Citing Riegel, the Ninth Circuit held that state requirements are preempted under the MDA only to the extent that they are different from, or in addition to, federal requirements. In sum, in order to state a claim that avoids both express and implied preemption, a plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA. Id. at 1233.

FDA performance standards were insufficient to plead a parallel claim); Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 283-84 (E.D.N.Y. 2009) (ruling that plaintiff’s reliance on defendant’s CGMP violations “does not save these claims from preemption as such requirements are simply too generic, standing alone, to serve as the basis” for her claim (internal citations and quotation marks omitted)); Morris v. Greenky, Index No. 2015EF2603, slip op. at 6 (N.Y. Sup. Ct. Onondaga Cnty. Feb. 10, 2016) (attached hereto as Exhibit B) (holding, in a case involving the same device as in this case—the BHR System—that “[s]tate law claims based upon alleged violations of broad [CGMP] regulations, without explaining how Defendant violated Federal law with respect to the BHR System, are not parallel claims and are therefore pre-empted”); Lutz-Cummings v. Medtronic, Inc., 2016 WL 3082314, at *5 (Minn. Dist. Ct. May 31, 2016) (“To state a parallel claim that escapes express preemption under Section 360k . . ., Plaintiffs must allege facts pointing to specific PMA requirements that Defendants violated that caused the specific alleged injury.”). In fact, the FDA itself explains that CGMPs “apply to so many different types of devices, [and] the regulation[s] do[] not prescribe in detail how a manufacturer must produce a specific device.” See Quality System (QS) Regulation/Medical Device Good Manufacturing Practices, FDA, http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarket Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 17 of 26 PageID #: 45 14 requirements/qualitysystemsregulations/ (last updated July 29, 2016) [hereinafter “Medical Device Good Manufacturing Practices, FDA”]. 4

The proposed Second Amended Complaint attached as Exhibit E to Plaintiffs' Motion shall be deemed filed. It is further ORDERED Defendant Smith & Nephew, Inc.'s Motion for Summary Judgment (Document 59) is GRANTED as follows: • Judgment is entered in favor of Smith & Nephew, Inc. as to Counts I, III, and V of the Second Amended Complaint on the basis that the claims set forth in those Counts are expressly preempted under 21 U.S.C. § 360k(a). 27 The dismissal also extends to Count VII, Plaintiffs' claim for loss of consortium, which is derivative of their other claims.

See Riley v. Cordis Corp., 625 F.Supp.2d 769, 787 (D. Minn. 2009) (holding that “express-warranty claims that are based solely on the contents of an FDA-approved label are expressly preempted by § 360k(a).”). Moreover, if Plaintiff’s breach of express warranty claim is based on non-FDA-approved representations, although such a claim 11 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 11 of 15 A11 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 12 of 16 PageID #: 142 could survive preemption, it would still ultimately fail here because, Plaintiff does not set forth the content of any express warranty nor identify the source of the express warranty (i.e., whether it was made in a publication, package insert, or advertising). Further, Plaintiff does not allege how it became the basis of a bargain between Plaintiff and Smith & Nephew.

Because only the federal government can enforce the FDCA and its regulations, any claims asserting violations of federal law would conflict with the FDA’s own extensive regulatory regime. Therefore, this Court should follow Buckman, Lewkut, and Medtronic and hold that, to the extent Plaintiff’s claims are not expressly preempted under 21 U.S.C. § 360k(a), they are impliedly preempted under 21 U.S.C. § 337(a). III. Plaintiff’s Breach Of Warranty Claims (Causes of Action 5-7) Are Barred Because Plaintiff Did Not Provide Pre-Suit Notice To Medtronic.

Id. at 1118 (quoting 21 U.S.C. § 360k(a)(1)). Plaintiff’s off-label promotion allegations— allegations not at issue in Stengel, but present in Perez—fall short of what is required to state a valid parallel claim.

Plaintiff’s State Law Claims (Counts 1–4) Conflict with the FDA Requirements for the Manufacture, Labeling, and Alteration of the Breast Implants and Are Preempted The second step of the preemption inquiry is the determination of whether Plaintiff’s state law claims rely on any requirement of California law applicable to Mentor MemoryGel Silicone Breast Implants “that is ‘different from, or in addition to’ federal requirements and that ‘relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device.’” Riegel, 552 U.S. at 323 (quoting 21 U.S.C. § 360k(a)). The MDA expressly preempts any state law claim that would impose different or additional duties relating to any requirement imposed through the PMA process.

Plaintiff’s manufacturing defect and negligence claims are inadequately pleaded. To state a claim that survives express preemption under 21 U.S.C. § 360k(a), Plaintiff “must allege,” among other things, that a “federal violation caused [Mr. Perez’s] injuries.” Millman, 2015 WL 778779, at *4 n.2; accord, e.g., Martin I, 32 F. Supp. 3d at 1033-34 (“To properly plead parallel claims that survive preemption, a plaintiff must allege facts (1) showing an alleged violation of FDA regulations or requirements related to [the device], and (2) establishing a causal nexus between the alleged injury and the violation.”)

Kinetic does not allege otherwise. Accordingly, all of the PMAs remain valid and 21 U.S.C. § 360k(a) still preempts any state-law claim that would impose additional or different requirements. See Bryant, 623 F.3d at 1205 n.4; In re Fidelis Leads I, 592 F. Supp. 2d at 1156; Talbott, 63 F.3d at 28.

Id. at 353. There is thus a “‘narrow gap’ through which a state-law claim must fit to escape preemption by the FDCA: ‘The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).’” Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th Cir. 2013) (quoting In re Medtronic, Inc., Sprint Fidelis Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010)) (emphasis in both).