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