Wyeth v. Levine: Supreme Court Rules on Implied Conflict Preemption for Prescription Drugs (One-Hour Audio Briefing)

Overview

April 1, 2009, 1:00 p.m. - 2:00 p.m. (E.D.T.)

Last term the U.S. Supreme Court decided Riegel v. Medtronic, Inc.,128 S. Ct. 999 (2008), in which the Court held that the Medical Device Amendments to the Food, Drug and Cosmetics Act expressly preempted state common-law negligence and strict liability claims involving medical devices that had gone through the pre-market approval process because those state claims imposed on the manufacturer “requirements” that related to safety and efficacy and were “different from, or in addition to” the relevant federal requirements. 

Thus, expectations were raised when the Court took up the appeal in Wyeth v. Levine, No. 06-1249 (U.S. Mar. 4, 2009).  Would this be the case in which the Court established the boundaries of implied conflict preemption for pharmaceuticals?  Ultimately, the Supreme Court rejected Wyeth’s conflict preemption argument and affirmed the judgment against the company, finding that it was not impossible for Wyeth to comply with federal regulations and state common law, and that state common law did not provide an obstacle to the achievement of the purposes and objectives of federal law.

To explain the significance of the Levine decision and its implications for pharmaceutical litigation and beyond, PLI is presenting a discussion between David C. Frederick – a leading Supreme Court advocate with Kellogg, Huber, Hansen, Todd, Evans & Figel, P.L.L.C. who successfully argued the appeal on Ms. Levine’s behalf – and Bert W. Rein – former White House Counsel and a founding member of Wiley Rein LLP, who represented Wyeth on the briefs before the Supreme Court.  Moderating the discussion will be J. Russell Jackson, a partner in the mass torts group at Skadden, Arps, Slate, Meagher & Flom LLP. 

Please join us to consider, among other issues, the following questions:

• What, exactly, is the holding of Wyeth v. Levine?  And does it apply beyond pharmaceutical cases?
• Can an implied preemption argument succeed in a pharmaceutical case after Levine?  If so, what would it require?
• What does the fact that Levine involved failure to warn claims say about potential preemption of design defect or manufacturing defect claims in drug cases?
• Does Levine – when read with Altria Group, Inc. v. Good, 129 S. Ct. 538 (2008) – provide a comprehensive framework for analyzing implied preemption arguments?
• What impact, if any, did Levine’s “presumption against preemption” have on the result? 
• Did Levine effectively overrule Geier v. American Honda Motor Co., 529 U.S. 861 (2000)?  And how do we synthesize the cases in which the Court has relied upon a “presumption against preemption” and those in which it has not?
• After Levine, what level of deference should be accorded to a regulatory agency’s statements about the preemptive effect of its rules made in:  (1) a ‘preamble’ to a rulemaking, (2) an amicus brief, (3) public comments, (4) communications to those companies that it regulates?
• Is there a policy reason for treating drugs and devices differently when it comes to preemption?

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