Wyeth v. Levine: The U.S. Supreme Court's New Approach to Preemption - Is Parochialism to Prevail?

Abstract

"This case illustrates that tragic facts make bad law." The words of Supreme Court Justice Samuel Alito appropriately describe the United States Supreme Court’s recent Wyeth v. Levine decision. This part March, the Court held in a 6-3 decision that approval of drug labels by the Food and Drug Administration does not preempt state: "failure to warn" claims against pharmaceutical manufacturers, marking a departure from the FDA’s position during the Bush Administration. In 2006 the FDA adopted a regulation arguably signifying that the approval of a pharmaceutical company’s product under the Food, Drug, and Cosmetic Act (“FDCA”) would preempt state tort claims brought by consumers injured by that product. The rejection of this policy in Wyeth likely will precipitate an increase in patent suits under state law, will likely increase the burden on pharmaceutical companies, and will ultimately result in the substitution of the decisions of lay jurors, rather than scientific experts, in determining the adequacy of a label or warning on pharmaceutical drugs.