48:1 Wyeth v. Levine: FDA Attempt to Preempt Common Law Claims Deemed Procedurally Deficient but Sets the Stage for Future Consideration of Substantive Sufficiency



In Wyeth v. Levine, the U.S. Supreme Court considered whether a manufacturer remains responsible for updating drug labels after the postmarket discovery of new risks or whether the FDA’s drug labeling decisions preempt common law claims. To resolve this conflict, the Court defined limits that federal preemption doctrines place on federal agency decisions over common law tort claims. Or more accurately, the Court defined procedural requirements that must be satisfied before it will address the substantive problem of defining the precise preemptive scope of federal regulations. However, a number of post-Wyeth events may soon present the Court with a procedurally sufficient problem that requires articulation of the substantive application of federal preemption doctrines to decisions made by federal agencies.