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State law tort claims preempted by FDCA

Drager v PLIVA, Inc.
--- F.3d --- (2014) (not yet published)

by Gregory S. Emrick, Associate
Semmes, Bowen & Semmes (

Plaintiff was the personal representative of the Estate of Shirley Gross, who alleged significant injuries as a result of her extended use of the generic gastroesophegeal reflux disease drug Reglan, manufactured by PLIVA. Plaintiff filed suit against both PLIVA and the name-brand manufacturers of Reglan, alleging various theories of state law tort liability arising out of the drug’s hazard from chronic use. After Plaintiff confirmed that the deceased, who had passed away during the pendency of the action, had only used the generic form of Reglan, the brand manufacturers were dismissed. The case was then stayed pending the determination of the Supreme Court case of PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). After the opinion in Mensing was issued by the Supreme Court, holding that state law failure-to-warn claims were preempted by the Federal Food, Drug, and Cosemtics Act, 21 U.S.C. §§301, et seq. (“FDCA”), PLIVA moved for a motion for judgment on the pleadings on the basis that the claims brought by Plaintiff in this action were by necessity state law failure-to-warn claims. The Court granted the motion, denied Plaintiff leave to amend the complaint to add, and Plaintiff appealed.

The 4th Circuit Court of Appeals reviewed the trial court’s decision de novo. The Court initially disposed of Plaintiff’s argument that the amendment should have been permitted, noting that Plaintiff had never filed a motion for leave to amend the complaint, and therefore, the trial court did not abuse its discretion to “declin[e] to grant a motion that was never properly made.” The Court then addressed the more substantive arguments that the Plaintiff’s claims were not preempted. The Court observed that Mensing established that generic drug manufacturers, like PLIVA, were “not entitled to unilaterally change their labeling and therefore any state law tort premised on the failure of a generic to alter its labeling was preempted.” Plaintiff’s state law claims included: 1) negligent testing, inspection and post-market surveillance, 2) defective design, 3) breach of implied and express warranties of merchantability or fitness for a particular purpose, and 4) negligent misrepresentation and fraudulent concealment about the safety of the product. The Court observed that since the generic drug manufacturer cannot change its warning, or its formula, absent preemption protection its only options would be to withdraw from the market, or accept state tort liability. As such, the Court held that regardless of the independent viability of the state law claims, the Plaintiff’s causes of action were preempted by the FDCA.