Justices say FDA-approved drug labels do not shield companies from legal damages
by Glenn Hess
In a major defeat for the pharmaceutical industry, the U.S. Supreme Court ruled on Wednesday that drugmakers can be sued in state court for harm caused by medicines that carry warning labels approved by the Food & Drug Administration (FDA).
Voting 6-3, the Justices upheld a $6.7 million Vermont jury award to musician Diana Levine, who lost her right forearm after Wyeth's anti-nausea drug Phenergan was improperly administered and gangrene set in. Her lawsuit claimed that Wyeth failed to adequately warn about the risks of a method of intravenous injection known as IV push (C&EN, Feb. 9, page 25).
Wyeth argued that FDA's approval of the drug and the prescribing information on its label effectively shields the company from liability claims based on state law.
"Wyeth fully complied with federal law in its labeling of Phenergan, which provided clear instructions and warnings about its use," says Wyeth's attorney, Bert Rein. "We believed that federal law prohibited the company from revising its product label as the Vermont court required, and we regret that the Supreme Court disagreed."
Justice John Paul Stevens says Wyeth could have unilaterally strengthened its warning about the IV push method of administration, and there is no evidence that FDA would not have ultimately approved such a labeling change.
"We conclude that it is not impossible for Wyeth to comply with its state and federal law obligations," he wrote in the court's majority opinion, which was joined by Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg, and Stephen G. Breyer.
Justice Clarence Thomas sided with the majority, but did not join Stevens' opinion.
"This case illustrates that tragic facts make bad law," Justice Samuel A. Alito wrote in a dissenting opinion that was joined by Chief Justice John G. Roberts and Justice Antonin Scalia. "The court holds that a state tort jury, rather than the FDA, is ultimately responsible for regulating warning labels for prescription drugs."
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