The FDA’s Argument for Eradicating State Tort Law: Why It Is Wrong and Warrants No Deference

By Allison Zieve and Brian Wolfman, Public Citizen Litigation Group

The FDA's Argument for Eradicating State Tort Law: Why It Is Wrong and Warrants No Deference

In January 2006, in a notice announcing the issuance of new drug labeling regulations, the Food and Drug Administration stated that FDA approval of a new drug preempts a range of product liability claims brought by patients injured by prescription drugs. Attorneys Allison Zieve and Brian Wolfman explain why the FDA’s preemption position is bad law, bad policy, and warrants no deference from the courts. This article appeared in the Bureau of National Affairs’s Toxics Law Reporter.