Personalized medicine and genetic malpractice

Abstract

Angelina Jolie’s recent revelation that she had prophylactic surgery to reduce her breast cancer risk after BRCA genetic testing has increased public interest in preventive genetic testing. This so-called “Angelina effect” exemplifies a growing consumer interest and medical uptake of genetic testing in response to the increased availability and utility of clinically relevant genetic data. The advent of next-generation DNA sequencing will fur ther accelerate this trend toward increased reliance on genetic data in the health-care system, and health-care providers, in almost every specialty, will be required to have some familiarity with genetic data. Yet, as the use and usefulness of genetic information in clinical decision making continues to expand, the specter of lawsuits against physicians and other health-care entities for genetic malpractice also becomes a reality. Consider the following three cases from the past year, which illustrate three major areas of genetic testing in which potential liability is a growing concern—cancer predisposition screening, prenatal testing, and pharmacogenomic profiling. A woman from Connecticut sued her physician for failing to warn that her extensive family history of breast cancer suggested a genetic risk of ovarian cancer. The Connecticut Supreme Court recently upheld a $4 million jury verdict to her after she went on to develop ovarian cancer. 1 A couple from Oregon successfully sued their physicians and hospital for negligence in performing and interpreting prenatal genetic testing for Down syndrome. The jury awarded the par ents $3 million in damages after the child was born with Down syndrome. 2 A woman from California sued her health-care providers for prescribing carbamazepine without first recommending genetic testing as recommended by the label approved by the Food and Drug Administration for patients of Asian ancestry. The woman, who is of Asian descent, developed Stevens– Johnson syndrome after being prescribed the drug. Her case is currently in arbitration. 3 It is too early to tell whether the initial wave of lawsuits against health-care providers for their alleged failure to recommend or properly interpret genetic testing will turn out to be a ripple, a rough chop, or a tidal wave. Of course, physicians are not the only potential target of such genetic malpractice lawsuits, as drug manufacturers, device makers, testing laboratories, health insurers, hospitals, genetic counselors, and even pharmacists face liability risks relating to genetic data or testing, although most of these potential targets often have effective defenses that shield them from liability. For example, drug manufacturers are protecting themselves from failure-to-warn claims by increasingly putting genetic information in the patient package insert, which shifts the liability exposure for warning patients about such risks to physicians under the learned intermediary doctrine. Healthcare payers and pharmacists often have statutory defenses that help limit their liability, which again are unavailing to physicians. Thus, physicians have been the targets of most genetic malpractice lawsuits to date and are likely probably to be at the greatest risk going forward. As we enter the era of personalized medicine, noninvasive prenatal testing and whole-genome sequencing, several factors suggest that physicians, in particular, will face growing risks of legal claims for genetic malpractice. 4 First, and most generally, history demonstrates that new medical technologies usually spur increases in medical malpractice litigation. 5 In part, this is a reflection of the reality that the more a provider is capable of doing, the more he or she should do, and the more something can go wrong and lead to a lawsuit. For example, before the advent of renal dialysis, most patients with renal failure died with few lawsuits filed; however, after dialysis became available, many more patients survived, yet more patients also filed lawsuits based on mistakes in using the technology or because the expectations of patients outpaced the actual performance of the new technology. 6 Similar trends have been documented surrounding the emergence of antiseptic practices, laparoscopic techniques and, now, even medical robotics. Moreover, when a new technology such as genetic testing is taken up by medical professionals unevenly, a gap develops between the care provided by early adopters versus that by late adopters, again providing an opening for liability based on the disparity in treatment, with both early adopters and late adopters facing potential risks for being too quick or not quick enough to adopt the new technology. Second, and more unique to personalized medicine, there are significant disagreements about the scope and timing of the implementation of genetic testing in the clinical context. Some experts contend that many personalized medicine applications are ready to be used now, whereas others advocate for a more cautious approach. For example, there is disagreement on whether genetic testing should be required before prescribing drugs such as warfarin or clopidogrel. These types of disagreements provide rich fodder for litigation. Moreover, given the rapid pace at which technology and clinical applications are