Forum

U.S. Supreme Court

Case Status

Decided

Docket Number

Term

2018 Term

Share

Questions Presented

Is a state-law failure-to-warn claim preempted when the FDA rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data; or must such a case go to a jury for conjecture as to why the FDA rejected the proposed warning?

Case Updates

U.S. Supreme Court holds that judges, rather than juries, must decide whether federal prescription-drug regulations preempt state failure-to-warn claims

May 20, 2019

Click here to view the opinion.

U.S. Chamber files coalition amicus brief at merits stage, arguing Supreme Court should reverse Third Circuit’s mistaken approach to Wyeth v. Levine’s “clear evidence” standard

September 21, 2018

Click here to view the amicus brief filed by the U.S. Chamber and Product Liability Advisory Council, Inc. The Chamber previously supported the cert. petition in this case.

Alan D. Untereiner of Robbins, Russell, Englert, Orseck, Untereiner & Sauber LLP served as co-counsel for the amici in this case.

Cert. petition granted

June 28, 2018

U.S. Chamber urges Supreme Court to clarify scope of conflict preemption after Wyeth v. Levine

September 26, 2017

The U.S. Chamber and Product Liability Advisory Council, Inc. filed an amicus brief urging the U.S. Supreme Court to review the scope of conflict preemption after Wyeth v. Levine, 555 U.S. 555 (2009). The brief explained that review is needed to resolve conflicts and confusion in the lower courts and to give meaningful effect to Wyeth’s statement that preemption exists where there is “clear evidence” that a manufacturer was unable to comply simultaneously with both federal and state law.

Alan E. Untereiner of Robbins, Russell, Englert, Orseck, Untereiner & Sauber LLP served as co-counsel for the amici in this case.

Case Documents

Search