The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any device receiving premarket approval is federally preempted from state tort claims. This means injured patients of medical device malfunctions are barred from seeking remedy against the manufacturers. Thus, the Cures Act potentially puts patients at greater risk but does nothing to provide those patients remedies for injury.
This Note argues that federal preemption for medical devices receiving premarket approval should be reconsidered. Because the regulatory framework for which Riegel was decided has now shifted, the Court should reevaluate its prior ruling. Additionally, Congress should amend the preemption clause in the Food, Drug, and Cosmetic Act to allow for state tort action. Finally, Congress should create a victim compensation fund, run by HHS, to allow victims to make no-fault injury claims and receive payments for their suffering.
Megan C. Andersen,
21st Century Cures Act: The Problem with Preemption in Light of Deregulation,
U. Mich. J. L. Reform
Available at: https://repository.law.umich.edu/mjlr/vol52/iss3/7