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Drug Approval Is Not a Shield From Lawsuits, Justices Rule

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A Vermont musician could not practice her livelihood after her arm was amputated because of gangrene. The gangrene developed as a result of a physician's assistant at a clinic using a a wrong technique for adminstering Phergan for nausea. The PA used IV Push instead of an IV drip or intravenous which is the right method. He missed the vein and and hit an artery causing the gangrene to develop. A Vermont state court awarded Ms Levine $6 million from Wyeth Pharmaceutical. Now the Supreme Court upheld the Vermont Court, with Justices Kennedy, Souter, Ginsberg, and Breyer joining Justice Stevens. Justice Thomas concurred. Scalia, Roberts and Alito were in dissent. Wyeth had a FDA approved label that warned against "inadvertent intra-arterial injection," but it did not say do not use IV Push. Justice Stevens writing the majority opinion said Wyeth's reading of the regulation was "cramped" and based on a "fundamental misundrstanding." He said "the manufacturer bears responsibility for the label at all times," and affirmed the Vermont Court's opinion that Federal law provides afloor not a ceiling for state regulation."

Large legal settlements in the pharmaceutical industry.

10/25/2006

The settlements also involve drug pricing and marketing.

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