FDA Preemption of State Tort Liability Lawsuits on FDA-Regulations Drugs and Devices

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I am honored to testify in these hearings on FDA preemption of state product liability lawsuits relating to FDA-approved drugs and medical devices. I will focus mainly on pharmaceuticals. In doing so, I will address the practical consequences of FDA preemption of liability litigation, and will largely ignore the complex legal issues to be discussed by other witnesses. By way of background, I am an economist who has specialized in government regulation, tort liability, information, and FDA regulation, beginning with my experience in the Bureau of Economics at the Federal Trade Commission in the 1980s.

The central issue in these hearings is whether state tort litigation against FDA-approved drugs and devices ) especially lawsuits alleging failure to warn ) should be preempted by FDA regulation including the content of the labels that accompany all approved drugs and devices. A current case now before the Supreme Court, Wyeth v. Levine, may strongly affect the role, if any, of preemption.

A commonly held view is that state tort liability litigation can do much good and
little harm because such litigation provides added protection to patients and consumers through compensation for injury, better information in the form of new warnings and disclosures, and improved drug safety (e.g., Kennedy 2008; Glantz and Annas 2008). I believe these views are largely unsupported, however. Economic reasoning and historical experience strongly suggest that FDA preemption, if it becomes standard law, would actually tend to improve patient welfare.

John E. Calfee is a resident scholar at AEI.

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About the Author

 

John E.
Calfee
  • Economist John E. Calfee (1941-2011) studied the pharmaceutical industry and the Food and Drug Administration (FDA), along with the economics of tobacco, tort liability, and patents. He previously worked at the Federal Trade Commission's Bureau of Economics. He had also taught marketing and consumer behavior at the business schools of the University of Maryland at College Park and Boston University. While Mr. Calfee's writings are mostly on pharmaceutical markets and FDA regulation, his academic articles and opinion pieces covered a variety of topics, from patent law and tort liability to advertising and consumer information. His books include Prices, Markets, and the Pharmaceutical Revolution (AEI Press, 2000) and Biotechnology and the Patent System (AEI Press, 2007). Mr. Calfee wrote regularly for AEI's Health Policy Outlook series. He testified before Congress and federal agencies on various topics, including alcohol advertising; biodefense vaccine research; international drug prices; and FDA oversight of drug safety.

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Wednesday, August 27, 2014 | 3:00 p.m. – 4:15 p.m.
Teacher quality 2.0: Toward a new era in education reform

Please join AEI for a conversation among several contributors to the new volume “Teacher Quality 2.0: Toward a New Era in Education Reform” (Harvard Education Press, 2014), edited by Frederick M. Hess and Michael Q. McShane. Panelists will discuss the intersection of teacher-quality policy and innovation, exploring roadblocks and possibilities.

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