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Suits Against Generic Pharm Manufacturers

By Janice G. Inman

Among the landmark decisions issued by the U.S. Supreme Court in the final weeks of its last session, one that affects the nation's consumers of generic drugs got less attention than it might have deserved. In Mutual Pharmaceutical Co. Inc. v. Bartlett, 2013 U.S. LEXIS 4702 (U.S. 6/24/13), the court overturned the award of millions of dollars in damages to a woman injured by the use of a generic version of a patented, FDA-approved drug, after finding that the manufacturer could not be held responsible through a state-law claim for defective design, because it was actually a failure-to-warn claim in disguise.

Failure-to-warn claims against generic drug manufacturers, which by federal law are required to use the same warning labels used by manufacturers of their products' brand-name equivalents, have been precluded by the Supreme Court's 2011 decision in PLIVA Inc. v. Mensing, 131 S. Ct. 2567 (2011).

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