Forum
U.S. Supreme Court
Case Status
Decided
Docket Number
06-1249
Term
2008 Term
Oral Argument Date
November 03, 2008
Questions Presented
Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration ("FDA") pursuant to FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.
Case Updates
Supreme Court addresses implied preemption of design defect claims for FDA-approved drugs
March 04, 2009
The Supreme Court held that federal law does not impliedly preempt the plaintiff's lawsuit. Although the decision makes clear that the particular facts of this case would not justify regulatory preemption, the Court nonetheless recognized that regulatory preemption of state laws and litigation would be appropriate in some circumstances. The Court left open the question of what circumstances would justify a finding of regulatory preemption.
U.S. Chamber files amicus brief
June 03, 2008
NCLC urged the Supreme Court to reject the Vermont Supreme Court’s erroneous decision to permit the plaintiff’s failure-to-warn lawsuit to proceed even though the FDA had approved the relevant drug labeling. In its brief, NCLC explained that state “failure-to-warn” lawsuits interfere with the capacity of the FDA to enforce meaningful drug labeling.
Cert. petition granted
January 18, 2008
U.S. Chamber urges Supreme Court to review implied preemption of design defect claims for FDA-approved drugs
April 20, 2007
Click here to view the Chamber's brief.