Tort/Negligence – Wrongful Death – Prescription Drug – Off-Label Use – Generic – Preemption

Perdue v. Wyeth Pharmaceuticals, Inc. (Lawyers Weekly No. 002-023-16, 11 pp.) (Louise Flanagan, J.) 4:15-cv-00208; E.D.N.C.

Holding: Plaintiff alleges that her decedent died as a result of taking a doctor-prescribed generic ventricular fibrillation drug for the decedent’s atrial fibrillation, an off-label use promoted both by the manufacturer of the name-brand drug and by the defendant-generic drug manufacturers. Plaintiff’s state-law negligence per se claim is based on defendants’ off-label promotion of their drug. Since plaintiff’s claim would not exist in the absence of the federal Food, Drug and Cosmetic Act, the negligence claim is preempted.

Defendants’ motions to dismiss are granted.

Where the FDCA and related regulations limit a generic drug manufacturer’s ability to attach additional warnings to their drugs, the FDCA preempts plaintiff’s claim that the generic manufacturers failed to provide adequate warnings as to the off-label use of their drug.

Plaintiff also bases claims on the failure to provide a medication guide. However, because the requirement to provide a medication guide to distributors is based solely on the requirements of the FDCA and related regulations, which requirements did not exist previously under North Carolina common law, plaintiff’s claims based upon failure to provide a medication guide are preempted.

Finally, plaintiff’s decedent took only the generic form of amiodarone. Under North Carolina law, a defendant may not be held liable for injuries allegedly caused by the use of another’s product. The manufacturer of the name-brand drug is entitled to dismissal.

Motions granted.