The Impact of Wyeth v. Levine on FDA Regulation of Prescription Drugs

Authors

Richard C. Ausness, University of Kentucky College of LawFollow

Abstract

On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act (FDCA). In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. In particular, the article considers two issues: 1) what effect will the Wyeth decision have on cases where FDA has concluded that there is insufficient scientific evidence to justify strengthening a warning and 2) are failure to warn claims against manufacturers of generic drugs preempted on actual conflict grounds because FDA does not permit them to change unilaterally change product labeling? A survey of FDA preemption cases decided in the past year indicates that the Wyeth decision has had a profound effect on lower federal courts and has led most of them to conclude that failure to warn claims against drug manufacturers are normally not preempted.

Part II discusses the preemption doctrine and its application to state law tort claims against product manufacturers. Part III examines the history of implied preemption of tort claims against manufacturers of FDA-approved prescription drugs prior to Wyeth. Part IV discusses the Wyeth decisions in the Vermont Supreme Court and the United States Supreme Court. Part V evaluates some of the prescription drug preemption cases that have been decided in the lower federal courts since Wyeth and concludes that these courts are now reluctant to preempt failure to warn claims unless a manufacturer affirmatively seeks permission from FDA to change a drug's labeling.

Document Type

Article

Publication Date

2010

3-19-2015

Notes/Citation Information

Food & Drug Law Journal, Vol. 65, No. 2 (2010), pp. 247-283

Repository Citation

Richard C. Ausness, The Impact of Wyeth v. Levine on FDA Regulation of Prescription Drugs, 65 Food & Drug L.J. 247 (2010).