Product Safety & Liability Report (BNA), Vol. 37, pp. 550-558, 2009
10 Pages Posted: 22 Sep 2012
Date Written: May 11, 2009
The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied preemption as a defense in pharmaceutical cases. In this Analysis & Perspective, attorney Brian Wolfman discusses the decision and its implications for prescription drug litigation as well as litigation in other areas that are regulated by the federal government.
After Wyeth, Wolfman says, a defendant in a prescription drug case must demonstrate a ‘‘tight fit between the labeling change proposed by the manufacturer (and rejected by the FDA) and the labeling change that the plaintiff contends would have prevented her injuries.’’ Moreover, he says, in light of Wyeth, agency claims of preemption with respect to other products or services are likely to be subject to increased judicial scrutiny, and it is unlikely that these claims will be accorded substantial deference unless they are tethered to a congressional authorization regarding preemption.
Keywords: Wyeth v. Levine, FDA, preemption, pharmaceutical cases, Supreme Court, CBE regulation, drug labeling
JEL Classification: K00, K30, K39
Suggested Citation: Suggested Citation
Wolfman, Brian, Wyeth v. Levine and Its Implications (May 11, 2009). Product Safety & Liability Report (BNA), Vol. 37, pp. 550-558, 2009; Georgetown Public Law Research Paper No. 12-138. Available at SSRN: https://ssrn.com/abstract=2150325