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Highlight Updates Express warranty claims

While Riegel did not address express warranty claims, many courts hold that federal law does not preempt an express warranty claim based on voluntary additional statements made by the manufacturer, rather than on FDA-approved statements in the product’s packaging and label.228 However, a court may perceive a conflict with the FDA’s approval of the safety and effectiveness of a device if the plaintiff claims that a manufacturer that complied with the FDA’s requirements breached an express warranty of safety and effectiveness.229

An FDA regulation lists the UCC’s implied “warranty of fitness” as an example of a state claim that is not preempted.230 Implied warranty claims are less likely to be preempted if they are based on violation of FDA standards231 rather than on general state standards of safety and effectiveness.232


  • 228 {228} See, e.g., Wildman v. Medtronic, Inc., 874 F.3d 862 (5th Cir. 2017) (warranty claim is preempted if it is based on a guarantee that the FDA expressly or implicitly approved, but this manufacturer’s warranty goes beyond what FDA evaluated in its approval process); Hafer v. Medtronic, Inc., 99 F. Supp. 3d 844 (W.D. Tenn. 2015) (claims based on breach of express warranties that manufacturer made voluntarily are not preempted); Alton v. Medtronic, Inc., 970 F. Supp. 2d 1069 (D. Or. 2013); Ramirez v. Medtronic, Inc., 961 F. Supp. 2d 977 (D. Ariz. 2013); Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal. 2013); Pinsonneault v. St. Jude Med., Inc., 953 F. Supp. 2d 1006, 1018–1019 (D. Minn. 2013) (express warranty claims escape preemption if they are based on voluntary statements, not those that FDA requires manufacturer to make); Cline v. Advanced Neuromodulation Sys., Inc., 914 F. Supp. 2d 1290 (N.D. Ga. 2012) (no preemption of claim for breach of express warranty, voluntarily made by manufacturer, that device will be free from defects in material or workmanship for one year); Desabio v. Howmedica Osteonics Corp., 817 F. Supp. 2d 197 (W.D.N.Y. 2011); Medtronic, Inc. v. Malander, 996 N.E.2d 412 (Ind. Ct. App. 2013) (claim based on manufacturer’s statement to physician during surgery not preempted); Cornett v. Johnson & Johnson, 48 A.3d 1041 (N.J. 2012). See also Ali v. Allergan USA, Inc., 78 U.C.C. Rep. Serv. 2d 515 (E.D. Va. 2012) (express warranty claims are preempted only if they, like these, are based on FDA-approved statements). But cf. Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015) (finding both express and implied warranty claims preempted; opinion cited plaintiff’s failure to identify a parallel FDA regulation but does not distinguish between express and implied warranties in this discussion; stating at page 1342 n.3 that plaintiff failed to plead the existence of any express warranty).

  • 229 {229} Godelia v. Doe I, 881 F.3d 1309 (11th Cir. 2018); In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1207 (8th Cir. 2010) (federal law preempts claim based on express warranty that product was safe, effective, fit, and proper for its intended use, because proof that the product was not safe, effective, or fit would be contrary to FDA’s approval).

  • 230 {230} 21 C.F.R. § 808.1(d)(1).

  • 231 {231} Bass v. Stryker Corp., 669 F.3d 501, 516–517 (5th Cir. 2012); Yost v. Stryker Corp., 71 U.C.C. Rep. Serv. 2d 396 (M.D. Fla. 2010); Purcel v. Advanced Bionics Corp., 2010 WL 2679988 (N.D. Tex. June 30, 2010) (implied warranty claim not preempted when it paralleled FDA’s findings that manufacturer’s violations of FDA requirements made product unsafe).

  • 232 {232} Riegel v. Medtronic, Inc., 552 U.S. 312, 329–330, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008); Bentzley v. Medtronic, Inc., 827 F. Supp. 2d 443 (E.D. Pa. 2011); Horn v. Boston Scientific Neuromodulation Corp., 2011 WL 3893812 (S.D. Ga. Aug. 26, 2011); Lemelle v. Stryker Orthopaedics, 698 F. Supp. 2d 668 (W.D. La. 2010).