The Supreme Court has ruled that generic drug manufacturers cannot be sued in state court for potential warning label shortcomings in the generic version of a federally approved drug.
In Mutual Pharmaceutical Co. v. Bartlett, the court ruled 5-4, agreeing with the generic drug manufacturer’s contention that federal law pre-empts a New Hampshire law that allowed a strict product liability lawsuit by Karen L. Bartlett.
Bartlett received a jury award of $21 million in 2004 after taking the anti-inflammatory drug sulindac, a generic form of Clinoril, which caused her outer skin layer to deteriorate and left her legally blind.
Justice Samuel Alioto, writing for the majority, said “state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law.” He cited a 2-year-old Supreme Court ruling, Pliva, Inc. v. Mensing, that prohibits drug manufacturers from independently changing their federally-approved drug labels.
“The Court of Appeals’ solution — that Mutual should simply have pulled sulindac from the market in order to comply with both state and federal law — is no solution,” Alioto wrote.