Failure-To-Warn Claims Against Generic Makers Preempted, High Court Rules

WASHINGTON, D.C. - Inadequate warning/labeling claims brought against generic drug manufacturers are preempted by federal regulations, the U.S. Supreme Court has ruled, overturning two federal appellate court decisions. Pliva Inc., et al. v. Mensing, et al., No. 09-993 (U.S. Sup. Ct.).

On June 23, the high court majority, led by Justice Clarence Thomas, held that accepting the argument that the manufacturers should have asked the Food and Drug Administration for help in changing the corresponding brand name labels "would render conflict preemption largely meaningless by making most conflicts between state and federal law illusory."

Five years after the FDA first …