Dist. Ct. did not err in dismissing plaintiffs’ state law actions alleging that defendants-manufacturers of “Depo-T” testosterone replacement drug failed to properly label said drug by adequately warning consumers of drug’s dangers. Basis of said dismissal was Dist. Ct.’s finding that defendants could not change instant drug label to add additional warnings because FDA regulations prohibited defendants from making unilateral labeling changes, where: (1) “Depo-T” had originally been approved via abbreviated new drug application (ANDA) process applicable for generic drugs; and (2) defendants’ current label conformed to what FDA had directed should appear on said label. Moreover, Ct. in Mensing,564 U.S. 604, held that state-law failure-to-warn claims against manufacturers of generic drugs were preempted by federal law. Fact that “Depo-T” eventually became reference listed drug (RLD) for its family of testosterone replacement drugs did not require different result.
Federal 7th Circuit Court
Civil Court
Food and Drug Administration