Product Liability Alert: Federal Law Does Not Preempt Claims Based On Generic Drug Manufacturers’ Failure To Update Safety Labels

On June 13, 2013, the California Court of Appeal issued its decision in Teva Pharmaceuticals USA Inc. v. Superior Court (Pikerie), ruling that federal law does not preempt a personal injury claim based on a generic drug manufacturer’s alleged failure to update its product safety label to conform to the brand-name drug label.

Plaintiff suffered injuries and filed suit against the manufacturers of a brand-name drug and its generic equivalents, claiming they failed to produce a safe product, to adequately warn plaintiff of the safety issues and to take other available steps within their control to warn plaintiff or protect her from injury.

The generic drug manufacturers demurred, claiming that plaintiff’s claims were preempted by federal law contained in the Federal Food, Drug and Cosmetic Act and discussed in PLIVA, Inc. v. Mensing (2011) 564 U.S. ____ [131 S.Ct. 2567] (Mensing). In Mensing, the Supreme Court held that any claims that a generic drug manufacturer should have included stronger warning labels than those approved for use on the equivalent brand-name drug are preempted by federal law. The Supreme Court explained that federal law required a generic drug’s label to match the brand-name drug’s label under the theory of the impossibility preemption doctrine. Thus, any state law requiring additional information on the generic drug label would make it impossible for the generic drug manufacturer to comply with its duty under federal law. Therefore, such a state requirement would be preempted by federal law.

Because the facts of Teva Pharmaceuticals were different from those of Mensing, plaintiff’s claims were not preempted. In Teva Pharmaceuticals, the generic drug manufacturer had a state law duty to prevent harm to consumers and a federal law duty to match its labels to the brand-name drug. Because it was not impossible for the generic drug manufacturer to comply with both state and federal requirements (i.e. update its drug labels to match the brand name drug), the preemption principles set forth in Mensing did not apply. The Court explained, “[C]ompliance with federal and state duties was not just possible; it was required.”

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June 28, 2013