83 Pages Posted: 21 Sep 2004 Last revised: 29 Jan 2010
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 - one that links the regulatory and litigation systems in an effort to retain the benefits (and temper the weaknesses) of each.
After comparing several possible options for structural links between the two systems, the article examines the possibility of a federal products liability litigation system involving qui tam suits on behalf of the United States as parens patriae. The system could be offered to companies on an opt-in basis. Companies that opted in would submit to more rigorous liability rules, but those rules would be applied by federal judges and an expert agency, rather than by state-court juries. Linkages between the litigation system and the agency could provide the agency with information concerning potential safety issues, and could provide the civil justice system with appropriate liability standards.
Ultimately, the article fails to establish that such a system would be superior to the status quo. It does, however, support the view that such a system would be preferable to preemption. Advocates of preemption should not cast the debate as a binary contest between preemption and the status quo; rather, they should also be required to show that preemption is superior to other alternatives, such as those discussed here.
Keywords: federal regulation, preemption, products liability, product safety, torts
Suggested Citation: Suggested Citation
Struve, Catherine T., The FDA and the Tort System: Postmarketing Surveillance, Compensation, and the Role of Litigation. Yale Journal of Health Policy, Law, and Ethics, Vol. 2, p. 587, 2005. Available at SSRN: https://ssrn.com/abstract=594067