High Court sides with musician in ruling against drug company
In a case involving a professional guitarist who lost an arm when injected with an antinausea drug, the justices said state consumer protections can go beyond federal regulations.
By Warren Richey | Staff writer of The Christian Science Monitorfrom the March 5, 2009 edition
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WASHINGTON - A Vermont musician has won her battle against the pharmaceutical company Wyeth over the adequacy of the warning label on an antinausea drug that caused her to lose her right arm.
In a 6 to 3 decision on Wednesday, the US Supreme Court rejected an appeal by Wyeth that the musician's lawsuit must be dismissed as preempted by federal drug laws and regulations.
Instead, the majority justices said the drug company could be held liable for an alleged violation of a state law requiring that consumers receive adequate warning about dangerous products.
"When the risk [of a significant negative reaction to its drug] became apparent, Wyeth had a duty to provide a warning that adequately described that risk," wrote Justice John Paul Stevens for the majority opinion.
The decision puts drug companies on notice that it is their responsibility, not that of the Food and Drug Administration, to ensure that its products feature clear warning labels.
Diana Levine, a professional guitarist, sued drug maker Wyeth, claiming that the company had given insufficient warning of the possible severe effects of one of its antinausea drugs called Phenergan. Her right arm was amputated after the drug was improperly injected into her arm, causing the onset of gangrene.
Investigation revealed that Wyeth was aware of 20 other individuals who had limbs amputated following the improper injection of Phenergan.
A Vermont jury awarded Ms. Levine $6.7 million in compensatory and punitive damages. The award was upheld by the Vermont Supreme Court.
The drug company appealed to the US Supreme Court, arguing that it would be difficult for pharmaceutical companies to operate under both federal regulations and assorted state laws.
The majority justices disagreed. "It is not impossible for Wyeth to comply with its state and federal law obligations," Justice Stevens wrote. Federal law allows drug companies to unilaterally strengthen warnings, he said in the opinion.
In a dissent, Justices Samuel Alito, Antonin Scalia, and Chief Justice John Roberts, said the Vermont labeling lawsuit should be preempted by federal regulations and prior labeling decisions made by the FDA.
"The FDA has long known about the risks associated with [injected use of Phenergan]," Justice Alito wrote. "Whether wisely or not, the FDA has concluded – over the course of extensive 54-year-long regulatory proceedings – that the drug is 'safe' and 'effective' when used in accordance with its FDA-mandated labeling."
Alito said the drug label includes adequate warnings, but that the medical technician who injected the drug into Levine's arm ignored six separate warning instructions. "[Levine] would be hard pressed to prove that a seventh would have made a difference," he said.
The case, Wyeth v. Levine (06-1249), is part of an emerging trend at the high court examining the scope of federal preemption of state laws. In December, the court sided with a group of smokers in Maine who filed a fraud lawsuit against Philip Morris for suggesting that their "light" and "low tar" cigarettes are a healthier alternative to regular cigarettes. The tobacco company had urged the high court to throw the suit out as preempted by federal law.
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