Phenergan Injury Leads to Drug Company Defeat
The U.S. Supreme Court ruled against the drugmaker Wyeth holding that pharmaceutical companies can be held liable for harm from medicines that carry warnings approved by federal regulators. As Orlando injury lawyers, we applaud this decision and support the important battle to hold the giant drugmakers accountable for the harm they cause innocent people.
By a 6-to-3 vote in a major defeat for the pharmaceutical industry, the high court ruled that U.S. Food and Drug Administration labeling approvals do not pre-empt state laws and shield companies from damages as part of liability claims.
A Vermont jury awarded $7 million in legal 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 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. The court also rejected the argument that Levine's claims were pre-empted because it was impossible for Wyeth to comply with both state law and federal labeling requirements.
The court found that Wyeth could have unilaterally added a stronger warning about the IV-push administration used with Levine, and there is no evidence the FDA would have rejected the change. Under federal law and FDA regulations, the manufacturer bears responsibility for the content of its label at all times, Stevens said in the 26-page opinion.
