‘Fifty FDAs’: An Argument for Federal Preemption of State Tort Law that is Less than Meets the Eye

Abstract

This white paper offers a comprehensive refutation of the “50 FDAs” argument in favor of federal regulatory preemption of state tort law in cases involving unreasonably dangerous drugs and medical devices.

The 50 FDAs argument posits that federal regulation of drugs and medical devices ought to preempt state tort law, because state tort law subjects manufacturers of these products to a wide range of inconsistent and unpredictable regulatory standards – the effective equivalent of having to comply with the regulations of 50 different FDAs. They contend that a better approach would be for FDA to adopt regulations imposing unitary federal standards that would supplant the entire state tort law system.

This white paper shows the 50 FDAs argument for what it really is: an attempt by drug and medical device manufacturers to limit citizen access to the courts so that they can avoid their civil law responsibilities, while at the same time trying to get a weak set of federal regulations that impose only minimal compliance costs. In this way, the 50 FDAs argument is part of the larger effort by regulated industry to preempt state tort law with weak regulations.

The authors of the white paper contend that the 50 FDAs argument should be rejected for the following reasons: 1. Despite industry assertions to the contrary, state tort laws are both uniform and predictable, and so are their application. If anything, the application of a unitary federal standard is more unpredictable than the application of state tort laws. 2. State tort law is an essential part of the way government in the United States functions, making good on the Constitution’s promise of jury trials in common law suits – thus giving citizens a chance to recover damages when they are harmed. 3. State tort laws help keep products safe. Fear of litigation makes a difference, as industry’s ongoing campaign to shield themselves from lawsuits demonstrates.

Keywords: regulatory preemption, tort law, drug and medical device safety