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

摘要: The dispute over FDA regulatory preemption is familiar: Preemption advocates assert that products liability suits stifle innovation, and proponents of tort counter the fails adequately to protect public persons injured by defective deserve compensation.The FDA's premarket approval process cannot detect all potential safety problems with a new drug; postmarketing surveillance essential, efforts in regard fall short. Advocates will find it difficult establish regulation should entirely displace system. This article examines whether case could be made for an intermediate approach - one links litigation systems effort retain benefits (and temper weaknesses) each.After comparing several possible options structural between two systems, possibility federal system involving qui tam on behalf United States as parens patriae. offered companies opt-in basis. Companies opted would submit more rigorous rules, but those rules applied judges expert agency, rather than state-court juries. Linkages agency provide information concerning issues, civil justice appropriate standards.Ultimately, such superior status quo. It does, however, support view preferable preemption. not cast debate binary contest quo; rather, they also required show other alternatives, discussed here.