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Diana Levine, a lifelong musician and guitar player, went to the hospital with a migraine.  She left with injuries that led quickly and irreversibly to the loss of her right hand.  Ms. Levine received an anti-nausea drug, Phenergan.  It was administered by the "IV push" method, resulting in an inadvertent introduction of the drug into an artery, which ultimately caused gangrene.

Ms. Levine filed suit in state court against the manufacturer of Phenergan, Wyeth, asserting that the drug's labeling provided an inadequate warning of the known dangers of the "IV push" method.  Wyeth, however, argued that because the label had gone through FDA approval and included some indication of potential dangers, they were not subject to any liability based on a failure to warn.  A jury nevertheless ruled in Ms. Levine's favor, and she was awarded $7.4 million in damages.  Wyeth appealed to the Vermont Supreme Court, but that court also rejected Wyeth's argument.  The majority held that the "federal labeling requirements create a floor, not a ceiling, for state regulation."  Finding that there was "no conflict between federal objectives and Vermont common law," Levine's state law claims were not preempted. Wyeth then appealed to the United States Supreme Court.

Wyeth may become the latest in a series of cases that have substantially altered consumer protection law in the United States.  Last term, in a significant anti-consumer decision, the Court held that persons injured by a negligently manufactured medical device cannot bring state law claims against the manufacturer for damages if the device received pre-market approval from the federal Food and Drug Administration ("FDA").  In Wyeth, the Court will address the same preemption issues as it relates to labeling of prescription drugs.

Because the Supreme Court agreed to hear Wyeth's appeal this term, it seems likely that the Court's most conservative members favor extending the preemption doctrine's reach.  If they succeed, pharmaceutical drug manufacturers will be shielded from liability and everyday Americans—like Diana Levine—who are harmed by their products will be left without a remedy.  The Court heard oral arguments in this case on Monday, November 3rd.

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