Posted On: April 9, 2008 by David Badertscher

Findlaw: Colacicco v. Apotex Inc.

FDA Authority Preempts State Tort Suits Over Antidepressant Drug Warnings

COLACICCO V. APOTEX INC.

(U.S. 3rd Cir., April 8, 2008) - In state-law tort actions brought in federal court against drug manufacturers of Paxil and Zoloft -- antidepressants known as selective serotonin reuptake inhibitors ("SRRIs") -- based on a theory that the drugs' labeling failed to warn the risk of increased suicidal tendencies, a federal appeals court finds that the underlying state law claims are preempted by, the FDA's regulatory actions under the Federal Food, Drug, and Cosmetic Act. Both cases were dismissed.