The Battle for Implied Preemption: Products Liability and the FDA

Abstract:     
A mere five years ago, the FDA began, for the first time in its 100 year history, to take the position that its prescription drug labeling regulations defeated the ability of injured plaintiffs to pursue common law tort claims based on the adequacy of the labeling. This position, radical to many and rational to others, places federal preemption of prescription drug labeling actions directly in the center of the debate over the proper roles of federal regulation and state tort laws in promoting product safety. The Supreme Court has added to that debate with a number of product liability preemption decisions in the past two decades. Seeking to promote both understanding and balance regarding the operation of preemption doctrine within products liability, this Article provides a comprehensive explanation of the applicability of preemption doctrine to prescription drug product liability actions. It explores the history of preemption doctrine as it relates to the food and drug laws, evaluates the arguments posited in favor of and against preemption, assesses the FDA's position on the application of that doctrine to current litigation, and provides direction to courts in defining the boundaries of implied preemption.

Keywords: products liability, preemption, food and drug laws, tort law

Working Paper Series