Academic

Gilhooley on FDA Preemption of Tort LIability (Wyeth v. Levine)

By Lawrence Solum

Margaret Gilhooley (Seton Hall University - School of Law) has posted The Battle Over Drug Preemption Reaches the Supreme Court: How Wide the Impact? on SSRN.  Here is the 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.

Full post as published by Legal Theory Blog on May 16, 2008 (boomark / email).