Wednesday, March 04, 2009
U.S. Supreme Court Rules That FDA Approval Does Not Shield Drug Maker
The United States Supreme Court has upheld a $6.7 million verdict for a woman who had to have her arm amputated after an anti-nausea drug hit an artery and caused gangrene. Even though the drug carried a warning of this rare complication and the FDA approved not only the drug but also the warning, Justice John Paul Stevens, writing for the majority, said that the drug maker could "unilaterally strengthen its warning." Click here to read the opinion.