By CYRIL TUOHY, managing editor of Risk & Insurance®
In 2000, Vermont musician Diana Levine was treated with the Wyeth drug Phenergan by a local clinic to relieve nausea caused by a migraine.
The drug, to be administered into her vein through the intravenous "push" method instead of the safer "drip" method, was by mistake injected into an artery. The incident led to infection causing the buildup of gangrene. Doctors eventually had to amputate part of her arm.
Levine sued Wyeth on the grounds that the company had not done enough to disclose the dangers of Phenergan, despite Food and Drug Administration-approved labels warning of the dangers of administering the drug through the intravenous push method.
A Vermont jury concurred, and awarded Levine $6.7 million in damages. Wyeth appealed and the case was upheld by the Vermont Supreme Court, which ruled that FDA drug regulations do not prevent a company from being sued pursuant to state common law over drug labeling.
In its defense, Wyeth argued that in this case federal drug regulations pre-empt state tort laws. As a result, the company said it could not be held liable since it followed the FDA's own regulations concerning warning labels.
Wyeth also said the FDA knew of the drug's risks and benefits, and that the company was not free to change the warnings on the label without violating federal law.
The U.S. Supreme Court, by a 6-3 majority, disagreed. It found that an FDA regulatory clause allows for changes in labels to strengthen dosage warnings and administration instructions to increase safe drug use, according to a blog posted by Darlene K. Alt and Nancy H. Van der Veer, attorneys with Edwards Angell Palmer & Dodge.
The Court also disagreed with Wyeth's argument that requiring it to comply with a state-law duty would overrule the FDA's own medical experts entrused with labeling decisions, Alt and Van der Veer wrote.
June 1, 2009
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