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Merck Sharp & Dohme Corp. v. Albrecht

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Supreme Court of the United States
Merck Sharp & Dohme Corp. v. Albrecht
Term: 2018
Important Dates
Argument: January 7, 2019
Decided: May 20, 2019
Outcome
Vacated and remanded
Vote
9-0
Majority
Chief Justice John G. Roberts • Clarence Thomas • Ruth Bader Ginsburg • Stephen Breyer • Samuel Alito • Sonia Sotomayor • Elena Kagan • Neil Gorsuch • Brett Kavanaugh
Concurring
Clarence Thomas • Samuel Alito • Brett Kavanaugh • Chief Justice John G. Roberts

Merck Sharp & Dohme Corp. v. Albrecht is a case argued before the Supreme Court of the United States on January 7, 2019, during the court's 2018-2019 term. The court vacated and remanded the ruling of the United States Court of Appeals for the 3rd Circuit, holding the question of agency disapproval should be decided by a judge, not a jury.[1] The case came on a writ of certiorari to the 3rd Circuit.[2]

HIGHLIGHTS
  • The case: Hundreds of lawsuits were consolidated against the drug manufacturer Merck Sharp & Dohme, claiming that the osteoporosis drug Fosamax caused thigh bone fractures and that the FDA-approved label failed to warn about this side effect. A district court dismissed the case, ruling that the claims were preempted by federal law. The circuit court reversed the lower court's ruling.
  • The issue: Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer's proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning.[3]
  • The outcome: The court vacated and remanded the ruling of the United States Court of Appeals for the 3rd Circuit, holding the question of agency disapproval should be decided by a judge, not a jury.[1]


    • You can review the lower court's opinion here.[4]

    Timeline

    The following timeline details key events in this case:

    • May 20, 2019: U.S. Supreme Court vacated and remanded the 3rd Circuit Court's ruling
    • January 7, 2019: Oral argument
    • June 28, 2018: U.S. Supreme Court agreed to hear case
    • August 22, 2017: Petition filed with U.S. Supreme Court
    • March 22, 2017: The Third Circuit Court reversed the lower court's ruling

    Background

    Hundreds of lawsuits were consolidated against the drug manufacturer Merck Sharp & Dohme, claiming that the osteoporosis drug Fosamax caused thigh bone fractures and that the FDA-approved label failed to warn about this side effect.[5]

    A district court dismissed the case, ruling that the claims were preempted by federal law. The court cited Wyeth v. Levine as precedent, which stated that "state-law failure-to-warn claims are preempted when there is 'clear evidence' that the FDA would not have approved the warning that a plaintiff claims was necessary."[4]

    The circuit court reversed the lower court's ruling. Because preemption is an affirmative defense, the burden of proof rested on Merck. The court ruled that Merck did not "[carry] its burden to prove that it is entitled to that defense as a matter of law." The ruling stated that the plaintiffs had "produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures—or at the very least, to conclude that the odds of FDA rejection were less than highly probable."[4]

    Question presented

    The petitioner presented the following question to the court:[3]

    Question presented:
    • Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer's proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning.

    Outcome

    In a unanimous opinion, the court vacated and remanded the ruling of the United States Court of Appeals for the 3rd Circuit, holding the question of agency disapproval should be decided by a judge, not a jury.[1]

    Justice Stephen Breyer delivered the opinion of the court. Justice Clarence Thomas filed a concurring opinion. Justice Samuel Alito filed a concurring opinion in judgment, but not in reasoning. Chief Justice John G. Roberts and Justice Brett Kavanaugh joined Alito's opinion.[1]

    Opinion

    In his opinion, Justice Breyer wrote:[1]

    “ "Clear evidence" is evidence that shows the court 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. ...

    Because the Court of Appeals treated the pre-emption question as one of fact, not law, and because it did not have an opportunity to consider fully the standards we have described in Part II of our opinion, we vacate its judgment and remand the case to that court for further proceedings consistent with this opinion. [6]

    		”

    Concurring opinion

    Justice Clarence Thomas filed a concurring opinion.[1]

    Justice Samuel Alito filed a concurring opinion in judgment, but not in reasoning. Chief Justice John G. Roberts and Justice Brett Kavanaugh joined Alito's opinion.[1]

    In his concurring opinion, Alito wrote:[1]

    “ I concur in the judgment because I agree with the Court’s decision on the only question that it actually decides, namely, that whether federal law allowed Merck to include in the Fosamax label the warning alleged to be required by state law is a question of law to be decided by the courts, not a question of fact. I do not, however, join the opinion of the Court because I am concerned that its discussion of the law and the facts may be misleading on remand. [6] ”

    Text of the opinion

    Read the full opinion here.

    Audio

    • Audio of oral argument:[7]

    Transcript

    Read the oral argument transcript here.

    See also

    External links

    Footnotes

    1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 Supreme Court of the United States, Merck Sharp & Dohme Corp. v. Albrecht, May 20, 2019
    2. ↑ Supreme Court of the United States, "17-290 Merck Sharp & Dohme Corp. v. Albrecht," accessed November 21, 2018
    3. ↑ 3.0 3.1 Supreme Court of the United States, "QPReport 17-290 Merck Sharp & Dohme Corp. v. Albrecht," accessed November 21, 2018
    4. ↑ 4.0 4.1 4.2 SCOTUSblog, "Merck Sharp & Dohme Corp. v. Albrecht," accessed November 21, 2018
    5. ↑ Oyez, "Merck Sharp & Dohme Corp. v. Albrecht," accessed November 21, 2018
    6. ↑ 6.0 6.1 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
    7. ↑ Supreme Court of the United States, Merck Sharp & Dohme Corp. v. Albrecht, argued January 7, 2019
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