New Hampshire law applies a hybrid design-defect standard that imposes liability for harm caused by a drug product if the drug product, in light of the manufacturer’s warning on the label, is unreasonably dangerous. Does such a framework avoid federal preemption issues that have doomed failure to warn negligence claims premised on taking allegedly dangerous generic pharmaceuticals? That was the question addressed by the Supreme Court at oral argument in Mutual Pharmaceutical Co. v. Bartlett, the third in a trilogy of cases addressing preemption of state tort claims against drug manufacturers based on federal laws mandating prescription drug labeling requirements. While several justices appeared uncomfortable with the possibility of creating a system that allowed for FDA approval to serve as both a ceiling and a floor for generic drug liability, overall it appeared that the Court would find preemption, consistent with the defendant and Solicitor General’s arguments.
Three years ago in Wyeth v. Levine, the Court held that a state law failure-to-warn claim related to a branded pharmaceutical was not preempted federal drug laws. The next year in a 5-4 decision, the Court held in PLIVA, Inc. v. Mensing that a negligence claim for failure to warn by a generic manufacturer was preempted by federal law because the Hatch-Waxman Act (which sets up the generic pharma framework) allowed for no discretion in what a generic pharmaceutical manufacturer can put on its label.
Mutual comes to the Supreme Court after the First Circuit upheld a New Hampshire Federal District Court’s jury verdict premised on the finding that a generic version of sulindac was unreasonably dangerous. The arguments before the Court centered on whether a design defect claim was somehow different from a failure to warn claim, and therefore merited a different result than the one reached in PLIVA.
Continue Reading U.S. Supreme Court Addresses “Failure to Warn” Negligence Claims in Rx Warning Labels