Transcript Medicolegal Issues in Pathology

Medicolegal Issues in
Anatomic Pathology
Mark R. Wick, M.D.
Malpractice Claims: Necessities
Negligence: Defined by “expert” testimony as
medical practice that breaches the national or
regional standard of care. This is defined as
the behavior expected of “prudent, careful, &
informed” physician.
 Injury: Must be objectively documented and
judged to be the direct consequence of the
negligent professional action.
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Items of Interest Regarding Medical
Malpractice Lawsuits
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Some states have an institutional cap for damages
that is much less than the cap for individual
practitioners (e.g., in Virginia the MC cap is ~$100K,
whereas the MD cap is $1.6 million)
Selected states allow the plaintiff to file a separate
civil action against the personal assets of the physician
if there is a malpractice judgment against the doctor
(double jeopardy)
The plaintiff’s lawyer is working on a contingency
basis– up to 33% of the monetary award to the
plaintiff goes to the attorney
Lawsuits Against Pathologists
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How likely is it that current practitioners in pathology
will be sued during their careers?
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Largely dependent upon geographic locale of practice– both
coasts, Florida, Texas, Illinois, and selected other
cities/counties are “hotbeds” of plaintiff attorney activity
Subspecialty practice area is also important–
dermatopathology, cytopathology, & hematopathology are
high-profile with regard to lawsuits against pathologists
Most pathologists now in practice will have at least one suit
filed against them during their careers
Lawsuits Against Pathologists
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Clinically “significant” diagnostic error rate in
surgical pathology & cytopathology ranges from
0.25% to ~6% in the published literature
Factors contributing to this situation include a
paucity of “hard” diagnostic criteria for many
conditions, some variation in individual visual
perception and decision-making, and incomplete or
misleading clinical information
Despite those realities, the American public & the
plaintiff’s bar expect a “zero error standard”
Surgical Pathology Claims Against the Doctors’
Company– 1998-2003
[Troxel DB: Am J Surg Pathol 2004; 28: 1092-1095]
Specimen
Type
% Claims
%FN
%FP
Total Claims (%)
Breast Bx
42
48
52
15.5
Melanoma
44
95
5
16
Lymphoma
14
57
43
5
FNA, Misc.
10
40
60
3.5
FNA, Breast
5
40
60
2
Gastric biopsy
12
42
58
4.5
Prostate biopsy
9
67
33
3
Lung biopsy
12
42
58
4.5
GYN pathology
31
74
16
11.5
Sarcoma pathology
15
80
20
5.5
Bladder pathology
5
100
0
2
Cysts
3
100
0
1
Miscellaneous
48
65
19
26*
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* Included cases involving failure to diagnose metastatic carcinoma (especially in lymph nodes), suits
against primary pathologists for mistakes made by their consultants (“vicarious liability”), failure
to solicit consultation or perform special diagnostic studies, frozen section misdiagnoses, and
actions resulting from specimen misidentification, processing, or mistakes in written or verbal
reporting
Changes in Claims Against Pathologists from
1995 to 2003– Data from The Doctors’ Company
Increased spectrum of claims, with regard to
organ systems and diagnoses
 Slight decrease in FNA-related claims
 Slight increase in melanoma-related claims
 New areas of litigation– soft tissue pathology,
GYN pathology, bladder pathology, pulmonary
pathology
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Why are Pathologists Being Increasingly Targeted
in Malpractice Suits?
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We are, partially, victims of our own success, through efforts of
the CAP & ASCP to increase our public visibility
“Because we are out there”… the plaintiff’s bar is always
looking to extend its sphere of operations (beyond OB,
Anesthesia, ER Medicine, etc.)
The media and other physicians increasingly tell patients that
we provide the “final answer” in their cases, and often
misrepresent the strengths and weaknesses of pathologic tests
& procedures (e.g., in Pap smear cases– c.f. A footnote in “A
Case of Need” by Michael Crichton -“The Papp [sic] smear is
the most accurate diagnostic test in all of medicine”)
How Do Suits Against Pathologists Usually
Happen?
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There is a “lag period”--- usually the biological evolution of the case over
time, or referral of the patient and his/her pathologic specimens to other
centers occasions a change in diagnosis and incites the filing of a suit
after legal consultation
The initial pathologist is usually blind-sided; there is rarely a continuous
train of information which culminates in the lawsuit
Sometimes the only “fault” of the pathologist is being the person on the
signout schedule when a “systems” mistake occurs; e.g., the mislabeling
or mixup of a specimen
The pathologist and/or the hospital is served with a written “bill of
complaint” from the court, usually necessitating personal delivery from
a law enforcement officer
The bill of complaint details the alleged act(s) of malpractice and the
supposed consequences to the patient (i.e., the damages)
Consultation with Risk Managers
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Virtually all medical centers and medical schools have
departments of risk management; these should be
contacted immediately if it is thought that a particular case
is at risk for a lawsuit. RM personnel would much rather
deal with many cases that “never go anywhere” than with
problems they know about only after the filing of a bill of
complaint
Conversations, meetings, and correspondence with RM
personnel are typically regarded as privileged under the
law, and the contents thereof are not “discoverable” by
plaintiff’s attorneys
Cases with serious procedural irregularities, major changes
in diagnosis, or anything inciting anger by the patient (or
their family) should be referred to risk management
immediately
As a general rule, pathologists should never speak to
plaintiffs directly after a suit has been threatened or filed,
or should do so only after consulting RM regarding known
case-related problems
Staying Out of
Trouble-101
What Should be Done After Receiving a Bill
of Complaint (BOC)?
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Meet with the attorney representing your hospital or
organization, as well as yourself, after sending them the
BOC to study
Your lawyer(s) will gather information about the case
from you and others, to prepare a written document
called a “response”– this is your protestation of
innocence of the charges made and is filed with the court
and the plaintiff’s attorney
NEVER speak or correspond in any way with the
plaintiff’s counsel after the process has begun, except in
the presence of your attorney(s)
Things to NEVER Do If You are Afraid of a
Lawsuit or Have Already Been Sued
Regarding a Specific Case
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NEVER talk to other people who have been named in the suit about
any details of the case, & certainly never attempt to influence
their remembrance of details or events;
NEVER try to alter or discard records, slides, or any other tangible
evidence;
NEVER speak or correspond directly with the patients, their family
members, or their attorneys about the case;
NEVER try to deflect your own potential culpability by blaming
others (“passing the poisoned buck”)– it is unprofessional and
hasn’t a prayer of working…
“Life On the Cheap”--Attorneys Trying to Get Something for Nothing
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Lawyers will sometimes attempt to bully their way into getting free
information by trying to talk with housestaff who are attached to an
attending physician being sued, or they will co-name the resident(s)
and try to talk with them first (free, of course…);
“Treating physicians” (attending doctors involved in the case but not
being sued) will be contacted for a deposition by the plaintiff’s
attorney, regarding the defendants’ actions;
ALL physicians being asked legal questions about a case in which they
are involved should have their own attorneys present; if they are not
named in the suit, they have the right to ask for reimbursement for their
time & efforts, and should do so.
The Medical “Expert” or
“Authority”—CAUTION!
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The meaning of “expert” or “authority” (or
“authoritative”) is very different in the law and in
common medical parlance
In a legal context, all of these terms imply
infallibility– therefore, each word in a textbook or
treatise that is deemed “authoritative” is, by
definition, unassailably correct
The word “scholarly” is much preferred in verbal or
written discourse about medical opinions and
publications– it carries no such hidden meaning
Malpractice Suits– Not Scarlet Letters
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Physicians who are sued, and who have
not committed wrongful acts out of true
negligence or personal impairment (e.g.,
substance abuse) should not take the
action personally if at all possible– it is
a business proposition for attorneys and
nothing more
Personal counseling by a psychiatrist or
psychologist is a good idea to work
through these concepts and avoid selfrecrimination
M
Specific Topics &
Subspecialty Areas in
Pathology Malpractice
ELEMENTS OF HISTOLOGICAL TISSUE
PROCESSING THAT CAN RESULT IN LEGAL
CLAIMS OF “NEGLIGENCE”
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Errors in:
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Prosection and fixation of the specimen by the pathologist
(or mixup of specimens by persons unknown before receipt in
the pathology laboratory)
Automated tissue processing
Paraffin embedding
Microtomy & slide preparation
Histochemical staining
Coverslipping
Interpretation
SOURCES OF TISSUE “FLOATERS” IN
MICROSCOPIC SECTIONS THAT CAN RESULT IN
MISTAKES IN DIAGNOSIS
 “Cutting board” floaters (flawed prosection
technique in the gross room)
 Automated tissue processor mishaps
(transplantation of small tissue fragments
from one specimen to another via instrument
solutions)
 Embedding room mistakes
 Poor water bath technique
Illustrative Case: Tissue Processing Mistakes
as Sources of a Lawsuit
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A 53 year old woman complained of persistent dyspepsia
and was subjected to a gastroesophagoduodenoscopy. The
gastroenterologist saw only “mild gastritis,” but obtained
several biopsies. These were unexpectedly read as
showing enteric-type adenocarcinoma, and a partial
gastrectomy was subsequently performed. There was no
evidence of malignancy in the resection specimen, despite
the fact that the entire mucosal surface was blocked for
microscopic examination.
“Floaters” in Surgical Pathology: Potential
Sources of Lawsuits
Biopsies from gastric biopsy specimen, taken from clinical “mild gastritis”
Blood group Ag immunostains done after negative gastrectomy procedure
BGA
BGB
Illustrative Case: Tissue Sampling Issues as
the Source of a Lawsuit
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A 46 year old woman had a needle core breast biopsy in 1995 for a
self-detected lesion in the right breast. It was interpreted as showing
fibrocystic changes only, and because the mammographer did not
have a high level of suspicion for malignancy, nothing further was
done. In 1997, the patient presented with right supraclavicular
lymphadenopathy, and a lymph node biopsy showed metastatic
breast carcinoma (GCDFP-15+/ERP+). The lesion in the right
breast was now larger and radiographically atypical, and excision of
it showed invasive ductal carcinoma. When recuts of the 1995
biopsy were prepared for referral of the patient to another medical
center, a focus of invasive carcinoma was seen that had not been
represented in the original set of slides.
Sampling Errors in Preparation of
Histologic Slides
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Sampling errors in histology can be limited by good laboratory
technique, but they cannot be eliminated entirely
Recommendations:
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Ask histotechnologists to mount several tissue cuts from small
biopsies on each slide, and obtain at least 3 levels of each tissue
block
Instruct histotechnologists to be sure to “face into” blocks
appropriately
Always have pathologists review any recuts that are prepared on
cases being sent away to other institutions, and compare them
with the original sections
Education of Histotechnologists on
Medicolegal Matters
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Plaintiffs’ attorneys are becoming increasingly aware of
the details of tissue processing and slide preparation in
the histology laboratory
The anonymity of the technologist no longer protects
him or her from being the target of a lawsuit, alone or
as a “representative” of the medical center
Educational efforts should therefore be directed at
histotechnologists in regard to their liability and
counter-measures to minimize mistakes and document
ongoing quality assurance programs in the laboratory
Hematopathology
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Cases concerning failure to diagnose
lymphoma principally concern the confusion
of follicular lymphoma with lymphoid
hyperplasia, and failure to recognize
extranodal lymphomas
Confusion between lymphoma/leukemia and
EBV or other viral infections and reactive
hematolymphoproliferations is also a pitfall
in this area
A high index of suspicion is essential in these
instances; immunophenotyping and at-leastinternal consultation (with documentation
thereof in the report) are strongly
recommended
EBV
“LIP”
Illustrative Case: Misdiagnosis of
Non-Hodgkin’s Lymphoma
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A 41 year old man presented with rapidly-worsening abdominal pain
and was found by abdominal MRI scan to have a thickened bowel
segment at the ileocecal junction. He underwent laparotomy and
resection of the intestine. Because of the presence of transmural
chronic inflammation and fibrosis in the bowel wall, a diagnosis of
Crohn’s disease was made. Despite treatment with steroids, the
patient had recurrent abdominal pain & weight loss and was found 9
months later to have a huge retroperitoneal mass. A biopsy
established the diagnosis of large-cell lymphoma, and retrospective
review of the original bowel resection disclosed tumor in that
specimen as well. The patient died 3 months later.
Resection specimen of ileocecal mass– gross & microscopic images
CD20
Where Do Immunostains Stand in
Malpractice Actions?
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Up until 1999, pathologists were “in limbo” in
regard to IHC, because stains were not certified by
the FDA for clinical use, and yet they were “state
of the art” in actual practice
Now, IHC is indeed considered a necessity of
“standard of practice;” it most often enters
medicolegal considerations where a lymphoma is
misdiagnosed as another form of undifferentiated
tumor & the wrong treatment is given
subsequently
Dermatopathology
The principal area of liability is that of
missed melanoma diagnosis; however,
suits have also been filed for overdiagnosis
of nevi as forms of melanoma;
 Another source of medicolegal action in
dermatopathology is the underdiagnosis of
squamous cell carcinoma or basal cell
carcinoma, with subsequent complications
from local tumor growth
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“Spitzoid” Melanoma
Pagetoid Spitz Nevus
Desmoplastic Melanoma Misinterpreted as Scar
Squamous Carcinoma Misinterpreted as
Pseudoepitheliomatous Hyperplasia
Illustrative Case: Misdiagnosis of
Malignant Melanoma
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A 35 year old woman had a 4 cm. irregularly pigmented lesion in the
skin of the left leg, for which she consulted a dermatologist. He took
a 3 mm. punch biopsy from the periphery of the mass, which was
interpreted pathologically as showing a compound nevus. The
patient was told she had a benign process and that it need not be
excised. When the mass enlarged and began to bleed 11 months
later, the patient saw another dermatologist who immediately did a
complete excision. That specimen showed an obvious melanoma in
vertical growth, with a Breslow depth of 4.1 mm., associated with a
compound nevus. The woman subsequently manifested metastases
in the brain and died 2 years later. The pathologist was sued but the
first dermatologist was not.
Cautionary Notes to Avoid
Dermatopathology Missteps
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If clinical information indicates that a melanocytic lesion
is larger than a biopsy in hand would suggest, make a
disclamatory statement in the report which indicates the
possibility of sampling error and suggests that excision
would be prudent;
If the biology of a melanocytic lesion cannot be
determined with certainty, do not try to do so!;
If a keratinocytic proliferation has been only superficially
sampled, avoid a definitive interpretation; the term
“atypical squamous proliferation” is a good alternative
Breast Biopsies-- Substrates for
Malpractice Actions
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Sources of legal claims pertaining
to breast biopsies:
 Failure to ink margins and
corresponding inability to
comment on them
 Failure to provide information
on tumor grade, type, size,
vascular invasion, surgical
margins, hormone receptor
status, and associated
microscopic findings in the
excised breast tissue
 Failure to distinguish in the
report between in-situ and
invasive carcinoma
ERP
Synoptic Reporting Forms in Surgical Pathology:
Keeping the Wolf from the Door
Breast J 2001 Jul-Aug;7(4):271-274
Synoptic/Checklist Reporting of Breast Biopsies: Has the Time Come?
Leong ASY.
Narrative descriptive reporting has been the traditional format employed in surgical
pathology for almost as long as its inception as a specialty. While the descriptive
prose has served us well in the past, its accuracy and readability is variable.
Descriptions of color, shape, and texture are often subjective. Surgical pathologists
are trained observers, but there are inherent differences in reporting style, and
descriptive prowess depends on language skills and vocabulary. These differences are
reflected in reports generated by pathologists in the same laboratory and may even
be more evident in reports from different laboratories and across nations using the
English language. The reproducibility of morphologic descriptions is thus a matter of
some concern.
FNA Misdiagnoses & Malpractice
Suits
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The most common site of lesions for which
FNA misdiagnosis results in lawsuits is the
breast-- this is because surgeons will often
perform definitive surgery based
principally on the FNA result and may
ignore other data;
Sparsely-cellular specimens should not be
interpreted with certainty, because of the
high rate of false-negative error that
attends them;
The most common source of falsepositivity is cellular fibroadenoma;
hence, if that lesion is in the clinical DDx,
the pathologist should be cautious in
making a diagnosis of CA
Illustrative Case: FNA Misdiagnosis
of Breast Carcinoma
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A 37 year old woman palpated a mass in the left breast on selfexamination, which was confirmed by her internist.
Mammographic examination yielded indeterminate results
with respect to the probable malignancy of the lesion, and a
consulting surgeon likewise was unsure whether the lesion was
carcinomatous or not. An FNA was performed, and a
diagnosis of adenocarcinoma was rendered by the pathologist.
Based on that information, the surgeon proceeded directly to a
simple mastectomy (the woman had small breasts). Surgical
pathologic examination of the lesion showed that it was a
cellular fibroadenoma. There was no evidence of in-situ or
invasive malignancy in the excised breast.
Fine needle aspiration biopsy of left breast mass
Excision of left breast mass
Cautionary Notes Regarding FNA
of the Breast
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Avoid overinterpretation of sparsely cellular specimens;
ALWAYS seek information on results of physical
examination and mammography, before a final
cytologic diagnosis is made (the “triple test”);
If there are doubts as to the finality of a diagnosis of
carcinoma in the FNA, advise the surgeon to perform a
frozen section of the lesion before a definite surgical
approach is taken
Illustrative Case: FNA Misdiagnosis
of Sarcoma
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A 24 year old man had a painless mass in the right
Achilles tendon, which had enlarged slowly over a 6
month period. He consulted an orthopedist, who
performed a fine needle aspiration biopsy on the
lesion. It was interpreted as showing “pigmented
villonodular tenosynovitis,” and no further therapy
was recommended. Eight months later, the mass
was larger still and it was excised, showing a clearcell sarcoma. Three years thereafter, chest
radiographs demonstrated pulmonary metastases.
Fine needle aspiration biopsy of mass in Achilles tendon
Excision of mass in Achilles tendon
Non-FNA, Non-GYN Cytology
Specimens & Malpractice Suits
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Exfoliative pulmonary cytology
specimens are relatively high-risk
medicolegally, because definitive
surgery may be undertaken based upon
them;
False-positive results (owing to the
effects of infarcts, granulomas, alveolar
damage, & other causes) are more
damaging than false-negative findings,
although the latter are not
inconsequential (e.g., failure to make a
timely diagnosis of small-cell carcinoma
in sputum)
Illustrative Case: Cytological Misdiagnosis of
Lung Cancer
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A 56 year old man was found to have a cavitary lesion in the
mid-left lung field, in a set of screening chest radiographs.
He underwent examination of several sputum cytology
specimens, which were negative for malignancy.
Subsequently, a bronchoscopy was performed with
bronchial brushing and washing. Cytologic specimens from
those procedures were interpreted as showing non-small-cell
carcinoma. A left pneumonectomy was performed,
pathologic examination of which demonstrated only a
histoplasmoma with surrounding bronchial atypical
squamous metaplasia. There was no evidence of in-situ or
invasive malignancy.
Chest radiograph & bronchial brushing cytology specimen
Resection specimen (upper left-H&E; upper right- GMS; lower- atypical
bronchial epithelial metaplasia)
Intraoperative Followup of Exfoliative Cytologic
Diagnosis of Lung Carcinoma
When exfoliative cytology is the only source of
a diagnosis of lung cancer, it is wise to prompt
the surgeon to ask for a frozen section on the
lesion before proceeding with a lobectomy (or
more);
 Granulomas, infarcts, organizing pneumonias,
and other benign processes may yield falsepositive cytologic results
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The Pap Smear Crisis
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In the past 15 years, plaintiffs’ attorneys have discovered Pap smears as a
“growth industry,” ignoring the fact that they are screening tests and not
intended for definitive diagnosis. The main issue is whether “atypical cells”
(no matter how scant) have been missed on smears preceding another one
(or a biopsy) that is diagnostic for SIL or invasive SCC. The situation is
worsened by the growing presence of several unscrupulous plaintiffs’
“experts” who will testify to virtually anything in this arena.
Pap Smears: What Are the Facts?
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Pap smears are associated with a 70-80% decrease in cervical
cancer-associated death rates.
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The irreducible false-negative Pap fraction is > 5 %.
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“Atypical cells of undetermined significance” is a poorly
defined category with poor interobserver and intraobserver
reproducibility.
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Pap-smear slides should be reviewed legally by "reasonable
pathologists" without knowledge of clinical outcome or details
of pending litigation.
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A 5-10% false-negative rate is an admirable goal; a 15-20%
rate is a more feasible standard.
Bethesda Terminology: Essentials
There is absolutely no
place for the old “Pap”
designations in
interpreting GYN
cytology;
 The updated Bethesda
terms, with therapeutic
recommendations, are
advised
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Illustrative Case: Pap Smear “Miss” or Not?
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A 36 year old married G2P2 woman had yearly Pap smears
that were interpreted as showing “reactive epithelial changes”
from 1995 through 1997. In 1998, she presented with
postcoital spotting and colposcopy showed a small cervical
lesion at 5:00. Biopsy revealed microinvasive squamous
carcinoma. Review of one 1997 Pap smear showed 2 atypical
squamous cells that were felt to be reactive by 2 expert
witnesses and “ASCUS; cannot rule out a high-grade lesion”
by the plaintiff’s expert. The patient had a hysterectomy and
sued because she said she had been prevented from expanding
her family as she had wished to do.
1997 Smear
1998 Conization Specimen
Suggestions Regarding
Administration of GYN Cytology
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Comply rigidly with all regulations set forth by state governing
agencies, CLIA, CAP, & JCAHO regarding handling of Pap
smears, & keep strict documentation;
Make certain that continuing cytology-related educational
activities for cytotechnologists and pathologists meet or exceed
recommended guidelines;
Make sure that a regular cytopathology-surgical pathology
correlation conference is held in regard to GYN specimens,
and keep good documentation of such;
DISCARD all Pap smears that are older than the period
prescribed in the local legal statute of limitations
What is the “Standard of Care” in Surgical
Pathology & Cytopathology?
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“Standard of care” is defined as the “practice of a
reasonable, careful, informed, & prudent physician who is
board-certified in his or her specialty”
This description does not mandate that one have
subspecialty board certification to make diagnoses in
hematopathology, dermatopathology, cytopathology, etc.
It also does not imply that all difficult cases in surgical
pathology or cytopathology must be sent to consultants
who are outside of one’s own institution
Showing a case to internal colleagues, and documenting that
this has been done and what the consensus diagnostic
opinion is, constitutes adherence to the standard of care,
even if the diagnosis proves to be incorrect!
Serving As An
“Expert” Witness
General Rules for Expert
Testimony
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Keep your testimony factual, and clearly within your area of
professional knowledge; there is no place for advocacy or
wild opinion in medicolegal work;
Charge reasonably for your time;
Seriously consider requests to serve as an expert if you are
asked to do so; if you don’t, some unscrupulous person
may…;
Don’t let yourself be tricked or goaded by attorneys; they
operate by rules that are completely different than those
applying to scientific or medical endeavors
Contributory Areas of the Law for
Pathology Experts
Diagnostic accuracy & timeliness;
 “Causation”-- a broad term encompassing the
pathophysiologic basis of disease, etiology,
epidemiology, and temporal evolution of a
pathologic condition (e.g., did a delayed diagnosis
of malignancy really cause metastasis, or did it
occur before the tumor was first noticed by the
patient, based on the best evidence in hand?)
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