Supreme Court: Federal law pre-empts state suits over drug label shortcomings

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.

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.