Patient Protection and Decision Aid Quality: Regulatory and Tort Law Approaches

Abstract

One of the most enduring debates at the intersection of administrative and tort law focuses on the challenge of identifying the most effective means of ensuring consumer safety. In some circumstances, standard-setting administrative regulations may be sufficient to protect consumers from harm while at the same supporting the growth of valuable industries. In other circumstances, regulation may need to be supplemented by a complementary tort regime that fills the compensation gap when consumers suffer injury. The discussion among policymakers and legal scholars about which system to favor is continually playing out in a variety of arenas, most notably in the medical industry – two recent Supreme Court decisions analyzing the preemptive effect of regulation in the pharmaceutical and medical device industries have addressed this critical issue head-on.A new development in medical practice promises to re-invigorate this debate. Many physicians are now incorporating decision support tools (also known as patient decision aids), such as brochures and videos that present facts and patient testimonials about treatment options, into the patient care process. Indeed, the 2010 Patient Protection and Affordable Care Act recognized the use of decision aids as one of the most promising developments in contemporary informed consent practice, and proposed a process for certifying decision aids before they are put into use. Commentators, however, have expressed concern that decision support tools created by for-profit corporations or other interested parties may dramatically increase the risk of exposing patients to bias and misinformation, particularly given the fact that no legal mechanism currently exists to protect against such harms. This Article is the first to position the expanded use of decision support tools within the greater scholarly conversation about administrative and tort law approaches to patient protection. It identifies key factors that policymakers in medical, environmental, and other contexts use to distinguish between situations where regulation alone may be sufficient to protect the public, and those where a complementary tort remedy may be necessary. When these factors are applied in the context of patient decisions, this Article argues that ex ante regulation may not be sufficient to guarantee the quality of decision support tools in the absence of a complementary tort remedy. This Article concludes by identifying the steps that would need to be taken to establish a system of ex post tort liability for creators of faulty decision aids, and explains the challenges associated with such a move.[SSRN posted version is a pre-publication draft]