HOT TOPICS
From the 92nd Annual PCOOS Conference, presented by the Pacific Coast Oto-Ophthalmological Society
Educational Objectives
| The goal of this program is to prevent medical malpractice lawsuits and improve the management of genetic eye
disease. After hearing and assimilating this program, the clinician will be better able to:
|
 | 1. Identify potentially problematic patients.
|
| 2. Recognize the importance of documenting every event in the patient’s chart.
|
| 3. Delineate the elements of an informed consent.
|
| 4. Demonstrate the role of genetics in several ophthalmologic conditions.
|
| 5. Integrate genetics into medical practice.
|
Faculty Disclosure
In adherence to ACCME Standards for Commercial Support, Audio-Digest requires all faculty and members of
the planning committee to disclose relevant financial relationships within the past 12 months that might create
any personal conflicts of interest. Any identified conflicts were resolved to ensure that this educational activity
promotes quality in health care and not a proprietary business or commercial interest. For this program, the faculty
and planning committee reported nothing to disclose.
Acknowledgements
Drs. Minkler and Gorin and Mr. Slavin were recorded at the 92nd Annual Pacific Coast Oto-Ophthalmological Society
Conference, held June 20-24, 2008, in Newport Beach, CA, and sponsored by the Pacific Coast Oto-Ophthalmological
Society. The Audio-Digest Foundation thanks the speakers and the Pacific Coast Oto-Ophthalmological
Society for their cooperation in the production of this program.
| ANATOMY OF A LAWSUIT— Donald S. Minckler, MD, Professor of Ophthalmology, Doheny Eye Institute,
and Professor of Ophthalmology and Emeritus Director of Glaucoma Services, the Keck School of Medicine
of the University of Southern California, Los Angeles, and Howard A. Slavin, JD, Lewis Brisbois
Bisgaard and Smith, Los Angeles
|
| Case: man, 60 yr of age, severely nearsighted, had end-stage bilateral glaucoma diagnosed years earlier; patient
on multiple medications and had had conjunctival reaction (pemphigoid) primarily related to epinephrine prodrug
used; filtering surgery recommended after eyelids fixed (floppy eyelid syndrome); over time, patient
noncompliant with treatment recommendations, disruptive in clinic, unpleasant, and missed many appointments;
“doctor shopping” for several years; as of February 1995, right eye had 20/40 vision, with mild cataract;
20/300 vision in left eye; clinic obtained, with significant effort, compassionate access to new glaucoma
drug which patient used only once; multiple refusals of filtering surgery, including free surgery (patient insisted
on waiting for Medicare coverage)
|
| Detecting potential problems: patient who presents as angry, vocal, and upset with previous care; patient
who runs case, instead of physician; patient with unreasonable expectations; in such cases, all dealings with
patient should be carefully documented; true especially in tertiary care center, where cases most likely complicated
|
| Informed consent: in preoperative period, patient from case above signed operative consent, hospital consent
for treatment, and 3-page complicated consent for randomized trial; at trial, patient claimed inability to read
consent forms; reasons included not having spectacles, being sedated before signing, and not understanding
content of forms; common for patients to claim insufficient information given and that they were not warned
of particular risks; important to document that informed consent given orally and in writing (document signed
and witnessed); easy for patient to not want to remember (especially if poor result occurs); preferable for patient
to sign document showing risks, hazards, complications, and alternatives on day before procedure; sedation
potentially impairs validity of consent form; not unusual for patient to claim he or she given papers to
sign and told “not to worry about it”; perception that event happened if written in chart; useful to have pictures;
appropriate documentation, especially after complication, very important as well as physician’s presence,
willingness to help, and reassurances to patient and family
|
| Steps involved: in many states, physician receives letter from attorney before lawsuit (appropriate time to inform
risk management department or professional liability insurer); statute of limitations—varies by state; in
California, 3 yr or 1 yr from date reasonably prudent person knew or should have known of negligence and
damages caused by physician; for child, maximum of 8 yr if child <18 yr of age (to prevent stale claims from
being filed; previously, patient injured as child or infant could wait until age of majority to file claim); in general,
statutes of limitations for medical malpractice from 1 yr to 3 yr after wrongful act; interrogatories and period
of discovery—in course of lawsuit, various ways in which attorneys acquire information; written
questions submitted to opposing party to be answered in writing, with answers verified (certified true and correct
under penalty of perjury); oral deposition (individual answers questions under oath from person seeking
information) another option; all questions and answers recorded, and written transcript in booklet form prepared;
information used in court, especially if different information given in trial (inconsistent testimony);
case defended by showing that involved physician adhered to or conformed to expected standard of practice
(what reasonable and prudent physician would have done under same or similar circumstances); not every
event has good explanation, but case ultimately defended by showing that involved physician adhered to standard
of care in everything performed; also possible to show that patient contributed to ultimate outcome (eg,
failure to follow instructions); defense experts—skilled academicians or clinicians; physician who takes on
care of patient has obligation to finish care; physician cannot abandon patient because patient unpleasant;
physician also cannot abandon patient’s claim if physician previously agreed to serve as expert
|
| Questions and answers: deposition of treating physician subsequent to malpractice claim—every state allows
physician to decline to answer question in which expert opinion requested; however, treating physician compelled
to answer matters involving own percipient witness position (what physician saw and performed in his or
her own care); physician cannot be compelled to be expert witness against his or her will; when fellows and resident
physicians see patients after office hours for attending physician—attending physician has ultimate responsibility;
ensure that patient receiving appropriate care from people providing it; documentation in chart of
everything that occurred highly recommended; terminating patient-physician relationship—ensure that patient
not left in position in which harm can occur due to failure to acquire medical care; in letter to patient terminating
relationship, provide names of other physicians or institutions that can continue care; terminating physician
should also specify that he or she is available by telephone or via office visit if patient has further problems, until
specific event or specific date occurs, and that in meantime, patient must continue with treatment recommendations;
letter should be sent by certified mail with return receipt requested (for documentation in chart); if patient
leaves against medical advice (AMA)—necessary to document; cannot force patient to accept care offered; patient
should be advised that he or she leaves at own peril; this process (informed refusal) similar to that of informed
consent; documentation in chart necessary (eg, if speaking to family member about patient leaving
AMA, identify family member); in general, relationship severed if patient leaves AMA, but physician not excused
from obligation of warning patient of risks; if patient later decides to resume relationship, physician’s
discretion whether to accept
|
| OCULAR GENETICS: IMPLICATIONS FOR THE GENERAL OPHTHALMOLOGIST —Michael B.
Gorin, MD, PhD, Harold and Pauline Price Chair in Ophthalmology and Professor of Ophthalmology, the
David Geffen School of Medicine at the University of California, Los Angeles, and Jules Stein Eye Institute
|
| Introduction: ophthalmology at forefront of genetics in concepts and advances; genetic issues include congenital
cataracts, corneoretinal dystrophies, genetic syndromes with retinal findings, and retinoblastoma; conditions
with strong genetic component—glaucoma with primary open angle or pigment dispersion; age-related
macular degeneration (AMD), myopia, amblyopia, and strabismus; age-related cataract (nuclear sclerosis);
certain subtypes of uveitis associated with specific HLA antigens; cystoid macular edema (CME) has higher
prevalence in people with hereditary retinal diseases; CME observed on optical coherence tomography (OCT)
in 20% to 30% of individuals who have cataract surgery; genetic predisposition seen in vaso-occlusive disease
as well as pharmacologic response to ocular agents
|
| Molecular ophthalmic genetics: identification of variations in specific genes that contribute to one’s risk for
disease; variations in genes disease-causing or disease-protective; old dogma that disease present if variant
present (or, one gene, one disease); genetic variations present that cause incomplete penetrance (person has
altered gene but no manifestations of disease); variable expressivity possible (different manifestations of disease
in family with same mutation); useful to look at family members; gene–environment interaction—in
AMD, smoking recognized risk factor; complex interaction in which variation in one gene may affect how
another variation in different gene manifests itself (eg, digenic inheritance [mutation in one gene does not
cause disease, and mutation in another gene does not cause disease, but manifestations seen if both mutations
present]); epistasis—variant in one gene activates or inactivates effects of another gene; multiple phenotypes
possible from mutations in same gene (eg, gene that causes most common form of Stargardt’s disease can
cause cone dystrophy, retinitis pigmentosa, and macular dystrophy); complexity of genome (wealth of variations
present in individual and diversity of interactions) determines manifestations, not just gene itself
|
| Integrating genetics into medical practice: recognize genetic contributions to observed disease; look beyond
ocular findings, and be aware that many genetic conditions have other systemic findings; be selective
in using diagnostic tests; combining clinical findings with family history may lead to different recommendations
for individual; if patient presents with possible genetic condition, first look at siblings (valid for recessive
and dominant conditions); if X-linked condition suspected, look at maternal side; if genetic
condition dominant, look at siblings and parents; tell patient to ask for more information from family about
genetic condition; obtaining good history important; often find clues about condition by looking beyond
eyes; sometimes necessary to tell patients and parents that abnormalities not seen at early stages of disease;
be sensitive to patient’s or parent’s guilt, anger, or depression (information about genetic condition sometimes
emotionally traumatic to patient); genetic diagnosis made not to label people but to better able determine
prognosis, treatment, and potential complications; molecular diagnostic testing—helps determine
diagnosis; going into new realm if performing test in asymptomatic individuals or other family members;
recognize that diagnostic testing imperfect; obtain help if not prepared to provide information and counseling;
genetic counseling—typically nondirective; rather, informative and educational; should address psychologic
and social interpersonal issues; explain to patient and family what testing can and cannot do and
how to interpret; counseling provided after testing performed; consider parental concerns and potential
stigma to child in deciding whether to perform diagnostic testing on asymptomatic at-risk children or
adults; availability of effective treatment factor in making decision; if unsure of diagnosis, do not just pick
one; having diagnosis does not mean knowing mode of inheritance; encourage evaluation of at-risk family
members; be selective about which tests to perform (eg, if diagnosis has no impact on clinical care, diagnostic
tests of limited benefit); sometimes useful to distinguish between stationary and progressive conditions;
many tests for research only and not applicable to clinical care
|
| Outlook for future: potential for more precise diagnosis; for AMD and glaucoma, genetic variations that
contribute significantly to risk not good predictors for patients; genetic testing may be limited by social
policy; genetic therapeutics—not simply gene therapy; also means behavior modification for some people
or lifestyle changes, medications, or focusing therapy more appropriately; www.genetest.org—excellent
resource; lists all registered laboratories around world that perform testing for research and clinical purposes,
as well as type of test performed; genetic information has appropriate time and place in person’s
life; pharmacogenomics—has advantage of providing knowledge of appropriate drug to use for individual;
disadvantage that enormous burden put on health system to determine small number of people for
whom drug appropriate; mandatory in certain situations
|
Suggested Reading
Blain D et al: Molecular diagnosis and genetic counseling in ophthalmology. Arch Ophthalmol 125:196,
2007; Brooks BP et al: Genomics in the era of molecular ophthalmology: reflections on the National Ophthalmic
Disease Genotyping Network (eyeGENE). Arch Ophthalmol 126:424, 2008; Davis GG: The art of attorney
interaction and courtroom testimony. Arch Pathol Lab Med 130:1305, 2006; Downs K et al: Molecular
testing for hereditary retinal disease as part of clinical care. Arch Ophthalmol 125:252, 2007; Floyd TK:
Medical malpractice: trends in litigation. Gastroenterology 134:1822, 2008; Geirsdottir A et al: Age-related
macular degeneration in very old individuals with family history. Am J Ophthalmol 143:889, 2007; Glabman
M: The top ten malpractice claims [and how to minimize them]. Hosp Health Netw 78:60, 2004; Gorney M:
The dilemma of the expert witness. Plast Reconstr Surg 121:1845, 2008; Hartz A et al: A new tool for assessing
standard of care in medical malpractice cases. Plast Reconstr Surg 117:1632, 2006; Hyman L et al: Ophthalmic
genetics: at the dawn of discovery. Arch Ophthalmol 125:9, 2007; Karl RC: The origins of
malpractice claims. Ann Surg 246:712, 2007; Lee KJ et al: Assent for treatment: clinician knowledge, attitudes,
and practice. Pediatrics 118:723, 2006; Patsner B: Expert witnesses: perpetuating a flawed system
and ethical issues related to medical expert testimony. Obstet Gynecol 107:739; author reply 739, 2006; Sieving
PA et al: Genetic ophthalmology and the era of clinical care. JAMA 297:733, 2007; Taqueti VR: Leaving
against medical advice. N Engl J Med 357:213, 2007; Wiggs JL: Genomic promise: personalized
medicine for ophthalmology. Arch Ophthalmol 126:422, 2008.
|
