FEIGE WIEDER v. ADVANCED BIONICS LLC (2025)

REPORT & RECOMMENDATION

Plaintiffs Feige Wieder and Joel Wieder (“the Wieders”), as parents of L.W., have filed this diversity action against defendant Advanced Bionics LLC (“Advanced Bionics”), bringing a number of state-law claims relating to a cochlear implant manufactured by Advanced Bionics. The claims are product manufacturing defect and design defect claims (Counts I, II), breach of implied warranty of merchantability (Count III), violations of §§ 349-50 of the New York General Business Law (Count IV), fraud (Count V), negligent failure to warn (Count VI), negligence (Counts VII, VIII), and loss of services (Count IX). See First Amended Complaint, filed Feb. 25, 2025 (Docket # 21) (“FAC”). Advanced Bionics has moved to dismiss these claims pursuant to Fed. R. Civ. P. 12(b)(6).¹ For the following reasons, Advanced Bionics’ motion to dismiss should be granted in part and denied in part.

I. BACKGROUND

A. Allegations of the Complaint

We assume the allegations of the FAC to be true as is required on a motion to dismiss. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). We also deem the FAC “to include any written instrument attached to it as an exhibit or any statements or documents incorporated in it by reference.” Cortec Indus., Inc. v. Sum Holding L.P., 949 F.2d 42, 47 (2d Cir. 1991), cert. denied, 503 U.S. 960 (1992).

Advanced Bionics is a manufacturer of cochlear implants, including the HiRes Ultra 3D line of implants. See FAC ¶¶ 30, 160. The U.S. Food and Drug Administration (“FDA”) classifies these implants as “Class III” medical devices. See id. ¶ 160. As such, each line of implants must secure a Pre-Market Approval (“PMA”) or a PMA Supplement from the FDA. See id. ¶¶ 175-76. A PMA or PMA Supplement application must supply the FDA with extensive information, including “proposed indications for use,” the device's “marketing history,” and the “methods used in manufacturing the device.” Id. ¶ 184 (quoting 21 C.F.R. § 814.20(b)). In 2018, Advanced Bionics secured a PMA Supplement for the HiRes Ultra 3D line of implants. Id. ¶ 55. The PMA Supplement for the HiRes Ultra 3D line is not publicly available. Id. ¶ 190.

The FAC incorporates an expert report from Dr. Anandhan Dhanasingh for the plaintiff in an action against Advanced Bionics brought in Canada. See Aff. of Anandhan Dhanasingh, annexed as Exs. 2-3 to FAC. Dr. Dhanasingh's report explains that HiRes Ultra 3D implants feature a “ring ground electrode” which is placed over another component of the device — the “electrode lead” — but which “does not covalently bind to the silicone material of the electrode lead.” FAC ¶ 63. The ring ground electrode's placement enables body fluid to “go between” the ring ground electrode and the silicone surface of the electrode lead, “enter[ing] the electrode lead at the welding point where the electrical connection from the electrode lead is welded to the ring ground electrode.” Id. Body fluid can then “enter the implant stimulator housing, thereby wetting the [device's] electronics,” which “can lead to short circuiting ․ causing undesirable [auditory] stimulation and/or lower-than-normal stimulation.” Id. ¶ 67. “To prevent body fluid ingress, during manufacturing a silicone seal is added ․ on both ends of the ring ground electrode.” Id. ¶ 63. “This seal is made of silicone elastomer material, like the electrode lead[,] and therefore does not covalently bind to the ring ground electrode.” Id. Further, the seal “is applied manually by manufacturing workers,” and is “not subject to a quality control process.” Id. ¶ 252. “Imperfections in the silicone seal application ․ exacerbate[ ] the fluid ingress from the device.” Id.

Between 2018 and 2019, two physicians implanted numerous HiRes Ultra 3D implants in patients as part of a clinical study in Hanover, Germany “conducted for” Advanced Bionics. Id. ¶ 209; see id. ¶ 210. The clinical study's findings revealed that the implants suffered from a high rate of failure and a short “median survival time” in patients. Id. ¶ 211. The two physicians were in contact with Advanced Bionics during the clinical study. See id. ¶ 212. Advanced Bionics would conduct “individual device failure analyses” on implants that had been removed (or “explanted”) from patients. Id. ¶ 213. In most cases, the analyses “revealed that the reason for the device failure was a short circuit caused by fluid ingress in the electrode pocket.” Id.

The study was not published until 2022. Id. ¶ 211. In a 2018 report, Advanced Bionics had disclosed “a CSR (Cumulative Survival Rate) of 99.87% (0.13% failure rate) for children implanted with the [HiRes Ultra 3D] after one year, and a CSR of 99.55% (0.45% failure rate) for children implanted with the DEVICE after two years.” Id. ¶ 255 (citing Advanced Bionics’ 2018 Global Implant Reliability Report, annexed as Ex. 13 to FAC). In a 2019 report, Advanced Bionics disclosed similar statistics. Id. ¶ 256 (citing Advanced Bionics’ 2019 Global Implant Reliability Report, annexed as Ex. 14 to FAC).

Advanced Bionics “reported the aforesaid data in device instructions, brochures, online, in medical publications and journals, and in literature to health[ ]care professionals, including plaintiffs’ doctors” Id. ¶ 258. But by December 2018, Advanced Bionics knew the “true failure rate” was significantly higher. Id. ¶ 257. The Wieders and their doctors “relied upon” data in the 2018 and 2019 reports in selecting a HiRes Ultra 3D implant for L.W., id. ¶ 262. L.W. has a severe hearing loss and the device was intended to correct that. See id. ¶ 97.

L.W. received his implant in a December 2018 surgery. Id. After the device was implanted and activated, L.W. continued to struggle to hear, and his speech development suffered accordingly. See id. ¶¶ 98-101. The Wieders grew concerned. See id. ¶¶ 99-100.

The Wieders’ concerns were magnified when, in February 2020, Advanced Bionics initiated a voluntary recall of un-implanted HiRes Ultra 3D implants. See id. ¶¶ 102, 72-75, 191-94. The “Urgent Field Action Notification” which accompanied the voluntary recall stated that Advanced Bionics had “detected an increase in the number of devices being explanted ․ due to performance issues ․ resulting from fluid ingress.” Id. ¶¶ 72, 191.

On February 23, 2021, an Advanced Bionics employee performed an “integrity test” on L.W.’s device, determining that the implant was operating properly. Id. ¶ 107. Between February 23, 2021, and February 23, 2022, however, L.W.’s device did not operate properly. Id. ¶ 108. Another Advanced Bionics employee performed a second “integrity test” a year later on February 23, 2022, and determined that the implant was dysfunctional. Id. ¶¶ 115-16. Advanced Bionics “recommended that plaintiffs contact a surgeon regarding explant of the DEVICE.” Id. ¶ 117. L.W.’s device was explanted in April 2022, id. ¶ 118, and a device failure analysis conducted by Advanced Bionics concluded that it had short-circuited, see id. ¶¶ 120-21 (citing Device Analysis Report, annexed as Ex. 8 to FAC).

L.W. subsequently received a second cochlear implant (one not manufactured by Advanced Bionics). Id. ¶ 118. This implant also failed to operate properly, in part due to scarring attributed to L.W.’s now-explanted HiRes Ultra 3D implant. See id. ¶¶ 125-27. L.W. is “left with a partially functioning cochlear implant, which has permanently affected his ability to hear, and by extension, his ability to speak and learn.” Id. ¶ 131.

B. Procedural History

The Wieders first filed suit against Advanced Bionics and Advanced Bionics’ parent, Sonova USA, Inc., in 2022. See Complaint, filed Dec. 21, 2022 (Docket # 1), in Wieder v. Advanced Bionics Corporation, No. 7:22-cv-10759 (S.D.N.Y. Dec. 21, 2022). The Wieders dismissed that suit without prejudice after entering into a tolling agreement with Advanced Bionics. See Order, dated Mar. 14, 2023 (Docket # 25 in No. 7:22-cv-10759).

The Wieders brought this action on November 7, 2024. See Complaint, filed Nov. 7, 2024 (Docket # 1.) The FAC, filed on February 25, 2025, lists nine state-law claims against Advanced Bionics: manufacturing defect (Count I), design defect (Count II), breach of implied warranty of merchantability (Count III), violations of N.Y. Gen. Bus. Law §§ 349-50 (Count IV), fraud (Count V), negligent failure to warn (Count VI), negligence (Counts VII, VIII), and loss of services (Count IX). See FAC. Advanced Bionics has moved to dismiss the FAC under Fed. R. Civ. P. 12(b)(6) asserting that the causes of action set out in the FAC are preempted by federal law or otherwise fail to state a claim for relief. See Mot.

II. LEGAL STANDARDS

A. Failure to State a Claim

A party may move to dismiss a complaint under Fed. R. Civ. P. 12(b)(6) where the complaint “fail[s] to state a claim upon which relief can be granted.” Fed. R. Civ. P. 12(b)(6). While a court ruling on a Rule 12(b)(6) motion to dismiss must treat the factual contentions contained in the complaint as true, this principle does not apply to legal conclusions. See Iqbal, 556 U.S. at 678 (2009); Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (“[A] plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.”) (citation and punctuation omitted). In other words, “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice,” Iqbal, 556 U.S. at 678, and thus a court's first task is to disregard any conclusory statements in the complaint, see id. at 679.

Next, a court must determine if the complaint, shorn of conclusory statements, contains “sufficient factual matter” which, if “accepted as true,” states a claim that is “plausible on its face.” Id. at 678 (citation and internal quotation marks omitted). “A claim has facial plausibility when the plaintiff pleads factual content that allows [a] court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. (citation omitted). This “plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Id. (citation omitted). “[W]here the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct,” the complaint is insufficient under Fed. R. Civ. P. 8 because it has “alleged—but it has not ‘show[n]’—‘that the pleader is entitled to relief.’ ” Id. at 679 (quoting Fed. R. Civ. P. 8(a)(2)).

“There are no special pleading requirements for product liability claims in general, or for Class III medical device claims in particular,” and a court “must keep in mind that much of the product-specific information about manufacturing needed to investigate such a claim fully is kept confidential by federal law.” Croci v. Zoll Med. Corp., 2025 WL 2307728, at *3 (S.D.N.Y. Aug. 11, 2025) (citing Bausch v. Stryker Corp., 630 F.3d 546, 557 (7th Cir. 2010)). The claim nevertheless must “satisfy the general Iqbal/Twombly pleading standards.” Franzese v. St. Jude Med., Inc., 2014 WL 2863087, at *3 (E.D.N.Y. June 23, 2014); accord Rosen v. St. Jude Med., Inc., 41 F. Supp. 3d 170, 184 (N.D.N.Y. 2014); Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395, 403 (S.D.N.Y. 2013).

B. Preemption

The Medical Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”) set up a regime for the oversight of medical devices. As the Supreme Court described it:

The devices receiving the most federal oversight are those in Class III, which include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators ․ In general, a device is assigned to Class III if it cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and the device is “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” or “presents a potential unreasonable risk of illness or injury.” § 360c(a)(1)(C)(ii).

․

Premarket approval is a “rigorous” process․ A manufacturer must submit what is typically a multivolume application. FDA, Device Advice—Premarket Approval (PMA) 18, http://www.fda.gov/cdrh/devadvice/pma/printer.html. It includes, among other things, 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. § 360e(c)(1). Before deciding whether to approve the application, the agency may refer it to a panel of outside experts, 21 CFR § 814.44(a) (2007), and may request additional data from the manufacturer, § 360e(c)(1)(G).

The FDA spends an average of 1,200 hours reviewing each application ․ and grants premarket approval only if it finds there is a “reasonable assurance” of the device's “safety and effectiveness,” § 360e(d). The agency must “weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” § 360c(a)(2)(C). It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives. It approved, for example, under its Humanitarian Device Exemption procedures, a ventricular assist device for children with failing hearts, even though the survival rate of children using the device was less than 50 percent. FDA, Center for Devices and Radiological Health, Debakey VAD Child Left Ventricular Assist System-H030003, Summary of Safety and Probable Benefit 20 (2004), http://www.fda.gov/cdrh/pdf3/H030003b.pdf.

Riegel v. Medtronic, Inc., 552 U.S. 312, 317-18 (2008). The MDA expressly preempts any state-law requirement concerning a medical device that “is different from, or in addition to, any requirement applicable” to the device under the FDCA and “relates to the safety or effectiveness of the device.” 21 U.S.C. § 360k(a). In Riegel, the Supreme Court articulated a two-step inquiry to determine whether the MDA expressly preempts a state-law requirement on a medical device. A court first “must determine whether the Federal Government has established requirements applicable to [the device].” 552 U.S. at 321. “If so, [it] must then determine whether the [plaintiff's] common-law claims are based upon [state-law] requirements with respect to the device that are ‘different from, or in addition to,’ the federal ones, and that relate to safety and effectiveness.” Id. at 321-22 (quoting 21 U.S.C. § 360k(a)). Riegel also clarified that “state-law requirements” encompass “common-law duties” enforced in tort. See id. at 324-25. Thus, under Riegel and related precedent, a plaintiff's state-law tort claims are preempted insofar as they “assert[ ] that the device in question ‘violated state tort law notwithstanding compliance with the relevant federal requirements’ and accordingly, impose[ ] requirements in addition to those imposed by federal law, contravening § 360(k).” Glover v. Bausch & Lomb, Inc., 6 F.4th 229, 237 (2d Cir. 2021) (quoting Riegel, 552 U.S. at 330). Put differently, to survive express preemption under the MDA, state-law tort claims must not impose requirements in addition to those imposed by federal law and they also must be “premised on a violation of FDA regulations.” Riegel, 552 U.S. at 330. “[T]he state duties in such a case ‘parallel,’ rather than add to, federal requirements.” Id.

In addition to the possibility of express preemption, state-law tort claims may also be impliedly preempted under section 337(a) of the FDCA, which provides that ‘all ․ proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States.” 21 U.S.C. § 337(a). As explained in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), the FDCA “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.” Id. at 349 n.4. In other words, the Supreme Court has interpreted § 337(a) to bar private plaintiffs from “attempting to directly enforce the FDCA.” Glover, 6 F.4th at 239. “To avoid implied preemption, the [Buckman] Court explained, claims must be based not on the FDCA, but on ‘traditional state tort law which ․ predated the federal enactments in question[ ].’ ” Id. at 237 (quoting Buckman, 531 U.S. at 353).

“Together, express and implied preemption under the FDCA, ‘operating in tandem, have created what some federal courts have described as a “narrow gap” for pleadings.’ ” Id. (quoting Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1327 (11th Cir. 2017)). “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).” Id. (quoting In re Medtronic, Inc., 623 F.3d 1200, 1204 (8th Cir. 2010)).

III. DISCUSSION

A. Count I (Manufacturing Defect)

New York law provides for a strict-liability claim alleging a manufacturing defect. “To establish a claim based on a manufacturing defect, plaintiff must prove that the product did not perform as intended and that it was defective at the time it left the hands of the manufacturer.” Fitzpatrick v. Currie, 52 A.D.3d 1089, 1090 (App. Div. 2008); see also Gelber v. Stryker Corp., 788 F. Supp. 2d 145, 155 (S.D.N.Y. 2011) (“[P]laintiff must show that a specific product unit was defective as a result of ‘some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction,’ and that the defect was the cause of plaintiff's injury.”) (quoting Colon ex rel. Molina v. BIC USA, Inc., 199 F. Supp. 2d 53, 85 (S.D.N.Y. 2001)). Here, Count I of the FAC lists numerous ways, in conclusory form, in which L.W.’s device was defective or deviated from approved specifications. See FAC ¶ 248. Ultimately, the FAC asserts more specifically that “[t]he nature of the defect in the subject DEVICE concerns the silicone sealing at the edge of the ring ground electrode.” Id. ¶ 250.² It alleges that the silicone seal “is applied manually by manufacturing workers” and that “[i]mperfections in the silicone seal application ․ constitute a manufacturing defect which exacerbates the fluid ingress from the device design.” Id. ¶ 252. The FAC also alleges that L.W.’s device “was defective as compared to other devices” because Advanced Bionics’ voluntary recall notice stated that “the vast majority” of HiRes Ultra 3D implants “function properly.” Id. ¶ 249. The FAC links L.W.’s injuries to the allegation that L.W.’s device was defective. See id. ¶¶ 264-65, 280-82. Finally, to survive express preemption under the MDA, the FAC attempts to set out a parallel violation of federal law. It ultimately concedes, however, that the Wieders are “not privy to the complete PMA for the subject DEVICE” and thus are “unable to provide the violations” that may have occurred as to “specific regulatory requirements” in the HiRes Ultra 3D's PMA Supplement. Id. ¶¶ 253, 254. However, the FAC elsewhere asserts that Advanced Bionics violated applicable Current Good Manufacturing Practice (“CGMP”) requirements contained in 21 C.F.R. § 820. Id. ¶ 279. To the extent that the Wieders’ claim in Count I is premised on Advanced Bionics’ alleged violation of federal requirements other than CGMP requirements, the Wieders have failed to plausibly assert a violation of “conduct that violates the FDCA.” Glover, 6 F.4th at 237. Thus, we consider only the allegation that Advanced Bionics failed to adhere to applicable CGMP requirements — a point plaintiffs address at length in their brief. See Opp. at 13-30.

The parties acknowledge that federal law imposes requirements on L.W.’s device, and that the Wieders’ manufacturing defect claim “relates to the safety or effectiveness of the device.” 21 U.S.C. § 360k(a)(2). Thus, the dispute is whether the Wieders’ claim is “different from” or “in addition to” the requirements imposed on L.W.’s device by the MDA (such that it is preempted) or identical to these requirements (such that it is not). 21 U.S.C. § 360k(a)(1). While defendant argues that plaintiffs do not assert a violation of a “specific federal law,” Mem. at 9, the Wieders do allege that L.W.’s device was “adulterated” in violation of 21 U.S.C. § 351(h) because, in manufacturing L.W.’s device, Advanced Bionics failed to adhere to applicable CGMP requirements. FAC ¶¶ 173, 279.

Advanced Bionics argues that CGMP requirements categorically “do not create federal requirements for purposes of avoiding express preemption.” Mem. at 13. It cites two district court decisions that take this position. See Pearsall v. Medtronics, Inc., 147 F. Supp. 3d 188, 197-98 (E.D.N.Y. 2015); Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 588 (E.D.N.Y. 2009). But we note that many other cases have not adopted this categorical approach. See Croci, 2025 WL 2307728, at *5 (collecting cases); see also Gallego v. Tandem Diabetes Care, Inc., 776 F. Supp. 3d 119, 136 (E.D.N.Y. 2025) (explaining the split of authority in the Second Circuit). We need not reach this issue, however, because we conclude that the FAC does not sufficiently plead that Advanced Bionics failed to adhere to applicable CGMP requirements.

First, the FAC is conclusory in its allegations that Advanced Bionics failed to adhere to applicable CGMP requirements. See FAC ¶ 279. While plaintiffs advert to specific CGMP requirements, see id. ¶ 278, merely repeating those requirements and alleging they were violated is insufficient. As courts have held, “Plaintiffs cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption.” Gelber, 788 F. Supp. 2d at 155 (quoting In re Medtronic, 592 F. Supp. 2d 1147, 1158 (D. Minn. 2009), aff'd, 623 F.3d 1200 (8th Cir. 2010)); accord Babayev v. Medtronic, Inc., 228 F. Supp. 3d 192, 215 (E.D.N.Y. 2017) (collecting cases).

Second, the allegation that the silicone seal around the ring ground electrode “is applied manually by manufacturing workers,” FAC ¶ 252, does not lead to an inference “that defendant deviated from the FDA approved plan and specifications” as contained in the CGMP requirements, Tansey v. Cochlear Ltd., 2014 WL 4829453, at *10 (E.D.N.Y. Sept. 26, 2014). Instead, plaintiffs must allege facts showing that the manual application of the silicone seal around the ring ground electrode in L.W.’s device violates applicable CGMP requirements. At one point, the FAC asserts that the manual application of the silicone seal is “not subject to a quality control process” generally, FAC ¶ 252, which might arguably reflect a violation of the requirement that “production processes” must “ensure that a device conforms to its specifications, 21 C.F.R. § 820.70(a).³ But the allegation that the silicone seal is not subject to any quality control process is itself conclusory as no explanation or detail is given as to what actually occurs in the HiRes Ultra 3D manufacturing process. In other words, the allegation is “a naked assertion[ ]” that a regulation was violated which is “devoid of further factual enhancement,” Iqbal, 556 U.S. at 678, or unsupported by “factual content that allows [a] court to draw the reasonable inference that the defendant is liable for the misconduct alleged,” id.

We have carefully examined the cases cited by plaintiffs that allowed alleged violations of CGMP requirements to advance. But in each instance, the allegations were of a far different character than those before us. In Gelber, there was a “warning letter” from the FDA that specifically concluded that a medical device manufacturer “failed to comply with the CGMP requirements.” 788 F. Supp. 2d at 158. There was also voluntary recall notice from the manufacturer which conceded that “internal acceptance criteria for manufacturing residual levels” (the manufacturing defect at issue) had been “exceeded.” Id. at 157. In Rosen, the plaintiff was armed with a medical device manufacturer's letter that specifically acknowledged “issues with defects.” 41 F. Supp. 3d at 175. In Tansey, the medical device manufacturer admitted that there had been “unexpected variations in the brazing process during manufacturing.” 2014 WL 4829453, at *1.

Here, the FAC cites to Advanced Bionics’ 2020 voluntary recall of the HiRes Ultra 3D line, which might suggest that Advanced Bionics violated applicable CGMP requirements. But citing to a voluntary recall, without more, does not plausibly allege a violation of a federal requirement. See Warmoth v. Medtronic, Inc., 2023 WL 3938464, at *5 (W.D. Okla. June 9, 2023) (“[R]eference to a recall without more is not the same thing as alleging a violation of federal law or failure to comply with federal law.”); see also Tripolskiy v. Bos. Sci. Corp., 2023 WL 5440785, at *5 (C.D. Cal. Aug. 18, 2023) (“[T]he FAC conclusorily alleges that Defendant's conduct violated federal regulations and that the [device] did not meet federal standards, based solely on the [device's] failure and product recalls, which is insufficient.”). Moreover, the “Urgent Field Action Notification” which accompanied the voluntary recall gives no indication that something went awry during manufacturing process — unlike the “warning letter” and notice in Gelber, the “Dear Doctor” letter in Tansey, or the admission in Rosen. See FAC ¶¶ 72, 191; Class 2 Device Recall Notice, annexed as Ex. 4 to FAC.

In sum, the allegations of the FAC do not show that Advanced Bionics violated CGMP requirements applicable to L.W.’s device. Accordingly, the manufacturing defect claim is not truly parallel and is expressly preempted by the MDA. Thus, Advanced Bionics’ motion to dismiss should be granted as to Count I.

B. Count II (Design Defect)

Under New York law, “[t]o establish a prima facie case for design defect, the plaintiff must show that the defendant ‘breached its duty to market safe products when it marketed a product designed so that it was not reasonably safe and that the defective design was a substantial factor in causing plaintiff[’]s injury.’ ” Hoover v. New Holland N. Am., Inc., 23 N.Y.3d 41, 54 (2014) (quoting (Voss v. Black & Decker Mfg. Co., 59 N.Y.2d 102, 106-07, (1983)); see also Croci, 2025 WL 2307728, at *7 (“To state a claim for defective design, a plaintiff must allege ‘(1) the product as designed posed a substantial likelihood of harm; (2) it was feasible to design the product in a safer manner; and (3) the defective design was a substantial factor in causing plaintiff's injury.’ ”) (quoting Colon ex rel. Molina, 199 F. Supp. 2d at 83). To meet these requirements, the FAC incorporates Dr. Dhanasingh's opinion that the HiRes Ultra 3D line was defectively designed inasmuch as the “ring ground electrode” design enabled body fluid to enter the device. See FAC ¶¶ 291-98. But Dr. Dhanasingh acknowledges that the HiRes Ultra 3D line is FDA-approved, see id. ¶ 296, and the FAC elsewhere concedes that Advanced Bionics “received FDA approval of a PMA Supplement for the subject HiRes Ultra 3D Cochlear Implant DEVICE,” id. ¶ 55. Accordingly, the FAC's allegations “directly challenge[ ] the FDA's judgment” in approving the allegedly defective ring ground electrode design and thereby seek to “impose[ ] different or additional standards” on the HiRes Ultra 3D line in violation of the MDA. Croci, 2025 WL 2307728, at *7. Such a “design defect claim[ ] regarding a PMA-approved device [is] squarely preempted by the MDA.” Simon, 990 F. Supp. 2d at 405 (citing Riegel, 552 U.S. at 323).

The plaintiffs argue that Kaemmlein v. Abbott Lab'ys, 564 F. Supp. 3d 58 (E.D.N.Y. 2021), stands for the proposition that design defect claims are not preempted by the MDA. See Opp. at 30-31. But in Kaemmlein, the plaintiff plausibly alleged that a medical device manufacturer “conceal[ed] knowledge of a potentially fatal defect based upon a design or implementation that deviated in function from that approved by the FDA.” Kaemmlein, 564 F. Supp. 3d at 68. Consequently, the Kaemmlein plaintiff's design defect claim paralleled a violation of federal law. See id. at 67. Here, there are no allegations showing that Advanced Bionics deliberately misled the FDA in such a manner.

The FAC asserts in conclusory fashion that “the subject DEVICE ․ deviated in a material way from [Advanced Bionics’] approved product design specifications, the PMA design specifications, [Advanced Bionics’] approved design performance standards, CGMP[s], and/or other applicable federal law and federal regulations.” FAC ¶ 290. To the extent that the Wieders are alleging that the design of L.W.’s device differed from the design approved in the PMA Supplement because Advanced Bionics declined to follow the FDA-approved design, this allegation is conclusory, as the FAC “does not contain any concrete factual allegations to back up th[is] legal conclusion[ ].” Simon, 990 F. Supp. 2d at 407. To the extent that plaintiffs are alleging that the design of L.W.’s device differed from the design approved by the FDA because of, as plaintiffs suggest in their response brief, “the inconsistent application of silicone around the third electrode,” Opp. at 30, plaintiffs are not alleging a design defect but a manufacturing defect. See Denny v. Ford Motor Co., 87 N.Y.2d 248, 257 n.3 (1995) (“In design defect cases, the alleged product flaw arises from an intentional decision by the manufacturer to configure the product in a particular way. In contrast, in strict products liability cases involving manufacturing defects, the harm arises from ․ some flaw in the fabrication process.”). For the reasons stated in the previous section, we have already rejected plaintiffs’ manufacturing defect claim.

Thus, Advanced Bionics’ motion to dismiss should be granted as to Count II.

C. Count III (Breach of Implied Warranty of Merchantability)

To state a claim for breach of implied warranty of merchantability, a plaintiff must allege “(1) that the product was defectively designed or manufactured; (2) that the defect existed when the manufacturer delivered it to the purchaser or user; and (3) that the defect was the proximate cause of the [injury].” Kaemmlein, 564 F. Supp. 3d at 75 (quoting Cavanagh v. Ford Motor Co., 2014 WL 2048571, at *5 (E.D.N.Y. May 19, 2014)); accord Fiuzzi v. Paragon Sporting Goods Co. LLC, 121 A.D.3d 431, 433 (App. Div. 2023). The parties agree that the Wieders’ claim for breach of implied warranty of merchantability rises or falls with their manufacturing defect and design defect claims. See Opp. at 43-44; Rep. at 2 n.2. Because their manufacturing defect and design defect claims fail, the Wieders fail to state a claim for breach of implied warranty of merchantability.

Thus, Advanced Bionics’ motion to dismiss should be granted as to Count III.

D. Count IV (New York General Business Law §§ 349-50)

N.Y. Gen. Bus. Law § 349 contains a general prohibition on “[d]eceptive acts or practices in the conduct of any business, trade or commerce or in the furnishing of any service.” N.Y. Gen. Bus. Law § 349(a). Similarly, N.Y. Gen. Bus. Law § 350 prohibits “[f]alse advertising in the conduct of any business, trade or commerce or in the furnishing of any service.” N.Y. Gen. Bus. Law § 350. Both of these sections contain provisions creating private rights of action to recover damages suffered as a result of such conduct. See N.Y. Gen. Bus. Law §§ 349(h), 350-e(3). The New York Court of Appeals has held that “[t]o successfully assert a claim under General Business Law § 349[ ](h) or § 350, ‘a plaintiff must allege that a defendant has engaged in (1) consumer-oriented conduct that is (2) materially misleading and that (3) plaintiff suffered injury as a result of the allegedly deceptive act or practice.’ ” Koch v. Acker, Merrall & Condit Co., 18 N.Y.3d 940, 941 (2012) (quoting City of N.Y. v. Smokes–Spirits.Com, Inc., 12 N.Y.3d 616, 621 (2009)); accord Cooper v. Anheuser-Busch, LLC, 553 F. Supp. 3d 83, 94 (S.D.N.Y. 2021).

Further, “a plaintiff must plausibly allege that the deceptive conduct was ‘likely to mislead a reasonable consumer acting reasonably under the circumstances.’ ” Mantikas v. Kellogg Co., 910 F.3d 633, 636 (2d Cir. 2018) (quoting Fink v. Time Warner Cable, 714 F.3d 739, 741 (2d Cir. 2013)). “[I]n determining whether a reasonable consumer would have been misled by a particular advertisement, context is crucial.” Id. (quoting Fink, 714 F.3d at 742). A court “therefore considers the challenged advertisement as a whole, including disclaimers and qualifying language.” Id. “[U]nder certain circumstances, the presence of a disclaimer or similar clarifying language may defeat a claim of deception.” Fink, 714 F.3d at 742.

Here, the FAC alleges that, “at the time the DEVICE, was marketed, sold and implanted in [L.W.],” defendant reported a Cumulative Survival Rate “of 99.87% (0.13% failure rate) for children implanted with the DEVICE after one year, and a CSR of 99.55% (0.45% failure rate) for children implanted with the DEVICE after two years.” FAC ¶ 347. In fact, plaintiffs allege, defendant “knew that the true failure rate for the DEVICE in children was between 26.9% and 50%.” Id. ¶ 349. Plaintiffs allege that the incorrect data were reported in “device instructions, brochures, online, in medical publications and journals, and in literature to health[ ]care professionals, including plaintiffs’ doctors.” Id. ¶ 350. Plaintiffs assert that defendant engaged in a deceptive and fraudulent practice by “withholding from patients, clinicians, doctors, and healthcare providers information regarding unacceptable failure rates, and known defects in the design of the DEVICE.” Id. ¶ 346. Plaintiffs also allege that defendant made materially misleading statements in that it “represented” that the HiRes Ultra 3D line was a “repackaging” of Advanced Bionics’ older HiRes 90K line, id. ¶ 356; misrepresented and concealed “the likelihood and/or possibility that the DEVICE would stop functioning properly ․ due to the ingress of physiologic fluid,” id. ¶ 360; concealed that “the design of the DEVICE permitted the ingress of bodily fluid, and that a safer design of the DEVICE was feasible,” id. ¶ 361; and misrepresented the “medical/surgical complications resulting from the use of the DEVICE,” id. ¶ 362.

While Advanced Bionics does not directly argue that its purportedly deceptive conduct not “consumer-oriented” as required by case law, it focuses its arguments on “labeling and marketing” materials. See Mem. at 17-18. And, obviously, any claim by plaintiffs must be limited to such “consumer-oriented” materials. Following from this limitation, defendant argues that plaintiffs’ claim fails because “§ 360k(a) preempts claims that would impose liability for FDA-approved labelling.” Mem. at 17. In fact, courts in this Circuit have held that N.Y. Gen. Bus. Law §§ 349-350 claims which “attack ․ FDA-approved label[s],” Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 288 (E.D.N.Y. 2009), or “assert[ ] that ․ FDA-approved promotional materials should have been ‘different’,” Tillet v. CooperSurgical, Inc., 2023 WL 4704091, at *6 (W.D.N.Y. July 24, 2023), come within the scope of § 360k(a). Accordingly, to the extent that the labelling, marketing and other consumer-oriented materials plaintiffs complain of were approved by the FDA or come within the scope of the PMA Supplement, any claims relating to them are preempted.

The existence of the MDA preemption statute means that for a plaintiff's claim under N.Y. Gen. Bus. Law §§ 349-350 to be “plausible,” the claim must at least allege that defendant's consumer-oriented statements were inconsistent with FDA-approved language or labelling. This is because to the extent the challenged statements are consistent with FDA-approved language or labelling, complaints about them would be preempted by the MDA. See Tillet, 2023 WL 4704091, at *6 (suit challenging statements that fall “within the confines of promotional materials explicitly approved as part of the PMA process” is preempted); Moody v. Allergan USA, Inc., 2017 WL 6949742, at *6 (W.D.N.Y. Dec. 5, 2017) (suit is preempted when “complaint fails to specify a representation made by defendant outside of the confines of the promotional materials explicitly approved as part of the PMA process”), adopted by 2018 WL 451824 (W.D.N.Y. Jan. 17, 2018); see generally McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir.2005) (“Where a federal requirement permits a course of conduct and the state makes it obligatory, the state's requirement is in addition to the federal requirement and thus is preempted.”).

Here, the complaint gives no indication of the how the challenged statements relate to or differ from statements approved by the FDA as part of the PMA process. Accordingly, Advanced Bionics’ motion to dismiss should be granted as to Count IV.

E. Count V (Fraud)

To state a claim for fraud under the common law under New York law, a plaintiff must allege “a misrepresentation or a material omission of fact which was false and known to be false by [the] defendant, made for the purpose of inducing the other party to rely upon it, justifiable reliance of the other party on the misrepresentation or material omission, and injury.” Ambac Assur. Corp. v Countrywide Home Loans, Inc., 31 N.Y.3d 569, 578-79 (2018) (quoting Pasternack v Lab'y Corp. of Am. Holdings, 27 N.Y.3d 817, 827 (2016)). Under Fed. R. Civ. P. 9(b), “in alleging fraud ․ a party must state with particularity the circumstances constituting fraud.” Consequently, “the complaint must allege the time, place, speaker, and sometimes even the content of the alleged misrepresentation.” Ouaknine v. MacFarlane, 897 F.2d 75, 79 (2d Cir. 1990). Here, plaintiffs attempt to make out a claim for fraud by adverting to the same statements complained of in Count IV (save for the representation that the HiRes Ultra 3D line was a “repackaging” of Advanced Bionics’ older HiRes 90K lines). See FAC ¶¶ 380, 384, 387, 388. The FAC is largely silent as to the particulars of these statements.

For the same reasons stated with respect to Count IV, to the extent that the statements complained of in Count V were approved by the FDA, any fraud claims related to them are preempted. See English v. Bayer Corp., 468 F. Supp. 3d 573, 580-82 (W.D.N.Y. 2020) (fraudulent misrepresentation claim would be preempted where complaint “do[es] not cite to any labeling or advertising that is so inconsistent with FDA-approved language as to be false or misleading”). Plaintiffs’ reliance on Kaemmlein is misplaced. See Opp. at 31. In Kaemmlein, the plaintiff alleged that a medical device manufacturer made misrepresentations to the FDA in the process of getting a PMA. See Kaemmlein, 564 F. Supp. 3d at 73. Thus, his state-law fraud claim, which was premised on those same misrepresentations, was found not to be preempted by the MDA. See id. The Wieders’ fraud claim, by contrast, is not premised on alleged misrepresentations to the FDA.

Plaintiffs’ reliance on Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017), is also misplaced. See Opp. at 34. There, the plaintiff's state-law fraud claim turned on representations made directly to him by a medical device manufacturer's agent that did not “impose any safety or effectiveness requirements on the [device]” and were thus beyond the scope of MDA preemption. Mink, 860 F.3d at 1333. Here, the statements the Wieders complain of relate to the safety or effectiveness of the HiRes Ultra 3D. Thus, Count V should be dismissed.

F. Count VI (Negligent Failure to Warn)

“To prevail on a claim for negligent failure to warn, a plaintiff must demonstrate that (1) a manufacturer has a duty to warn (2) against dangers resulting from foreseeable uses about which it knew or should have known, and (3) that failure to do so was the proximate cause of the harm.” State Farm Fire & Cas. Co. v. Nutone, Inc., 426 F. App'x 8, 10 (2d Cir. 2011) (summary order) (citing Liriano v. Hobart Corp., 92 N.Y.2d 232, 237 (1998)). Here, the FAC alleges that the “warnings, instructions, and directions” accompanying L.W.’s device “failed to warn” the Wieders, L.W.’s doctors, the medical community at large, and the general public “of the dangerous propensities of the DEVICE.” FAC ¶ 407; see id. ¶¶ 411-13. It alleges that these “warnings, instructions, and directions” should have included “added instructions and contraindications for use,” “added descriptions of adverse events,” and the “true and accurate failure rate of the DEVICE.” Id. ¶ 414. The FAC also alleges that Advanced Bionics failed to company with “PMA monitoring and reporting requirements.” Id. ¶ 417; see id. ¶ 415. In so doing, Advanced Bionics allegedly breached a state-law “duty to warn the medical community of all potential dangers.” Id. ¶ 419. The FAC alleges that, but for Advanced Bionics’ failures, L.W. would not have been implanted with a HiRes Ultra 3D device, see id. ¶ 417 — the ultimate source of his injuries, see id. ¶¶ 424-25.

To the extent that plaintiffs’ negligent failure to warn claim challenges the FDA-approved “warnings, instructions, and directions” accompanying L.W.’s device, the MDA preempts this claim. First, the FAC nowhere alleges that these “warnings, instructions, and directions” deviated from language approved by the FDA; therefore, it “has not alleged conduct ․ ‘that violates the FDCA,’ a necessary prerequisite to avoid express preemption.” Dains v. Bayer HealthCare LLC, 2022 WL 16572021, at *5 (N.D.N.Y. Nov. 1, 2022) (quoting Glover, 6 F.4th at 237). Second, to the extent the FAC is alleging that these “warnings, instructions, and directions” should have included language “beyond the labeling the FDA approved, such claims are also expressly preempted,” id., because plaintiffs would be seeking to impose “a state requirement that is ‘different from, or in addition to,’ the FDA's requirements in violation of § 360k,” A.F. v. Sorin Grp. USA, Inc., 346 F. Supp. 3d 534, 543 (S.D.N.Y. 2018); accord Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 256 (E.D.N.Y. 2014).

To the extent that plaintiffs’ negligent failure to warn claim rests on Advanced Bionics’ failure to warn the Wieders, L.W.’s doctors, and the medical community at large, see FAC ¶ 411, the MDA preempts this claim as well. This is because the FAC “fail[s] to identify a federal requirement that defendant warn the public and health[ ]care professionals directly that its devices were defective.” Bertini, 8 F. Supp. 3d at 256. As a result, plaintiffs’ ‘failure to warn’ theory ․ does not ‘parallel’ federal requirements.” Id.; accord A.F., 346 F. Supp. 3d at 544 n.8.

The FAC does allege that Advanced Bionics failed to comply with “PMA monitoring and reporting requirements” and as a result breached a state-law “duty to warn the medical community.” FAC ¶¶ 417, 419.

The first issue raised by this allegation is whether there is a New York state-law duty to warn the medical community that parallels PMA monitoring and reporting requirements. We are aware of some court decisions which assert that there is such a duty. See A.F., 346 F. Supp. 3d at 544 (“[A] manufacturer's duty to take steps that are reasonably necessary to warn the medical community [under New York law] may include warning the FDA as required by the MDA. To the extent Plaintiffs assert a claim for failure to warn the FDA, that claim is not preempted.”); Gale v. Smith & Nephew, Inc., 989 F. Supp. 2d 243, 251 (S.D.N.Y. 2013); Kaemmlein, 564 F. Supp. 3d at 70-73; Rosen, 41 F. Supp. 3d at 185. But these cases do not seem to grapple with New York law that makes clear that the duty to warn runs to a “learned intermediary,” not a regulatory agency, and that a learned intermediary is a “medical professional[ ] who use[s] the device in the treatment of patients.” Banker v. Hoehn, 278 A.D.2d 720, 721 (App. Div. 2000). (emphasis added). This aspect of New York law was explicitly recognized in Tillet. See Tillet, 2023 WL 4704091, at *4. As stated in Tillet, the FDA does not qualify as a “learned intermediary” because “[t]he FDA does not treat patients” and “does not prescribe and supervise the effects of various treatments.” Id. Further, as noted in Tillet, there would be no basis for any argument that a warning to the FDA necessarily or even likely results in a warning to treatment providers: “[w]hen adverse events are reported to the FDA, there is no reasonable assurance that the information will be disseminated to the appropriate professional with the treating relationship to the patient because the FDA is not required to publicly release such reports.” Id. (citation omitted). Therefore, a failure to warn claim under New York law is “different from, or in addition to” a manufacturer's duty to supply adverse event reports to the FDA and is thus preempted under the MDA. 21 U.S.C. § 360k(a)(1). Other cases have reached a similar conclusion. See Pearsall, 147 F. Supp. 3d at 200-02; English, 468 F. Supp. 3d at 580.

Even if it could be said that New York state law parallels PMA monitoring and reporting requirements, Count VI still fails because the allegations in the FAC that Advanced Bionics failed to make required reports to the FDA are conclusory and in part contradictory.⁴ The FAC asserts in one place that Advanced Bionics “consistently reports to the FDA, that the DEVICE problems are not ‘Adverse Events,’ but instead identifies their reporting as a ‘Product Problem,’ to evade scrutiny or further FDA action,” FAC ¶ 228, but in another place, it acknowledges that the FDA received “multitudes of adverse event reports detailing the failure of the HiRes[ ] Ultra 3D Cochlear Implant,” id. ¶ 226. The FAC also asserts that Advanced Bionics failed to give the FDA notice of the “findings” of the 2018-2019 clinical study of the HiRes Ultra 3D line, id. ¶ 214, but it notes that the results of the clinical study were not published until December 2022, id. ¶ 207, several years after L.W. received his device. The FAC does not assert that Advanced Bionics failed to give the FDA notice of the data underlying the study.

These variegated allegations stand in stark contrast to the “specific deficiencies in the timeliness and content of Defendants’ reports to the FDA” alleged in A.F., 346 F. Supp. 3d at 544, or the allegation in Kaemmlein that the defendant “reviewed 42 product reports showing evidence of premature battery depletion due to lithium cluster bridging; yet failed to take action commensurate with this risk and failed to timely advise the medical community or the FDA,” 564 F. Supp. 3d at 71 n.8.

The Wieders’ response brief asks the Court not to “ignore[ ] the substantial history of the device included in the Amended Complaint,” Opp. at 43, alluding to the troubled HiRes 90k and 90k Advantage lines which preceded the HiRes Ultra 3D line and on which the HiRes Ultra 3D line is based, FAC ¶¶ 41-42. These lines were recalled in 2004 and 2006 for issues with “excessive moisture and/or physiologic fluid in their components.” Id. ¶ 45; see id. ¶ 43. The Court fails to see the relevance of this “substantial history,” which says nothing about Advanced Bionics’ compliance with FDA reporting requirements as to the HiRes Ultra 3D line.

Accordingly, Advanced Bionics’ motion to dismiss should be granted as to Count VI.

G. Counts VII, VIII (Negligence)

Counts VII and VIII allege negligence based on the testing done by the Advanced Bionics representative in 2021.

Defendant does not argue the MDA preempts the Wieders’ negligence claims. Rather, it argues that these claims fail as a matter of law because “there is no duty” that runs from Advanced Bionics to plaintiffs and that the FAC does not satisfy Rule 8 because it “fails to establish any breach of any duty.” Mem. at 35.

To state a claim for negligence in New York, a plaintiff must allege “that a defendant: (1) owed a duty of care; (2) breached that duty; (3) that the breach was the proximate cause of the plaintiff's injuries; and (4) damages.” Tansey, 2014 WL 4829453, at *14 (citing Vega v. Fox, 457 F. Supp. 2d 172, 183 (S.D.N.Y. 2006)); accord Alvino v. Lin, 300 A.D.2d 421, 421 (App. Div. 2002).

Thus, “a threshold question in tort cases is whether the alleged tortfeasor owed a duty of care to the injured party.” Espinal v. Melville Snow Contractors, Inc., 98 N.Y.2d 136, 138 (2002). “[T]he existence and scope of a duty is a question of law requiring courts to balance sometimes competing public policy considerations.” Id. These include “the economic impact of a duty, pertinent scientific information, the relationship between the parties, the identity of the person or entity best positioned to avoid the harm in question, the public policy served by the presence or absence of a duty[,] and the logical basis of a duty.” In re New York City Asbestos Litig., 27 N.Y.3d 765, 788 (2016). Considerations of public policy have led New York courts to impose a tort-law duty on professionals “to exercise reasonable care, irrespective of their contractual duties,” in the performance of their services. Sommer v. Fed. Signal Corp., 79 N.Y.2d 540, 551 (1992). This duty “has been imposed based on the nature of the services performed and the defendant's relationship with its customer.” Dormitory Auth. v. Samson Constr. Co., 30 N.Y.3d 704, 711 (2018); accord Glanzer v. Shepard, 233 N.Y. 236, 239 (1922) (“It is ancient learning that one who assumes to act, even though gratuitously, may thereby become subject to the duty of acting carefully, if he acts at all.”) (Cardozo, J.).

The Restatement of Torts (Second) § 323 provides:

One who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of the other's person or things, is subject to liability to the other for physical harm resulting from his failure to exercise reasonable care to perform his undertaking, if

(a) his failure to exercise such care increases the risk of such harm, or

(b) the harm is suffered because of the other's reliance upon the undertaking.

Restatement of Torts (Second) § 323 (Am. L. Inst. 1965). Section 323 of the Restatement of Torts (Second) as well as a related provision, § 324A, have been cited by New York courts as reflective of New York law. See, e.g., Schwartz v. Greenfield, Stein & Weisinger, 90 Misc. 2d 882, 886 (Sup. Ct. 1977); Spooner v. Nat'l. Elevator Inspection Servs., Inc., 161 Misc. 2d 73, 77 (Sup. Ct. 1994); accord Stanford v. Kuwait Airlines Corp., 1990 WL 209408, at *3 (S.D.N.Y. Nov. 28, 1990).

Here, the FAC alleges that a representative of Advanced Bionics conducted “integrity testing” of plaintiff's device on February 23, 2021, FAC ¶¶ 432, 452, and incorrectly “conclude[ed] that the subject DEVICE was operating properly,” id. ¶¶ 441, 453. It is further alleged that, as a result of the improper testing, the “explanatation of the DEVICE was unnecessarily delayed,” which resulted in “hearing loss in [plaintiff's] right ear, speech delays, developmental delays, scarring and/or increased scarring in and around the cochlear” and a less successful second cochlear implant. FAC ¶¶ 445, 455. These allegations are sufficient to meet the test in § 323(a) of the Restatement of Torts (Second), which requires allegations that the failure to exercise care “increase[d] the risk” of harm. Additionally, it is clear that Advanced Bionics should have “recognize[d]” that the testing was “necessary for the protection of” L.W. Restatement of Torts (Second) § 323.

Applying the factors outlined in In re New York City Asbestos Litig, Advanced Bionics was in the best position to avoid the harm in question as it made the device and was responsible for the training of its own agent. The “integrity testing” obviously required special skill and knowledge. Also, Advanced Bionics had a direct relationship with L.W. inasmuch as its device was implanted in L.W. and its agents tested the device. Finally, public policy would be furthered by having Advanced Bionics responsible for providing accurate testing of its own product.

Advanced Bionics’ argument that “there is no duty” centers on two cases. See Mem. at 35-36. In Greenwood v. Tehrani, 2017 WL 4083099 (Sup. Ct. Sep. 15, 2017), a state trial court dismissed a negligence claim against the manufacturer of a medical device for failing to ensure that the plaintiff's physician used the device in a “safe, indicated manner,” holding that “the manufacturer is not responsible for how the physician uses the device and renders the medical care.” Id. at *2. But here, unlike the manufacturer in Greenwood, Advanced Bionics directly provided services to L.W. through its employee. Notably, these services involved the use of “proprietary EFI software” unavailable to “healthcare professionals” such as L.W.’s physician. FAC ¶¶ 209, 208; see also Advanced Bionics Site Visit Reports, annexed as Ex. 6 to FAC, at 1, 3, (indicating that the integrity tests involved an “EFI Analysis Tool”). Counts VII and VIII take issue with these services, not with L.W.’s device itself.

In Dupere v. Ethicon, Inc., 2022 WL 523604 (S.D.N.Y. Feb. 22, 2022), the district court dismissed a negligence claim against the manufacturer of a medical device for “[in]adequately test[ing] [the device] for safety before and after launch[ ],” holding that “New York's highest court would not recognize a tort imposing liability for ․ failure to test” among those “available in New York to assert a product liability claim for negligence against a manufacturer.” Id. at *2, *4. This case has no relevance because in Counts VII and VIII, the Wieders are not asserting a product liability claim.

In the only case that we have been made aware of where testing was done on an implanted medical device by the manufacturer, the court found that there was a duty of care imposed. In Tansey, the plaintiff brought negligence claims against a cochlear implant manufacturer after the manufacturer's employees tested her device post-implantation and allegedly wrongly concluded that it was not operating properly or that explant surgery was necessary. 2014 WL 4829453, at *14. Tansey held that the plaintiff adequately “allege[d] that defendant and its agents owed [her] a duty.” Id.

Advanced Bionics separately argues that “the Amended Complaint fails to establish any breach of any duty” because it “fail[s] to allege facts indicating that Advanced Bionics had reason to know that L.W.’s device had failed prior to the February 2022 test.” Mem. at 35, 36. But as Advanced Bionics concedes, the FAC alleges “that Advanced Bionics should have known that the testing it had performed ‘was not sensitive enough to determine’ that L.W.’s device was not operating properly and that Advanced Bionics lacked the proper equipment to properly test the device.” Id. at 36-37 (quoting FAC ¶ 434). Furthermore, other allegations in the FAC support the inference that Advanced Bionics had reason to know that L.W.’s device had failed prior to the February 2022 test. The FAC details a study of the HiRes Ultra 3D line conducted for Advanced Bionics which revealed that the average device failed within three years. See FAC ¶¶ 209-12. It also details the 2020 voluntary recall of un-implanted HiRes Ultra 3D devices over concerns about fluid ingress, see id. ¶¶ 72-75, 191-94, along with the Wieders’ mounting concerns that L.W.’s device was not operating properly, see id. ¶¶ 99-106. These allegations lend plausibility to the FAC's assertion that Advanced Bionics, after assuming a duty of care to plaintiffs by testing L.W.’s device, breached that duty by concluding, incorrectly and in the face of evidence to the contrary, that the device was operating properly or that it need not be explanted. Accordingly, Advanced Bionics’ motion to dismiss should be denied as to Counts VII and VIII.

H. Count IX (Loss of Services)

Plaintiffs label Count IX as “loss of services” but in fact seek damages only for loss of “comfort, society, and companionship,” FAC ¶ 463, and for their incurring of “medical expenses, educational expenses, and other expenses” to care for L.W. as a result of defendant's conduct, id. ¶ 464.

Advanced Bionics first argues that the Wieders’ claim fails because all of their “underlying claims” fail. Mem. at 37. This argument is rejected because not all of the Wieders’ underlying claims fail.

Defendant also argues that “New York law generally ‘denies recovery for grief, loss of society, affection, conjugal fellowship and consortium’ as a result of injuries to a child.” Id. (citing Matthias v. United States, 475 F. Supp. 3d 125, 142 (E.D.N.Y. 2020)). This does appear to be a correct statement of New York law. See, e.g., Charles v. Suvannavejh, 28 Misc. 3d 1157, 1161 (Sup. Ct. 2009) (“In no instance may a parent claim loss of a child's society, comfort, or affection”); accord Matthias, 475 F. Supp. 3d at 142 (“New York law ‘denie[s] recovery for grief, loss of society, affection, conjugal fellowship and consortium’ for death of a minor family member.”) (quoting Rodriguez v. New York, 2014 WL 12917808, at *6 (E.D.N.Y. Jan. 24, 2014)). Accordingly, such claims will not be available in this case.

However, Count IX also includes claims for “medical expenses, educational expenses, and other expenses” to care for L.W. as a result of defendant's conduct. FAC ¶ 464. Defendant gives no reason why plaintiffs cannot make such claims.⁵ Instead, defendant argues that the complaint fails to “set forth any facts or evidence detailing the services that L.W. could have provided.” Opp. at 37; accord id. at 38 (“Plaintiffs have not alleged any facts demonstrating what services L.W. could have provided but for the injuries alleged in this case.”). But plaintiffs in this count are not seeking damages for loss of actual services that would have been provided by L.W. Because defendant does not explain why the plaintiffs cannot seek to recover the “medical expenses, educational expenses, and other expenses” they have paid or will pay for L.W.’s care, the motion to dismiss this count should be denied.

IV. CONCLUSION

For the foregoing reasons, the motion to dismiss (Docket # 23) should be granted as to Counts I through VI and denied as to Counts VII, VIII and IX.

PROCEDURE FOR FILING OBJECTIONS TO THIS REPORT AND RECOMMENDATION

Pursuant to 28 U.S.C. § 636(b)(1) and Rule 72(b) of the Federal Rules of Civil Procedure, the parties have fourteen (14) days (including weekends and holidays) from service of this Report and Recommendation to file any objections. See also Fed. R. Civ. P. 6(a), 6(b), 6(d). A party may respond to any objections within 14 days after being served. Any objections and responses shall be filed with the Clerk of the Court. Any request for an extension of time to file objections or responses must be directed to Judge Ho. If a party fails to file timely objections, that party will not be permitted to raise any objections to this Report and Recommendation on appeal. See 28 U.S.C. § 636(b)(1); Fed. R. Civ. P. 72; Fed. R. Civ. P. 6(a), 6(b), 6(d); Thomas v. Arn, 474 U.S. 140 (1985); Wagner & Wagner, LLP v. Atkinson, Haskins, Nellis, Brittingham, Gladd & Carwile, P.C., 596 F.3d 84, 92 (2d Cir. 2010).

FOOTNOTES

1.   See Advanced Bionics’ Motion to Dismiss, filed Mar. 18, 2025 (Docket # 23) (“Mot.”); Advanced Bionics’ Memorandum of Law in Support, filed Mar. 18, 2025 (Docket # 23-1) (“Mem.”); Plaintiffs’ Memorandum of Law in Opposition, filed Apr. 29, 2025 (Docket # 31) (“Opp.”); Advanced Bionics’ Reply Memorandum of Law in Support, filed May 20, 2025 (Docket # 33) (“Rep.”).

2.   In their brief, plaintiffs say the FAC “clearly identifies” that the manufacturing defect they allege is the ring ground electrode's “failure ․ to covalently bind to the silicone electrode lead” and “the application of the silicone sealing at the edge of ring ground electrode.” Opp. at 25-26. But as Advanced Bionics rightly observes, the ring ground electrode's “failure ․ to covalently bind to the silicone electrode lead” is indicative of “inadequate design, not that the manufacturing process went awry for L.W.’s device,” Mem. at 23. Therefore, the Court's analysis of Count I focuses on the “application of the silicone sealing at the edge of ring ground electrode.”

3.   Advanced Bionics argues that “any claim based on Advanced Bionics’ quality control and product surveillance procedure ‘violating’ federal requirements is implied preempted” because such a claim seeks to enforce those federal requirements, which only the FDA may do under Buckman. Mem. at 14. We disagree. If defendant's failure to adhere to proper standards gives rise to a state-law claim which parallels a federal requirement, Riegel makes clear that such a claim may proceed. 552 U.S. at 330.

4.   Plaintiffs at one point suggest that Advanced Bionics failed in its duty not just to warn the FDA but to “notify infant plaintiff's physician or the medical community.” Opp. at 35. But any state law claim that requires notifications to L.W.’s “physician or the medical community” would obviously not parallel any federal requirements and thus is preempted under the MDA.

5.   Indeed, the Restatement of Torts (Second) § 703 notes that such an action is specifically permitted: “One who by reason of his tortious conduct is liable to a minor child for ․ bodily harm is subject to liability to ․ the parent who is under a legal duty to furnish medical treatment for any expenses reasonably incurred or likely to be incurred for the treatment during the child's minority.” Restatement of Torts (Second) § 703 (Am. L. Inst. 1977).

GABRIEL W. GORENSTEIN United States Magistrate Judge