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Merck Sharp & Dohme Corp. v. Doris Albrecht, et al.

Paid petition · United States Court of Appeals for the Third Circuit, No. 14-1900 · judgment March 22, 2017

Decided · May 20, 2019

Pre-decision estimate: 2% cert probability

Before the decision, well below the 4.1% base rate, with no standout signals pointing toward a grant.

Question presented

In Wyeth v. Levine, 555 U.S. 555 (2009), this Court held that the FDA's approval of a drug label does not, standing alone, insulate the manufacturer from failure-to-warn liability under state tort law. At the same time, the Court recognized that if "the FDA would not have approved" the label demanded by state law, then the manufacturer could invoke an "impossibility'' preemption defense. Id. at 571. In this case, it was "undisputed" that (i) "the FDA was aware of the possible link" between petitioner's drug and the risk at issue; (ii) petitioner "submitted a comprehensive safety update to the FDA reporting . . . numerous studies" finding "such an association"; (iii) petitioner "proposed warning language" about this risk, but the FDA "rejected" it; (iv) the FDA stated that the "conflicting nature of the literature d[id] not provide a clear path forward” and that it needed "more time" to consider "the issue of a precaution"; and (v) only later, after a report from a task force, did the FDA become "confident” that an association "potentially'' existed. Pet.App.59a-60a. The Third Circuit nonetheless held that a jury could find that petitioner had not shown by "clear and convincing evidence" that the FDA would have rejected a warning label of the type that respondents claim state law required. See Pet.App.37a, 56a-57a. The question presented is: 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? JUSTICE ALITO TOOK NO PART. October 26, 2018 JUSTICE ALITO IS NO LONGER RECUSED.

Counsel of record

For petitioner
Shay Dvoretzky
Skadden, Arps, Slate, Meagher & Flom LLP

For respondent
Michael L. Beckman
Viles & Beckman

Case

Conference history
Distributed for 3 conferences

Amicus briefs
4 cert-stage · 13 merits
(4 supporting pet./neither, 9 respondent)

Argument & decision

Argued January 7, 2019 — Shay Dvoretzky · David C. Frederick. Audio and transcript

Decided May 20, 2019. Opinion by Breyer.

Proceedings

Jun 21 2019
JUDGMENT ISSUED.
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.
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.
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.
Dec 14 2018
Reply of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Dec 11 2018
Record requested from the U.S.C.A. 3rd Circuit.
Dec 03 2018
Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument GRANTED.
Nov 30 2018
CIRCULATED
Nov 28 2018
SET FOR ARGUMENT ON Monday, January 7, 2019
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 14 2018
Brief of respondents Doris Albrecht, et al. filed.
Oct 26 2018
Justice Alito is no longer recused in this case.
Oct 12 2018
Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed.
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.
Sep 17 2018
Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp..
Sep 13 2018
Joint appendix (2 volumes) filed. (Statement of costs filed)
Sep 13 2018
Brief of petitioner Merck Sharp & Dohme Corp. filed.
Sep 12 2018
Blanket Consent filed by Respondents, Doris Albrecht, et al..
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.
Jun 28 2018
Petition GRANTED. Justice Alito took no part in the consideration or decision of this petition.
Jun 27 2018
DISTRIBUTED for Conference of 6/27/2018.
Jun 07 2018
Supplemental brief of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Jun 05 2018
DISTRIBUTED for Conference of 6/21/2018.
Jun 05 2018
Supplemental brief of respondents Doris Albrecht, et al. filed. (Distributed)
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).
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.
Nov 08 2017
DISTRIBUTED for Conference of 12/1/2017.
Nov 08 2017
Reply of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Oct 25 2017
Brief of respondents Doris Albrecht, et al. in opposition filed.
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.
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 21 2017
Order extending time to file response to petition to and including October 25, 2017, for all respondents.
Sep 20 2017
Blanket Consent filed by Respondents, Albrecht, Doris, et al. on 09/21/2017
Sep 19 2017
Waiver of right of respondents Esther Parker & Pamela Paralikis to respond filed.
Sep 11 2017
Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp. on 09/12/2017
Aug 31 2017
Waiver of right of respondents Affronti, Joanne, et al. to respond filed.
Aug 22 2017
Petition for a writ of certiorari filed. (Response due September 25, 2017)
Jun 27 2017
Application (16A1264) granted by Justice Alito extending the time to file until August 22, 2017.
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.