Wyeth v. Levine
By JOEL COHEN, head of Clifford Chance's U.S. litigation practice, and SARAH BLACKMAN, associate and also a member of the litigation practice
The key issue for drug manufacturers and others was whether compliance with federal FDA standards in producing and labeling pharmaceuticals immunizes a company from lawsuits brought under state laws. In a 6-3 ruling in favor of the plaintiff, Diana Levine, the Court decided it did not, and provided some clarification on the pre-emption standards in products liability cases.
In Wyeth, Diana Levine brought a failure-to-warn action under state tort law against drug manufacturer Wyeth concerning its anti-nausea drug, Phenergan. Wyeth previously had obtained FDA approval for the drug. Ms. Levine alleged that Phenergan had been administered to her to treat migraine headaches through the "IV-push method," where the drug is injected directly into the patient's vein. When administered, the drug entered Ms. Levine's artery by accident, causing gangrene that resulted in the amputation of her forearm. Ms. Levine alleged, among other arguments, that the drug's labeling was inadequate in that it did not instruct clinicians to use a safer method of administration.
Wyeth set forth two arguments in favor of pre-emption. First, it argued that it was impossible for it to comply with its state-law duty to strengthen Phenergan's label while also complying with federal regulations, since the FDA prohibited Wyeth from changing the label without federal approval. The Court disagreed, finding that it was possible to have complied with both state and federal obligations. In doing so, it cited an FDA regulation allowing a manufacturer to strengthen a warning at the time of filing its application for FDA approval, rather than waiting for FDA approval before revising the label's language.
Second, Wyeth argued that Congress intended to leave drug labeling decisions to the FDA as an expert agency and that allowing state tort litigation would obstruct the purpose of the federal regulation. Wyeth cited the preamble to a 2006 FDA regulation expressly stating that FDA approval of labeling pre-empts conflicting state law. The Court rejected this argument on the basis that it "relies on an untenable interpretation of congressional intent and an overbroad view of an agency's power to pre-empt state law." The Court stated that where a regulation might pre-empt state law, it is the Court's role to analyze the competing federal and state duties for conflict rather than deferring to an agency's conclusion on pre-emption.
What does this mean for drug manufacturers?Drug manufacturers will continue to face dual regulation under federal and state laws, but the future direction of pharmaceutical litigation remains uncertain given the status of pre-emption jurisprudence.In its 2008 ruling in Riegel v. Medtronic, the Court favored pre-emption in the context of medical device litigation. That members of Congress unveiled new legislation to reverse Medtronic a day after the Wyeth ruling is a measure of Wyeth's impact.
April 15, 2009
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