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Administrative Law Keyed to Popper
Wyeth v. Levine
Citation:
555 U.S. 555 (2009)Facts
Diana Levine, a professional musician, received Phenergan to treat nausea associated with a migraine headache. The drug was administered through the “IV-push” method, whereby it was injected directly into her vein. Either the needle penetrated an artery or the drug escaped from the vein into surrounding tissue, coming in contact with arterial blood. This caused gangrene, requiring amputation of her right hand and eventually her entire forearm. Phenergan’s FDA-approved label contained warnings about the risk of gangrene and amputation following inadvertent intra-arterial injection, but did not specifically contraindicate the IV-push method. Levine sued Wyeth, claiming that the labeling was defective because it failed to instruct clinicians to use the IV-drip method instead of the higher-risk IV-push method. Wyeth argued that federal law preempted Levine’s state-law claims because the FDA had approved Phenergan’s label.
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