|Docket:||09-993 / 09-1039|
The question presented in PLIVA, Inc. v. Mensing is:
Whether the Eighth Circuit abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the FDA-approved labeling for the listed (or branded) drug.
The question presented in Actavis Elizabeth, LLC v. Mensing is:
The Drug Price Competition and Patent Term Restoration Act (the “Hatch-Waxman Amendments” to the Food, Drug and Cosmetic Act) and its implementing regulations require a generic drug manufacturer to maintain the labeling for a generic the “same as” the labeling for the “brand” or “listed” drug that is its bioequivalent. The question presented is whether the Eighth Circuit Court of Appeals misinterpreted that requirement and the doctrine of conflict preemption when it concluded that generic drug manufacturers could be held liable under state law for failing to strengthen the warnings in the labeling for the generic drug.
These two cases are consolidated for oral argument with Actavis, Inc. v. Demahy, No. 09-1501. The Supreme Court will hear arguments in the cases on March 30, 2011.
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