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The Supreme Court Wednesday ruled against the drugmaker Wyeth, holding that pharmaceutical companies can be held liable for harm from medicines which carry warnings approved by federal regulators.
By a 6-3 vote, the high court ruled that labeling approvals by the Food and Drug Administration do not pre-empt state laws and shield companies from legal damages as part of liability claims.
A Vermont jury awarded $7 million in damages to a guitarist, Diana Levine. Part of her arm had to be amputated after she was improperly injected with the anti-nausea drug Phenergan made by Wyeth as part of treatment for a migraine.
The justices affirmed a Vermont Supreme Court ruling that upheld the award and rejected Wyeth’s argument that labeling approvals by the FDA pre-empts state law liability claims.
“The question we must decide is whether the FDA’s approvals provide Wyeth with a complete defense to Levine’s tort claims. We conclude that they do not,” Justice John Paul Stevens concluded in the court’s majority opinion.
Levine’s attorneys said Wyeth should have given stronger warnings about the dangers of administering the drug in the way she received it. But Wyeth said it acted properly by including the FDA’s approved warnings on the label for the drug.
Federal pre-emption has been a goal of the pharmaceutical industry for years and had been supported by the Republican Bush administration and business groups upset by large damage awards.
Wyeth and other drug companies argued state juries looking at the experience of one patient do not have the expertise to determine if a drug has proper warnings.
Chief Justice John Roberts and Justices Antonin Scalia and Samuel Alito dissented. “This case illustrates that tragic facts made bad law,” Alito wrote.
(Reporting by Lisa Richwine and James Vicini, editing by Gerald E. McCormick, Dave Zimmerman)