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The Fda And The Tort System: Postmarketing Surveillance, Compensation, And The Role Of Litigation, Catherine T. Struve

All Faculty Scholarship

The dispute over FDA regulatory preemption is familiar: Preemption advocates assert that products liability suits stifle innovation, and proponents of tort liability counter that the FDA fails adequately to protect the public and that persons injured by defective products deserve compensation. The FDA's premarket approval process cannot detect all potential safety problems with a new drug; postmarketing surveillance is essential, and the FDA's efforts in that regard fall short. Advocates of preemption will find it difficult to establish that FDA regulation should entirely displace the tort system. This article examines whether a case could be made for an intermediate approach …