Featured Expert Column
by Frank Cruz-Alvarez, Partner, Shook, Hardy & Bacon, L.L.P., Miami office, and Travis Robert-Ritter, an associate in the firm’s Miami office.
On December 6, 2013, the U.S. Court of Appeals for the Sixth Circuit in Strayhorn v. Wyeth Pharm., Inc., No. 12-6195, — F.3d —-, 2013 WL 6224337 (6th Cir. Dec. 2, 2013) significantly limited drug manufacturers’ exposure to liability from harm caused by generic prescription drugs. Applying recent U.S. Supreme Court precedent, the Sixth Circuit held that the federal scheme governing generic prescription drugs preempts state-law failure-to-warn claims against generic drug manufacturers for injuries caused by their products. Id. at *6-17. The court also concluded that under state law, brand-name drug manufacturers may not be held liable for harm caused by other companies’ generic versions of their drugs. Id. at *20-26. In sum, the Sixth Circuit reasoned that federal and state law combined to eliminate failure-to-warn claims for injuries caused by generic prescription drugs.
The appeal arose out of the consolidation of seven cases filed against the manufacturers of the drug Reglan and its generic equivalent, metoclopramide. Id. at *1. The plaintiffs alleged that they ingested generic metoclopramide, causing them to develop a serious neurological disorder known as tardive dyskinesia. Id. The district court dismissed plaintiffs’ claims against both the generic and brand-name manufacturers. Id. An appeal ensued.
Turning first to plaintiffs’ claims against the generic drug manufacturers, the Sixth Circuit concluded it was bound to dismiss the claims based on the Supreme Court’s reasoning in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013). See Strayhorn, 2013 WL 6224337 at *5-17. In PLIVA, Inc. v. Mensing, the Supreme Court held that state-law failure-to-warn claims raised against certain generic drug manufacturers were preempted by federal law. 131 S. Ct. at 2577-2578. A group of plaintiffs had argued that the generic drug manufacturers should be held liable under state law because the warnings on their drugs were inadequate. Id. at 2572-2574. The Supreme Court soundly rejected the argument, explaining that the federal statutory scheme governing generic drugs limits manufacturers to using the same label and warnings approved for the generic drug’s brand-name equivalent. Id. at 2574-2578. Because this federal limitation made it impossible for the manufacturers to meet their obligations under both federal and state law, plaintiffs’ failure-to-warn claims were preempted. Id.
The implications and reach of this holding were solidified by Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013). There, the Supreme Court was faced with whether federal law preempted state-law design-defect claims asserted against a generic drug manufacturer. Id. at 2470. The state law at issue imposed a duty on manufacturers to ensure that the drugs they market are not unreasonably safe, which was evaluated by examining the drug’s chemical composition and the adequacy of the drug’s warnings. Id. In deciding that plaintiff’s claims were preempted, the Supreme Court noted that federal law barred generic drug manufacturers from using a different, safer chemical composition than is used in the generic drug’s brand-name equivalent. Id. at 2471. The manufacturer could therefore only meet its state-law duty by providing greater warnings or withdrawing the product from the market. Id. at 2472-2478. The Supreme Court rejected this obligation as inconsistent with its federal preemption jurisprudence, holding that the reasoning of Mensing worked to extinguish any state-law obligation to strengthen generic drugs’ warnings and that a private actor is not required to cease selling a product when federal and state law impose inconsistent duties. Id.
Applying the framework established by Mensing and extended by Bartlett, the Sixth Circuit correctly held that plaintiffs’ state-law failure-to-warn claims were preempted by the federal scheme governing generic drugs. See Strayhorn, 2013 WL 6224337 at *5-17. The Court explained:
To the extent that the plaintiffs allege that the Generic Manufacturers should have unilaterally changed the label to reflect any danger posed by long-term use of the drug, this claim is clearly preempted. And to the extent that the plaintiffs allege that the drug itself should have been modified to conform to the properties described in the label, generic manufacturers are prohibited by their federal duty of sameness from designing their drugs differently . . . .
Id. at *14 (citations omitted). In light of plaintiffs’ concession that their design-defect claims did not survive Bartlett, the Sixth Circuit concluded that the reasoning of Mensing preempted plaintiffs’ argument that the generic drug manufacturers should have warned of greater health risks associated with their product. Id. at *26.
Upon addressing plaintiffs’ claims against the generic manufacturers, the Sixth Circuit examined whether a brand-name drug manufacturer may be held liable for providing inadequate warnings that generic manufacturers were then foreseeably obligated to use. Id. at *20-26. The court noted that plaintiffs’ claims against these companies were governed by state statute, which required a plaintiff to be injured by the defendant’s product; the fact that plaintiffs were harmed by metoclopramide rather than Reglan doomed their claim under state law. Id. at *20-22. Id. But the court continued, emphasizing in dicta that established precedent shows that a brand-name manufacturer owes no duty of care to a consumer ingesting a product manufactured by a different company. Id. at *24-25.
For these reasons, the Sixth Circuit held that federal and state law combined to eliminate failure-to-warn claims for injuries caused by generic prescription drugs. The conclusion is a logical and well-reasoned extension of established Supreme Court federal preemption jurisprudence. Indeed, other circuits are likely to follow the path forged by the court. The court’s holding is consistent with the congressionally designed regulatory scheme intended to create low-cost generic prescription medication that can be made available to millions of sick Americans.