Document Type

White Paper

Publication Date



As consumers, we assume that the automobiles, pharmaceuticals, medical devices, and other products we purchase are generally safe for their intended uses. We rely on manufacturers to design and produce safe products, and we assume that federal regulators are conscientious watchdogs of the marketplace. In most instances, our assumptions are valid and we safely go about our lives. But the regulatory system is now frayed to the point that dangerous products sometimes slip through the cracks. Vioxx, Firestone/ATX tires, and toxics-laden children’s toys have endangered and harmed millions. In these cases, society depends on the state courts as a venue for injured people to seek justice.

Over the years, product manufacturers have worked hard to deny injured consumers’ access to the courts – and during the Bush Administration, they had powerful allies in the White House and throughout the Executive Branch. Complaining of excessive damage awards and unpredictable legal terrain, manufacturers have adopted the argument that federal regulatory actions preempt injured consumers’ lawsuits for things like negligence, defective design, or failure to warn. The preemption argument is based on the Constitution’s Supremacy Clause, under which Congress has the power to invalidate, or “preempt,” state law through enactment of appropriate legislation. The defense bar has misappropriated that limited legal doctrine. Protective regulatory action should not be used to shield manufacturers from having to prove that their products are safe. But that is precisely what the regulatory preemption doctrine does: it gives judges the ability to throw legitimate victims out of court before they have even had a chance to make their case that their injuries were caused by a dangerous product. Furthermore, the claim asserted by numerous federal agencies late in the Bush Administration that federal actions could and should preempt state common law constituted an unsound and unprecedented policy shift.

This white paper lays out a different perspective on regulatory preemption. Instead of looking at regulatory preemption as a tool for limiting corporate liability, this paper recognizes that preemption is a tool for structuring power between states and the federal government. Especially in the context of public health and safety, all levels of government have a legitimate interest in determining the ideal level of protective regulation. In addition, this paper treats the preemption debate as a question of the relative powers of Congress, the courts, and federal administrative agencies. The Supremacy Clause makes Congress the primary decisionmaker in setting federal preemption policy, though the courts and agencies have tried to usurp some of that authority in recent years.

Creative Commons License

Creative Commons Attribution-Noncommercial 3.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial 3.0 License