Steering clear of malpractice claims
Edward P. Fody, MD
Marva West Tan, RN, ARM
Last in a series on pathology claims managed by the St. Paul and
MMI Companies Inc., St. Paul, Minn. This month: prostate cancer claims.
Analyses of breast pathology claims were published in the April and
May issues, and analyses of melanoma cases were published in the August
issue. Some facts may have been changed in the following cases to
Case 1 - Prostate cancer diagnosed in core needle biopsy,
radical prostatectomy specimens negative for cancer
Allegation: Misdiagnosis of core needle biopsy
specimen, unnecessary radical prostatectomy with sequelae.
Defendants: Pathologist No. 1 and pathology
Facts of case: In August 1998, a 53-year-old
man had a core needle biopsy of the prostate performed in a urologist’s
office with the specimen sent to a pathologist for analysis.
On Aug. 18, Pathologist No. 1 reported that one of six specimens
was positive for adenocarcinoma:
Pathologist No. 1 further noted that he discussed this finding at
the department of pathology daily meeting and that the members of
the department agreed with the diagnosis.
- Prostate, core biopsy (left mid gland). Small focus of infiltrating
adenocarcinoma (Gleason’s 3 + 3: 6).
- Benign glandular and stromal prostatic hyperplasia.
On Aug. 19, Pathologist No. 1 issued an amended report with the
additional comment that an immunohistochemical stain for high-molecular-weight
keratin was performed on three of six core needle biopsy specimens.
A few small glands did not stain with high-molecular-weight keratin
and were "thus suspicious for confirming the diagnosis of a small
focus of cancer."
On Oct. 26, the patient had a radical prostatectomy with bilateral
pelvic node dissection.
On Oct. 28, the hospital pathologist (Pathologist No. 2) issued
Legal action: On Aug. 16, 2000, the plaintiff
filed a claim naming Pathologist No. 1 and the pathology group practice.
The claim alleged misdiagnosis of prostate cancer leading to an unnecessary
prostatectomy, unspecified complications, physical pain, humiliation,
embarrassment, inconvenience, medical expenses, and lost earnings.
About six months later, the plaintiff dropped the claim after his
expert pathologist witness reviewed the core needle biopsy slides
and agreed with Pathologist No. 1’s interpretation. Costs were limited
to defense attorney’s fees.
- Prostate, radical prostatectomy—marked acute and chronic
prostatitis, moderate hyperplasia and peripheral atrophy—no
- Bilateral obturator lymph nodes—no tumor seen in three
- Bladder neck biopsy—no tumor seen.
Loss prevention issues
Clinical issues and standard of care
This case raises several issues concerning the proper handling of
difficult cases. These cases and the issues they raise occur frequently
in the day-to-day practice of surgical pathology. That Pathologist
No. 1 took advantage of several quality assurance procedures was
key to the successful outcome of the claim.
Use internal consultation
When several pathologists are working in a group practice, difficult
cases should always be shared with the group. For pathologists in
solo practice, a sharing agreement with nearby pathologists may
fulfill the same function. Many groups follow the practice of having
all cancer cases and unusual cases reviewed by at least one other
pathologist, and some groups have all biopsies reviewed. Sometimes,
when appropriate, multiple pathologists are asked to review the
same case. Document all of these reviews, either on the surgical
pathology report or in the department’s internal quality assurance
file. In this case, Pathologist No. 1 was careful to show the prostate
biopsy to other members of his group and to inform the urologist
of their concurrence with his diagnosis.
Perform additional studies
Additional studies may take the form of submitting additional tissue,
obtaining recuts of certain tissue blocks, or performing special
stains. In biopsies, the tissue is generally submitted so there
will be no additional tissue to process. In this case, Pathologist
No. 1 performed an immunohistochemical stain for high-molecular-weight
keratin on three of six core needle biopsy specimens. A few small
glands did not stain, which confirmed the diagnosis of carcinoma.
Obtain outside consultation
Outside consultation with a recognized expert is valuable in difficult
or unusual cases. When such a consultation is sought, discuss your
plan with the referring physician. Although the final choice of
a consultant always rests with the pathologist, generally the clinician
will be asked to concur in the selection. Such consultation may
delay the diagnosis for up to two weeks, but the final result will
generally be worth it. The clinician and patient will appreciate
that a world-class expert at a prominent medical center has reviewed
the case. Outside consultation was not obtained in this case, probably
because Pathologist No. 1 was confident of his diagnosis.
Using an outside consultation demonstrates good practice, brings
additional expertise to the diagnostic process, and generally increases
defensibility of a claim. But outside consultation is not a guarantee
against a malpractice claim. Plaintiffs determine whom to name as
defendants in a lawsuit and may name both the primary and the consulting
pathologist who will be held individually to the pathologists’ standard
Follow quality assurance procedures
Proper quality assurance in surgical pathology protects the pathologist,
the clinician, and the patient. The patient has a greater likelihood
of a correct diagnosis. The clinician is guided as to the proper
treatment. And the pathologist has some protection should the correctness
of the diagnosis ever be questioned.
In this case, a lawsuit was filed after a 53-year-old man underwent
a prostatectomy for carcinoma discovered on a needle biopsy and
no tumor was found in the prostatectomy specimen. The original needle
biopsy showed a small focus of carcinoma in one of six needle biopsy
specimens. Pathologist No. 1 obtained and documented concurrence
of other members of his group in the original diagnosis and further
confirmed the diagnosis by immunohistochemical stains for high-molecular-weight
keratin. These steps stood Pathologist No. 1 in good stead when
the plaintiff’s expert witness, who concurred in the original diagnosis,
reviewed the case.
Poor communication plays a part in many malpractice claims and
may have influenced this claim. The management of patients with
a single focus of well to moderately differentiated prostate carcinoma
on needle biopsy is controversial. In this case, the patient’s relative
youth (53 years) may have influenced the urologist and the patient
to decide upon a prostatectomy. After an initial needle biopsy of
a solitary focus of well-differentiated carcinoma, not all prostatectomy
specimens reveal cancer. Had this possibility been discussed with
the patient before the operation, a lawsuit may have been avoided.
Notice of potential claim
Pathologist No. 1 first became aware of a potential claim when the
patient’s attorney requested the core needle biopsy slides. Pathologist
No. 1 called his insurer for advice, and the claim consultant arranged
for defense of the potential claim.
Early notification of a potential claim to your insurer and risk
manager is an important step in the defense of any claim because
evidence can be preserved and witness testimony obtained while memories
are fresh. In some cases, early resolution of the patient’s complaints
can prevent a formal lawsuit or moderate the settlement amount.
Pathologists should report the following to their insurer:
Preserve the medical record
- Any adverse medical event resulting in a patient injury that
could potentially result in a claim.
- Requests from a patient’s attorney for medical records or pathology
slides. Some requests may be in relation to an automobile accident
or workers’ compensation claim rather than a potential malpractice
claim. If you are unsure about release of information, contact
your insurer. Do not release any medical information without the
patient’s written authorization.
- Any threat of legal action or demand for compensation. Complaints
from angry, dissatisfied patients or family may fall into this
- The receipt of formal lawsuit papers, that is, summons and complaint.
Do not ignore or fail to respond to a summons and complaint because
you may lose the lawsuit if your defense attorney does not respond
appropriately by certain deadlines.
Do not inappropriately alter, amend, or correct a pathology report or any other
part of the medical record once you have received notice of a potential claim.
Most hospitals and pathology departments have guidelines on the proper manner
for correcting medical records or issuing addenda. Inappropriate medical records
changes can severely damage the defendant physician’s credibility and lead to
a serious problem in defense of a claim. Although this risk management advice
is not new, a few physicians every year continue to make this mistake with negative
consequences to their defense.
Case 2 - Prostate cancer diagnosed in core needle
biopsy, radical prostatectomy specimen negative for cancer
Allegation: Misdiagnosis of cancer, unnecessary
surgery, pain and suffering, and loss of consortium.
Defendants: Pathologist No. 1 and pathology
Facts of case: A 65-year-old man had an increase
in his prostate-specific antigen screening test from 1.7 in 1996
to 3.9 in 1997. On Jan. 28, 1998, the patient had an ultrasound-guided
core needle biopsy of the prostate.
On Jan. 30, Pathologist No.1 reported that one of six samples
was positive for cancer: Prostate biopsy, right mid: adenocarcinoma
of prostate, histologic grade 2/5.
The patient’s urologist discussed treatment options with the patient
and addressed possible complications of radical prostatectomy, including
incontinence and impotence. On April 2, 1998, the patient had a
radical perineal prostatectomy.
On April 9, Pathologist No. 2 issued a report:
On April 20, external consulting Pathologist No. 1 reported:
- Bladder neck (biopsy)—fibromuscular stroma.
- Prostate (radical prostatectomy)—acute and chronic prostatitis
with atrophic changes; chronically inflamed and hyperplastic periurethral
glands. Unremarkable seminal vesicles. Margins of resection are
free of neoplasia, further assessment pending extramural consultation.
The patient complained of urethral burning, perineal firmness, incisional
pain, incontinence, and impotence in the postoperative period. The
urologist, over a six-month period, documented repeated discussions
with the patient regarding the discrepancy between the final pathology
report and the biopsy report. The urologist explained to the patient
that "a very small volume malignancy was picked up by ultrasound and
- Prostate (radical prostatectomy)—benign prostatic tissue
with a mixed diffuse atrophy, widespread chronic inflammation
with multiple scattered lymphoid follicles. Nodular hyperplasia
is present. No carcinoma identified.
In June 1998, Pathologist No. 1 sought an external consultative
review of the prostate biopsy slides. External consulting Pathologist
- Prostate, needle biopsy: benign prostatic hypertrophy: basal
cell hyperplasia. Mild atrophy. Moderate chronic inflammation.
Mild acute inflammation.
Legal action: On March 31, 2000, the plaintiff
filed a claim naming Pathologist No. 1 and his pathology group practice
as defendants. Allegations included misdiagnosis of cancer, unnecessary
prostatectomy, pain and suffering, and loss of consortium. The defense
expert witness pathologist interpreted the biopsy slides as negative
The plaintiff and his wife made excellent witnesses at their deposition.
The plaintiff testified that he had chronic pain, was incontinent
and impotent, and tired easily. He said he had not had a positive
response to Viagra or Prostin and did not want to undergo surgery
for impotence. The defense attorney felt that the wife’s testimony
was compelling. She testified, "My husband sits here in pain, wearing
a diaper, we likely won’t be able to have a normal sex life together
after 40 years of marriage, and he had this operation for no good
reason." The suit was subsequently settled on behalf of Pathologist
No.1 in the mid ranges.1
Loss prevention issues
Clinical issues and standard of care
A 65-year-old man had serial determinations of serum PSA, which
showed an increase, although the final value remained just below
the upper limit of the reference range. A prostate biopsy was performed
that was interpreted as showing adenocarcinoma. The patient underwent
a prostatectomy that revealed no evidence of carcinoma. Upon subsequent
review, several consultants could not confirm the presence of carcinoma
in the original biopsy. The patient had an unfavorable postoperative
course and filed a lawsuit against Pathologist No. 1 and his group.
In striking contrast to the prior case, Pathologist No. 1 did
not follow useful quality control procedures. The biopsy was difficult
to diagnose, but apparently no internal consultation was sought.
No recuts or immunohistochemical studies were performed to attempt
to better characterize the abnormal glandular focus thought to be
carcinoma. Finally, no external consultation was sought until after
the prostatectomy had been performed. Performance of any of these
quality control measures may have avoided the erroneous diagnosis
of carcinoma, the prostatectomy, and the lawsuit.
Cancer claims awards
Cancer-related claims are among the most costly claims experienced
by physicians, and awards continue to rise. Jury Verdict Research,
an organization that tracks and publishes jury awards in professional
liability claims, recently reported an increase in the median award
for all types of cancer claims, from $1 million in 1995 to $2.32
million in 2000.2
Seeking a second opinion in difficult or questionable cases is
one way that pathologists can gain consensus on a diagnosis and
increase defensibility of a potential claim. Consultations should
follow established practice rather than be informal hallway or "curbside"
consults. Second opinions may be even more prudent in cancer diagnoses.
Some academic medical centers, such as M.D. Anderson in Houston,
are beginning to offer second opinions via their Internet sites.3
Pathologists who use Internet sites to locate and obtain second
opinions should be careful to deal with reputable centers, follow
any state statute regarding telemedicine, and use organizations
that have technology professional liability coverage.4
1. For purposes of this article, mid ranges are
from $100,000 to $500,000.
2. Awards for cancer claims are on the
rise. Personal Injury Verdict Awards, vol. 10, issue 3, Jan.
21, 2002: 1-2. See also www.juryverdictresearch.com.
3. See Clinical & Scientific Resources
on M.D. Anderson’s Web site at www.mdanderson.org.
4. Weber DO, Toub D. Heading to the Internet
for second medical opinions. Medicine on the Net, vol. 8,
No. 1, January 2002: 1-5. See Medicine on the Net online
Susan Tannenbaum, MD, chair of the CAP Insurance Committee, concludes:
Malignant melanoma is a serious and controversial subject. Experts
sometimes differ on the best way to protect against liability in
such cases. The experts do, however, agree that one must be diligent
in documenting that every effort was made to render the proper diagnosis.
This often includes seeking and documenting an expert second opinion.
Dr. Fody, a member of the CAP Insurance Committee, is chief of the Department
of Pathology, Erlanger Medical Center, Chattanooga, Tenn. At the time of this
writing, Tan was senior communicator, health care risk services, St. Paul.