In 2009, the United States Supreme Court handed down a seminal decision regarding the liability of drug manufacturers for failure to adequately warn of the risks associated with using a particular drug. The Court examined the argument of a drug manufacturer that it could not be held liable for a failure to warn, eventhough it would have been possible to issue a more updated warning label, because the FDA had already approved the drug, and its manner of uses, as safe.
The case, Wyeth v. Levine, 129 S. Ct. 1187 (2009), arose out of an incident whereby the injection of a drug caused a woman to suffer gangrene from a known side effect, which ultimately resulted in the amputation of her arm.
The drug at issue, Phenergan, is an antihistamine used to treat nausea. The injectible form of the drug can be administered two different ways. One way is through a traditional IV, and the other is more akin to a shot. If the drug accidentally enters an artery, it causes immediate and irrevercible gangrene. When the patient was given the drug, she was given it in the shot manner, and it somehow entered an artery, causing gangrene, which ultimately resulted in the amputation of her forearm.
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