The U.S. Supreme Court ruled on June 23, 2011 that generic drug companies cannot be sued under state law over allegations that they failed to provide adequate label warnings about potential side effects. By a 5-4 vote, the justices ruled in favor of Israel’s Teva Pharmaceutical Industries Ltd., Mylan Inc.’s UDL Laboratories and Iceland-based Actavis Inc. by overturning U.S. appeals court rulings that allowed such lawsuits.
The companies argued that federal law barred such lawsuits because the drug had been approved by the U.S. Food and Drug Administration. Federal law requires generic drugs to have the same labels as their brand name equivalents. Justice Clarence Thomas in the court’s majority opinion agreed. He said federal drug regulations applicable to generic drug manufacturers directly conflicted with and thus pre-empted state lawsuits.