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Case Profile

Docket Number17-290
Term2018
Full NameMerck Sharp & Dohme Corp. v. Doris Albrecht
Short NameMerck Sharp & Dohme Corp. v. Albrecht
PetitionerMerck Sharp & Dohme Corp.
RespondentDoris Albrecht
Date Argued (Reargued)Jan. 7, 2019
Date Decided

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.

Case Events

NoDateDescription
46 2018-11-28SET FOR ARGUMENT ON Monday, January 7, 2019
45 2018-11-21Amicus brief of American Association for Justice submitted.
44 2018-11-21Amicus brief of Jerome P. Kassirer, M.D., et al. submitted.
43 2018-11-21Brief amici curiae of Public Law Scholars filed.
42 2018-11-21Brief amici curiae of Tort Law Professors John C. P. Goldberg and Benjamin C. Zipursky filed.
41 2018-11-21Brief amicus curiae of The Cato Institute filed.
40 2018-11-21Brief amici curiae of MedShadow Foundation, et al. filed.
39 2018-11-21Brief amici curiae of Joseph Lane, M.D., and Vincent Vigorita, M.D. filed.
38 2018-11-21Brief amici curiae of Commonwealth of Virginia, et al. filed.
37 2018-11-21Brief amicus curiae of Public Citizen filed.
36 2018-11-14Brief of respondents Doris Albrecht, et al. filed.
35 2018-10-26Justice Alito is no longer recused in this case.
34 2018-10-12Motion of the Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed.
33 2018-09-20Brief amicus curiae of United States filed.
32 2018-09-20Brief amici curiae of Pharmaceutical Research and Manufacturers of America, et al. filed.
31 2018-09-20Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
30 2018-09-20Brief amicus curiae of Washington Legal Foundation filed.
29 2018-09-17Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp..
28 2018-09-13Joint appendix (2 volumes) filed. (Statement of costs filed)
27 2018-09-13Brief of petitioner Merck Sharp & Dohme Corp. filed.
26 2018-09-12Blanket Consent filed by Respondents, Doris Albrecht, et al..
25 2018-07-27Motion for an extension of time to file the opening briefs on the merits filed.
24 2018-07-27Motion 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.
23 2018-06-28Petition GRANTED. Justice Alito took no part in the consideration or decision of this petition.
22 2018-06-27DISTRIBUTED for Conference of 6/27/2018.
21 2018-06-07Supplemental brief of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
20 2018-06-05Supplemental brief of respondents Doris Albrecht, et al. filed. (Distributed)
19 2018-06-05DISTRIBUTED for Conference of 6/21/2018.
18 2018-05-22Brief amicus curiae of United States filed (Corrected brief received 5/29/18).
17 2018-05-22Brief amicus curiae of United States filed (to be corrected and reprinted).
16 2017-12-04The 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.
15 2017-11-08Reply of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
14 2017-11-08DISTRIBUTED for Conference of 12/1/2017.
13 2017-10-25Brief of respondents Doris Albrecht, et al. in opposition filed.
12 2017-09-25Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
11 2017-09-25Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed.
10 2017-09-22Application (16A1264) granted by Justice Sotomayor extending the time to file until August 22, 2017. (Justice Alito is recused)
9 2017-09-22Because 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.
8 2017-09-21Order extending time to file response to petition to and including October 25, 2017, for all respondents.
7 2017-09-20Blanket Consent filed by Respondents, Albrecht, Doris, et al. on 09/21/2017
6 2017-09-19Waiver of right of respondents Esther Parker & Pamela Paralikis to respond filed.
5 2017-09-11Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp. on 09/12/2017
4 2017-08-31Waiver of right of respondents Affronti, Joanne, et al. to respond filed.
3 2017-08-22Petition for a writ of certiorari filed. (Response due September 25, 2017)
2 2017-06-27Application (16A1264) granted by Justice Alito extending the time to file until August 22, 2017.
1 2017-06-23Application (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.

Case Counsels

NameParty NameDescriptionAddressPhoneType
Alan Edward UntereinerProduct Liability Adisory Council, Inc., et al.Counsel of RecoRobbins, Russell, Englert, Orseck, Untereiner & Sauber, LLP1801 K Street, N.W.Suite 411LWashington, DC 20006auntereiner@robbinsrussell.com202-775-4500other
Brian A. GoldsteinAffronti, Joanne, et al.Counsel of RecCellino& Barnes, P.C.2500 Main Place Tower, 350 Main StreetBuffalo, NY 14202-3725brian.goldenstein@cellinoandbarnes.com716-888-8888respondent
Cory L. AndrewsWashington Legal FoundationCounsel of RecWashington Legal Foundation2009 Massachusetts Avenue, N.W.Washington, DC 20036candrews@wlf.org202.588.0302other
David C. FrederickDoris Albrecht, et al.Counsel of RecoKellogg, Hansen, Todd, Figel & Frederick, PLLC1615 M Street, NW, Suite 400Washington, DC 20036dfrederick@kellogghansen.com(202)-326-7951respondent
Jeffrey Bryan WallUnited StatesAmicusActing Solicitor GeneralUnited States Department of Justice950 Pennsylvania Avenue, NWWashington, DC 20530-0001jeffrey.b.wall@usdoj.gov202-514-2217other
Michael L. BeckmanEsther Parker & Pamela ParalikisCounsel of RecordViles & Beckman6350 Presidential CourtFt. Myers, FL 33919239-334-3933respondent
Robert Allen Long Jr.Pharmaceutical Research and Manufacturers of AmericaCounsel of RecordCovington & Burling, LLPOne CityCenter850 Tenth St., NWWashington, DC 20001rlong@cov.com(202) 662-6000other
Shay DvoretzkyMerck Sharp & Dohme Corp.Counsel of RecordJones Day51 Louisiana Avenue NWWashington, DC 20001-2113sdvoretzky@jonesday.com(202)-879-3939petitioner
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