Supreme Court Wyeth Decision Puts Pre-emption At Risk

On March 4, 2009 the U.S. Supreme Court decided the controversial case of Wyeth v. Levine in favor of patient-plaintiff Diana Levine. The Court rejected Wyeth's argument that the FDA's approval of its labeling pre-empted a claim for personal injury arising from a failure to warn. The decision is a major set-back for the pharmaceutical industry and the reliance on compliance with FDA standards in defending private actions. Indeed, as a result of the ruling, the Supreme Court has subsequently vacated an important appellate court decision which had barred a consumer fraud claim based on FDA approval and oversight.

The controversy surrounding the labeling in the Wyeth case is centered on two methods for administering Phenergan: "IV-Push" and "IV-Drip." The IV-Push method presents a significant risk of gangrene infection when the needle is misplaced and the drug leaks into an artery. This risk exists regardless of the experience level of the attending physician. The IV-Drip method dramatically reduces that risk. Levine sued Wyeth under state strict liability law for failing to adequately warn of the risks associated with Wyeth's anti-nausea drug Phenergan, which can cause gangrene infection when administered intravenously. Phenergan caused a gangrene infection in Levine's arm when it was administered intravenously and led to the amputation of Levine's arm.

Although the drug warns of the risk the IV-Push method presents, a Vermont jury found that the warning concerning the IV-Push method was not adequate when weighing the risk against the benefits of the treatment. The drug was administered to Levine using the IV-Push method. Levine was awarded $6.7 million by a Vermont jury for the damages she suffered as a result

Wyeth argued that the jury verdict addressing the labeling of Phenergan would conflict with the FDA approval of its labeling Wyeth had previously obtained. Wyeth's argument was not based on any express regulation, but was rather based on the implied reasoning that Wyeth could not have adjusted the labels to adhere to stricter state law obligations without violating federal regulations. The Supreme Court rejected Wyeth's argument, finding that that in the absence of express statutory language to evidence Congress' intent to pre-empt state law, no pre-emption exists.

This decision is a major set-back for the pharmaceutical industry in that it calls into doubt reliance on implied FDA approval of labeling as a variety of cases. As it relates to advertising, the decision may jeopardize the Third Circuit's decision in Pennsylvania Employee Benefits Trust Fund v. Zeneca, Inc., 499 F.3d 239, 244 & 249-52 (3d Cir. 2007) which held that that state law claims for false advertising and consumer fraud challenging labeling and advertising could not be asserted because such claims challenge the FDA's exclusive authority and could result in inconsistent judicial determinations. On March 9, 2009, the Supreme Court vacated and remanded the Pennsylvania Employee Benefits Trust Fund decision in light of its Wyeth ruling.

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