PHILADELPHIA—“Breast cancer is the most frequent misdiagnosis leading to professional liability litigation, and the most common breast cancer malpractice lawsuit is for misdiagnosis,” Kenneth Kern, MD, said at a 47th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG). Furthermore, failing to detect breast cancer is among the top three law-suit-causing diagnostic errors made by internists, radiologists, general surgeons, OB-GYNs, and family practitioners, said Dr. Kern, of the University of Connecticut School of Medicine and Dartmouth Medical School. Dr. Kern derived these conclusions from several databases, including the NCI’s SEER (Surveillance, Epidemiology and End-Results) Program, the Physician Insurers Association of America Data Sharing Reports, and the US Civil Litigation survey.
Among plaintiffs claiming misdiagnosis of breast cancer, the subgroup suing because of diagnostic delay has clear characteristics, Dr. Kern said. Their triad of characteristics include a false-negative mammogram, a self-discovered breast mass, and young age.
Between the age when a cancer commonly occurs and the median age of malpractice litigants lies an age differential that Dr. Kern called the “litigation gap.” It ranges from 8 years in male reproductive cancers to 27 years in female reproductive cancers. “Seventy-five percent of all breast cancer patients filing diag-nostic-delay malpractice suits are under age 45 (median, 42),” he noted.
An uncommonly young age for cancer is also the most frequent factor in misdiagnosis lawsuits involving eight other cancers: cutaneous, gastrointestinal, head and neck, lung, male reproductive, female reproductive, musculoskeletal, and urologic, Dr. Kern added.
False-Negative Mammograms
In the triad of characteristics common to these misdiagnosis lawsuits, a false-negative mammogram is not a particularly surprising element. “It’s almost random whether you will see something or not on a mammogram for a woman under 50,” Dr. Kern said, adding that physicians typically support settling these cases out of court.
In almost 75% of breast cancer misdiagnosis suits, physicians found a palpable mass on initial presentation, but subsequently performing mammography still left them open to a substantial risk for misdiagnosis and lawsuits.
“About half of misdiagnosis lawsuits involve a negative mammogram with palpable mass present,” Dr. Kern said. “Yet attempts at diagnosis beyond mammography are virtually nonexistent. Physicians are lulled into the misdiagnosis of breast cancer by the young age of patients and false-negative readings of mammography, not by vague findings or difficult diagnostic situations.”
To reduce their exposure to lawsuits when patients present with palpable findings and negative mammograms, Dr. Kern advised physicians to make liberal use of fine-needle aspiration biopsy, large-core biopsy, or open surgical biopsy.
Dr. Kern noted further that with the media attention given the breast cancer prevention conferred by tamoxifen(Drug information on tamoxifen) (Nolvadex) in recent trials, patients are spontaneously asking, “At what level of risk do I need tamoxifen?” To answer that question, Dr. Kern suggested use of widely available risk calculators, such as the “risk disk,” distributed by Zeneca and others. ASCO’s Special Working Group, in its Technology Assessment Report, concluded that women age 35 and older with a 5-year cancer risk of 1.7% or higher may be considered tamoxifen candidates, based on all available literature from 1990 to 1998.
