Supreme Court Docket Report - Decision Alert - March 4, 2008

Originally published March 4, 2009

Keywords: Wyeth, Food and Drug Administration, FDA, FDCA, federal preemption, drug labeling, failure to warn

Today the Supreme Court issued a decision, described below, of interest to the business community.

Wyeth v. Levine, No. 06-1249 (previously discussed in the January 21, 2008 Docket Report).

Under the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., a manufacturer must receive the approval of the Food and Drug Administration (FDA) before marketing a new drug. See 21 U.S.C. § 355(b). The FDA exercises continuing regulatory authority over approved drugs, and it normally must pre-approve any change in drug labeling. See 21 C.F.R. § 314.70. In order to resolve a dispute among the lower courts regarding the preemptive effect of FDA approval, the Supreme Court granted certiorari in Wyeth v. Levine, No. 06-1249, to determine "whether FDA drug labeling judgments preempt state-law product liability claims