The Preemption Decision of Wyeth v. Levine: Analysis and Impact on the Pharmaceutical Industry
In this teleconference, we will discuss the Wyeth v. Levine decision in depth, focusing on the immediate and long-term effects on company regulatory processes. Underscoring the importance of proactive interactions with the FDA, among others, and taking into account the FDA's increased authority over drug safety, labeling and risk minimization issues, we will analyze avenues available to the industry for maximizing the likelihood of success in asserting a preemption defense. In addition, we will discuss ways of reducing potential product liability exposure even where preemption is unavailable.
We will also consider the future of preemption in the context of the Riegel v. Medtronic case, which upheld the preemption defense in the context of medical devices, as well as the anticipated efforts by some in Congress to legislatively override that decision.