product safety

Diana Levine suffered from chronic migraine headaches for many years. So, in April 2000, when she went to a local clinic to get treatment, she knew what to expect. She’d received the same treatment several times before: an injection of Demerol for the pain, and an injection of an antihistamine called Phenergan to treat the nausea that accompanies both migraine headaches and Demerol itself. Everything was normal — except for how the drugs were actually administered. The physician’s assistant who gave her the drugs accidentally injected the Phenergan into an artery, instead of a vein, causing tissue death and gangrene. Ms. Levine, a professional musician, eventually had to have her arm amputated.

Levine naturally sued the physician’s assistant, the supervising physician, and the clinic for malpractice. After all, Phenergan’s FDA-approved label specifically warned against injection into an artery, precisely explaining the likely, tragic side-effects. But Levine also sued the pharmaceutical company that manufactures Phenergan, Wyeth, arguing that the warnings were not clear enough. Despite Wyeth’s defense that the drug had been on the market since 1955, FDA had known about the gangrene risk since 1967, and the agency had explicitly approved the warning that was included on the label, a Vermont jury awarded Levine $6.8 million dollars.

Wyeth appealed the jury verdict, arguing that, because it had complied with FDA regulations on both product safety and labeling, and because there was no new information about Phenergan’s risks that would supersede FDA’s judgment about the warning language, FDA regulation should preempt the state tort claim. And FDA agreed. Nevertheless, the Vermont Supreme Court affirmed the verdict, and Wyeth further appealed to the U.S. Supreme Court, which hears oral argument in the case today.
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