Genomics is becoming a prevalent part of medical practice as we move into an era of personalized or precision medicine. Yet most physicians have had no formal training in genetics, and there are concerns about whether the health infrastructure is prepared for the clinical implementation of genomic medicine. Given this situation, medical malpractice litigation, which we refer to in the genomics context as genomic malpractice, would seem to be a major threat to health care providers. This paper identifies ten "red flags" signaling potential liability risk for health care providers relating to genomic medicine. Additionally, this paper provides the first ever comprehensive empirical study of genomic malpractice litigation in the United States. Over the past 40 years of such litigation, the frequency of such cases has risen modestly, but still remains at a fairly low level with 12 or fewer reported cases being closed per year. A total of 202 reported cases were identified and analyzed. Even more perplexing, the cases that have been litigated demonstrate a relatively high rate of success for plaintiffs; moreover, the average payout in such cases is an order of magnitude higher than traditional medical malpractice cases. The study concludes by assessing the reasons behind the relatively low rate of litigation, which is attributed primarily to the slower than expected uptake of genomic medicine by health care providers and the reluctance of plaintiffs' lawyers to take such complex and scientifically-intense cases. However, given the 10 red flags discussed in the paper and the herd behavior of plaintiffs' attorneys, there is no basis for complacency going forward as genomics continues to infuse more and more areas of the practice of medicine.
|Original language||English (US)|
|Number of pages||37|
|Journal||Food and Drug Law Journal|
|State||Published - Jan 1 2018|
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