Preemption and Regulatory Failure

This symposium was convened to address the growing and seemingly conflicting jurisprudence governing federal preemption of state damage actions. One way to evaluate the evolution of preemption law is to examine it through the lens of litigation under the preemption provision of the 1976 Medical Device Amendments ( MDA ) to the federal Food, Drug, and Cosmetic Act - a provision that in many respects is typical of express preemption provisions in regulatory statutes and has spawned a high volume of litigation. The question raised in cases under the MDA is whether the Act\u27s preemption provision nullifies state damage actions based on personal injuries caused by medical devices that are defective, poorly designed, or promoted in ways that do not alert patients (and physicians) to the risks that attend their use. The answer to that question depends on how one reads the MDA preemption provision