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Can Businesses Be Sued Even When They Have Met FDA Requirements?

The Federalist Society is sponsoring a debate today on this topic at Ave Maria Law School (being webcast live now), featuring AEI scholar Michael Greve, former FDA General Counsel Dan Troy, and Professors Peter Hammer and Lars Noah.

In January, the FDA restated in the preamble to its regulations on prescription drug information its long-standing belief that federal regulations preempt state-law "failure-to-warn" claims, which, together with similar statements from the CPSC and NHTSA, has caused some hue and cry from the Washington Post and New York Times (via Childs), which quotes Greve:

"What has been happening is largely reactive and responsive to industry demands that arise because the industries are confronting similar problems—private liability lawsuits and state attorneys general," said Michael S. Greve, the John G. Searle scholar at the American Enterprise Institute and director of the research organization's Federalism Project. "What Professor McGarity thinks as insufficiently demanding standards, too many people think of as outrageously demanding. Many people think that too high standards imposed by the states hamper research and innovation."

"I just don't see how enforcement by Eliot Spitzer or trial lawyers in Beaumont, Tex., will yield better results," he added.

The FDA notes other reasons for uniform standards.

Product liability lawsuits have directly threatened the agency�s ability to regulate manufacturer dissemination of risk information for prescription drugs in accordance with the act. In one case, for example, an individual plaintiff claimed that a drug manufacturer had a duty under California State law to label its products with specific warnings that FDA had specifically considered and rejected as scientifically unsubstantiated. ...

State law actions can rely on and propagate interpretations of the act and FDA regulations that conflict with the agency� s own interpretations and frustrate the agency�s implementation of its statutory mandate. For example, courts have rejected preemption in: State law failure-to-warn cases on the ground that a manufacturer has latitude under FDA regulations to revise labeling by adding or strengthening warning statements without first obtaining permission from FDA. ... In fact, the determination whether labeling revisions are necessary is, in the end, squarely and solely FDA�s under the act. ... FDA interpret-s the act to establish both a �floor� and a �ceiling,� such that: additional disclosures of risk. information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise false or misleading. Given the comprehensiveness of FDA regulation of drug safety, effectiveness, and labeling under the act, additional requirements for the disclosure of risk information are not necessarily more protective of patients. Instead, they can erode and disrupt the careful and truthful representation. of benefits and risks that prescribers need to make appropriate judgments about drug use. ...

FDA noted that liability concerns were creating pressure on manufacturers to expand labeling warnings to include speculative risks and, thus, to limit physician appreciation of potentially far more significant contraindications and side effects

The AEI Liability Project has the relevant selections in the January 20 entry on the Documents in the News page.

Press coverage has treated the FDA statement as a new legal rule, but it has not gone through the notice-and-comment process, so it has no more force of law than the amicus briefs it has been filing (and that far too many courts have been disregarding) in cases for years. The Wall Street Journal (via Lattman) has more on the future endaround.

I wrote in favor of FDA preemption in my AEI working paper on the Vioxx litigation. In 2002, Greve wrote on attorneys general targeting of the pharmaceutical industry and the need for federal preemption in "States' Rights On Steroids". Earlier this year, Jack Calfee wrote about the problem of overwarning for AEI and the New York Sun. Peter Pitts wrote an editorial for the Washington Times (via Prince).



Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.