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Merck Sharp & Dohme Corp. v. Albrecht

Supreme Court of the United States

January 7, 2019, Argued; May 20, 2019, Decided

No. 17-290.


 [*1672]  Justice Breyer delivered the opinion of the Court.

When Congress enacted the Federal Food, Drug, and Cosmetic Act, ch. 675, 52 Stat. 1040, as amended, 21 U. S. C. §301 et seq., it charged the Food and Drug Administration with ensuring that prescription drugs are “safe for use under the conditions prescribed, recommended, or suggested” in the drug’s “labeling.” §355(d). When the FDA exercises this authority, [**829]  it makes careful judgments about what warnings should appear on a drug’s label for the safety of consumers.

For that reason, we have previously held that “clear evidence” that the FDA would not have approved a change to the drug’s label pre-empts a claim, grounded in state law, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug. See [***7]  Wyeth v. Levine, 555 U. S. 555, 571, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (2009). We here determine that this question of pre-emption is one for a judge to decide, not a jury. We also hold that “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 central issue in this case concerns federal pre-emption, which as relevant here, takes place when it is “‘impossible for a private party to comply with both state and federal requirements.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U. S. 472, 480, 133 S. Ct. 2466, 186 L. Ed. 2d 607 (2013). See also U. S. Const., Art. VI, cl. 2. The state law that we consider is state common law or state statutes that require drug manufacturers to warn drug consumers of the risks associated with drugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulates the information that appears on brand-name prescription drug labels. The alleged conflict between state and federal law in this case has to do with a drug that was manufactured by petitioner Merck Sharp & Dohme and was administered to respondents without a warning of certain associated risks.

The FDA regulates [***8]  the safety information that appears on the labels of prescription drugs that are marketed in the United States. 21 U. S. C. §355(b)(1)(F); 21 CFR §201.57(a) (2018). Although we commonly understand a drug’s “label” to refer to the sticker affixed to a prescription bottle, in this context the term refers more broadly to the written material that is sent to the physician who prescribes the drug and the written material that comes with the prescription bottle when the drug is handed to the patient at the pharmacy. 21 U. S. C. §321(m). These (often lengthy) package inserts contain detailed information about [*1673]  the drug’s medical uses and health risks. §355(b)(1)(F); 21 CFR §201.57(a).

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139 S. Ct. 1668 *; 203 L. Ed. 2d 822 **; 2019 U.S. LEXIS 3542 ***; 27 Fla. L. Weekly Fed. S 828; Prod. Liab. P20,623; 2019 WL 2166393


Notice: The LEXIS pagination of this document is subject to change pending release of the final published version.


In re Fosamax Alendronate Sodium Prods. Liab. Litig., 852 F.3d 268, 2017 U.S. App. LEXIS 5075 (3d Cir. N.J., Mar. 22, 2017)

Disposition: Vacated and remanded.


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Business & Corporate Compliance, Governments, Agriculture & Food, Federal Food, Drug & Cosmetic Act, Constitutional Law, Supremacy Clause, Federal Preemption, Civil Procedure, Trials, Jury Trials, Province of Court & Jury, Administrative Law, Agency Rulemaking, Supreme Law of the Land