Filter Results CategoriesCart
Highlight Updates The FDA’s Exclusive Enforcement Authority

The Medical Device Amendments and the prescription, generic, and over-the-counter medication provisions discussed above are all part of the Food, Drug, and Cosmetic Act (FDCA). One provision of that Act states that “all such proceedings . . . for the enforcement, or to restrain violations of, [the Food, Drug, and Cosmetic Act] shall be by and in the name of the United States.”275

Most courts hold that this provision does not preclude the assertion of parallel claims based on traditional state tort law.276 The statutory text supports this conclusion, as “such proceedings” appears to refer not to state law suits by injured consumers but to previous statutory sections that spell out the FDA’s enforcement authority.

A 2014 Supreme Court decision, POM Wonderful L.L.C. v. Coca-Cola Co.,277 explicitly rejected the argument that this provision forecloses private claims under other federal statutes that seek to enforce FDCA standards.278 While the Supreme Court’s decision dealt with the impact of this provision on a suit seeking to enforce a federal law, the Lanham Act, its conclusion should apply equally to state law claims that seek to enforce FDA standards.279


  • 275 {275} 21 U.S.C. § 337(a).

  • 276 {276} See, e.g., Bass v. Stryker Corp., 669 F.3d 501, 513–514 (5th Cir. 2012); Hughes v. Boston Scientific Corp., 631 F.3d 762, 775 (5th Cir. 2011); Dayan v. Swiss-American Products, Inc., 2017 WL 9485702 (E.D.N.Y. Jan. 3, 2017) (mag.) (claim that sunscreen misrepresented its FDA-mandated SPF rating is not preempted), adopted by 2017 WL 1214485 (E.D.N.Y. Mar. 31, 2017); Wright v. Medtronic, Inc., 81 F. Supp. 3d 600, 607–608 (W.D. Mich. 2015) (FDA’s exclusive enforcement authority does not preempt claim that violation of an FDA requirement also violates traditional state law); McAfee v. Medtronic, Inc., 2015 WL 3617755 (N.D. Ind. June 4, 2015); Gavin v. Medtronic, Inc., 2013 WL 3791612, at *4–5 (E.D. La. July 19, 2013). But cf. McDaniel v. Upsher-Smith Laboratories, Inc., 893 F.3d 941 (6th Cir. 2018) (failure to warn claim that relied solely on generic drug manufacturer’s failure to give the consumer the medication guide recommended by FDA rule is preempted); Caltagirone v. Cephalon, Inc., 190 A.3d 596 (Pa. Super. Ct. 2018) (claim framed as violation of FDA’s restrictions against promotion of medication for off-label use is preempted). But see Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1128 (D. Minn. 2011) (per se negligence claim cannot be based on violation of FDA regulations because only federal government can file suit for these violations); Timberlake v. Synthes Spine, Inc., 2011 WL 711075 (S.D. Tex. Feb. 18, 2011) (relying on a district court decision without noting that it was vacated in relevant part by Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011)).

  • 277 {277} 573 U.S. 102, 134 S. Ct. 2228, 189 L. Ed. 2d 141 (2014).

  • 278 {278} Id., 573 U.S. at 116–117.

  • 279 {279} See National Consumer Law Center, Unfair and Deceptive Acts and Practices § 2.5.9 (9th ed. 2016), updated at (full discussion of POM Wonderful).