Forum
U.S. Supreme Court
Case Status
Docket Number
Term
2018 Term
Lower Court Opinion
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
- Lower Court Opinion -- In re Fosamax (Alendronate Sodium) Products Liability Litigation (Third Circuit).pdf
- Cert. Petition -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- PhRMA Amicus Brief -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- U S Chamber26 PLAC Amicus Brief Merck Sharp26 Dohme Corp v Albrecht U S Supreme Court
- Brief in Opposition for Respondents -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- Reply iso Cert. Petition -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- Brief for the United States as Amicus Curiae -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- Supplemental Brief for Respondents -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- Supplemental Brief iso Cert. Petition -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- Brief for Petitioner -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- Joint Appendix, Volume I -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- Joint Appendix, Volume II -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- Washington Legal Foundation Amicus Brief -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- U.S. Chamber and PLAC Amicus Brief -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- Brief of United States -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- PhRMA, et al. Amicus Brief (merits) -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf
- Opinion -- Merck Sharp & Dohme Corp. v. Albrecht (U.S. Supreme Court).pdf