In Wyeth v. Levine, the Court noted that directly injecting the drug into a patient’s vein significantly increased the risk of “catastrophic consequences.” The Plaintiff argued that even though Phenegran’s labeling warned of the danger of gangrene and amputation following injection, it failed to instruct physicians to use an IV-drip method. In August 2004, a trial court found in favor of the Plaintiff.
Writing for the majority, Justice John Paul Stevens noted that the trial court “determined that there was no direct conflict between FDA regulations and Levine’s state-law claims because those regulations permit strengthened warnings without FDA approval on an interim basis and the record contained evidence of the at least 20 reports of amputations similar to Levine’s since the 1960s.” Stevens concluded that, “In short, Wyeth has not persuaded us that failure-to-warn claims like Levine’s obstruct the federal regulation of drug labeling. Congress has repeatedly declined to pre-empt state law, and the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight. Although we recognize that some state-law claims might well frustrate the achievement of congressional objectives, this is not such a case.”