The FDA and the Tort System: Postmarketing Surveillance, Compensation, and the Role of Litigation

Abstract

Both the tort system and the FDA seek to protect consumers of medical products. The tort system provides compensation when a consumer is harmed by a defective product and sets incentives for companies to design safer products. The FDA imposes an elaborate system of prior restraint: Pharmaceuticals and some medical devices must undergo extensive testing and stringent risk/benefit analysis before the FDA will approve them for marketing. Formerly, the FDA viewed its risk/benefit analysis as setting a floor but not a ceiling for product safety: FDA-approved products could be marketed, but the manufacturer might still incur liability if a court later decided that a product was defective or a warning was inadequate. This view has changed in recent years, however, as policymakers have stressed the need to bring innovative medical treatments to market. Some now argue that the FDA review process should set both a floor and a ceiling: FDA approval of a new product indicates not only that the product can be marketed, but that it should be; FDA rejection of a proposed product warning means not only that the warning is unnecessary, but that it could be counterproductive.