Many observers consider the Food and Drug Administration (FDA) vital for the protection of consumer health and safety. One hundred years ago, Congress established the entity that would become the FDA and authorized it to regulate foods and drugs, critical responsibilities that the agency has long discharged carefully. Throughout the past century, the FDA's regulatory power has expanded systematically, albeit gradually, while legislatures and courts in the fifty American jurisdictions broadened liability exposure for manufacturers that sold defective products that injured consumers. Observers have recently criticized the agency for overseeing pharmaceuticals too leniently, even as states increasingly narrowed manufacturers' liability exposure. For instance, numerous jurisdictions have elevated burdens of proof and circumscribed damage awards.

Substantially less clear is the relationship between FDA regulation and the products liability cause of action. Conventional wisdom holds that agency mandates and common law suits occupy distinct, albeit intersecting, universes. Comparatively few legislative and judicial bodies in the states assign great relevance to defendants' conformity with regulation, and only a small number expressly apply a "regulatory compliance defense." However, scrutiny reveals that more jurisdictions address conformity in ways that profoundly, yet subtly, affect the cause of action. Because compliance and the defense have significant effects on personal injury litigation, they require evaluation, which this Article undertakes.

Part I provides an overview of this Article's scope. Part II then descriptively analyzes the origins and expansion of FDA regulation. Part III details the weight legislatures and courts have traditionally accorded compliance and the increasing relevance that both assign to the concept, ascertaining that a growing number of states make conformity a factor that limits defendants' liability exposure. Part IV next reviews whether the disadvantages of this phenomenon outweigh the benefits and finds that they do. This Article concludes by proffering suggestions that recognize the compelling societal value of drugs, the importance of uniform manufacturer regulation, and the acute need for the essentially individualized patient consideration that common law suits afford.

Document Type


Publication Date