Following the U.S. Supreme Court's March 2009 landmark decision in Wyeth v. Levine, state and federal courts have struggled with how to apply Levine to failure-to-warn products liability claims against generic pharmaceutical manufacturers. Since Levine involved only a brand drug, and because generic drug manufacturers' federal preemption arguments differ from those of brand-drug companies, courts in the wake of Levine have been unable to reach a consensus on whether Levine equally applies in the context of generic drugs. The federal government, however, will soon supply its views on generic preemption to the U.S. Supreme Court, providing key guidance and clarification on whether the U.S. Food and Drug Administration (FDA) believes that failure-to-warn suits against generic drug manufacturers are preempted by the Hatch-Waxman Act and other federal laws and regulations.
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