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Supreme Court to hear 3 cases involving labeling of generic medicines

The US Supreme Court [official website; JURIST news archive] on Friday granted certiorari [order, PDF] in three cases related to the duty of generic drug manufacturers to list possible side effects on the labels of medicines they produce. The three cases, PLIVA Inc. v. Mensing [docket; cert. petition, PDF], Actavis v. Mensing [docket; cert. petition, PDF] and Actavis v. Demahy [docket; cert. petition, PDF] were consolidated and will receive one hour of oral argument time. In each of the three cases, the drug manufacturers sought review after appellate courts ruled that the plaintiffs' cases could move forward and that federal law did not preempt their state law claims. Both plaintiffs suffered a neurologic side effect, tardive dyskinesia [NIH backgrounder], from their use of the generic drug metoclopramide to treat gastric reflux.

These consolidated cases will answer a question that the Supreme Court left open when it decided Wyeth v. Levine [JURIST report] in 2009—namely, is state law preempted in drug labeling cases when the drug is a generic, rather than name-brand medication. In the Wyeth decision, the court held that manufacturers of name-brand medicines bear primary responsibility for product labeling, and that the silence of the Food, Drug, and Cosmetic Act [text] on the issue of preemption was sufficient proof that Congress did not contemplate preemption in medication labeling. The court stated that manufacturers may themselves initiate strengthened warning labels to comply with state and federal requirements. The court's decision in Wyeth upheld a Vermont Supreme Court's affirmance of a $6.7 million jury award for the plaintiff.

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