Supreme Court’s Decision in the Case Involving Drug Labels Awaited

By Alice Carver
14:30, November 3rd 2008
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Supreme Court’s Decision in the Case Involving Drug Labels Awaited

Musician Diana Levine, who lost her arm eight years ago after she received treatment with one of drugmaker Wyeth’s drugs, Phenergan, argues today before the U.S. Supreme Court that a state ruling should be overturned. At issue is whether the federal government can limit lawsuits by consumers who have been harmed by prescription medications. After hearing arguments, the Supreme Court will have to decide on Monday if patients who suffered serious drug adverse events could file a lawsuit if they consider manufacturers of the medicines hadn’t cautioned them adequately about the risks associated with the drugs.

Levine’s case, that could limit liability claims against drugmakers if one of their medicines causes harm, is one of the most watched business cases of the Supreme Court’s team.

The Vermont musician sued the drug company after she received treatment with one of their drugs, Phenergan, in 2000. The drug, which was administered through IV-push, was supposed to relief her nausea, but instead, due to being improperly injected, it forced doctors to amputate her arm.

“I never expected to sue anyone in my life,” Levine said at the beginning of the trial. It’s just “sometimes it takes something like this to make it known when a drug is not being used right,” she added.

Wyeth, formerly known as American Home Products, was found guilty of not warning doctors about the risk of Phenergan intravenous injections. But the drugmaker argued that the label had FDA’s approval.

The jury awarded Levine $6.7 million, agreeing that Wyeth should have been clearer in its warning label about the risks of improperly administering the drug. Wyeth says it acted properly by including the U.S. Food and Drug Administration’s approved warnings on the label for its drug. The FDA-approved label allows it to be administrated via “IV-push” (the drug is injected into a vein), intramuscular injection or a slow intravenous drip into a vein.

Levine says Wyeth should have changed the drug’s label to bar IV-push administration. She said she was never told the risks of this method – that includes possible irreversible cangrene if done incorrectly, as it was mentioned on the label – and she would have chosen another method rather than loosing her arm.

Wyeth and the administration are asking the high court to rule that the drugmakers may not make changes to labels without the approval of the Food and Drug Administration and that people cannot sue under state law for harm caused by an FDA-approved drug. The drugmaker argues in its appeal that the federal Food and Drug Administration should be the only one to decide whether drug labels have been properly written, instead of a jury that can only take into consideration individual arguments of the drugs in question.

According to the U.S. Chamber of Commerce, the Vermont musician case could affect millions of other business outside the pharmaceutical industry that face liability claims.



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