Preemption and Medical Devices: The Courts Run Amok

Perhaps the most dramatic indication that the courts have shifted attitudes on health and safety matters comes from recent cases relating to medical devices and preemption. In this Article, we review the law relating to preemption, the Cipollone decision, the preemption provisions of the MDA, the regulations issued by the Food and Drug Administration ("FDA") relating to preemption, and the impact of Cipollone on court interpretations of the MDA. Based on our review of the intended preemptive effect of the MDA, we conclude that it is unlikely that either Congress or the FDA intended for the MDA to preempt state tort claims. Moreover, even if preemption were justified for some tort claims-a proposition we reject-the courts have extended the rationale in Cipollone far beyond anything that the Supreme Court intended in its ruling.

In short, we maintain that the courts have run amok in their rulings on preemption.