Recent Developments in Health Law

Abstract

When the Supreme Court in PLIVA v. Mensing determined that certain state tort law failure-to-warn claims against generic drug companies were pre-empted by federal drug regulations, the pronouncement was met with substantial criticism. In light of the Court's decision two years earlier in Wyeth v. Levine, where the Court allowed a similar claim against a brand-name drug manufacturer to proceed, many complained the resulting Levine-Mensing dichotomy created an arbitrary distinction between brand-name and generic drugs, allowing an injured patient's ability to recover to hinge solely on the happenstance of whether the individual had taken the brand-name or generic version. But, although Mensing cut back significantly on the ability of plaintiffs to make state law failure-to-warn claims against generic drug manufacturers, the case did not completely prohibit such claims. Instead, the Court banned only failure-to-warn claims premised on an argument that the generic drug company needed to change its label in order to meet state tort law duties. If plaintiffs can advance other theories independent of a formal label change, such as a failure to adequately warn a physician about a recent change to the drug's label, then they may still be able to proceed against generic drug manufacturers.