What went wrong?
Lessons learned from breast pathology malpractice claims
Susan Tannenbaum, MD
Marva West Tan, RN, ARM
Following are analyses of closed breast pathology claims managed by
The St. Paul and MMI Companies Inc., St. Paul, Minn., the CAP-endorsed
professional liability insurer. Some facts may have been changed in
the following cases to protect confidentiality.
Case No. 1
Misdiagnosis of a fine-needle aspirate
Allegation: Failure to properly interpret
a pathology slide of fine-needle aspiration, misdiagnosis of breast
cancer, and unnecessary lumpectomy and left axillary node removal:
scarring, lymphedema, pain and numbness in arm, anxiety, and sleep
Defendants: Pathologist No. 1, Pathologist
No. 2, and surgeon
Facts of case: Mrs. A, a 50-year-old woman,
was seen by a surgeon in his office for a 1-cm mass at 9 o’clock
in the lower inner quadrant of her left breast. Family history was
positive for breast cancer in two sisters. Mrs. A had undergone
a prior breast biopsy for benign disease.
Following is the sequence of events:
Mrs. A was seen postoperatively for fatigue, contracting axillary
band, arm swelling, and depression, for which she received medication,
physical therapy, wrist brace, and counseling. During this time, Mrs.
A complained to more than one practitioner that she was very upset
about her experience.
- Feb. 20, 1998. The surgeon performed a fine-needle aspiration
of the mass in his office.
- Feb. 24, 1998. Pathologist No. 1 made the cytological
diagnosis of "breast needle aspirate containing clusters of malignant
epithelial cells. The pattern is that of an adenocarcinoma." A
note added that Pathologist No. 2 "has reviewed the smear and
concurs in this diagnosis." No clinical history was provided to
the pathologist. The patient was told she had malignant cells
and surgery was planned.
- Feb. 26, 1998. Mrs. A had a left breast lumpectomy and
left axillary node dissection as a hospital inpatient. The surgical
specimen was labeled a mass by the operating room staff but described
as fatty tissue in the gross pathological description. Pathologist
No. 1 diagnosed the surgical specimens as breast biopsy with area
of hemorrhage and foam cells consistent with prior needle aspirate.
Mild duct hyperplasia is present but no evidence of malignancy.
Multiple (11) axillary nodes, all negative for metastatic carcinoma.
- Feb. 28, 1998. Mrs. A was discharged.
- March 4, 1998. Outside consultant Pathologist No. 1 was
asked to provide a second opinion on the surgical pathology specimen.
- March 16, 1998. Outside consultant Pathologist No. 1
diagnosed the surgical specimens as left breast needle aspiration
biopsy-atypical ductal cells present. Left breast excisional biopsy
and axillary lymph node dissection-mild duct hyperplasia, no evidence
of carcinoma, 11 benign lymph nodes.
- March 18, 1998. The surgeon informed Mrs. A that her
breast mass was benign. This occurred 20 days after the procedure
and 22 days from when Mrs. A was informed that the FNA showed
Legal action: Approximately two years after
surgery, Mrs. A filed a suit naming the surgeon and Pathologists
No. 1 and No. 2 as defendants. Expert pathology witness No. 1, in
a blind review, indicated that he interpreted the cytopathology
slide of the fine-needle aspiration as infiltrating ductal carcinoma.
Expert pathology witness No. 2 interpreted the slide as entirely
benign duct cells. The case was settled in the low ranges,* with
approximately one-third of the settlement allocated to the two defendant
pathologists and two-thirds to the surgeon.
Clinical issues and standard of care: This
may have been a difficult fine-needle aspirate to interpret—the
first expert pathologist agreed with the original diagnosis, while
the second expert pathologist disagreed. One should remember that
in interpreting breast fine-needle aspirate specimens, an impression
of "suspicious cells, suggest biopsy for confirmation," may be more
prudent than an unequivocal diagnosis of malignant cells, unless
the features of malignancy, such as increased cellularity, dyshesion,
monomorphism, nuclear membrane irregularity, and presence of macronucleoli,
are clearly seen.1 The finding
in the original FNA of "clusters of malignant cells" raises questions
about lack of dyshesion and might, therefore, cause one to reconsider
a diagnosis of malignancy. This is especially true if the habits
of the surgeon are not completely known to the pathologist or when
it is not possible to discuss the findings with the surgeon.
The surgeon’s practices are also at issue. The surgeon did not
perform a triple test—that is, a mammogram, clinical examination,
and FNA—and communicate these findings to the pathologist.
Furthermore, although a lumpectomy following an equivocal, suspicious,
or malignant interpretation of an FNA is within the standard of
care, performing a lymph node dissection without a tissue diagnosis
is needlessly aggressive. In 1998, when the surgery was conducted,
performing a sentinel node biopsy would have been within the standard
of care, but not without a tissue diagnosis. The surgeon requested
a frozen section to evaluate the margins of the lumpectomy but did
not request a frozen section diagnosis of the lesion to confirm
the FNA findings before proceeding to lymph node dissection. Since
the procedure was a lumpectomy for a clinically palpable mass, a
frozen section of the lesion would have been in order and would
have most likely prevented the lymph node dissection. If loss of
diagnostic tissue due to frozen section was perceived to be a problem,
an intra-operative touch preparation might have revealed the true
nature of the ill-defined breast mass.
When Pathologist No. 1 became aware of the discrepancy between
the FNA and biopsy material for this patient, he should have issued
a timely report that reflected this discrepancy.
A reasonable way to have handled this would have been to include
the following statements in the biopsy report:
These actions serve two purposes: They generate a complete report
and give the impression of a conscientious pathologic review of the
case, and they establish a timely and forthright process that avoids
a delay in telling the patient about an unanticipated outcome.
- A clear, unequivocal tissue diagnosis, such as, "fibrocystic
condition, proliferative type, with intraductal hyperplasia, apocrine
metaplasia, etc. . . ."
- A clear, explicit review of the cytology (FNA) material with
a reinterpretation of the cells in light of the tissue findings,
suggesting that the atypical cells seen on the FNA were reinterpreted
as within the spectrum of fibrocystic condition. Since hemorrhage
and foam cells were seen in the biopsy material, it is unlikely
that the cytologic and tissue samples came from different areas
of the breast.
- A statement that a final or addendum report would follow after
the relevant material was reviewed by an outside consultant (outside
consultant Pathologist No. 1).
While referring the case to an outside consultant for examination
is reasonable, this should not delay reporting to the patient for
Finally, holding a frank discussion of the problem with the surgeon
is in order. Delivering unanticipated news to a patient should be
handled with great care, regardless of whether the news is good
or bad. The pathologist and surgeon can discuss how to formulate
the language to be used with the patient.
Lack of clinical history from the surgeon:
The surgeon did not provide a clinical history to Pathologist No.
1 with the fine-needle aspiration specimen. Pathologists should
educate referring physicians about the importance of providing a
clinical history or contact the physician for more information if
necessary. Expert witness No. 2 noted that a pathologist should
be more cautious in issuing a diagnosis of a malignancy in the absence
of clinical history.
Delay in reporting results to the patient:
The delay of approximately three weeks in informing the patient
that she did not have breast cancer may have contributed to Mrs.
A’s stress, anxiety, and dissatisfaction with her care, or even
to a perception that her physicians were not being honest with her.
Clinical pathology laboratories should be able to provide prompt
turnaround of results, including outside consultations, and should
employ methods to keep referring physicians and their patients informed
of delays, particularly when a critical diagnosis is under consideration.
Patient with unanticipated outcomes: Mrs.
A’s repeated complaints that she was upset about her unanticipated
outcome was an indicator of a potential claim. Following unanticipated
outcomes, patients often need more than one opportunity to discuss
the event and ask questions. Good patient-physician communication
is thought to be one of the best protections against professional
liability claims. Early intervention following an unanticipated
outcome in the form of an honest discussion of the event, emotional
support, empathy, and necessary medical care, may prevent a complaint
from becoming a claim. The organizational risk manager and legal
counsel can provide advice on how to discuss an event without admitting
While the moral and ethical precepts of being honest with patients
are not new, the concept of disclosure following unanticipated outcomes,
including medical errors, has received increased national attention
in the wake of the current emphasis on patient safety. As of July
1, 2001, the Joint Commission on Accreditation of Healthcare Organizations’
new patient safety standards required that "Patients, and when appropriate,
their families are informed about the outcomes of care, including
unanticipated outcomes."2 This
standard is a work in progress, and many procedural issues need
to be resolved. Some facilities, such as the Veterans Affairs Medical
Center in Lexington, Ky., have followed a disclosure policy for
years and believe this approach has moderated liability payments.3
Pathologists should familiarize themselves with their facilities’
disclosure policies and procedures following unanticipated outcomes,
and they should consider how they can collaborate with referring
physicians to strengthen patient-physician rapport.
1. DeMay RM. The Art and Science of Cytopathology.
Chicago, Ill.: ASCP Press; 1996;2:866.
2. JCAHO. Accreditation Manual for Healthcare
Organizations. Patient Safety Standard [RI.1.2.2.]. Oak Brook,
Ill.: JCAHO; 2000.
3. Kraman SS, Hamm G. Risk management: extreme
honesty may be best policy. Ann Intern Med. 1999;131(2):
Case No. 2
Misdiagnosis of a breast biopsy
Allegations: Misdiagnosis of breast biopsy,
delay in diagnosing breast cancer, failure to conduct proper evaluations
and re-evaluations, pain, and mental and physical anguish.
Defendants: Surgeon No. 1, Pathologist No.
1, Pathologist No. 2, pathology group practice, radiologist, and
hospital. All defendants, except Pathologist No. 2 and the pathology
group practice, were dismissed.
Facts of case: Mrs. C, a 41-year-old woman,
found a lump on her left breast during breast self-examination.
A mammogram report identified no abnormality but an ultrasound revealed
a solid mass in the left breast. The radiologist recommended biopsy.
The patient’s family physician referred her to Surgeon No. 1.
Following is the sequence of events:
Outside consultant Pathologist No. 1 noted in his report that both
biopsies showed an invasive carcinoma with tubular and invasive cribriform
patterns as well as intraductal cribriform component. The predominant
pattern, however, was tubular, and the lesion was classified as tubular
- Aug. 20, 1993. Surgeon No. 1 noted a 1- to 1.5-cm nodular
density in the superior central portion of the left breast and
performed an outpatient incisional biopsy.
- Aug. 20, 1993. Pathologist No. 1 completed a gross evaluation
and frozen section of the breast biopsy and deferred diagnosis.
- Aug. 21, 1993. Pathologist No. 1 was not on duty so Pathologist
No. 2 completed the microscopic evaluation of the breast biopsy
specimen and reported the diagnosis as complex sclerosing lesion
(radial scar), left breast.
- August 1993. Surgeon No. 1 advised the patient that the
biopsy showed no cancer and recommended a followup mammogram in
- July 1994. The patient had a mammogram, which did not
reveal a mass. Ultrasound was -not performed.
- December 1994. The patient found a second lump in her
left breast. Surgeon No. 1 advised her that it was scar tissue
or neurophysical changes -related to menstruation or perimenopause.
A mammogram taken around this time noted that neoplastic lesion
couldn’t definitively be excluded.
- January 1995. On physical examination, Surgeon No. 1
found an abnormality inferior to the left superior central biopsy
site, which was more pronounced than the earlier finding at 1.5
to 2 centimeters. Surgeon No. 1 recommended an incisional bi-opsy
and it was completed on April 4.
- April 4, 1995. Pathologist No. 3 diagnosed the second
incisional -bi-op-sy as well-differentiated invasive ductal carcinoma.
Tumor focally appears to be present at the margin of surgical
- April 10, 1995. Outside consultant Pathologist No. 1
issued a report after reviewing slides from the Aug. 20, 1993
and April 4, 1995 breast biopsies. The report stated that the
Aug. 20 biopsy slides showed tubular carcinoma and ductal carcinoma
in situ, and the April 4 biopsy slides showed tubular carcinoma.
Mrs. C experienced emotional distress postoperatively and was treated
with antidepressants. She was offered but declined counseling. The
patient then underwent four cycles of chemotherapy and a course of
- April 17, 1995. Surgeon No. 1 recommended a mastectomy with
lymph node removal.
- April 20, 1995. Outside consultant Pathologist No. 2 reviewed
both sets of biopsy slides and reported that the Aug. 20, 1993
biopsy slides showed left breast, tubular carcinoma, and the April
4, 1995 slides also showed left breast, tubular carcinoma. The
pathologist added a note indicating the presence of a cribriform
component but predominant tubular pattern.
- April 24, 1995. The patient elected to go to Surgeon No. 2 for
the left modified radical mastectomy and lymph node excision with
left breast reconstruction.
- April 25, 1995. Pathologist No. 4 issued a report following
the mastectomy with the diagnosis of adenocarcinoma, metastatic
within three of 17 left axillary lymph nodes. The report also
noted that no residual carcinoma was found in the biopsy site.
Estrogen receptor negative, progesterone receptor focally positive
(analysis performed in a specialty laboratory).
- April 26, 1995. Outside consultant Pathologist No. 3 reviewed
the biopsies from April 20, 1995 and reported lymph node with
metastatic adenocarcinoma consistent with breast primary. Estrogen
receptor negative, focally positive for progesterone receptor.
Legal action: Approximately four months after
the mastectomy, Mrs. C filed a claim naming Surgeon No. 1, Pathologist
No. 1, Pathologist No. 2, the pathology group practice, a radiologist,
and the hospital as defendants. All defendants, except for Pathologist
No. 2 and the pathology group practice, eventually were dismissed.
Mrs. C’s treating oncologist, on deposition, stated that Mrs. C
had a stage II cancer on diagnosis, which reduces her long-term
survival relative to a stage I cancer. The oncologist had no opinion
regarding the patient’s prognosis had she been diagnosed with cancer
in August 1993 rather than April 1995. The pathology expert witnesses
consulted were not able to support Pathologist No. 2’s diagnosis
of the initial breast biopsy. The claim was settled in the mid ranges*
on behalf of Pathologist No. 2 and the pathology group practice.
Clinical issues and standard of care: The
distinction between radial scar and tubular carcinoma is known to
be problematic mammographically, since tubular carcinoma resembles
and may arise in a radial scar, and histologically in a core biopsy
or frozen section, where the full architectural appearance of the
lesion may not be appreciated or where freezing artefact may distort
the morphological appearance.
In difficult cases, immunostaining for actin is helpful in identifying
the myoepithelial cells of benign lesions, while S-100 and 34BE12
stains are less specific.1,2
Perhaps the best lesson from this case is that you won’t make
the diagnosis if you’re not thinking of it. For this reason, some
pathologists routinely get a second opinion from a colleague on
all but the most obvious radial scar or sclerosing adenosis lesions.
Another quality assurance measure applicable to this case is to
review and compare the frozen section diagnosis with the permanent
section diagnosis, particularly when two members of the group have
made the respective interpretations. In this case, the error might
have been caught early since the first pathologist deferred the
frozen section interpretation while the second made the diagnosis
on permanent section.
High-risk diagnosis-breast cancer: Missed or delayed breast cancer
diagnoses are one of the most frequently litigated and costly categories
of physician claims. These claims often involve women under age
50 who present with a self-identified lump. Many were either not
referred for further evaluation or had no followup testing after
a negative mammogram. While women’s health care providers, such
as family physicians, internists, and gynecologists, compose the
largest group of defendants, surgeons, radiologists, and pa-thol-ogists
are often defendants.3 Kern notes
that a negative mammogram report, such as Mrs. C had in July 1994,
should not deter a clinician from further evaluation in the presence
of a palpable mass suspicious for carcinoma.4
All physicians need to be aware of the risk issues seen most often
in breast-related claims. Because breast care is fragmented across
many specialties, some insurers recommend implementing clinical
algorithms for evaluating and treating breast problems.5
Other risk-prevention strategies include thoroughly documenting
clinical data, tracking and following up test results, and setting
up strong lines of communication among physicians and between patients
and their physicians.
1. Tavassoli F. Pathology of the Breast.
2nd ed. New York, NY: McGraw Hill Health Professions Division; 1999:440.
2. Rosen P. Breast Pathology Diagnosis by Needle
Core Biopsy. Philadelphia, Pa.: Lippincott Williams & Wilkins;
3. Zylstra S, et al. Defense of breast cancer
malpractice claims. The Breast Journal. 2001;7(2):76-90.
4. Kern KA. Breast cancer and malpractice: a surgeon’s
perspective on risk prevention. Seminar Breast Disease. 1998;1:22-31.
5. Managing Risk in Breast Care: Circle of Care:
a set of breast care algorithms. Risk Management Foundation, Harvard
Medical Institutions and ProMutual Group of Massachusetts; 2001.
Dr. Tannenbaum is a pathologist at Quest Diagnostics Inc., Teterboro, NJ,
and chair of the CAP Insurance Committee. Tan is senior communicator, health
care risk services, The St. Paul. The authors would like to thank Helen Feiner,
MD, a pathologist specializing in breast pathology, for her expert review of