|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.
|Date||Proceedings and Orders |
|Jun 23 2017||Application (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 2017||Application (16A1264) granted by Justice Alito extending the time to file until August 22, 2017.|
|Aug 22 2017||Petition for a writ of certiorari filed. (Response due September 25, 2017)|
|Aug 31 2017||Waiver of right of respondents Affronti, Joanne, et al. to respond filed.|
|Sep 11 2017||Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp. on 09/12/2017|
|Sep 19 2017||Waiver of right of respondents Esther Parker & Pamela Paralikis to respond filed.|
|Sep 20 2017||Blanket Consent filed by Respondents, Albrecht, Doris, et al. on 09/21/2017|
|Sep 21 2017||Order extending time to file response to petition to and including October 25, 2017, for all respondents.|
|Sep 22 2017||Because 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 2017||Application (16A1264) granted by Justice Sotomayor extending the time to file until August 22, 2017. (Justice Alito is recused)|
|Sep 25 2017||Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed.|
|Sep 25 2017||Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.|
|Oct 25 2017||Brief of respondents Doris Albrecht, et al. in opposition filed.|
|Nov 08 2017||DISTRIBUTED for Conference of 12/1/2017.|
|Nov 08 2017||Reply of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)|
|Dec 04 2017||The 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 2018||Brief amicus curiae of United States filed (to be corrected and reprinted).|
|May 22 2018||Brief amicus curiae of United States filed (Corrected brief received 5/29/18).|
|Jun 05 2018||DISTRIBUTED for Conference of 6/21/2018.|
|Jun 05 2018||Supplemental brief of respondents Doris Albrecht, et al. filed. (Distributed)|
|Jun 07 2018||Supplemental brief of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)|
|Jun 27 2018||DISTRIBUTED for Conference of 6/27/2018.|
|Jun 28 2018||Petition GRANTED. Justice Alito took no part in the consideration or decision of this petition.|
|Jul 27 2018||Motion for an extension of time to file the opening briefs on the merits filed.|
|Jul 27 2018||Motion 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 2018||Blanket Consent filed by Respondents, Doris Albrecht, et al..|
|Sep 13 2018||Joint appendix (2 volumes) filed. (Statement of costs filed)|
|Sep 13 2018||Brief of petitioner Merck Sharp & Dohme Corp. filed.|
|Sep 17 2018||Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp..|
|Sep 20 2018||Brief amicus curiae of United States filed.|
|Sep 20 2018||Brief amicus curiae of Washington Legal Foundation filed.|
|Sep 20 2018||Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.|
|Sep 20 2018||Brief amici curiae of Pharmaceutical Research and Manufacturers of America, et al. filed.|
|Oct 12 2018||Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed.|
|Oct 26 2018||Justice Alito is no longer recused in this case.|
|Nov 14 2018||Brief of respondents Doris Albrecht, et al. filed.|
|Nov 21 2018||Brief amici curiae of Tort Law Professors John C. P. Goldberg and Benjamin C. Zipursky filed.|
|Nov 21 2018||Brief amici curiae of MedShadow Foundation, et al. filed.|
|Nov 21 2018||Brief amici curiae of Public Law Scholars filed.|
|Nov 21 2018||Brief amici curiae of Commonwealth of Virginia, et al. filed.|
|Nov 21 2018||Brief amici curiae of Joseph Lane, M.D., and Vincent Vigorita, M.D. filed.|
|Nov 21 2018||Brief amicus curiae of The Cato Institute filed.|
|Nov 21 2018||Brief amicus curiae of Public Citizen filed.|
|Nov 21 2018||Brief amici curiae of Jerome P. Kassirer, M.D., et al. filed.|
|Nov 21 2018||Brief amicus curiae of American Association for Justice filed.|
|Nov 28 2018||SET FOR ARGUMENT ON Monday, January 7, 2019|
|Nov 30 2018||CIRCULATED|
|Dec 03 2018||Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument GRANTED.|
|Dec 11 2018||Record requested from the U.S.C.A. 3rd Circuit.|
|Dec 14 2018||Reply of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)|
|Dec 18 2018||Record received from the U.S.C.A. 3rd Circuit is electronic.|
|Dec 18 2018||Record from the U.S.D.C. District of New Jersey is electronic and located on PACER.|
|Jan 07 2019||Argued. 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 2019||Judgment 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 2019||JUDGMENT ISSUED.|
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