"Pre-empted: Will The Supreme Court Gut Product Defect Claims Against Drugs Approved By The FDA?" Joint Mtg w/ NevBio & Boyd School of Law IP Society

Kelly Evans, Partner at Snell & Wilmer, will be discussing the case of Wyeth v. Levine that was argued at the Supreme Court on November 3, 2008 at the November 24th NevBio meeting. If the Supreme Court rules in favor of Wyeth in the Levine case then it may result in the preemption of a broad category of mass tort pharma cases that have recently resulted in huge verdicts against pharma companies (i.e. Vioxx). This is a closely watched case for both the pharmaceutical and legal industries.

The meeting will be Monday-November 24th at UNLV's Boyd School Law Bldg Room 102
12:30 P.M.Lunch & Lecture ($20) UNLV at 4505 S. Maryland Pkwy., Las Vegas, NV 89154
Please RSVP at 702-839-7222 or e-mail jlaub@regenmd.org

The following is from the Supreme Court of the United States Wiki as of November 6, 2008. Authorship: Michael Blaisdell. (1)

Diana Levine, a bass player and author of children's music in Vermont, visited a clinic to receive treatment for headache-related nausea but wound up developing tissue deterioration and gangrene in her arm, ultimately leading to its amputation. Clinic staff attending to Ms. Levine had administered the antihistamine Phenergen using a delivery technique known as an "IV push," inadvertently injecting the drug into one of Ms. Levine's arteries in the process. Although both Wyeth (the drug's manufacturer) and the FDA were aware that the "IV push" created a risk of inadvertent arterial injection and gangrene, the FDA had nevertheless approved labeling for Phenergen that warned against - but did not prohibit - IV push administration.

Ms. Levine brought a common-law negligence claim in Washington Superior Court against Wyeth, claiming that Phenergen's labeling was inadequate because it did not prohibit IV push delivery. Wyeth countered that because use of the warning label was mandated by the FDA pursuant to its authority under the Food, Drug and Cosmetic Act (FDCA), Ms. Levine's state tort suit was impliedly preempted by federal law in two ways: (1) it was impossible for Wyeth to satisfy both the labeling requirement of the FDA and the demands of Vermont's common law; and (2) state liability for use of an FDA-approved label would present an obstacle to the federal objectives of the FDCA.

The superior court instructed jurors that they could consider the FDA's approval of the label in making their negligence determination, but that the label's compliance with FDA rules did not establish the adequacy of the warnings therein. At the conclusion of the trial in 2005, the jury found in Ms. Levine's favor, awarding her more than $6 million in damages.

Wyeth appealed, and in October 2006, a divided Vermont Supreme Court upheld the ruling.
This case, Wyeth v. Levine, gives the Supreme Court another chance to mediate the relationship between organic, common-law jury verdicts and the cold machinery of the Supremacy Clause. After its February 2008 decision in Riegel v. Medtronic, in which it held that federal law expressedly preempted common-law suits against manufacturers of FDA-approved medical devices, the Court now considers the scope of federal preemption in the pharmaceutical industry, whose applicable federal regulations contain no express preemption clause.

1. "Wyeth v. Levine." Authorship: Michael Blaisdell. Scotus Wiki. November 2008.

Kelly Evans is a partner at Snell & Wilmer where his practice is focused on product liability defense, employment, and intellectual property litigation. His product liability litigation focuses on defending automotive and pharmaceutical manufacturers. Kelly's employment litigation practice includes representing employers in discrimination, harassment, wrongful discharge, and contractual matters. His intellectual property litigation concentrates on unfair competition, trade secrets, restrictive covenants, and trademark and patent infringement. Kelly has extensive experience in state and federal court, and before administrative agencies.