28 Pages Posted: 17 Jan 2008
The positive and normative relationships between FDA regulation of pharmaceutical drugs and state tort law have gained much attention in recent years, with FDA aggressively asserting preemptive effect, some state courts resisting, and the U.S. Supreme Court relatively active on preemption issues, including several now pending before the Court. Prominent scholars of torts and regulation have analyzed these issues from a variety of rich perspectives.This paper weighs in on this debate, making several contributions.
First, it augments prior analyses of the comparative institutional competence, going beyond the common emphasis on relative expertise to stress the agency's far greater democratic accountability and policy learning capacity.
Second, having made the case for broad FDA preemption in the drug area, it proposes an exception to FDA preemption that is both broader and narrower than under existing law or the existing scholarship. The exception to preemption would be broader in that it would go beyond fraud on the agency to encompass all disclosure deficits on the part of drug manufacturers, whether fraudulent, negligent, or innocent. The exception to preemption would be narrower in that in order to survive a motion to dismiss, the tort plaintiff would have to meet a hyper-heightened pleading standard requiring greater specificity with respect to both the allegations of disclosure deficit and the supporting factual evidence than that required by the already heightened standard that the Federal Rules of Civil Procedure now imposes on federal court complaints alleging fraud.
The third proposed change concerns the status under state tort law of a regulatory compliance defense, which only Michigan has adopted as a complete defenser state law. Although modifying FDA preemption principles as I propose would block much design and warning defect litigation in state courts (at least prima facie) as a matter of federal law, there is much to be said for also effecting this change as a non-constitutional matter under state tort law by crafting a regulatory compliance defense consistent with my other proposed changes. The paper concludes with a brief discussion of whether FDA preemption, properly designed, would leave a compensation void with respect to those harmed by FDA-regulated drugs.
Keywords: administrative law, regulation, tort law, preemption, constitutional law
Suggested Citation: Suggested Citation
Schuck, Peter H., FDA Preemption of State Tort Law in Drug Regulation: Finding the Sweet Spot. Roger Williams University Law Review, Forthcoming. Available at SSRN: https://ssrn.com/abstract=1078013