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The portion of the Federal Food, Drug, and Cosmetic Act that applies to prescription drugs does not contain an express preemption provision.246 In 2009, the United States Supreme Court held that this Act does not preempt state failure to warn claims regarding name-brand prescription drugs.247 The Court relied heavily on the fact that, even though the FDA had approved the existing label for the medication, the manufacturer could have added a stronger warning once it became aware of side effects. The Court indirectly suggested, however, that preemption of a duty-to-warn claim might be appropriate if there was “clear evidence” that the FDA would have rejected the addition of the proposed warnings to the drug’s label.248

The Court specifically rejected the FDA’s view, expressed in a preamble to a regulation, that the Act impliedly preempted state tort law. The Court held that this preamble was inconsistent with the evidence of Congress’s purposes and with the FDA’s own long-standing position. It also expressed concern about the manner in which the FDA adopted it, without affording states or interested parties notice or opportunity for comment and without providing a reasoned explanation.

Since the Supreme Court’s decision, courts have held that federal law does not preempt a claim that a manufacturer was negligent in bringing a drug to market249 or that a drug was adulterated.250 However, the Sixth Circuit held that federal law preempted a design defect claim regarding a name-brand prescription drug.251


  • 246 {246} Eve v. Sandoz Pharm. Corp., 2002 WL 181972 (S.D. Ind. Jan. 28, 2002); Rite Aid Corp. v. Levy-Gray, 876 A.2d 115, 130 (Md. Ct. Spec. App. 2005), aff’d on other grounds, 894 A.2d 563 (Md. 2006).

  • 247 {247} Wyeth v. Levine, 555 U.S. 555, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (2009).

  • 248 {248} Id., 555 U.S. at 572. See also Merck Sharp & Dohme Corp. v. Albrecht, ___U.S.___, 139 S. Ct. 1668, 203 L. Ed. 2d 822 (2019) (question whether clear evidence that FDA would not have approved change to label is for judge, not jury, to decide); Dolin v. GlaxoSmithKline L.L.C., 901 F.3d 803 (7th Cir. 2018) (claim against prescription drug manufacturer for failing to add a warning to the label that generic manufacturer used is preempted when FDA had rejected manufacturer’s request to add the warning); Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp. 2d 1264 (W.D. Okla. 2011) (finding FDA’s previous rejection of enhanced warning persuasive; state failure to warn claim preempted). But cf. Mason v. SmithKline Beecham Corp., 596 F.3d 387 (7th Cir. 2010) (rejecting argument that FDA would have rejected additional warning on antidepressant).

  • 249 {249} Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010).

  • 250 {250} LeFaivre v. KV Pharm. Co., 636 F.3d 935 (8th Cir. 2011).

  • 251 {251} Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015).