College of American Pathologists
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What went wrong?

Lessons learned from breast pathology malpractice claims

April 2002
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 disruption.

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:

  • 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 malignant cells.
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.

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:

  • 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).
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.

While referring the case to an outside consultant for examination is reasonable, this should not delay reporting to the patient for two weeks.

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 liability.

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): 963-967.

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:

  • 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 one year.
  • 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 resection.
  • 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.
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 carcinoma.

  • 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.
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 radiation therapy.

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; 1999: 127.

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 this article.