Supreme Court Strengthens Preemption Defense for Manufacturers


In Wyeth v. Levine, 555 U.S. 555 (2009), the United States Supreme Court held that certain failure to warn claims against manufacturers of brand-name pharmaceuticals were not preempted by the Federal Food, Drug and Cosmetic Act. This past week, the Supreme Court reached the opposite conclusion with respect to manufacturers of generic pharmaceuticals. In so holding, the Court clarified that “impossibility” preemption (where it is impossible to comply with both federal and state law) may preclude state law claims unless a manufacturer can unilaterally comply with both federal and state law.

In Pliva v. Mensing, 564 U.S. ___ (2011), the plaintiffs had been prescribed Reglan in 2001 and 2002, and had received the generic form of that drug, metoclopramide, from their pharmacists. Plaintiffs later developed tardive dyskinesia, a neurological disorder. They filed suit against the manufacturers of metoclopramide arguing that the drug caused their disorder and the manufacturers failed to provide adequate warnings labels.

In order to obtain approval from the Food and Drug Administration (“FDA”), manufacturers of a “new drug” must demonstrate that the drug is safe and effective. This can be a lengthy and expensive process. In 1984, Congress passed the Hatch-Waxman Amendments, which allowed “generic drugs” to obtain approval simply by showing that the drug was “bioequivalent” to an approved brand-name drug, and was identical to the brand-name drug in certain other respects. By statute and regulation, the warnings provided with the generic drug must be identical to the warnings required by the FDA on the brand-name counterpart.

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