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Mar 12, 2009 FDA approvals won't save companies..
A musician had a Wyeth anti-nausea drug mistakenly injected into an artery, even though a label, approved by the US Food and Drug Administration (FDA), warned against such practice. The patient's forearm was amputated. The patient was entitled to a US$6.7-million award, after she sued drug maker Wyeth. The federal government supported Wyeth in arguing that FDA-approved labels should shield drug makers when they are sued for damages. The ourt's opinion is "Failure-to-warn actions, in particular, lend force to the FDA's premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times." The company called the full court's decision "disappointing, not only for Wyeth, but for patients and public health in general".« Back |
