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.
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.
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