U.S. Supreme Court

Case Status


Docket Number



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.

Case Documents