The Battle Over Drug Preemption Reaches the Supreme Court: How Wide the Impact?

13 Pages Posted: 14 May 2008

Date Written: May 7, 2008

Abstract

The extent to which FDA decisions preempt tort liability for prescription drugs has become an important and contentious issue. The agency has issued a Preemption Policy that favors preemption when a drug manufacturer consults with the agency about a risk. The Supreme Court has considered two preemption cases this term and is expected to make an important ruling on drug preemption next term in Wyeth v. Levine. Wyeth has some unusual factors, though, since the label had a warning about the risks from the method of administration, and the plaintiff's expert testified that the label should not have allowed the method at all.

The most important and difficult preemption question is the liability for risks that are found from use after the drug is on the market. This paper will examine the factors that could limit the scope of the Wyeth decision. Instead of having a broad rule that there never is preemption or there always is preemption, a better approach is to focus preemption on matters that the agency has specifically addressed based on current and accurate information. The consultation process between the agency and the drug company also needs to be made more transparent about the information available about emerging risks.

Keywords: drug preemption, drug safety, torts, products liability, Wyeth v. Levine

Suggested Citation

Gilhooley, Margaret, The Battle Over Drug Preemption Reaches the Supreme Court: How Wide the Impact? (May 7, 2008). Seton Hall Public Law Research Paper No. 1132822, Available at SSRN: https://ssrn.com/abstract=1132822 or http://dx.doi.org/10.2139/ssrn.1132822

Margaret Gilhooley (Contact Author)

Seton Hall Law School ( email )

One Newark Center
Newark, NJ 07102-5210
United States

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