At issue was a lawsuit by Vermont guitarist Ms. Levine, who lost an arm to gangrene after Wyeth’s anti-nausea drug Phenergan was inadvertently injected into one of her ateries during a push IV injection. Ms. Levine had gone to a clinic for treatment of a migraine headache.
Ms. Levine argued that Phenergan’s labeling, though approved by the Food and Drug Administration, didn’t provide proper warnings of the risk of administering the drug through a push IV injection instead of using an IV-drip. A Vermont jury awarded her damages. The Vermont Supreme Court upheld the award, FDA drug regulations don’t prevent a company from being sued under state law over drug labeling.
Wyeth argued that Ms. Levine’s lawsuit, which was based on Vermont law, should be preempted by federal drug regulations. The FDA, Wyeth said, knew of the drug’s risks and benefits and instructed the drug maker to use labeling that accommodated both.
Washington–The U.S. Supreme Court, in a major loss for pharmaceutical manufacturers, ruled 6-3 Wednesday that a Vermont woman, Diana Levine, is entitled to a 6.7 million judgement against Wyeth for injuries she suffered after taking one of the drug maker’s medicines.
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