Liability in the delivery of personalized medicine: driver, impediment, or both?

Personalized medicine (PM) has the potential to transform medicine and the health care system over the next decade. An overlooked variable that will play an important role in the implementation of PM is the potential for legal liability. Physicians, a key gatekeeper in the uptake of PM, are at the greatest risk of liability. Currently, there is great uncertainty, disagreement and rapid change with regard to the use of PM tests in clinical care. It is during this period of uncertainty and change where the potential for liabilityis at its greatest and thus the need for comprehensive legal research and analysis of the intersection of these issues is most pressing. This proposed project seeks to fill the gap in the understanding of PM liability risks by providing legal doctrinal, empirical, and policy research on the risks, impacts and possible policy approaches with regard to PM liability. The results of this project can help to better understand and predict the future course of PM and to identify the key legal and policy levers that may be available to ensure that liability plays a beneficial rather thn detrimental role in the implementation of PM. This project has five primary objectives. This project will provide a comprehensive investigation and analysis of potential liability to physicians, first by examining the applicable claims, defenses and doctrines that will, provide the legal framework for liability, and which themselves are currently undergoing important changes. Second, we will evaluate the potential risks of liability to physicians by integrating the doctrinal analysis with the fact patterns and evidence in four likely PM case studies, as well as by evaluating liability lessons from the uptake of previous medical technologies and practices. Third, we will examine the likely impact liability will have on physicians, patients, and the broader adoption, availability and implementation of PM. Fourth, we will identify and evaluate policy tools that can be used to better manage risks and uncertainties in the PM arena. Finally, we will communicate the findings and implications of our project through an outreach program targeting three key stakeholder groups: (i) physicians and medical educators; (ii) patient groups and advocates; and (iii) legal practitioners (including judges). At this critical juncture in the rollout of PM, before widespread liability has taken hold, it is very important and useful to comprehensively study and make widely available the best information and projections of the risks and relevant factors for physician liability relating to PM. PUBLIC HEALTH RELEVANCE: The advent of personalized medicine (PM) has the potential to greatly impact and improve patient care by providing the opportunity for better tests, better drugs, and overall better health outcomes. The increased risk of legal liability for physicians wil ultimately influence which technologies will be adopted and rejected in the PM space, shape the relevant standard of care, dictate public health outcomes, and affect access to PM technologies and the care that the ultimate beneficiary, the patient, receives. Better understanding, communication and policy interventions relating to PM liability risks can help to ensure that liability has a beneficial rather than detrimental impact on PM uptake and implementation.