Physician liability: the next big thing for personalized medicine?

The era of personalized medicine is approaching – more slowly than many originally predicted, but nevertheless advancing in fits and starts [1]. The central concept of personalized medicine is sound – healthcare can potentially be more effective and efficient if it is personalized by targeting the genetic or molecular profile of individual patients rather than applying the traditional ‘one-size-fits-all’ approach to diagnosis and management. As Francis Collins, the Director of the US NIH, recently noted, “the power of the molecular approach to health and disease has steadily gained momentum over the past several decades and is now poised to c atalyze a revolution in medicine” [2]. Yet, despite the promise and potential, a variety of impediments and barriers have slowed down the implementation and uptake of personalized medicine [3]. Notwithstanding a few noteworthy exceptions, there has been relatively little application of molecular profiling in the routine practice of medicine to date [1,4,5]. A number of specific challenges have been identified to the wider integration of personalized medicine into routine medical care, including: clinical usefulness and improved outcomes will need to be demonstrated; tests will need to be validated and their costs will need to come down; payers will need to reimburse fairly for genetic tests; and physicians will need to increase their knowledge about genetics in general [6,101]. Liability serves as a wild card in the rollout of personalized medicine, though it is a factor that has received relatively scant attention to date [7–10]. As has been seen for many other scientific advances, liability can be a powerful driver for widespread behavioral change and the adoption of emerging technologies, an effect that may be beneficial or detrimental to the overall societal welfare depending on the circumstances. In the context of genetics, liability could drive the adoption of beneficial personalized medicine technologies that promote patient safety and allow patients to avoid unnecessary costs and side-effects. Alternatively, liability could force actors to prematurely deploy technologies that are unproven, wasteful and detrimental to healthcare. More likely, liability will have both effects in different scenarios and contexts. To date, there have been but a smattering of lawsuits asserting liability claims based on personalized medicine. But the nature and dynamics of these types of personal injury and medical malpractice lawsuits is that the activity smolders at a low level for years until suddenly catching fire and engulfing entire companies, industries or practice areas in an inferno of expensive litigation. As new genetic technologies and procedures slowly infuse the practice of medicine, the potential impacts of liability relating to p ersonalized medicine must be considered. This article addresses the potential role of liability in personalized medicine, focusing primarily on physicians. The next section describes the dynamic nature of liability for medical technologies generally, noting the potential of innovative technologies and Liability is likely to be a major driver for the future direction and implementation of personalized medicine, spurring the adoption of genetic tests and other pharmacogenomic technologies, in some cases appropriately, and in other cases prematurely or as inefficient defensive medicine. While all entities in the personalized medicine chain will face liability risks, physicians will be at the greatest risk owing to their lack of defenses, limited experience in dealing with genetics and the growing disparities within the profession in implementing new medical technologies. The history of liability for genetic testing, primarily in the prenatal testing context, suggests that liability will often be both unpredictable and influential in changing medical practice. It is critical to anticipate and attempt to prevent such liability risks in a proactive manner so to minimize the disruptive impact that liability can cause.