MEMORANDUM AND ORDER INTRODUCTION Plaintiff Shafigheh Koublani (“Plaintiff”) brings this action against Defendants Cochlear Limited and Cochlear Americas Corporation (“CAM,” and together with Cochlear Limited, “Defendants”) alleging the following causes of action under New York state law: (1) strict products liability, (2) negligence, (3) breach of warranty, and (4) failure to warn. This matter concerns alleged defects in Defendants’ Nucleus Implant Bandage and Splint Kit for MRI (the “MRI Kit”), which is utilized to stabilize magnetic components of cochlear implant hearing devices during magnetic resonance imaging (“MRI”) procedures. Presently before the Court is Defendant CAM’s motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6). [DE 22].1 While Plaintiff’s claims are not preempted by federal law, Plaintiff has failed to state a claim upon which relief may be granted. For that reason, CAM’s motion is GRANTED. BACKGROUND To facilitate the reader’s understanding of this matter, the Court begins with an overview of the Food and Drug Administration’s (“FDA”) regulatory scheme for medical devices before setting forth the facts alleged in the Complaint. A. FDA Approval Process The FDA regulates the “safety and effectiveness” of medical devices pursuant to the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act. See 21 U.S.C. §360c et seq. Every covered “medical device” fits into one of three classifications, which determines the level of FDA oversight: Class I (the least), Class II, or Class III (the most). Id. §360c(a); see id. §321(h)(1) (defining “medical device”). Class III is “the default category for new (that is, post-1976) medical devices.” Ivy Sports Med., LLC v. Burwell, 767 F.3d 81, 83-84 (D.C. Cir. 2014) (Kavanaugh, J.) (detailing the FDA classification scheme); see 21 U.S.C. §360c(f)(1) (“Any device intended for human use…is classified [as] class III unless…”). Class III devices must endure the FDA’s premarket approval (“PMA”2) process, a “rigorous regime” in which the FDA spends 1,200 hours per device on average assessing: full reports of all studies and investigations of the device’s safety and effectiveness that have been published or should reasonably be known to the applicant; a “full statement” of the device’s “components, ingredients, and properties and of the principle or principles of operation”; “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device”; samples or device components required by the FDA; and a specimen of the proposed labeling. Riegel v. Medtronic, Inc., 552 U.S. 312, 317-18, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008) (quoting 21 U.S.C. §360e(c)(1)). If, after review, the FDA has “reasonable assurance” of the device’s safety and effectiveness, it may enter the market. 21 U.S.C. §360e(d). Manufacturers of a PMA device may not make changes “affect[ing] [its] safety or effectiveness” without first obtaining a “supplemental PMA.” Id. §360e(d)(5)(A)(i); 21 C.F.R. §814.39(a). The FDA evaluates “application[s] for supplemental premarket approval…under largely the same criteria as an initial application,” except that the FDA requires only enough information to review the proposed modifications. Riegel, 552 U.S. at 319 (citing 21 U.S.C. §360e(d)(5); 21 C.F.R. §814.39(c)). A device avoids PMA review if (a) the FDA, upon de novo review, determines it meets the Class I or II statutory definitions, 21 U.S.C. §§360c(a)(1)(A)-(B), or (b) it is “substantially equivalent” to a pre-existing classified device, id. §§360c(f)(1)-(3), (i)(1)(A). Per statute, Class I devices present “no unreasonable risk of illness or injury” and are regulated by “general controls.” Id. §360c(a)(1)(A). Class II is comprised of devices ineligible for Class I status “because the general controls by themselves are insufficient to provide reasonable assurance of the[ir] safety and effectiveness” but “for which there is sufficient information to establish special controls to provide such assurance.” Id. §360c(a)(1)(B). A device is “substantially equivalent” to a pre-existing classified device — that is, a predicate Class I, II, or III device — if it has “the same intended use” and either “the same technological characteristics” or the same safety and effectiveness. Id. §§360c(f)(1)-(3), (i)(1)(A). The FDA’s review for “substantial equivalence,” the premarket notification “§510(k) process,” is named after the statute’s previous location. Riegel, 552 U.S. at 317; see 21 U.S.C. §360(k). On average, the §510 process takes the FDA twenty hours per device. Medtronic, Inc. v. Lohr, 518 U.S. 470, 479 (1996). Though “[t]he §510(k) notification process is by no means comparable to the PMA process,” id. at 478-79, it is the means by which “[m]ost new Class III devices enter the market.” Riegel, 552 U.S. at 317. To be clear, “§510(k) is ‘focused on equivalence, not safety,’” and PMA “is focused on safety, not equivalence.” Id. at 323 (emphasis in original) (internal citations omitted) (quoting Lohr, 518 U.S. at 493). Devices “enter[ing] the market through §510(k) have ‘never been formally reviewed under the [Medical Device Amendments] for safety or efficacy,” whereas premarket approval is granted “only after [the FDA] determines that a device offers a reasonable assurance of safety and effectiveness.’” Id. (internal citations omitted) (quoting Lohr, 518 U.S. at 493). B. CAM’s PMA and Supplemental PMAs Cochlear Limited, an Australian corporation, designs and manufactures cochlear implant hearing aid devices, which it distributes across the United States through its American subsidiary CAM, a Delaware corporation with a Colorado principal place of business. (Compl.
10-11, 13 [DE 18]; Def. Mem. at 3 n.3 [DE 22-1]). In June 25, 1998, CAM obtained PMA for its “Nucleus 24 Cochlear Implant System,” a device “intended to restore a level of auditory sensation to adults and children via electrical stimulation of the auditory nerve.” (FDA Premarket Approval No. P970051).3 CAM has subsequently supplemented this implant system’s PMA for its newer and related devices. Of note is the FDA’s supplemental PMA on June 15, 2015, which approved the CAM’s “Nucleus CI522 Cochlear Implant System,” referred herein as the “CI522.” (FDA Supplement No. S1264 (“S126 Supp. PMA”), Ex. B to Decl. of Lauren S. Colton (“Colton Decl.”)). The CI522 is not directly in issue, and it suffices to know that it is a surgically implanted electronic hearing aid device comprised of internal (i.e., surgically implanted) and external components held together by a magnet. (Compl.
