Clinical Review

4 Cases of Faulty Follow-Up: Cutting the legal risk of breast cancer screening

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References

Reality: Patients do detect malignancies by self-exam

Breast cancer can be difficult to diagnose in its earliest stages. Correct diagnosis may be preceded by multiple complementary examinations, the first of which is likely to be the patient’s breast self-examination. Although self-examination has been derided in some professional circles of late, many physicians are alerted to the presence of a breast mass only after a patient reports finding a “lump.”

Each such mass requires clinical investigation, starting with a breast exam to evaluate symmetry, contour, texture, nodularity, the mass itself, tenderness, and any nipple discharge.

Mammography is imperfect

Although mammography is the most widely used screening tool, its reliability is limited, particularly in young women, whose dense, fibroglandular tissue can obscure the diagnosis. The number of false-negative reports may make mammography a questionable diagnostic tool for symptomatic women—unless the results are positive.

No “best” technology

Ultrasound yields information about variations in tissue sound transmission, while cytology reveals the microscopic appearance of the cells and other tissue components.

Each assessment tool has its place and limitations, and these vary from patient to patient.

Lawsuit is likely if screening ends too soon

OLIVIA’S CLAIM

Negative mammogram, palpable mass

Olivia was 31 when she reported finding a mass in her breast. Her ObGyn examined her and noted “dense fibroglandular breast tissue with specific nodularity.” A diagnostic mammogram followed and was negative. When the physician observed no changes at a visit 2 months later, Olivia was told she need not return until her next annual examination. When she did, she was diagnosed with infiltrating ductal carcinoma.

After reviewing the case, defense experts noted, “It is common to find negative mammograms and yet have palpable masses that require either ultrasound or core biopsy for diagnosis. This patient had specific complaints at numerous intervals in the course of her clinical history. The physician’s inaction may have [been responsible for the] change in her clinical course.”

Olivia’s case closed with an indemnity payment of just under $1 million.

In the absence of comprehensive follow-up, a malpractice suit alleging “failure to diagnose breast cancer” is likely, as in Olivia’s case.

Misdiagnosis is another common cause of litigation. According to surveys conducted by the Physician Insurers Association of America (PIAA) in 1990 and 1995,4,5 breast cancer is the number 1 most frequently misdiagnosed condition in malpractice claims. The most common reason given by expert reviewers in the PIAA study: “Physical findings failed to impress the physician.” Consider this example:

JACQUELINE’S CLAIM

Cancer or galactocele?

Jacqueline, 33, was told by her ObGyn that a breast mass discovered while she was in labor was a “clogged milk duct.” The medical record was not annotated. When the same mass was palpated postpartum, Jacqueline was told it was a sebaceous cyst. Again, the medical record failed to reflect the findings. One year later, Jacqueline changed physicians and underwent fine-needle aspiration, which confirmed malignancy.

Defense experts faulted the physician for his poor recordkeeping and failure to order a mammogram, ultrasound, or any follow-up despite the continued concerns of the patient.

This case closed with an indemnity payment in the $1 million range.

4 essentials of good breast care

1. CLINICAL BREAST EXAM

Perform annually, at minimum
Develop and follow guidelines
Obtain medical history and identify high-risk patients
Ask the patient if she has any breast complaints
Pay special attention to any patient-detected abnormality
Ask patient if another clinician is currently providing breast care
Follow up previous complaints in both routine and episodic visits
Immediately evaluate gravidas with breast complaints
Follow to resolution any patient with a breast complaint

2. SCREENING MAMMOGRAM

Develop and follow screening guidelines
Consider screening at-risk women earlier than others
Compare current mammogram with previous films
Beware of false negatives

3. DIAGNOSTIC MAMMOGRAM (when abnormalities are present)

Have patient identify any lump or abnormality
Assume cancer until it is ruled out
Perform ultrasound if mammogram is inconclusive
If ultrasound is inconclusive, proceed to tissue diagnosis

4. TISSUE DIAGNOSIS

Perform tissue diagnosis or refer if abnormality does not resolve by follow-up breast exam or imaging studies
Correlate results of fine-needle aspiration or biopsy with clinical findings and mammography

5. OTHER IMPERATIVES

Communication

Identify which physician is coordinating care
Explain the benefits and limits of mammography to the patient
Develop and implement a system for tracking results and follow-up that includes all providers
Develop and implement a system for notifying patients of findings

Documentation

Record every step, including follow-up plan
Use a breast diagram to record physical findings

Source: ProMutual Group. Managing risk in breast care. Cambridge, Mass.

“Systems approach” to cutting risk of lawsuits

The cases of Lucy, Fiona, Olivia, and Jacqueline represent only some of the issues that give rise to malpractice claims. Since breast care is fragmented across medical specialties, a systematic approach is encouraged.

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