FDA-Approved Labels - No Guarantee against Lawsuits

By Anna Boyd
14:00, March 6th 2009
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FDA-Approved Labels - No Guarantee against Lawsuits

The US Supreme Court ruled against pharmaceutical company Wyeth on Wednesday in a case involving guitarist Diana Levine who had lost part of her arm after she was improperly injected with the anti-nausea drug Phenergan made by the drugmaker as part of treatment for a migraine.

By a 6-to-3 vote, a Vermont jury awarded $7 million in legal damages to Levine who sued Wyeth alleging that it failed to sufficiently warn of serious risks associated with intravenous injection of the medication.

“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. Moreover, he said Wyeth could “unilaterally strengthen its warning,” especially after it learned of at least 20 cases before Levine’s injury in which an injection led to gangrene and amputation.

On the other hand, Bert Rein, an attorney for Wyeth said “the medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and how they should be described on the product label.”

Levine burst into tears when hearing the ruling: Next to getting my hand back, it’s the best way they can do. I’m on the ceiling. I’m just so high about this. I’m so glad,” she told reporters on a conference call. She further said she would happily trade the money for her arm. “I miss my arm. I really miss my arm. I grieve the loss of my arm, nine years later. I would give $6 million for my right arm,” she said.



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