Pennsylvania Supreme Court Keeps Generic Drug Makers on the Hook
By: chris.placitella @ Sep 18, 2014
In a significant win for the public health, the PA Supreme Court yesterday held generic drug makers accountable for dangerous generic drugs. The Pennsylvania Supreme Court rejected an appeal by Teva Pharmaceuticals USA Inc. and other generic drugmakers battling a lower court’s ruling that product liability claims of thousands of generic Reglan users weren’t necessarily preempted by federal law, allowing their suits over the digestive drug to proceed. A three-judge state Superior Court panel issued a split decision in July 2013, finding that most of the Reglan-related design defect, negligence, false advertising, breach of warranty and other claims in the cases, which are pending as part of a mass tort program in the Philadelphia County Court of Common Pleas, were not preempted by federal law under the U.S. Supreme Court‘s landmark Pliva v. Mensing decision.The Mensing decision found that state-law failure-to-warn claims against generics manufacturers were preempted because the Hatch-Waxman Amendments require generics to use the same warning label as brand-name companies. The Pennsylvania Superior Court’s decision, however, found that Mensing addressed only failure-to-warn claims on product labels that were brought before the Food and Drug Administration Amendments Act was passed in 2007. This is an important case in the fight against dangerous drugs.
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