The United States Supreme Court’s ruling in Pliva v. Mensing, 131 S. Ct. 2567 (2011), was a landmark decision for generic pharmaceutical manufacturers. In Mensing, the court held that failure-to-warn claims against generic pharmaceutical manufacturers were impliedly pre-empted by federal law. The court’s decision was premised on its conclusion that under the Food, Drug and Cosmetic Act (FDCA), generic manufacturers “have an ongoing federal duty of sameness,” which requires that the labeling and warnings for generic pharmaceuticals be identical to those of their brand-name counterparts. Because the FDCA and existing regulations under the Food and Drug Administration (FDA) make it impossible for generic manufacturers to unilaterally change their labels to strengthen or add new warnings, the court held that failure-to-warn claims were impliedly pre-empted.
Since Mensing was decided, numerous courts have tried to address the breadth and scope of the decision. Whereas plaintiffs have typically argued that Mensing only pre-empts a very narrow category of failure-to-warn claims, generic manufacturers have taken the position that Mensing should be broadly applied to pre-empt other types of claims.
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