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Supreme Court to rule on drug warning labels

November 6, 2008 by  

Drug warning labels are under legal scrutinyOn Monday, attorneys for the Bush administration argued in front of the Supreme Court that drug companies should be shielded from consumer lawsuits even if they fail to warn patients about risks which could have long reaching effects on their health.

The case involves Diana Levine, a Vermont woman who had her arm amputated after an IV push of the anti-nausea medication Phenergan struck an artery, causing gangrene.

A jury awarded Levine $6.7 million in her suit against Wyeth, the drug’s maker, which the company appealed claiming the federal Food, Drug and Cosmetic Act prevents state lawsuits that conflict with federal drug regulations like warning labels approved by the U.S. Food and Drug Administration.

Levine’s lawyer, David Frederick, argued that Wyeth didn’t do everything in its power to warn of the potential dangers.

"The manufacturer has a duty of due care, a duty to analyze new information on risk and to make appropriate change in the warning to reflect that," said Frederick. "It didn’t live up to that duty."

According to Wyeth’s website, Phenergan has been on the market since 1951 and is typically used to treat the effects of inhaled allergens or food allergies.

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