent a future malpractice action.
Complications that develop during surgery are characterized by their episodic
and somewhat unpredictable nature and can be defended in most cases (if dealt with
properly) as being inherent to the practice of medicine. There are other types of
problems that are much more difficult to defend, and these are errors of process that
allow seemingly preventable events to occur. Some of these errors are quite obvi-
ous: wrong patient, wrong eye, wrong lens inserted. Others, such as poor measure-
ment techniques, number transpositions, unreasonable expectations, and poor
documentation of events, are not always so clear until it is too late. Managing this
type of issue (preventing errors rather than dealing with their consequences) falls
into the area of risk management. It deals with the analysis of large numbers of
events and determination of if and when mistakes were made and how best to pre-
vent them from occurring again. Although risk management techniques were origi-
nally developed to save insurers money, the primary beneficiaries of this process
when applied to the medical field are ophthalmologists and their patients in terms
of better outcomes and reduced stress and anxiety. The tools required are simple in
concept and inexpensive to implement. They involve both common sense and
learning from the experiences, both good and bad, of others.

“An Ounce of Prevention Is Worth a Pound of Cure”

A recent case with which I was involved will show just how important risk manage-
ment issues can be. Some details in this case, as in the others discussed later in the
chapter, have been altered slightly to protect the identity of the physicians involved,
but the basic facts remain unchanged. A very skilled young ophthalmologist had
scheduled several cases at a facility he did not often use. He brought with him one
member of his own team who was familiar with his surgical routine, but she ended
up serving as first assistant on all the cases and was therefore unavailable to work
with the operating room personnel provided by the facility. The three cases went like
clockwork with no surgical complications, and it was only at the first postoperative
visits that it was discovered that all three patients had received the wrong power
implants, including one patient who received a 29D lens instead of a 20D implant.
In addition to potential malpractice litigation, the mistake resulted in state licensure
action against the physician. Defending these actions caused a major disruption in
the physician’s life and practice. This is an example of “perfect surgery” compli-
cated not by technical inadequacy but rather by a cascade of preventable mistakes.
How in the world could this have happened? In retrospect, it was easy to see. No
one individual took charge to be certain that things were being done correctly, because
everyone else assumed that someone else was doing so. It was in fact nonmedical
process issues that went awry leading to medical liability consequences. The physician
Chapter 11. Cataract Surgery 105

was “too busy” with surgical concerns to be sure that the powers were correct and did
not consider this to be part of his responsibility. The first assistant assumed someone
else had checked the powers as was done at the facility where the physician usually
worked, so she did not inquire. The circulating staff, unfamiliar with the surgeon’s
routine, did not know that the physician recorded the specific lens power in a set place
in the medical record and expected the staff to look there before handing him the
appropriate lens. They assumed that the lenses, which were all in the operating room
on a table and not marked with patient identifiers, were stacked in the right order based
on the operating room schedule, and they simply worked their way down the pile.
At every point along the way, any of the individuals involved could have
stopped this disaster from happening. Either the surgeon or the first assistant,
knowing that they were operating with a crew unfamiliar with their routine, could
have asked the circulating staff if they had checked the lens power against the chart
record. The circulating staff, unfamiliar with that same routine, could have asked
the surgeon how they were supposed to know which lens was intended for which
patient. Each lens could have been clearly labeled with the correct patient’s name,
or only one lens at a time could have been placed in view with the rest laid aside
until the proper patient was in the room. There was no system in place that every-
one understood, no process that required the “could have” possibilities discussed
above to become the “must be” actions required to ensure an error-free environ-
ment. This was a risk management failure of major proportions.
Much of the information in this chapter is related to similar risk management
issues as they apply to cataract surgery and is based on the knowledge and experi-
ence gained from reviewing hundreds of cataract-related malpractice cases like the
one above coupled with over 25 years as a practicing anterior segment surgeon. The
suggestions that follow are general in nature rather than indicating, for example,
which specific antibiotic (if any) should be used for preoperative prophylaxis.
Many of the recommendations are personal opinions, and no attempt is being
made, and no inference should be taken, that the standard of care for cataract sur-
gery is being defined in this discussion. The standard of care is actually determined
by the community of ophthalmologists, not a single individual, and will evolve as
progress is made in the field. It is important that ophthalmologists follow the litera-
ture closely and stay abreast of the current best practices as they pertain to cataract
surgery. That is the arena in which the standards of care are defined.

General Risk Management Issues

OMIC has available on its website (www.omic.com) a large volume of risk manage-
ment materials that all ophthalmologists, not just OMIC insureds, are free to access
and download. These include articles on risk management and specific informed
consent documents for many of the issues that are covered in this chapter.
There are several areas that are important but not specific for cataract surgery.
One is a legible medical record that accurately documents the events that have
106 S.A. Kamenetzky

taken place in the care of the patient. The medical record should be contemporane-
ously generated and contain sufficient detail so that it can be used in a court of law
if necessary to reconstruct the events that occurred. Entries should contain identifiers
so that the individual responsible for the information (physician, nurse, technician)
can be determined, and all entries should be initialed to attest to their accuracy.
Electronic medical records are wonderful for many things, but they often contain
errors that are repeated from examination to examination or boilerplate language
that continues to be inserted long after it is relevant (such as a description of a cata-
ract long after it has been removed), so they need to be reviewed closely.
Never alter the medical record under any circumstance for any reason. This is
particularly important following a complication at surgery. There is often the temp-
tation to do this to document what “really happened,” but a very defensible case can
be rendered indefensible by this action even if the intent was to clarify the situation
rather than to obscure the facts. Attorneys spend a lot of time comparing various
copies of records obtained at different times, and, once the honesty of the physician
can be questioned, it is virtually impossible to win a case in front of a jury.
Corrections or addenda when required should be clearly marked with the date, time,
and identity of the person making the entry and should leave the original record
intact.
Careful and accurate communication with patients when complications develop
is also critical. A truthful description of what occurred and how it was dealt with is
not an admission of fault. All communications should be documented in great detail
in the medical record, and any questions the patient asked and the answers provided
should be included. Second opinions regarding treatment of complications should
be obtained sooner rather than later and in all instances when the patient requests
one.
Informed consent for surgery needs to be well documented in the record and
should be obtained, when possible, well before the date of surgery. Informed con-
sent is a process (not merely a form that the patient signs) in which the operating
surgeon needs to be intimately involved. Educational videos, other educational
tools, and office personnel can be used to expedite the process, but the responsibil-
ity for being certain that adequate informed consent has been obtain remains with
the operating surgeon. It is best if the document signed by the patient is procedure
specific, with the actual risks and potential benefits clearly spelled out rather than
a general “consent for surgery form” used by multiple specialties at a facility.
The operative report must be an accurate record of what actually took place
during each specific case. Increasingly, however, “predictated” operative reports
that add the specific patient name, date, and eye treated to a previously created
template that describes a typical case are being used. This type of documentation is
not ideal under any circumstance (two surgeries are rarely totally identical) but may
suffice in an uncomplicated case. However, if the surgery is complicated, they
should not be used (even if amended by hand), because they rarely contain enough
detail to be useful if litigation ensues. It is extremely important in complicated
cases to have an exquisitely detailed operative report that describes what happened
as well as both the actions and thought processes that went into treating the com-
Chapter 11. Cataract Surgery 107

plication. If several choices of how to deal with the problem were considered, they
should all be outlined and the reasons for choosing the one used clearly explained.
Plaintiff’s expert witnesses are often critical of the defendant physician’s treatment
of a complication, and a scanty operative note allows them to fill in the missing data
in a way that is most beneficial to their client. If there are no holes in the operative
report, they may quibble with the method chosen, but are on much weaker ground
if it was a reasonable option because the physician who was there and faced with
having to make a real-time decision will often receive deference from a jury that
can understand that hindsight makes everything clearer.
Postoperative instructions to patients should always be written and should be in
a form that patients can clearly understand. This includes using languages other
than English when appropriate. In particular, the patient must understand how to
reach the physician at any time in the event serious problems develop before or
between scheduled visits. If sample drugs are used, they should be clearly labeled
with dosage and frequency directions. If the patient is to be comanaged, the plan
for the transfer of care must be clearly understood by all parties. In particular, it is
critical that the comanager have sufficient training, experience, and licensure to
carry out the delegated duties.

Considerations Specific to Cataract Surgery

Endophthalmitis

The complication of endophthalmitis following cataract surgery is fortunately quite


rare but unfortunately quite devastating in terms of return of useful visual function.
The low incidence is somewhat surprising considering recent studies that demon-
strate the frequency of bacterial contamination of the anterior chamber during cata-
ract surgery. The incidence ranges from 1/1,000 to 1/3,000 and seems to be the
same in most series worldwide. Because the frequency of endophthalmitis is so
low, there are few well-controlled prospective studies of the risk factors involved
in its development.
The questions of whether to use preoperative prophylactic antibiotics and which
one to use have no clear answer that can be supported by well-designed studies. There
are new studies every year, some of which seem to show that the actual choice of a
specific antibiotic is not critical. It is known that preoperative administration of anti-
biotics does lower the level of the bacterial flora of the conjunctiva, but it is not clear
how this relates to the incidence of postoperative infection, because many of the bac-
teria that cause infections are not typically found in the normal conjunctival flora.
Povidone iodine 5% applied topically during the preparation is thought to offer some
protection. Despite lack of strong evidence of efficacy, most ophthalmologists in the
United States do pretreat with topical antibiotics because of concerns regarding poten-
tial increased liability in the event an infection develops in an untreated patient.
108 S.A. Kamenetzky

There are other issues that should be considered preoperatively as well. Lids and
lashes should be well prepped and draped, and diseases such as blepharitis, meibo-
mianitis, and lacrimal outflow obstruction should be adequately treated before
elective cataract surgery is performed.
Intraoperative and postoperative treatment with antibiotics is also common and
accepted as the standard of care by most ophthalmologists. Drops, injections,
collagen shields, and intracameral and subconjunctival routes of administration
have all been used, but personal preference, rather than scientific evidence, seems
to be the main driver in determining the route.
The duration of postoperative treatment varies considerably, and there are no
good studies available to answer the question of exactly how long antibiotic drops
should be continued. Topical treatment is often continued until the frequency of
topical steroids is reduced. There is also a feeling that the incidence of postopera-
tive infection may be higher in patients who have suffered complications such as
capsular rupture or vitreous loss, so these patients should be followed up especially
carefully postoperatively.
Self-sealing clear corneal incisions are popular now because of better surgical
exposure, less astigmatism, compatibility with topical anesthesia, and brighter red
reflex. There is some evidence in the literature (but also some to the contrary) to indi-
cate that the frequency of postoperative endophthalmitis is higher when a clear cor-
neal approach is used. This may be due to inadequate wound closure, which allows
bacteria to enter the eye with rubbing or blinking. To avoid this issue, a meticulous
watertight seal of the corneal wound is critical, and sutures or cyanoacrylate adhesive
should be used if there is any concern at all about the integrity of the wound.
Successful treatment of infection when it occurs depends on prompt diagnosis
and early aggressive intervention. It is surprising how frequently the defense of
cases with postoperative infection hinges on how and when the treating physician
was first notified by the patient that there was a problem. Frequently these calls
occur outside of normal office hours and are not documented contemporaneously
(or even at all). Patients may not remember exactly what they told the physician
and visa versa, and a poor visual result may further impair their recall when a legal
case is brought. If there is a timely entry in the chart, in almost every instance the
physician’s testimony will be believed if there is a conflict between the physician
and the patient as to what actually transpired. All ophthalmologists need a system
of making sure every conversation, in or out of the office, is promptly documented
in the patient’s chart. The information should include the important details of the
discussion, the time the actual conversation took place, and the time it was entered
into the patient record. There are many systems available that allow this to be done
relatively easily using either paper or electronic health records. The operating sur-
geon should also make sure that all physicians providing coverage or comanaging
the patient follow these same guidelines.
In addition to documenting all contacts with postoperative patients, it is also criti-
cal that those patients who complain of loss of vision, pain, or other atypical findings
be seen promptly. How promptly is always the issue. Although there is no clear
answer, it is better to err by seeing them sooner rather than later. If there is any doubt
Chapter 11. Cataract Surgery 109

whatsoever in the ophthalmologist’s mind, the patient should be seen the same day as
the call rather than waiting until the next day. Office staff should have a protocol in
place that ensures that all postoperative patients get immediate appointments if they
call the office with unusual postoperative complaints. Covering ophthalmologists and
any comanagement partners should treat the patients under the same protocol.
A recent case emphasizes the importance of this process and how lack of docu-
mentation and coordination with covering physicians can make a very defensible
case, one that must be settled. An elderly man, after adequate work up and a good
informed consent that included a warning about the danger of loss of vision, under-
went cataract surgery that was complicated by capsular rupture and vitreous loss,
which were appropriately documented and treated. The patient was examined the
next day and was doing well, but later the same day the covering physician (the
surgeon’s partner) was called and remembered being told only that the patient had
a scratchy eye. She directed the patient to continue to take his drops and added
acetaminophen and told him to come to the office for follow up the following day.
When he did so, a severe bacterial endophthalmitis was diagnosed. Despite vigorous
treatment, the patient lost the eye and filed suit.
You might be wondering what the issue here is: endophthalmitis is a known
complication that can lead to loss of the eye despite proper treatment. However, the
situation was complicated by the fact that the covering physician never documented
her conversation with the patient and his wife in the chart until almost 3 months
after the event. She remembered the caller denying vision changes, redness, or pain
and simply relating a foreign body sensation, and this is what was eventually
entered in the chart. With no significant complaints and taking into account that the
patient had been seen earlier that day, the covering ophthalmologist felt comforta-
ble waiting to see the patient until the following day.
The patient and his wife were adamant that the physician was told of pain and
other more significant problems, and the covering physician was just as adamant
that she had not been told any of this. Neither party had a written record of the
conversation, but only the ophthalmologist has the obligation to have such a record.
Interestingly, both the plaintiff and defense experts agreed that the treatment was
below the standard of care if the patient’s version of what occurred was correct.
They also agreed that it was not substandard care if the ophthalmologist’s recollec-
tion of the conversation was accurate. The result was a standoff, forcing the com-
pany to settle a case that certainly could have been defended. The physician now
has an entry in the National Practitioner Data Bank and a large settlement on her
record because of a situation that could easily have been avoided if standard risk
management protocol had been followed.
Patients whose postoperative clinical course falls outside the normal pattern
should be considered to possibly have endophthalmitis until that diagnosis has been
ruled out. Appropriate referral and consultation are indicated sooner rather than
later, and a vitreoretinal surgeon comfortable with diagnosis and treatment of this
condition is a valuable partner. This avoids the “if only you had come in sooner, we
might have been able to save your eye” discussion, which can poison the well when
this complication arises.
110 S.A. Kamenetzky

Elective Refractive Surgical Procedures Involving


Lens Extraction

With improvements in surgical techniques and lens implant technology, clear lens
extraction with lens implantation (refractive lens exchange) as a technique for
improving uncorrected visual acuity has increased in popularity. This is now being
performed not only for patients with high myopia and hyperopia but also for those
with more moderate refractive errors and even for simple presbyopia. Patients under-
going this type of surgery with implantation of monofocal, multifocal, astigmatic, and
accommodating lenses present unique problems for the ophthalmologist.
As you might expect, patients who are paying significant sums out of pocket to be
able to see without their glasses or contacts are quite demanding and have very high
expectations. For this reason, patient selection is of critical importance. Those with
preexisting pathology, such as corneal disease or retinal issues that would likely pre-
clude a good visual result, make very poor surgical candidates. Patients who cannot
comprehend the risks and have unreasonable (as opposed to high) expectations
should be approached with caution. Very carefully documented informed consent is
a must, with potential complications receiving the same attention as the proposed
benefits of the procedure. Care should be taken not to guarantee results or exaggerate
the likely visual outcome. Physicians should also not misrepresent their own experi-
ence with these procedures or the track record of the lens that will be used. In particu-
lar, it is important to be certain that the lens chosen will actually perform as advertised.
In some states, in addition to malpractice cases being pursued by disgruntled patients,
consumer fraud actions for false and misleading advertising have been filed in which
patients have charged that the information given them as part of the advertising and
marketing of the practice and the informed consent were misleading.
From a purely risk management point of view, an ophthalmologist who cannot reli-
ably perform a reproducible, complication-free cataract extraction should probably not
perform elective refractive surgery involving lens extraction. If the posterior capsule
breaks and vitreous is lost, it is less likely that the postoperative visual result will match
preoperative expectations. Those performing this type of refractive surgery should
have ready access to and sufficient training and experience with other corneal refrac-
tive surgery techniques that are often required to “touch up” the final product.
In addition to the surgical skills required for these procedures, other issues must
be addressed long before the trip to the operating room. The most important is accu-
rate data collection. Without proper care in this area, technically successful surgery
will not deliver the desired visual result. In a process that requires multiple measure-
ments, the opportunity for measurement-induced error is high. These errors may be
additive in their effect on the final vision obtained. For this reason, the preoperative
refraction, anterior chamber depth, keratometry, and axial length must be determined
with great precision using good technology and the findings accurately recorded.
Errors in transcription occur much more frequently than you might imagine.
Appropriate formulas for calculating the lens power should be used with par-
ticular attention to eyes that are either very long or very short. Data should be
Chapter 11. Cataract Surgery 111

reviewed well before the trip to the operating room, and findings that do not make
sense clinically should not be used until the issues have been resolved. Five min-
utes spent in checking and double-checking data preoperatively can save hours of
pain, expense, and aggravation postoperatively. Preoperative consultation with
experienced colleagues may also be quite helpful in dealing with more difficult
or unusual cases.

Off-Label Use of Pharmacologic Agents

General Considerations

The Food and Drug Administration (FDA) is the agency that is responsible for
approving new drugs for the treatment of disease. After assessing the safety and
efficacy of a particular pharmaceutical agent, it requires the manufacturer to create
a “label” that describes the dosage, frequency, route of administration, and other
parameters to be used when the drug is administered to treat that particular condi-
tion. Once a drug has been approved for one condition, the FDA does not regulate
its use for other diseases or purposes, considering that the “practice of medicine” is
best left to the physician’s discretion. A major exception to this rule is that sched-
uled narcotics can be used for only those indications that have been approved.
Ophthalmologists are using more and more pharmacologic agents “off label”
during cataract surgery, and certain rules should be followed to limit liability. The
FDA protocol indicates that “if physicians use a product for an indication not in the
approved labeling, they have the responsibility to be well informed about the
product, to base its use on firm scientific rationale and on sound medical evidence,
and to maintain records of the product’s use and effects.” More details are available
on the FDA’s website (www.fda.gov).
If a drug is used off label, it is important to be certain that its use will improve
the safety or outcome of the procedure, that it has been carefully studied for the
specific clinical situation, and that the risk/benefit ratio is clearly favorable. Use of
drugs with only marginal utility and “fad of the month” choices should be scrupu-
lously avoided because their use will be very difficult to defend if there is a prob-
lem. Similarly, if there are two drugs of equal efficacy and one is approved and the
other is off label, use of the approved drug is always the safest choice.
Most cataract surgeons do not get a specific informed consent document signed
by the patient when they plan to use medications off label during a case. Although
obtaining such a form is not absolutely necessary and certainly not the standard of
care, it may be wise to do so, especially if the use of the particular medication is
not widespread. OMIC has a sample consent form on its website that can be used
as a template with modifications as needed. Regardless of whether a specific form
is signed, the informed consent process should be followed, and the patient should
be told the reasons why the agent is being used.
112 S.A. Kamenetzky

Specific Drugs Used Off-Label During Cataract Surgery

Intracameral lidocaine (1% nonpreserved) has been used for many years if sensa-
tion begins to return during the surgical procedure. It is generally believed to be
safe and effective, although there is some evidence that its routine use does not
increase overall patient comfort. If a capsular dye to stain the anterior lens capsule
is necessary, it is recommended that the on-label trypan blue ophthalmic solution
0.06% be used instead of the off-label older agent indocyanine green, which is more
difficult to formulate for intracameral use.
Intracameral steroids and antibiotics are not generally used during routine
cataract surgery by most ophthalmologists. There is no evidence that they have sig-
nificant intraocular toxicity when properly formulated and administered. There is
also no good evidence that they actually reduce the evidence of endophthalmitis or
intraocular inflammation.

Anticoagulation and Cataract Surgery

Before the advent of small incision cataract surgery, it was generally thought that
aspirin, nonsteroidal antiinflammatory agents, and Coumadin® should be discontin-
ued prior to cataract surgery to minimize the risk of bleeding. Although objective
peer-reviewed data are lacking, the trend now is not to discontinue these agents
prior to small incision surgery, particularly when topical anesthesia is used. It is
thought that, for many patients, the systemic risk from stopping the drugs (stroke
or thrombus formation) may be greater than the risk of bleeding during the proce-
dure. Although there is not an absolute contraindication to the use of retrobulbar or
peribulbar anesthesia techniques in patients maintained on anticoagulants, caution
should be used and the increased risk of bleeding explained to the patient. Subtenon
anesthesia is generally safe, but the frequency of subconjunctival hemorrhage is
probably higher. All patients taking Coumadin® should have an international nor-
malized ratio (INR) performed close to the surgery date to be certain that the value
is not well above the desired therapeutic range.
If the surgeon believes that the surgery should not be done with the patient
taking Coumadin®, it is important that the decision be made in conjunction with
the patient’s primary care physician or internist. Those physicians may agree to
discontinue the drug if the risk is thought to be acceptable. However, ophthal-
mologists should never discontinue the drug on their own, as a complication that
develops following that unilateral decision will likely result in a nondefensible
situation. If discontinuing anticoagulation is not possible, the patient can be con-
verted to intravenous heparin anticoagulation over several days and weaned from
the Coumadin®. The heparin can then be briefly discontinued to allow the surgery
to take place and then restarted along with the Coumadin® and continued until a
stable INR is reached.
Chapter 11. Cataract Surgery 113

Second Eye, Monocular Patients and Same-Day Bilateral


Cataract Surgery

The indications for removing a cataract from the second eye are no different
from those for the initial surgery: the presence of a cataract that impairs visual
function and the anticipated benefits of surgery exceed the risk. The time inter-
val between surgeries is variable but should be sufficient to be certain that there
are no complications in the first eye. In particular, it is important to verify that
there is not a “power surprise” error that could translate as well to the second
eye. For this reason, it is reasonable to quickly refract and not just pinhole
patients during the follow-up office visits to make sure that all is well. Because
the incidence of endophthalmitis peaks between 4 and 6 days after surgery, most
ophthalmologists wait at least 1 to 2 weeks before operating on the second eye.
Rushing the surgery can leave the ophthalmologist in a difficult position if com-
plications occur.
Functionally monocular patients should have the same indications for surgery as
any other patient, but in reality this is usually not the case. A serious complication
in a monocular patient can lead to a lot of second guessing, soul searching, and
hindsight analysis on the part of both the patient and the operating surgeon.
Additional attention to candid informed consent is critical to be certain that the
patient fully understands the potential downside risks (including total loss of
vision) of the surgery as well as the benefits. Memories fade when complications
occur, and complete documentation of the process is critical. It is prudent to take a
cautious approach when offering advice in this situation.
Most surgeons do not perform bilateral cataract surgery on the same day because
of the concern of bilateral simultaneous complications. There are reports of bilat-
eral endophthalmitis in this situation. There may be instances when same-day
surgery is in the best interest of the patient. For some individuals with advanced
bilateral cataracts who require general anesthesia for surgery or those with signifi-
cant health issues a single session may be most prudent. The reasons for taking this
approach should be documented in the informed consent. Under these very unusual
circumstances, the second eye should be prepped and draped after the first case is
completed, a second set of instruments should be used, and special precautions
should be taken to be certain that the correct implant is placed in each eye.

Cataract Surgery in the Presence of Ocular


and Systemic Diseases

Improvements in surgical techniques and advances in pharmacologic agents now


make cataract surgery appropriate for many patients who would have been inoperable
in the past. Special attention to preoperative and postoperative management is often
required. Patients with significant systemic health issues should receive proper
114 S.A. Kamenetzky

clearance from their physicians before surgery is performed. Issues such as hyper-
tension, cardiac status, and diabetes should be stable before elective surgical proce-
dures are performed. If a laboratory test or x-ray is ordered as part of the
preoperative routine, it must be reviewed and the proper action taken if the result is
abnormal. “Failure to diagnose” cases in which obviously serious pathology such
as lung cancer is ignored because no one looked at the preoperative x-ray results
are becoming more frequent and often result in sizeable judgments against the
ophthalmologist even in the absence of any ophthalmology-related complication.
Diseases such as glaucoma should be under good medical control before elective
surgery is scheduled, and postoperative pressure management needs to be particularly
aggressive to avoid further damage. Realistic expectations in the face of comorbid
ocular conditions are essential, and the limits these conditions may place on postop-
erative acuity must be carefully explained and documented or the diminished vision
postcataract surgery will be blamed on the surgery, not the underlying pathology.
Patients with chronic uveitis should probably be treated preoperatively with
steroids and/or immunosuppressive agents topically and/or systemically before
elective cataract surgery is performed. Aggressive postoperative treatment is also
usually required, and a flare up of the inflammatory process should be anticipated
and the patient monitored accordingly. These patients often have capsular and
zonular changes related to chronic steroid administration, and the planning for sur-
gery should take these potential issues into account. Ophthalmologists should
rarely if ever administer immunosuppressive agents without the assistance of an
internist familiar with their use and complications.
Patients with prostate disease need to be quizzed particularly carefully preopera-
tively to learn whether they have taken Flomax or similar agents that may make
cataract surgery extremely difficult because of their effect on the iris tissue (“floppy
iris syndrome”). Surgeons unprepared to deal with this issue will find themselves
struggling to catch up in the middle of the case. At the present time, the literature
suggests that stopping the medication does not mitigate the problem, and various
treatment options have been described. Most importantly from a liability point of
view, this issue has been so well documented that an ophthalmologist who fails to
inform the patient of a potential problem or fails to prepare in advance for the addi-
tional risks of surgery may have difficulty prevailing if litigation ensues.

General Considerations for the Adoption of New Technology

Ophthalmologists must keep current on the development of new technologies, sur-


gical techniques, and pharmacologic advancements. Review of relevant scientific
journals and attendance at continuing education seminars, meetings, and grand
rounds at academic centers are ways this can be done. “Innovations” often appear
with such rapidity that careful evaluation of their efficacy is difficult because true
evidence-based research is lacking. This is particularly troublesome in the new
technology area where the marketing division is often way ahead of any reasonable
Chapter 11. Cataract Surgery 115

concrete evidence of superiority over currently available products. Many “break-


throughs” have been consigned to the waste can within a very short period of time.
A healthy skepticism regarding some of the claims made for these products is
important, because the ophthalmologist, not the company, is stuck with the result if
the device does not perform as promised. This is of particular concern in the area
of new lens implants, which are often promoted as a simple cure for almost every
problem. It is often useful to check the European literature to see if lenses, which
are often released earlier there, are still being used when they finally are approved
for use in the United States. If the answer is no, beware, because “FDA approved”
is not necessarily a synonym for “better.”

Anesthetic Issues in Cataract Surgery

Improvements in anesthetic techniques have increased the options available for cata-
ract surgeons, offering increased flexibility and safety. This increase means that they
must become more adept and comfortable with a variety of choices, turning what was
once a more or less routine decision into one that should be closely tailored to both the
specific needs of the patient and the preference of the surgeon. Although topical
anesthesia has increased in popularity recently, there is no correct answer in most
instances to the question of which of the available techniques is “best.” Different
ophthalmologists will choose different methods for similar patients and yet obtain very
satisfactory results. Each technique has advantages and disadvantages, and a detailed
discussion of this topic is beyond the scope of this chapter (see Chapter 10).
It is important, however, during the preoperative examination to assess which
technique might be best for that particular patient. Considerations include the type
of surgical incision being considered, the level of anxiety of the patient and his or
her ability to cooperate, the anticipated length and complexity of the procedure, and
the level of experience and anxiety of the operating surgeon. Those who are rela-
tively inexperienced or might take longer to complete the procedure might want to
consider techniques that produce both prolonged anesthesia as well as akinesia.
A totally uncooperative patient might do best with general anesthesia if the patient’s
health permits this choice. Whatever technique is chosen, it is important that the
surgeon be comfortable with it and that it be discussed in advance with the patients
so they will know what to expect and what is expected of them. Surgeons who
administer the agents themselves should obtain the informed consent.
If the task is being delegated to an anesthesia professional, it is usually the
responsibility of that individual to obtain the informed consent. When the injection
has been delegated to another provider, such as an anesthesiologist, nurse anesthetist,
or resident physician, the issue of the level of competence to perform the delegated
task often arises. It is important that the operating surgeon be certain that those
providers administering the injection are adequately trained. If there are any unu-
sual anatomic issues, such as a shallow orbit, staphyloma, or extremely long axial
length, the surgeon must communicate that information to the individual giving the
116 S.A. Kamenetzky

injection, particularly if that person is not an ophthalmologist and would not be


expected to be aware of this unusual condition. Including this information in the
preoperative admission note is an easy way to accomplish this.
The situation discussed above led to a very large settlement in a case I reviewed
several years ago. A young monocular patient with 20/40 acuity was scheduled for
cataract surgery under local anesthesia. Because the patient had a condition that
would make communication during surgery difficult, it was thought that topical
anesthesia would be contraindicated. A nurse anesthetist (CRNA) administered the
local using a peribulbar technique and perforated the eye, and the vision was lost.
Ordinarily this would be more of an issue for the CRNA (who was experienced in
administering local injections for eye surgery) than for the ophthalmologist.
However in this instance, the patient had a shallow orbit and an axial length of close
to 30 mm. Neither of these issues was conveyed to the CRNA, and it was thought
by experts that both issues should have been because they were unusual and not
likely to be detectable by a CRNA based on his training and experience. The case
resulted in a large settlement for the plaintiff.
If an anesthetic soaked pledget is used as part of the preoperative routine, it is
important that there be a protocol in place to ensure that it is removed before the
surgery commences. This would seem to be a trivial issue, but legal action accusing
ophthalmologists of negligence based on a retained pledget discovered weeks to
months postoperatively is not nearly as unusual as one might think. Usually these
end with no significant damages against the operating surgeon or facility, but the
time and dollars spent to defend the incident can reach surprising levels.

Conclusion

If you are like me, you probably assumed that most cases of medical malpractice
related to cataract surgery are the result of technical incompetence: an unskilled
ophthalmologist “botching” a cataract operation and paying the price. Actually,
I have learned, and OMIC data confirm, that cases based on allegations of inade-
quate technical skill are the exception rather than the rule. The majority of claims
and suits I have seen involve instances of either poor judgment or process errors (or
both) rather than inferior technical ability.
Why is this so? To some degree, it can be attributed to the high skill level of the
typical practicing ophthalmologist. More important, however, is the fact that it is
much less difficult to explain complications of a complex surgical procedure
(which most patients and juries understand are often unavoidable) than it is to jus-
tify placement of a wrong power lens or transcription errors or other issues that
most patients feel are easily avoided and should “never” occur. These process
errors are not medical in nature and are more easily understood by patients (and
juries), and no amount of rationalization can explain them away.
Averting these problems clearly trumps having to deal with them. Prevention cent-
ers on preparation, and preparation in large part hinges on having proper policies and
Chapter 11. Cataract Surgery 117

procedures in place to anticipate and avoid those problems that by their nature can be
avoided. Whether the issue is as complex as careful preplanning for difficult surgical
cases or as simple as checking the preoperative test results to avoid missing out-of-
control diabetes, time and effort spent in this fashion always pays a large dividend.
Ophthalmologists who have ever been forced to deal with a claim or suit or even the
threat of one will confirm this without hesitation. There is an old adage that “Judgment
comes from experience and experience comes from bad judgment.” Risk manage-
ment is simply a way of getting the experience needed for good judgment by learning
from the bad judgment and misfortunes of others rather than having to make all the
mistakes for yourself. No pain, all gain—now that is the way to go.
Chapter 12
Cornea: External Disease and Contact Lenses

Peter R. Laibson

Introduction

Malpractice as it relates to the cornea involves many of the same issues as other
specialties in ophthalmology. Problems relating to informed consent, failure to
diagnose, failure to treat appropriately, surgical complications, and poor outcome
could potentially be faced by all ophthalmic surgeons. Graft rejection, on the other
hand, is a problem unique to corneal specialists.
Aside from refractive surgery, which is covered in Chapter 20, the main surgi-
cal operation that corneal specialists perform is the corneal transplant. Pterygium
surgery is the second most common surgical procedure. There are very few law-
suits relating to corneal transplant or pterygium surgery, and most of these suits
are the result of surgical complications and poor outcomes. In the over four dec-
ades that I have been at the Wills Eye Institute, there have been approximately
14,000 corneal transplants performed. Only eight lawsuits relating to corneal
transplants are known, with none resulting in a verdict for the plaintiff. The
Ophthalmic Mutual Insurance Company (OMIC) has several suits involving cor-
neal transplants on file, and these also relate mostly to surgical complications or
poor outcomes.

Case 1

Postoperative Endophthalmitis

A 75-year-old woman underwent a corneal transplant for aphakic bullous keratopathy.


Her preoperative vision was 20/60 in the right eye and 20/400 in the left eye, with
normal intraocular pressure. The procedure was done under general anesthesia.
A mechanical anterior vitrectomy was performed, and the wound was closed
with four interrupted 10-0 nylon sutures and a running 10-0 nylon suture. The
original four sutures were removed, leaving her with a 20 bite running nylon suture.
The wound was tested for leakage postoperatively and was found to be secure.

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 119


doi: 10.1007/978-0-387-73341-8; © Springer 2008
120 P.R. Laibson

Subconjunctival injections of gentamycin and cefazolin were given, as well as cor-


ticosteroids. The patient was seen on postoperative day 1 and was comfortable. The
graft was clear and the wound intact, with normal intraocular pressure and vision
of 20/200. An appointment was made for the following week, and she was
instructed to call the office if there were any signs of increased pain, visual loss,
redness, or any other untoward situation.
The next morning the patient called and reported that her eye was more uncom-
fortable and she felt her vision was not as good. She was seen that morning, approxi-
mately 48 hours after the corneal transplant, at which time the wound was secure, the
cornea slightly hazy, with many cells in the anterior chamber and a 3+ flare. These
findings at this postoperative period are indicative of possible endophthalmitis, and
she was referred to the retina service for evaluation and care.
Subsequently, the retina specialist saw the patient that day and diagnosed bac-
terial endophthalmitis. She was admitted to the hospital and treated for this surgi-
cal complication. Unfortunately, the organism recovered was a streptococcal
bacterium and the patient did poorly. The final visual acuity in the operated eye
was hand motions, despite intensive appropriate care by the retina specialist for
bacterial endophthalmitis. The patient sued the corneal surgeon for the surgical
complication and poor outcome. As the patient could not obtain an expert witness
to testify that there had been malpractice on the part of the corneal surgeon, the
suit was dropped.

Comments

There were several reasons that the suit could not be carried forward, which exem-
plify the appropriate postoperative care for a patient with a corneal transplantation:
1. The patient had been told to call the office at the first sign of any untoward situ-
ation, such as increased pain, loss of vision, ocular discharge, or increased
redness.
2. The patient was appropriately seen the same morning that she called. It is impor-
tant for surgeons to instruct the office personnel answering the telephone that
patients who have had a corneal transplant be seen immediately, soon after sur-
gery. These patients may be subject to elevated pressure, endophthalmitis,
intraocular hemorrhage, or other complications within the first few days of sur-
gery and therefore must be considered emergency patients. The office personnel
answering the telephone must know to ask the specific question about whether
the patient has had recent surgery.
3. The corneal transplant patient with endophthalmitis was seen promptly when she
called and then appropriately referred to an ophthalmologist who specialized in
the treatment of endophthalmitis. In some centers, the anterior segment surgeon
treats endophthalmitis, but in others this is left to the vitreoretinal specialists. In
areas where vitreoretinal specialists are not readily available, the ophthalmologist
Chapter 12. Cornea: External Disease and Contact Lenses 121

who is suspicious of endophthalmitis should initiate treatment if the patient can-


not be seen that day by a vitreoretinal specialist.
There are three important lessons to be learned from this patient with endoph-
thalmitis. First, appropriate postoperative instructions must be given to the patient
to call at the first sign of something unusual occurring. Second, instructions must
also be given to the office personnel to make sure that, upon answering the tele-
phone, the patient is seen as an emergency and not delayed for a day or several days
for the convenience of the ophthalmologist. Finally, appropriate referral to the
proper physician who is able to see the patient and treat the endophthalmitis as an
emergency must be available for the patient. Documentation by the ophthalmologist
is imperative throughout these steps. In the case of this patient, the poor visual
outcome was unavoidable, as the infection was due to a streptococcal organism.
The standard of care was observed, although the outcome was very unsatisfying.
There are other emergent situations that can occur with a patient who has had a
corneal transplant. One is a call from a patient, even weeks, months, or years after
the surgery, concerning decreased vision. These patients may be subject to graft
rejection and also must be considered as emergency patients. They must be seen
within the next 24 hours to initiate therapy if this is graft rejection or to reassure the
patient that it is not graft rejection.
Another emergent situation is the patient who has had a herpes simplex virus
infection. The answering service or the personnel who answer the phone during the
day must ask the patient who calls with a complaint if he or she is a herpes simplex
virus patient as well. Patients who call with a nonspecific red eye may have their
examination delayed if it is merely a conjunctivitis, but if there is a history of
herpes the patient must be seen immediately to rule out a new outbreak of dendritic
keratitis or stromal keratitis.

Case 2

Suture Removal

A patient who had a corneal transplant 1 year prior was seen by another ophthalmolo-
gist (not the corneal surgeon) for a foreign body sensation in the grafted left eye.
Sutures were still in place, and the vision was 20/40− in the right eye and 20/30− in
the operated left eye. The cornea was clear, but there was some pooling of fluorescein
indicating a flat area inferiorly. Computed tomography (CT) was not performed. The sutures
were buried and intact. Three sutures inferiorly were removed to alleviate the foreign
body sensation from what was thought to be a dellen effect. The knot of the 5:00
o’clock suture was resistant, and, after cutting the suture and removing it with a jeweler’s
forceps, a small 2:00 o’clock wound dehiscence of the graft host interface occurred.
There was no aqueous leakage with the Seidel test. Five days later the vision
122 P.R. Laibson

had dropped to counting fingers at 3 feet, and there was 10D astigmatism present,
which had not been present prior to suture removal.
The ophthalmologist had informed the patient of the need for suture removal to
hopefully alleviate the foreign body sensation. The physician did not get written
consent for this procedure, nor was there a note on the chart indicating a risk/benefit
discussion for suture removal. There was no documented discussion of alternate
treatment. Although the vision could be improved with a contact lens, the patient
was very unhappy with the visual result and a lawsuit ensued.

Comments

This patient, who presented with foreign body sensation after corneal transplantation,
had had excellent vision, with a clear cornea. Although the sutures were intact, the
treating ophthalmologist felt that a dellen effect inferiorly might be the cause of the
foreign body sensation. Generally speaking, corneal surgeons do not obtain written
consent for suture removal after corneal transplantation, but because the ophthalmologist
treating the patient was not the corneal surgeon, it would have been wise to obtain a
written consent for this procedure. Lacking a written consent, documented discussion
of the risk/benefit relationship of removing the sutures would be appropriate.
Generally speaking, where vision is excellent after corneal transplantation, it is not
wise to remove three adjacent sutures, as this may cause significant astigmatism. In
this case, with the small wound dehiscence, although Seidel negative, the wound
dehiscence and suture removal were responsible for the development of a significant
amount of astigmatism. The standard of care would require a physician to discuss
with the patient the possibility that suture removal could cause increased astigmatism,
although the main reason to remove sutures is to eliminate astigmatism.
The lesson here is that if one is not the corneal surgeon, it is preferable to use
alternative means to treat a foreign body sensation short of suture removal unless
the suture is loose or exposed. Three adjacent sutures should not be removed with
excellent vision. Discussion of the risk/benefit relationship for removing these
sutures should have been documented.

Case 3

Choroidal Hemorrhage After Surgery

A 75-year-old patient with a history of Fuchs’ dystrophy and previous cataract


extraction with an anterior chamber lens implant was scheduled for corneal trans-
plantation and intraocular lens exchange in the left eye because of corneal edema.
The patient’s vision had been decreasing in the eye to be grafted and also was
Chapter 12. Cornea: External Disease and Contact Lenses 123

significantly reduced in the right eye. An anterior vitrectomy was performed in


preparation for a sutured posterior chamber lens. During surgery the patient suffered
an expulsive choroidal hemorrhage, and an evisceration had to be done. The patient
claimed that the surgeon had not informed him before the procedure that bleeding
and hemorrhaging were additional risks of the procedure, even though he had told
the physician he had an artificial heart valve and was taking Coumadin for a heart
condition. The informed consent form, however, did include the possibility of infec-
tion, hemorrhage, and loss of vision as potential complications with this operation.
The question arose as to whether this patient on Coumadin had an increased risk
of choroidal hemorrhage or whether the age of the patient and the complicated
nature of the surgery (corneal transplantation, intraocular lens exchange, and
anterior vitrectomy) were the causes of the hemorrhage. One concern was the fact
that a discussion between the surgeon and the patient relating to the increased risk
of continued bleeding with patients on Coumadin was not explicitly documented on
the chart, nor was there any documentation that a conversation had taken place
between the surgeon and the patient’s cardiologist, although such an encounter had
occurred. The surgeon felt that the surgery could be performed safely with the
patient on Coumadin and, additionally, that taking the patient off Coumadin repre-
sented an increased and unwarranted cardiac risk.
One potential expert witness for the defense felt that replacing the anterior
intraocular lens with a posterior sutured intraocular lens prolonged the surgery and
therefore increased the risk of a suprachoroidal hemorrhage, although he concurred
that this was the appropriate surgery for this case. Coumadin did not increase the
risk but would make controlling a hemorrhage more problematic. A documented
discussion would have been helpful for the surgeon, but, despite this, the case was
dismissed for cause.
In two other corneal transplant surgeries, intraoperative and postoperative bleeding
relating to suprachoroidal hemorrhages were the reasons the patients initiated litigation.
Although these hemorrhages are rare, they do occur, particularly in long procedures such
as penetrating keratoplasty, where the eye is open for an extended period of time.
In one case, nausea and vomiting occurred after the corneal transplant, and the
patient alleged she was not handled appropriately. There was no postoperative visit
on day 1, but the patient was seen on the second day after surgery. The standard of
care is generally a 24-hour visit after a penetrating keratoplasty. Even if that visit
had occurred, in the case of a postoperative suprachoroidal hemorrhage, most sur-
geons would not have intervened surgically for at least several more days unless the
intraocular pressure was significantly elevated. When the patient was seen on the
second postoperative day and the choroidal hemorrhage recognized, observation
only was indicated, which was the appropriate treatment, considering that the pres-
sure was not elevated.
In another case related to a suprachoroidal hemorrhage, while under general anesthesia
during a corneal transplant procedure, the patient’s entire body spasmed as if awakening.
This occurred after only 2 of 16 sutures had been placed in the donor button, causing
expulsion of the intraocular contents coincidental with a choroidal hemorrhage.
Unfortunately, the anesthesia chart did not mention the patient awakening or lightening.
124 P.R. Laibson

The surgeon’s operative report, however, references the complication, a suprachoroidal


hemorrhage, but does not indicate that this resulted from the patient awakening during the
general anesthesia administered for the corneal transplant.
This intraoperative incident should have been mentioned in the anesthesia record
and would have made it easier for the corneal surgeon to be dismissed from the case
or be subject to minor liability. It is very important for surgeons who, in many cases,
work under general anesthesia to make sure that the anesthetist intubates the patient
and keeps the patient under deep enough anesthesia to complete the corneal trans-
plant. The anesthetist in this case was responsible for the surgical complication.

Eye Banks and Litigation

There has been at least one major lawsuit involving an eye bank donation of corneal
tissue. The eye bank had removed the tissue without obtaining the family’s consent.
To make matters worse, the family had consented to an autopsy but had particularly
mentioned not to remove the eyes. A corneal surgeon in another state had received
one of the corneas and had performed a corneal transplant. He was sued, along with
the eye bank, but was eventually dropped from the suit when it was realized that it
was the eye bank’s responsibility to obtain permission for use of the corneas and
not the responsibility of the corneal transplant surgeon.
Several other suits along these lines have been initiated, but the ophthalmic sur-
geon generally has been released. With over 1 million corneal transplants having been
performed in the United States over the past 40 years, these suits are extremely rare,
and the corneal surgeon should not be concerned about being involved. The Eye Bank
Association of America, which has very strict guidelines for corneal donations and
consents, monitors eye banks very strictly and requires appropriate education and
training for member eye banks in their efforts to obtain appropriate legal consent.

The Emergency Room and Litigation

The emergency room is a prime area for the genesis of lawsuits. Generally, oph-
thalmologists do not like to be called out of their busy offices or homes to see
patients in the emergency room. Therefore, they often prescribe over the telephone.
In addition, patients with ocular inflammation, decrease in vision, and pain frequently
present themselves to the emergency room or accident ward first rather than being
seen in the ophthalmologist’s office.
Telephone consults by ophthalmologists and treatment in emergency rooms by
nonophthalmologists both have the potential to lead to faulty diagnosis and inaccu-
rate treatment, producing unnecessary discomfort, pain, and possibly loss of vision.
There are several specific areas of concern from emergency room care that are
illustrated by lawsuits that have occurred in these situations.
Chapter 12. Cornea: External Disease and Contact Lenses 125

Case 1

A patient called the insured ophthalmologist, complaining of irritation in the right


eye. The ophthalmologist instructed the patient to go to the local emergency room,
where she was seen with symptoms of conjunctival irritation, a small amount of
purulent discharge, but a clear cornea. The pupil was slightly constricted. The
emergency room physician called the ophthalmologist for consultation, and it was
decided, over the phone, that since the cornea appeared to be clear, the patient had
a corneal abrasion as opposed to a corneal ulcer. The patient was sent home with
antibiotics, a prescription for pain medication, and a patched eye.
Later in the day, the patient’s mother phoned the ophthalmologist and reported
that the pain medication prescribed in the emergency room had worn off and the
patient could no longer tolerate the patch. The ophthalmologist prescribed Demerol,
and the patient was told to make an appointment in the office the following day. At
that examination, a corneal ulcer was diagnosed, and she was immediately referred
to a corneal specialist and admitted to the hospital. Aggressive antibiotics were
administered, but the Pseudomonas infection, which was diagnosed, led to severe
central corneal scarring and ultimately resulted in a corneal transplant. Eventually,
the patient did recover good vision after the corneal transplant, but a lawsuit
ensued, resulting in a judgment against the ophthalmologist.

Comments

There are several facts that mitigate against the ophthalmologist. First, the emer-
gency room physician, who was not an ophthalmologist, did not use a slit lamp in
the examination. The ophthalmologist who sends a patient to be seen in an emer-
gency room should make sure that the emergency room physician has access to a
slit lamp and is familiar with slit-lamp examination. Just instilling fluorescein in the
eye and using a Woods’ light, as is often done in smaller emergency rooms where
a slit lamp is not available, is not appropriate for diagnosing ocular inflammation.
The ophthalmologist who referred this patient to the emergency room should have
known that and should have seen the patient himself or made sure the physician in
the emergency room had access to the proper diagnostic materials.
When pain occurred later in the day, the ophthalmologist prescribed Demerol by
phone. It is essential that any emergency room physician, intern, resident, or consulting
ophthalmologist treating an emergency room patient be thorough and complete in her
or his evaluation before ordering medication. In addition, the ophthalmologist should
have seen the patient if pain had persisted. The eye patch that the emergency room
physician had applied was contraindicated in this case of a bacterial ulcer.1
It is now clear that contact lens abrasions should never be patched as part of the
treatment, even if antibiotics are used. Contact lens corneal abrasions are notorious for
initiating Pseudomonas infection in the cornea. In this situation, when the patient was
126 P.R. Laibson

seen on day 1, there was just a corneal abrasion from the contact lens and no sign of
infection. Patching overnight, despite the use of erythromycin ointment, allowed the
Pseudomonas organisms to multiply in a warm culture-like setting beneath the patch.
It is not the ophthalmologist who is usually to blame for patching these contact
lens abrasions or any abrasion but rather the emergency room physician, who is not
cognizant of the fact that abrasions should not be patched and should be treated
with frequent antibiotics. These patients with contact lens abrasions should be seen
the next day to make sure their abrasions have healed. The patients should be told
that if the eye is worse, they should call back immediately.
Another aspect of infections related to contact lenses made headlines around the
world in 2006. Up until that year, fungal corneal infections were generally very
uncommon in contact lens users. Initially there was an outbreak of fungal corneal
infections in Singapore, which then appeared in the United States.2,3 To have so
many corneal infections (over 100) in a 1-year period was highly unusual. This out-
break of fungal keratitis has been traced to a contact lens solution manufactured by
Bausch & Lomb—Renu with Moisture Lock. Not all of these infections were in
patients who used the Bausch & Lomb solution, but a great majority of the infections
were traced to patients who did use it. It is not clear why this particular commercial
solution has been so prominent in fungal infections with contact lens use, but it is
obvious that there is some process going on that allows fungal infection to occur
despite the use of this supposedly antiinfective contact lens solution. No organisms
have been found in it, but the ability of the solution to prevent fungal infections is
obviously decreased. Numerous lawsuits are now underway, and these have been
moved into class action suits because of the large numbers involved. The manufac-
turer rather than the ophthalmologist is the target of these suits.
A similar situation developed 25 years ago with the organism Acanthamoeba,
when patients who cleaned their contact lenses with salt solution made with distilled
water and salt tablets succumbed to an outbreak of an Acanthamoeba infection.
There had never been corneal infections caused by Acanthamoeba before 1980. The
use of distilled water to make salt solutions was found to be the culprit in these con-
tact lens infections, as Acanthamoeba is ubiquitous in most water solutions, even
distilled water. Certainly not all Acanthamoeba infections can be traced to distilled
water and salt tablets, but a great majority of them were so traced, and when this
practice was stopped the number of infections due to Acanthamoeba with contact
lens use significantly diminished.

Case 2

A 22-year-old man was seen in the emergency room following an accident at work,
during which a foreign body struck his right eye. A full-thickness corneoscleral
laceration and small hyphema were seen during the slit-lamp evaluation. No foreign
body was found in the anterior chamber, which was deep, and there was no sign of
aqueous leakage. The patient was given topical antibiotics, a patch was applied, and
Chapter 12. Cornea: External Disease and Contact Lenses 127

he was told to return the next day. His vision at this initial examination was 20/20
in the unaffected eye and 20/50 in the injured eye. The patient returned the next day
with vision of 20/40, and no aqueous leakage from the anterior chamber was seen.
The patch was stopped, the antibiotics were continued, and he was told to return in
4 days.
The next day, the second day after the accident, the patient referred himself
to an ophthalmologist when his vision decreased. Vision was noted to be hand
motions now, and no leakage was seen from the wound. There was no view of
the anterior chamber, and the patient was referred to a retina specialist who did
a B scan. A reflective image in the vitreous was noted, but no retinal detachment
was detected. It was felt that the reflection in the vitreous could represent a
foreign body, and a CT scan confirmed an intraocular foreign body. The patient
underwent a lensectomy, vitrectomy, and an unsuccessful attempt at removal of
the foreign body. He was given intraocular antibiotics and 2 days later was
taken back for further surgery to remove the foreign body. A pars plana vitrec-
tomy with membrane peeling, partial retinectomy, and foreign body removal
was done. Eventually the patient had an enucleation for uncontrolled
endophthalmitis.

Comments

In this case the emergency room physician who saw the patient could not be
defended, as he did not do a CT scan, x-ray, or B scan at the initial visit. Although
there was no aqueous leak, with a full-thickness laceration and a hyphema, it was
essential to do the appropriate examination of the posterior pole to rule out an
intraocular foreign body. Despite the attempts at foreign body removal, which were
unsuccessful at first, the endophthalmitis that had ensued made it more difficult to
remove the foreign body.
Most of the liability in this case was placed in the hands of the initial physician
who did not order the appropriate tests on the initial visit. Obtaining an x-ray, CT
scan, or B scan when a full-thickness laceration is evident in the cornea or corneoscleral
area should be routine to rule out the possibility of a retained intraocular foreign
body.

Case 3

A 10-year old boy presented to the emergency room with tearing, conjunctival
injection, and slight blurred vision in one eye. This condition had been present for
2 days prior to the emergency room visit. The physician in the emergency room,
who was not an ophthalmologist, used a penlight and diagnosed conjunctival injec-
tion and follicular hypertrophy, but as the cornea appeared clear during the penlight
128 P.R. Laibson

examination, the patient was told that the cornea was not involved. The patient was
treated as a possible bacterial conjunctivitis or an allergic conjunctivitis. The patient
was given Blephamide drops to use four times a day. Blephamide is a combination
of sulfacetamide 10% and prednisolone 0.25%. The patient was told to return in 2
days to the emergency room.
When the patient returned, the eye was still infected, the vision was slightly
reduced, and the patient still had discomfort. At this point, the emergency room
physician referred the patient to an ophthalmologist for treatment. On examination
that afternoon, the ophthalmologist found acute dendritic keratitis, with a dendritic
ulcer in the cornea. Two days use of Blephamide probably made the dendritic
lesion worse, as steroids are contraindicated with herpetic dendritic keratitis.
Unfortunately, this patient went on to form stromal and disciform keratitis, with
loss of vision and the necessity for chronic treatment of his herpetic stromal kerati-
tis. Whether this would have occurred without the use of Blephamide is not clear,
but the emergency room physician was sued.

Comments

There is really no defense for any physician who starts topical steroids, even if
combined with antibiotics, for anyone who has an acute red eye if there has been
no slit-lamp examination to definitely rule out herpes simplex virus infection. If the
emergency room physician had prescribed just an antibiotic and sent the patient to
the ophthalmologist a day or two later, there would have been far less issue about
treating this patient inappropriately, even if he did not improve. The important les-
son here is that every emergency room physician, whether ophthalmologist or non-
ophthalmologist, must use a slit lamp to rule out herpes simplex virus infection if
topical steroids are going to be used on the eye.
Ophthalmologists seeing patients for external disease problems, either in their
offices or in an emergency room, must not take short cuts in their diagnoses.
Patients seen in the emergency room with corneal abrasions must have a full slit-
lamp examination with fluorescein dye, or a similar diagnostic dye, and they should
not be patched but rather treated with antibiotics and seen appropriately in a day or
two to determine how the disease course is going. Nonophthalmologists who do not
use a slit lamp in the emergency room must never treat a patient with topical ster-
oids, even though steroid, antibiotic combinations such as Blephamide, TobraDex,
or Vasocidin are tempting to use to treat both the infectious part of the problem and
the inflammatory component as well. These medications should be reserved for
only those patients who have had a slit-lamp examination with appropriate diagnos-
tic dye to rule out possible viral keratitis. Emergency room physicians/ophthalmol-
ogists must always order the appropriate tests, with x-ray, CT scan, or B scan, to
rule out posterior segment involvement.
With the slit-lamp appearance of a full-thickness scar, a posterior examination
always should be done. A dilated fundus examination is not enough, as the foreign
Chapter 12. Cornea: External Disease and Contact Lenses 129

body may be in the far periphery or may have slipped behind the iris so that it is
not visible on indirect ophthalmoscopy after dilated pupil examination. The last
point to be made is the fact that physicians should err on the side of seeing the
patients sooner rather than later. Follow up of a patient is particularly important for
any ocular inflammation but particularly for possible infections, whether they be
bacterial, fungal, Acanthamoeba, or viral. It must be impressed upon the ophthal-
mologist that if patients do not keep their follow-up appointments, they should be
called, and this should be documented on the chart. Chart documentation of calls to
the patient is critically important in the defense of lawsuits.
With these precautions, the ophthalmologist can feel comfortable in diagnosing
and treating appropriately and not fearing a lawsuit for a bad outcome. If the physi-
cian follows the standard of care, and if there is a bad outcome, it is a much easier
case to defend.

Acknowledgment I would like to thank OMIC (Ophthalmic Mutual Insurance Company) for
providing background information. Further information can be found at www.omic.com.

References

1. Clemons CS, Cohen EJ, Arentsen JJ, Donnenfeld ED, Laibson PR. Pseudomonas ulcers following
patching of corneal abrasions associated with contact lens wear. CLAO 1987;12(3):161–164.
2. Khor WB, Aung T, Saw SM, et al. An outbreak of Fusarium keratitis associated with contact
lens wear in Singapore. JAMA 2006;295:2867–2873.
3. Chang DC, Grant GB, O’Donnell K, et al. Multistate outbreak of Fusarium keratitis associated
with use of a contact lens solution. JAMA 2006;296:953–963.
Chapter 13
Drugs

Simon K. Law

Magnitude of the Problem

A review of data collected on 117,000 claims and lawsuits by the Physician


Insurers Association of American (PIAA) reveals that medication errors are the
second most frequent reason for claims against physicians and result, cumula-
tively, in the second highest indemnity paid, following faulty diagnosis and
evaluation.1 According to a National Center for Health Statistics report in 1992,
medications are ordered or provided at more than 19 million patient visits a year
to an ophthalmologist’s office. With such a large volume of prescribing activity,
it is not surprising that claims related to drug prescribing constitute a significant
proportion of all claims for malpractice damages in ophthalmology.2
This chapter aims to help practicing ophthalmologists avoid malpractice litiga-
tion related to prescribing and using drugs in ophthalmic care. A series of topics
pertinent to prescribing and using drugs in a routine ophthalmic practice are pre-
sented in a question and answer format.

What Is the Most Important Method to Avoid Medication


Errors or Claims in Prescribing Drugs?

Mistakes can occur in any step in drug prescribing and result in a malpractice
claim. However, the first and likely the most important step in prescribing would
be to administer a therapy appropriately for a specific diagnosis. In order to pro-
vide the best possible care for our patients, we have to keep ourselves up to date
with the current medical information. In the digital era, the volume of medical
information available can be intimidating. On the other hand, there also exist very
sophisticated data retrieval systems on every conceivable aspect of medicine capa-
ble of collating publications on a given disease entity with related drug therapy.
Ophthalmologists should establish and maintain at least a minimal screening proc-
ess of the more significant publications in their specialty.
Application of the published literature in patient care should follow four steps:
(1) formulate a clear clinical question about a patient’s problem; (2) search the literature

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 131


doi: 10.1007/978-0-387-73341-8; © Springer 2008
132 S.K. Law

for relevant clinical articles; (3) critically appraise the evidence for its validity and
usefulness; and (4) implement useful findings in clinical practice. Such a conscien-
tious and explicit practice of using the best external evidence when making medical
decisions is called evidence-based practice.
In an evidence-based review of available clinical studies, the highest rating is given
to randomized trials and metaanalyses. However, clinicians must understand the limita-
tion of the published literature in terms of its generalizability and applicability to their
patients and integrate clinical expertise and patient’s choice into the clinical decision.3,4
Evidence-based reviews of current topics in medication use in ophthalmology are con-
ducted and published in major journals to provide up-to-date information for ophthalmologists.
Both for-profit and nonprofit organizations are providing evidence-based reviews in a wide
variety of topics in medicine, many of which are accessible through the Internet or available
to clinicians by subscription. One such nonprofit organization is the Cochrane Collaboration,
founded in 1993 and named for the British epidemiologist Archie Cochrane. It is an inter-
national independent organization, dedicated to produce and disseminate up-to-date
evidence-based reviews of health care interventions worldwide. The major product of the
Collaboration is the Cochrane Database of Systematic Reviews, which is published quar-
terly as part of “The Cochrane Library” on the website www.cochrane.org.
Another source of relevant information for prescribing in ophthalmology is the rigor-
ous medical practice guidelines developed by the American Academy of Ophthalmology.
Practicing ophthalmologists should be familiar with them. The practice guideline and the
evidence-based approach may provide a basis for correct prescribing of medication and
turning down patient demands for high-cost or questionably beneficial intervention and
offer a refuge from malpractice litigation.5

What Is the Role of the Physicians’ Desk Reference


in Prescribing?

The Physicians’ Desk Reference (PDR) contains warnings issued by drug manufactur-
ers of all relevant adverse information about all products they market. If a drug com-
pany has given such warnings and the physician has not heeded them, then the physician
is clearly not on solid ground. However, clinicians should not rely on the PDR as the
last word on product information, especially related to the safety of therapy. Some rare
but severe side effects may be recognized only after market approval.4

What Medications Are Implicated the Most in Lawsuits


Against Ophthalmologists?

Corticosteroids and antibiotics are the two classes of medications most often impli-
cated in claims against ophthalmologists. The reasons that these two classes of
medications are linked to lawsuits are probably related to the severity of the
diseases that require their use and their systemic effects and side affects.1,2,6
Chapter 13. Drugs 133

What Kind of Medical or Drug Information Should


Ophthalmologists Be Aware of When Prescribing?

Allergy

Prescribing a medication to a patient with a documented allergy to that medication


is one of the most common causes of medication error claims. For this reason, all
allergies to common medications used in the practice of ophthalmology should be
recorded in a prominent place on the front of the chart or in another location that
will not be concealed by other reports or notes.
It is always a good practice before writing out a prescription to ask again if the
patient has any known drug allergies. Because many prescriptions are handled over
the phone, assistants should be trained always to check for drug allergies in the
patient’s chart or verbally with the patient prior to finally issuing a prescription
over the phone. The telephone conversation and prescription should be documented
in the medical records.

Update of Medication Administration

Before procedures that carry a significant risk, the proper techniques of drug admin-
istration, such as subtenon injection of steroid depot and topical application of silver
nitrate, should be carefully reviewed. One may choose to consult a colleague who is
experienced in the procedure to assist or supervise the first several times.

Drug Interaction

We must be aware of interactions of drugs we prescribe with those that the patient
is already using. Some of the interactions may have severe outcomes. For example,
the potentiating effect of acetazolamide on warfarin sodium may result in a major
hemorrhage.

How Much Documentation Is Necessary?

In analyzing malpractice claims against ophthalmologists that were closed with


patient indemnification of at least $250,000, altered records, poor documentation,
and informed consent problems are among the most frequent factors influencing the
decision to seek a settlement.7 Appropriate documentation is never too much.
Adequate notations should be made in office records of what was prescribed
and why. Diagnosis correlated to prescribed therapy is a must. A notation about
134 S.K. Law

follow up should also be included. Documentation in cases that require prolonged


treatment should include that a discussion has taken place regarding the reasons
for the prolonged treatment, the side effects and complications of treatment, and
the consequences of not using the drug. Any pamphlets and fact sheets describing
the risks of long-term drug therapy given to the patient should be documented, as
well as telephone or email communication between the office and the patient. One
may consider using a duplicated prescribing pad that automatically produces an
extra copy of the prescription for filing either chronologically or as a part of the
patient’s chart.

How Can Charts and Medical Records Help Avoid


Prescription Errors?

Keeping information regarding the current condition of the patient up to date can
help ophthalmologists avoid possible adverse drug–drug or drug–medical condition
interactions. A built-in system in the initial examination or follow-up forms or
electronic medical record template to require obtaining the patient’s current list of
medications or changes in medical condition, recent hospitalization, new medica-
tions, or newly developed allergies can serve such purpose.
Some medications and medical conditions may affect the way we prescribe
medications. Important examples are system anticoagulation therapy and decrease
of pulmonary or cardiac function. A newly known allergic drug reaction may
require a change in the ocular therapy.
One way to alert the ophthalmologist is to place information regarding the aller-
gic reaction and important systemic medical condition or medication on an area of
the chart that is obvious or flashed on the initial page of the electronic medical
record. For instance, a patient with chronic obstructive pulmonary disease or
asthma, a sulfa allergy, or on systemic anticoagulation therapy would have this
information listed on the chart in an obvious location.

How to Avoid Errors in Writing Prescriptions

Although there are limited data on the rate of prescribing errors on an outpatient
ophthalmic basis, such errors in an eye hospital setting may serve as a reference. In
a single specialty eye hospital in the United Kingdom, 8% of prescription sheets
were found to have errors. Errors consisted of incorrect patient details such as
patient name, hospital number, or date of birth, illegibility, incorrect format, pre-
scriptions for which the prescribing doctor could not be identified, and incorrect
drug dosage, timing, or route of administration.8 Prescribing ophthalmologists
should review and be familiar with the correct format of prescription writing as
required by the pharmacy law and always write legibly.
Chapter 13. Drugs 135

Prescribing errors regarding drug dose, schedule, or route of administration may be


minimized with computerized medical record keeping. In a study of the impact of
computerized prescribing on the outpatient prescribing errors in adult primary care
practice, physician reviewers judged that advanced computerized prescribing with
decision support (such as drug-dose checking and drug-frequency checking) could
have prevented 97% of prescribing errors and 95% of potential adverse drug events.9
Other than error in prescription writing, failure of communication between
physician and patient and among physicians caring for the same patient is another
major source of malpractice claims in medication error. An analysis of medication
error claims by the PIAA in which indemnity payments were made, problems in
communication accounted for approximately 18% of all claims. They include com-
munication failure between physician and patient (6.7%), inadequate medical his-
tory (4.7%), failure to note previously listed allergy (3.7%), and communication
failure between physician and other provider (3.0%).10

How Should Ophthalmologists Handle Medication Refills?

Refills are authorized by the physician or, more often, by the office personnel.
Ophthalmologists should develop and train office workers to adhere to the policy
of authorization of refill with appropriate documentation. In some instances,
pharmacists have refilled the prescription and claimed they had been given a verbal
order by the physician, and patients have lied to pharmacists by saying approval
had been given by the physician when in fact it had not been given. It is not unusual
to have patients miss follow-up appointments for a long period of time (months to
years) but continue receiving refills of medications from different physicians and
pharmacies. Patients who have missed follow-up appointments should be advised
to return to be evaluated before further authorization of refill is given to the
pharmacist.

How to Handle Drug Samples

A sample is defined as a unit of drug intended not to be sold but rather to promote
the sale of the drug. Samples from manufacturers and distributors may be distributed
only to practitioners licensed to prescribe.
When a sample is given to a patient, no charge should be incurred. Although
samples are not required to be labeled as medication dispensed by a pharmacist,
clear instruction of use should be given.
Some physicians dispense medication directly to the patients as a way to supple-
ment their incomes. Pharmacists asked the U.S. Food and Drug Administration
(FDA) to stop such practice and apply the Durham-Humphrey Amendment’s standard
to physicians as well. However, the FDA took the position that the labeling requirements
136 S.K. Law

of the law apply only to pharmacists, not physicians. On the other hand, many
states enacted legislation in the 1980s mandating that dispensing physicians meet
the same or similar dispensing requirements as pharmacists.11

Should Generic Eye Medication Be Used?

Supposedly, a generic drug is a drug that has the same composition quantitatively as
well as qualitatively of the active compound as the original drug. It also has the same
pharmaceutical mode of action and the same bioavailability, as determined in bioa-
vailability studies. However, this may not be the case with ophthalmic drops.12
The Drug Price Competition and Patent Term Restoration Act of 1984 laid the
foundation for current generic drug policy. This act requires that the bioequivalence
of the generic drug to the parent compound be demonstrated. Bioequivalent drug
products are products that contain the same active ingredients; are identical in
strength or concentration, dosage form, and route of administration; and have com-
parable bioavailability when studied under similar conditions. For bioequivalence to
exist, bioavailability (the rate and extent to which a drug is absorbed or is otherwise
available to the treatment site in the body) of the various products must be similar
when administered at the same dosage and under similar conditions. However, bio-
availability studies do not usually measure drug availability at the site of action, but
only their concentration in blood or body fluids. It is obviously difficult to assess
drug penetration and bioavailability by the eye. Animal testing also is unable to
address the compliance issues that may result from generic substitution.12
According to Title 1 of the Drug Price Competition and Patent Term Restoration
Act, exception excipients (or inactive ingredients) may differ from the reference-
list drug. For a topical ophthalmic solution, exception excipients include preserva-
tives, pH adjusters, antioxidants, thickening agents, buffers, and substances to
adjust tonicity. In other words, essentially all excipients in a topical ophthalmic
solution are considered exception excipients and can differ from the reference-list
drug. Generally, if the exception ingredient in the generic product does not have a
concentration that is greater than that in another approved product administered in
a similar fashion, then it will be presumed safe. A quantitative difference is defined
as a concentration greater then ±5% compared with the reference-list drug.12 In the
case of ophthalmic products, considerations with respect to “generic equivalence”
may also include the delivery device, namely, the bottle and droplet tip.13
Recent problems with generic ophthalmic products do suggest inequivalence to
the brand products. For example, (1) some generic formulations of prednisolone
acetate 1% were noted to have poorly suspended constitutions, and caking of the
drug precipitated product clogging the dropper tip; and (2) generic diclofenac has
been associated with many cases of corneal toxicity, ranging from superficial punc-
tate keratopathy to full corneal melting.13
Problems with bioequivalence can be more severe in developing countries.
Twenty percent of generic ciprofloxacin eye drops sold in India were underpotent.
Chapter 13. Drugs 137

In a number of preparations the antibiotic content was sufficiently low as to have a


potential impact on clinical outcome and possibly to the selection of resistant iso-
lates in individual patients.14
Another example of differences between brand products and generic equivalents
is Timoptic-XE (Merck) and timolol gel-forming solution (Falcon Laboratories).
The generic product received an AB rating from the FDA in the absence of head-
to-head study data even though these products are suspended in different extended-
release gel vehicles.13
Often, generic substitution is advocated for saving cost to the patients and the
health care system. However, the calculated daily costs of some generic substitu-
tions were found to be similar to those of the corresponding brand products.15
Although generic substitution of ophthalmic medications is widespread and
increasing, little is known regarding the effectiveness of these generic products
compared with the parent ophthalmic drugs. When questions about a generic sub-
stitution are raised, all that we can honestly answer as prescribing physicians is that
a new generic drug has not been tested against the parent drug, and, therefore, it is
unknown if the generic substitution will work in the same way. When generic sub-
stitution is required or allowed, it is the responsibility of the physician to be vigilant
in monitoring the effectiveness of the generic substitution, the tolerability, and the
compliance of the use of the generic substitution.

What Is the Responsibility of Ophthalmologists in Prescribing


Drugs When Comanaging Patients with Other Specialists?

There is a number of systemic illnesses that have ocular manifestations, and it is not
uncommon that ophthalmologists have to manage such patients with other special-
ists. When comanaging patients with internists, such as rheumatoid patients on
Plaquenil, patients with severe ocular inflammatory disease on a systemic corticos-
teroid or immunosuppressant, orbital cellulitis patients, or patients in treatment for
tuberculosis, make sure that the individual areas of responsibility are clearly docu-
mented in the patient’s record (e.g., who is managing the dosage and monitoring the
response or complications). Report all test results to the comanaging physician either
in written form or with a documented phone call. Make sure the patient understands
your role and any important symptoms that should be reported to you.16

Can Ophthalmologists Prescribe Off-Label Uses of Medication?

Off-label use has always been widespread in ophthalmology, because few drugs are
specifically FDA-approved for the eyes. The list of off-label treatments is long. For
instance, ophthalmologists use intravitreal triamcinolone acetonide, labeled for
138 S.K. Law

intramuscular use, to treat age-related macular degeneration, diabetic macular


edema, and retinal vein occlusion; glaucoma surgeons use 5-fluorouracil (5-FU)
and mitomycin-C (MMC) for glaucoma surgery; and comprehensive ophthalmologists
use MMC to prevent the recurrence of pterygia following excision, cornea surgeons
use glue on the cornea. Once a drug is approved for use, individual physicians for
any indication may prescribe it without violating federal law. The FDA considers
such prescribing the “practice of medicine” and has chosen not to regulate such
practices.17
Off-label use of a drug is sometimes the standard of care. What is important is
that we have to make sure we are doing what the standard of care dictates. Physicians
should consider if there are published peer-reviewed articles supporting the use of
the new treatment and whether the treatment is being used by a reasonable number
of other practitioners with the same level of training.
Ophthalmologists should discuss all options with patients and be clear if
the recommendation is an off-label use; and they should document the deci-
sion-making process and the informed consent discussion that led to using a
drug off label. Ophthalmologists should also heed the drug’s history of
adverse events and advise and monitor patients accordingly. Doctors who
want to proceed should have the patient sign a consent form. A number of
off-label consent forms are posted on the website of the Ophthalmic Mutual
Insurance Company (www.omic.com), including forms for Avastin, MMC
when used in glaucoma and refractive surgery, and off-label photorefractive
keratectomy. 18

What Are the Requirements When Using Investigational Drugs?

Two types of investigational new drugs (INDs) were formally recognized,


those with commercial applicability or marketing potential (commercial INDs)
and those designed to meet the needs of individual investigators (noncommer-
cial INDs).
The first method of obtaining an IND is to enroll the patient in an ongoing
clinical trial by the drug’s sponsor, usually as part of a commercial IND. The
other method to obtain a nonapproved drug is to enroll a patient under a “treat-
ment” or “compassionate use” protocol (the vast majority of noncommercial
INDs). The FDA clearly prefers incorporation of patients into an ongoing spon-
sored program.17
Patients enrolled in a commercial investigation of a new drug adhere to the pro-
tocol of the study that is approved by a local institutional review board. Patients are
carefully monitored for effects and side effects of the drug during and often beyond
the duration of the study. Informed consent from the patient is an integral part of
the IND process. Failure to meet FDA requirements with experimental or investi-
gational drugs may constitute strong evidence in support of a negligence action in
the event of any proximate injury to the patient.
Chapter 13. Drugs 139

Is it Legal to Prescribe Marijuana?

Marijuana is listed as a schedule I controlled substances. Schedule I drugs are sub-


stances that have a high potential for abuse, no currently accepted medical use in
treatment in the United States, and lack accepted information on the safety of their
use, even under medical supervision. However, marijuana has many supporters
who firmly believe in its medicinal value. One of the medicinal values in ophthal-
mology is intraocular pressure reduction in glaucoma.
Some states, such as California, have enacted laws allowing patients with legiti-
mate medical need as certified by a physician the right to possess or grow marijuana.
These state laws, however, do not change the fact that marijuana is a schedule I
drug under federal law. The laws also do not allow marijuana to be dispensed by
pharmacists. States that authorize medical marijuana place patients who wish to
possess and use the drug in a conflict of law position. Although the laws allow a
qualified patient to legally possess or grow marijuana, they do not define how much
medical marijuana a patient may legally possess, resulting in some patients being
arrested by the state for growing too many plants.
Obtaining the drug or the plants creates additional problems because many
patients cannot grow their own. In response, cannabis buyer cooperatives were
created for the purpose of manufacturing and distributing marijuana to the patients.
The U.S. Justice Department challenged the legality of one of these cooperatives,
ultimately leading to a U.S. Supreme Court decision that the cooperative violated
the Controlled Substances Act by manufacturing and distributing marijuana.19

How to Prescribe for Special Patient Groups

Women with Childbearing Potential and Pregnant Women

During pregnancy, any drug that is absorbed systemically can affect both the preg-
nant woman and the fetus. Therefore, the clinician must consider the adverse
effects of the drug itself as well as its potential for teratogenicity.
Medications are categorized by the FDA according to the potential risk to the
fetus into five categories:
Category A: Controlled studies with pregnant women have failed to demonstrate
a risk to the fetus in the first trimester, and there was no evidence of risk in later
trimesters. The possibility of fetal harm appears remote.
Category B: Animal reproduction studies either have not demonstrated a fetal
risk but there are no controlled studies with pregnant women or have shown an
adverse effect that was not confirmed in controlled studies with women in the
first trimester and there was no evidence of a risk in later trimesters.
Category C: Animal studies have revealed adverse effects on the fetus (tera-
togenic, embryocidal, or other) and there are no controlled studies in women, or
140 S.K. Law

studies with women and animals are not available. Drugs should be given only
if the potential benefits justify the potential risk to the fetus.
Category D: There is positive evidence of human fetal risk, but the benefits from
use by pregnant women may be acceptable despite the risk (e.g., if the drug is
needed in a life-threatening situation or for a serious disease for which safer
drugs cannot be used or are ineffective).
Category X: Studies with animals or humans have demonstrated fetal abnormalities
or there is evidence of fetal risk based on human experience, or both, and the risk
of the use of the drug by pregnant women clearly outweighs any possible benefit.
The drug is contraindicated for women who are or may become pregnant.
Because it is almost impossible to ethically conduct controlled studies with pregnant
women to evaluate the risk of a drug to the fetus, hardly any drugs that are used clini-
cally are in category A. Most of the ophthalmic drugs are in either category B or C.
A drug in category B is not necessarily safer than one in category C with regard to
teratogenicity, because animal studies are often not applicable to human beings.
Certainly, drugs in categories D and X should be avoided as much as possible.
It is well known that systemic absorption of certain topical ophthalmic drugs by
mucosa membrane can achieve therapeutic levels. Ophthalmologists should fully
discuss the unknown risk of toxicity to the fetus with pregnant women or women with
childbearing potential. This is particularly important for those ophthalmic illnesses
that require chronic therapy, such as glaucoma. In addition to the possible teratogenic
potential, the pharmacologic effects from systemic absorption of ophthalmic drugs on
the fetus prior to delivery and the neonate after delivery should be considered. For
instance, topical β-blocker usage before delivery may decrease the fetus’ heart rate,
and topical pilocarpine usage before delivery may cause hyperthermia, hyperemia,
diaphoresis, restlessness, or and seizures in the newborn. This symptom complex may
be mistaken for neonatal meningitis and cause needless therapy.20
Particular caution is necessary and the risk/benefit ratio must be considered
whenever drug treatment is contemplated for a pregnant woman. All routine nones-
sential ophthalmic medications should be avoided during pregnancy. Ophthalmologists
are encouraged to refer to the National Registry of Drug-Induced Ocular Side
Effects for updated information regarding the side effects of ophthalmic medications
for pregnant or lactating women.

Nursing Women

The potential toxicity of drugs and chemicals that are excreted in breast milk may
be difficult to detect. Virtually all investigations of milk secretion and synthesis
have been carried out in animals, and there are considerable differences in the
compositions of milk of different species. Drug excretion into milk may be accom-
plished by binding to the proteins or to the surfaces of the milk fat globules. With
few exceptions, all drugs that are present in the maternal circulation are transferred
Chapter 13. Drugs 141

into milk. Unless studies on the nursing infant’s blood or urine are performed, there
is no way of determining the actual amount of drug being absorbed by the infant
from the milk.21 In one study, the timolol level (5.6 ng/mL) in the breast milk of a
nursing mother on topical timolol therapy was six times higher than in the plasma
(0.93 ng/ml).22
Nursing women who require chronic ophthalmic drugs should be counseled on
the potential risks of excretion of drugs in milk and on the potential toxicity to
infants. Alternatives including avoiding breast milk should be discussed.

Pediatric Populations

Infants and children have increased potential for ocular and systemic drug-induced
adverse reactions for several reasons. (1) They may receive an excessive dose
owing to the difficulty in instilling drops, particularly if they are uncooperative;
(2) administration of a drug may be continued by a parent or nurse who does not
recognize early signs of drug toxicity; (3) differences exist between children and
adults in their physiologic responses to the same drug; (4) drug absorption through
the conjunctival epithelium and skin may be more rapid in infants; (5) metabolic
enzyme systems are immature, especially in neonates, and may prolong the half-
lives of drugs; and (6) the dosage relative to blood volume, body weight, and sur-
face area is greater for infants and children (blood in adults dilutes an absorbed
drug 20 times more than in neonates).20
Ophthalmologists should be aware and cautious of some commonly used topical
ophthalmic drugs that may have potent and dangerous systemic adverse reactions
in pediatric populations. The list includes but is not limited to the following:
1. The systemic hypertension and cardiotoxic effects of the higher concentrations
(10%, 2.5%) of phenylephrine (Neo-Synephrine) are especially dangerous in the
infant with intracranial bleeding or with a left-to-right shunt.
2. Infants, blond children, children with spastic paralysis or brain damage, and
children with Down’s syndrome have an increased susceptibility to anticholin-
ergic (parasympatholytic) drugs, such as atropine, homatropine, scopolamine,
and cyclopentolate.
3. Serious ocular and systemic adverse effects of corticosteroids instilled in the eye
in high doses or on a long-term basis can occur in the pediatric age group. These
effects include secondary open-angle glaucoma, posterior subcapsular cataracts,
Cushing’s syndrome with adrenal suppression, and decreased resistance to bac-
terial, viral, and fungal infections. The potential danger of ocular side effects is
magnified in children because it is often difficult to measure intraocular pressure
accurately and to monitor lenticular changes.
4. Serious allergic reactions of some topical antibiotics, some leading to death,
have been reported. Such reactions include irreversible bone marrow suppres-
sion with chloramphenicol, Stevens-Johnson syndrome, and aplastic anemia with
sulfonamide.
142 S.K. Law

5. More pronounced systemic effects from topical antiglaucoma medications occur


in pediatric patients, such as the systemic bronchopulmonary toxic effects of
topical β-blockers in neonates and infants and the central nervous system
depressive effects of selective α2-agonists.
Phenylephrine 1% in combination with cyclopentolate 0.2% (Cyclomydril) can be
safely given to all infants for mydriasis or cycloplegia. For cycloplegia in pediatric
patients past early infancy and in darkly pigmented children, the 0.5% or 1% con-
centration can be used. Tropicamide (Mydriacyl) 0.5% or 1% eye drops combined
with phenylephrine 2.5% eye drops also produce wide pupillary dilation for indirect
ophthalmoscopy in infants and children.20

How to Reduce the Risk of Delivering Drugs Via a Needle


to the Eye

Drug delivery by needle in ophthalmic care includes peribulbar and retrobulbar


injections of anesthesia, absolute alcohol, and major tranquilizers such as chlorpro-
mazine; subtenon or subconjunctival injections of steroids, antibiotics, and antime-
tabolites; and intraocular or intravitreous injections of steroids, antibiotics, and
newer medications such as anti–vascular endothelial growth factor. Because few
drugs that are given subconjunctival or intraocularly are specifically FDA approved,
and injection of medications into or around the eye with a needle carries significant
risks, it is important for ophthalmologists to be especially vigilant to maintain clear
communication with the patients, adhere to the off-label use requirement, be famil-
iar with the current standard of care, and document appropriately.
When reasonably confident that patients would benefit from a drug,
ophthalmologists should discuss all options, the nature of off-label use, the current
standard of practice of the proposed therapy, and the possible complications of the
therapy. The common risks of direct drug delivery with a needle into the eye are
bleeding, retinal detachment, and infection. An additional risk of injecting a steroid
intraocularly is increased intraocular pressure. For an injection around the eye, such
as retrobulbar or peribulbar injection and subconjunctival or subtenon injection,
perforation or penetration of the globe may be the most alarming complication with
serious outcomes that often lead to litigation.23
Ophthalmologists should take the time to review the proper technique for admin-
istration of mediation by needle around the eye or ask a colleague who is experi-
enced in the procedure for supervision initially. In addition, one should also be
aware of the clinical signs and symptoms to recognize a complication quickly and
manage the patient’s injury promptly and properly. Signs and symptoms of compli-
cations include severe pain, sudden loss of vision, floaters, sudden increase in
intraocular pressure, shallowing of the anterior chamber, vitreous hemorrhage, poor
red reflex, hypotony, and a poking-through sensation. When a complication occurs,
the ophthalmologist should maintain good rapport with the patient, keeping him or
Chapter 13. Drugs 143

her fully informed of all aspects of the clinical situation, and obtain necessary and
appropriate consultations. Appropriate risk management officers should be notified
and early contact made with the insurance carrier.23

Do Not Forget that Some Patients Have Poor Eye Sight

The following medical error reported anonymously on the Mortality and Morbidity
Rounds on the Web (Web M&M) of the Agency for Healthcare Research and
Quality (AHRQ), an online journal and forum on patient safety and health care
quality, highlighted the importance of the physician’s awareness of the patient’s
visual limitation in the compliance of medical therapy24:
An elderly man developed a deep vein thrombosis during his hospital stay. At discharge,
he was to receive enoxaparin (Lovenox) for self-administration at home in addition to other
medications. Before leaving the hospital, he was given written information sheets regarding
his medications and received counseling from a nurse and a pharmacist.
Several days after discharge, the patient called the primary care triage nurse and stated that
he had been discharged with a bag of medications and some injections, but that he could
not administer them because he could not read the instructions. After retrieving his chart,
the triage nurse noted that the patient was blind and, upon questioning, also learned that he
lived alone.

Although the patient of this story was not receiving an ophthalmic therapy, any
ophthalmic practice certainly has a number of patients who have very limited vision
or are legally blind and experience similar difficulties in using their medications.
Ophthalmologists need to identify any factors that might impede the patient’s com-
pliance with therapy. It might involve a proactive and respectful discussion of their
ability to perform self-care tasks, perform manual tasks independently, and read,
understand, and follow written instructions. Ophthalmologists should also involve
the caregiver of the patient in providing therapy. Alternative therapies need to be
considered for patients who cannot adhere to a medical therapy.

How Does Compliance of Drug Use Legally Affect


One’s Practice?

Noncompliance could lead to an undeserved liability claim against the ophthalmologist.


Sometimes when medical malpractice claims arise, the role of noncompliance in
causing the injury or poor result may not be fully appreciated by those evaluating
the claim. Thus, identifying noncompliant patients becomes extremely important
for purposes of risk management.
Poor compliance may reflect a suboptimum patient–physician relationship. In
analyzing malpractice claims against ophthalmologists who suffered indemnifications
of at least $250,000, Kraushar and Robb7 reported that 43% of claims of alleged
144 S.K. Law

malpractice occurred within 1 month of the initial physician–patient encounter and 17%
occurred at the initial encounter. The lack of time for development of patient–physician
rapport is a major risk factor of litigation.7

How Can the Ophthalmologist Improve a Patient’s


Compliance with Drug Therapy?

It has been reported that having a good understanding of disease improved patients’
regimen compliance by up to 10 times.25 Much research effort has been initiated by
major ophthalmic organizations, including the American Glaucoma Society, to
identify barriers to drug compliance and solutions to improve it. Some suggestions
to improve compliance include the following:
1. Ask open-ended questions about the treatment regimen to reveal whether the
patient is using the medication properly. For example, ask “How often do you
use the timolol eye drop?” instead of “Are you using the timolol eye drop?”
2. Identify the reasons of noncompliance. Some of the reasons include difficulty in
administration of the medication, intolerance of the medication, lack of under-
standing of the purpose for using the medication, inability to afford it, or belief that
the inconvenience or side effects of a medication outweigh its benefits.
3. Provide patients with medication instructions or fact sheets. Patient Medication
Fact Sheets for many common drugs, including β-blocker eye drops, oral corti-
costeroids, topical corticosteroids, long-acting miotic eye drops, miotic eye
drops and gel, steroid eye drops, and ointment, can be ordered from the United
States Pharmacopeial Convention (USPC) by writing to 12601 Twinbrook
Parkway, Rockville, MD 20852, or by calling 800-227-8772.
4. Keep medical regimens, especially in chronic therapy, simple. For instance, maxi-
mize the monotherapy in glaucoma medical management or switch to another
medication instead of adding more medication, use medications that require less
frequent dosing, and avoid medications that had an immediate intolerable side
effect upon instillation.
Ophthalmologists should document such a communication with a patient to secure
compliance with treatment, as well as any refusal or delay in treatment that is caused
by a patient.

How Can Ophthalmologists Provide Patient Counseling


Regarding Medications?

In a study of glucocorticoid therapy, the PIAA Medication Error Study found that after
“incorrect dose” “communication failure between physician and patient” was the most
common error.2 With the increased availability of in the public media and especially
on the Internet, many patients are well informed about the potential for drugs applied
to the eye to affect a wide variety of body functions. Moreover, pharmacists are
Chapter 13. Drugs 145

required to provide extensive information and counseling to patients about possible


effects of their eye drops. However, an ophthalmologist who prescribes the eye drops
should not delegate the responsibility to other professionals or to the media.
It is inexcusable for an ophthalmologist who is knowledgeable about and experi-
enced with the medications prescribed and familiar with the clinical condition of the
individual patient to not review with a patient specific effects or side effects of a drug
and provide instruction in the proper use of the eye drop. It is also important that the
patient be aware of the potential for a generalized effect from the eye drop. A simple
review and a periodic update of symptoms will foster awareness of systemic ill-
nesses that could be affected by ocular therapy. In addition, it is equally important
to communicate with primary care physicians about the ocular therapy and its poten-
tial effects.
The physician should document that a discussion took place regarding the poten-
tial side effects of a prescribed drug and the consequences of not using the drug.
Any pamphlets and fact sheets describing the risks of long-term drug therapy given
to the patient should also be noted.

How to Avoid Claims Related to Problems Arising


from Pupil Dilation

Pupil dilation is part of the routine eye examination, but it may result in a short-term
visual disturbance in some patients. There have not been many liability actions
related to the use of dilating drops, according to the OMIC. However, it is wise to
avoid surprising patients with even mildly distorted vision that they may blame as
the cause of a problem after an eye examination.26
It is prudent to discuss the potential effects of glare, lack of accommodation, and
possible blurred vision particularly with patients who drive to the office for their eye
examination. Receptionists may alert each patient at the time the appointment is made
that dilation may cause side effects, which might make driving difficult. This will
allow the patient to arrange to have a friend or family member do the driving to and
from the appointment. The OMIC Publication Archives also advises physicians who
administer dilating drops to instruct patients to wear sunglasses and to avoid driving
or operating dangerous machinery afterwards.
Before cycloplegic or mydriatic drops are instilled, it is important to ask each
patient about potential allergic reactions. If the anterior chamber is shallow, precau-
tions should be taken to avoid acute glaucoma. Routine dilation by technicians or
nurses prior to examination by the ophthalmologist is not encouraged.

Conclusion

Ophthalmology is a unique specialty that provides both medical and surgical


therapies in nearly equal proportions to the patients. The large volume of prescrip-
tion activity places ophthalmologists in a vulnerable legal environment. However,
146 S.K. Law

by consistently acting in a timely and appropriate manner in the best interest of the
patients, ophthalmologists will continue to enjoy the rewarding patient–physician
relationship and to do no harm.

References

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2. Brick DC. Medication errors result in costly claims for ophthalmologists. Surv Ophthalmol
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Chapter 13. Drugs 147

22. Lustgarten JS, Podos SM. Topical timolol and the nursing mother. Arch Ophthalmol
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aspects of four cases. Surv Ophthalmol 1994;39:141–145.
24. Iezzoni LI. Discharge blindly. Agency for Healthcare Research and Quality (AHRQ) Web
Morbidity and Mortality (Web M&M) Rounds on the Web. Case and Commentary. December
2005. Available at: http://www.webmm.ahrq.gov/case.aspx?caseID=111.
25. Zimmerman T. Facilitating patient compliance in glaucoma therapy. Surv Ophthalmol
1983;289(Suppl):S252–S257.
26. Deutsche RA. Discuss potential side effects of eye drops. OMIC publication archives. Argus,
January 1992. Available at: http://www.omic.com/resources/risk_man/deskred/clinical/9.cfm.
Chapter 14
Emergencies

Peter H. Morse

Introduction

Regardless of how punctilious one is in the practice of medicine, there is no infalli-


ble protection against malpractice litigation. Attention to certain details, however,
minimizes the risk. When reviewing potential medical malpractice cases, the omis-
sion of seemingly obvious examinations or precautions for whatever reason is often
incomprehensible and an inchoation of disaster.
The spectrum of diseases eliciting urgent consultation by a patient, from trivial
to severe, may encompass nearly every ophthalmologic condition as well as many
systemic diseases having ophthalmologic symptoms or manifestations. Not all
ocular diseases threaten significant morbidity or blindness, and most ophthalmo-
logic diseases are not emergencies. This chapter concerns problems that commonly
prompt patients to seek immediate attention and that, if neglected, may cause pre-
ventable impairment or serious or irreversible loss of vision. The subjects outlined
are areas of vulnerability repeatedly explored by attorneys.

Physician–Patient Relationship

Over the past few years, great improvements have been made for emergent care.
Emergency room physicians are generally knowledgeable about ophthalmologic
disease, and most emergency rooms have adequate instruments for evaluation of a
patient with ocular complaints. Nonetheless, visits by a patient to the emergency
room or as an unscheduled appearance at an ophthalmologist’s office are frequent
sources of litigation.
The management of emergency ophthalmologic conditions, whether in the office
or the emergency room, involves risks that are unique to these situations. By defini-
tion, in an emergency there is insufficient time to develop as meaningful a physician–
patient relationship as would be possible in managing a more chronic condition such
as cataract or diabetic retinopathy. Furthermore, the outcomes of acute problems
such as a ruptured globe, a traumatically avulsed eyelid, or an intraocular foreign

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 149


doi: 10.1007/978-0-387-73341-8; © Springer 2008
150 P.H. Morse

body carry a significant risk of permanent severe vision loss or cosmetic deformity
despite appropriate, competent, and successful management. For this reason, it is of
paramount importance to provide to the patient pertinent information regarding risks,
benefits, and alternatives by means of a discussion of informed consent that is prop-
erly documented in the record.

Responsibility

There are many causes of unfortunate outcomes. Assigning responsibility to only


the treating physician for any adverse event is unwarranted. Consultants may also
commit errors. Paramedical personnel may give false reassurance or inaccurate
information to patients. Certain diseases are unfortunately beyond the scope of
treatment. Patients may delay seeking consultation for conditions that if treated at
an earlier time would more likely than not have had a favorable outcome. An infant
or child is dependent on the attentiveness and diligence of the parent or guardian.
After urgent treatment has been rendered, patients may also neglect instructions for
subsequent care.
Common misdiagnoses or omissions by responsible medical personnel occur as
a result of hasty evaluation and disposition or the assumption that the patient’s
complaint is trivial. If misdiagnosis, faulty treatment, or false reassurance occurs,
it is often assumed that the patient will return or seek another opinion. Unfortunately,
this is not always the case. An abatement of symptoms may cause a delay in a
patient’s return. Strangely, there is often a feeling by the physician of indemnity
against malpractice comparable to a motor car accident in that the misfortune
always happens to another person. Every step of patient care should be planned
with the benefit of the patient as the objective and not for the purpose of avoiding
malpractice litigation.

Emotional Issues

In any medical consultation, there is patient anxiety. Emotion in urgent matters,


which are of greater concern to the patient, is invariably involved to varying
degrees in litigation. Strong emotional reactions are often seen on the part of
patients, concerned relatives, physicians, and attorneys. A patient’s concerns, con-
cepts, understanding of disease, expectations, or demands are often bizarre but need
to be addressed. Attempts should be made by all responsible medical personnel to
explore the facets in every situation. One must not assume anything without ques-
tioning and definition.
No encounter between a physician and a patient is satisfactory without allaying
the patient’s fears and formulating a comprehensible plan for treatment of the dis-
ease or injury. Often when asked if he or she has any questions, a patient feels lack
Chapter 14. Emergencies 151

of sufficient knowledge to respond. Use of unexplained medical terminology may


also be confusing. It is best to ask, “What worries you about your eyes?” In addition
to an oral explanation, written material given to the patient may be helpful.

Communication

Lack of continuous communication between physician and patient and among phy-
sicians caring for a patient is a serious concern. A common patient allegation is “I
was not told anything.” If the physician appears overwhelmed or rushed or is abu-
sive to the office staff, an unfavorable impression is created.
If there is an untoward occurrence, some medical practitioners attempt to escape
by withdrawing and remaining incommunicative. Others manifest hostility toward
the patient. Both of these defense mechanisms are very harmful.
Paramedical personnel may be culpable. One lawsuit involved a patient
postoperatively suffering excruciating pain caused by very high intraocular pressure
following vitrectomy with fluid–gas exchange. Paramedical personnel caring for
the patient failed to notify the surgeon and the patient was blinded. The verdict was
against the hospital and its personnel.

History

A history given by the patient may be inaccurate but must be recorded with care. If
a history is written by a medical assistant, it must always be evaluated by the treat-
ing physician. If an injury occurs while a patient is at work, the date, time, location,
and names of companies and individuals involved must be documented in the medi-
cal record.

Examination

The patient’s visual acuity must always be noted. An examination must not be
abbreviated or terminated because the patient is difficult or uncooperative. Sedation
or general anesthesia may be necessary for some patients, especially children.
Struggling with a patient needs to be avoided and can cause serious damage if there
is a lacerated globe. A common mistake is reflex recording of PERLA (pupils equal
in size, react to light and accommodation) despite the fact that the examination
has not been performed. In general, consultation with an appropriate specialist is
advisable when there is any uncertainty of findings or disposition. Consultations
may involve ophthalmologists, otorhinolaryngologists, radiologists, neurologists,
neurosurgeons, plastic surgeons, pediatricians, internists, and anesthesiologists.
152 P.H. Morse

Documentation

Detailed documentation is of the utmost importance. Meticulous record keeping


includes history, findings on examination, results of tests, diagnosis, treatment,
and prognosis. If an invasive procedure is contemplated, a signed informed con-
sent from the patient must be obtained. Informed consent, including the probable
outcome without treatment, the risks and benefits of treatment, and the likely
results, is for the benefit of the patient, enabling him or her to make an intelligent
choice. However, informed consent does not protect the physician from a malprac-
tice suit.
The following example illustrates oversight in treatment and documentation.
A patient with intraocular pressure elevated to a dangerous level was given
medication to reduce the intraocular pressure and sent home without further
evaluation. This assumption of intraocular pressure control was erroneous and
led to blindness. In such a case, one must not discharge the patient until the
intraocular pressure is reduced to an acceptable level. This involves noting spe-
cific treatment and measurements of intraocular pressure, including the time
interval. Malpractice litigation has occurred because this information was not
obtained and documented and excessively elevated intraocular pressure resulted
in injury to the patient.
If a patient is referred to another physician, an appointment should be made and
the patient provided with the name, address, and telephone number of the physician
to whom the referral has been made. An explanation for the reason of referral is
also important.
Contents of telephone conversations, persons communicating, and dates and
times should be recorded in the patient’s history. Documentation of a patient’s
refusal of testing, treatment, or referral or leaving against medical advice must
be made.

Special Case Situations

Children, if frightened or in pain, may present particular problems in evaluation.


Child abuse must always be considered. For children, sedation, a papoose board, or
even general anesthesia are options. A child’s vision may sometimes be evaluated
by using the “E” game or Allen pictures. Although a child may not always be
examined with a slit lamp, the use of a magnifying lens with a penlight held by an
assistant is very helpful. Often injuries to children occur while playing with another
child when adults are not observing. Perforation of the eye with a sharp object is
common. An asymmetry of the pupil may be seen in such injuries but is easily
missed if the child is not calm and the examiner does not have adequate magnifica-
tion and illumination. On occasion, intoxicated adults or adults in extreme pain
present problems in examination.
Chapter 14. Emergencies 153

Ancillary Tests

Commonly used tests to evaluate an urgent situation, especially one involving


trauma, are computed tomography (CT) scan, magnetic resonance imaging,
ultrasound, and conventional x-rays. In acute trauma, CT is good for bone imag-
ing. There is no contraindication for use in cases of suspected or confirmed iron-
containing foreign body, pacemakers, or external life support. Computed
tomography may be useful for patients with suspected intraocular foreign body,
hemorrhagic chemosis, orbital fracture, intracranial or orbital hemorrhage, or
ruptured globe.
Magnetic resonance imaging is advantageous for evaluation of vascular
lesions, intracranial diseases, intraocular tumors, cavernous sinus thrombosis,
and optic nerve lesions. In general, soft tissue resolution is better with magnetic
resonance imaging than with CT. Magnetic resonance imaging is, however, con-
traindicated for metallic foreign bodies, especially those containing iron, cochlear
implants, cardiac pacemakers, intracranial magnetic vascular clips, and claustro-
phobic patients.1
Conventional x-rays are useful for visualization of foreign bodies, especially
metallic. When CT is unavailable, an x-ray is often satisfactory and in some cases
is preferable even when more sophisticated technologies are available.

Emergencies

Most ocular disease or trauma is not emergent. Some argue that there is no ophthal-
mologic emergency. Others, however, regard chemical burns and retinal artery
occlusions as emergencies.

Chemical Burns

Irrigation of the eye with water immediately after contact with a potentially
damaging chemical solution is the best and often only treatment available. This
must be performed at the workplace, as delay caused by transportation of the
patient to an emergency room or physician’s office may result in additional
damage. The eye must be thoroughly irrigated and the lids retracted. Particulate
matter must be removed from the fornices. Retained granules of lye may cause
damage to the overlying retina if the chemical passes through the sclera. When
there is extensive destruction of tissue, adequate subsequent treatment should be
planned to prevent symblepharon.2 Thermal burns may also create deformity or
malfunction.
154 P.H. Morse

Central or Branch Retinal Artery Occlusions

Treatment of central and branch retinal artery occlusions is controversial. Many


ophthalmologists regard these occlusions as untreatable, and some regard them as
indications of acutely threatening systemic disease. Central retinal artery occlu-
sions may rarely be a manifestation of giant cell (cranial) arteritis. Evaluation by
an internist is advisable and must extend beyond carotid artery auscultation and
Doppler studies.3 Other physicians regard treatment with pentoxifylline, hyper-
baric oxygen, intravenous recombinant tissue plasminogen activator, or selective
ophthalmic artery catheterization with infusion of recombinant tissue plasminogen
activator or urokinase to be helpful.4 Such treatments are not of incontrovertible
efficacy and are not available in every medical facility.

Urgent Conditions

Some conditions in and of themselves may not be urgent but may have an accom-
panying complication or occurrences that may require urgent treatment.

Giant Cell Arteritis

Giant cell (cranial) arteritis must be considered especially in individuals over 70


years of age complaining of jaw claudication, pain in the head, face, and neck,
fever, night sweats, lost of appetite, and general malaise with joint and body
aching. Ocular symptoms and findings of giant cell arteritis include anterior or
posterior ischemic optic neuropathy, central retinal artery occlusion, cilioretinal
artery occlusion, cotton wool spots, poorly reactive pupils, conjunctival injec-
tion, corneal edema, low intraocular pressure, homonymous hemianopia, corti-
cal blindness, abnormal extraocular movements from palsy of cranial nerves III,
IV, or VI, diplopia, eye pain, and transient obscuration of vision. Similar pains
including the eye may occur in internal carotid artery dissection. If the patient
has arteritic ischemic optic neuropathy, immediate treatment does not restore
lost vision but usually prevents involvement of the fellow eye or more serious
fatal complications.5,6 Optic neuritis as a manifestation of giant cell arteritis
must be distinguished from nonarteritic ischemic optic neuropathy and optic
neuritis.7,8
Some encounters, as in the following case, illustrate complications arising
from failure of protracted vigilance. An elderly lady complaining of sudden loss
of vision in her right eye was seen in an ophthalmology clinic shortly before
5:00 PM. Markedly reduced vision with a pale swollen optic nerve was noted,
and the patient was sent to the laboratory for erythrocyte sedimentation rate and
Chapter 14. Emergencies 155

C-reactive protein evaluations. A note requesting a report of the erythrocyte


sedimentation rate and the ophthalmologist’s telephone number was sent along
with the patient. She was given an appointment to see an internist early the next
morning for evaluation of giant cell arteritis and corticosteroid maintenance or
treatment. The laboratory failed to report the erythrocyte sedimentation rate
value to the ophthalmologist, and the internist who saw the patient the next
morning did not consider it sufficiently elevated to create suspicion of giant cell
arteritis. The patient was treated with one aspirin tablet daily. One week later the
patient experienced severe visual loss in her fellow eye and was taken to an
emergency room. The diagnosis of giant cell arteritis was entertained, and high-
dose intravenous corticosteroids were instituted. Temporal artery biopsy con-
firmed the diagnosis of giant cell arteritis. A lawsuit was filed against the clinic,
including both the ophthalmologist and the internist. The settlement was in favor
of the patient. One must never assume that because the test result is requested
that the report will be made. The ophthalmologist’s assumption was that if the
result were abnormal a call would be made. Furthermore the patient was to see
an internist the next morning was expected to receive appropriate treatment. The
ophthalmologist was considered guilty for not diligently seeking the test result
by calling the laboratory and the internist for not making the correct diagnosis.
Another interesting complexity in this case was that the defense lawyer was
hired by the insurance company to represent the clinic and not the individual
physicians, who were thus considered equally culpable.

Edema of the Optic Nerve Heads

Edema of the optic nerve head does not always cause decreased vision. Any swell-
ing of the optic nerve head, whether unilateral (disc edema) or bilateral and usually
associated with increased intracranial pressure (papilledema), requires prompt
investigation. This topic is discussed in greater detail in Chapter 16.

Lid Lacerations

Lacerations of the lids must be carefully repaired. Inattention to canalicular repair


or notching of the lower lid margin may cause chronic epiphora. If the levator
palpebrae superioris aponeurosis is severed and not repaired, blepharoptosis will
occur. While none of the aforementioned injuries threatens blindness, some possi-
ble accompanying injury may well do so.9 In any lid trauma, the eye must be
inspected as deeper lacerations may involve the eye itself and be associated with
a retained intraocular foreign body. In one legal case, a dart had not only perfo-
rated the lid but had also entered the eye, creating a hole in the retina that was
neglected.
156 P.H. Morse

Corneoscleral Lacerations

Corneoscleral lacerations are commonly not diagnosed especially in children with


darker colored irides. Such lacerations often occur when the child is playing alone
or with other children in which case an accurate history is impossible. With darker
colored irides, there is less contrast between the iris and the pupil. Children are
often frightened and in pain. Squeezing of the lids is reflex when any form of
retraction is attempted. Sedation, magnification, and brighter illumination is
required to adequately examine such infants. Delay or failure to repair such
lacerations often results in visual impairment or blindness. Conjunctival lacerations
must also be carefully examined to be certain that there is no underlying scleral
perforation or laceration.10
One legal case involved a young child who was examined and diagnosed with
conjunctivitis by an emergency room physician. Antibiotics were prescribed.
Another opinion was sought a few weeks later, and a 6-mm corneoscleral laceration
with iris incarceration and a teardrop-shaped pupil was seen. Review of the emer-
gency room physician’s notes revealed the notation “PERLA,” which would have
been impossible. An asymmetric or misshapen pupil is often a clue to severe
trauma and frequently not observed. The child experienced a fibrovascular ingrowth
with an irreparable tractional retinal detachment. The legal settlement was favora-
ble to the plaintiff.

Rupture of the Globe

Severe blunt trauma may cause a rupture of the globe. The eye may be deformed
with visible loss or incarceration of intraocular content. However, especially with
accompanying orbital hemorrhage, the rupture of the globe may be occult. The
intraocular pressure may be normal. Surgical exploration may be required and must
extend quite far posteriorly, often requiring temporary detachment of one or more
rectus muscles to obtain adequate exposure.

Intraocular Foreign Bodies

Occasionally intraocular foreign bodies cannot be distinguished from orbital for-


eign bodies, which carry much less risk. In any perforation or laceration of the eye,
one must suspect and perform appropriate examinations to exclude a retained mag-
netic or nonmagnetic intraocular foreign body. This is particularly true when there
is a history of hammering on metal. Such studies include CT scan, ultrasound, and
x-rays.11 Lacerations and perforations of the globe frequently involve extensive
surgical repair many times in several stages. Repair of the laceration, removal of a
Chapter 14. Emergencies 157

secondary cataract, removal of the foreign body, repair of retinal defect or


detachment, and corneal transplant are common. The risk of infection, although
possible, is surprisingly small but must not be disregarded. Retention of some
foreign material may cause long-term toxicity and loss of vision.
One legal case involved a man who was striking metal with metal and felt some-
thing fly into his left eye. He was seen by an emergency room physician who diag-
nosed a corneal tear with a misshapen pupil. An ophthalmologist came to see the
patient in the emergency room and subsequently saw the patient in his office.
Because the corneal laceration was self-sealing, it was not sutured until 10 days
later. At this time, the traumatic cataract was removed and a posterior chamber
intraocular lens inserted. No attempt was made to discover an intraocular foreign
body. The patient’s vision in his left eye returned to 20/20. Eight months later, the
vision in the patient’s left eye decreased to 20/40 and heterochromia iridis was
noted. Still no examinations were performed to ascertain the presence of an intraoc-
ular foreign body. Approximately 13 months after the injury, the patient was legally
blind with respect to both central vision and visual field. There was a marked
decrease in the electroretinogram in the affected eye. A consultant confirmed the
presence of an intraocular foreign body and the diagnosis of siderosis bulbi.

Endophthalmitis

Exogenous endophthalmitis is most common as a complication of cataract surgery.


However, it may be seen following any perforating trauma or intraocular surgery, includ-
ing vitrectomy. The rate and degree of damage depends on the pathogenicity and viru-
lence of the organism. If any suspicion of endophthalmitis exists, diagnosis and treatment
are urgent. Not every case has a classic appearance, and pain is not always present.
Anterior chamber and vitreous taps with Gram stain and intraocular fluid sent for culture
and sensitivity should be requested. Unless the patient’s vision is reduced to the percep-
tion of light, intravitreal antibiotics are the treatment of choice.12

Orbital Disease

The orbit may be affected by numerous conditions, some of which require prompt
diagnosis and attention. The possibility of more serious disease will vary according
to history and findings on examination.

Orbital Cellulitis

The symptoms and signs of painful proptosis, lid and conjunctival edema
with ophthalmoplegia along with fever and general malaise should raise
158 P.H. Morse

suspicion of orbital cellulitis. 13 Because immunodeficiency is increasingly


common, one must entertain the possibility of mucormycosis. 14 Other syn-
dromes or diseases that must be considered with various combinations of
pain, proptosis, signs of congestion, vision loss, and defect in function
of cranial nerves III, IV, V, and VI include the superior orbital fissure
s yndrome, Tolosa-Hunt syndrome, cavernous sinus thrombosis, orbital apex
syndrome, and carotid-cavernous sinus fistula. 15 If not expeditiously diag-
nosed and treated, some cases of cavernous sinus thrombosis and carotid-
cavernous sinus fistula can be fatal.

Orbital Hemorrhage

Any cause of severe orbital hemorrhage may secondarily create an elevated


intraocular pressure or pressure on the optic nerve, creating ischemia.

Orbital Fractures

In cases of severe and often blunt trauma, an orbital fracture with compression of
the optic nerve is possible. Orbital floor fracture with entrapment of a rectus muscle
may not only cause an immediate impairment of extraocular movement (EOM) but
also cause a persistent impairment of extraocular movements if there is permanent
damage to the muscle.16
Patients manifesting orbital disease, especially those with systemic symptoms
and signs, frequently require consultation with an appropriate subspecialist. Some of
the differentiating aspects among these diseases are quite subtle, and, unless an oph-
thalmologist is thoroughly familiar with these diseases, serious errors may occur.
Most ophthalmologists are not going to undertake treatment of complicated systemic
diseases.

Cranial Nerve Palsies

Cranial nerve palsies may appear as isolated phenomena. They are seldom emer-
gent, but aneurysmal cranial III nerve palsy, usually with a dilated pupil, requires
a prompt consultation with a neurosurgeon. This is especially the case in younger
patients 20 to 50 years old without a high risk factor for vascular disease such as
diabetes mellitus or hypertension.17,18
Although rupture of an aneurysm is uncommon, the possibility should not be
disregarded. An on-call resident saw a patient with a cranial III nerve palsy. He
was unfamiliar with the possible etiologies, performed a visual field examination,
and sent the patient home. During the night, the aneurysm ruptured and the
patient died.
Chapter 14. Emergencies 159

Flashes of Light and Floaters

Ophthalmologically, the symptoms of flashes of light and floaters are most fre-
quently associated with posterior vitreous detachment. At the time of posterior
vitreous detachment, a retinal tear may occur. Prophylactic treatment of retinal
breaks remains controversial. If a patient experiences such symptoms and is told by
an ophthalmologist there is no evidence of ocular disease and later develops a reti-
nal detachment, the possibility of a lawsuit is frequently explored.19

Rhegmatogenous Retinal Detachment

Rhegmatogenous retinal detachment is not an ophthalmological emergency. However,


most cases are surgically operated with 24 to 48 hours of diagnosis. More expeditious
surgery is scheduled if the macula has not detached. Following successful surgery
and especially if the macula was detached, the restoration of vision is often disap-
pointing to the patient. Lawsuits are often explored because of allegations of delay in
diagnosis and treatment.20

Angle Closure and Other Glaucomas

If angle closure glaucoma is not diagnosed and the intraocular pressure is suffi-
ciently high, permanent visual impairment as severe as blindness may occur.21 Other
types of secondary glaucoma with acute or dangerously elevated intraocular pres-
sure may cause similar damage. Hyphema, especially in patients with sickle cell
disease, may elevate the intraocular pressure to threatening levels.22

Corneal Ulcer, Descemetocele, or Perforation

A corneal ulcer with a descemetocele or perforation requires urgent surgical


therapy.23

Iridocyclitis

Iridocyclitis (iritis) or anterior uveitis is commonly misdiagnosed, especially when


a patient is not examined with a slit lamp. Adverse sequelae of incorrect diagnosis
rarely cause serious damage. The formation of posterior synechiae for 360° creat-
ing iris bombe with elevated intraocular pressure is an exception.
160 P.H. Morse

Additional complications associated with iridocyclitis are peripheral anterior


synechiae, hypotony, cystoid macular edema, and disc edema. Other manifesta-
tions usually from chronic disease are cataract, cyclitic membrane, and band
keratopathy.24

Problems with Immunocompromised Patients

Although not limited to immunocompromised patients, causes of acute loss of


vision requiring prompt evaluation include endogenous endophthalmitis, necrotizing
retinitis caused by cytomegalovirus, toxoplasmosis, or herpes viruses, and syphi-
litic chorioretinitis.25

Conclusion

The optimum clinical evaluation and treatment of many diseases is often controversial,
and no method guarantees success. Controversy is legitimate if there is more than one
acceptable approach to a problem. Damages must be created by a deviation from an
acceptable standard of medical care expected from a reasonably well-qualified
physician encountering a situation with identical or similar circumstances. Occasionally
unjustified malpractice litigation will occur. The best protection is to consider the ben-
efit of the patient as primary. One of the pillars of the practice of medicine is to allay
a patient’s fears, which often requires some self-sacrifice and inconvenience on the
part of the physician. Meticulous and complete documentation is mandatory. If any
uncertainty in diagnosis and treatment remains, consultation with another physician is
very advisable. Proper communication with the patient and involved medical person-
nel is most important.
When a patient is seen with an emergent or urgent situation, no abbreviation of
important aspects of the examination should occur. The brief examples of litigation
cited are not singular or unique but are recurrent themes in cases submitted by
attorneys for review to potential expert medical witnesses.

References

1. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:55–77.
2. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:163–171.
3. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:335–338.
4. Purvin V, Kawasaki A. Neuro-Ophthalmic Emergencies for the Neurologist. Neurologist
2005;11(4):204–205.
Chapter 14. Emergencies 161

5. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:83, 356–358.
6. Purvin V, Kawasaki A. Neuro-Ophthalmic Emergencies for the Neurologist. Neurologist
2005;11(4):200–202.
7. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:358–360.
8. Purvin V, Kawasaki A. Neuro-Ophthalmic Emergencies for the Neurologist. Neurologist
2005;11(4):198–200.
9. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia:
Lippincott-Raven; 1998:84-85, 97–106.
10. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:81-82, 207–226.
11. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:83-84, 309–318.
12. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:82, 275–283.
13. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:85, 131–132.
14. Purvin V, Kawasaki A. Neuro-Ophthalmic Emergencies for the Neurologist. Neurologist
2005;11(4):214–215.
15. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:387–391.
16. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:85, 107–116.
17. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:369–372.
18. Purvin V, Kawasaki A. Neuro-Ophthalmic Emergencies for the Neurologist. Neurologist
2005;11(4):217–222.
19. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:347–348.
20. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:87, 285–307.
21. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:235–255.
22. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:231–234.
23. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:83, 194–198.
24. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:138.
25. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-
Raven; 1998:144–150.
Chapter 15
Glaucoma

Robert F. Sanke and Paul P. Lee

Introduction

Treatment for glaucoma is similar to the treatment given in other areas of medicine,
requiring thoughtful evaluation of the patient followed by an appropriate care plan.
Research in glaucoma, however, has expanded the basic understanding of the
nature of the disorder, creating situations and additional legal risks to confront the
physician. Several major studies performed over the past 20 years have better iden-
tified the risk factors associated with both the presence and the progression of
glaucoma.1–4 They also have increased those concerns that a physician must address
to protect the patient’s vision and avoid legal liability. Situations now exist that
were not imagined in the past. Established duties such as informed consent and
standard of care continue to be applicable to glaucoma, but recently updated stand-
ards and expectations have been established for glaucoma as they have been for
medicine in general. The more important ones are addressed here.

Glaucoma Management

Glaucoma has been identified as a neuropathy of the optic nerve and divides easily
into open angle and closed angle types. Established practice patterns already exist
for the treatment of glaucoma and include medication, surgery, and laser therapy.
Because a specific type of treatment may be personally difficult for the patient or
of only temporary duration in halting damage to the optic nerve, there are situations
in which the physician, exercising his or her best judgment in selecting a treatment
plan, may sometimes choose to either follow an established practice pattern or
select one that differs from commonly accepted treatment practices. The individual
characteristics of the patient will influence the success of any treatment, and these
must also be considered by the physician when formulating a treatment plan.
The topical medicines used today, including β-blockers, prostaglandin agonists,
and carbonic acid inhibitors, are now much easier for the patient to use because
they are applied less often during the day and also have fewer side effects and less

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 163


doi: 10.1007/978-0-387-73341-8; © Springer 2008
164 R.F. Sanke and P.P. Lee

discomfort when applied. Laser trabeculoplasty has also been useful as the next
step in treatment, often making it possible to avoid aqueous drainage surgery such
as trabeculectomy, which was formerly the next step in cases of inadequate pres-
sure control. Of all the alternatives, the use of topical agents is currently considered
the first line of glaucoma treatment and is indicated for most patients. Despite the
advantages, however, a number of patients will still find it difficult to take their
medicines on schedule and in the manner prescribed. This lack of compliance will
eventually result in the typical glaucomatous optic nerve changes accompanied by
visual field loss.
Compliance itself is the patient’s willingness and ability to adhere to the treatment
plan established by the ophthalmologist and is based on factors specific to the indi-
vidual patient. A lack of compliance is usually occasioned by a change in the patient’s
mental or physical status or a lifestyle change. This type of noncompliance is not
willful and not the result of failure of the interpersonal exchange between physician
and patient. Noncompliance becomes a problem when it leads to damage to the optic
nerve and vision loss. To prevent this damage and loss of vision, the ophthalmologist
is justified in advancing treatment to the next level whether it be laser or surgical
intervention even though medical treatment would still be effective. In such cases
the physician is permitted to substitute his or her best judgment and to depart from
the usual and customary practice of using topical agents that are still effective.
Anyone treating glaucoma must have a continued awareness of the effectiveness of
the treatment modalities prescribed. If glaucomatous change progresses and visual
damage occurs, the physician must be prepared to alter treatment in order to best
accommodate the situation of the patient.5

Risk Factors for Glaucoma

The multicenter studies mentioned at the beginning of this chapter have identified
several previously unsuspected risk factors that precede the development of glaucoma
and that must be considered when evaluating the patient. Not including this new
information into the patient examination can result in liability for any adverse conse-
quences resulting from the oversight. Among both established and recently recog-
nized risk factors are a reduced central corneal thickness, a family history of
glaucoma, the amount of increase in intraocular pressure at diagnosis, the presence of
high myopia, vascular disorders such as migraine, the patient’s age at diagnosis,
African-American heritage, and the amount of increase in cup to optic disc ratio at
the time of diagnosis. Furthermore, assuming that intraocular pressures in the “nor-
mal” range (10 to 21 mm Hg) preclude the possibility of glaucoma developing in a
particular patient is unjustified, and even these low pressures may lead to the progres-
sion of glaucomatous optic nerve damage and a significant loss of vision.
Individuals with two or more risk factors should be examined at more frequent
intervals to identify early the onset of glaucoma, because damage to the optic nerve
is cumulative throughout the patient’s life and early diagnosis will reduce later
Chapter 15. Glaucoma 165

damage. This concern has become especially important as the nature of normal-
tension glaucoma has become better understood. This type of glaucoma is the situ-
ation in which the intraocular pressures remain within the “normal” range despite
obvious and progressive optic nerve damage. Legal doctrine requires the physician
to take reasonable precautions in treating the patient and addressing these risk fac-
tors for glaucoma has become a legal requirement. Failure to reexamine the suspect
patient at appropriate intervals to ensure the early diagnosis of normal-tension
glaucoma also violates the physician’s common law duty to the patient.6,7
Consider the following situation. A woman with high myopia was examined peri-
odically by her physician to measure and treat the myopia. Other than occasional
attacks of migraine, vertigo due to low blood pressure, and a family history of glau-
coma, she was in excellent health with no subjective symptoms. Intraocular pressures
were measured at each examination and were always within the “normal” range for
these values. As part of his “routine examination” the physician had always examined
her undilated fundus using a direct ophthalmoscope. On one occasion the patient was
examined by another physician who dilated her pupils, examining her fundus using
an indirect ophthalmoscope. Because of the unusual appearance of her optic
nerves, he also performed a slit-lamp examination using a 90-diopter lens to better
evaluate the discs. The patient was found to have a bilateral optic cup to disc ratio of
0.6 with shallowing of the cup temporally plus glaucoma-specific changes in her
peripheral visual fields. The diagnosis of normal-tension glaucoma was made. The
patient sued the original physician for her partial loss of peripheral vision because of
his failure to do a dilated examination of the optic nerves, especially given her risk
factors. Her original physician claimed as a defense that her intraocular pressures
were always “normal,” and he had no reason to suspect glaucoma. The court held that
her history of migraine and high myopia were risk factors for ocular problems includ-
ing glaucoma and that a more thorough examination was indicated.

Pediatric Glaucoma

Pediatric glaucoma is not adult glaucoma just as pediatrics is not adult medicine.
Failure to remember this can lead to diagnostic and management problems with
legal consequences. In the presence of the classic triad for primary congenital
glaucoma consisting of epiphora, photophobia, and blepharospasm, the diagnosis
will usually be obvious for the ophthalmologist. Enlargement of one or both cor-
neas from the increased intraocular pressure makes the diagnosis easier. When only
epiphora or photophobia is the presenting symptom in an infant, a more thorough
examination is necessary to establish the diagnosis. This includes a dilated fundus
examination, because disc changes can occur more rapidly even at lower pressures
in infants. A cup to disc ratio of greater than 0.3 is rare in the normal infant while
not at all unusual in congenital glaucoma. Having an index of suspicion followed
by an appropriate examination will usually reveal the correct diagnosis, avoiding a
failure to diagnose on the part of the ophthalmologist.
166 R.F. Sanke and P.P. Lee

Although primary congenital glaucoma is the most common type of infantile


glaucoma, the physician must also have an awareness of other physical condi-
tions that may lead to glaucoma. Secondary glaucoma can occur in the child
with Marfan’s syndrome, aniridia, Sturge-Weber syndrome, and less com-
monly in neurofibromatosis. In these conditions and in cases of corneal
dysgenesis, the measurement of intraocular pressure plus a dilated fundus
examination focused on the disc are necessary to fulfill the physician’s duty to
the patient.7

Options in Glaucoma Management

Because of individual differences arising from the patient’s current health status
and past medical history, an element of uncertainty exists in any patient’s response
to a particular treatment. In the management of glaucoma it sometimes becomes
necessary to alter the initial treatment plan if it fails to be effective in protecting the
patient’s vision. The changes may include additional or different topical medica-
tions, laser trabeculoplasty, or surgical drainage procedures such as trabeculectomy
or a tube drainage device.8,9
Consider the following situation. A patient had primary open angle glaucoma
with intraocular pressures that were becoming increasingly difficult to control
using topical medication alone. Laser trabeculoplasty had not provided sufficient
pressure reduction. The surgeon originally planned a trabeculectomy and dis-
cussed this in detail with the patient, obtaining proper consent for the procedure.
Trabeculectomy is creation of an opening into the globe under a flap of sclera with
the flap covered by the bulbar conjunctiva and Tenon’s capsule, thereby providing
a relatively controlled exit for the aqueous in the anterior of the eye. During the
surgery the surgeon realized the condition of the conjunctiva would not allow for
a successful trabeculectomy and decided instead to place a tube drainage device.
He informed the patient, under local anesthesia, of his decision during the surgery
itself, although the patient later stated he had no recollection of the conversation
because of the medicine he had been given. Because the patient afterward com-
plained of discomfort allegedly due to the presence of the drainage device attached
to his eye, he sued on the grounds of lack of consent for the change of procedure.
In the preoperative discussion the surgeon had raised the possibility of placement
of a tube drainage device. Both the patient and the surgeon were aware of the need
to control intraocular pressure to preserve vision. Despite this patient’s claim of
pain and discomfort from the device, in this instance the surgeon’s experience in
identifying conditions that could lead to an unsuccessful outcome was an important
component of the surgery itself and was his successful legal defense. Preoperative
consultation must include a brief description of possible contingencies to avoid
later liability and must include the surgeon’s freedom to select what appears to be
the best course during the surgery.
Chapter 15. Glaucoma 167

Nontraditional Treatment for Glaucoma

Glaucoma is a disorder whose etiology is still only partially understood, mak-


ing treatment challenging and not always successful with consequences that
are potentially debilitating to the patient. As a result, patients are often
attracted to nontraditional treatment because of frustration with the limited
results or with the difficulty in using their current treatment, because of their
dissatisfaction with the physician, or a combination of these. The patient in
such a situation may turn to nontraditional therapy such as special diets,
exotic treatments, or the use of herbs or other botanicals, including cannabis,
all of which have been touted for the treatment of glaucoma. This decision
may be suggested or reinforced by information obtained from nonprofes-
sional sources. The patient is likely to incur vision loss when using alterna-
tive treatments despite their glowing claims to preserve or enhance vision,
and the physician should be especially on guard, without being offensive or
appearing dogmatic, to avoid any perception of encouragement in unproven
or untested treatments.10,11
Consider the following situation. A patient complained to her physician of her
lack of faith in his prescribed remedies. He responded by pointing out that her pres-
sures had remained under good control, and the progressive damage to her optic
nerves had been stopped. The patient wanted not control but a cure and questioned
the direction and adequacy of the treatment. She announced that she wanted to try
a botanical treatment that was advertised in the media. The physician in his frustra-
tion said she was free to do what she felt was best but to let him know the result if
she tried the botanical. The patient had not been seen for several years before being
examined once again by the original physician. By then she had sustained increased
damage to the optic nerves with a corresponding loss in visual field. The patient
sued the physician because he gave no warning of the risk of damage if she pursued
her plans for alternative treatment. The court held for the patient, saying that under
the circumstances the physician erred by not warning the patient more emphatically
and in a manner by which the patient would likely understand the potential risks of
the alternate treatment, and for vaguely implying that the unorthodox treatment
might be useful.
The question arises whether the patient is actually aware of the risk that is being
assumed. In the situation in which the patient knowingly fails to comply with the
physician’s instructions or selects a course of treatment different from the one rec-
ommended by the physician, the law considers the patient to have accepted the
consequences of his own actions. Legally this is termed the assumption of risk. The
physician’s duty is to inform the patient of the potential risks for glaucomatous
damage arising from the failure to follow customary practices. The physician must
also point out any risk, if known, arising from the patient’s choice of alternative
treatment. To be legally protected the physician should always place in the patient’s
record information about the patient’s actions and decisions that may affect
treatment.12
168 R.F. Sanke and P.P. Lee

Management of the Noncompliant Patient

The physician–patient relationship may occasionally experience a strain or tension


that interferes with good glaucoma care. This is particularly true because primary
open angle glaucoma is a life-long condition that, although controllable, requires
good communication and interaction to form a workable partnership between phy-
sician and patient. Like any long-term relationship, the effectiveness of the relation-
ship may weaken because of interpersonal factors. If it becomes obvious to the
physician that, despite the best efforts at reaching a workable accommodation, the
treatment goals are not being reached because the patient is not cooperating, it is
often advisable to terminate the professional relationship. The patient will usually
find another ophthalmologist who can provide a workable situation. To continue in
a negative relationship is to risk visual loss for the patient and potential liability to
the ophthalmologist. There is a specific manner by which this can be accomplished,
and the physician is advised to follow this protocol.13

Glaucoma Research and the Physician’s Professional Interests

The physician who is treating glaucoma may sometimes be engaged in basic glau-
coma research or clinical evaluation of an experimental medication, device, or pro-
cedure. Although the U.S. Food and Drug Administration (FDA) is authorized by
law to investigate and approve for use additions to the treatment armamentarium,
the individual physician may still be involved in the development of new treatments
and as a result may make them available for a particular patient. Providing experi-
mental treatment to the patient can also create a personal benefit for the physician
that may be monetary or may advance his reputation or career in a nonmonetary
way. In these situations the physician has the duty to inform the patient that he may
also receive a potential benefit in addition to any benefit that may accrue to the
patient. This is an extension of the doctrine of informed consent and in these cir-
cumstances it must be communicated to the patient.14

Technology in Glaucoma Treatment

The field of glaucoma over the past few decades has expanded widely its diagnostic
and therapeutic capabilities. Whereas 30 years ago topical medicines were the
mainstay of glaucoma treatment, newer technology has since then slowly been
added to the treatment options available. Lasers were the first addition. Argon laser
trabeculoplasty alters the microstructure of the trabecular meshwork, increasing
outflow of aqueous from the eye, and has been in use now for a number of years.
More recently selective laser trabeculoplasty using a pulsed neodymium-YAG
Chapter 15. Glaucoma 169

laser has been introduced and works in a similar manner. Mechanical drainage
devices, such as the Krupin, the Ahmed, and the Baerveldt tube drains, have also
become a regular part of glaucoma therapy.
Because newer treatments, despite extensive evaluation, can still have as yet
undiscovered negative consequences, a question arises concerning the nature and
extent of the physician’s responsibility and liability for these consequences. The
physician’s duty to inform the patient must include anything that may affect the
patient’s decision to accept or reject treatment. This includes the use of a new
medicine, a new technique, or a new instrument. In the case of something that is
experimental, this status must also be communicated to the patient, emphasizing
the possibility that unknown negative consequences may occur. When the physi-
cian has fully communicated all the information that may influence the patient’s
decision, the patient’s free acceptance of any risk will have been established.
When introducing new technology, it is important to stay within the parameters
established by the manufacturer and by the FDA, which approves it use, and within
any established and customary practices that would apply to the situation. As men-
tioned earlier, when departing from customary practice, the physician has the duty
to fully inform the patient of this departure and to discuss possible risks that may
occur. Everything necessary for the patient’s free decision must be provided in
order to establish valid informed consent.15
Consider this situation. A glaucoma patient was advised of the availability of a
new laser treatment that decreases the secretion of aqueous humor, and, following
discussion of the treatment, the patient agreed to its use. The laser had been
approved for this specific use by the FDA, and the physician used it according to
the instructions provided by the manufacturer and within the purpose and guide-
lines established by the FDA. Following treatment with the new laser, the patient
developed hypotony and a reduction in vision. She sued the manufacturer of the
laser for failure of the instrument to control the intraocular pressure in the manner
predicted, and she also brought suit against the physician for her loss of vision. The
court in this case recognized that the physician had used the instrument according
to the manufacturer’s established instructions as well as within the FDA guidelines
and therefore held the manufacturer solely liable for the equipment failure and the
resulting visual loss.
As the practice of medicine in general and glaucoma management in particular
changes with the increase in knowledge of diagnosis and treatment, issues will arise
that may have legal consequences. Evidence-based medicine relating to newer
drugs and instrumentation will alter the balance of duty and responsibility between
the manufacturer and the physician who uses them.16 Recent advances in technol-
ogy have already influenced medicine, and practice support systems such as tele-
medicine and electronic records will cause even further change and raise additional
questions. Situations in glaucoma management will surely occur that cannot be
imagined in today’s practice of medicine but that will nonetheless affect the legal
environment.
Especially in the area of glaucoma, keeping abreast of the latest knowledge and
developments, always putting the patient’s best interests first, and giving consideration
170 R.F. Sanke and P.P. Lee

and respect to the patient’s point of view are the best approach to reduce the physi-
cian’s legal risk. Established legal doctrines and duties can be expected to continue
unchanged, but, as the options for diagnosis and treatment increase, these established
duties will expand and become more narrowly defined, resulting in new duties and
responsibilities for the physician. Because glaucoma is a life-long disorder, frequent
and appropriate evaluation of the patient at risk and initiation of treatment at the earli-
est signs of glaucomatous change will continue to be the best protection for the
patient’s vision throughout his life. Attention to the patient’s individual situation and
personal risk factors will enable the physician to establish the best and most effective
treatment program while minimizing legal risk and liability. Putting the patient’s inter-
est first has long been a pillar of established medicine, and this is just as true today as
it ever was.

References

1. Collaborative Normal-Tension Glaucoma Study Group. Comparison of glaucomatous pro-


gression between untreated patients with normal-tension glaucoma and patients with thera-
peutically reduced intraocular pressures. Am J Ophthalmol 1998;126:487–497.
2. Heijl A, Leske MC, Bengtssen B, Hyman L, Hussein M. Reduction of intraocular pressure
and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol
2002;120:1268–1279.
3. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: a
randomized trial determines that topical ocular hypotensive medication delays or prevents the
onset of primary open-angle glaucoma. Arch Ophthalmol 2002;120:701–713, 829–830.
4. Lichter PR, Musch DC, Gillespie BW, et al. Interim clinical outcomes in the Collaborative
Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or
surgery. Ophthalmology 2001;108:1943–1953.
5. Henderson v. Heyer-Schulte Corp. of Santa Barbara, 600 S.W.2d 844 (Tex. Cir. App.-Hous [1
Dist.] 1980), 28.
6. Restatement (Second) of Torts 282 (1965).
7. Helling v. Carey, 83 Wash.2d 514,519, 2d 981.
8. Preston v. Hubbell, 87 Cal App.2d 53, 196 P.2d 113 (Cal. App. 2 Dist. 1948), 98.
9. Kennedy v. Parrott, 243 N.C. 355, 90 S.E.2d 754 (N.C. 1956), 99.
10. Weil v. Seltzer, 873 F.2d 1453, 277. U.S. App. D.C. 196 (D.C. Cir. 1989), 161, 166.
11. Shorter v. Drury, 103 Wash.2d 645 P.2d 116 (Wash. 1985), 167.
12. Payton v. Weaver, 131 Cal.App.3d 38, 182 Cal Rptr. 225 (Cal. App. 1 Dist. 1982), 21, 24.
13. Lee PP. Medico-legal issues in glaucoma. In: Epstein DL, ed. Chandler and Grants Glaucoma.
Baltimore: Williams & Wilkins; 1997:648–654.
14. Moore v. Regents of the University of California, 271 Cal. Rptr. 146, 793 P.2d 479 (Cal. 1990),
115, 284.
15. Kernke v. Menninger Clinic, Inc., 172 F.Supp.2d 1347 (D. Kan. 2001), 282.
16. Bujak JS, Lister E. Is the science of medicine trumping the art of medicine? Physician
Executive 2006;32:18–21.
Chapter 16
Neuroophthalmology

Andrew G. Lee

Introduction

Why is neuroophthalmology a special risk for general ophthalmic medical malpractice


claims? Neuroophthalmology is a relatively small part of most general ophthalmic practices.
Unfortunately, several features of neuroophthalmic practice create special risk for the com-
prehensive ophthalmologist. It has been my experience that, although claims against neu-
roophthalmologists are rare, neuroophthalmic-based claims against comprehensive
ophthalmologists are not. First, clinical decisions about neuroophthalmic conditions may
have vision-threatening or life-threatening consequences. Second, because these are often
“high stakes” decisions, earlier diagnosis and treatment make a big difference in final out-
come. Third, as opposed to other more common ophthalmic subspecialties, neuroophthal-
mic consultation may not be easily accessible, timely, or available to the comprehensive
ophthalmologist. Fourth, the cost of a neuroophthalmic paid claim is often higher than the
typical ophthalmology claim. About 15% of the paid claims (n = 17) of the Ophthalmology
Mutual Insurance Company (OMIC) closed with a “large loss” (≥$ 250,000). These 17 paid
claims represented a disproportionate 59% of OMIC’s total paid indemnity (average
$ 433,285). Interestingly, in the OMIC series, the number one payout was $ 790,000 for a
“failure to diagnose brain tumor” that led to death. In addition, a second case of “failure to
diagnose giant cell arteritis” ($ 250,000) was among the “large loss” cases.1
This chapter presents composite but real closed cases as well as a few modified
cases drawn from the author’s medicolegal consultation practice to highlight specific
areas of concern, risk management and the potential for systems based failures in
neuroophthalmic cases. I want to emphasize that the recommendations in this chapter
are meant to be guidelines for care and not necessarily the “standard of care.”

What Types of Claims Occur from


Neuroophthalmology Cases?

Although statistically, complications related to cataract surgery and undiag-


nosed retinal detachment are the most common causes of ophthalmic medical
malpractice litigation, “missed diagnoses” in neuroophthalmology when they

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 171


doi: 10.1007/978-0-387-73341-8; © Springer 2008
172 A.G. Lee

occur tend to result in higher payouts. Kraushar et al. reported 121 ophthalmic
malpractice claims, and “failure or delay in diagnosis” represented 35% of
claims and 63% of indemnification. The “failure to diagnose” retinal detach-
ment was the most common cause.2–4 In Bettman’s review of 412 claims, 9 (2%)
were “motility,” 9 (2%) were neuroophthalmologic procedures,” and 8 (1.9%)
were “tumors.”5–8 In my consultative medicolegal practice, “failure to diagnose
or delay in diagnosis” (“sin of omission”) for giant cell arteritis, compressive
optic neuropathy (e.g., meningioma), sellar/chiasmal/pituitary tumor, and toxic
medication effect (e.g., ethambutol and chloroquine/hydroxychloroquine toxic-
ity) have been the most common. “Failure to treat” is a less common claim than
“failure to diagnose” in my experience, but “failure to timely diagnose and treat
visual loss from papilledema” (usually pseudotumor cerebri) is the leading
culprit.9,10

Case 1: Optic Atrophy

A 55-year-old male with hypertension and diabetes presented with “acute awareness”
of visual loss in his right eye (oculus dexter [OD]) while shaving the morning of pres-
entation. An ophthalmologist examined the patient and found 20/50 OD and 20/20 OS
(oculus sinister [left eye]). The pupil examination by the technician shows PERRLA
(i.e., pupils equal, round, and reactive to light and accommodation). Slit-lamp exami-
nation discloses a “moderate nuclear cataract OD <more than> OS.” Ophthalmoscopy
shows “possible mild optic atrophy OD and a normal optic nerve OS with a cup to disc
ratio of 0.4.” The ophthalmologist writes the following: “Impression: ‘?’ mild optic
atrophy and cataract OD. Plan: Return in 3 months.”
The patient returns in 2 months with worsening vision OD to 20/100. The tech-
nician reports: “PERRLA.” Confrontation visual field testing shows an inferior
altitudinal-type of visual field defect OD and is normal OS. The ophthalmologist
records the following impression: “possible mild optic atrophy OD—likely old
ischemic optic neuropathy due to inferior altitudinal defect” and “Return—3
months.” The patient calls the office and reports “worsening vision OD” and the
ophthalmologist orders a “scan.” The patient returns 1 month later with a noncon-
trast head computed tomography (CT) scan that has been read as “normal.” The
ophthalmologist tells the patient by phone that “there is nothing to worry about”
and to keep the 3-month follow-up appointment.
The patient seeks a second opinion 2 months later from a second ophthalmolo-
gist. The vision is now hand motions only OD and 20/20 OS. A right afferent pupil-
lary defect is detected. The formal (Goldmann) visual field test shows inferior and
central loss OD and a superotemporal visual field defect respecting the vertical
midline OS. The optic nerve is diffusely pale OD.
The second ophthalmologist tells the patient that he needs to have an “MR scan
right away” and a postcontrast cranial magnetic resonance imaging (MRI) of the
Chapter 16. Neuroophthalmology 173

sella shows a pituitary adenoma compressing the right optic nerve and the junction
of the optic nerve and chiasm. The second ophthalmologist tells the patient and his
family that he needed to see a “neuroophthalmologist” and “that if only they had
come in sooner the vision might have been preserved.”
What went wrong?
1. I would recommend that the extremely common but insufficient clinical abbre-
viation for the pupil exam, “PERRLA,” should be avoided by the ophthalmolo-
gist. “PERRLA” makes no assessment of the relative afferent pupillary defect
(RAPD), the single most important objective evidence for an optic neuropathy
in a patient with unilateral visual loss.
2. “Optic atrophy” is not a diagnosis. It is an ophthalmoscopic description of a
clinical examination finding and does not define the etiology. Describing the
“optic atrophy” with adjectives such as “?,” “maybe,” or “possible” does not
protect the ophthalmologist and does not obviate the need for differential
diagnosis and evaluation. Patients with “optic atrophy” should have docu-
mentation of the presence or absence of clinical evidence for an optic neu-
ropathy, including assessment for an RAPD, a formal visual field test, and
possibly photographic or nerve fiber analysis (e.g., optical coherence tomog-
raphy). Bettman in a review of 276 medicolegal cases disclosed the medical
reasons for filing these claims were usually based on “sins of omission or
commission in “basic ophthalmology” rather than the omission of sophisti-
cated testing or procedures. The recommendations of Dr. Bettman included
that physicians should plan for the care of emergencies, order imaging as
needed, use consultants, stay well within one’s level of competence, and of
course “document everything.”
3. Inferior altitudinal defect is common but not diagnostic in nonarteritic ante-
rior ischemic optic neuropathy (NAION). The clinical diagnosis of NAION
requires (i) a clinical history of acute unilateral visual loss, (ii) documenta-
tion of the initial optic disc edema phase (i.e., the “anterior” in NAION), and
(iii) stability over time with resolution of the disc edema. The presence of
optic atrophy at the first visit is not compatible with the diagnosis of acute
NAION. The small cup to disc ratio is the structural risk factor (i.e., “disc at
risk”) for NAION, and the fellow eye should be examined for this finding. I
would recommend that any patient with unexplained visual loss have consid-
eration for formal perimetry. Patients with a visual field defect on confronta-
tion testing should undergo formal visual field testing to exclude a subtle
lesion in the contralateral eye (e.g., junctional scotoma as in this case) and
to detect a vertical step if present (e.g., homonymous or bitemporal
hemianopsia).
4. The second ophthalmologist inadvertently adds “fuel to the fire” by suggest-
ing that “earlier diagnosis and treatment” would have made a difference in the
case and criticizing the care of the first ophthalmologist. Many cases of medi-
cal malpractice are triggered by the comments or criticism from another
provide.
174 A.G. Lee

Table 16.1 Common errors in evaluating optic atrophy


• Failure to document presence or absence of clinical evidence for optic neuropathy in sus-
pected optic atrophy (e.g., relative afferent pupillary defect [RAPD], formal visual field,
optic nerve assessment)
• Failure to document etiology for unexplained optic neuropathy (i.e., “optic atrophy” is not a
diagnosis)
• Failure to check or document presence or absence of RAPD or delegating this task to the
technician (e.g., pupils equal, round, and reactive to light and accommodation)
• Failure to perform, review, or interpret a visual field test (e.g., formal visual field), failure to
confirm an abnormal confrontation visual field examination with formal perimetry, or failure
to confirm with serial evaluation the stability of visual loss in a patient with suspected optic
neuropathy
• Failure to recognize that any optic neuropathy can produce any visual field defect
• Failure to recognize a vertical step (e.g., hidden within diffuse depression or drift across the
vertical meridian due to artifact, other superimposed causes of visual field loss, or poor test
reliability)
• Failure to perform a timely and appropriate neuroimaging study in unexplained optic neu-
ropathy, junctional visual field loss, bitemporal hemianopsia, or homonymous hemianopsia*
• Failure to order the correct neuroimaging study (e.g., for possible compressive optic neurop-
athy, in general postcontrast fat suppressed orbital and head MRI is superior to noncontrast
CT scan for optic neuropathy)
• Failure to review the neuroimaging study (even with a “normal” report) with the neuroradi-
ologist
• Failure to consider referral to a specialist (e.g., neuroophthalmologist) for unexplained, com-
plex, and/or progressive optic neuropathy
*
I would recommend orbit and head with fat suppression and gadolinium magnetic resonance
imaging (MRI) for optic neuropathy. Sella sequence cranial MRI with and without contrast should
be performed for junctional or bitemporal loss. Cranial MRI with and without contrast is recom-
mended for homonymous hemianopsia. Magnetic resonance imaging is superior to computed
tomography (CT) in the majority of neuroophthalmic conditions (except for need for a faster
study; for examination of bone, acute blood, fracture, trauma, and some orbital conditions; and for
patients who cannot undergo an MRI). Contrast for both MRI and CT should always be consid-
ered unless there is a contraindication.

Table 16.1 lists some common errors that can complicate the evaluation of optic
atrophy.

Case 2

A 12-year-old white female presented with headache and blurred vision in both
eyes (OU). An optometrist notes 20/60 vision OU and bilateral optic disc edema
with a macular star figure of exudate in both eyes. No vitreous cells were noted.
The patient had an esotropia of 30 prism diopters in primary position that was
incomitant in lateral gaze with a moderate abduction deficit OU. The optometrist
calls the ophthalmologist’s office and describes the findings. The ophthalmologist
diagnoses “infectious neuroretinitis OU and sensory esotropia” on the telephone
Chapter 16. Neuroophthalmology 175

and recommends laboratory testing with the pediatrician for cat scratch disease,
Lyme disease, and tuberculosis and an appointment in 2 weeks in the office.
The patient’s mother calls the ophthalmologist’s office and “demands” that the
appointment be “moved up.” The receptionist tells her that she will work on the schedul-
ing but the mother is “frantic.” The office phone encounter form states “Anxious mother
called about scheduling.” The patient’s mother calls 1 week later and reports that the
vision is worsening and that the headache is increasing. The laboratory evaluation from
the pediatrician returns as “negative.” The pediatrician records the negative results but
does not call the patient or the ophthalmologist. The patient’s mother calls a second time
2 days later and the ophthalmic technician discusses the case with the ophthalmologist
and reassures the patient’s mother to keep the scheduled appointment.
The patient develops worsening headache, does not keep the outpatient appoint-
ment, and instead is seen in the emergency room. A second ophthalmologist records
the vision as hand motion OU with papilledema and bilateral sixth nerve palsies.
A cranial CT scan shows a posterior fossa tumor. The blood pressure is normal.
Urgent neurosurgical consultation and posterior fossa craniectomy with resection of
tumor is performed at the second hospital, but the patient is left with no light percep-
tion vision and optic atrophy OU. The first ophthalmologist wonders why the patient
did not show up for her appointment. A malpractice claim is filed 6 months later.
At the time of deposition, the patient’s mother testifies she felt “neglected and
that no one would help her,” that the technician told her “not to worry and stop
being a worry-wart” and that “two more days would not make a difference.” The
physician testified that the ophthalmic technician had informed him of the patient’s
mother’s phone call and included details of the patient’s vision, symptoms, and
signs. The physician testified that the patient’s mother was told to bring the child
in to the office if she was worsening. No documentation of this content for the
phone encounter was available in the chart.
What went wrong?
1. Patients with bilateral optic disc edema should be presumed to have papilledema
until proven otherwise. Optic disc edema from any cause (e.g., ischemic optic
neuropathy, papilledema, malignant hypertension) may produce exudate in the
macula and is not pathognomonic for infectious neuroretinitis.
2. Patients with a neuroophthalmic finding should be evaluated for other findings
(i.e., “Is the finding isolated?”). Other symptoms (e.g., diplopia, headache) and
signs (e.g., sixth nerve palsy) of increased intracranial pressure should trigger
more aggressive and prompt evaluation, including neuroimaging.
3. Telephone triage may be appropriate in many circumstances. In general, how-
ever, objective neuroophthalmic findings should prompt further evaluation by
an ophthalmologist or neuroophthalmologist rather than “diagnosis by phone.”
4. Communication among providers is important. If laboratory evaluation is per-
formed and is positive or negative, then all of the physicians involved in the
medical care of the patient should be informed.
5. Telephone calls should be documented, including persons involved, time and
date of call, specific contents of the phone encounter, triage decision based on
176 A.G. Lee

the facts of the case, and the disposition of the call and any recommendations
for further urgent or emergency evaluation. In general, patients with poten-
tially serious conditions should discuss the findings with the physician rather
than the technician. Hepler emphasized that risk factors for litigation associ-
ated with ophthalmic staff include improper triage of emergency patients, per-
ceived abandonment, lack of confidentiality, improper maintenance of medical
records, and perceived lack of compassion and skill on the part of staff mem-
bers, pejorative comments and editorial comments.11,12 Bettman cited the
following important ophthalmic office personnel factors: “friendly, courteous
attitude, no matter how ‘trying’ the circumstance, and proper training of the
personnel in handling of emergencies.”2

Case 3

A 35-year-old African-American female presented with neck pain and blurred vision
to the emergency room. A cranial CT was normal. A lumbar puncture showed nor-
mal cerebrospinal fluid content with no evidence of subarachnoid hemorrhage or
meningitis. No opening pressure was performed. No visual acuity was measured,
and no documentation of the fundus examination was recorded. The emergency
room physician diagnoses “migraine.” The patient was referred to a neurologist in 1
week. The neurologist treated the patient with migraine medicine, documented the
emergency room encounter findings, and recommended an ophthalmology consulta-
tion in 1 or 2weeks for the blurred vision. The neurologist saw “possible blurred disc
margins” and started the patient on acetazolamide 250 mg per day. The patient then
lost vision to hand motions OU over the next few days. The ophthalmologist docu-
mented papilledema OU and performed an optic nerve sheath fenestration OU, but
the vision did not recover. An MRI scan is normal, and a repeated lumbar puncture
showed an opening pressure of 500 mm of water. A lumboperitoneal shunt was per-
formed, but the vision remained hand motion and optic atrophy OU developed.
Table 16.2 lists some common errors that can complicate the evaluation and treat-
ment of papilledema.

Table 16.2 Common errors in evaluation and treatment of papilledema


• Failure to consider diagnosis of papilledema in bilateral optic disc edema
• Failure to perform timely and appropriate evaluation, including neuroimaging and lumbar
puncture
• Failure to check blood pressure in bilateral optic disc edema for malignant hypertension
• Failure to consider urgent surgical treatment (e.g., optic nerve sheath fenestration) for
patients with visual loss at presentation
• Failure to obtain an opening pressure at the time of lumbar puncture
• Failure to measure visual acuity or formal perimetry or to perform ophthalmoscopy in a
patient with possible pseudotumor cerebri
Chapter 16. Neuroophthalmology 177

Case 4

A 65-year-old white female developed new-onset headache. She saw her family
care doctor, who diagnosed “sinusitis” and treated the patient with antibiotics.
Two weeks later the headache worsened, and she had blurred vision OD. The
family practitioner referred the patient to an ophthalmologist. On examination,
the visual acuity was 20/40 OD and 20/30 OS. The technician recorded
“PERRLA.” The fundus examination was normal OU. The patient was referred
back to the family practice physician. The next day, Friday, July 4th, the patient
called the office at 4:50 PM with complaints of increasingly severe headache. The
receptionist who took the call informed the patient that the doctor had already
“left for the holiday.” The patient went to the emergency room that night and had
a CT scan of the head and a lumbar puncture that were normal. The patient
reported to the emergency room doctor that she has had several episodes of tran-
sient monocular visual loss OD and jaw claudication for the past 3 weeks but had
already been seen by her ophthalmologist and family doctor for these problems.
The emergency room physician called the ophthalmologist, who was watching
the fireworks with his family downtown. The ophthalmologist told the emergency
room doctor to schedule the patient to be seen on Monday. The patient was dis-
charged from the emergency room with the diagnosis of “migraine.” The next
day, Saturday, the patient lost vision OU to no light perception.
A second ophthalmologist saw the patient and diagnosed bilateral pallid disc
edema consistent with arteritic anterior ischemic optic neuropathy. An erythrocyte
sedimentation rate was normal at 15 mm/hr, but the serum C-reactive protein was ele-
vated at 16 mg/dL. A temporal artery biopsy showed temporal arteritis, and the patient
was treated with steroids without improvement in her vision. The family doctor, when
notified of the impending lawsuit, altered the medical record to include a “negative
review of systems” including “no jaw claudication.” The first ophthalmologist testi-
fied at deposition that he had asked the emergency room doctor on the phone about
the presence of jaw claudication and recommended an erythrocyte sedimentation rate
evaluation. There is no documentation in the emergency room record regarding this
discussion. The family doctor, emergency room physician, and first ophthalmologist
reach a substantial settlement with the patient.
What went wrong?
1. New-onset headache with or without visual loss in the elderly should be consid-
ered to be temporal arteritis until proven otherwise.
2. The standard of care does not change based on time of day, day of week, or
holiday.
3. Patients with possible temporal arteritis should be evaluated urgently, as the
natural history of untreated giant cell arteritis can lead to blindness. In the
Kraushar and Robb series, the most frequent risk factors were altered records,
poor documentation, informed consent problems, failure to see the patient
promptly, and failure to obtain or follow the advice of a consultant.
178 A.G. Lee

Table 16.3 Common errors in evaluation of giant cell arteritis


• Failure to evaluate new-onset headache in the elderly
• Failure to triage or refer new diagnosis of temporal arteritis
• Failure to consider or to document appropriately pertinent positive or negative review of sys-
tems (e.g., headache, scalp tenderness, jaw claudication, polymyalgia rheumatica)
• Failure to consider occult giant cell arteritis in elderly patients with visual loss
• Failure to order erythrocyte sedimentation rate (ESR) or C-reactive protein in suspected
giant cell arteritis
• Failure to consider that the ESR may be normal in temporal arteritis
• Failure to start or maintain adequate corticosteroid therapy in giant cell arteritis
• Failure to recognize the significance of “red flags” for giant cell arteritis (e.g., transient mon-
ocular visual loss preceding ischemic optic neuropathy, posterior ischemic optic neuropathy,
bilateral visual loss, pallid disc edema, nonembolic central retinal artery occlusion, cilioreti-
nal artery occlusion, ocular ischemic syndrome)
• Failure to perform temporal artery biopsy*
*
I believe that establishing pathologic diagnosis is helpful in preventing inappropriate or too rapid
tapering of the steroid treatment and for justifying continued treatment in the face of steroid
related side effects.

Table 16.3 lists some common errors that can complicate evaluation of giant cell
arteritis.

Case 5

A 65-year-old white female presented to her ophthalmologist with painless progressive


visual loss OU. The past medical history was significant for Mycobacterium avium
intracellulare infection of the lung treated by a pulmonary specialist with ethambutol
1,200 mg per day for 3 months. The patient saw an ophthalmologist and reported the
visual blurring. The visual acuity was 20/40 OU, and a mild cataract was detected.
The technician reported no relative afferent pupillary defect. The fundus was normal.
The ophthalmologist diagnosed “mild cataract” OU. The patient returned 3 weeks
later with worsening vision OU at 20/100 OU. The ophthalmologist wrote, “No disc
edema or optic atrophy—doubt toxicity. Schedule visual field next visit.” Two weeks
later, the patient underwent a computerized Humphrey 30-2 visual field (HVF) test
that was unreliable OU. The ophthalmologist noted “? Mild temporal pallor” and
wrote “HVF—unreliable” and recommended referral to a neuroophthalmologist. The
ophthalmologist wrote a note to the pulmonary doctor about the possibility of etham-
butol toxicity but told the patient that he has to “check with the pulmonary doctor”
before stopping the medicine. The pulmonary doctor is “on vacation,” and the phone
message from the ophthalmologist and the letter regarding the possibility of toxicity
remained on the desk of the pulmonologist.
Three weeks later the patient saw the neuroophthalmologist, who performed
Goldmann perimetry that showed a dense cecocentral scotoma OU and counting fin-
gers vision OU. The optic nerves showed bilateral temporal pallor. The ethambutol
Chapter 16. Neuroophthalmology 179

Table 16.4 Common errors in evaluating toxic optic neuropathy


• Failure to consider medications as a potential cause for visual loss (e.g., ethambutol,
hydroxychloroquine, chloroquine, amiodarone)
• Failure to consider toxic retrobulbar optic neuropathy in differential diagnosis of unex-
plained visual loss (normal optic nerve initially)
• Failure to consider that bilateral and symmetric optic neuropathy may not have a RAPD
• Failure to perform formal visual field testing in patients with unexplained visual loss
• Failure to repeat or further evaluate patients with an “unreliable” automated perimetry
• Failure to communicate in a timely manner the need to discontinue potentially toxic medica-
tion to patient and prescribing physician
• Failure to consider referring a patient with unexplained optic neuropathy
• Failure to consider dose (mg/kg), duration of treatment, and risk factors for toxicity (e.g.,
body weight, renal or liver dysfunction)

was discontinued, but the patient did not recover her vision. The neuroophthalmolo-
gist scolds the patient for not discontinuing the medication sooner.
Table 16.4 lists common errors that can complicate the evaluation of toxic optic
neuropathy

References

1. Ophthalmic Mutual Insurance Company. http://www.omic.com/resources/risk_man/deskref/


litigation/16.cfm.
2. Kraushar MF, Robb JH. Ophthalmic malpractice lawsuits with large monetary awards. Arch
Ophthalmol 1996;114:333–337.
3. Kraushar MF, Turner MF. Medical malpractice litigation in ophthalmology: the New Jersey
experience. Ophthalmic Surg 1986;17:671–674.
4. Kraushar MF. Recognizing and managing the litigious patient. Surv Ophthalmol 1992;37:
54–56.
5. Bettman JW. A review of 412 claims in ophthalmology. Int Ophthalmol Clin 1980;20:131–142.
6. Bettman JW. Office personnel and medicolegal claims. Surv Ophthalmol 1982;27:64–66.
7. Bettman JW. Seven hundred medicolegal cases in ophthalmology. Ophthalmology 1990;97:
1379–1384.
8. Bettman JW. Special problems in ophthalmic subspecialties. Ophthalmology 1979;86:
1246–1252.
9. Donin JF. Special risk areas in ophthalmology. Neuro-ophthalmology. Int Ophthalmol Clin
1980;20:93–107.
10. Donin JF. The neuro-ophthalmology trap: failure to diagnose. Ophthalmology 1979;86:
1240–1245.
11. Hepler RS. Ophthalmology personnel in risk management. What office personnel need to
know to keep you out of trouble. Ophthalmology 1990;97:1385–1389.
12. Lanckton AV. How to avoid malpractice claims. Arch Ophthalmol 1996;114:339–340.
Chapter 17
Oncology

Devron H. Char

It is relatively straightforward to avoid malpractice litigation involving patients


with ophthalmic oncologic problems. Almost all cases in which a general ophthal-
mologist is named have to do with the failure to diagnose and institute treatment in
a timely manner. Very few cases (almost all either eyelid or conjunctival neo-
plasms) are ones involving either treatment errors or poor treatment results that
impacted either vision or life.1
Almost all malpractice suits involving general ophthalmologists and patients
with eyelid or conjunctival lesions are those in which the physician has failed to
diagnose and treat the tumor in a timely manner. Four major principles should
avoid this problem in its entirety. First, any older patient with a unilateral
“blepharitis or conjunctivitis” should have a biopsy either with a platinum spat-
ula scraping (in the case of a conjunctival lesion) or with a forceps and scissors
for a conjunctival or lid lesion. In neither setting will an incisional biopsy
adversely affect systemic prognosis. Furthermore, the French, in the early
1700s, showed that many lid tumors could be “repaired” using the laissez-faire
approach. Thus, the cosmetic effects of a biopsy similarly are negligible.
Patients at risk for an eyelid tumor include those with various DNA repair syn-
dromes, which can present in childhood (xeroderma pigmentosum, Bloom’s
syndrome, etc.), patients who have a great deal of sun exposure, and those with
a prior cutaneous malignancy. Worrisome is the eyelid mass or ulcer that is
either pigmented or nonpigmented, often with new vessels in the area, loss of
lashes, inflammatory changes, or other signs of chronic irritation. In this setting,
a biopsy should be done.
In the conjunctiva, the most common malignancies are epithelial tumors, either
squamous cell carcinoma (or its localized precursor, intraepithelial carcinoma
[also called conjunctival intraepithelial neoplasia]) or conjunctival melanomas. In
either setting, one can quickly discern if it is possibly one of these lesions because
both involve the epithelium. If topical tetracaine is placed in the eye and the lesion
does not move when a Q-tip moves the conjunctiva, this is not one of those neo-
plasms. It is also important to test human immunodeficiency virus (HIV) status in
a patient with possible squamous cell carcinoma who is under 50 years old,
because there is a high prevalence of this malignancy in patients with acquired
immunodeficiency syndrome (AIDS). In younger patients with squamous cell

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 181


doi: 10.1007/978-0-387-73341-8; © Springer 2008
182 D.H. Char

neoplasia of the conjunctiva, HIV disease must be ruled out. Again, there is no
negative effect of biopsy in conjunctival lesions.
Orbital tumefactions and lesions that simulate them rarely lead to malpractice
suits, although these can occur. Ironically, more commonly I have seen patients with
undiagnosed thyroid orbitopathy than those with neoplastic processes sue an ophthal-
mologist for failure to diagnose and treat in a timely manner. The one area that can
be problematic is childhood proptosis. Although most adults with orbital disease can
be evaluated in a standard manner, children with proptosis require emergent evalua-
tion to avoid preventable visual loss from either infections or tumors.
Several investigations have shown that, in adults, the most common cause of
unilateral or bilateral proptosis is thyroid orbitopathy. Any patient with proptosis or
signs of optic nerve dysfunction (loss of color vision, afferent pupil defect, or
changes in the nerve fiber layer or optic atrophy) should have good quality, thin
section, orbital imaging. Ultrasonography in centers that manage many patients
with ophthalmic oncologic problems is quite accurate, but, for the general ophthal-
mologist, high quality magnetic resonance imaging (MRI), preferably with thin
sections and fat saturation gadolinium studies using a 3T magnet, is the best choice
for imaging approach. The rational for this statement is that the quality of both
computed tomography (CT) and MRI scans is really dependent on the equipment
and on the patient’s cooperation. With excellent equipment and well-developed
protocols, one can obtain as good a scan as those performed in a major ophthalmic
oncologic center. In contrast, I have seen a number of suits where the ultrasound
was diagnostic, but not correctly interpreted, even in large university centers with-
out sufficient experience with ophthalmic oncologic processes.
Most patients with thyroid orbitopathy present within 18 months of the diagno-
sis of hyperthyroidism, but a minority of patients will present with just eye signs
and no systemic symptoms. As described earlier, vision loss of unexplained origin
mandates an imaging study. Many years ago Jonathan Trobe noted that up to 80%
of patients with compressive thyroid optic neuropathy were not diagnosed by the
primary ophthalmologist. The scans will obviously allow the correct diagnosis in
such settings. In addition, over 95% of patients with thyroid orbitopathy can be
diagnosed by simple thyroid blood tests. A serum thyroid stimulating hormone
(TSH) level is the first-line test for hyperthyroidism because a 2-fold change in the
serum thyroxin level produces a more than 50-fold change in the serum TSH.
Hyperthyroid patients have immeasurably low TSH levels. Those whose thyroid
gland has either spontaneously involuted or been destroyed by the autoimmune
processes often have thyroid stimulating immunoglobins. Both types of studies
should be performed when this diagnosis is suspected.
Intraocular tumors and lesions that simulate them generate the largest number
of lawsuits I have seen. Most of the lawsuits regarding children are retinoblast-
oma cases and not initially diagnosed by the pediatrician. Frankly, I have not
seen a retinoblastoma lawsuit directed against an ophthalmologist. As a profes-
sion we have been excellent when a child is referred with the possibility of an
abnormal eye finding to have an appropriate evaluation in ophthalmic oncologic
centers.
Chapter 17. Oncology 183

The two most common problems that have led to litigation involving adults have
been failure to diagnose and treat uveal melanoma in a timely manner and a failure
to diagnose and treat an intraocular lymphoma. Diagnosis and management of an
atypical uveal melanoma can be difficult. Historically, 20% of the eyes removed
with a clinical diagnosis of a uveal malignant melanoma contained a simulating
lesion on histologic examination. Similarly, 10% of eyes with opaque media that
were submitted to the Armed Forces Institute of Pathology, had unsuspected uveal
melanoma. In 2006, the diagnostic accuracy with patients who have a melanoma
large enough to require treatment approaches 100% in major ophthalmologic onco-
logic centers. How do we avoid missing a patient with a uveal malignant melanoma?
One, it is imperative to be overly cautious in the evaluation of patients with a uni-
lateral media opacity. About three to four times a year, I manage patients with a
unilateral cataract who have had axial length measurements and placement of an
intraocular lens. With several of these patients, the surgeons actually had difficulty
inserting the lens because there was a <more than>10 mm thick ciliochoroidal
melanoma that made lens implantation difficult. Any patient with unilateral media
opacity requires diagnostic ultrasonography in addition to axial length
measurements.
Another group of patients involved in litigation are those who have been seen
with minimal retinal symptoms (flashes, floaters, visual field defect) or a sentinel
vessel, were evaluated without dilation by an ophthalmologist, and then had the
diagnosis of uveal melanoma made a year or two later in another office. Obviously,
the lawyers query whether this could have been diagnosed earlier. The standard of
care in most states requires a dilated fundus examination when the patient is seen
for routine ophthalmic care, and it is imperative that this be documented on the
chart. It is possible to defend the fact that a peripheral uveal melanoma was missed
in the course of an ophthalmologic evaluation if there is documentation that the eye
was dilated and the periphery was examined. What is much more difficult is the
scenario when the patient has a tumor and there is no documentation that a dilated
examination was performed. This becomes especially vexing with the patient who
has symptoms of flashes, floaters, or a sentinel vessel peripherally and but for
whom there is no evidence that a dilated examination had been performed.
In a recent paper we published, approximately 35% of reasonable sized melano-
mas were not discovered on primary ophthalmologic examination. Those data can
be interpreted two ways. One interpretation is that if this number of cases is missed,
can you assume that it is not malpractice to be unable to diagnose a melanoma? The
other interpretation is that a number of these cases should have been diagnosed
(because the mean size of these tumors is over 5 mm in thickness), and perhaps we
should be a little more judicious in our fundus examinations.
A more difficult diagnostic problem is in the patient who unfortunately is not
diagnosed as having a tumor prior to the surgical management of another condition
(usually a unilateral media opacity or vitreous hemorrhage and retinal detachment
following an anterior segment procedure), meaning the diagnosis is established late
in the disease course. I will give you two disturbing examples. One was a patient
we saw several years ago who had cataract extraction with a nonclearing vitreous
184 D.H. Char

hemorrhage. Vitrectomies were done on two separate occasions, and we were asked
to see the patient when there were black masses growing out of the vitrectomy inci-
sions. The second case was a patient who had intractable intraocular pressure eleva-
tion after cataract surgery and vitrectomy, and we were brought in after the patient
had a Molteno valve with amelanotic growths around that area.
As clinicians, I think the most difficult problem we face diagnostically is when a
patient has a very atypical response to therapy. I have always approached such
patients with the assumption that we possibly have made an error and therefore have
to start the evaluation again from “ground zero” because of the possibility of a missed
diagnosis. Certainly for a patient who has had a cataract and now for some reason
develops a hemorrhage, or especially has a nonclearing hemorrhage, the possibility
of a tumor should be considered, and diagnostic ultrasound makes good sense.
Several rarer forms of malignancy can be difficult to diagnose, but because of
their rarity they are less likely to initiate a lawsuit. We have seen a few patients
present with a ring melanoma. Unfortunately, while these can be diagnosed with
fine-needle biopsy, often they will present either as a unilateral glaucoma with just
pigment present asymmetrically in the angle of one eye or, less commonly, as what
appears to be a focal iris small tumor but with increased pressure in that eye. In
either of these settings, the possibility of a melanoma that is a ring type should be
considered and the patient referred for further evaluation.
Intraocular lymphomas have generated several lawsuits. Any older adult with
diffuse uveitis (involvement of the vitreous as well as the anterior chamber), espe-
cially with yellowish-white choroidal-retinal infiltrates, should be presumed to
have an intraocular lymphoma until you prove it otherwise. The management of
these patients is obviously outside the purview of a general ophthalmologist, but
the possibility of an intraocular lymphoma should be raised for patients over 50
years old with “diffuse uveitis.” Obviously, most patients in this age group with this
presentation would not have intraocular lymphoma, but the failure to consider this
diagnosis can place the clinician in legal jeopardy.
Several points are important to emphasize in commonality with other causes of
ophthalmic malpractice litigation. I am impressed, having reviewed a number of
cases, that the physician’s ability to be compassionate and caring are probably as
important (and some would say more so) than the quality of their care in preventing
or resulting in a malpractice case. There was a California physician who I thought
was probably in the top 10% of practicing ophthalmologists but who I saw four
different legal actions against mainly because, in each case, he managed to alienate
patients who achieved less than perfect results (which certainly does happen to all
of us). At the other extreme, there was another physician in Northern California
who probably should have lost his license many times but was so charming that
most patients did not initiate lawsuits against him even when they should have.
If you are asked to perform a definitive procedure for an ophthalmic oncology
problem, it is imperative to provide appropriate informed consent. In eyelid or
conjunctival tumors, even though we have <more than>98% local control rate,
I always counsel patients about a possible false-positive or negative pathology
result (for both diagnosis and tumor margins). In eyelid surgery we also counsel
Chapter 17. Oncology 185

patients that it may be necessary to do more than one procedure to reconstruct the
eyelid (even though this is necessary <less than>0.1% of the time). In cases with
an intraocular tumor, the possibilities of false-positive or false-negative diagnosis,
loss of vision, retinal detachment, cataract, and vitreous hemorrhage, as well as
possible development of metastatic disease, should be discussed.
A final three points that are pertinent to all ophthalmic malpractice litigation are
the following. One, if one is sued, it is imperative that the chart remain untouched
and no attempt made to revise it. Revision of a chart basically will destroy any
chance of successfully defending a lawsuit. Two, it is important when you are sued
to inform your malpractice carrier immediately about it and ask the carrier to quickly
suggest a possible consultant (to review the case). Three, in the setting of a malprac-
tice suit, further discussion with either the patient or his or her representatives should
be avoided.

Reference

1. Char DC. Tumors of the Eye and Ocular Adnexa. Hamilton, Ontario: BC Decker; 2001.
Chapter 18
Ophthalmic Plastic Surgery

Tanuj Nakra and Norman Shorr

Introduction: Special Considerations for a Unique Subspecialty

In the family of ophthalmology subspecialties, ophthalmic plastic surgery is the


adopted child. There are probably more differences than there are similarities with
the other subspecialties. The diseases that oculoplastic surgeons treat are unique,
and the surgeries they perform are quite different from those of ophthalmology
colleagues. These unique attributes of ophthalmic plastic surgery warrant special
consideration in the study of ophthalmology and the law.
From a legal perspective, the practice of oculoplastic surgery has risks similar to
those of other ophthalmology subspecialties, but perhaps most unique is the high
visibility nature of the operations. The eye–periocular complex is arguably the most
significant aesthetic feature of the entire body, and thus problems in oculoplastic
surgery are highly visible to the patient. Problems in this area also fall under the
scrutiny of all the patients’ family members and friends. Thus, there is a complex
set of interactions between the patients’ emotions regarding their appearance and
their functional oculoplastic problems. This emotion and high visibility are present
not only with elective cosmetic procedures but also with reconstructive and func-
tional surgeries, as well as medical treatments.
The specialty of ophthalmic plastic surgery overlaps with other nonophthalmo-
logic specialties. There is significant complementary interest with dermatology,
head and neck surgery, neurosurgery, and general plastic surgery, and there are
lessons to be learned from the legal experiences of these specialties. Each specialty
has its own inherent risks that are transitive to the specialty of ophthalmic plastic
surgery. For example, operating on skin brings up the subject of dermal fibrosis,
which may cause functional limitations and cosmetically obvious permanent
changes. Surgery in the orbit or on the face has the potential to cause muscular or
neurologic impairment. Lacrimal surgery interfaces with intranasal and sinus
surgery.
Cosmetic surgery comprises a significant portion of the ophthalmic plastic sur-
geon’s practice, and certainly there are those who specialize only in cosmetic sur-
gery. Anytime surgery is directed at a nonmedically necessary problem, patients
have higher expectations and less tolerance for anything except a maximal result.

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 187


doi: 10.1007/978-0-387-73341-8; © Springer 2008
188 T. Nakra and N. Shorr

Accordingly, building rapport with the patient is absolutely essential, and it is


imperative to carry out extensive presurgical counseling, as well as pre- and post-
operative photography.
As subspecialists, ophthalmic plastic surgeons frequently function as consult-
ants to comprehensive ophthalmologists, specialty ophthalmologists, as well as
general practitioners. The role of a consultant has special legal implications. The
words and attitudes of the consultant can lead the patient to seek legal counsel
against the referring or previous physician if problems were missed or misman-
aged. A consultant must maintain a nonjudgmental attitude and avoid inflammatory
words. The consultant should carefully define the scope of the evaluation and redi-
rect the patient to the referring physician for ongoing management and care of
nonspecialty issues.1 A consultant may be named in a lawsuit primarily involving
a patient and the referring physician.
In general, this textbook is designed to familiarize ophthalmologists and subspe-
cialists with the legal implications of practicing ophthalmology. A goal of this
endeavor is to prevent legal action against the reader. Accordingly, this chapter is
written with this end in mind.
This chapter should serve as a guide for physicians and is not designed to deline-
ate the standard of care in ophthalmic plastic surgery. We practice in a unique aca-
demic and university environment. Our approach is not necessarily representative
of the community at large and should not be construed as the standard in the
community

The Informed Consent: An Opportunity for Dialogue

The process of informed consent is essential in the practice of quality medicine


regardless of medical specialty. Informed consent is composed of information pro-
vided to and acknowledged by the patient. This process should not be considered
solely a legal requirement or a malpractice prophylaxis maneuver but an opportu-
nity to engage the patient in an educational session about the patient’s condition
and options for management. One of the most effective tools at building rapport is
to walk the patient through the process of informed consent. Although this book
features a chapter dedicated to the details of informed consent in ophthalmology
(see Chapter 7), there are several aspects of the process that deserve special atten-
tion with regard to ophthalmic plastic surgery.
It is imperative that any physician performing ophthalmic plastic surgery proce-
dures understands the following axiom: the more elective the procedure, the more
extensive the requirements for a detailed informed consent. This statement is true
not only from a legal viewpoint but also from an ethical and humanistic perspec-
tive. The process is an opportunity to fully educate the patient before a procedure
that has the potential to significantly improve function and appearance but also
carries the risk of producing a deterioration of function and perhaps cosmetic dis-
figurement. It is important to recognize and manage unrealistic expectations, as is
Chapter 18. Ophthalmic Plastic Surgery 189

demonstrated by the comment, “Doctor, I know you are a specialist, and so these
things won’t happen.” These patients require extra time to be educated and to
understand and to grasp the limitations and risks.
When a patient has minimal or no preoperative medical symptoms and under-
goes an elective procedure, the disappointment caused by an unsuccessful surgery
or complications is all the more bitter. Consider the middle-aged female patient
who undergoes elective upper blepharoplasty and experiences severe postoperative
new-onset symptoms of dry eyes. Neglecting to discuss this potential postoperative
effect prior to performing the surgery would be unfortunate from both a legal and
an ethical perspective. Anything told to the patient prior to surgery is accepted as
an explanation, whereas anything told to the patient after the surgery can be per-
ceived as an excuse. Often the process of informed consent allows the physician to
measure the patient’s expectations and then to help tailor the expectations appro-
priately. Explanations can be designed to encourage patients to focus on improve-
ment, not perfection. “Ms. Jones, perfection is not possible, but we can certainly do
our very best to achieve an improvement here.”
If there are particular maneuvers that are usually performed to avoid complica-
tions during surgery, these may suggest potential areas for specific discussion during
the informed consent process. For example, during inferior orbit surgery, we specifi-
cally identify the inferior oblique muscle to avoid injury, and so we discuss with
patients the risks of double vision after surgery. Another example is our application
of ointment to the cornea during eyelid surgery to prevent a corneal abrasion, and so
we discuss with patients the risks of corneal abrasion or ulceration after surgery.
With any given procedure, there is a distinction between what needs to be dis-
cussed during the informed consent process and what is not required by the stand-
ard of care. For example, while discussing the potential complications of ptosis
surgery, it is prudent and necessary to review the potential need for revision surgery
for asymmetry or contour abnormalities. Certainly, the vast majority of ptosis sur-
geons would discuss these possibilities, and this is what constitutes the standard of
care. However, it may not be necessary in the discussion to bring up the possibility
that a fire could erupt in the operating room as a result of electrocautery and cause
first-degree burns to the facial skin. Although this scenario is a rare possibility, it
falls under the category of rare and unusual circumstances that a physician is not
required to review in the informed consent. If brought under courtroom scrutiny,
the jury would be asked to make a determination of whether there was sufficient
disclosure to allow the patient to make an informed consent.2 In fact, it may not be
possible or practical to name every conceivable potential complication.
The informed consent process in ophthalmic plastic surgery should always
include three general items. First, when discussing surgery involving a skin inci-
sion or soft tissue manipulation, the potential for cosmetic disfigurement from
unexpected healing should be revealed. Dermal and soft tissue healing varies from
individual to individual, and therefore fibrosis outside of the standard deviation can
lead to unpredictable results. Second, the rare but possible risk of vision loss,
including blindness, should be discussed. In New York state, a plaintiff success-
fully prosecuted a case of corneal laceration during ptosis surgery; the informed
190 T. Nakra and N. Shorr

consent process omitted the discussions of vision-related complications.3 Finally,


patients must be informed that, with any surgery, there is the potential need for
reoperation. The reasons to return to the operating room may be functional or
reconstructive in nature.
Perhaps the most important idea to convey during the informed consent process
is the concept of risk. It is preferable to use real-world examples rather than quoting
esoteric numbers. In our practice, we have a routine method of simplifying the dis-
cussion of surgical risk in order to facilitate understanding. Often the explanation
is similar to the following scenario:
Ms. Jones, I want you to know that there are risks of unwanted results and consequences
as a result of your entropion surgery. Anything can happen—any question you ask, the
answer could be yes. Is it possible that you could lose vision? Yes. Is it possible that you
will not be happy with the results of surgery? Yes. Is it possible that you could die on the
operating room table? Yes. But let’s talk about the chances that the event will happen.
What are the chances that we could have an earthquake during surgery? What are the
chances that you could be involved in a car accident the morning of surgery on your way
here? What are the chances that you could have an infection after surgery?

As a final point, the process of informed consent is often perceived by the patient
as a sobering discussion of potentially negative consequences. From a psycho-
logical perspective, a patient who has a positive outlook before surgery is more
likely to be satisfied with the results of surgery. The physician should always end
the discussion of informed consent on an upbeat but realistic note. “Ms. Jones,
I believe that you are a good candidate for this surgery, and we can both look
forward to the potential benefits of this surgery with a positive attitude,” or “You
are an acceptable candidate for a potential improvement, recognizing that you
have asymmetry.” Use of the word potential conveys optimism yet acknowledges
that the result is not certain.

The Slippery Slope Concept: Planning for Disappointment


Prevents Disappointment

Maintaining the doctor–patient relationship is paramount to minimizing risk, as this


relationship is based on mutual trust and understanding. Failing to anticipate events
that will derail the doctor–patient relationship can be a physician’s legal Achilles’
heel. In particular, combining functional and cosmetic surgery sets up a delicate
and complex set of expectations from the patient. For example, a patient may ask,
“Doctor, while you are performing my ptosis surgery, can you remove some of my
extra skin?” Alternatively, the physician may suggest, “As we are doing the ptosis
surgery anyway, we should address the eyebrows . . . deal with the nevus on the
eyelid . . . address the lower eyelids.” Payment for these procedures may involve a
combination of insurance and self-pay. Any perceived imperfect result could be a
set-up for disappointment. Patients focus on subtle asymmetry after ptosis surgery
and blepharoplasty and wonder, “Will there be a need for more surgery? Shouldn’t
Chapter 18. Ophthalmic Plastic Surgery 191

reoperation be at no cost to me?” These events can begin a downward spiral of dis-
trust and negativity stemming from disappointment that was not discussed, hence
the slippery slope.
The definition of cosmetic surgery should be made quite clear to the patient:
cosmetic surgery is surgery that the insurance company deems not medically neces-
sary. For example, dermatochalesis excision “on the side” during ptosis surgery is
considered cosmetic surgery. In addition, the patient should be made to understand
that all surgery, both medically necessary and cosmetic, is performed on a fee-for-
service basis. This concept is self-evident for functional surgery. When explaining
the risks of reoperation to a patient who undergoes insurance-covered scleral
buckle surgery for retinal detachment, it goes without saying that the insurance
company will also be billed if further vitrectomy surgery is required to complete
the retinal detachment repair. On the other hand, patients often perceive cosmetic
surgery to be in a different category of billing. After all, when a patient goes to a
salon for a haircut, if he or she is unhappy with a certain aspect of the style, cannot
he or she demand that the hairstylist “fix” the unacceptable area without charge?
In the “slippery slope” model, the doctor–patient relationship breaks down from
both sides. The patient is unhappy with the result and does not expect to pay for a
“touch up.” The physician is unhappy because she did everything possible, spent an
extra hour on the surgery, did her very best, and now the patient wants the physician
to pay for the operating room cost and to absorb the cost of revision surgery. When
both the patient and the physician become resentful, the “slippery slope” becomes
more slippery, and the doctor–patient relationship quickly deteriorates. If there has
been no preoperative discussion of how to manage disappointment, the patient pro-
ceeds with reoperation surgery full of resentment. If the revision surgery is not suc-
cessful, the patient will have very little patience and may seek legal counsel.
To anticipate the “slippery slope,” there should be a preoperative agreement, a
fee-for-service arrangement, to manage perceived disappointment from cosmetic
surgery or the cosmetic portion of a mixed cosmetic–functional surgery. A detailed
discussion should take place prior to embarking on surgery regarding the fee-for-
service nature of surgery and reoperations. This agreement should be discussed and
documented. The essence of the agreement might be, “I will do my very best, and
I will not take advantage of you. If we have to revise the surgery, there will be a
fee.” If the physician prefers not to enter into detailed conversations with patients
regarding financial arrangements, a responsible employee that usually handles
financial discussions may perform the agreement.
The practitioner unaccustomed to this concept of a fee-for-service relationship
may be shy to discuss such detailed financial agreements regarding further surgery.
However, a fee-for-service agreement does not undermine the doctor–patient rela-
tionship. In contrast, it strengthens the relationship by rooting the patient in the
reality of the risk of complications and undesired results that are possible in all sur-
gical endeavors, including cosmetic surgery. A patient who undergoes cosmetic
surgery with a realistic and balanced outlook is much more likely to be satisfied
with the results than a patient who is expecting an “extreme makeover” without
compromise.
192 T. Nakra and N. Shorr

Functional Eyelid Surgery: Risks and Pitfalls


for the Busy Practitioner

A major portion of the practice of an ophthalmic plastic surgeon focuses on func-


tional eyelid problems. Frequently, these conditions require surgery. Despite the
high frequency and usual straightforward nature of these procedures, several poten-
tial legal pitfalls exist in preoperative planning and surgical care for the various
categories of procedures.
Several risks are common for any eyelid surgery, and the material risks of harm
must be discussed before surgery. During eyelid surgery, all imaginable harm may
occur during the injection of anesthetics, as well as the incision and manipulation
of eyelid tissue. The protective mechanism of the eyelids for the ocular surface may
be negatively affected by surgery. Lagophthalmos, retraction, other types of eyelid
malposition, and poor orbicularis function may lead to a compromised ocular sur-
face. Sutures can rub against the eye or conjunctiva and cause irritation. The poten-
tial end result may range from dry eye and exposure keratopathy to chemosis and
corneal ulceration. While it may not be feasible to name every conceivable compli-
cation, acknowledging that vision-threatening problems are rare but possible is
highly recommended from a legal as well as an ethical perspective.
One of the most common procedures performed is ptosis surgery. Yet, ptosis
surgery perhaps is one of the most complex and unpredictable surgeries in the cat-
egory of eyelid surgery. From a patient’s perspective, the surgery does not seem
complex. After all, how difficult is it to just “lift the droopy eyelids a bit?” Only
after lengthy explanations reviewing the contribution of eyebrow compensation,
Herring’s law, and the difficulty of interpreting the intraoperative effects of local
and intravenous sedation on levator function might a patient begin to understand
the complexity of the surgery. Thus patients should be counseled on the potential
need for reoperation after ptosis surgery for various reasons. Insufficient eyelid
elevation, overelevation, contour abnormalities, and asymmetry are all possible
results following ptosis surgery, even in the hands of a very experienced surgeon.
We routinely quote a 20% reoperation rate after ptosis surgery for our patients.
Prior to surgery, we try to prepare patients mentally for imperfection by openly
discussing the possibility of minor asymmetries. When a less-than-perfect result
occurs, patients are not surprised, and further management discussions can proceed.
On the other hand, an excellent result causes a patient to celebrate.
A delicate subcategory of functional eyelid surgery consists of eyelid neoplasms.
Contrary to common belief, patients sue much more frequently from delay in diagnosis
in oncology rather than morbidity related to the cancer itself or its treatment.3 A classic
illustration of this scenario is the elderly patient with a “chronic chalazion” that does
not respond to medical treatment; the underlying sebaceous cell carcinoma can rapidly
become systemically malignant if not identified and managed appropriately. Multiple
lawsuits have occurred over the misdiagnosis and/or delay in diagnosing eyelid neo-
plasms. In one analysis, the most common allegation group in malpractice is “failure
to diagnose,” and the most common specific allegation is “failure to diagnose cancer.”4
Chapter 18. Ophthalmic Plastic Surgery 193

Cancer is a complex legal topic with emotional overtones, and it deserves special
attention as any morbidity may cause a patient to seek to blame. When in doubt, per-
form a biopsy, and inform the patient of the risk of carcinoma upon presentation of the
suspicious lesion.
One of the most frequent office-based procedures in ophthalmic plastic surgery
is the excisional biopsy of an eyelid lesion. Many surgeons routinely perform sev-
eral of these procedures a day. The majority of cases carry benign clinical diag-
noses: papilloma, inclusion cysts, hydrocystomas, nevi, and so forth. However,
occasionally a lesion that may have appeared benign unexpectedly turns out to be
a skin cancer. Therefore, a biopsy log should make its way into every ophthalmolo-
gist’s practice. Specimens sent for pathologic examination may take several days
to be processed and read. Occasionally a patient will miss a follow-up appointment,
especially if a small lesion was excised completely from a clinical perspective.
Patients have little motivation to return to the biopsy surgeon if they were referred
primarily for lesion excision. Occasionally, the pathology laboratory may not
notify the physician of biopsy results, even if the final diagnosis is ominous. When
both events happen, the results can be disastrous. A biopsy log lists all tissue sent
for histopathology, and its regular review is a safety net for preventing diagnosed
but unmanaged situations.

Orbit and Lacrimal Surgery: Avoid Management Pitfalls

When faced with orbital and lacrimal disease, the ophthalmic plastic surgeon must
navigate a wide differential of possibilities. General categories include neoplasm,
inflammation, and infection. The differential may include diagnoses with severe
potential morbidity or even mortality. Careful work-up is indicated, including
imaging studies, if indicated.
As in eyelid tumors, cases of orbital and lacrimal neoplasms can become legally
ominous if not diagnosed promptly and managed appropriately. Orbital neoplasms
have the potential to disfigure a patient, cause sensory and motor neuropathy, and
produce further morbidity and/or mortality from local and systemic spread.
Moreover, the treatments may also be disfiguring and/or cause visual and func-
tional morbidity. Careful adherence to the specific standard of care for managing
the individual cancer can prevent suits alleging inappropriate procedure or manage-
ment. During the informed consent for orbit neoplasm surgery, the specific risk of
pupil dysfunction after surgery should be discussed. For example, after a successful
dissection and removal of an intraconal hemangioma, damage to the parasympa-
thetic plexus entering the posterior globe can cause an irregular shape or dilation of
the pupil. Despite the success in removing the neoplasm, a patient with light irides
may have symptoms of glare or photophobia with a dilated pupil. A patient may
even scrutinize the cosmetic consequence of asymmetric pupils.
Graves’ disease often causes a significant impact on patients’ long-term qual-
ity of life. It is a frustrating and debilitating disease that often requires multiple
194 T. Nakra and N. Shorr

stages of medical and surgical management. Patients who are confused, suffering
a chronic disease, and experiencing permanent disfigurement and loss of function
can become angry and depressed. If a careful doctor–patient relationship has not
been nurtured through extensive education and empathy, lawsuits may result. The
cornerstone of Graves’ disease management is careful patient education. Detailed
discussions of the staged surgical approach to the disease is helpful in preparing
the patient for the long road to improvement and the potential need for reopera-
tion at any point.5 In addition, the patient can then accept the idea that orbital
surgery may change or cause diplopia, and orbital or muscle surgery might
improve or perhaps even worsen eyelid position. The reality that recession of an
extraocular muscle may cause relative proptosis should be pointed out. Of course,
any disease with the potential for optic neuropathy also requiring multiple surger-
ies bears the possibility for vision loss at any stage as a complication of manage-
ment or as a direct effect of the disease process. Careful documentation of patient
discussions and clinical evaluations can validate a carefully staged and appropri-
ately explained management plan, even if the final result is not satisfactory to the
patient. Pre- and postoperative photography visually documents the disease and
results of surgery.
Orbital and lacrimal infections have the potential to spread rapidly across the
face and posteriorly into the cavernous sinus and cranial fossa. These infections can
cause significant morbidity and, in rare instances, mortality. The vague nature of
the initial clinical presentation and the unpredictability of the disease course require
appropriate early evaluation and workup. A delay in management can lead to mor-
bidity that might give a patient reason to seek legal counsel. Significant infections
should prompt specialty consultation. Infectious disease specialists can provide
valuable assistance in choosing appropriate antibiotics. Otorhinolaryngologists can
assist in the management of sinusitis. The comanagement of facial fungal infections
with an otorhinolaryngologist is highly recommended, as endoscopic sinus surgery
is often indicated early in the evaluation and management of mucormycosis and
aspergillosis. The ophthalmologist should maintain a high suspicion for these infec-
tions, as they are rapidly progressive and have significant potential for serious
harm. Chronic dacryocystitis is usually caused by simple nasolacrimal duct
obstruction, but in the back of the clinician’s mind should always remain the suspi-
cion for nasal and lacrimal neoplasms that can masquerade as seemingly more
straightforward diagnoses.
Nasolacrimal duct obstruction can be a frustrating problem for patients. Surgery
for nasolacrimal duct obstruction involves dissection into the nasal cavity, and
bony removal maneuvers have the potential to inadvertently enter sinuses and to
cause intranasal scarring and even cerebrospinal fluid leaks. These risks should be
discussed with a patient prior to surgery. As in any surgery, complications should
be carefully disclosed and monitored, not concealed.
Vigilance and responsive care are of the utmost importance to maximize the care
of the patient with orbital or lacrimal disease. The patient who requires surgery
should have extensive counseling and education, as orbital and lacrimal diseases
are frequently difficult for patients to understand.
Chapter 18. Ophthalmic Plastic Surgery 195

Ocular and Facial Trauma: Difficult for Both Patients


and Surgeons

In the treatment of a trauma patient, the physician is potentially facing an uphill


battle from a legal perspective. Trauma patients are among the most frequent group
to initiate legal action against their physicians, and several factors are stacked
against the physician. Often a patient requires immediate or semiurgent surgery,
and there is little time for the physician to develop rapport with the patient.
Furthermore, the trauma often damages delicate periocular structures, and the
patient has difficulty in differentiating loss of function from the trauma and saved
function from the surgical repair. The patient may require several staged surgeries,
perhaps with different subspecialists, which may lead to a protracted recovery.
Despite heroic attempts at reconstruction, patients may still be severely disfigured
from their perspectives. Several strategies may be helpful in minimizing the
chances of a trauma-related legal action.
A rapid and careful workup is required in cases of trauma. There should be a
high suspicion for foreign bodies, especially intraocular organic and metallic for-
eign bodies. A patient with no apparent facial or ocular surface penetration may
have an occult self-sealing corneal, limbal, or scleral wound. Intraocular foreign
bodies, if missed, have very significant legal ramifications against the physician.6
The visual prognosis of an apparently uninjured eye can rapidly deteriorate in cases
of endophthalmitis and/or metal toxicity. Immediate x-ray imaging should be per-
formed in cases of suspected intraocular foreign body, and, if a foreign body is
identified, urgent vitreoretinal consultation is needed. Similarly, there should be
careful consideration of removing orbital foreign bodies. Imaging studies and the
clinical history can help differentiate the two general categories of foreign body
composition (organic and inorganic) and two general categories of penetration
(stable or unstable). Unstable foreign bodies can affect orbital and globe function
and may even penetrate into the cranial vault. Thus consultation with the neurosur-
gery service should be considered, if necessary. Generally, organic foreign bodies
carry a risk of infection and should be removed, whereas inorganic and inert mate-
rials need not be removed unless their location is unstable.
Facial fracture repair requires broad surgical exposure. As a result, there is
inherent risk of collateral damage to orbital and facial function. Detailed preopera-
tive discussions should include the risk of inducing strabismus and the rare risks of
sensory and motor nerve damage.
As is true in all circumstances, but especially in trauma situations, careful docu-
mentation is mandatory. Documentation of the accident and the preoperative
workup, including radiologic results, should be performed. In the long run, patients
have poor recollection of conversations at the time of emergency/urgent care, and
so documenting the discussion of risks and alternatives should be performed. An
ancillary staff member should witness surgical consents. Photodocumentation of
the patient’s clinical examination is highly recommended, as patients immediately
posttrauma may not be in a state of mind to digest the realities of the injury, and
196 T. Nakra and N. Shorr

photography can capture the extent of the damage. Reviewing the preoperative
photos with the patient during the recovery period is helpful in allowing the patient
to understand better their preoperative state and to appreciate better their postopera-
tive condition.
A patient with a poor outcome may occasionally seek redress for grievances.
Occasionally, the trauma/reconstructive surgeon may be called as a witness when
the patient takes another party to trial. The surgeon may be asked to comment on
the extent of the injury and on the long-term prognosis. Again, photographs taken
by the surgeon at the time of initial evaluation may be quite helpful. Written docu-
mentation is crucial. As a pattern, the style of recording information into the chart
should be nonbiased and matter of fact. Whatever is written in the chart may be
asked to be read out loud to the jury, word for word. Opinions expressed by the
patient should be in quotations or, alternatively, should be documented as, “The
patient states that.…”

Cosmetic Facial Surgery: Minimize Risk


by Managing Expectations

Once a taboo topic, cosmetic surgery is now fashionable. “Honey, this surgery is
you! Just let me remove these bags and lift right here—we’re going to make you
young again.” Scripted television clip or real life? Reality-based television shows
have brought cosmetic surgery to the center stage of modern entertainment and into
the homes and minds of society in an unprecedented manner. Patients believe that
the “extreme makeover” is not only possible but routine.
Attending to the patients’ expectations of cosmetic surgery is perhaps the most
important factor in successfully treating cosmetic patients and minimizing the legal
risks involved. It is essential to balance a discussion of the proposed treatments
with the potential risks and limitations. The discussion should not be hurried, and
an attempt should be made to educate the patient as much as is reasonable with
regard to the patient’s specific anatomy and the surgical techniques suggested to
achieve a desired outcome. An educated patient is more likely to have realistic
expectations. Effort should be made to understand the patient’s psychologic and
psychiatric status. Simple direct questioning can uncover patients’ motivations for
surgery. When patients expect that cosmetic surgery will transform their lives, save
their marriages, or relieve their clinical depression, then the surgery is a setup for
disappointment. Patients with body dysmorphic disorder often seek the services of
a plastic surgeon, and subjective dysmorphia can extend to the face. Relatively
minor facial features can become overly exaggerated in the patient’s mind and lead
to obsessive scrutiny of these features. It is the duty of the surgeon to unearth these
psychologic states with screening questions. Failure to identify those patients who
harbor unrealistic expectations can result in an unsatisfied patient who will be more
likely to sink into depression and surface with a lawsuit. Referring the patient for a
second opinion by a trusted colleague who can deal with the patient in a friendly
Chapter 18. Ophthalmic Plastic Surgery 197

and knowledgeable manner can strengthen the patient’s confidence in the original
physician’s impression and plan.
There are several key points of discussion during a cosmetic consultation.
Patients should understand that plastic surgery is about improvement, not perfec-
tion or transformation. Using a mirror, underlying subtle or obvious asymmetries
and challenging anatomy should be demonstrated to the patient. Patients are often
unaware that every human, including themselves, has subtle asymmetry. It should
be explained that while improvement is possible, patients should still expect some
asymmetry after surgery. After careful assessment of their skin type, patients
should be given a realistic prediction of how their skin will heal and what type of
scar to expect. Common risks, such as dry eye symptoms after blepharoplasty,
should be thoroughly reviewed. Rare risks should be mentioned, and the patient’s
reaction can often serve as a psychological test of their expectations: an informed
patient with a balanced outlook should not be overly rattled by discussions of
severe complications.
As in other areas of ophthalmic plastic surgery, there is great importance for
photodocumentation of the preoperative status of the patient. Not only do photo-
graphs serve a valuable purpose in demonstrating before and after results to both
the patient and physician, they also can serve as a reminder to patients of asym-
metries and irregularities that were present before surgery. It is common for a
patient who has never noticed their relative right-sided mild blepharoptosis to focus
on it extensively during postblepharoplasty self-examination. For this patient, dem-
onstrating the preexisting ptosis in a preoperative photograph can prevent the
patient from believing that the surgery caused the ptosis.
An expanding area of the cosmetic ophthalmic practice includes the usage of
paralytic agents (e.g., botulinum toxin A) and fillers (e.g., collagen, hyaluronic
acid). Risks to discuss in detail with patients undergoing injection of paralytic
agents should include the possibility of temporary ptosis and lagophthalmos.
Patients receiving paralytic subcutaneous injections should be monitored for these
complications and treated accordingly. Botulinum toxin A may spread inadvert-
ently to an adjacent area and cause unwanted paralysis that can appear as if the
patient has had a stroke. These unwelcome effects will occur in rare instances but
can be devastating for the few patients to whom it does occur. The effects can last
up to 3 months with no satisfactory treatment. For these reasons, a thorough
informed consent is valuable.
The multitude of facial fillers flooding the market has expanded options for
facial sculpting; however, fillers can result in granuloma formation in select
patients, as well as dissatisfaction with the result. If the filler is a nonabsorbable
material, these problems may become significant chronic issues. The patient under-
going facial fillers should be informed of these risks.
With the increasingly complex palette of laser skin resurfacing technologies, some
ophthalmic plastic surgeons perform laser facial skin rejuvenation. Some risks are
to the type of laser technology, ablative or nonablative, that should be discussed
with patients. Ablative lasers may induce irregular pigmentation in patients with even
mild to moderate skin pigmentation; dark-skinned patients should have pretreatment
198 T. Nakra and N. Shorr

testing of a concealed skin patch to assess specific postlaser pigmentation results.


Ablative lasers denude the epithelium and thus carry a risk of infection; consideration
for viral and/or bacterial prophylaxis should be made for patients at risk. Carbon
dioxide lasers have the specific risk of causing a fire in the procedure room. In our
practice, we stop oxygen delivery, and remove all oxygen tubing from the patient. In
addition, we outline the face with wet towels and keep a basin of water available in
the event of a fire. These prophylactic maneuvers are recorded in the operative report.
Nonablative lasers do not directly bare the dermis but can deliver significant energy
to the specific dermal structures. Risks of posttreatment pigmentation abnormalities
should be discussed, and full-thickness burns are possible. Occasionally, nonablative
procedures can be quite painful, and patients should be informed of this reality.
In this time of ubiquitous cosmetic facial surgery, there is an everexpanding
subset of patients who have had a poor result. Either the patient is unhappy with the
cosmetic outcome of the surgery, or the patient is experiencing dysfunction as a
result of surgery. Ophthalmic plastic surgeons frequently encounter patients who
present with the “overdone blepharoplasty,” who demonstrate signs of lagophthal-
mos and exposure. Other presentations include increased asymmetry after surgery,
eyelid contour abnormalities, and periocular hollowness. It is challenging to treat
this subset of patients, as they have preexisting resentment before even encounter-
ing the specialist. In these cases, it is appropriate to spend extra time assessing psy-
chological status, educating patients, and dispelling false beliefs. A patient in this
category may manifest strongly unrealistic expectations; the patient may say, “My
previous doctor was terrible, but I know you can fix all my problems.”
Unhappy patients seeking specialty consultation after previous surgery can mani-
fest anger toward their previous physician or even openly express their litigious inten-
tions. “My previous surgeon was a butcher.” It is inappropriate and detrimental to
deride previous surgery or to encourage patients to seek legal counsel. No good can
come of it, and surely it does nothing for managing the patient’s current functional and
cosmetic complaints. A supportive attitude and a positive proactive affect may steer a
patient away from continuing a spiral of negativity that may incite legal action.

Anesthesia Administration and Medications: Prevent Problems


with Vigilance and Diligence

Pain is alleviated during ophthalmic plastic surgery by the administration of anes-


thetic agents from a qualified, dedicated, anesthesia provider. The aspects of every
surgical case that must be analyzed in great detail include the patient’s history and
physical evaluation prior to the development of an anesthesia care plan.
Close inspection of the patient’s underlying health should precede any surgical
procedure or decision for pharmaceutical treatment. Complete preoperative evalu-
ation by a generalist physician should precede elective surgery. Not only does this
fulfill a legal recommendation that the examination be performed but also the
examination may uncover important diagnoses pertinent to surgery, such as liver
Chapter 18. Ophthalmic Plastic Surgery 199

failure (which may increase bleeding time), hypertension (which might exacerbate
intraoperative bleeding), or cardiac risk factors. In addition, the generalist may
perform an assessment of the risk of preoperative cessation of aspirin and clodo-
prigel. The surgeon is best to avoid counseling the patient to stop these medications
without the approval of the generalist or cardiologist.
In perioperative care, there are numerous occasions in which the surgeon prescribes
or administers drugs. Drug-related incidents of morbidity are the root cause of multi-
tudes of malpractice cases. There have been many lawsuits for complications relating
to the administration of local anesthesia. Perforation of the globe during the injection of
local anesthetic agents is a most feared complication and has been successfully brought
to trial. Injection of local anesthetic directly into an extraocular muscle belly can cause
restrictive strabismus.7 Ophthalmologists should also be cognizant of drug interactions,
such as the potentiation of warfarin by acetazolamide. Oral glucocorticoids are pre-
scribed frequently for facial surgery and the treatment of orbital disease. Significant side
effects are possible, including exacerbation of glycemic control for diabetics, inhibition
of gastric protection, femoral head necrosis, and even psychiatric side effects. Often,
eyelid and orbital disease is treated with triamcinolone suspension injection. These
injections are performed so frequently that often informed consent is omitted, and even
verbal explanation of complications is omitted. Complications such as glaucoma, sys-
temic absorption, skin depigmentation, subcutaneous fat atrophy, and vascular occlu-
sion do occur. The legal culpability of these complications of drug administration fall
to the prescribing physician, and so physicians must maintain due diligence in prescrib-
ing medication and explain these risks to patients prior to administration.
Ophthalmic plastic surgery is distinct from surgery of the other ophthalmic special-
ties by the relatively larger nature of the surgeries with greater potential for bleeding.8
Larger volumes of local anesthetic are often required, increasing the potential for sys-
temic effects of injected agents. There have been several well-publicized cases of mor-
tality from overdosage of injectable anesthetics in cosmetic surgery. Surgeons should
maintain a working knowledge of the maximum dosages of lidocaine, Marcaine, and
epinephrine to stay out of trouble. In addition, the recognition and treatment of local
anesthetic toxicity is vital. A crash cart is generally a requirement for surgery centers
and should be considered for any clinic situation where minor surgery is performed
without intravenous anesthesia. Surgeons should maintain their certification in
Advanced Cardiac Life Support for the safety of their patients, as well as for their own
legal protection in the event that cardiopulmonary resuscitation care is required.

Conclusion: Conscientiousness and the “Art” of Medicine

While practicing ophthalmic plastic surgery, it is easy to become bogged down with
legal details, implications, and defensive practice maneuvers. However, this chapter
and even this entire textbook can be distilled down to the following statement: avoid
malpractice by running a conscientious practice and perfecting the “art” of medicine
and surgery.9–14
200 T. Nakra and N. Shorr

A physician who is diligent, thorough, and thoughtful will stay out of trouble in
diagnosis and management. This is achieved by combining the cumulative knowl-
edge of a physician’s training and ability with an attentive work ethic. Staying out
of “trouble” is the key to avoiding lawsuits. After all, “trouble” is a maloccurrence
that leads a patient to blame and leads a case to a court of law. Without “trouble,”
there can be no lawsuit.
Perfecting the art” of medicine is a complicated, esoteric subject. Yet it is essen-
tial to the practice of every physician and a crucial cornerstone in prophylaxis
against malpractice. The art of medicine requires sensitivity and the ability to listen,
which allow the establishment of rapport. The art of medicine is also engaging the
patient in a detailed discussion of the clinical findings and treatment plan, empow-
ering the patients to understand their clinical status and potential management
options, which leads to realistic expectations. In the end, connecting with a patient
as a fellow human being builds a relationship that does not break down, even in the
face of adversity.

References

1. Brooten KE. Malpractice: A Guide to Avoidance and Treatment. 1987. Orlando: Grune &
Stratton; 1987.
2. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians (How to Avoid, How to
Win). Boston: Little, Brown; 1977.
3. Kraushar MF, Robb JH. Ophthalmic malpractice lawsuits with large monetary awards. Arch
Ophthalmol 1996;114(3):333–337.
4. Lobe TE. Medical Malpractice, A Physician’s Guide. New York: McGraw-Hill; 1995.
5. Shorr N, Seiff SR. The four stages of surgical rehabilitation of the patient with dysthyroid
ophthalmopathy. Ophthalmology 1986;93(4):476–483.
6. Bettman, JW. Ophthalmology: The Art, The Law, and a Bit of Science. Birmingham, AL:
Aesculapius; 1977.
7. Ando K, Oohira A, Takao M. Restrictive strabismus after retrobulbar anesthesia. Jpn J
Ophthalmol 1997;41(1):23–26.
8. Sarwer DB, Pruzinsky T, Cash TF, Goldwyn RM, Persing JA, Whitaker LA. Psychological
Aspects of Reconstructive and Cosmetic Plastic Surgery. Philadelphia: Lippincott Williams &
Wilkins; 2006.
9. Campion FX. Grand Rounds on Medical Malpractice. Chicago: American Medical Association;
1990.
10. Kraushar MF. Medical malpractice experiences of vitreoretinal specialists: risk prevention
strategies. Retina 2003;23(4):523–529.
11. Kraushar MF. Recognizing and managing the litigious patient. Surv Ophthalmol
1992;37(1):54–56.
12. Kraushar MF, Turner MF. Medical malpractice litigation in cataract surgery. Arch Ophthalmol
1987;105(10):1339–1343.
13. Leaman TL, Saxton JW. Preventing Malpractice: The Co-Active Solution. New York: Plenum
Medical Book Co.; 1993.
14. MacKauf SE. Advanced Medical Malpractice: Anesthesiology, General Surgery, and
Neurology. New York: Practicing Law Institute; 1977.
Chapter 19
Pediatric Ophthalmology

Edward L. Raab

Introduction

Efforts that lower the physician’s risk also usually result in better patient care.
Limiting risk exposure is to a considerable extent a common sense endeavor, the
main thrust being to apply, as physicians typically do on a daily basis, the principles
of best practice.
Pediatric ophthalmology is characterized by the necessity to make crucial deci-
sions and take actions intended to serve the young patient for a lifetime. Liability
for inappropriate practice can in some instances be imposed 20 or more years
beyond the event, and the damages could be monumental.
This chapter details several situations in pediatric ophthalmology that if
approached improperly could expose the physician to liability. Some aspects of the
discussion extend to ophthalmologic practice beyond the care of children. While
not to be taken as legal advice, appropriate avoidance measures will be suggested.
Note: even though in any of these settings your status as an employee may shift the
obligation of payment of a judgment elsewhere, you will nevertheless be cited in
the National Practitioner Data Bank.

The Unaccompanied Minor

What should take place when confronted with an unaccompanied minor presenting
for examination? This would be unpermitted “contact,” as minors are considered to
be without capacity to consent. Of all the items to be discussed, this probably is the
easiest to address. It is more a matter of patient convenience than quality of care.
In general, parents or a guardian (a reliable adult who may not always be for-
mally appointed) are responsible for health care decisions for an underage child.
There are legally defined exceptions for minors who are married, pregnant, parents,
self-supporting, or a member of the military (so-called emancipated minors).
Routine eye care is rarely permissible for a minor who does not qualify as one of
these exceptions.

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 201


doi: 10.1007/978-0-387-73341-8; © Springer 2008
202 E.L. Raab

It is most unlikely that a child would on his or her own initiative report for an
examination, especially one likely to include the dreaded “blurring drops,” against
the express wishes of a parent. However, it would be hazardous to rely on this “real
life” inference of parental consent. The safest course is to require written authoriza-
tion or consent by telephone. The latter requires a reasonable good faith belief that
the consenting person at the remote location is the appropriate individual.
For problems that are more urgent but not true emergencies, relatives or an adult sib-
ling may stand in for an absent guardian. Here, too, the circumstances should be such that
there is reason to accept what is represented as to the accompanying adult’s identity.

Duty to Third Parties

We have a duty of care to our child patients, exercised through their parents or
guardian. The responsible adult legally is a stand in for the child. Can there some-
how be an additional duty to third parties, one that usually does not exist toward
those who may accompany or even assist a competent adult in a medical care
setting? The following illustrations are derived from actual cases
A young child received a poliomyelitis vaccination. Her principal care giver was
a parent whose own resistance to infection was reduced by recent surgery. The child’s
pediatrician did not inform the parent of the precautions to be taken in handling the
child’s waste and secretions. The parent contracted the disease and successfully sued
the physician for negligence in failing to provide the pertinent information.1
A psychiatrist was informed by a disturbed patient of intent to kill another per-
son, whom the patient named. The psychiatrist concluded that warning the intended
victim would violate physician–patient confidentiality. The patient accomplished
the killing. The victim’s family successfully sued the doctor for the victim’s wrong-
ful death resulting from the negligent failure to warn.2
The law distinguishes different degrees of closeness between third parties and
patients, either child or adult. Those who are either responsible for the minor or
for an incapacitated patient’s general welfare and have decisional power and
regular interaction with such a patient, or those emotionally close to the patient
but who may not be formally responsible, have been included within the duty to
warn assumed by the physician, which arises when the third party is known to
be at risk from a specific threat and when the harm is readily foreseeable.
Accordingly, as just one example, the discovery by the pediatric ophthalmologist
of a retinoblastoma as the explanation for a white appearance to the pupil, especially
when bilateral, calls for investigation of parents, siblings, and perhaps close relatives
in order to establish, by the detection of spontaneously regressed lesions and by
modern genetic analysis, the likelihood of very young children of the family and its
extension and of as yet unborn children being similarly afflicted. Omission of such
widely practiced counseling and analysis could be regarded as negligent care,
because there is a specific, foreseeable threat of harm to ascertained individuals.
Once again, protection for the physician enhances overall quality of care.
Chapter 19. Pediatric Ophthalmology 203

Promises

“This operation will cure the glaucoma.” “These glasses will straighten your child’s
crossed eyes.”
Such absolute declarations should be avoided. We know from experience that
such statements are not always true. They are promises of results and if relied on
by the patient in accepting treatment can be viewed as making a contract. This is
not the same as malpractice and has the strategic advantages of not requiring expert
testimony, and a longer statute of limitations.
The physician should studiously avoid any discussion that could be construed as
an express promise. Expressing confidence that falls short of a promise in an out-
come based on reliable evidence or your own experience (“therapeutic assurance”)
is consistent with good medical practice and a much safer course.

Abandonment

A physician–patient relationship can be terminated by the physician for any reason


or for no reason provided it is done with adequate notice and an offer to furnish the
patient’s record to a successor physician. However, bad consequences from aban-
donment of a patient during a course of treatment would be difficult to defend.
Suppose you have under your care a child with an established diagnosis of juve-
nile rheumatoid arthritis. On one or more prior occasions, your examination has
shown no uveitis. The patient does not appear for the next scheduled visit.
Now suppose alternatively that in a similar situation, you have detected uveitis
and prescribed treatment. As proposed above, this child too is a “no show.” In both
instances, you have appropriately counseled the responsible adult of the necessity
for periodic follow up. Is your risk different in the two situations?
Abandonment applies when the patient is under an active course of care, which does
not include merely a series of checkup visits for a certain diagnosis. Regardless, although
the first scenario is essentially a periodic screening, best medical practice calls for at least
a reasonable attempt to reschedule the appointment. Especially if such an effort is docu-
mented in the patient’s record, the risk of liability for a subsequent poor outcome is rather
low. For the second child, a more vigorous attempt (again with documentation) to rees-
tablish care is called for, as the child is in the midst of treatment for a potentially destruc-
tive disease. In another context familiar to the pediatric ophthalmologist, a child on an
occlusion program for amblyopia, whose vision is periodically checked and the regimen
adjusted, probably is under active treatment that may include the danger of occlusion
amblyopia of the previously preferred eye, whereas the same child, undergoing interval
vision checks once occlusion is discontinued, probably is not.
There is no rigorous definition of what constitutes a “reasonable” or sufficiently
“vigorous” attempt. These determinations are fact specific and will be decided by a
jury, if matters go that far. Properly documented efforts are not only medically correct
but the best defense against the necessity for a jury to consider the question at all.
204 E.L. Raab

The Consultant

Most pediatric ophthalmology patients are referred for care, not merely for guid-
ance. The ophthalmologist may report to the referring physician, but this is largely
informational. A referral for diagnosis and treatment by a physician who is not a
member of our specialty clearly implies that the patient (through his or her guard-
ian) and the ophthalmologist understand that they are in a mutual undertaking.
Consider the following: you attend grand rounds or you are with a colleague in
the staff dining room or at the scrub sink. You comment on a case. Your advice is
followed; harm to the patient results, and you are sued. What is your risk of liability
in this setting? As shown in several courts,3 reasonable jurors probably would not
find any implication of a physician–patient relationship in this type of encounter,
the existence of which most likely is even unknown to the patient.
In another context involving an unaware patient, the outcome could be different.
Suppose now that you are the ophthalmologist on call for your hospital’s pediatric
emergency room, and you are informed of a patient with an eye problem. Must you
see the patient, or is telephone advice sufficient?
Several cases have indicated that it would be a departure from the standard of
care to not personally attend a patient in these circumstances when indicated by the
communicated findings.4 In the end, it is a matter of judgment; the response
involves a weighing of the likely consequence of the injury if not immediately
attended by a knowledgeable specialist against the inconvenience of your personal
participation. Although the patient has not consulted you or even necessarily knows
your identity, he or she has presented for care by the hospital, of which you are the
understood designee to carry out the hospital’s obligation. When in doubt, go.
There also are occasions when you as the treating ophthalmologist seek consul-
tation for your patient. What if in this instance you do not accept the consulted
ophthalmologist’s recommendations? Given that you found it necessary to go beyond
your own capabilities in the first place, are you at risk for a malpractice verdict if
you ignore the advice and the case has a poor result?
Ultimately, you are not bound to follow a consultant’s recommendation, but
your reasons for rejecting it should be documented. What is important is that these
reasons be sound and preferably based at least in part on your own experience and
that it is clear that you considered the consultant’s suggestions.

Right Eye or Left Eye?

Imagine the disaster (it has happened) when a mistake as to side occurs in an enu-
cleation, even though in most cases the eye indicated for that operation is readily
apparent. The possibility of error for interventions of a less critical nature also can-
not be ignored; should correction of strabismus involve the only good eye of an
amblyopic patient or one with a structural defect in one eye, other than in limited
special circumstances (e.g., null-point motor nystagmus)?
Chapter 19. Pediatric Ophthalmology 205

Surgical facilities have increasingly become aware of the necessity to guard


against such errors. Marking the operative site on the patient and “time outs” for
verbal review of the proposed procedure among all participants are now institutional
policy at many facilities, reinforced in some instances by state law or regulation.
Errors of this type usually occasion much finger pointing, but the last clear
chance for prevention lies with the surgeon. No source, including the patient’s
impression, the hospital’s operation schedule, and the insurance company’s author-
ization, other than your own record establishes the ultimate facts.
It is my practice to have my entire record available at the procedure and affix
the sheet stating my plan to the wall or an instrument stand for ready reference
rather than to bring only a short summary prepared as a brief admission note,
because other questions about examination details may arise during the operation,
especially in repeat strabismus procedures. The risk avoidance value of observing
this ritual exceeds by far any slight inconvenience.

Novel Treatment

There are occasions when the physician finds justification for treatment that is nei-
ther established nor experimental, such as disinsertion and reattachment of all four
horizontal rectus muscles for motor nystagmus.5 In such situations, the actual surgi-
cal handling may be entirely conventional; it becomes “novel treatment” by appli-
cation in a novel setting.6 What risk-limiting precautions are appropriate here?
Professional common sense should prevail. Most important, there should be no
increase in the expected occurrence rate of dangerous complications. Second, the
remedy should relate logically to what is known about the abnormal condition.
Published experience with the treatment by other ophthalmologists is valuable for
this purpose. If there is no such prior evidence and the treatment is essentially
untried, this calls for adherence to a full investigational protocol. Again, whatever
lessens risk has a positive effect on quality of care.

Off-Label Prescribing

The term off label refers to the use of drugs and devices not authorized by the U.S.
Food and Drug Administration (FDA), usually because they have not been evalu-
ated for safety and efficacy in certain populations or in certain dosages. The pack-
age inserts for such drugs typically contain the warning “not approved for children”
or a similar message. This situation is changing somewhat. Since 1998, the FDA
has had a “pediatric rule” that requires studies on children as part of a new drug
application unless children do not contract the disease the drug treats or the out-
come is already known.
206 E.L. Raab

Among the most serious conditions leading the pediatric ophthalmologist to


prescribe off label are certain forms of childhood glaucoma, retinoblastoma, and
severe uveitis from various causes. In such cases there are few effective alterna-
tives, so it is even possible that failure to prescribe off label could be deemed
malpractice.
What liability exposure attaches to off-label prescribing? The FDA provides a
Practice of Medicine Exemption under which it is lawful to vary the conditions of
use of a drug from those detailed in the package insert without FDA approval, pro-
vided that the unapproved use is based on reasonable medical evidence, without
fraudulent intent and that it requires the same judgment and prudence as exercised
in medical practice in general.
The items of prudence considered critical are a good faith effort to evaluate all
that is known about the drug and informed consent from the child’s caregiver,
many of whom will notice the “not approved for children” warning. I have found
it best to anticipate their hesitation by pointing out the difference between disap-
proved and nonapproved and that what is known about the drug’s effects, as well as
prior experience, reasonably indicates that its use is appropriate.

Retinopathy of Prematurity

Experience has shown retinopathy of prematurity (ROP) to be a leading risk set-


ting for the pediatric ophthalmologist. Modern concepts of appropriate care for
premature infants are based on the premise, firmly supported by recent technical
advances and a body of sound clinical studies, that the disastrous consequences
of ROP can be avoided in most cases. The key is timely detection.7 Legal action
mostly involves a break in the screening sequence once the infant is discharged
from the nursery.
Consider the following actual occurrence: A pediatric ophthalmologist provides
ROP screening services to the neonatal intensive care unit (NICU) of a regional
hospital. The NICU has sole responsibility for identifying the infants at risk requir-
ing screening. Examination of one such infant results in a properly charted note
stating a diagnosis of “immature retina” in zone 2 and recommending a repeated
screening in 2 weeks. The attending neonatologist misinterprets the note as conclu-
sively ruling out ROP and transmits this information in his discharge note to the
infant’s succeeding pediatrician, who considers the follow up to be only routine and
elective. The parents arrange the next appointment by a delayed effort and cannot
secure an appointment until several weeks later. At this examination, advanced
ROP is evident, with a poor visual outcome. The pediatric ophthalmologist is
named as one of the defendants in the subsequent lawsuit.
This is a rather typical scenario for ROP incidents that result in malpractice
lawsuits. Omitting discussion here of how liability might be apportioned between
the hospital neonatologist and the successor pediatrician, what was the ophthal-
mologist’s exposure, and how might it be minimized?
Chapter 19. Pediatric Ophthalmology 207

The case points out the importance of a thoroughly understood practice pattern
among these participants. While “immature retina” arguably should have been
understood by the neonatologist as not eliminating the possibility of ROP, espe-
cially because a short interval repeated screening was recommended, there should
be an established understanding among the involved physicians regarding what
meaning such an ophthalmologic description conveys.
There should be further understanding of whether responsibility for follow up is
shared by the ophthalmologist or remains with the nursery or the subsequent pedia-
trician during the stage of screening, however many sessions are required before
terminating scrutiny. Because the latter two coordinate all care during and follow-
ing discharge, logic suggests that the responsibility best remains with them, but this
is entirely a local determination. However, at the point where any degree of ROP
has been detected, the capacity to address the matter has gone beyond the primary
care givers, and it would be difficult for the pediatric ophthalmologist to deny some
share of responsibility while being in the better position to carry out the necessary
treatment or to secure this service from a colleague.
In the case described above, no ROP was evident at the first screening, but
through a misunderstanding of the result, follow up was not arranged appropriately
through no fault of the ophthalmologist. What then constituted his risk? It was that
there was no system in place within his office for spotting compliance failures and
assisting in efforts at rectification.
Other opportunities for a break in the system can occur. It is important that when
medical considerations prevent the ophthalmologist from accomplishing the
screening, this should be documented in the chart and some type of reminder
should exist for restoring the infant to the schedule. When the screening ophthal-
mologist is not the person responsible for treatment, this too increases the possibility
of a communication failure and gives a further responsibility to ensure compliance
when the referral for treatment arises.
It is best to memorialize this or any other variation of understanding in a docu-
ment freely available and universally adopted, but consistent custom and practice
will govern in the alternative. Be aware that these understandings fix the working
relationships at a particular institution, but no agreement to assign responsibility for
any aspect of care elsewhere from where the facts of the specific case indicate it
should lie will immunize against liability for negligence. The patient is not bound
by arrangements between the involved physicians.

Final Thoughts

Try to accomplish an entire examination in one visit; it limits what might otherwise
“fall through the cracks” if the patient does not return. You might avoid missing a
retinal lesion, causing what may otherwise appear to be a routine strabismus problem
or one that explains why an infant with supposed amblyopia is not improving with
adequate occlusion.
208 E.L. Raab

Although it may seem clear that a tearing infant has lacrimal obstruction, always
harbor a suspicion of congenital glaucoma. No ophthalmologist, especially not a
pediatric ophthalmologist, should overlook this possibility.
Surgical over- and undercorrection of strabismus occurs frequently enough.
Avoid characterizing these as complications, because they are within the spectrum
of foreseeable outcomes, even though disappointing. Your informed consent pro-
cedure should establish this view.
Your informed consent discussions should include risks, benefits, and alterna-
tives respecting the proposed treatment, but full disclosure still leaves room for you
to rank the alternatives. Remember also to present not only the alternatives but also
their risks and benefits as well as those of your preference. As to risks, the discus-
sion is not complete without giving some idea of the likelihood of any risk material-
izing. I have seen several instances of adults with strabismus unduly discouraged
from improving their self-image and business/social acceptance through surgery by
an exaggerated estimate of the risk of intractable postoperative diplopia. Surely this
unusual complication should be revealed, but in proper perspective relative to the
likelihood of achieving the anticipated benefits.

References

1. Tenuto v. Lederle Laboratories, et al. 90 N.Y.2d 606; 687 N.E.2d 1300; 665 N.Y.S.2d 17 (N.Y.
Ct. App. 1997).
2. Tarasoff v. Regents of University of California, et al. 13 Cal.3d 177; 529 P.2d 118; 118 Cal.
Rptr. 129 (Sup. Ct. Cal. 1974).
3. Sawh v. Schoen. 215 A.D.2d 291; 627 N.Y.S.2d 7 (N.Y. A.D. 1st Dept. 1995).
4. Thomas v. Corso. 265 Md. 84; 288 A.2d 379 (Md. Ct. App. 1972).
5. Hertle RW, Dell’ Osso LF, FitzGibbon EJ, Yang D, Mello SD. Horizontal rectus muscle tenot-
omy in children with infantile nystagmus syndrome: a pilot study. JAAPOS
2004;8(6):539–548.
6. Cowan DH. Innovative Therapy v. Experimentation. 21 Tort&Ins. L.J. 1986;21:619–623.
7. American Academy of Pediatrics, Section on Ophthalmology, American Academy of
Ophthalmology, American Association for Pediatric Ophthalmology and Strabismus. Screening
examination of premature infants for retinopathy of prematurity. Pediatrics 2006;117(2):572–
576. Erratum in Pediatrics 2006;118(3):1324.
Chapter 20
Refractive Corneal Surgery

James J. Salz and Anne M. Menke

Introduction

Few ophthalmic subspecialties generate as much public enthusiasm and criticism


as refractive eye surgery: Tiger Woods’ professional success after his refractive
surgery may lend a certain glamour to LASIK (laser-assisted in situ keratomileu-
sis), but websites devoted to “LASIK disasters” abound. In this chapter, a refractive
surgeon with extensive research and clinical experience and a health care risk manager
assess how refractive surgery has fared in the courtroom.
To provide the reader with an overview of the topic of medical malpractice
and refractive surgery, we present overall ophthalmic claims experience and com-
pare the incidence of refractive surgery claims to that of other types of eye cases
(e.g., cataract surgery). Then each of the three most common refractive surgery
procedures—radial keratotomy (RK), photorefractive keratectomy (PRK), and
LASIK—are analyzed from a risk management and professional liability perspec-
tive, followed by a discussion of recent cases with multimillion dollar awards that
have garnered national attention. The chapter concludes with a review of pertinent
literature and a discussion of how to minimize the risks of a claim.

Ophthalmic Mutual Insurance Company’s Overall


and Subspecialty Claims Statistics

Formed by members of the American Academy of Ophthalmology (AAO) in 1987,


Ophthalmic Mutual Insurance Company (OMIC) now insures about 35% of oph-
thalmologists who can choose their own liability carrier. Through 2005, OMIC had
2008 closed cases, of which 424 (21%) resulted in an indemnity payment. Payments
ranged from a low of $500 to a high of $1,800,000, with a median payment of
$75,000. Overall, OMIC has paid $55,950,884 in indemnity payments on behalf of
its insured ophthalmologists.
Ophthalmic Mutual Insurance Company tracks claims by ophthalmic procedure
and subspecialty and is thus in a position to respond to those ophthalmologists who

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 209


doi: 10.1007/978-0-387-73341-8; © Springer 2008
210 J.J. Salz and A.M. Menke

believe that refractive surgeons have more claims and larger indemnity payments
than ophthalmologists who do not perform refractive surgery. This impression is
reinforced by articles about the large awards in some of the recent LASIK cases,
leading nonrefractive surgeons to surmise that they are not as great a risk to an
insurance company and should, therefore, be charged lower premiums. A look at
the data challenges some of these assumptions.
Figure 20.1 graphs refractive and cataract claims between 1998 and 2004 and
shows that cataract consistently and significantly exceeds LASIK in number of
claims. Figure 20.2 compares the incidence or frequency of claims filed from 2002

Refractive Claims by Date Reported


100 (through 12/31/2004)
90
88
80 79
70
RK
60
55 57 PRK
cases

50 51 LASIK
40 39 Cataract
38
30 31
28 37
20 19
21 16
10
7
0
95 96 97 98 99 2000 2001 2002 2003 2004
year

Figure 20.1 Refractive versus cataract frequency, 1998–2004

Claims by Ophthalmic Subspecialty


Opened per year July 1, 2005
90
80
2002
70
60 2003

50 2004

40 2005

30
20
10
0
Ca

LA

Co

Re

Ne

Pe

G
cu

la

en
SI

di
ta

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uc
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at
ra

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a

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om
a

al
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O
as

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a
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th

Figure 20.2 Claims by ophthalmic subspecialty


Chapter 20. Refractive Corneal Surgery 211

through 2005 for the various subspecialties in ophthalmology. Here again, cataract
claims rank highest in all 4 years, arguably reflecting its status as the most fre-
quently performed surgery in the United States. Although LASIK was second after
cataract in 2002 (79 cataract, 55 refractive, 40 retina), general or comprehensive
ophthalmology began outranking it as of the following year (cataract 88, general
37, refractive 31). By 2004, it was a distant third (cataract 57, general 29, refractive
16), and its frequency continues to decline.
The incidence of claims is important in setting premiums, but the average and
total payments for these claims are perhaps even more important. Figure 20.3
shows the average settlement in 11 categories. Pediatric ophthalmology and
neuroophthalmology both averaged over $300,000, while general ophthalmology
was sixth at $155,377, LASIK eighth at $95,562, and cataract ninth at $86,366.
Although some may be tempted to imagine that retinopathy of prematurity (ROP)
cases are driving the pediatric figures, claims involving ROP did not even make it
into the top 10 payments for that age group.
Figure 20.4 summarizes the total amount of money paid out for the various sub-
specialties between 2001 and 2004. Here, general ophthalmology ($6,215,092) was
by far the highest, with cataract second ($3,713,747), pediatric ophthalmology third
($3,184,014), and LASIK fourth ($2,484,613). One reason that general ophthalmol-
ogy, excluding cataract and LASIK surgery, is the highest relates to a million-dollar
award involving a patient who had a lung lesion listed in his x-ray report from his
routine physical examination performed as part of his preoperative work-up. The
report was not reviewed by the ophthalmologist, anesthesiologist, or the nursing staff,
and the patient died a couple of years later from lung cancer.

$350,000

$300,000

$250,000

$200,000

$150,000

$100,000

$50,000

$0
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at

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eu

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l

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er
op

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re
at
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ac

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en
O
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t

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6)

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a
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ia
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ic

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3)

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s

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)

2)
os
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3)

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0)

Figure 20.3 Average settlement by ophthalmic subspecialty


212 J.J. Salz and A.M. Menke

$7,000,000

$6,000,000

$5,000,000

$4,000,000

$3,000,000

$2,000,000

$1,000,000

$0
C

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at

et

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ic
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at
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26

(1

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t(

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ia
)
43

)
ic

(1

0)

r(
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s
)

0)
)

2)
os
(2
(1

e
3)

(1
0)
Figure 20.4 Total settlement by ophthalmic subspecialty

Refractive Surgery Claims by Procedure

Radial Keratotomy

The OMIC experience with RK claims has been surprisingly favorable. Figure 20.5
shows the incidence of refractive claims by procedure from 1989 through 2002. There
were only a handful of RK claims up to about 1996 when PRK was approved by the
U.S. Food and Drug Administration (FDA). Very few surgeons continued performing
RK after 1996, and it is generally accepted that it was a transitional procedure with
many associated problems. The size of the optical zone, number of incisions, direction
of the incisions, metal versus diamond blades, amount of myopia, patient age, incision
depth, crossing incisions, peripheral re-deepening, and postoperative cortisone drops
were all subjects of great debate—without much hard science to settle the questions.
The RK procedure itself weakened the peripheral cornea and unusual results—
so called “over- and underresponders”—were common. It was performed by hand,
usually in a private office, with relatively inexpensive equipment after attending RK
courses, which were readily available from both corporate and private sponsors,
and with little regulation controlling the equipment or the surgeons. The procedure
caused anywhere from 3 to 4 to 32 to 64 permanent scars in the cornea. Glare and
star bursting around lights at night were considered to be not complications but
instead expected postoperative events. Optical zones were generally only as small
as 3.0 mm, but some surgeons made them as small as 1.0 mm in an attempt to push
the limits of the operation to include more potential patients.
With all of these known problems, why was the OMIC experience generally
favorable? The answer is that OMIC implemented underwriting requirements and
provided risk management support specific to RK. In order to be covered for
Chapter 20. Refractive Corneal Surgery 213

60

50 Projected

40
cases

30 RK
PRK
20 LASIK Actual

10

0
'89 '90 '91 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02
year

Figure 20.5 Refractive surgery, 1989–2002

the RK procedure, the insured ophthalmologist had to complete an application


questionnaire that asked about the training, patient selection (amount of myopia
and astigmatism), number of incisions, and size of the optical zone. Proctoring was
required for surgeons new to the procedure. Unless the policyholder agreed in writ-
ing to abide by the requirements, coverage for RK malpractice claims was not
available. Initially only unilateral surgery was permitted, and insureds used an
informed consent form provided by the company.
To assist surgeons who performed RK, the ophthalmologists on OMIC’s Risk
Management Committee and OMIC staff offered written support via underwriting
requirements for the proper performance and risk management seminars that
covered informed consent, complications, and discussions of malpractice issues.
OMIC also staged a mock trial involving a fictional RK malpractice case, with
ophthalmologists on OMIC’s Board of Directors starring as the judge, plaintiff,
defendant, and their attorneys at the American Academy of Ophthalmology’s
annual meeting.
Although a few policyholders left the company because they felt these require-
ments were too restrictive, the net result of these underwriting and risk management
efforts was a very favorable claims experience. The OMIC surgeons did not use
small optical zones or 32 incisions with crossing transverse incisions, nor did they
perform RK on patients who were −10D. They informed their patients of the risks
and benefits and asked them to sign a detailed informed consent about the proce-
dure. Thus, even though the RK procedure was far from ideal, very few OMIC sur-
geons were sued, and none of the suits resulted in significant judgments. This was
not necessarily the case for ophthalmology in general. There were many lawsuits
and several large awards, some over a million dollars. They generally involved
inappropriate surgery with too many incisions, optical zones that were too small,
and poorly informed patients.
214 J.J. Salz and A.M. Menke

Photorefractive Keratectomy

The OMIC claims experience for PRK parallels the RK claims history. Figure 20.6
graphs the claims experience for RK, PRK and LASIK between 1995 and 2006.
There have been very few PRK claims—none for the past 5 years—nor has OMIC
paid any large PRK awards. There are several reasons why the PRK claims are sig-
nificantly lower than the LASIK claims. First, there are fewer PRK cases performed
than LASIK. The annual International Society of Refractive Surgeons of the
American Academy of Ophthalmology (ISRS/AAO) survey of members tabulates
approximately nine LASIK procedures for every one PRK.1 Fewer cases performed
translates to fewer possible law suits.
It is also generally accepted that PRK is an inherently safer procedure despite
the small risk of infection and corneal haze. When infections do occur, they are
easier to treat as they are on the surface rather than under a LASIK flap,
more responsive to antibiotics, and thus only occasionally lead to severe visual
loss. Corneal haze usually clears with time and rarely causes permanent visual loss;
use of mitomycin C has further reduced this risk. Two complications associated
with LASIK, corneal ectasia and dry eye syndrome, are uncommon after PRK.
Post-LASIK ectasia and preexisting form fruste keratoconus have resulted in two
recent multimillion dollar plaintiff awards; this issue is addressed in more detail
later in the discussion of LASIK.
Finally, high volume surgery and comanagement are more commonly associated
with LASIK than with PRK. Most corporate-type laser centers focus on LASIK,
and these centers perform a high percentage of the laser vision procedures in the
United States. Both high volume surgery and comanagement were associated with
increased claims frequency in a study of the OMIC refractive surgery claims

Refractive Claims by Date Reported


(through July 1, 2006)
60
55
50

40
RK
cases

30 37 31 PRK
LASIK
20 19
21 16
10 12
7
4
0
95 96 97 98 99 20 20 20 20 20 20 20
00 01 02 03 04 05 06
year

Figure 20.6 Refractive surgery, 1995–2006


Chapter 20. Refractive Corneal Surgery 215

experience by Abbott et al.2 These conclusions and the discussion they generated
are discussed in detail in the literature review; the risk management section
provides recommendations on how to minimize the risk of a lawsuit regardless of
surgical volume and how to safely comanage patients.

Laser In Situ Keratomileusis

In 1996, PRK became the first laser vision correction procedure to be approved by
the FDA. Although it was deemed safe and effective, it never became popular with
the general public because it was associated with significant discomfort and
delayed visual recovery. Patients’ experiences with LASIK were different: the com-
bination of minimal discomfort and rapid visual recovery provoked a “WOW!”
reaction from patients who responded enthusiastically to the almost immediate
improvement in their vision and near complete visual recovery by the morning after
surgery. Bilateral simultaneous surgery became very popular, and the number of
LASIK procedures escalated dramatically. Within a couple of years of its introduc-
tion in the United States in 1996–1997, more than a million LASIK procedures
were being performed, and ophthalmologists began to advertise widely, and at
times aggressively, in order to attract patients.
Soon enough, stories of complications emerged, which is hardly surprising given
that LASIK is a technologically more difficult procedure requiring more surgical skill
than PRK. In addition, early microkeratomes were difficult to assemble, maintain, and
use. Figure 20.1 details the OMIC claims incidence between 1995 and 2004, when
LASIK claims rose from 7 in 1998 to a peak of 55 in 2002. This uptick in claims
frequency correlates with the increases in both the number of LASIK procedures being
performed and the number of ophthalmologists insured by OMIC, which rose from
1,700 members in 1996 to 2,968 insureds in 2002. A similar spike was noted in cataract
claims over that time period. Figure 20.6 clarifies, however, that the LASIK frequency
trend was short-lived. Although the number of policyholders continued to climb,
LASIK claims kept decreasing; as of June 2006, there were only four.
Figure 20.7 details the average indemnity payment per LASIK claim between
2001 and 2005, which ranged from $31,000 to $56,000—except for 2003. That year,
there were 12 claims and a much higher average settlement of $156,000, largely due
to two significant awards. In one case, a patient underwent bilateral simultaneous
surgery and later developed corneal ectasia with irregular astigmatism, ghosting, and
best-corrected visual acuity of 20/30. The patient’s topography indicated form fruste
keratoconus. Most refractive surgeons consider this a contraindication to LASIK
surgery. Photorefractive keratectomy might be an option if the surgeon provides the
patient with information about the possible increased risk for postoperative problems
associated with ectasia. The insured surgeon in this case, however, did not review the
topography, disclose the presence of form fruste keratoconus to the patient, or have
the patient sign a procedure-specific informed consent document. The case settled
for $250,000.
216 J.J. Salz and A.M. Menke

Average LASIK Settlement


as of July 1, 2005
Settlements/ Ave. 156,217
160000
2001 (3) $ 31,667
140000
120000
2002 (6) $ 58,333 90,831
100000
80000
2003 (12) $ 156,217 58,333
60000 45,833
31,667
35,400
2004 (5) $ 35,400 40000
20000
2005 (3) $ 45,833 00000
2001 2002 2003 2004 2005 all
years

Figure 20.7 Average laser in situ keratomileusis settlements

That same year, another patient sustained a buttonhole flap complication in the first
eye, allegedly resulting from a violent head movement during the microkeratome pass.
The flap was repositioned without ablation of the bed, and surgery on the second eye
was cancelled. The patient developed central corneal haze and irregular astigmatism
with best-corrected vision of 20/40. As in the prior case, there were questions about
the patient’s candidacy and the consent. No preoperative pachymetry was performed,
and subsequent examinations revealed that the patient had a “thin” cornea.
The patient’s consent for surgery must be both voluntary and informed. To the
dismay of some surgeons, the legal standard is what a prudent layperson would need
to know in order for the choice to be informed, not what the surgeon feels is neces-
sary. The surgeon in question first met the patient on the day of surgery but did not
document a discussion of the risks and benefits, so the plaintiff argued he was not
informed. Moreover, the informed consent document was signed immediately before
the procedure, allowing the plaintiff to argue that the consent was coerced instead of
voluntary. As readers have no doubt surmised, the patient’s care was comanaged. In
addition to limited contact before the surgery, the ophthalmologist examined the
patient only on the first postoperative day; subsequent examinations were per-
formed by the comanaging optometrist. Documentation problems surfaced, as no
documentation of the head movement could be found. While both the surgeon and
the operating room technician confirmed the incident during depositions, the other
standard of care concerns led to a settlement of $450,000. In response to these cases,
OMIC modified its refractive surgery underwriting requirements pertaining to the
role the surgeon must play in determining patient candidacy and informed consent
(see the risk management discussion at the end of the chapter).
Figure 20.8 charts OMIC’s LASIK trials between 2000 and 2006. In five
cases, the jury returned defense verdicts. The only two plaintiff verdicts occurred
in 2006. In the first case, a loss of suction during the microkeratome pass led to
Chapter 20. Refractive Corneal Surgery 217

Refractive Trials
3/6/00 RK Progressive postoperative Defense verdit
hyperopic shift
11/27/01 LASIK-decentered flap Plaintiff Verdict $2,200
5/8/02 LASIK-wrinkled flap Defense verdict
6/2/03 PRK-decentration & abnormal Defense verdict
healing
12/01/03 LASIK-mild DLK postoperatively Defense verdict
6/19/06 LASIK-topography suspect Plaintiff Verdict $944,000
keratoconus?
(Surgeon performed less than 100
procedures)
6/26/06 LASIK-loss of suction Plaintiff Verdict $275,000
Pupil not dilated when
suction ring applied

Figure 20.8 Trials involving laser in situ keratomileusis

a buttonhole flap. The surgeon responded correctly by replacing the flap without
performing the laser ablation, and the patient had successful repeat LASIK sev-
eral months later. A buttonhole flap is a known complication of LASIK and
would normally be considered a maloccurrence rather than malpractice. A video
of the procedure showed that after application of the suction ring, the pupil did
not dilate and the tonometer indicated inadequate pressure. The plaintiff’s expert
testified that both of these findings were indications of pseudosuction, which
should have alerted the surgeon to abort the microkeratome pass. While the
patient acknowledged an uncorrected visual acuity of 20/20, he continued to
experience glare, halos, and loss of contrast sensitivity. The jury found in favor
of the plaintiff and awarded damages of $275,000.
The second trial resulted in OMIC’s highest award in a LASIK case and focused
on patient selection. One plaintiff expert suspected the patient had form fruste kera-
toconus, even though he acknowledged that the corneal topography was within
normal limits. The well-qualified defense experts all felt that the topography and
pachymetry were normal and that the patient was indeed an appropriate candidate
for the procedure, thus confirming the second opinion the surgeon had obtained
prior to the procedure from a fellowship-trained corneal specialist and the support-
ive evaluation of OMIC’s Claims Committee. Despite the absence of indications of
preexisting keratoconus, the patient developed ectasia after LASIK. This develop-
ment is consistent, the defense argued, with the incidence of keratoconus in the
general population, which is approximately 1 per 2,000. Indeed, this patient may
well have developed keratoconus without LASIK. Some felt that the ectasia in this
case may have been related to a thicker than expected flap, which resulted in a
postablation residual bed of less than 250 mm. These technical issues were not the
basis of the jury’s plaintiff verdict, however. Instead, as they explained in interviews
after the trial, the members of the jury felt that the approximately 100 cases performed
218 J.J. Salz and A.M. Menke

by the surgeon did not adequately prepare him to handle this case. They were not
swayed by the expert testimony that this known complication could have happened
to any surgeon and awarded the plaintiff $944,000, which, after the addition of pre-
trial interest, resulted in an indemnity payment of $983,772.

Recent Significant Nonophthalmic Mutual Insurance Company


Laser In Situ Keratomileusis Awards

Large awards in refractive surgery are usually granted for economic reasons involv-
ing lost earnings and significant health care bills, as happened in the OMIC ectasia
case just discussed. The jury believed that the plaintiff, an attorney, lost past and
future wages despite the fact that visual acuity was near normal with contact lenses
following penetrating keratoplasty. There have been at least four recent multimil-
lion dollar awards involving LASIK cases. Two of these focused on the adequacy
of the informed consent of patients with large scotopic pupils, and two involved
post-LASIK ectasia.

Pupil Size

The first multimillion dollar award involved a commercial airline pilot. Despite
obtaining an excellent uncorrected visual acuity, he was initially granted a jury
award of $4,000,000 (less $600,000 for the 15% fault attributed to him) based on
his contention that he would not have agreed to have the surgery if he realized
that night time glare and halos could make it hazardous for him to fly at night.
Admitting that the standard informed consent mentioned this as a possibility, the
plaintiff questioned the accuracy of the measurements of his scotopic pupils and
the size of the optical zone delivered by the laser, which were subsequently found
to be larger than the original measurements. The expert witness for the plaintiff
initially stated that because the true optical zone of the laser was smaller than the
6.5 mm pupil size measured during his independent medical examination, the
patient should have been consented differently. The jury agreed that the pilot
should have been informed that his larger than normal pupils increased his risk
and might interfere with his ability to fly. The case was appealed. The trial court
granted a new trial because the plaintiff’s key expert changed his testimony on
the size of the optical zone after the verdict. The Court of Appeals overturned the
new trial, and the case was settled pending the appeal.3
The other pupil-related case resulted in a jury verdict for the plaintiff for
$3,002,950. The plaintiff’s scotopic pupils were measured by a technician to
be 5.5 mm, but subsequent measurements were 7.5 mm. The patient had a non–
wavefront-based treatment in 2001 with a 6.5 mm ablation diameter. The plaintiff’s
position was that he should have been warned that because of his large pupils he
was at increased risk for night vision disturbances.4
Chapter 20. Refractive Corneal Surgery 219

Post–Laser In Situ Keratomileusis Ectasia

The plaintiff in the first post-LASIK ectasia case was a stockbroker who claimed
loss of past and future earnings despite having adequate visual acuity with hard
contact lenses. Preoperative topography in this case showed signs of form fruste
keratoconus according to the plaintiff’s expert, who opined that the patient should
have been informed that the surgery was contraindicated. The patient’s procedure
took place in a commercial laser center; the abnormal topography was apparently
not discussed by either the surgeon or the comanaging optometrist. The jury found
in favor of the plaintiff and awarded $7,250,000—$4,500,000 in lost wages and
$2,750,000 for pain and suffering.5
In the other case, the topography, pachymetry, slit-lamp examination, and family
history were all normal. The defendant was a fellowship trained, nationally
recognized corneal expert, as were the defense experts, who testified that the sur-
geon had met the standard of care. Nevertheless, the jury awarded the plaintiff $3
million. As in one of the OMIC cases described earlier, this patient may have been
the 1 in 2,000 who was destined to develop keratoconus. In both instances, the
LASIK surgery may have accelerated the progression.6

Literature Review of Malpractice Issues in Refractive Surgery

Dr. Richard Abbott, OMIC Board Member and Chairman of the OMIC Underwriting
Committee, was the lead author of a paper based on his analysis of OMIC’s first
100 PRK and LASIK claims.7 Dr. Abbott concluded in the study2 that
[T]he chances for incurring a malpractice claim or lawsuit correlates significantly with
higher surgical volume and a history of a claim or lawsuit. Additional risk factors that
increase in importance with high surgical volume include physician gender, advertising
use, preoperative time spent with the patient and co-management with optometrists.

Not explicitly stated in the article, but clarified in a subsequent interview, his goal
was to obtain data to drive OMIC’s underwriting and risk management protocols so
the company could continue to proactively reduce the risk of refractive surgery.7
Associating surgical volume and comanagement with quality of care was chal-
lenged in discussions and articles that responded to the study. Some ophthalmolo-
gists argued that analyzing the incidence of lawsuits per cases performed would
indicate that high volume surgeons had a lower risk of suits given their vast experi-
ence with the procedure.7–9 Indeed, low volume surgeons in one study were shown
to have a higher number of complications.10 Moreover, they felt that despite the
number of surgeries performed, they, along with their staff, did spend adequate
“chair time” with each individual patient.
Dr. Abbott clarified that the study did not look at the relative risk per case,
but instead the overall higher number of cases when compared with low vol-
ume surgeons.7 While he agreed that surgeons with less experience do indeed
have higher complication rates, he explained that whether they are sued
220 J.J. Salz and A.M. Menke

depends for the most part on how they handled the complication. Comanagement
was associated with higher risk in relation to the volume; it was not an inde-
pendent variable. The greater risk is due to the complexity of comanagement
itself, he stated.

How to Minimize the Likelihood of Refractive


Surgery Lawsuits

A lawsuit is a traumatic experience, both emotionally and financially. To help oph-


thalmologists avoid claims and their distressing impact, OMIC has developed risk
reduction materials and made them available on its website for use by all ophthal-
mologists. Risk reduction consists of managing patient expectations and proac-
tively comanaging patient care.

Manage Patient Expectations

First, ophthalmologists need to manage patient expectations by careful advertising,


prudent patient selection, and patient-friendly informed consent. Advertising,
including patient brochures and videos, must be truthful and professional, as well
as consistent with the information provided during the informed consent process.
An explanation of the rules governing physician advertising and an advertising
review form are available in the Risk Management Recommendations section at of
OMIC’s website.11,12

Patient Selection: Pupil Size

The importance of the scotopic pupil size in predicting night vision complaints is
confusing. Two recent studies by Schallhorn et al.13 and Pop and Payette14 failed to
find that large scotopic pupils were predictive of night vision complaints. Other
reports15,16 indicate that large scotopic pupils are associated with an increase in higher
order aberrations and night vision complaints. Rather than wait for more studies to
resolve the issue, manufacturers have opted to advise patients. Thus the latest patient
information brochures on wavefront-based surgery from both Visx and Alcon warn
of a potential association between large scotopic pupils and night vision difficulty.
From a risk management perspective, if a patient has an unusually large scotopic
pupil (greater than 6.5 mm), it would be advisable to discuss the potential increased
risk of night vision complaints. Prospective patients should understand that
although in most cases these improve with time, some patients have prolonged dif-
ficulty and may require drops to reduce pupil size to help alleviate their symptoms.17,18
The patient’s vocation and hobbies may be significant factors to consider. The
OMIC’s sample consent form for LASIK includes a discussion of this issue.19
Chapter 20. Refractive Corneal Surgery 221

Patient Selection: Ectasia

From a liability perspective, the main issue with post-LASIK ectasia is whether
there were any abnormal findings in the preoperative evaluation that could be
considered a contraindication to the surgery. In effect, the defensibility of the case
can come down to the interpretation of the topography. If the inferior cornea 3 mm
below the center of the pupil is more than 1.5D steeper than the superior cornea
3 mm above the pupil, this may indicate form fruste keratoconus. In borderline cases,
other tests may be helpful, including pachymetry over the steep area to see if it is
thinner inferiorly than centrally, dilated retinoscopy looking for scissoring of the
light reflex, and manual keratometry looking for subtle distortion of the mires. The
history can also be important. A positive family history of keratoconus or
unstable refraction, particularly changes in the amount or axis of astigmatism, can
increase the suspicion that the patient may actually have early keratoconus. Findings
such as these should be discussed with the patient, and LASIK should not be performed.
Photorefractive keratectomy with proper informed consent can be considered as a
safer option, but there are also cases of ectasia reported following it as well.20
The other potential risk factor in post-LASIK ectasia is leaving a residual bed
of less than 250 mm. During the preoperative evaluation, surgeons should be very
aware of the corneal thickness, depth of the planned ablation, and estimated flap
thickness. Because the thickness of the actual flap can be considerably thicker than
planned, intraoperative subtraction pachymetry should be performed, especially in
any case where the corneal thickness and ablation depth might leave a residual bed
less than 250 mm. If the intraoperative pachymetry shows that the 250 mm rule
could be violated, the flap should be replaced without the excimer ablation. To
address the potential patient safety and liability issue of post-LASIK ectasia,
OMIC modified its sample LASIK and PRK informed consent documents to
address this issue.21

Informed Consent

Two specific issues that may need to be discussed during the informed consent
process have just been addressed. This topic is so important that another chapter of
this book is devoted to the general subject of informed consent, and we here want
to emphasize a few other aspects of the consent process for refractive surgery that
deserve special emphasis.
First, the timing of the consent is important. Ideally, the informed consent is ini-
tiated by the surgeon, but in reality this rarely happens in a busy refractive surgery
practice. During the initial consultation the surgeon or a staff member should
emphasize that PRK and LASIK are both surgeries and like all surgeries carry
some risk. Many patients feel that because the surgery is performed with a laser it
is not “real surgery.” Advertising that refers to “procedures,” excludes any mention
of risks, and describes subsequent surgeries as “enhancements” instead of retreat-
ment only reinforces this misconception.
222 J.J. Salz and A.M. Menke

Infection and the rare possibility of significant loss of vision should be mentioned
because patients understand that an infection is a possible complication of all surgical
procedures. The staff should also explain and demonstrate that under- and over-
corrections are always possible even if they can usually be improved by a retreatment.
If the patient has anything unusual, such as large scotopic pupils, need for a high
correction, high astigmatism, or borderline dry eye, the implications of these findings
should be discussed and documented in the record. Unusual complications such as
buttonhole flaps, haze, and irregular astigmatism are generally covered in the
written informed consent. If a retreatment is indicated, informed consent for it
should be obtained. See the OMIC sample retreatment consent form.22
The written consent form should be given to the patient to take home well before
the surgery. The patient should be encouraged to read it with friends and/or family
members and to call with any questions so that misapprehensions can be cleared up. It
is also wise to put a note in the record that the risks and benefits of the procedure were
discussed with the patient and all questions were answered, especially if the patient has
any findings that indicate an increased risk for complications. If necessary, the consent
can then be signed on the day of surgery provided (1) the surgeon has already had a
consent discussion with the patient and (2) the patient has not received any sedation.

Proactively Comanage Patient Care

Many cataract and refractive surgeons comanage patients. Ophthalmic claims expe-
rience indicates that this method of care delivery can increase patient safety and
liability risks if not properly performed. “Comanagement of Ophthalmic Patients”22
is a useful resource. It addresses scope of practice issues, how to select and creden-
tial comanagers, training and protocols, informed consent for comanagement,23
communication, availability, and supervision. The driving principle should always
be patient safety, as determined by the operating surgeon, who has the ultimate
responsibility for determining the patient’s candidacy, obtaining the informed
consent, and recognizing and managing complications.

Conclusion

Once performed by only a minority of ophthalmologists and greeted with skep-


ticism by doctors and patients alike, LASIK is now a household word, and
many cataract surgeons who insert multifocal intraocular lenses are considering
performing it for the first time as part of biopic treatment packages. Refractive
surgeons can improve patient safety and reduce their liability exposure by keep-
ing their skills current and by adopting the risk management measures gleaned
from the claims experiences of their colleagues.
Chapter 20. Refractive Corneal Surgery 223

References

1. ISRS/AAO Survey.
2. Abbott, RL, Ou RR, Bird M. Medical malpractice predictors for ophthalmologists performing
LASIK and photorefractive keratectomy. Ophthalmology 2003;11:2137–2146.
3. Post v. University Physicians, Inc.
4. Larson v. Weis, M.D. and N. Refractive Surgery Ctr., 21 Nat. J.V.R.A. 4:C6 (Minn. Dist. 2006).
5. Maggie Haberman. He wins $7.25M In Botched Eye Surgery Suit. New York Daily News
(July 31, 2005).
6. $3 million awarded for botched LASIK eye surgery. Lawyers USA, August 14, 2006, citing
Gropack v. TLC Laser Eye Centers; June 28, 2006; Nassau County Supreme Court, Mineola,
N.Y.; Judge Roy Mahon.
7. Smith SE. Deciphering medical malpractice predictors. Cataract Refract Surg Today
2004;4(2):45–53.
8. Donnenfeld ED. Surgical volume and patient care. Cataract Refract Surg Today
2004;4(2):54–56.
9. Hoffman J. Study turns up the “volume.” Ophthalmol Manage 2004;Apr:146–148.
10. Stulting RD, Carr JD, Thompson KP, et al. Complications of LASIK for the correction of
myopia. Ophthalmology 1999;106:13–20.
11. Menke AM. Advertising medical services. Available at: http://www.omic.com/resources/
risk_man/forms/medical_office/AdvMedServices.rtf.
12. Menke AM. Review of advertisement for medical services. Available at: http://www.omic.
com/resources/risk_man/forms/medical_office/AdvReviewForm.rtf.
13. Schallhorn SC, Kaupp SE, Tanzer DJ, et al. Pupil size and quality of vision after LASIK.
Ophthalmology 2003;110:1606–1614.
14. Pop M, Payette Y, Risk factors for night vision complaints after LASIK for myopia.
Ophthalmology 2004;111:3–10.
15. Chalita MR, Chavalia S, Xu M, et al. Wavefront analysis in post-LASIK eyes and its
correlation with visual symptoms, refraction, and topography. Ophthalmology 2004;
447–453.
16. Maguen E, Schlanger J, Wong J, Salz J. Relationship between total aberrations (RMS) and
pupil size in ametropic eyes with the LADAR wave system [abstr]. Invest Ophthalmol Vis Sci
2003;44E.
17. Randazzo A, Nizzola F, Rossetti L, et al. Pharmacologic management of night vision distur-
bances after refractive surgery, results of a randomized clinical trial. J Cataract Refract Surg
2005;31:1764–1772.
18. McDonald JE II, El Moatassem Kotb AM, Decker BB. Effect of brimonidine tartrate ophthal-
mic solution .02% on pupil size in normal eyes under different luminance conditions.
J Cataract Refract Surg 2001;27:560–564.
19. Informed consent for LASIK. Available at: http://www.omic.com/products/bus_products/
downloads/forms/LASIKconsent121404.rtf.
20. Malecaze F, Coullet J, Calvas P, et al. Corneal ectasia after photorefractive keratectomy for
low myopia. Ophthalmology 2006;113:742–746.
21. Informed consent for LASIK retreatment. Available at: http://www.omic.com/products/bus_
products/downloads/forms/LasikRetreatmentConsent.rtf.
22. Menke, Anne M. Comanagement of ophthalmic patients. Available at: http://www.omic.com/
resources/risk_man/forms/medical_office/Comanagement%20of%20Ophthalmic%20Patient
s.rtf.
23. Consent for comanagement after eye surgery. Available at: http://www.omic.com/resources/
risk_man/forms/patient/ComanagementConsent.rtf.
Chapter 21
Retina and Vitreous

Marvin F. Kraushar and Peter H. Morse

Vitreoretinal Risk Factors for Ophthalmologists

Comprehensive ophthalmologists and vitreoretinal specialists must be particularly


diligent when managing patients with vitreoretinal diseases. Practically every vit-
reoretinal diagnosis has the potential for severe visual impairment or blindness. It
can be further expected that a significant number of patients will experience pro-
found, irreversible visual loss as a result of their disease before or despite success-
ful treatment. Our best efforts cannot prevent a percentage of the treatment we
provide from being unsuccessful. The devastating visual prognosis of most of vit-
reoretinal diseases virtually ensures a poor visual result after failed treatment.1
Patient education regarding risks during the informed consent discussion thus
acquires even greater significance when managing patients with these diseases.
Mention should be made of the possibility of no visual improvement or further
vision loss despite successful therapy. It is of paramount importance that an optimal
physician–patient relationship is established and nurtured throughout the course of
treatment. This is often difficult because of the abrupt manifestation of symptoms
of many vitreoretinal diseases, such as central retinal artery occlusion, retinal tear,
retinal detachment, endophthalmitis, and intraocular foreign bodies, which usually
require expeditious treatment the day of the first visit. In these circumstances, there
is insufficient time to establish as strong a relationship as would be possible prior
to an elective procedure. Patient apprehension in such situations can make compre-
hension of pertinent details less reliable.

Vitreoretinal Specialist Consultations

Vitreoretinal specialists are at risk for litigation by patients seen in consultation


who feel they have an unsatisfactory result from previous treatment by a compre-
hensive ophthalmologist. A significant number of these patients sue the consultant
despite receiving no treatment.1 Many of the initial diagnoses are complications of
appropriate treatment by the referring physician. Common examples are retinal

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 225


doi: 10.1007/978-0-387-73341-8; © Springer 2008
226 M.F. Kraushar and P.H. Morse

detachment with pseudophakia, endophthalmitis, retained lens fragments after cata-


ract surgery, cystoid macular edema, suprachoroidal hemorrhage, and dislocated
intraocular lenses. These patients may understandably harbor some inherent resent-
ment before they encounter the vitreoretinal specialist.1 Some suits may be stimu-
lated by a physician’s attempt to escape from an unfavorable result. This may cause
erratic behavior on the part of the physician, varying from hostility to excessive
apology.
The litigation may also be comprehensive against all individuals and institutions
having contact with the patient during the alleged mishap. Such suits often have the
intention of dropping the claim against the vitreoretinal surgeon if during discovery
it is demonstrated that he or she was not liable. Unfortunately, such a claim will
cost the medical malpractice insurance company money to defend and if the
expenses are too great the sum may be added to the vitreoretinal surgeon’s claim
total and may thus affect future premiums.

Allegations

Most claims for negligent diagnosis (failure or delay) of vitreoretinal disease are
brought against comprehensive ophthalmologists. Although allegations of negli-
gent diagnosis are the most common reason for litigation in other ophthalmic sub-
specialties and most other specialties,2–5 it is a relatively uncommon cause of
litigation against vitreoretinal specialists.1,6 This is probably because of the greater
experience of vitreoretinal consultants in the diagnosis of these problems and also
because the patient is initially seen by a comprehensive ophthalmologist before the
referral is made, thus alerting the consultant to the possible diagnosis. Most allega-
tions against vitreoretinal specialists are for negligent treatment.1,6

Appointments

Office staff must be well educated regarding symptoms of possible emergency situ-
ations to ensure that patients complaining of these symptoms are given prompt
appointments. When in doubt, the staff should have clear instructions to speak with
the physician. If a new or established patient with possible emergent symptoms
calls the office and refuses a prompt appointment, the procedure for informed
refusal should be followed. This means warning the patient of the risk of not being
seen promptly and documenting the warning with a note in the record as well as
sending written notice of the risk of not being seen by return receipt mail.
Technically the physician–patient relationship is not established until the patient
is seen by the doctor. However, in today’s litigious society, it is not difficult to
imagine a clever attorney suing on behalf of a new patient calling about the sudden,
recent onset of flashes and floaters, refusing a prompt appointment, and developing
Chapter 21. Retina and Vitreous 227

a retinal detachment. The same procedure should be followed for patients missing
postoperative appointments or appointments for continuing therapy for cystoid
macular edema, photodynamic therapy, and other diseases requiring subsequent
treatment.

Diagnostic Problems

Medications and Tests

Documentation of informed refusal is indicated for patients who do not agree to bilat-
eral pharmacologic mydriasis. Patients often use the excuse, “I have to go back to work
when I leave the doctor’s office.” Bilateral intravenous fluorescein angiography may
also be refused, and this also requires warning of risks with documentation.
Warnings about the potential difficulties that may be encountered should be
given and documented in the medical record when a patient leaves the office in a
state of partial or complete pharmacologic mydriasis. The documentation can be
easily accomplished by means of a check-off box or an ink stamp. Reversing drops
and/or disposable tinted glasses can be helpful. Although ophthalmologists are
well aware of the risk that these patients may suffer an injury because of a “slip
and fall,” there is a new, more far-reaching risk about which to be concerned.
A Massachusetts court ruling in 2006 involved a patient on hypoglycemic medica-
tion who suffered an episode of low blood sugar while driving and hit and injured
a motorcyclist who eventually sued the physician. There was no documentation in
the record of the physician warning his patient, the auto driver, regarding this
risk. The court ruled the physician has a “special duty” when “an individual does
something that creates or increases the risk that a person will harm a third party.”7
It seems reasonable to assume that this “special duty” may some day be applied to
an ophthalmologist who fails to warn and to document the warning to a patient
leaving the office after pupillary dilation regarding the risk of injuring a third party
in an auto accident.
Informed consent is appropriate and advised for intravenous fluorescein angiog-
raphy, because significant problems can occur. It is of paramount importance that
the tip of the needle be monitored by gentle palpation during injection of fluores-
cein to ensure that extravascular accumulation of dye is promptly diagnosed in time
to stop the injection. There have been successful lawsuits against physicians
because of skin sloughs from extravascular dye reactions that required plastic sur-
gery. It is both appropriate and compassionate to include a warning about the
postangiogram change in color of the skin and urine, which can be a shock to the
uninformed patient or companion.
Test results should be promptly reported to and discussed with the patient, and
the conversation should be documented. This is a good risk prevention measure,
and it also improves the physician–patient relationship.
228 M.F. Kraushar and P.H. Morse

Retinal Tear/Detachment

The most frequent error in the diagnosis of ocular diseases that leads to litigation is
delay or failure to diagnose a retinal tear or detachment.2–4 These suits are usually
against comprehensive ophthalmologists.6 Typical problems revealed by review of
claims include failures to dilate the pupil for ophthalmoscopic examination of the
ocular fundus, examine the peripheral retina including the ora serrata, to look for
retinal pigment cells in the anterior vitreous, and to document the examination by
making a drawing in the record. Attempting to convince a jury that a dilated ocular
fundus examination was done merely by noting it in the chart in the absence of an
actual drawing seriously risks jeopardizing the jury’s confidence and credibility in
the ophthalmologist. A time-saving practice is to have a check list or ink stamp in
the chart where the physician can indicate the pupil was dilated and what instru-
ments were used for the examination, such as direct or indirect ophthalmoscope and
slit lamp with contact or noncontact precorneal lenses.
It is important to remember that the physician’s performance is measured
against the standard of an average physician. Provided the appropriate diagnostic
steps have been taken, missing a retinal break may be excusable. There have been
claims of failure to diagnose a retinal detachment in a patient complaining of a
progressing peripheral visual field defect and an apparently normal ocular fundus
examination. If a visual field examination had been obtained, it would have alerted
the physician to a flat or partial retinal detachment.
A common example of a claim for failure to diagnose a retinal tear or detachment
is that of a patient complaining of floaters and flashes of light who on examination
has a posterior vitreous detachment with no apparent retinal breaks. Several weeks
later the patient sees a second ophthalmologist because of persistent symptoms, and
a retinal detachment is found. Under most circumstances it will be difficult for a
plaintiff’s expert to say “within a reasonable degree of medical certainty” that there
was a missed retinal break on the visit to the first physician, because the symptoms
of a retinal tear and vitreous detachment can be similar. Furthermore, posterior
vitreous detachment may be progressive, and the tear may occur at a later time than
that of the initial symptoms. A retinal break may be present for many weeks before
a detachment develops. If the flap of a horseshoe break in attached or detached retina
is shriveled or if the posterior edge of the break is rolled, it is strongly suggestive
that the break is not fresh. One or more demarcation lines in an inferior retinal
detachment is a sign of chronicity. Intraretinal cysts are also indicative of a long-
standing detachment. In the absence of these findings, dating the occurrence of a
retinal tear cannot be accurate purely on the basis of symptoms. If the examiner is
confident there is neither a tear nor a detachment, the patient should be told to return
immediately if the symptoms increase, and this warning should be documented.
The bottom line for risk prevention and for optimal patient care in this situation is as
follows: if the examiner cannot feel completely confident in ruling out a tear or detach-
ment in the eye of a symptomatic patient by means of the indirect ophthalmoscope with
scleral depression, a contact or precorneal lens, and visual fields, the patient should be
Chapter 21. Retina and Vitreous 229

referred to a vitreoretinal specialist immediately. “A request for the opinion of another


physician does not reflect badly on your competence. On the contrary, it shows your
honesty in dealing with the situation and your concern for the patient’s welfare.”8

Endophthalmitis

Practically all endophthalmitis claims are brought against cataract surgeons for fail-
ure or delay in diagnosis. Occasionally the operating vitreoretinal surgeon is also sued
for negligent treatment of the endophthalmitis. Despite the myriad claims in the sum-
mons and complaint, these lawsuits almost always involve the allegation of a postop-
erative evening or late night telephone call by the patient to the surgeon or covering
physician claiming that the patient made specific complaints that were consistent with
endophthalmitis and that the physician failed to see the patient in a timely manner,
thus depriving the patient of the opportunity for a better result. Some cases involve
inadequate or no coverage when the primary physician is not available.
In the final analysis it becomes a question of contradictory statements by the
parties involved. The problem for the defense is almost always the failure of the
on-call physician to document the conversation by the following morning. Very
often no note is made in the record for several weeks or until the lawsuit is insti-
tuted at which time the on-call physician writes a lengthy document attempting to
note every complaint of the patient and every patient response to the physician’s
questions. Juries are understandably not likely to put much faith in a document
written so long after the fact, because it is unreasonable for them to expect the phy-
sician’s recall can be so exquisitely accurate so long after the occurrence.
The best and most powerful defense to an allegation of not seeing the patient is
putting contemporaneous, detailed documentation in the chart by the following
morning. It will probably discourage the plaintiff’s expert from advising a lawsuit,
and it will certainly impress a jury favorably. It is logical to assume the reason
many ophthalmologists do not remember to document these conversations is
because they occur after office hours. The patient’s chart is unavailable, and often
the patient complaints may seem minor. The telephone call may be from another
physician’s patient with whom the on-call doctor is unfamiliar. Fortunately, when
there is no reliable proof as to what was or was not said by either party, the jury
tends to believe the ophthalmologist. Regardless of the severity of the injury, it is
often difficult for the patient to prevail in these claims.

Choroidal Melanoma

The frequency of claims for misdiagnosis of lesions resembling melanoma or failure


to diagnose a malignant choroidal melanoma is significantly less than that of previous
230 M.F. Kraushar and P.H. Morse

years because of modern diagnostic techniques. Suspicious lesions, such as nevi or


subretinal hemorrhages, should be carefully documented and monitored. If there is
any doubt as to the diagnosis, patients should be referred for vitreoretinal consulta-
tion. Photographs in the patient’s chart are helpful for comparison on subsequent
examinations. A more detailed discussion on this topic is presented in Chapter 17.

Miscellaneous

Claims of negligent diagnosis for prevalent vitreoretinal diseases, such as diabetic retin-
opathy, age-related macular degeneration, and retinal vascular disease, are uncommon.1

Medical Treatment

Topical Medications

Lawsuits involving treatment with topical medications are uncommon. The usual
precautions, especially intraocular pressure monitoring and observation for cata-
ract, should be taken and documented for prolonged treatment with corticosteroids.
It is good practice not to prescribe antibiotics unless absolutely indicated. The
appropriate tests should be ordered and the results documented for patients during
extended therapy of any chronic problem if there is a risk of harmful local or sys-
temic effects from the medication.

Periocular/Retrobulbar Medications

The usual precautions should be observed when delivering any anesthetic or thera-
peutic medication by injection anywhere around the exterior of the eyeball. This is
discussed in Chapters 10 and 13.

Intraocular Medications

The recent off-label use of intravitreal corticosteroids for macular edema and anti-
vasoproliferative or other drugs for choroidal neovascularization has raised new
questions about medical ethics.9 Because the safety and efficacy of some of these
medications have not been tested by well-designed clinical trials, an appropriate
informed consent is indispensable with respect to ethics and risk prevention.
Chapter 21. Retina and Vitreous 231

Possible deleterious side effects, which may occur over a longer time, have also not
been determined. This topic is covered in Chapter 13.

Laser Treatment for Diabetic Retinopathy

Background diabetic retinopathy, or proliferative diabetic retinopathy, is the most


common retinal problem treated with laser. Lawsuits by patients undergoing focal,
grid, or panretinal laser have been brought for every possible reason, including failure
to treat, delay in treatment, initially treating the incorrect eye, and negligent treatment.
Suits have been initiated for continued vision loss following treatment, failure to
improve vision, and alleged decreased vision due to negligent treatment.2 All of these
allegations are indicative of the need for an effective informed consent discussion.
Inadequate panretinal photocoagulation over an appropriate time interval allow-
ing proliferative diabetic retinopathy to progress is not uncommon. Such delay may
allow development of tractional retinal detachment and other complications requir-
ing vitrectomy and unnecessary loss of vision that might have been obviated with
adequate and timely treatment. Cases of a patient seeking the opinion of a second
ophthalmologist following protracted neglect by the initial ophthalmologist have
prompted attorneys to attempt to sue the second ophthalmologist because of the
extensive advanced disease.

Laser and Medical Treatment of Age-Related Macular


Degeneration

Litigation has been brought by patients with age-related macular degeneration for
many of the same reasons as for diabetic retinopathy. The poor visual prognosis for
most cases of exudative age-related macular degeneration, problems unique to
photodynamic therapy, and anti–vascular endothelial growth factor treatment with
the frequent need for repeated treatment make an effective informed consent dis-
cussion essential for patient education. Many of the newer anti–vascular endothe-
lial growth factor or off-label medications have shown a short-term relative benefit
but no proven long-term success. What may seem a relative triumph in preservation
or restoration of vision to the ophthalmologist may not represent useful vision to
the patient and lead to dissatisfaction.

Laser Treatment of Arterial and Venous Retinal Vascular Diseases

Litigation for laser treatment for retinal vascular disease is uncommon. This may
be related to the relatively better visual prognosis of this group of diseases.
232 M.F. Kraushar and P.H. Morse

Laser/Cryotherapy Treatment of Retinal Tears

Failure or delay of treatment, negligent treatment, and improper choice between


cryotherapy or laser has been alleged. It is important to discuss the choice of the
therapeutic modality and the reason for not using others in the informed consent
discussion.

Treatment of Central Retinal Artery Occlusion

There have been lawsuits for delay or failure to treat as well as negligent treatment
of central retinal artery occlusion (CRAO) despite the fact that there is significant
controversy regarding the timing of intervention and the efficacy of the therapy.
Accurate assessment of pretreatment visual acuity is not always dependable,
because some patients are so shocked by the sudden, severe loss of vision they may
assume the eye is blind and do not look for residual vision. Some patients with a
patent cilioretinal artery may eventually discover an island of vision and falsely
assume it is the result of treatment. For risk prevention purposes as well as for
optimal patient care, it is advisable to go through the steps of treatment for most
patients who have been symptomatic for less than 24 hours. There have been law-
suits alleging failure to diagnose cranial arteritis in elderly patients with CRAO.
While CRAO has been reported secondary to pressure on the eyeball from
improper facial support for patients undergoing spine surgery in the prone position,
it can also occur in patients during lengthy prone positioning for surgery even with
proper facial support. In these instances, if proptosis of the globe is noted in the
recovery room the ophthalmologist has an opportunity for risk prevention by
decompressing the orbit.10 Hypertensive patients often with diabetes mellitus or
papilledema have developed CRAO and optic atrophy because the blood pressure
was excessively lowered for prolonged periods during general anesthesia.

Treatment of Rhegmatogenous Retinal Detachment

Allegations of delay in treatment of rhegmatogenous retinal detachment (RRD) can


be problematic for the defense. Although there are pilot studies suggesting similar
visual results in detachments repaired after 1 day and after 7–10 days of macular
involvement, there are no data from randomized, controlled studies for compassion-
ate reasons. The evidence-based data for this situation are not extensive. Furthermore,
good fellow eye vision and the element of denial are but some of the confounding
problems in patient awareness of the symptoms of retinal detachment and dating the
actual onset of macular involvement. It appears advisable not to delay treatment any
longer than is necessary not only for humanitarian reasons but also because it can be
Chapter 21. Retina and Vitreous 233

difficult to convince jurors, many of whom believe that most retinal detachments are
emergencies that a longer delay did not affect deleteriously.
Pneumatic retinopexy, scleral buckle, and pars plana vitrectomy are used to
repair rhegmatogenous retinal detachments. Lawsuits have been brought for
improper choice of technique. Patients have also sued for alleged improper choice
of thermal reaction among diathermy, cryotherapy, and indirect laser. It is advisa-
ble to involve the patient in the choice of technique and the reasons for the
surgeon’s choice.
The negligent use of intraocular gas with vitrectomy has resulted in devastating loss
of vision in some patients. This is usually caused by excessive postoperative intraocu-
lar pressure, which may occur if an expansile percentage of gas is prepared by mistake
or if an excessive volume of gas is injected. Failure to evaluate the intraocular pressure
at the conclusion of a fluid–gas exchange or following an intraocular air or gas injec-
tion may also allow dangerous elevation of the intraocular pressure.
It is the surgeon’s responsibility to educate the patient receiving intraocular gas
regarding head positioning, prohibition of air travel, and nitrous oxide use during
anesthesia for emergency surgery. These warnings must be documented, preferably
with a patient signature. Such documentation would have been a strong defense in
a claim initiated by a patient who had a pneumatic retinopexy and lost light percep-
tion from obstruction of the central retinal artery during elective spine surgery with
nitrous oxide anesthesia only 3 days later. The patient never told the vitreoretinal
surgeon about the planned spine surgery. He never told the spine surgeon and the
anesthesiologist about the gas, and they never asked. Contemporaneous documen-
tation is often the difference between winning and losing these lawsuits.
Patients requiring one or more pars plana vitrectomies for proliferative vitre-
oretinopathy can elicit great sympathy from a jury as they recall their multiple pro-
cedures, weeks of face-down positioning, pain, and suffering. These experiences in
combination with a poor visual result and the unfortunate cosmetic appearance of
a hypotonous eye can bring a large monetary award in the event of a plaintiff ver-
dict for a claim of negligent surgery. For these reasons an effective informed con-
sent is a sine qua non. A caring, sympathetic vitreoretinal surgeon can assuage the
anxiety and resentment of most of these patients.

Pars Plana Vitrectomy for Problems Other than Rhegmatogenous


Retinal Detachment

Patients with more serious problems affecting vision, such as diabetic traction retinal
detachment, choroidal neovascular membranes, acute retinal necrosis, and central
retinal vein obstruction, typically have had poor vision for a significant period of time
and thus may be relatively resigned to the state of monocular vision. If these patients
participate in an effective informed consent discussion, litigation should be less likely
in the event of minimal visual improvement or failed surgery. Patients experiencing
poor monocular vision for only a brief period of time, as in endophthalmitis or
234 M.F. Kraushar and P.H. Morse

rhegmatogenous retinal detachment, are understandably concerned and usually less


prepared to cope with the concept of permanent monocular vision loss. These patients
require all the caring the surgeon and staff have to offer. The necessarily abbreviated
preoperative interval for development of the physician–patient relationship further
compounds the problem.
Patients with relatively good preoperative visual acuity, as often seen with
epiretinal membranes, macular holes, retained lens fragments after cataract surgery,
and subluxated intraocular lenses, can be expected to have higher expectations for
good vision and greater disappointment if it is not achieved. Because these proce-
dures are relatively more elective, informed consent is of paramount importance.
Documentation of the significant risk of postoperative cataract formation in phakic
patients is essential.

Treatment of Intraocular Tumors

Treatment of intraocular tumors is discussed in Chapter 17.

Treatment of Retinopathy of Prematurity

Retinopathy of prematurity has perhaps the highest risk of litigation of any vitre-
oretinal disease. A large number of these young patients will have little or no vision
despite optimal treatment, and treatment failures are not uncommon. Furthermore,
in many states the statute of limitations can run for 15 to 20+ years, and thus many
physicians are at risk of litigation in their retirement. Because awards for malprac-
tice claims have escalated dramatically over the years, it can be expected that the
award for a claim closed 15 to 20 years after the treatment will exceed the upper
limit of the physician’s insurance coverage by a significant margin. A classic exam-
ple of this is an ophthalmologist who was the only retina surgeon to practice in his
area in the late 1950s. He volunteered to see the premature infants at no charge, as
at that time health insurance for newborns was uncommon. Three years before he
retired he was sued by a patient who was about to reach the age of 21 at which time
the statute of limitations was to expire. The lawsuit alleged negligence when the
baby was born in 1961 at which time the typical insurance coverage was $10,000.
The claim, 20 years later, was for 2 million dollars. The lawsuit was eventually
dropped but not before the retina surgeon lost 35 pounds and practically all of his
hair. When these considerations are combined with the facts that management of this
disease is time consuming and few if any of these patients have insurance, it seems
unjust that the treating physicians are not accorded some form of immunity from liti-
gation. This is especially true when the alleged complication for which the ophthal-
mologist is being sued occurred some years after he or she last examined the patient.
Litigation in the management of this condition is discussed in Chapter 19.
Chapter 21. Retina and Vitreous 235

Conclusion

The poor visual prognosis for most vitreoretinal diseases carries a significant risk
for reduced vision even with successful management. Vitreoretinal diseases are
thus high risk diagnoses for both the patient and the treating physician. Effective
risk management for the treatment of these patients begins with educating the
patient through the process of informed consent, which should include the possibil-
ity of complications and of visual acuity that may be less than expected by the
patient. A thorough explanation makes it more likely that the patient will be satis-
fied with or accept the final result. Complete contemporaneous documentation of
warnings, prognoses, reciprocal patient responsibilities, and possible complications
is powerful evidence in the event of litigation. If a competent, caring, sympathetic
physician takes these steps, the risk of litigation will be effectively minimized.

References

1. Kraushar MF. Medical malpractice experiences of vitreoretinal specialists. Retina


2003;23:523–529.
2. Sorrel AL. Failure to diagnose is the No.1 allegation in liability lawsuits. AMA News
2006;49:8–9.
3. Kraushar MF, Turner M. Medical malpractice litigation in ophthalmology: the New Jersey
experience. Ophthalmic Surg 1986;17:671–674.
4. Bettman JW. Ophthalmology: The Art, the Law and a Little Bit of Science. New York:
Aesculapius; 1977:75.
5. Kraushar MF, Robb JH. Ophthalmic malpractice lawsuits with large monetary awards. Arch
Ophthalmol 1996;114:333–337.
6. Kraushar MF. Medical malpractice litigation in the management of vitreoretinal diseases.
Arch Ophthalmol 1987;105:187–190.
7. Arsenault v. McConarty, 21 Mass. L. Rptr, 2006;500.
8. Alton WG. Malpractice: A trial lawyer’s advice for physicians. Boston: Little, Brown;
1977:56.
9. Holekamp NM. The ethics of Avastin. Retina Times 2006;16:32.
10. Leibovitch I, Casson R, Laforest C, Dinesh S. Ischemic orbital compartment syndrome as a
complication of spinal surgery in the prone position. Ophthalmology 2006;113:105–108.
Chapter 22
Uveitis

C. Stephen Foster

Introduction

The provision of good health care is the goal and raison d’etre of all physicians.
Meeting the appropriate standard of care goes a long way towards achieving a
good medical outcome. Compliance with the applicable standard of care also goes
far toward building rapport and goodwill with one’s patients. Good care and good-
will are laudatory goals in and of themselves. Additionally, the achievement of
these goals will stand the physician in good stead in those instances in which poor
medical outcomes occur despite appropriate care. Poor medical results can and do
occur because of the inexact nature of medicine. Disability and death cannot be
avoided and occur without negligence despite the best efforts of physicians exer-
cising their best judgment.
The purpose of this chapter is to discuss ways to implement good care for
the management of patients with uveitis and improve and build a meaningful
physician–patient relationship. In so doing, brushes with the legal system (whether
a claim, a lawsuit, or a Board of Registration in Medicine complaint) may inciden-
tally be avoided.

Documentation

The importance of completeness of documentation cannot be overstated. It is of


paramount importance in the management of patients with uveitis. At the same
time, not everything said or done can be documented. For instance, it would be
impossible to document all negatives. It would, however, be judicious to document
negatives that are significant to diagnosis such as a negative finding that causes one
to lean toward a diagnosis that is benign and away from a diagnosis that is life
threatening. As in many aspects of medicine, balancing and exercise of appropriate
judgment are required.
It is sometimes said that if it is not documented, it was not done. Obviously, this
is not always the case. You will always be able to testify to what was done regardless

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 237


doi: 10.1007/978-0-387-73341-8; © Springer 2008
238 C.S. Foster

of whether it was documented. Under the law, oral testimony and documentary
evidence are theoretically entitled to equal weight. As a practical matter, however,
documentation of treatment provided wins out in virtually all instances in which the
plaintiff alleges treatment was not provided. Of all the things that can be a disadvan-
tage to a physician who is accused of negligence, failure to adequately document in
the patient’s medical record is by far the most commonly damning element. In the
face of good documentation in the medical record, the sole argument then left to the
complainant is that the record has been altered. Of course, one of the worst things
that could ever be done from a medicolegal perspective is alteration of the record.
This must never occur. Rather, the record should be well documented contempora-
neously. If additional information is necessary and/or appropriate, the further docu-
mentation should be clearly labeled as an addendum.

Detailed Patient Questionnaire

To properly treat your patient with uveitis, you must take a full and complete his-
tory. A detailed patient questionnaire allows you to learn more about your patient
and permits further insightful questioning of the patient at the initial visit and/or
subsequently. We have used an extensive questionnaire at the Massachusetts Eye
Research and Surgery Institute with special customization for inflammatory
disease that I designed many years ago, the use of which, along with follow-up
questioning, provides by far the greatest source of diagnostic leads of any of our
activities and also demonstrates to the patient our effort in eliciting further signifi-
cant information.
The more you know of the patient’s medical history and family medical history,
the better the position from which you are able to consider various diagnoses and
differential diagnoses and the better documented your records are regarding the
quality of your patient care efforts. For instance, a family history of certain condi-
tions may place the patient at greater risk for such conditions and require the oph-
thalmologist to discuss said greater risk when advising the patient of possible
diagnoses and/or treatment options. For example, it is now clear that the child with
juvenile idiopathic arthritis–associated uveitis has a greater risk of an especially
stubborn course of disease if there is a family history of psoriasis. Knowing
this, both doctor and parents may be motivated to advance such a child to steroid-
sparing immunomodulatory therapy sooner rather than later in an effort to induce a
steroid-free durable remission and avoid development of cataract or glaucoma or
vision loss from retinal damage from recurrent or chronic inflammation.
A detailed questionnaire, history, and initial examination build the foundation
on which future treatment rests. Time and effort spent at this stage are not only
appropriate and indicated but help to establish the requisite rapport with the patient.
While you are evaluating the patient for necessary care, the patient is likewise
evaluating you and your manner of caring, noting, for example, that you have
reviewed the questionnaire that they completed prior to their encounter with you
Chapter 22. Uveitis 239

and noting that the information there is important to you, stimulating you to inquire
further into certain responses on the questionnaire.

Chief Complaint and History of Present Illness

Three things are required at this point in documentation of the chief complaint and
the history of the present illness: detail, detail, detail. The time of onset of presenting
symptoms as well as any change in symptoms prior to the time of the first visit when
the formulation of a diagnosis and treatment plan are developed may all be critical
to diagnosis and treatment as well as defense of the critical diagnosis and treatment
plan. Whether the signs and symptoms are bilateral and the intensity of the signs and
symptoms may also prove determinative in the patient’s care as well as in the court-
room. The presence or lack of nonvisual complaints should also be documented
where important to diagnosis or to exclusion of diagnosis. For instance, documenta-
tion that the physician inquired about the presence or lack of general malaise or the
presence or lack of jaw claudication is important in that these symptoms may be
significant to the diagnosis or exclusion of the diagnosis of giant cell arteritis.

Review of Systems: Use of a Questionnaire

The written questionnaire or template is a wonderful starting point. A start, how-


ever, is all that it actually is. Questionnaires and templates are a beginning of the
thought toward the goals of diagnosis and treatment, which are far down the road
from these limited tools. In certain cases, the review of systems may not require
questions beyond the routine of the questionnaire. By necessity, the questionnaire
and template, however, cannot encompass all aspects of review of systems.
Thought must be given on occasion to items not contained on the questionnaire or
template. This, as well as the patient rapport building aspect of taking the medical
history, is why it is important for the physician to be willing and eager to think
beyond and outside the box of the questionnaire and template.

Medications

All of the patient’s medications need to be documented. The patient’s medications


may lead to questions regarding history that otherwise may never have been asked.
Dosage and frequency must also be recorded. For instance, the adequacy of the
medication to accomplish the desired goal can be properly assessed only if the dos-
age and frequency are known. Interaction of medications must also be considered
before a medication can be appropriately prescribed by an ophthalmologist.
240 C.S. Foster

Examination: Eye and Otherwise

The record should reflect all aspects of the eyes that are examined. All other aspects of
the examination should also be reflected in the records so as to document the findings
considered by the ophthalmologist. For example, for the patient with a history of recur-
rent uveitis with a review of systems questionnaire indicating that the patient has an
episodic itchy, scaly rash on leg or scalp or elbow may prompt the ophthalmologist to
consider psoriasis as a possible entity associated with the patient’s uveitis. An examina-
tion of the patient’s fingernails may disclose tiny punctate pits; these should obviously
be documented in the medical record. Even if nail pitting is not detected, documentation
of that negative extraocular finding is equally worthy of documentation.

Formulation of a Differential Diagnosis

It is important to document not only the leading diagnosis or impression but also
the other diagnoses in the differential. Consideration should always be given to
testing and/or follow up for any potential diagnosis that is life, limb, or vision
threatening. Be prepared to justify why a test or follow up was not done to rule out
these types of potential diagnoses. For instance, it may be that the potential diag-
nosis was so remote that further testing or examination was not indicated. For
example, although the patient with uveitis and associated retinal vasculitis could
have Wegener’s granulomatosis as the underlying cause of these findings (and
antineutrophil cytoplasmic antibody testing is easy and appropriate to request),
chest and sinus computed tomography scanning may represent overreaching defen-
sive medical testing in the absence of any sinus or chest symptoms on review of
medical systems in the mind of even the most prudent physician, and so he may
choose not to do such testing.

Formulation of a Plan: Laboratory Tests, Referral,


and Treatment

The record needs to reflect what the ophthalmologist considered in formulating a


plan. Documentation should reveal the thought process as to laboratory tests,
referral, and treatment. If laboratory tests and/or referral were considered but not
ordered for the time being, in certain cases it may be appropriate to document the
reasons for delay or for not doing such at all. For example, the patient with uveitis
with the greatest concentration of cellular activity in the vitreous might be consid-
ered potentially to have central nervous system–intraocular large cell lymphoma,
with neurology consultation and vitreal biopsy as part of the plan if fluorescein
angiography, electroretinography, and HLA-A29 testing do not disclose that the
Chapter 22. Uveitis 241

patient has all of the features that speak more strongly for the diagnosis of birdshot
retinochoroidopathy. Thus, the risks and the expense to the patient of the more
invasive testing are appropriately deferred until the noninvasive studies have been
completed. However, the documentation has clearly demonstrated the physician’s
thought processes and in particular that he has considered the possibility of lym-
phoma and plans to pursue that possibility in the event that the noninvasive studies
are negative.

Diagnosis

After consideration of the patient’s history, review of systems, examination, tests,


and laboratory results, what is the most likely diagnosis? What are the other possi-
ble diagnoses in order of most likely to least likely? What is the worst case sce-
nario? Are additional tests, follow-up examination, or referral indicated to attempt
to avoid vision loss or worse? Does the record reflect your thought process? Can
you defend your thought process from the record or otherwise? Asking yourself
these questions now may avoid your being asked these questions later by the patient
or a representative of the patient.

Advice to Patient

In treating patients, the prudent and caring ophthalmologist should advise his
patient of the differential diagnoses along with the signs and symptoms of such,
particularly when a differential diagnosis may have devastating consequences. For
instance, a patient may have what appears to be a comparatively benign condition,
such as a retinal tear. The condition, however, may be a precursor to a detached
retina. Accordingly, the patient must be fully advised as to the initial signs and
symptoms of a detached retina in order that the patient may respond in a timely way
to receive the necessary treatment and avoid vision loss.

Discussion of Potential Risks and Complications

Often, the patient is anxious and overwhelmed by the potential diagnoses, treat-
ment options, and possible outcomes. In these circumstances, the patient does not
always hear and retain what is being discussed and/or “filters” the discussion in
a light most positive for the patient’s prognosis. Given that lack of informed con-
sent provides a separate and distinct basis for recovery against a physician, it is
critical to document the treatment options, alternatives, and potential risks and
complications.
242 C.S. Foster

The Risk of Failure to Diagnose

Failure to diagnose is a matter of major importance in medicolegal actions.


Uveitis patients may have an infection that is difficult to diagnose until late in the
course of disease (e.g., herpes simplex recurrent uveitis), or they may have cancer
as the cause of the “uveitis,” with the highly lethal central nervous system–
intraocular large cell lymphoma being the preeminent example of this “masquer-
ade.” Documentation of consideration of such possibilities can go a long way in
making clear that the ophthalmologist has not been negligent in his intellectual
assessment of the patient. Referral of the patient, of course, sooner rather than
later in the case of uveitis that is unusual, stubborn, and particularly chronic, that
is recurrent, or that is producing damage that is a threat to vision is the other pre-
ferred practice pattern that can provide the patient the best standard of care.

Consideration of Referral to a Specialist

If the diagnosis remains unclear or if it is clear but implicates the need for further spe-
cialization, refer the patient sooner rather than later. Seldom is a physician criticized
solely for referral. Instead, the criticism comes if the referral has been delayed. Involving
a specialist early avoids this potential basis of criticism but, more importantly, provides
the patient with more specialized care while you may or may not remain directly
involved in the patient’s care. Even if you may no longer see the patient, your continuing
to seek or receive reports will avoid any basis for any claim for alleged abandonment that
unfortunately can follow an abrupt cessation in care, particularly if the possibility of a
poor outcome has been raised. Finally, be complete in the information provided to the
specialist, including your potential diagnoses even though you believe the specialist has
a greater ability than you to reach the appropriate diagnosis. This will avoid a claim that
not all significant information was conveyed to the specialist.

The Risk of Failure to Timely Refer

The risk of allegations of negligence as a consequence of failure to refer a patient with


uveitis to a subspecialist who has done additional training in the form of ocular immu-
nology or uveitis fellowship training may be underappreciated. Our experience1 and
that of others2–6 indicate a surprising prevalence of referral after irreversible damage
from chronic or recurrent intraocular inflammation has occurred, with a shocking one-
third of patients blind in at least one eye at the time of the initial referral visit. This is
especially disappointing in light of the fact that if the uveitis in these patients is then
typically abolished (generally after steroid-sparing immunomodulatory therapy) it
indicates the irrefutable fact that the uveitis was treatable and raises the argument that
Chapter 22. Uveitis 243

Table 22.1 Types of uveitis requiring early referral to an ocular immunologist


Juvenile idiopathic arthritis–associated uveitis
Steroid-dependent chronic uveitis
Steroid-resistant uveitis
Posterior uveitis
Retinal vasculitis

within all probability vision in the now blind eye would have been salvaged had the
patient been referred to the subspecialist earlier. Therefore, we believe that referral
early in the course of the care of patients with the types of uveitis listed in Table 22.1
to an ocular immunologist/uveitis specialist demonstrates the comprehensive ophthal-
mologist’s high level of knowledge and high level of concern for his patient’s care. It
also demonstrates his understanding of current preferred practice patterns, even if such
referral means that the patient must travel some distance for what may turn out to sim-
ply be a one time consultation visit, following which the primary ophthalmologist can
continue to care for the patient, with long distance collaboration with the consultant
and possibly with comanagement with a local chemotherapist.

Communications with Other Physicians

In communications with a primary care physician, a specialist, or other physician, it


is critical that it is crystal clear what your and the other physician’s responsibilities
are or will be. It should be stated without equivocation who is now responsible for
each aspect of the patient’s care, including who will follow up on each of the various
medical issues of the patient. Such delineation may involve partial responsibility and
follow up by a number of physicians with overall responsibility and coordination
perhaps resting primarily with one physician whether it is a primary care physician
or possibly a specialist, such as an oncologist during a period of cancer treatment.

The Risk of Failing to Treat Properly

Certain disorders have been discovered to have such poor long-term outcomes (eye
or otherwise) with corticosteroid monotherapy that two learned uveitis societies,
following evidence-based medicine and peer-reviewed literature review exercises,
rendered the opinion that those disorders should be treated (or at the very least
should be offered treatment) with immunomodulatory therapy.7 Such diseases
include uveitis secondary to sympathetic ophthalmia, Vogt-Koyanagi-Harada dis-
ease, Adamantiades-Behcet disease with retinal involvement, and uveitis or retinal
vasculitis caused by Wegener’s granulomatosis or by polyarteritis nodosa. We
agree with these opinions. In fact, in some instances, such as with polyarteritis
244 C.S. Foster

nodosa and Wegener’s granulomatosis, failure to offer such therapy is almost guar-
anteed to ensure the patient’s death from these potentially lethal diseases. Clearly,
no doctor wants to be party to such outcomes, nor should he be willing to be party
to blindness as an outcome either, when effective therapy, employed early in the
course of the stubborn uveitis, is available.

The Risk of Treatment-Associated Complications

Treatment-associated complications may also trigger litigation, with allegations


of negligence. The potential side effects of immunomodulatory therapy are well
known, and these risks are typically well managed by the ocular immunologist
or other chemotherapist who monitors the patient on such therapy through fre-
quent face-to-face encounters and hematologic and serologic monitoring. The
ophthalmologist who is not specifically trained in such matters obviously must
engage the services of an appropriate expert to manage this aspect of his
patient’s care. However, the ophthalmologist himself is exposed to the risk of
treatment-associated complications that could result in encounters with the legal
system. Complications of topical corticosteroid therapy (cataract and glaucoma),
of systemic corticosteroid therapy (osteoporosis, diabetes mellitus, hyperten-
sion, psychosis, myopathy, and even morbid obesity include but a few of the
myriad and legendary potential and sometimes inescapable side effects of
chronic systemic corticosteroid therapy), of intraocular injection therapy (endo-
phthalmitis, retinal detachment, glaucoma, cataract), and of surgical therapy (the
legendary complications of surgery on the “complicated” uveitic cataract) are all
risk exposures for the ophthalmologist caring for the patient with uveitis.
Most are avoidable with proper strategic planning and therapy choice, but,
clearly, documentation of discussions with the patient regarding treatment options
and the risk/benefit ratio of each approach is essential in risk management vis-à-vis
malpractice litigation. Consider the following example. A patient with chronic,
indolent posterior uveitis for many months was referred to a vitreoretinal specialist
who found a previously undiagnosed metallic intraocular foreign body. The uveitis
was responsive to only oral steroids. After surgical removal of the intraocular for-
eign body the uveitis persisted and the oral steroids were continued. The patient
developed aseptic necrosis of the hip and sued for improper informed consent,
claiming he was not advised of the risk of hip necrosis and would not have consented
to the oral steroids had he been so advised. At trial the surgeon said that among the
warnings he gave to the patient prior to surgery was the possibility of death from the
anesthetic, the likelihood of which he felt was approximately 1 in 30,000. The plain-
tiff’s attorney then showed the jury the Physician’s Desk Reference, which estimated
the risk of hip necrosis at 1 in 10,000. He admonished the vitreoretinal surgeon for
failing to warn the patient of the risk of hip necrosis, which was three times more
likely than anesthetic death. The jury found for the plaintiff and gave him a large
award. The verdict was reversed on appeal by a second jury who felt that no reason-
Chapter 22. Uveitis 245

able patient would have refused the steroid therapy based on the significant risk of
permanent severe vision loss and the relatively small risk of hip necrosis.

Documentation After a Poor Outcome

As with the informed consent discussion, physician’s statements following a poor


outcome are often misheard and misconstrued. Patients who have had a poor out-
come resulting from a recognized complication of a procedure even with the best of
care are understandably anxious and upset. Expressions of sorrow that a bad result
has occurred can and should be made but with the awareness that this can be misun-
derstood as admissions of fault. Accordingly, it remains important to document
completely what has been said. It is likewise as important to document the response
of the patient, particularly when (after the outcome) the patient expresses prior
understanding of possible risks, particularly the risk that materialized. A patient’s
statement of gratitude for the care given, continued confidence despite the poor out-
come, and/or a wish to continue care should also be documented. Unfortunately,
such statements may later be denied, particularly if not documented.

Conclusion

Medicine always has been and remains an inexact science. Guarantees cannot rea-
sonably be given because poor outcomes occur unavoidably without negligence.
Steps such as those suggested in this chapter can be taken, most importantly to
improve patient care and, incidentally, to avoid involvement with the legal system.

References

1. Dana MR, Merayo-Lloves J, Schaumberg DA, et al. Visual outcomes prognosticators in juve-
nile rheumatoid arthritis associated uveitis. Ophthalmology 1997;104:236–244.
2. Rosenberg KD, Feuer WJ, Davis JL. Ocular complications of pediatric uveitis. Ophthalmology
2004;111:2299–2306.
3. Edelsten C, Reddy MA, Stanford MR, Graham EM. Visual loss associated with pediatric uveitis
in English primary and referral centers. Am J Ophthalmol 2003;135:676–680.
4. Ozdal PC, Vianna RNG, Deschenes J. Visual outcomes of juvenile rheumatoid arthritis associ-
ated uveitis in adults. Ocular Immunol Inflamm 2005;13:133–138.
5. Kump LI, Cervantes RA, Androudi SN, et al. Visual outcomes in children with juvenile idio-
pathic arthritis associated uveitis. Ophthalmology 2006;113:1874–1877.
6. Zak M, Fledelhius H, Pedersen FK. Ocular complications and visual outcome in juvenile
chronic arthritis: a 25 year follow-up study. Acta Ophthalmol Scand 2003;81:211–215.
7. Jabs D, Rosenbaum JT. Guidelines for the use of immunosuppressive drugs in patients’ ocular
inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol 2001;131:679.
Part 3
Personal and Business Considerations
Chapter 23
Physician and Defendant: Living and Coping
with a Double Life

Sara Charles

Introduction

After a bad outcome and, later, as named defendants in civil litigation, physicians,
unbeknownst to others, often begin to feel as though they are living a double life.
They are concerned about their affected patient and continue to devote themselves
to their work with patients as though nothing has happened, but, at another level,
they are preoccupied with their own concerns about survival, protecting themselves
against anxiety and hurt, and devoting their time to defending their good name.
How can they manage their seemingly conflicted, but all too human, concerns,
carry out their work, respond to the demands of the legal process, and emerge from
the experience stronger and more self-assured professionals? To master this serious
life stressor and maintain their integrity and equilibrium, physicians need to explore
what the event means to them personally, recognize the emotions it generates,
understand the reasons for these emotions so that they can distinguish what they
can and cannot control, correct any distortions related to the event, and make
changes that help them emerge as a confident and healthier person.

The Environment Surrounding a Medical Malpractice Charge

Without a national campaign to focus their attention, the public quickly, if under-
standably, loses interest in and consciousness about the litigation crisis. Popular
culture associates bad medical outcomes and malpractice suits with “bad doctors.”
Thirty years into the medical malpractice litigation crisis, the general public has a
subtler view of the crisis, understanding that bad outcomes may not necessarily
result from substandard care. The public possesses greater sophistication about
access to care, especially related to obstetrics1; the economic costs associated with
the current system, including rising insurance premiums and defensive medicine1;
the evidence that the tort system fails to achieve its goals for patients and society
effectively2; and the emotional repercussions of bad outcomes for both patients and
doctors.3–5

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 249


doi: 10.1007/978-0-387-73341-8; © Springer 2008
250 S. Charles

Despite creative and consistent efforts to relieve or change it, however, the tort
system governing medical malpractice remains essentially intact. The result is that
laypersons and professionals continue to blame someone for bad outcomes.
Additionally, questions arise frequently about the behavior of physicians after bad
outcomes and how “truthful” they are in disclosing them to patients. In this little-
changed environment, professionals receive little sympathy and physicians sued
for malpractice continue to feel isolated, misunderstood, and lacking in support.

Assessing the Meaning of the Event

What does it mean to be charged with malpractice in today’s environment? Despite


recent efforts to diminish the “culture of blame” within health care, physicians
remain the principal targets of inquiry whenever a bad outcome occurs. Their
immediate instinct is to question their own role in the outcome. Later, if publicly
charged with malpractice, they examine themselves more deeply about potential
culpability and its meaning within the context of their personal and professional
lives.
Irrational fears lurk in the background; they feel that they will suffer some form of
personal, career-ending, or financial destruction. CBS commentator Andy Rooney gave
voice to these fears after he was publicly accused of making discriminatory remarks: “It
is not clear to me whether I have been destroyed or not but I know that a denial from
anyone does not carry anywhere near the same weight as an accusation.”6
Typically, physicians embark upon concomitant complex psychological proc-
esses, known as appraisal,7 within the context of their own life history and circum-
stances by asking a series of questions: “What is this all about? How does this
lawsuit make me feel about myself? How does this impact my feelings of compe-
tence and professionalism? Do I feel that the charges have some basis or are they
totally fraudulent? How will this affect my work and my professional relation-
ships? Will this lawsuit change my relationship with my family, impact my health,
or alter my long-term ambitions or goals? Do I feel overwhelmed, seething with
anger, or terribly misunderstood? Can I manage my feelings or do I feel they are
out of control? Do I feel powerless or hopeless?” How we answer these questions
gives us clues about the meaning and impact of the event on us. The answers also
reveal how we can begin to cope.

Recognizing the Emotions Associated with the Event

The meaning of the event that characterizes the source of threat or benefit of the expe-
rience has a direct impact on the physician’s subjective feelings. Internist Dr. Richard
Allen, whose patient died suddenly from complications secondary to orthopedic sur-
gery, described his experience both before and after litigation had been filed8:
Chapter 23. Coping with a Double Life 251

It’s like someone who has a malignancy in remission. You know the old term, “whistling
by the graveyard?” You know it’s there and you try to suppress it. You put it in the back of
your mind, in your subconscious but it always creeps back no matter what. . . . You know
that someday it’s going to show up. . . . I was made aware that the family had contacted an
attorney and the chart had been requested so at that point, I reported it to my malpractice
carrier . . . so nothing more was heard, this is about 19 months before the actual suit was
filed. [When it was filed] it was absolutely terrible. It was terrifying. It was depressing. I had
acute anxiety. I actually went into atrial fibrillation.

Seen in the emergency room on the Saturday morning his fibrillation began,
Dr. Allen was treated and back at work on Monday. Unbeknownst to his colleagues,
Dr. Allen, swept up in a whirlpool of feelings, lived a double life as physician and
defendant for the next 3 years.
Dr. Allen possessed a capacity for self-observation and was able to identify “a
conflict of emotions” that captured the meaning of this experience for him: a strong
drive for self-preservation; a fear of being psychologically damaged by the event;
fears about the limits of his liability and the amount of monetary damages that might
eventually be assessed; guilt and anger for being involved in a case that was literally
“out of his control,” especially because he was away on vacation when the surgery
and its aftermath occurred; shame that his sense of honor was being impugned; anger
that the orthopedic surgeon, who was also a friend of the patient, was not named in
the suit; and feelings of anger and betrayal based on the belief that his associate was
trying to incriminate him rather than accept any blame for his management of the
case. The most distressing emotion was anger: “I was very angry. I’m sure the anger
contributed to the surge of adrenaline that put me into atrial fibrillation.”
This well-functioning physician, marginally involved in the sudden death of a
patient and in subsequent litigation, reacted as any person does when he or she experi-
ences a significant life event with all its attendant losses. A widower or recent divorcee,
for example, not only loses a spouse but usually suffers a change in social and economic
status. A physician involved in a serious adverse event, especially one that precipitates
subsequent litigation, is no different. It takes time to adapt and respond to these real and
potential losses. Dr. Allen, for example, later decided to settle mainly because he feared
that his health would be comprised by the stress associated with a trial.

Understanding Emotional Reactions to Serious Life Events

Understanding ourselves and our experiences equips us well to anticipate and mas-
ter our reactions. Horowitz9 describes the normal phases by which individuals
experience any major life event. For physicians involved in a bad outcome, espe-
cially a catastrophic event that later leads to a lawsuit, both the event and its conse-
quences may be experienced as “major.”
Initially there is an outcry—an overwhelming sense that, “no, this can’t happen, this
can’t be true.” The magnitude of the event is literally too much to absorb so that we feel
stunned or shocked and sometimes temporarily out of touch with our surroundings. We
252 S. Charles

experience “distress” with feelings of confusion, anger, anxiety, or a range of other


unpleasant and threatening emotions and symptoms. Distress is a normal, usually self-
limited response of short duration, but in some persons the symptoms may persist.
Gradually, we realize that what we feared has actually happened and changed our life.
We are next aware of alternating periods of denial, during which we consciously
or unconsciously put the event out of our minds, and intrusion, during which we
experience unsolicited thoughts, feelings, and preoccupations associated with the
event. We may feel calm and in good emotional balance when some seemingly
innocuous stimulus generates a rush of memories and disruptive feelings. We then
consciously push the unwanted thoughts and feelings to the background in order to
resume our normal life. The closer in time that we are to the trauma, the more fre-
quently we are bothered by these preoccupations and the more psychological energy
we expend to control our thoughts and feelings. When we pass the emergency depart-
ment that was the scene of the event, for example, we may feel overwhelmed with
memories and negative feelings. As time passes these intrusions generally diminish
as does our vulnerability to disruption. Because there is no “time” in the unconscious,
whenever we are reminded of the event, it feels as though it is happening freshly.
Dr. Laura West’s obstetric patient sustained a complicating adult respiratory
distress syndrome and, after 85 days in the intensive care unit, suffered a cardiac
arrest after being fed a fatty emulsion intravenously rather than through her port.
Efforts to revive the young patient failed.
It was devastating. It changed everything in my life. . . . I was a young doctor. I had this
catastrophic event . . . everyday I questioned myself. I had graduated first in my med school
class. . . . I had been the chief resident. . . . I was as well prepared and well trained as I could
be but I doubted myself every day. . . . It was just agony. I had trouble closing abdomens.
I thought the patient would bleed to death. I eventually got over that over time. . . . I was
sued for, basically, wrongful death. . . . After four years of hell, the case was ultimately dis-
missed with prejudice. In other words, we had won. The case was going to go no further
because I really hadn’t done anything wrong.10

Dr. West was clearly traumatized and plagued for years with periods of denial and
intrusive thoughts about her role in the event and her feelings of competence. She would
do her best to attend to all patients and their concerns and, in some sense, deny the real-
ity of this catastrophic event. Every surgery, however, reminded her of her patient. Her
sleep was interrupted constantly with concerns about her patients and how the lawsuit
would play out. Her effort to keep her “double life” in balance was an “agony.”
During these long years she was psychologically engaged in working through
the experience, which uses psychological energy to put the event into some per-
spective and deal with its emotional repercussions. This hard work begins the proc-
ess of healing. It takes time to absorb the facts associated with the event, especially
if a bad outcome is due to a mistake. The physician needs to put the facts into per-
spective, make the necessary adaptations, and regain psychological equilibrium.
It was during this time, for example, that Dr. Allen recognized the complexities
of his relationship with his associate that led eventually to the dissolution of their
partnership. He also accepted that, despite feeling it was unfair, he, not the ortho-
pedic surgeon, had been sued. Although both Dr. Allen and Dr. West emerged
Chapter 23. Coping with a Double Life 253

from the experience as far more confident, competent, and mature clinicians, the
psychological toll on them and their families was significant, and they experienced
major changes in their personal and professional lives.

The Charge of Negligence and Physicians’ Reactions

When an adverse event involves the threat of litigation or when litigation occurs,
two major factors contribute to physicians’ emotional reactions: their own person-
ality traits and the nature of tort law.

The Personality Traits of Physicians

Ordinary people defend themselves against perceived threats by using obsessive-


compulsive defense mechanisms that help them feel in better control. This is
marked by a preoccupation with orderliness, perfectionism, and an excessive
devotion to work and productivity. Gabbard11 identified a “triad” of associated
obsessive-compulsive traits that physicians typically share: a vulnerability to doubt,
a propensity to guilt feelings, and an exaggerated sense of responsibility.
Physicians express their vulnerability to doubt by questioning whether they
considered all the options in their diagnosis or treatment of their patient; they tend
to feel guilty if they fail to meet their sometimes onerous perception of the profes-
sional standard of care; and they worry about whether they have done everything
possible to help their patient even when the situation was entirely out of their
control. Physicians do not readily balance these reactions, and this may lead to
overwork, neglect of family obligations, and a drive for perfectionism that is incom-
patible with a healthy life. If used wisely, these personality characteristics contribute
to the care of their patients. When physicians are sued, however, these same traits
become the source of considerable distress. Feeling “out of control,” physicians
may begin to doubt themselves, feel guilty, and think that they failed to “do
enough.” All of these feed into the playbook of the plaintiff’s attorney.

Tort Law

Medical malpractice claims are torts, in contrast to crimes, that seek a civil sanction,
usually compensation. They require that a person or entity be accused of failing to
meet the standard of care and, by so doing, cause the patient to sustain an injury that
deserves compensation. This public allegation of failing to meet the standard of care
against a person whose identity relies on meeting that standard sets off deeply felt
psychological repercussions. The central psychological event of litigation is the
254 S. Charles

Outcome of 217,682 Medical Malpractice Claims


PIAA National Data (1985-2006)

2,531 565
11,631 (1.2%) (.3%)
(5.3%) 1,501
(.7%) No Payment

Settled-Plaintiff
60,705
(27.9%) Verdict-Defendant

Verdict Plaintiff

Mediation-
140,744 Defendant
(64.7%) Mediation-Plaintiff

Figure 23.1 Outcome of closed medical malpractice claims (1985–2006). (Physician Insurers
Association of America (PIAA), Rockville, MD, with permission.)

public accusation of failure against a person who is already uniquely sensitive to the
slightest suggestion of failure. Such persons experience legal action as a direct
assault on their sense of integrity.
It is helpful for physicians to recognize that in the tort system negligence must be
charged if the patient is to achieve compensation: the accusation is merely the means to
an end. Recent evidence suggests that neither goal of the tort system—the efficient and
fair recompense for injured patients and the rooting out of incompetent doctors—is
currently achieved.2 It is also helpful to know that almost 70% of the cases filed result in
no payment to the plaintiff; that is, they are found to be groundless, dropped, dismissed,
or result in a trial verdict in favor of the physician (Figure 23.1) Most physicians believe
that the system is unfair and that there should be other means for patients to achieve
justice for injury in the health care system. Nonetheless, until significant change in the
system occurs, physicians will continue to be principle targets of such accusations.
Impelled to restore their good name and demonstrate that these accusations are
not only false but unwarranted, physicians feel estranged from the inherently adver-
sarial legal world. They feel tethered to an unfamiliar but well-established legal
process that in stark contrast to the fast-paced, decision-making cadence of medical
practice seems frustrating, slow moving, and time consuming.

Identifying Areas of Control

Physicians react in their own distinctive ways to a malpractice suit, and, in fact, to each
suit filed against them. Their primary challenge is to understand what they can and can-
not control so that they can transform what feels like a “double life” into one integrated
whole in which they can function as responsible clinicians and successful defendants.
Chapter 23. Coping with a Double Life 255

Physicians have a great advantage in knowing their own strengths and weak-
nesses. If they can observe changes in their characteristic ways of thinking and
behaving under stress, they can identify the sources of their distress and make nec-
essary changes. Physicians overwhelmed with financial concerns, for example, find
it is useful to review their current financial status, review or initiate long-term
financial plans, and reassess their malpractice coverage and their potential for loss,
along with other relevant issues. Well-versed in and comfortable with that knowl-
edge, physicians are far better qualified to contribute to decisions about whether to
settle or pursue the case. Although his health was his primary motivation in settling,
the suit distressed Dr. Allen because of its impact on his relationship with his part-
ner. He gained control by reviewing his financial status, confronting his partner
about his role in the case, settling the case for a minimal amount, dissolving his
partnership, and selling his practice to a local hospital.
Depending on their own particular circumstances, physicians may allow them-
selves more leisure time, redistribute their time commitments to work and family,
improve their office procedures, enhance their risk management strategies, and
schedule the time necessary for preparation for depositions. They may implement
other changes that help them feel in better control of their own lives and to profit
from the support of others during this difficult period in their lives.

Correcting Distortions Relevant to the Experience

One of the most difficult challenges for physicians after a bad outcome, especially after
making a clear medical error or being sued for malpractice, is to face and accept their
own humanity and its attendant vulnerabilities. To do this they need the help of family,
friends, and colleagues who provide understanding, support, and a sense of safety.
Physicians are thwarted in sharing their experiences by their own lawyers who
warn them not to talk to anybody about their situation for fear that they might say
something that suggests culpability and therefore jeopardizes the legal defense of the
case. This is classic good legal advice, but it is not good psychological advice. It is
true that doctors can talk with their lawyers, claims professionals, and others directly
protected by the law, but often these resources are insufficient to provide that emo-
tionally “safe” and comfortable place that they need. Many physicians can talk with
their spouses, who are often knowledgeable and supportive, especially if they are
physicians themselves. Others find that a trusted colleague or friend is the best
resource.12 In conversations with these persons, physicians can discuss their personal
feelings about the incident and the lawsuit but not the technical details of the case,
thereby safeguarding the concerns of legal counsel. By talking about our experience
with others and listening to their feedback, we can begin to gain some distance and
perspective that gradually allows us to see a “true” picture of what really happened.
After negative events in the medical setting, physicians almost always become
central players in sentinel event reviews, mortality and morbidity conferences, and
other forms of debriefing and investigation that review the technical details of the
256 S. Charles

situation. Physicians do not always perceive these venues as “safe,” because they
seek to find the responsible culprit so that sanctions can be initiated. The most suc-
cessful investigations are conducted within an environment of understanding and
support so that the participants can learn from the incident rather than feel intimated
and therefore defensive and withholding about their behavior. Some observers sug-
gest that delaying these sessions for a reasonable length of time so that those
involved can achieve some perspective on the event is more useful than reviews
scheduled when the participants are still suffering the emotional aftershocks of the
incident.13
Physicians are also in need of support as they prepare to interact with
aggrieved patients. Often the adverse event is totally unanticipated, and its details
and causation may be cloudy or, in some circumstances, strikingly clear. In any
case, physicians must put their emotional response “on hold” until they inform
and respond to the patient’s and family’s totality of concerns. In preparation for
this discussion, the primary physician may find it useful to consult with a risk
manager or involved associate to achieve a proper perspective on the event.
Generally speaking, the best approach to disclosure is to reveal as “much as the
doctor knows” at the time. Risk managers, of course, will generally caution phy-
sicians about how they disclose what they know relative to culpability for the
event. Patients and their families as well as physicians themselves can have
deeply rewarding and healing experiences when disclosure after a bad outcome
is sensitive, informative, and timely.

Emerging as a Stronger and Healthier Person

Achieving a sense of perspective about and accepting the event and their role in it
can strengthen physicians personally and make them better defendants. This can
only be accomplished by hard work and with the help of other sensitive, trustwor-
thy, and reliable persons. As one physician remarked, “I am acting in the best physi-
cal, mental, professional and spiritual shape possible in anticipation of this case
moving forward.”14 Physicians following this approach improve their chances of
integrating this experience into both their personal and professional lives.

References

1. American Medical Association. Medical Liability Reform—Now! July 19, 2006. Available at:
http://www.ama-assn.org/go/mlrnow. Accessed September 26, 2007.
2. Miller D. Liability for Medical Malpractice: Issues and Evidence. A Joint Economic Committee
Study. Jim Saxton, Vice Chairman. United States Congress, May 2004.
3. Gilbert SM. Wrongful death: a memoir. New York. W.W. Norton, 1997.
Chapter 23. Coping with a Double Life 257

4. Hilfiker D. Healing the Wounds: A Physician Looks at his Work. New York: Pantheon Books;
1985.
5. Charles SC, Kennedy EC. Defendant: A Psychiatrist on Trial for Medical Malpractice. New
York: Vintage Books; 1986.
6. Gerard J. Callers besiege CBS over Andy Rooney. New York Times, February 10, 1990.
7. Lazarus RS, Folkman S. Stress, Appraisal and Coping. New York: Springer; 1984:22–25.
8. Charles SC, Frisch PF. Adverse Events, Stress and Litigation. New York: Oxford University
Press; 2005:58, 94.
9. Horowitz MJ. Treatment of Stress Response Syndromes. Washington, DC: American
Psychiatric Press; 2003.
10. Charles SC, Frisch PF. Adverse Events, Stress and Litigation. New York: Oxford University
Press; 2005:20, 216.
11. Gabbard GO. The role of compulsiveness in the normal physician. JAMA 1985;254:2926–2929.
12. Berlinger N. After Harm: Medical Error and the Ethics of Forgiveness. Baltimore: The Johns
Hopkins University Press; 2005:89.
13. Kenardy JA, Carr VJ. Debriefing post disaster: Follow-up after a major earthquake. In:
Raphael B, Wilson JP, eds. Psychological Debriefing: Theory, Practice and Evidence.
Cambridge, England: Cambridge University Press; 2000:174–181.
14. Anonymous surgeon. Physicians and Medical Malpractice Litigation. Report to the Council of
Medical Specialty Societies. Chicago: Survey Research Laboratory, University of Illinois;
2003.
Chapter 24
Medical Malpractice Insurance: Selection
of Companies and Policies

Eric S. Poe

Introduction

One of the most important decisions a physician needs to make each year is which
medical malpractice insurance policy to buy. The three fundamental areas that
should influence the physician’s decision are: (1) the cost of the insurance, (2) the
policy form, and (3) the financial condition of the insurance carrier. Generally, most
physicians focus on only the cost of a policy, when all three topics should be given
equal weight. Not being fully cognizant of the other two components would be simi-
lar to negotiating and purchasing a car without asking or determining whether the
car even runs. How would you feel after negotiating a very low price for a car but
later found out that it did not start? When considering that medical malpractice
insurance protects a doctor’s personal assets, one would assume that physicians
would pay attention to the other factors, but sadly it is often not until the insurance
carrier either goes out of business or the physicians face additional unexpected bur-
dening costs that they realize their mistakes.

The Cost of the Policy

Traditionally, the cost of a medical malpractice policy can be evaluated by simply


reading the invoice each year. The reality is, however, that the ultimate cost to a
physician may actually depend on the policy form that the physician purchases as
well.

The Policy Form

Generally, there are only two types of professional liability insurance policies that
are offered to physicians throughout the United States: (1) the occurrence-type
policy and (2) the claims-made policy.

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. 259


doi: 10.1007/978-0-387-73341-8; © Springer 2008
260 E.S. Poe

In an occurrence-type policy, you are covered against any patient who sues you for
medical malpractice as long as the incident occurred when you were insured with the
carrier. This is similar to a typical auto insurance policy in which if you rear-end
another car in December 2005 and you sell your car in January 2006, you are still
covered against the claim even if the person does not file a lawsuit against you until
June 2006, because the negligent act occurred when you had a policy in effect.
In contrast, in a claims-made policy, you are covered against a person who sues
you for medical malpractice if two conditions are met: if the incident occurred
when you were insured with the carrier and if, at the time the lawsuit is filed, you
are still insured with the carrier. In the example using auto insurance, if you were
to be involved in the same accident described previously, you would not be cov-
ered, because at the time the lawsuit was filed against you, you were no longer
insured with the insurance carrier. However, in a claims-made policy you can pro-
tect yourself against such a lawsuit, even if it was filed after you left the insurer, if
you purchase a supplemental “endorsement,” often referred to as a tail. This
optional tail endorsement typically costs two to three times the physicians’ prior
year’s premium at the time they leave the insurance carrier. Often physicians can
avoid this very costly tail if they meet one of three conditions: (1) if the physician
dies during the policy (his estate does not need to purchase the tail endorsement);
(2) if the physician becomes permanently disabled; or (3) if the physician is with
the insurance carrier for at least the 5 previous years, is over 60 years old, and
decides to permanently retire. If one of these conditions is met, often the insurer
will provide the tail free of charge.
Although the “free” tail endorsement is often considered a major benefit to the
physician in a claims-made policy, it is also the most often misunderstood portion
of the policy. First, a physician should realize that a claims-made policy was intro-
duced by the medical malpractice industry to meet their needs, not to address the
needs of the physician. Claims-made policies enable the insurer the ability to adjust
their rates and premiums more quickly than an occurrence type policy.
The primary benefit to physicians of the claims-made policy is the cost savings.
In fact, the cost savings is typically what allures them to purchase the claims-made
policy, as generally a claims-made policy will cost 35% of the cost of an occurrence-
type policy in the initial year. However, the savings automatically diminish for the
physician each year until the fifth year of the claims-made policy, when the cost
becomes the same as the occurrence-type policy. In fact, the typical escalating costs
in the claims-made policy provide that the claims-made policy will be 35% of the
cost of the occurrence-type policy in the first year, 65% in the second year, to 80%
in the third year, and will generally be 90% in the fourth year from the occurrence-
type policy. Generally, physicians are unaware of the fact that the savings of the
claims-made policy is predetermined by the insurance companies as the company
has already filed for these escalating factors with their state’s department of insur-
ance prior to issuing the policy.
As stated earlier, the advantages of a claims-made policy to the insurance
companies far outweigh those cost advantages to the physicians. One of the
most important advantages to the insurance company is that it can raise rates to
Chapter 24. Medical Malpractice Insurance 261

its policyholders at a more rapid pace, while ensuring that most physicians will
be forced to pay those rate increases. For example, when any insurance company
chooses to raise its rates, it typically has the fear that such a rate increase can
cause its current policyholders to shop around and consequently leave their insur-
ance company, which would hinder their projections to collect more total premi-
ums. However, physicians faced with a rate increase in a claims-made policy are
forced to purchase a very costly tail if they desire to leave the insurer. Historically,
the most common problem with a claims-made policy is that most physicians
anticipate receiving the “free” tail endorsement and therefore never set aside
capital to purchase a tail; then, when faced with a rate increase, they have no
choice but to absorb it. Renewing under such a circumstance also increases the
physicians’ tail endorsement cost by that rate increase percentage as well.
In fact, in 1982, the “claims-made” form of coverage for physicians was intro-
duced in New York and several insurers began solely offering these policies to their
physicians. As a result, a number of physicians were forced to close their busi-
nesses because they were faced with unaffordable and unpredictable rising tail
costs by insurance companies. In 1991, as an “emergency measure,” the New York
Insurance Department stated, “It has become apparent that there are medical mal-
practice situations where claims-made coverage has proven impractical or unwork-
able,” promulgating a regulation requiring that every insurer offer to physicians
“occurrence-type” policies. The implementation of this regulation ended the
“claims-made crisis” in New York.
The main advantage of the traditional occurrence-type policy is rather simple: it
provides physicians the freedom to choose different insurance coverage each year,
without incurring any additional and unpredictable costs. The largest complaint by
most physicians is the unpredictable nature of the costs associated with medical
malpractice insurance, and, by purchasing an occurrence-type policy, physicians
are capable of ensuring that they can afford to shop for other insurance if their rates
increase substantially.

Common Misconceptions About the Free Tail

Without question, the largest misconception for physicians is related to the condi-
tions that provide for the “free” tail endorsement. Most physicians believe that with
a claims-made policy the insured is entitled to free tail endorsement coverage after
5 years with the carrier. Typically, they believe they can simply remain with the
carrier for 5 years, and, because they are over 60 years of age, a free tail endorse-
ment will be provided. Unfortunately, they do not foresee the scenarios in which
they will not qualify because of intervening factors.
First, the physician fails to realize that remaining with the insurance carrier for
5 years is not their unilateral decision. In other words, the insured does not
always have the option to remain with the carrier for 5 years. Physicians are often
nonrenewed by their insurance company before reaching that 5-year mark. The
262 E.S. Poe

nonrenewal rights by an insurance company are generally very broad, and physicians
can often be nonrenewed simply because they were named in a lawsuit during the
year. Also, it is a realistic possibility that a physician’s insurance company will
cease issuing policies in the state a physician practices. If this occurs, a physician
will have no option in many cases but to purchase a tail.
Furthermore, physicians must realize that the 5-year requirements along with
being 60 years old are not the only scenarios beyond their control, because the free
tail endorsement also requires that the physician retire as well. The retirement
requirement means never seeing a patient again. Unless physicians have saved up
two to three times their prior year’s insurance premium to purchase a tail when they
are cancelled or not renewed, they can be in a very precarious position. Remember,
each malpractice policy is governed by contract law and is simply a one-year con-
tract with no guarantee of future coverage beyond that policy term.
Agents and brokers, who are paid a considerable commission, typically 10% of a
physicians’ policy cost each year, attempt to persuade physicians to purchase a claims-
made policy despite its inherent pitfalls by telling a physician that he or she can always
buy “nose” or “prior acts” coverage with a new insurance company instead of paying
an exiting tail endorsement. Unfortunately, the truth is that some insurance companies
do not offer “nose” coverage or typically termed “prior acts” coverage for incidents that
occurred prior to the purchase of their policy. Furthermore, even if such coverage is
available through the new insurer, it must be paid up front—as in occurrence-type poli-
cies—and the costly tail endorsement must still be paid upon leaving the new insurance
company. More frightening is the fact that the definition of the “rates in effect at the
time” when a physician wishes to endorse the policy has been a topic of debate that has
put many physician groups into a dangerous situation.
Therefore, if a physician chooses to purchase a claims-made policy, or has no
choice but to purchase such a policy because of the availability in his or her state, he
or she should understand the inherent pitfalls associated with such a policy.
Physicians, at the very least, should evaluate each insurance company through its
track record of rate increases over time in order to assess the likelihood of another rate
increase. This information can be obtained rather easily by calling the respective state
department of insurance. Physicians should also make sure they understand the con-
ditions of the claims-made policy provisions and not rely solely on verbal explana-
tions. When the time arrives and a physician is faced with costs and invoices that were
not adequately explained to them, only their policy language will protect them. Also,
as a precaution, a physician should always set aside the appropriate amount of capital
equal to their tail cost to avoid having to face closing their practice to an unexpected
retirement or financing a loan to pay for an unanticipated costly tail endorsement.

Consent to Settle Clause

In addition to the need for physicians to analyze what type of policy they choose to
purchase, they also must identify the meaningful clauses contained in the policy
Chapter 24. Medical Malpractice Insurance 263

language. One of the most common clauses found in medical malpractice policies
is the “consent to settle” clause. The purpose of introducing the consent to settle
clause in the 1990s was to attract physicians by providing them the illusion that
they will possess the peace of mind to know that the insurance company will not
be capable of settling a lawsuit without their consent. Although the clause seems
simple enough in description, its practical application is far more complex.
First, a physician must dispel the notion that an insurance company’s claims
manager or executive officer will settle frivolous claims simply because the
defense attorney costs are higher than the settlement offer. The reasons are simple.
Generally, most medical malpractice lawsuits are generated and taken by a few
large plaintiff attorney law firms within that state, and, if an insurance company or
claims manager gains the reputation of settling claims without merit, they will most
certainly increase the number of claims filed against them in the future. Second,
unless odd circumstances exist, such as an insurance company placed under reha-
bilitation, an insurance company has the same interest in not paying out for lawsuits
that have no merit.
Although there may be physicians who may insist that they have been involved
in a past scenario whereby their insurance company settled a lawsuit without merit,
one must realize that the viewpoint of a highly trained physician and that of an
experienced trial attorney can be vastly different. First, physicians accused of medi-
cal malpractice feel their management of the patient was not a deviation from the
standard of care, and, although this may be clear in their minds, an experienced
defense attorney realizes it is not whether this is a fact but whether he or she can
prove this to a sympathetic jury. Many times the only evidence to protect a physi-
cian are illegible notes in medical records and disputed testimony. Physicians may
believe their defense against the claim is strong, but an experienced defense attor-
ney, and an even more experienced claims manager who has seen the disposition of
hundreds of medical malpractice claims, may be of the opinion that indicates the
true risk of taking the case to trial.
The primary reason why a consent to settle clause is rendered meaningless to a
physician is because it may expose physicians to their greatest risk, as one of the greatest
protections for physicians when they go to trial is their ability to sue their insurance carrier
for acting in “bad faith” by not settling the claim prior to a jury verdict.
Physicians must understand that insurance companies have a fiduciary duty to
their policyholders to prevent their policyholders from exposure of their own per-
sonal assets. This responsibility means that if an insurance company has the ability
to settle a case below the policy limit of the physician prior to a jury verdict and
fails to do so, when it “should have reasonably known” that a jury verdict could
expose a physician to its own personal assets, it can be held liable for “bad faith”
against its policyholder. Although the standard of what constitutes a “bad faith”
claim against an insurance company may vary from state to state due to the state’s
case law, this is generally the standard adopted by many courts.
For example, let us say a physician who buys a $1 million liability limit is being
sued by a patient plaintiff for medical malpractice. After discovery, the plaintiff’s
attorney offers to settle the claim for the policy limits of $1 million. In response,
264 E.S. Poe

despite reasonable evidence to support that the physician could be liable for negli-
gence, the insurance company refuses to settle the claim and proceeds to trial. At
trial, the jury finds in favor of the plaintiff for a judgment of $3 million. Because
plaintiff attorneys would much rather seek the insurance company’s “deep pockets”
of capital than the limited personal assets of the physician in order to recover the
excess of $2 million not covered by the insurance policy – they will approach the
physician and offer to settle the excess $2 million claim in exchange for the “bad
faith” rights of the physician against the medical malpractice insurance company.
In summary, when or if a physician refuses to settle a claim that the medical
malpractice insurance company wishes to settle, they will tear down their final wall
of protection against a plaintiff’s attack on their personal assets.

What Policy Limits to Choose

One of the most common questions asked by physicians is, “How much insurance is
enough?” If you take the necessary steps to protect yours assets, the minimum permit-
ted by your licensing board or the state regulation is likely sufficient. In fact, there is
more evidence to suggest that when physicians purchase high policy limits, they may
be causing more medical malpractice lawsuits against themselves. The reason this
occurs is because, during discovery, it is within the plaintiff’s rights to find out what
each physician being sued has for medical malpractice insurance and the policy limits
of that policy. The plaintiff’s attorneys ask this primarily to determine which insur-
ance company faces the largest exposure associated with the malpractice claim.
An example commonly found is when a “failure to diagnose” claim is made
against an obstetrician as well as the radiologist. Typically, obstetricians carry the
minimum limits required by most states, which is a $1 million per occurrence pol-
icy, while radiologists typically carry the higher limits of at least $3 million per
occurrence. If a plaintiff’s attorney can make any allegation of malpractice that
would associate the injury to the radiologist, he or she would be exposing the medi-
cal malpractice insurer for the radiologist to a possible $3 million loss. The tremen-
dous trial experience of insurance claims managers who see the high policy limits
at stake will be more likely to settle the claim at a higher value than if the policy
limit were lower. In essence, higher policy limits can actually create a larger “tar-
get” for the plaintiff’s attorney to seek.
Those physicians who believe they should purchase higher policy limits because
of jury verdicts or settlements discussed in the newspapers should understand that
settlements are typically always below the policy limit. When one reads of a settle-
ment in the newspaper of $2 million for a medical malpractice case, it is most likely
because the limits of the policies associated with that medical malpractice case
were either $2 million or below. More importantly, plaintiff’s attorneys also have
their interests to protect. When one considers that 80% of all medical malpractice
cases that go to trial are won by the defense, it should not be a surprise that a plain-
tiff’s attorney would also have an apprehension of going to trial.
Chapter 24. Medical Malpractice Insurance 265

The Financial Condition of the Insurance Company


Issuing the Policy

Too often in recent history, insolvent medical malpractice insurers have placed
physicians’ personal assets at risk. Physicians commonly are misled to believe an
insurance carrier is more stable simply because of its size. However, the reality is
that most medical malpractice insurers that have gone insolvent (similar to declar-
ing a bankruptcy) or that have discontinued writing policies have been the nation’s
largest carriers. One could argue that there is more data to support the theory that
in the field of medical malpractice insurance, larger could actually mean riskier.
The following medical malpractice insurance carriers were recently deemed insol-
vent or ceased operations:
PHICO Insurance Company: The nation’s eighth largest malpractice insur-
ance company was declared insolvent and placed in liquidation in 2001 by the
Commonwealth of Pennsylvania.
St. Paul: The nation’s largest malpractice insurance company in 2001 exited the
insurance market in 2002.
MIIX Group, Inc.: The nation’s seventh largest malpractice insurance com-
pany in 2002 discontinued issuing policies in 2002. At the time, MIIX execu-
tives stated publicly it had sufficient assets to pay losses. In 2004, it was placed
into rehabilitation by the state of New Jersey and found to be deficient to pay
losses by over $300 million surplus.
Medical Liability Mutual Insurance Company: The current largest medical
malpractice insurance company was downgraded to a B– rating by A.M. Best in
2004, and is now currently requesting to be not rated and not to participate in the
rating process.
Reliance Insurance: This company was deemed insolvent in 2001.
The biggest misconception about larger insurance carriers is that, because they
have large stated assets, they are financially secure. However, assets alone should
not be used as a strong indication of financial strength in the insurance industry.
Unlike typical unregulated businesses, insurance carriers collect premiums well in
advance, assuming liabilities into the future. For example, in the medical malpractice
insurance field, insurance companies do not pay the majority of the claims until
years after the policy is written. Therefore, insurance carriers will accumulate capital
at the start of each policy, which is stated as assets. Consequently, insurance carriers
reserve a portion of this capital to pay for claims that will be paid in the future, and
these potential claims are considered possible liabilities, or “loss reserves.” In sum-
mary, if one were to determine financial strength based on assets of an insurance
carrier, it would be similar to determining a person’s wealth without looking at the
person’s liabilities. How financially secure is an insurance company with $100 mil-
lion of assets if it has over $110 million in possible liabilities to pay?
Therefore, assets alone should not be relied on as an accurate barometer when
trying to assess financial stability because they do not illustrate how much capital
266 E.S. Poe

the insurance carrier has available for a possible “cushion” if losses are worse than
anticipated. In fact, financial strength ratings by rating bureaus such as A.M. Best
and Weiss are chiefly based on the level of “cushion,” termed surplus, each insur-
ance carrier maintains in relation to the amount of premiums it collects. The larger
the surplus an insurance carrier maintains in ratio to how much it collects every
year is more accurate at measuring an insurance carrier’s financial strength. This
“premium to surplus ratio” is the most significant measure of financial strength, as
it measures an insurance carrier’s ability to pay for claims, even if its predictions
for losses are inaccurate.
In addition, rating bureaus further determine their ratings of financial stability
and strength by analyzing an insurer’s historical track record of predicting its
losses. Obviously, if an insurer has a track record of setting insufficient capital
aside for its claims, the accuracy of how much surplus it truly maintains can be
considered questionable. For example, an insurer can systematically and purpose-
fully under-reserve for its existing claims in order to increase its publicly reported
surplus in the short term. Therefore, the historical track record of an insurer’s
ability to set accurate reserves is typically what determines the credibility of the
insurer’s stated surplus.
Regardless of the type of company, prospective policyholders should evaluate
the financial and operating strength of the company. One way to do this is to
review the company’s A.M. Best rating. A.M. Best is an independent rating
agency that evaluates the adequacy of reserves, soundness of investments, control
of expenses, and capital and surplus sufficiency of companies. If a medical mal-
practice insurance carrier has completed 5 years of operation, it is eligible for rat-
ing by A.M. Best. A.M. Best has been publishing its opinion on the financial
strengths of insurance companies since 1899. You can find the rating of your
insurance carrier on their website at www.ambest.com. Another way to evaluate a
company is to look at its annual report. The report will give some important finan-
cial data that should be considered by a physician before selecting an insurance
carrier. First, however, you need to understand the basic terms related to analyzing
an insurance company:
Surplus: It is important that an insurance company have sufficient financial
resources to meet all current as well as expected future claims. Surplus is the
sum of items shown on a company’s balance sheet under the heading “policy-
holder surplus.” Surplus represents the amount by which assets exceed liabilities
and is the net worth of the company.
Loss reserves: Establishing loss reserves is complex. There are two classes of
claim reserves: indemnity reserves and expense reserves. Expense reserves are
further classified as allocated loss adjustment expense (ALAE) reserves and unal-
located loss adjustment expense (ULAE) reserves. The incurred losses is the
money set aside to pay present and future claims as well as defense attorney fees
or expert witness fees (ALAE) and in-house claims operations (ULAE). You
should examine how accurately your insurer has been setting its loss reserves in
the past by looking at its “reserve development” in A.M. Best’s full rating report.
Chapter 24. Medical Malpractice Insurance 267

Loss reserves to surplus ratio: The ratio of loss reserves (including reserves for
loss adjustment expenses) to surplus (R/S) indicates the company’s ability to
cover unanticipated reserve deficiencies. Industry regulators recommend that
this ratio not exceed 4:1.
Although these terms may seem intimidating, your understanding of them can
make the difference between choosing a financially reputable and strong insurer or
putting your personal assets at risk.

Conclusion

Physicians have much more to worry about now than in the past regarding medical
malpractice insurance. They no longer can afford to rely on their agent or broker,
who may have a strong financial interest in their choice of medical malpractice
insurer. Physicians spend countless hours keeping abreast of developing medical
techniques, drugs, and treatments each year; unfortunately, keeping abreast of their
medical malpractice insurance company also needs to be added to this list. Not
spending at least a few hours a year analyzing your medical malpractice insurance
can cost you your personal assets in the future.
Index

A Allergies, drugs for, 133


AAO (American Academy of Ophthalmology), Amaurosis, 95
103, 132, 209, 213 American Academy of Ophthalmology.
Abandonment, pediatric ophthalmology See AAO
relating to, 203 American Board of Ophthalmology, 55
Acanthamoeba, 126, 129 American Glaucoma Society, 144
Accidental injection Ancillary tests, emergencies relating to, 152
intra-arterial, 97 Anesthesia, 91–101
intravenous, 97 accidental intra-arterial injection, 97
Acetazolamide, 133, 176 accidental intravenous injection, 97
Acquired immunodeficiency syndrome. amaurosis, 95
See AIDS brainstem, 96–97
Administration complications of, 91
of anesthesia, for ophthalmic plastic general
surgery, 198–199 complications of, 98
of medication, update of, 133 IOP, 93, 94, 99
Adverse events, revelation of, conundrum MH, 99
of apology and for globe penetration or perforation,
apology 93–95, 159
inadequate, 88 issues of, in cataract surgery, 115–116
structure and effect of, 87 local, general considerations of
behavior, modification of, 85 complications of, 92–93
conclusion to, 88 risk factors, 92
introduction to, 85 systemic toxicity, 93
offense, gravity of, 86 myotoxicity, 97–98
ordinary courtesies relating to, 86 oculocardiac reflex, 97
risk, prevention of, 86–87 for ophthalmic plastic surgery, 198–199
Advice optic nerve, atrophy of, 95–96
for medical expert, 45–46 optic nerve sheath, penetration of, 96
to patient, regarding uveitis, 241 retrobulbar hemorrhage, 93, 94, 95, 96
Agency for Healthcare Research and Quality. summary about, 99–100
See AHRQ topical, 92
Age-related macular degeneration, laser and Anesthesiologists, 91
medical treatment for, 231 Angle closure and other glaucomas, 159
AHRQ (Agency for Healthcare Research and Anterior vitrectomy, 119, 123
Quality), 143 Antibiotics, 132
AIDS (acquired immunodeficiency intracameral steroids and antibiotics, 112
syndrome), 181 topical, 141
Allegations, 5 Anticholinergic drugs, 141

269
270 Index

Anticoagulation, cataract surgery Cataract surgery


and, 112 anesthetic issues in, 115–116
Aphakic bullous keratopathy, 119 anticoagulation and, 112
Apology complications of, 103–104
conundrum of, 85–88 conclusions about, 116–117
inadequate, 88 considerations specific to, 107–109
structure and effect of, 87 elective refractive surgical procedures,
Appeal, trial relating to, 62 involving lens extraction, 110–111
Areas of control, identified by physician/ endophthalmitis, 107–109
defendant, 254–255 general risk management issues about,
Arterial and venous retinal vascular diseases, 105–107
laser treatment of, 231 high expectations relating to, 103
Arteritis, giant cell, 154–155 infection relating to, 108
Assumption, of risk, 167 informed consent for, 106
Atrophy introduction to, 103–104
optic, 172–174 new technology for, general considerations
of optic nerve, 95–96 for adoption of, 114–115
Attendance, at trial, 57–58 OMIC relating to, 105, 111, 116
Attorney. See also Defense attorney; pharmacologic agents, off-label use of,
Plaintiff’s attorney relating to, 111
selection of, 50 postoperative treatment of, 108
Attorney-physician-insurance company in presence, of ocular and systemic
relationship, 50 diseases, 113–114
Avastin, 138 refractive surgery claims v., 210
risk prevention relating to, 104–105
second eye, monocular patient,
B and same-day bilateral, 113
Battery, 66 specific drugs used off-label during, 112
Behavior, modification of, 85 volume of, 103
Benefits, alternatives and, of informed Cefazolin, 120
consent, 70–71 Cellulitis, orbital, 157–158
Bilateral cataract surgery, 113 Central or branch retinal artery occlusions,
Bilateral optic disc edema, 174–176 154. See also CRAO
Billing records, 33 Central retinal artery compression or
Bioequivalent drug products, 136 occlusion. See CRAO
Biopsy, 181 Certified Registered Nurse Anesthetist. See
Bleeding CRNA
corneal transplant relating to, 123 Charge
ophthalmic plastic surgery associated to jury, 62
with, 199 of negligence, reactions to, 253
Blephamide drops, 128 Charts, 35
Blepharitis, 181 medical records and, drugs relating to, 134
Blepharoplasty, 189, 197 Chemical burns, 153
Brainstem anesthesia, 96–97 Childbearing potential, women with, drugs for,
Bupivacaine, 92 139–140
Burns, chemical, 153 Choroidal hemorrhage, after surgery, 122–124
Choroidal melanoma, 229–230
Chronic uveitis, 114
C Ciprofloxacine eye drops, 136
Cancer, 193 Claims-made policy, 259–261
Carcinoma, squamous cell, 181 Client intake
Cardozo, Benjamin, 65 by paralegal, 29
Case analysis, plaintiff’s attorney relating to, by plaintiff’s attorney, 29–30
29–32 Cocaine, 92
Index 271

Cochrane Collaboration, 132 CRAO (central retinal artery compression or


Cochrane Database of Systemic occlusion), 93, 94, 99, 232
Reviews, 132 Criteria, for medical expert, 42
Codefendants, 8 CRNA (Certified Registered Nurse
Comanaging patients, 137, 222 Anesthetist), 91, 96, 97, 100, 116
Company issuing policy, financial condition Cross-examination
of, 265–267 of defendant physician, 17
Comparative v. contributory negligence, 25 defense attorney’s styles of
Compensatory damages, 24 dramatic questioner, 17–18
Complaints, 51, 239 ingratiating questioner, 18
Conjunctival melanomas, 181 prepared questioner, 18
Conjunctivitis, 181 Cryotherapy treatment, for retinal tears, 232
Consent form, 72–73 Curriculum vitae, 33
Consent, informed. See Informed consent Cyclomydril, 142
Consent material, presentation of, 69–70
Consent to settle clause, 262–264
Consultant D
jury, hiring of, 36 Damages, 24, 29–30
for pediatric ophthalmology, 204 Daubert v. Merrill Dow Pharmaceuticals, 509
vitreoretinal specialist, 225–226 U.S. 579 (1993), 37
Contact lenses. See Cornea: external disease Decision to proceed, by plaintiff’s attorney,
and contact lenses 31–32
Contributory negligence, 25 Defendant
Conundrum of apology, 85–88 case of, 14–15
Cornea: external disease and contact lenses settlements and, 56
choroidal hemorrhage, after surgery, Defendant physician
122–124 cross-examination of, 17
introduction to, 119 expertise of, 16
litigation jury’s reaction to, 15–17
emergency room and, 124–129 testimony of, 15–17
eye banks and, 124 Defense attorney
postoperative endophthalmitis, 119–121 codefendants working with, 8
suture removal, 121–122 comparative v. contributory negligence
Corneal laceration, 189 relating to, 25
Corneal surgery claims. See Refractive corneal cross-examination styles of, 17–18
surgery claims damages relating to, 24
Corneal transplant, 119–121 defendant physician’s testimony relating
bleeding relating to, 123 to, 15–17
Coumadin relating to, 123 defendant’s case relating to, 14–15
emergent situations after, 121 defense expert’s testimony relating to,
postoperative instructions regarding, 121 18–19
Corneal ulcer, descemetocele, defense helped by, 7
or perforation, 159 deposition preparation by, 7–8
Corneoscleral lacerations, 156 deposition testimony and trial testimony,
Corticosteroids, 132, 141 differences between, 9–10
Cosmetic disfigurement, 189 Good Samaritan Laws relating to, 23–24
Cosmetic facial surgery, 196–198 hiring own attorney v., 21–22
Cost, of medical malpractice insurance, 259 joint and several liability relating to,
Coumadin, 112, 123 24–25
Countersuits, 63 jury relating to
Courtesies, adverse events relating to, 86 judge and, roles of, 11
Courthouse conduct, 58 judge v., 10
Covering physician, 6 selection of, 11–12
Cranial nerve palsies, 158 opening statements of, 12
272 Index

Defense attorney (cont.) of informed consent, 73


physician-patient relationship relating medical records and, 79–82
to, 22–23 after poor outcome regarding uveitis, 215,
physician’s testifying questions relating 237–238
to, 9 Documents, 35
plaintiff’s case relating to, 13–14 Double life, of physician/defendant, 249, 251,
settlement negotiations relating to, 19 252, 254
statute of limitations relating to, 19–21 Doubt, as emotional reaction, 253
summations relating to, 19 Dramatic questioner, 17–18
Defense expert, testimony of, 18–19 Drug interaction, awareness of, 133
Denial, as emotional reaction, 252 Drug Price Competition and Patent Term
Deponent, 53–54 Restoration Act of 1984, 136
Deposition Drugs. See also FDA; INDs; Medication;
examination before trial as, 53–56 Off-label drugs
preparation for, 7–8, 34 anticholinergic, 141
transcript of, 55 avoiding medication errors or claims in
videotape of, 34 prescribing of, 131–132
Deposition testimony and trial testimony, for allergies, 133
differences between, 9–10 charts and medical records relating to, 134
Descemetocele, 159 drug interaction, awareness of, 133
Diabetic retinopathy, laser treatment in handling drug samples, 135–136
for, 231 medication administration, update
Diagnosis, uveitis relating to, 240, 241, 242 of, 133
Diagnostic problems, with retina and vitreous, in medication refills, 135
227–230 necessary documentation relating to,
Diclofenac, 136 133–134
Differential diagnosis, uveitis relating to, 240 for needle to eye, 142–143
Dilantin, 29 for pupil dilation, 145
Discovery rule, 20–21 in written prescriptions, 134–135
Discovery, the process of conclusions about, 145–146
examination before trial (depositions), 53–56 generic eye medication, use of, 136–137
expert’s report, 53 in lawsuits against ophthalmologists, 132
interrogatories, 53 off-label use, during cataract surgery, 111, 112
records, review of, 52–53 OMIC relating to, 138, 145
Discussant and discussion, informed consent patient counseling regarding, 144–145
regarding, 70 patient’s compliance with, improvement
Discussion of, 144
discussant and, informed consent relating in PDR, 132
to, 70 prescribed by ophthalmologists
of potential risks and complications of investigational, 138
uveitis, 241 marijuana, 139
of risks, 79 for nursing women, 140–141
Diseases off-label, 137–138
arterial and venous retinal vascular, 231 for pediatric populations, 141–142
external and contact lenses, cornea relating when comanaging patients with other
to. See Cornea: external disease and specialists, 137
contact lenses for women with childbearing potential
Graves’, 193–194 and pregnant women, 139–140
orbital, 157 prescriptions for, documentation
prostate, 114 relating to, 133–134
systemic and ocular, cataract surgery in problem, magnitude of, 131
presence of, 113–114 samples of, errors in handling of, 135–136
Documentation use of, legal affect’s on one’s practice,
drug prescriptions relating to, 133–134 143–144
of emergencies, 152 Dysmorphia, 196
Index 273

E Endophthalmitis, 107–109, 229


Ectasia. See Refractive corneal surgery as emergency, 157
claims postoperative, 119–121
Edema Epithelial tumors, 181
bilateral optic disc, 174–176 Errors
of optic nerve heads, 155 common, in evaluation of
Effect, of apology, 87 giant cell arteritis, 178
Elective refractive surgical procedures, optic atrophy, 174
involving lens extraction, papilledema, 176
110–111 toxic optic neuropathy, 179
Emergencies in handling, of drug samples, 135–136
ancillary tests relating to, 152 Evidence-based practice, 132
angle closure and other glaucomas, 159 Examination. See also Cross-examination
central or branch retinal artery before trial (depositions), 53–56
occlusions, 154 for uveitis, 240
chemical burns, 153 Expert. See also Defense expert, testimony of;
communication relating to, 151 Medical expert
conclusions about, 160 medical opinion of, basis of, 42
corneal ulcer, descemetocele, report of, discovery relating to, 53
or perforation, 159 Expertise, of defendant physician, 16
cranial nerve palsies, 158 Expert witness
documentation regarding, 152 credentials of, 35
emotional issues relating to, 150–151 selection of, 52
endophthalmitis, 157 trial judge and, 37–39
examination, 151 of unethical plaintiff, retribution
giant cell arteritis, 154–155 for, 63–64
globe, rupture of, 156 External disease and contact lenses, cornea
history relating to, 151 relating to. See Cornea: external
immunocompromised patients, problems disease and contact lenses
with, 160 Eye
intraocular foreign bodies, 156–157, 195 generic medication for, 136–137
introduction to, 149 needle to, drug errors in, 142–143
iridocyclitis, 159–160 right v. left, in pediatric ophthalmology,
lacerations 204–205
corneoscleral, 156 second, monocular patient, same-day
lid, 155 bilateral cataract surgery and, 113
light and floaters, flashes of, 159 Eye banks, litigation and, 124
optic nerve heads, edema of, 155 Eye drops, ciprofloxacine, 136
orbital cellulitis, 157–158 Eyelid surgery, functional, 192–193
orbital disease, 157
orbital fractures, 158
orbital hemorrhage, 158 F
physician-patient relationship, 149–150 Facial fracture repair, 195
responsibility relating to, 150 Facial surgery, cosmetic, 196–198
RRD, 159 Facial trauma, 195–196
special case situations, 152 Failure
Emergency room, litigation and, 124–129 risk of, to diagnose uveitis, 242
Emergent situations, after corneal serious life events relating to feelings of,
transplant, 121 253–254
Emotional issues, emergencies relating to, FDA (Food and Drug Administration), 111,
150–151 212, 215
Emotional reactions, to serious life events, drugs and, 135, 137, 138, 139, 142
250–254 glaucoma and, 168, 169
Emotions, medical malpractice charge pediatric ophthalmology and, 205, 206
relating to, 250–251 Fee-for-service arrangement, 191
274 Index

Financial condition, of company issuing policy H


loss reserves relating to, 266 Health Insurance Portability and
loss reserves to surplus ratio Accountability Act. See HIPAA
relating to, 267 Hemorrhage
misconceptions about, 265 choroidal, 122–124
rating bureaus relating to, 266 orbital, 158
surplus relating to, 266 retrobulbar, 93, 94, 95, 96
Floaters, flashes of, 159 Herpes simplex virus infection, 121, 128
5-fluorouracil, 138 HIPAA (Health Insurance Portability and
Food and Drug Administration. See FDA Accountability Act), 48
Fracture repair, facial, 195 Hippocrates, 65
Fractures, orbital, 158 Hiring
Free tail endorsement, common misconcep- of attorney, 21–22
tions about, 260, 261–262 of jury consultant, 36
Frye v. United States, 293 F. 1013 (D.C. Cir. HIV (human immunodeficiency virus),
1923), 37–40 181, 182
Fuchs’ dystrophy, 122 Human immunodeficiency virus. See HIV
Functional eyelid surgery, 192–193 Hyaluronidase, 93

G I
Gatekeeper role, of trial judge, 37, 42 Immature retina, 207
General anesthesia Immunocompromised patients,
complications of, 98 problems with, 160
IOP, 93, 94, 99 Inadequate apology, 88
MH, 99 INDs (investigational new drugs), 138
Generic eye medication, use of, 136–137 Infections
Gentamycin, 94, 120 cataract surgery relating to, 108
Giant cell arteritis, 154–155, 177 herpes simplex virus, 121, 128
common errors in evaluation of, 178 mycobacterium avium intracellulare, 178
Glaucoma, 114, 159 pseudomonas, 125, 126
FDA and, 168, 169 Informed consent, 227
introduction to, 163 for cataract surgery, 106
management of, 163–164 conclusion about, 74–75
noncompliant patient with, 168 definition of, 66–67
options in, 166 exceptions to, 68–69
as neuropathy, of optic nerve, 163 history of, 65–66
pediatric, 165–166 indications for, 68
primary congenital, 166 informed refusal, 74
research for, physician’s professional lawsuit standard for lack of, 69
interests and, 168 for ophthalmic plastic surgery, 188–190
risk factors for, 164–165 process of
treatment of consent form, 72–73
nontraditional, 167 consent material, presentation of,
technology in, 168–170 69–70
Globe discussant and discussion, 70
penetration or perforation of, 93–95, 159 documentation, 73
rupture of, 156 patient, questions for and by, 71–72
Goldmann perimetry, 172, 178 risks, benefits, alternatives, 70–71
Good Samaritan Laws, 23–24 setting during, 70
Good Samaritans, 28 purposes of, 67–68
Graves’ disease, 193–194 for refractive corneal surgery, 221–222
Gravity, of offense, 86 as risk prevention strategies, 79
Guilt, as emotional reaction, 253 Informed refusal, 74
Index 275

Ingratiating questioner, 18 L
Injection, accidental Laboratory tests, referral, and treatment plan,
intra-arterial, 97 for uveitis, 240–241
intravenous, 97 Lacerations, 155, 156
Injury, nature and extent of, 29 Lacrimal surgery, 187, 193–194
INR (international normalized ratio), 112 Laser. See LASIK; Retina and vitreous,
Insurance. See Medical malpractice; OMIC medical treatment for
Insurance company-attorney-physician Laser-assisted in situ keratomileusis. See
relationship, 50 LASIK
International normalized ratio. See INR Laser skin resurfacing techniques,
International Society of Refractive Surgeons 197–198
of the AAO. See ISRS/AAO Laser trabeculoplasty, 164, 166, 168
Interrogatories, 32–34 LASIK (laser-assisted in situ
Intra-arterial injection, accidental, 97 keratomileusis), 209, 210,
Intracameral lidocaine, 112 211, 214, 215–219
Intracameral steroids and antibiotics, 112 Lawsuits. See also Countersuits; Medical
Intraocular foreign bodies, 156–157, 195 malpractice; Prelawsuit activities
Intraocular lens exchange, 122 informed consent relating to, 69
Intraocular lymphoma, 183, 184 against ophthalmologists, drugs relating to,
Intraocular medications, 230–231 132
Intraocular pressure. See IOP Legal effect’s, on practice, drug use relating
Intraocular tumors and lesions, 182 to, 143–144
Intravenous injection, accidental, 97 Legible medical record, importance of,
Intravitreal triamcinolone acetonide, 137 105–106
Investigational new drugs. See INDs Lens, contact. See Cornea: external disease
IOP (intraocular pressure), 93, 94, 99 and contact lenses
Iridocyclitis, 159–160 Lens exchange, intraocular, 122
ISRS/AAO (International Society of Lens extraction, elective refractive surgical
Refractive Surgeons of the procedures involving, 110–111
AAO), 214 Lens implantation, 110
Lesions and tumors, intraocular tumors, 182
Liability, 29
J joint and several, 24–25
Joint and several liability, 24–25 vicarious, 5–6
Judge Lid lacerations, 155
jury and, roles of, 11 Lidocaine, 92
jury v., 10 Light and floaters, flashes of, 159
trial, 37–39, 42 Literature review, of refractive corneal surgery
Jury malpractice claims, 219–220
to defendant physician, reaction of, Litigation
15–17 emergency room and, 124–129
deliberations of, verdict and, 62 eye banks and, 124
judge and, roles of, 11 Litigious patient, identifying and managing of,
judge v., 10 82–83
selection of, 11–12, 58 Local anesthesia, 92–93
Jury consultant, hiring of, 36 Loss reserves, 266
Justice Department, U.S., 139 to surplus ratio, 267

K M
Keratectomy. See PRK Macular degeneration, age-related, laser and
Keratitis, 128 medical treatment for, 231
Keratotomy. See Refractive corneal surgery Malignant hyperthermia. See MH
claims Maloccurrence, 5
276 Index

Malpractice. See Medical malpractice narrative summary, 51–52


Malpractice claims, of refractive corneal patients’ suits relating to, 47
surgery, literature of, 219–220 physician-attorney-insurance company
Management, of glaucoma, 163–164 relationship, 50
noncompliant patient with, 168 prelawsuit activities, 47–49
options in, 166 settlement, 56–57
Manage patient expectations, for refractive summons, 49
corneal surgery, 220 trial, 57–62
Marijuana, 139 unethical plaintiff’s expert witness,
Medical expert retribution for, 63–64
advice for, 45–46 Medical misadventure, 5
basis for expert opinion of, 42 Medical records, 33
criteria for, 42 charts and, drugs relating to, 134
introduction to, 41 collection and review of, 30–31
minefields for, 44–45 documentation and, 79–82
needed for, 41 legible, importance of, 105–106
process of, 42–43 request for, 48
testimony of, 43–44 Medication. See also Drugs; Retina and
Medical malpractice vitreous, medical treatment for
basic terminology for administration of, update of, 133
allegations, 5 errors in, avoidance of, 131–132
introduction to, 3 for ophthalmic plastic surgery, 198–199
maloccurrence, 5 refills of, avoiding errors in, 135
medical misadventure, 5 tests and, for retina and vitreous, 227
negligence, 4 for uveitis, 239
proximate cause, 4–5 Melanomas
respected minority, 5 choroidal, 229–230
standard of care, 3–4 conjunctival, 181
tort, 4 uveal, 183
vicarious liability, 5–6 MH (malignant hyperthermia), 99
charges of Minefields, for medical expert, 44–45
assessing meaning of, 250 Misconceptions, about free tail endorsement,
correcting distortions relevant to, 260, 261–262
255–256 Mitomycin-C, 138
emotions associated with, 250–251 Models, 35
environment surrounding, 249–250 Modification, of behavior, 85
claims, outcomes of, 254 Monocular patient, second eye, same-day
insurance for bilateral cataract surgery and, 113
company issuing policy, financial Mortality and Morbidity Rounds on Web.
condition of, 265–267 See Web M&M
conclusion to, 267 Mycobacterium avium intracellulare
consent to settle clause, 262–264 infection, 178
cost of, 259 Mydriacyl, 142
free tail, common misconceptions Myotoxicity, 97–98
about, 260, 261–262
introduction to, 259
policy form, 259–261 N
policy limits, choosing of, 264 Nadbath block, 92
suit, sequence of events in NAION (nonarteritic anterior ischemic optic
attorney, selection of, 50 neuropathy), 173
complaint, 51 Narrative summary, 51–52
countersuits, 63 Nasolacrimal duct obstruction, 194
discovery, the process of, 52–56 National Board of Medical Examiners, 33
expert witness, selection of, 52 National Practitioner Data Bank, 33
Index 277

National Registry of Drug-Induced Ocular Ophthalmic Mutual Insurance Company.


Side Effects, 140 See OMIC
Needle to eye, drug errors in, 142–143 Ophthalmic plastic surgery
Negligence, 4 anesthesia administration and medication
charge of, reactions to, 253 for, 198–199
comparative, 25 bleeding associated with, 199
contributory, 25 conclusions about, 199–200
Negotiations, settlement, 19 cosmetic facial surgery, 196–198
Neuroophthalmology functional eyelid surgery, 192–193
claim types from cases of, 171–179 handling disappointment with, 190–191
introduction to, 171 informed consent for, 188–190
Neuropathy, of optic nerve, 163 ocular and facial trauma, 195–196
Nonarteritic anterior ischemic optic orbit and lacrimal surgery, 193–194
neuropathy. See NAION paralytic agents used for, 197
Noncompliant patient, with glaucoma, 168 risks of, 187
Nonophthalmic laser in situ special considerations for, 187–188
keratomileusis, 218–219 Ophthalmic subspecialty
Nontraditional glaucoma, treatment of, 167 claims by, 210
Novel treatment, for pediatric ophthalmology, risk management on, 89
205 settlement by
Nursing women, drugs prescribed for, average, 211
140–141 total, 212
Ophthalmologists. See also Drugs
risk prevention strategies of, 83–84
O vitreoretinal risk factors for, 225
Occlusions. See Central or branch retinal Optic atrophy, 172–174
artery occlusions common errors in evaluation of, 174
Occurrence-type policy, 259–261 Optic nerve
Ocular atrophy of, 95–96
and facial trauma, 195–196 dysfunction of, 182
and systemic diseases, cataract surgery in neuropathy of, 163
presence of, 113–114 Optic nerve heads, edema of, 155
Oculocardiac reflex, 97 Optic nerve sheath, penetration of, 96
Offense, gravity of, 86 Orbital cellulitis, 157–158
Off-label drugs Orbital disease, 157
prescribed by ophthalmologists, Orbital fractures, 158
137–138 Orbital hemorrhage, 158
prescribed for pediatric ophthalmology, Orbital tumefactions, 182
205–206 Orbit and lacrimal surgery, 193–194
Off-label pharmacologic agents, used during
cataract surgery, 111, 112
OMIC (Ophthalmic Mutual Insurance P
Company), 119 Papilledema, 175, 176
cataract surgery relating to, 105, common errors in evaluation of, 176
111, 116 Paralegal, client intake by, 29
drugs relating to, 138, 145 Paralytic agents, 197
neuroophthalmology relating to, 171 Pars plana vitrectomy, for problems other than
refractive corneal surgery claims statistics RRD, 233–234
of, 209–212 Patients
statistics of, for refractive corneal surgery comanaging of, drugs relating to,
claims, 209–212 137, 222
Oncology, 181–185 counseling of, regarding drugs, 144–145
Opening statements, 12, 59 drug compliance of, improvement of, 144
Operative report, 106–107 immunocompromised, problems with, 160
278 Index

Patients (cont.) Phenylephrine, 141, 142


informed consent questions for and by, Photorefractive keratectomy. See PRK
71–72 Physician
litigious, identifying and managing of, covering, 6
82–83 defendant, testimony of, 15–17
manage expectations of, for refractive opinions of, 8
corneal surgery, 220 and patient relationship, 22–23, 27, 48
monocular, second eye, same-day bilateral during emergencies, 149–150
cataract surgery and, 113 during pediatric ophthalmology, 203
noncompliant, with glaucoma, 168 during plastic surgery, 190–191
and physician relationship, 22–23, 27, 48, risk prevention strategies relating to,
78–79, 149–150, 190–191, 203 78–79
postoperative instructions to, 107 research for glaucoma and, 168
prudent, 71 testifying questions of, 9
suits of, 47 uveitis communications with other, 243
trauma, 195 Physician and defendant. See also Defendant
uveitis relating to, 238–239, 241 physician
PDR (Physicians’ Desk Reference), areas of control identified by, 254–255
132, 244 charge of negligence, reactions to, 253
Pediatric glaucoma, 165–166 double life of, 249, 251, 252, 254
Pediatric ophthalmology emerging as stronger and healthier person,
abandonment relating to, 203 256
consultant relating to, 204 introduction to, 249
FDA and, 205, 206 medical malpractice charge
final thoughts about, 207–208 assessing meaning of, 250
introduction to, 201 correcting distortions relevant to,
novel treatment for, 205 255–256
off-label prescribing for, 205–206 emotions associated with, 250–251
physician and patient relationship during, environment surrounding, 249–250
203 personality traits of, 253
promises about, 203 serious life events, understanding
right eye v. left eye, 204–205 emotional reactions to, 250–254
ROP, 206–207 support needed by, 256
third parties relating to, 202 tort law relating to, 253–254
unaccompanied minor relating to, trial testimony of, 60–61
201–202 Physician-attorney-insurance company
Pediatric populations, drugs prescribed for, relationship, 50
141–142 Physician Insurers Association of America.
Penetration See PIAA
of globe, 93–95 Physicians’ Desk Reference. See PDR
of optic nerve sheath, 96 PIAA (Physician Insurers Association of
Perforation, of globe, 93–95, 159 America), 131, 135, 144
Periocular/retrobulbar medications, 230 Plaintiff
PERLA (pupils equal in size, react to light and case of, 13–14
accommodation), 152 settlements and, 56
PERRLA (pupils equal, round, and reactive to unethical, expert witness of, retribution for,
light and accommodation), 172, 63–64
173, 177 Plaintiff’s attorney
Personal counsel, 22 case analysis relating to
Personal feelings, about serious life events, client intake-history and damages,
255 29–30
Personality traits, of physician/defendant, 253 decision to proceed, 31–32
Pharmacologic agents, off-label use of, for external, 31
cataract surgery, 111, 112 injury, nature and extent of, 29
Index 279

liability, 29 Pupils equal, round, and reactive to light and


medical records-collection and review, accommodation. See PERRLA
30–31 Pupil size
conclusion of, 36 LASIK relating to, 218
depositions relating to, 34 refractive corneal surgery relating
interrogatories relating to, 32–34 to, 220
introduction to, 27–29
trial preparation by, 34–36, 49
Plaquenil, 137 Q
Policy form, for medical malpractice Questionnaire, patient, regarding uveitis,
insurance 238–239
claims-made, 259–261
free tail endorsement as part of, 260,
261–262 R
occurrence-type, 259–261 Radial keratotomy. See RK
Policy limits, choosing of, 264 RAPD (relative afferent papillary defect), 173
Post-laser in situ keratomileusis Rating bureaus, 266
ectasia, 219 Records
Postoperative endophthalmitis, 119–121 billing, 33
Postoperative instructions medical. See Medical records
corneal transplant regarding, 121 review of, 52–53
to patients, 107 Referral, to specialist, regarding uveitis, 242
Postoperative treatment, of cataract Refills, in medication, avoiding errors
surgery, 108 in, 135
Potential risks and complications, of uveitis, Refractive corneal surgery claims
discussion of, 241 conclusion to, 222
Practice of Medical Exemption, 206 introduction to, 209
Predeposition conference, 54 LASIK, 215–218
Prednisolone acetate 1%, 136 nonophthalmic, 218–219
Pregnant women, drugs prescribed for, post-laser in situ keratomileusis ectasia,
139–140 219
Prelawsuit activities, 47–49 pupil size relating to, 218
Prepared questioner, 18 literature review of malpractice issues in,
Prescriptions. See Drugs 219–220
Pretrial mock trial, 36 minimize likelihood of
Prevention, of risks. See also Risk prevention ectasia relating to, 221
adverse events relating to, 86–87 informed consent relating to, 221–222
Primary congenital glaucoma, 166 manage patient expectations, 220
Private detectives, 13–14 proactively comanage patient care, 222
PRK (photorefractive keratectomy), 209, pupil size relating to, 220
214–215 OMIC statistics relating to, 209–212
Proactively comanage patient care, for PRK, 209, 214–215
refractive corneal surgery, 222 RK, 209, 212–213
Problem, of drugs, magnitude of, 131 Refractive surgery
Proparacaine, 92 1989-2002, 213
Prostate disease, 114 1995-2006, 214
Proximate cause, 4–5 cataract surgery claims v., 210
Prudent patient, 71 elective, 110–111
Pseudomonas infection, 125, 126 LASIK, 209
Ptosis surgery, 190, 191, 192 PRK, 209, 214–215
Pulsed neodymium-YAG laser, RK, 209
168–169 Relative afferent papillary defect. See RAPD
Punitive damages, 24 Research for glaucoma, physician’s
Pupil dilation, drugs for, 145 professional interests and, 168
280 Index

Respected minority, 5 Risk


Responsibility assumption of, 167
emergencies relating to, 150 benefits, alternatives, of informed consent,
serious life events relating to sense of, 70–71
253 complications and, about uveitis, 241
Retina and vitreous discussion of, 79
allegations relating to, 226 of failure, uveitis relating to,
appointments relating to, 226–227 241–245
conclusions about, 235 of ophthalmic plastic
diagnostic problems surgery, 187
choroidal melanoma, 229–230 prevention of, adverse events relating
endophthalmitis, 229 to, 86–87
medications and tests, 227 Risk factors
retinal tear/detachment, 228–229 for glaucoma, 164–165
vitreoretinal risk factors, of local anesthesia, 92
for ophthalmologists, 225 vitreoretinal, 225
vitreoretinal specialist consultations, Risk management issues, about cataract
225–226 surgery, 105–107
Retina and vitreous, medical treatment for Risk management, on ophthalmic
age-related macular degeneration, laser and subspecialties and related
medical treatment for, 231 fields, 89
arterial and venous retinal vascular Risk management support, 212
diseases, laser treatment of, 231 Risk prevention, 47
CRAO, 232 cataract surgery relating to,
diabetic retinopathy, laser treatment for, 104–105
231 effective strategies of
intraocular medications, 230–231 discussion of risks, 79
periocular/retrobulbar medications, 230 documentation and medical records,
retinal tears, laser/cryotherapy treatment 79–82
of, 232 good results of, 77–78
retinopathy of prematurity, 234 informed consent relating to, 79
RRD, 232–233 introduction to, 77
pars plana vitrectomy for problems litigious patient, identifying and
other than, 233–234 managing of, 82–83
topical medications, 230 opportunities for perceptive
Retina, immature, 207 ophthalmologists, 83–84
Retinal artery occlusions, central or branch, physician-patient relationship relating
154. See also CRAO to, 78–79
Retinal tear RK (radial keratotomy), 209,
and detachment, 228–229 212–213, 214
laser/cryotherapy treatment of, 232 ROP (retinopathy of prematurity), 206–207,
Retinal vascular diseases, arterial and venous, 234
laser treatment of, 231 RRD (rhegmatogenous retinal detachment),
Retinopathy 159, 232–234
diabetic, laser treatment for, 231 Rush, Benjamin, 65
of prematurity. See ROP
Retribution, for unethical plaintiff’s expert
witness, 63–64 S
Retrobulbar block, 93 Same-day bilateral cataract surgery,
Retrobulbar hemorrhage, 93, 94, 95, 96 second eye, monocular patient
Retrobulbar/periocular medications, 230 and, 113
Rhegmatogenous retinal detachment. Selection
See RRD of attorney, 50
Right eye v. left eye, in pediatric of expert witness, 52
ophthalmology, 204–205 of jury, 11–12, 58
Index 281

Serious life events, understanding emotional Tests


reactions to ancillary, emergencies relating to, 152
appraisal of, 250 laboratory, referral, and treatment plan,
denial, 252 for uveitis, 240–241
exaggerated sense of responsibility, 253 for retina and vitreous, 227
failure relating to, 253–254 Tetracaine, 92
guilt, 253 Third parties, pediatric ophthalmology relating
intrusion, 252 to, 202
outcry relating to, 251 Thyroid orbitopathy, 182
personal feelings about, 255 Timolol gel-forming solution, 137
working through, 252 Timoptic-XE, 137
Serum TSH (thyroid stimulating hormone) TobraDex, 128
level, 182 Topical anesthesia, 92
Settlements, 56–57 Topical antibiotics, 141
defendants and, 56 Topical β-blocker, 140, 142
negotiations of, 19 Topical medications, for retina and vitreous,
plaintiffs and, 56 230
Squamous cell carcinoma, 181 Topical steroids, 128
Standard Tort/tort law, 4, 253–254
of care, 3–4 Toxicity, systemic, 93
of lawsuit, informed consent relating to, 69 Toxic optic neuropathy, common errors in
Stare decisis, 65 evaluation of, 179
State v. Cavallo, 88 N.J. 508 (1982), 38 Transcript, of deposition, 55
Statute of limitations, 19–21, 32 Transplant, corneal. See Corneal transplant
Steroids Trauma, facial, 195–196
intracameral, 112 Trauma patient, 195
topical, 128 Trial, 57–62
Structure and effect, of apology, 87 appeal relating to, 62
Subpoena duces tecum, 48 attendance at, 57–58
Sufficient disclosure, 189 courthouse conduct at, 58
Summations, 19 examination before, 53–56
Summons, 49 jury relating to
Support charge to, 62
physician/defendant in need of, 256 deliberations of, verdict and, 62
risk management, 212 selection of, 11–12, 58
Supreme Court, U.S., 37, 139 opening statements at, 59
Surgery. See also Cataract surgery; plaintiff’s attorney’s preparation for,
Ophthalmic plastic surgery 34–36, 49
choroidal hemorrhage after, 122–124 charts, 35
Surplus, 266 documents, 35
Suture removal, 121–122 jury consultant, hiring of, 36
Systemic and ocular diseases, cataract surgery models, 35
in presence of, 113–114 pretrial mock trial, 36
Systemic toxicity, 93 summations at, 61
Trial judge
expert witnesses and, 37–39
T function of, 38
Technology gatekeeper role of, 37, 42
in glaucoma treatment, 168–170 hearings and, 37
new, for cataract surgery, 114–115 Trial testimony
Terminology. See Medical malpractice deposition testimony and, differences
Testimony. See also Trial testimony between, 9–10
of defendant physician, 15–17 of others, 59–60
of defense expert, 18–19 of physician defendant, 60–61
of medical expert, 43–44 Truman v. Thomas, 74
282 Index

Tumors potential risks and complications,


epithelial, 181 discussion of, 241
intraocular, 182 referral to specialist regarding, 242
risk of failure
to diagnose, 242
U in proper treatment, 243–244
Ulcer, corneal, descemetocele, or perforation, to timely refer, 242–243
159 in treatment-associated complications,
Unaccompanied minor, pediatric ophthalmology 244–245
relating to, 201–202
Underwriting requirements, 212
Unethical plaintiff’s expert witness, retribution V
for, 63–64 Vasocidin, 128
Unilateral or bilateral proptosis, 182 Venous and arterial retinal vascular diseases,
United States Pharmacopeial Convention. laser treatment of, 231
See USPC Verdict, jury deliberations and, 62
United States v. Addison, 498 F.2d 741 (D.C. Vicarious liability, 5–6
Cir 1994), 38 Videotape, of deposition, 34
USPC (United States Pharmacopeial Vitrectomies, 119, 123, 184, 233–234
Convention), 144 Vitreoretinal risk factors, for ophthalmologists,
Uveal melanoma, 183 225
Uveitis Vitreoretinal specialist consultations,
advice to patient regarding, 241 225–226
chief complaint and history of, 239 Vitreous. See Retina and vitreous
chronic, 114
communications with other physicians
regarding, 243 W
conclusion to, 245 Warfarin sodium, 133
detailed patient questionnaire regarding, Web M&M (Mortality and Morbidity Rounds
238–239 on Web), 143
diagnosis of, 241 Women
differential diagnosis relating to, 240 with childbearing potential, drugs for,
documentation, after poor outcome 139–140
regarding, 215 nursing, drugs prescribed for, 140–141
documentation regarding, 237–238 pregnant, drugs for, 139–140
examination for, 240 Written prescriptions, errors in, 134–135
introduction to, 237
laboratory tests, referral, and treatment
plan for, 240–241 X
medications for, 239 Xylocaine 2%, 94

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