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Generic drug design-defect claims preempted

WASHINGTON — In a victory to generic pharmaceutical companies, the U.S. Supreme Court ruled today that state design-defect laws that impose a duty on generic drug makers to either change their labeling in violation of federal law or pull the drug from the market are preempted.

“[S]tate laws that require a private party to violate federal laws are pre-empted,” wrote Justice Samuel A. Alito Jr. for the 5-4 court in Mutual Pharmaceutical Co. v. Bartlett.

The ruling strikes down a 1st U.S. Circuit Court of Appeals decision upholding a verdict for a plaintiff who developed a degenerative skin disease after taking the generic version of the non-steroidal anti-inflammatory drug Clinoril, called sulindac. She brought a drug design-defect claim under New Hampshire law and ultimately won a $21 million verdict against the pharmaceutical company.

The drug manufacturer appealed, arguing that the claim was preempted under federal laws that require generic drugs to have the same chemical composition and carry the same label as their brand-name equivalent. The plaintiff argued that the claim was not preempted because it is not impossible to comply with both federal regulations and state tort laws — drug makers can either pay tort judgments for defective products, or choose not to sell the drug. The 1st Circuit agreed with her and affirmed.

But the Supreme Court’s majority disagreed.

“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,” Alito wrote. “Rather, adopting the Court of Appeals’ stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court’s pre-emption case law.”

Justice Stephen G. Breyer wrote a dissent that was joined by Justice Elena Kagan, and Justice Ruth Bader Ginsburg joined a dissent written by Justice Sonia M. Sotomayor.