Opinion ID: 6321804
Heading Depth: 4
Heading Rank: 1

Heading: which is different from, or in addition to, any

Text: requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. 8 Under Riegel v. Medtronic, Inc., 9 we apply a two-prong inquiry to evaluate whether state law claims are preempted under § 360k(a). 10 First, we determine whether the federal government has “established requirements applicable to [the medical device].” 11 Class III devices subject to PMA, like those at issue here, “automatically” satisfy the first prong. 12 Second, we evaluate whether the state law claims are based on “requirements with respect to the device that are ‘different from, or in addition to,’ the federal ones, and that relate to safety and effectiveness.” 13 If they are, the 8 21 U.S.C. § 360k(a). 9 552 U.S. 312 (2008). 10 Id. at 321-22. 11 Id. at 321. 12 Bass v. Stryker Corp., 669 F.3d 501, 507 (5th Cir. 2012). Reddick argues on appeal that he “believes” Medtronic’s Class III devices did not go through the traditional PMA process. “A new device need not undergo premarket approval if the FDA finds it is ‘substantially equivalent’ to another device exempt from premarket approval,” which is referred to as § 510(k) approval. Riegel, 552 U.S. at 317. Unlike PMA, “the § 510(k) approval process does not impose federal requirements on a device.” Bass, 669 F.3d at 507. In his SAC, however, Reddick alleged that Medtronic’s Class III devices received PMA, not § 510(k) approval. Because Reddick failed to plead sufficient facts in support of his § 510(k) theory, we conclude that Riegel’s first prong is met. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). 13 Riegel, 552 U.S. at 321-22 (quoting § 360k(a)). 5 Case: 21-30169 Document: 00516231793 Page: 6 Date Filed: 03/09/2022 No. 21-30169 state law claim is preempted. 14 “[P]arallel” claims, however, are not preempted even if they relate to the safety and effectiveness of a device. 15 A state law claim is “parallel” if it “provid[es] a damages remedy . . . premised on a violation of FDA regulations.” 16 Even if a state law claim is parallel, a district court may still dismiss it if the claim is “impermissibly conclusory and vague.” 17 In Funk v. Stryker Corp., 18 we held that a complaint that does not “specify the manufacturing defect,” “specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury,” or “tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process” is insufficient to state a parallel products liability claim. 19 Similarly, in Naquin v. Medtronic, Inc., 20 a recent unpublished opinion applying Funk, we affirmed the district court’s dismissal of claims for design defect, construction defect, failure to warn, and breach of express warranty due to inadequate pleading. 21 As in the present case, Naquin involved Medtronic’s allegedly defective defibrillators. 22 The complaint only “ma[de] numerous conclusory allegations . . . [without] details as to how a violation of federal regulations” 14 See § 360k(a); Riegel, 552 U.S. at 321-22. 15 Riegel, 552 U.S. at 330. 16 Id. 17 Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011). 18 631 F.3d 777. 19 Id. at 782. 20 No. 20-30793, 2021 WL 4848838 (5th Cir. Oct. 18, 2021) (per curiam) (unpublished). 21 Id. at . 22 Id. at . 6 Case: 21-30169 Document: 00516231793 Page: 7 Date Filed: 03/09/2022 No. 21-30169 led to a manufacturing defect, a design defect, or an inadequate warning. 23 Naquin’s express warranty claims were also conclusory because he did not “reproduce any specific warranty . . . or specify its precise source.” 24 Reddick asserts four theories of liability under the LPLA: defective construction, defective design, failure to warn, and breach of express warranty. 25 Under the Riegel inquiry’s second prong, all four claims impose “requirement[s]” on Medtronic that relate to the “safety and effectiveness” of its devices. 26 The issue, therefore, is whether Reddick adequately pleaded 23 Id. at . 24 Id. (citing Wildman v. Medtronic, Inc., 874 F.3d 862, 870 (5th Cir. 2017)). 25 In the SAC, Reddick also references a potential claim regarding “off label” use of the Medtronic devices. The district court determined that an “off label” claim, to the extent that Reddick alleged one, is “not an available theory” under the LPLA. See La. Stat. Ann. § 9:2800.54 (stating that “[a] product is unreasonably dangerous if and only if” it is defectively designed, it is defectively constructed, an adequate warning has not been provided, or it does not conform to an express warranty) (emphasis added). In his appellate brief, Reddick links his “off label” allegation to his express warranty claim. To the extent that Reddick otherwise argues that his “off label” claim is distinct from the four liability theories under the LPLA, we agree that it is not an available theory. 26 See § 360k(a); La. Stat. Ann. § 9:2800.55 (imposing liability if “at the time the product left its manufacturer’s control, the product deviated in a material way from the manufacturer’s specifications”); id. § 9:2800.56 (imposing liability if “[t]here existed an alternative design for the product that was capable of preventing the claimant’s damage” and the potential damage to the claimant “outweighed the burden on the manufacturer of adopting such alternative design and the adverse effect, if any, of such alternative design on the utility of the product”); id. § 9:2800.57 (requiring the manufacturer to use “reasonable care to provide an adequate warning”); id. § 9:2800.58 (imposing liability if the product “does not conform to an express warranty made at any time by the manufacturer about the product if the express warranty has induced the claimant . . . to use the product and the claimant’s damage was proximately caused because the express warranty was untrue”); see also Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919, 930-33 (5th Cir. 2006) (holding that design defect, failure-to-warn, and breach of express warranty claims under LPLA were preempted by § 360k(a)). 7 Case: 21-30169 Document: 00516231793 Page: 8 Date Filed: 03/09/2022 No. 21-30169 parallel state law claims to avoid preemption. He did not—all four of Reddick’s claims are “impermissibly conclusory and vague.” 27 As to the defective design and construction claims, Reddick alleged only “upon information and belief” that Medtronic’s devices were defective without providing sufficient factual support. He did allege that some of Medtronic’s devices have been subject to recalls and that the FDA has warned Medtronic about manufacturing adulterated products in Puerto Rico. He failed to plead, however, that his devices in particular were part of those recalls or that the recalls were related to the unnecessary shocks that he experienced. On appeal, Reddick also argues that “[n]ew recent facts” about an April 2021 recall of the ICD provide further support for his claims, but we “may not consider new evidence” that was “not before the district court at the time of the challenged ruling.” 28 Lastly, Reddick insists that the res ipsa loquitur doctrine makes his allegations sufficient, but res ipsa loquitur does not cure an otherwise conclusory pleading that fails to state a claim equivalent to a violation of FDA safety standards. 29 Similarly, Reddick did not provide any factual support for his failureto-warn claim. He alleged only that Medtronic “failed to warn [him] . . . regarding the unreasonably dangerous and defective products that were implanted and used in [his] care and treatment,” neglecting to plead any applicable FDA-approved warnings or that Medtronic departed from them. Finally, we agree with the district court that Reddick’s breach of warranty claim is preempted as well. Reddick’s claim is similar to the one 27 Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011). 28 Theriot v. Par. of Jefferson, 185 F.3d 477, 491 n.26 (5th Cir. 1999). 29 See Funk, 631 F.3d at 782. 8 Case: 21-30169 Document: 00516231793 Page: 9 Date Filed: 03/09/2022 No. 21-30169 that we recently addressed in Naquin. 30 As we reasoned there, a breach of warranty claim under the LPLA must be pled “with particularity.” 31 Reddick alleged that Medtronic violated an oral “lifetime warranty” on the ICD. He also alleged Medtronic violated a separate “10 and 11 year warranty” that applied only to the lead. Reddick failed, however, “to reproduce any specific warranty in his pleadings or specify its precise source,” and he did not allege that he was induced to use Medtronic’s devices due to those warranties. 32 As in Naquin, Reddick “gets more specific” on appeal by arguing that the warranties came from Medtronic’s advertisements and its website, but he “still fails to identify a specific web page or specific warranty terms.” 33 Thus, we agree with the district court that all four of Reddick’s LPLA claims are too conclusory to state a parallel claim that avoids preemption under § 360k(a).