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United States Supreme Court Grants Certiorari in Wyeth V. Levine, No. 06-1249, to Consider Preemptive Scope of FDA Approval of Prescription Drug Labeling |
February 5, 2008
The United States Supreme Court has granted drug manufacturer Wyeth's petition for certiorari in Wyeth v. Levine, - S.Ct. -, 75 USLW 3500, 76 USLW 3018 (U.S. Vt. Jan 18, 2008) (No. 06-1249), to review the Vermont Supreme Court's analysis of the preemptive scope of the Food and Drug Administration's ("FDA") approval of labeling of the prescription drug Phenergan. See Wyeth v. Levine, - A.2d -, 2006 WL 3041078 (Vt. Oct. 27, 2007), Prod.Liab.Rep. (CCH) P 17,627, 2006 VT 107. Wyeth has marketed the anti-nausea drug Phenergan with FDA approval for over fifty years. The drug is administered either through intramuscular injection, intravenous injection through an established IV drip, or through direct intravenous injection via a "push IV." Over forty years ago Wyeth received a report of gangrene and subsequent amputation of a patient's limb resulting from arterial blood exposure to the drug which was associated with push IV administration. Over the next several decades Phenergan's label was changed, with FDA approval, to warn of incidents of necrosis, gangrene, and amputation following IV injection, and to note the benefit of IV administration through an established IV infusion. In 1997 Wyeth submitted, and the FDA considered but rejected, a proposed label that added additional language related to IV push administration of the drug. The FDA directed Wyeth to "retain the verbiage" in its current label.
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The views expressed in this article are solely the views of the author and not Martindale-Hubbell. This article is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance. |
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