Update: Top Court Hears Arguments in Wyeth & Levine Case

By Alice Carver
16:00, November 4th 2008
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Update: Top Court Hears Arguments in Wyeth & Levine Case

Patients and drug companies are still waiting for a decision of the U.S. Supreme Court in Levine’s case. The case Wyeth & Levine could affect millions of other business outside the pharmaceutical industry that face liability claims.

Levine’s case, one of the most watched business cases of the Supreme Court’s team, seeks answers to questions like: Can the federal government limit lawsuits by consumers who have been harmed by a prescription medication?, Can the drug makers make changes to the labels without the approval of the Food and Drug Administration?

According to recent reports about the case, attorney Seth Waxman, arguing for Wyeth, told the court that the prescribing instructions for the drug, Phenergan, “plainly comprehended and warned about the specific risks” of giving the drug in the way Levine received it.

The Vermont musician, Diana Levine, received treatment with Phenergan in 2000. The drug was supposed to relief her nausea but it was improperly injected and the woman lost her arm. Wyeth, formerly known as American Home Products, was found guilty of not warning doctors about the risk of Phenergan intravenous injections. 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.

The drug’s labels mentioned possible irreversible cangrene if the procedure called “IV-push” was done incorrectly.

On the other hand, Levine's lawyer said Wyeth knew the injection method used for Levine was dangerous and the company should have put a stronger warning on the drug. Levine said she was never told the risks of this method and she would have chosen another method rather if she knew she would loose her arm. Wyeth’s attorney said the label had FDA’s approval. As it was mentioned on the label, the drug could be administrated via “IV-push” (the drug is injected into a vein), intramuscular injection or a slow intravenous drip into a vein. The company insisted they were not allowed to change the warnings due to FDA rulings.

An answer is still awaited in this case and drug makers want to know if they can be held responsible for harm caused by the drugs after they have been approved by the FDA.



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