US Supreme Court to consider availability of pre-emption defense for generic drug manufacturers
16 December 2010
On 13 December 2010 the United States Supreme Court granted certiorari in three consolidated cases to determine whether generic drug manufacturers can be held liable under state law for inadequate warnings where the product labels conform with the labels provided by the name brand manufacturers. This case is expected to have far-reaching implications for generic drug manufacturers and will test the limits of Wyeth v. Levine, 129 S. Ct. 1187 (2009), which held that failure-to-warn claims against name brand manufacturers are not preempted by the Food, Drug, and Cosmetic Act (FDCA).
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