As many trial lawyers, legal scholars, tort law afficionados and others are aware, on Monday the Supreme Court is set to hear oral argument in Wyeth v. Levine.
Today the Boston Globe published an AP article that gives a good and succinct overview of the case.
Wyeth Pharmaceuticals is appealing a $6.7 million verdict from a Vermont jury in favor of Diana Levine, a woman who received an IV-push of the drug Phenergan which accidentally punctured an artery and led to the amputation of her arm below the elbow. Wyeth knew for years that administering Phenergan in this way could result in the drug coming into contact with an artery and ultimately lead to irreversible gangrene, yet the company never warned doctors of this risk. The drug’s warning label had been approved by the FDA.
At issue is whether FDA-approved warnings for pharmaceuticals serve as a floor of protection for consumers or instead a ceiling. In other words, the justices will decide if a drug manufacturer should receive immunity for failure to warn claims if a drug contains an FDA-approved warning.
Notably, as I wrote in a recent post and has been reported widely in the media, Congressman Henry Waxman issued a report revealing that key FDA staff had objected to Bush administration efforts to shield drug manufacturers from liability under principles of preemption.
Also in a recent post, see how the FDA previously failed to timely alert women about dangers associated with use of the Ortho-Evra birth control patch; a dozen women died due to related blood clots before the warning came out.
Seth Waxman, who is arguing on behalf of Wyeth, served as solicitor general in the Clinton Administration. David Frederick, an Assistant Solicitor General under Waxman, will argue on behalf of Levine.
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