Georgia residents and countless others across the nation received good news today. In a surprise decision handed down today the United States Supreme Court held that drug manufacturers who fail to warn of known dangers are not immune from liability due to the federal preemption doctrine.
\nIn the case of Wyeth v. Levine , the Supreme Court was confronted with a situation in which drug manufacturer Wyeth had been sued by Levine. Wyeth manufacturers the anti-nausea drug Phenergan. Levine had been injected with Phenergan by a clinician using the IV-push method whereby the drug is injected directly into a vein. However, the drug entered an artery and doctors were forced to amputate her arm below the elbow.
\nLevine sued in the state courts of Vermont alleging among other things, that Wyeth knew of the increased risks of using the drug by the IV-push method, but failed to provide adequate warnings to healthcare practitioners. A Vermont jury determined that Wyeth was liable under state failure to warn claims and awarded damages against Wyeth.
\nWyeth appealed arguing that prior approval of the label for Phenergan by the FDA preempted all state law actions, in effect granting them immunity from suit.
\nThe Supreme Court squarely rejected this argument, finding that Wyeth\u2019s argument would shift the burden of providing adequate warnings to the FDA when the duty to warn rests directly upon the manufacturer.
\nThis is a major victory for consumers across the United States.<\/p>\n