It has been more than a decade since the last malpractice crisis and, as the insurance market has stabilized, healthcare providers have benefited from stable-to- falling premiums. This same pattern of calm-after-the-storm was seen with the malpractice crises of the 1970s and 1980s, and on both occasions the respite was short-lived.
Although we do not know when the next crisis will appear or what form it will take, the millions of patients who meet criteria for cancer-related, genetic testing but who have not been tested represent an area of potentially overwhelming exposure.
The two main concerns are BRCA mutations and Lynch Syndrome. Approximately 1 in 400 persons carries a pathogenic, BRCA mutation. Affected women have a 50-70% lifetime risk of breast cancer and a 15% to 64% lifetime risk of ovarian cancer. Lynch Syndrome (hereditary non-polyposis colon cancer) is even more common, affecting 1 in 350 patients. These individuals face a 70% lifetime risk of colon cancer, along with elevated risks of endometrial, gastrointestinal and genitourinary cancers. For most of these patients, their genetic mutation and associated cancer risk is their most important healthcare issue.
Based on a population of 320 million people, there are nearly two million carriers of these mutations in the United States. For an average-sized primary care practice of 2,400 patients, this equates to six patients with BRCA mutations and seven patients with Lynch Syndrome.
Unfortunately, despite the presence of screening recommendations from multiple scientific entities and the increased awareness created by the actress Angelina Jolie’s revelation that she carried a BRCA mutation, the vast majority of these patients have not been tested and fewer than 5% have been identified. This is not only a public health concern, it is a medical-legal powder keg.
Because it takes time for lawsuits to progress through the legal system, published opinions related to genetic testing are just starting to appear. A Connecticut case, Downs v. Trias, involved a 48-year-old mother who met criteria for BRCA analysis. Unfortunately, her physician failed to appreciate this and the patient went untested. She subsequently developed ovarian cancer, was found to be BRCA positive and sued her physician, alleging that timely genetic testing would have allowed her to undergo prophylactic surgery and thereby avoid ovarian cancer. At trial, the jury awarded her $4 million, an amount that was upheld on appeal.
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This type of lawsuit is problematic in several ways. First, because genetic testing of at-risk individuals is currently recommended by multiple organizations (e.g., USPSTF, ACOG, ASCO and ACS), it is difficult to defend a physician who does otherwise, especially given the severity of the potential consequences.
Second, because these cases usually involve serious injury or premature death from a preventable cancer, they are expensive to settle. Finally, because the mutations are relatively common, the overall cost quickly becomes unmanageable.