US Supreme Court to consider availability of pre-emption defence for generic drug manufacturers

By Lauren S. Colton and Allison J. Caplis Hogan Lovells

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 failure-to-warn claims against name brand manufacturers are not pre-empted by the Food, Drug and Cosmetic Act (FDCA).