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Merck Sharp & Dohme Corp. v. Albrecht

Docket No. Op. Below Argument Opinion Vote Author Term
17-290 3d Cir. Jan 7, 2019 May 20, 2019 9-0 Breyer OT 2018

Holding: “Clear evidence” that the Food and Drug Administration would not have approved a change to a drug’s label – thus pre-empting a state-law failure-to-warn claim – is evidence showing that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning; the question of agency disapproval is primarily one of law for a judge to decide.

Judgment: Vacated and remanded, 9-0, in an opinion by Justice Breyer on May 20, 2019. Justice Thomas filed a concurring opinion. Justice Alito filed an opinion concurring in the judgment, in which Chief Justice Roberts and Justice Kavanaugh joined.

DateProceedings and Orders (key to color coding)
Jun 23 2017Application (16A1264) to extend the time to file a petition for a writ of certiorari from July 23, 2017 to August 22, 2017, submitted to Justice Alito.
Jun 27 2017Application (16A1264) granted by Justice Alito extending the time to file until August 22, 2017.
Aug 22 2017Petition for a writ of certiorari filed. (Response due September 25, 2017)
Aug 31 2017Waiver of right of respondents Affronti, Joanne, et al. to respond filed.
Sep 11 2017Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp. on 09/12/2017
Sep 19 2017Waiver of right of respondents Esther Parker & Pamela Paralikis to respond filed.
Sep 20 2017Blanket Consent filed by Respondents, Albrecht, Doris, et al. on 09/21/2017
Sep 21 2017Order extending time to file response to petition to and including October 25, 2017, for all respondents.
Sep 22 2017Because Justice Alito now realizes that he should have recused himself from consideration of this application, the order of June 27, 2017, is vacated. Pursuant to Rule 22.2, the application (16A1264) to extend the time to file a petition for a writ of certiorari from July 23, 2017 to August 22, 2017, has been submitted to Justice Sotomayor.
Sep 22 2017Application (16A1264) granted by Justice Sotomayor extending the time to file until August 22, 2017. (Justice Alito is recused)
Sep 25 2017Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed.
Sep 25 2017Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
Oct 25 2017Brief of respondents Doris Albrecht, et al. in opposition filed.
Nov 08 2017DISTRIBUTED for Conference of 12/1/2017.
Nov 08 2017Reply of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Dec 04 2017The Solicitor General is invited to file a brief in this case expressing the views of the United States. Justice Alito took no part in the consideration or decision of this petition.
May 22 2018Brief amicus curiae of United States filed (to be corrected and reprinted).
May 22 2018Brief amicus curiae of United States filed (Corrected brief received 5/29/18).
Jun 05 2018DISTRIBUTED for Conference of 6/21/2018.
Jun 05 2018Supplemental brief of respondents Doris Albrecht, et al. filed. (Distributed)
Jun 07 2018Supplemental brief of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Jun 27 2018DISTRIBUTED for Conference of 6/27/2018.
Jun 28 2018Petition GRANTED. Justice Alito took no part in the consideration or decision of this petition.
Jul 27 2018Motion for an extension of time to file the opening briefs on the merits filed.
Jul 27 2018Motion for an extension of time to file the opening briefs on the merits granted. The time to file the joint appendix and petitioner's brief on the merits is extended to and including September 13, 2018. The time to file respondents' brief on the merits is extended to and including November 14, 2018.
Sep 12 2018Blanket Consent filed by Respondents, Doris Albrecht, et al..
Sep 13 2018Joint appendix (2 volumes) filed. (Statement of costs filed)
Sep 13 2018Brief of petitioner Merck Sharp & Dohme Corp. filed.
Sep 17 2018Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp..
Sep 20 2018Brief amicus curiae of United States filed.
Sep 20 2018Brief amicus curiae of Washington Legal Foundation filed.
Sep 20 2018Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
Sep 20 2018Brief amici curiae of Pharmaceutical Research and Manufacturers of America, et al. filed.
Oct 12 2018Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed.
Oct 26 2018Justice Alito is no longer recused in this case.
Nov 14 2018Brief of respondents Doris Albrecht, et al. filed.
Nov 21 2018Brief amici curiae of Tort Law Professors John C. P. Goldberg and Benjamin C. Zipursky filed.
Nov 21 2018Brief amici curiae of MedShadow Foundation, et al. filed.
Nov 21 2018Brief amici curiae of Public Law Scholars filed.
Nov 21 2018Brief amici curiae of Commonwealth of Virginia, et al. filed.
Nov 21 2018Brief amici curiae of Joseph Lane, M.D., and Vincent Vigorita, M.D. filed.
Nov 21 2018Brief amicus curiae of The Cato Institute filed.
Nov 21 2018Brief amicus curiae of Public Citizen filed.
Nov 21 2018Brief amici curiae of Jerome P. Kassirer, M.D., et al. filed.
Nov 21 2018Brief amicus curiae of American Association for Justice filed.
Nov 28 2018SET FOR ARGUMENT ON Monday, January 7, 2019
Nov 30 2018CIRCULATED
Dec 03 2018Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument GRANTED.
Dec 11 2018Record requested from the U.S.C.A. 3rd Circuit.
Dec 14 2018Reply of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Dec 18 2018Record received from the U.S.C.A. 3rd Circuit is electronic.
Dec 18 2018Record from the U.S.D.C. District of New Jersey is electronic and located on PACER.
Jan 07 2019Argued. For petitioner: Shay Dvoretzky, Washington, D. C.; and Malcolm L. Stewart, Deputy Solicitor General, Department of Justice, Washington, D. C. (for United States, as amicus curiae.) For respondents: David C. Frederick, Washington, D. C.
May 20 2019Judgment VACATED and case REMANDED. Breyer, J., delivered the opinion of the Court, in which Thomas, Ginsburg, Sotomayor, Kagan, and Gorsuch, JJ., joined. Thomas, J., filed a concurring opinion. Alito, J., filed an opinion concurring in the judgment, in which Roberts, C. J., and Kavanaugh, J., joined.
Jun 21 2019JUDGMENT ISSUED.