Opinion ID: 177259
Heading Depth: 1
Heading Rank: 3

Heading: Breach of Express Warranty Claims

Text: In the Master Consolidated Complaint, Plaintiffs alleged the breach of express warranties that Sprint Fidelis Leads were safe, effective, fit and proper for their intended use. The district court concluded that these claims are preempted because the safety and effectiveness of the leads are matters solely for the FDA, and because the FDA determined that the leads were safe and effective. Medtronic Leads, 592 F.Supp.2d at 1164. On appeal, Plaintiffs argue that express warranties are not state requirements preempted by § 360k because the `requirement[s]' imposed by an express warranty claim are not `imposed under State law,' but by the warrantor.  Cipollone v. Liggett Group, Inc., 505 U.S. 504, 525, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (plurality opinion) (emphasis in original). Though Cipollone construed a different, narrower express preemption provision, the opinion suggests that breach of express warranty claims are not expressly preempted by § 360k. See In re Medtronic, Inc., Implantable Defibrillators Litig., 465 F.Supp.2d 886, 898 (D.Minn.2006); contra Parker v. Stryker Corp., 584 F.Supp.2d 1298, 1303 (D.Colo.2008). However, we need not decide that issue. To succeed on the express warranty claim asserted in this case, Plaintiffs must persuade a jury that Sprint Fidelis Leads were not safe and effective, a finding that would be contrary to the FDA's approval of the PMA Supplement. A state common law claim is preempted if it actually conflicts with the federal requirement  either because compliance with both is impossible, or because the state requirement stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Lohr, 518 U.S. at 507, 116 S.Ct. 2240 (Breyer, J., concurring) (quotations and citations omitted). The MDA in § 360k expressly prohibits States from imposing requirements in addition to federal requirements. The district court correctly concluded that this express warranty claim interferes with the FDA's regulation of Class III medical devices and is therefore conflict preempted. See Gomez v. St. Jude Medical Daig Div., Inc., 442 F.3d 919, 932 (5th Cir.2006); cf. Pet Quarters, Inc. v. Depository Trust & Clearing Corp., 559 F.3d 772, 780-81 (8th Cir.2009).