Thoughts on Preemption in the Wake of the Levine Decision

Abstract

This article discusses the prospects for preemption doctrine in the wake of the Supreme Court’s decision in Wyeth v. Levine. Part I describes the Levine decision. Part II examines the majority’s holding as it relates to impossibility preemption and considers the future of the doctrine in failure-to-warn suits after Levine. We argue that the announced standard for impossibility preemption — the clear evidence standard — should be interpreted reasonably and not in a manner that effectively eviscerates the doctrine. We also describe other instances of impossibility in the food and drug regulatory context that were not presented to the Court. Part III considers Levine’s obstacle preemption analysis and its implications for future pharmaceutical tort litigation. We conclude that the future for obstacle preemption is uncertain, unless FDA conducts rulemaking on the issue or the Court reconsiders the substantial evidence that state tort litigation impedes FDA’s proper functioning.

Keywords: preemption, FDA, products liability