The Real Impact of Wyeth v. Levine: How to Survive in a Post-Preemption World

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In a 6–3 vote, the Supreme Court has struck down the FDA’s position that its labeling regulations trump state laws regarding what drug labels should disclose. Without that defense, you’re exposed to billions of dollars of claims under dozens of different legal standards.

You could change your FDA-approved labeling to match differing state requirements and risk the agency declaring your product mislabeled. Or you could stick with labels that meet federal standards but open you up for a wave of lawsuits and decades of litigation.

Or you could join two legal experts who have followed the case from the beginning and are currently reviewing the decision to tell you why the justices made the decision and how you can walk the line between federal regulations and often contradictory state laws …

In a 90-minute Encore presentation, two members of the FDA-specialty law firm Hyman, Phelps & McNamara, P.C., Kurt Karst, who personally attended the oral arguments before the Supreme Court on Nov. 3, 2008, and consumer litigation expert John Fleder, will analyze the specifics of the ruling and provide actionable strategies and tips you need in light of the decision.

Kurt and John will walk you through the court’s disagreements with Wyeth’s positions, show how the ruling differs from Riegel v. Medtronic, reveal important lessons within the dissenting opinion and explore ways drug companies can protect themselves from lawsuits without violating federal labeling rules.
Sign up your entire team to listen in and discover:

  • A review and analysis of the decision and the reasoning behind it
  • The differences between the decisions in Wyeth v. Levine and Riegel v. Medtronic — How can the Supreme Court support preemption for devices but not drugs?
  • What flaws the majority opinion found in Wyeth’s argument
  • A description of the political environment in Washington, D.C. — Is there any chance Congress will give the FDA preemption authority?
  • What companies can learn from the dissenting opinion
  • Practical tips and strategies for surviving in a post-preemption world — How can companies protect themselves from lawsuits under differing state failure-to-warn laws without having their products declared misbranded by the FDA?

Find out how the ruling in Wyeth v. Levine immediately changes the way you should approach labeling your products and how you can avoid lawsuits while keeping the FDA from declaring your products misbranded. Register now and you'll get an opportunity to ask your toughest questions during the Q&A session.

This presentation is a must for drug and biologic firm employees who need to protect their companies from lawsuits and regulatory sanctions, including:
  • Senior management
  • Risk analysis officials
  • General/corporate counsel
  • Outside attorneys
  • Regulatory/legislative affairs professionals
  • Medical affairs
  • Sales and marketing officials

Kurt Karst is an associate at Hyman, Phelps & McNamara, P.C., the largest dedicated food and drug law firm in the country. Prior to joining in 2001, Kurt was a law clerk at the firm and a lobbyist for F. Hoffmann-La Roche. in Washington, D.C. He is a 2001 graduate of the American University Washington College of Law, and holds a bachelor’s degree in political science and German from Marquette University (1995 magna cum laude). Kurt served as an articles editor for the American University Law Review and in 1995, was awarded a Fulbright Scholarship for post-graduate studies in Germany. Kurt has published in the American University Law Review, the Food and Drug Law Journal, FDLI Update, and is co-author of the Food and Drug Law Institute's Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives. He is admitted to practice law in the Washington, D.C. and Maryland. 

John Fleder is a partner at Hyman, Phelps & McNamara, P.C. Prior to joining the firm in 2000, he served as the director of the Justice Department’s Office of Consumer Litigation between 1985 and 1992, after serving in various other capacities in that office since 1973. John also served a stint as a Special Assistant U.S. Attorney in Baltimore. As director of the Office of Consumer Litigation, he directed enforcement cases in federal court for the FDA, FTC and Consumer Product Safety Commission (CPSC). While in the government, John was co-lead counsel in the highly publicized trials held in Brooklyn, N.Y., in which two executives of the Beech-Nut Nutrition Corporation were convicted of multiple felonies for defrauding the public into buying adulterated apple juice. He specializes in litigation and internal investigations concerning clients involved in criminal, civil and regulatory matters relating to the FDA, FTC and CPSC. John received his B.A. in 1969 from Franklin & Marshall College and his J.D. in 1972 from New York University. John is admitted to practice in the Washington, D.C. and numerous federal courts, including the U.S. Supreme Court.

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Date: March 30 – April 17, 2009
Location: Your office or conference room (no need to travel!)
Time: Anytime

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