Wyeth v. Levine

555 U.S. 555 (2009)

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Nature of the Case

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Facts

Directly injecting Phenergan into a patient’s vein creates a significant risk of catastrophic consequences. Phenergan is an antihistamine used to treat nausea. The injectable form of Phenergan can be administered intramuscularly or intravenously, and it can be administered intravenously through either the “IV-push” method, whereby the drug is injected directly into a patient’s vein, or the “IV-drip” method, whereby the drug is introduced into a saline solution in a hanging intravenous bag and slowly descends through a catheter inserted in a patient’s vein. The drug is corrosive and causes irreversible gangrene if it enters a patient’s artery. Levine (P) visited a local clinic for treatment of a migraine headache. She received an intramuscular injection of Demerol for her headache and Phenergan for her nausea. Because the combination did not provide relief, she returned later that day and received a second injection of both drugs. The physician assistant administered the drugs by the IV-push method, and Phenergan entered Levine’s artery. P developed gangrene, and doctors amputated first her right hand and then her entire forearm. P incurred substantial medical expenses and the loss of her livelihood as a professional musician. P brought an action for damages against D, relying on common-law negligence and strict liability theories. P alleged that the labeling was defective because it failed to instruct clinicians to use the IV-drip method of intravenous administration instead of the higher risk IV-push method. P alleged that Phenergan is not reasonably safe for intravenous administration because the foreseeable risks of gangrene and loss of limb are great in relation to the drug’s therapeutic benefits. D filed a motion for summary judgment, arguing that P's claims were pre-empted by federal law. These arguments were rejected. The trial judge instructed the jury that it could consider evidence of D's compliance with FDA requirements but that such compliance did not establish that the warnings were adequate. The jury found that D was negligent, that Phenergan was a defective product as a result of inadequate warnings and instructions, and that no intervening cause had broken the causal connection between the product defects and P’s injury. The trial court denied D’s motion for judgment as a matter of law. The court rejected D’s pre-emption arguments. The Vermont Supreme Court affirmed.