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In its FDA approved warnings, Wyeth specifically referenced that “extreme care” should be used in the administration of the drug by IV-push to avoid perivascular extravasation or inadvertent intra-arterial injection which would “likely” cause “gangrene requiring amputation.”48


Levine claimed that the


labels were insufficient because they failed to instruct health care providers to use the IV-drip method rather than the higher risk IV-push method. Levine offered evidence that the drug should never be administered by IV-push.49 Te question presented in Wyeth v. Levine was whether


the FDA’s drug labeling judgments “preempted state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.”50


Wyeth made two51


judgment as to the adequacy of drug labeling for the “expert judgment of the FDA.”52


Te Supreme Court held that


federal law did not preempt Levine’s claim that Phenergan’s label did not contain an adequate warning about using the IV-push method.53


As to the first argument, Wyeth contended that following


FDA approval of a manufacturer’s labeling, a “changes being effected” (CBE) regulation permitted a manufacturer to change its label without prior FDA approval only to “reflect newly acquired information.”54


In Wyeth’s view, it could only preemption arguments:


first, that it would have been impossible for it to comply with a state law duty to modify Phenergan’s labeling without violating federal law; and second, that the state tort action created an unacceptable obstacle to the accomplishment of Congressional objectives because it substituted a jury’s


48 555 U.S. ---, 129 S.Ct. at 1191, 1192 & fn. 1. 49 555 U.S. ---, 129 S. Ct. at 1192. 50 555 U.S. ---, 129 S. Ct. at 1193. 51 Wyeth abandoned its field preemption argument. 555 U.S. ---, 128 S. Ct. at 1192.


38 Trial Reporter / Winter 2010


have changed Phenergan’s label in response to new information that the FDA had not considered, rendering it impossible to comply with state law obligations to provide a stronger warning without violating federal law. Wyeth contended that Levine had not identified any newly acquired information following FDA label approval.55


Te Supreme Court disagreed, noting


that Wyeth’s argument “misapprehends both the federal drug regulatory scheme and its burden in establishing a preemption


52 555 U.S. ---, 128 S. Ct. at 1193. 53 555 U.S. ---, 128 S. Ct. at 1204. Te Supreme Court specifically noted that, contrary to the dissent’s suggestion, it was not addressing the broader question whether a state rule proscribing intravenous administration would be preempted.


54 555 U.S. ---, 129 S.Ct. at 1196. 55 555 U.S. ---, 129 S.Ct. at 1196-1198.


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