Wieder et al v. Advanced Bionics LLC

1

2

BACKGROUND

Familiarity with the factual background and relevant procedural history of this case as set forth in the Report is assumed. See R. & R. at 2-5. This action is referred to Magistrate Judge Gorenstein for general pretrial supervision and for report and recommendation on dispositive motions. See Order of Reference to Magistrate Judge, ECF No. 8. On March 18, 2025, Defendant moved to dismiss, ECF No. 23. On November 20, 2025, Magistrate Judge Gorenstein issued a Report and Recommendation addressing that motion. See R. & R. On December 4, 2025, Plaintiffs filed their Objections to the Report. See ECF Nos. 36, 37. On December 18, 2025, Advanced Bionics filed its Opposition to Plaintiffs See

objections and oppositions, the Court adopts the

miss Counts One through Six of the Complaint and to deny the

Motion to Dismiss as to Counts Seven through Nine.

LEGAL STANDARD

I. Standard of Review dispositive motions and make proposed findings of fact and recommendations, generally Vaccariello v. XM Satellite Radio, Inc., 295 F.R.D. 62, 67 (S.D.N.Y. 2013).¹ accept, reject, or modify, in whole or in part, the findings or recommendations made by the ing a report and recommendation. 28 U.S.C. § 636(b)(1)(C).

findings and

id.; see Fed. R. Civ. P. 72(b) (same). In

3

court has an obligation to make a de novo determination as to those portions of the Report and Vaccariello, 295 F.R.D. at 67. The district

judge has discretion when weighing the recommendations and proposed findings. See United States v. Raddatz, 447 U.S. 667, 683 (1980) (holding that the violate Art. III so long as the ultimate decision is

address only those portions of the propos Vaccariello, 295

responses argued in an attempt to engage the district court in

de novo review.

Vega v. Artuz, No. 97 Civ. 3775, 2002 WL 31174466, at *1 (S.D.N.Y. Sep. 30, 2002); see also Owusu v. N.Y. State Ins., 655 F. Supp. 2d 308, 313 (S.D.N.Y. 2009). not consider new arguments raised in objec

recommendation that could have been raised before the magistra United States v. Gladden, 394 F. Supp. 3d 465, 480 (S.D.N.Y. 2019); see Piligian v. Icahn Sch. of Med. at Mount Sinai arguments and factual assertions cannot

properly be raised for the first time in objections to the report and recommendation, and indeed may not be deemed ob

When there is no timely objection by either party, the district court may accept the report Nelson v. Smith, 618 F.

only conclusory or general objections, or

simply reiterates the original arguments, the [c]ourt will review the [r]eport st Pinkney v. Progressive Home Health Servs., No. 6 Civ. 5023, 2008 WL 2811816, at *1 (S.D.N.Y. July 21, 2008).

4

II. Motion to Dismiss t must contain sufficient factual matter, Sacerdote v. N.Y. Univ.,

9 F.4th 95, 106 (2d Cir. 2021) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)). In assessing y, accepting all factual allegations therein as true

and drawing all reasonable inferenc Id. at 106-07. The Court must,

Id. at 107 (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)).

DISCUSSION

The Report recommended that Advanced Bioni respect to Counts One through Six, and denied with respect to Counts Seven through Nine. Plaintiffs object to the recommendations to dismiss Counts One through Six, which the Court addresses in turn below. The Court then addresses the portions of the Report recommending that the Motion to Dismiss be denied as to Counts Seven through Nine of the FAC, to which neither party has objected.

At a high level, the Report recommended dismissing Counts one through Six as preempted to the federal Food, Drug and Cosmetic Act

ess preemption under the MDA, state-law tort

claims must not impose requirements in addition to those imposed by federal law and they also Riegel v. Medtronic,

Inc.

Id. (quoting Riegel, 552 U.S. at 330). Here, the Report recommended dismissal of various state law claims because Plaintiffs failed to allege violations of relevant

5

these recommendations are discussed in turn below.

I. Count One: Manufacturing Defect manufacturing defect be dismissed as preempted. See R. & R. at 10-14. The Report reasoned that the Wieders did not adequately plead that Advanced Bionics had failed to comply with applicable quirements set forth at 21 C.F.R. § 820, and

that their manufacturing defect claim was therefore preempted.²

The Wieders raise several objections on this point. First, they argue that they stated a violation of CGMP requirements, by alleging that the silicone sealing of the implant is performed by hand and is not subject to quality control. See the Wieders still do not allege any specific violation of the applicable CGMP requirements. The fact that the silicone sealing on the device was applied by hand does not, by itself, necessarily imply that there was a violation of any particular applicable CGMP requirement.³And merely saying that there was no quality control is also insufficient to establish a violation. Cf. Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395, 406-07 (S.D.N.Y. 2013) (holding that allegation that defendants manufactured

6

claim). The Wieders protest that happened during the manufacturing process . . . without access to But, as explained in more detail below with

respect to their design defect claim, plaintiffs bear the burden of demonstrating a specific deviation from federal regulatory requirements in order to state a claim in this context, and the Wieders have not done so here.

Next, the Wieders argue that Advanced Bioni

Ultra 3D implants renders their allegation of a violation of a federal requirement plausible. See cases holding that a voluntary recall alone does

not establish a violation of federal requirements. See R. & R. at 14 (citing, inter alia, Warmoth v. Medtronic, Inc., No. Civ. 21-712, 2023 WL 3938464, at *5 (W.D. Okla. June 9, 2023)). The Report also acknowledged several cases cited by the Wieders finding that plaintiffs had sufficiently alleged a manufacturing defect based in part on a voluntary recall; but the recalls in those cases were accompanied by documents acknowledging the possibility of manufacturing defects. See R. & R. at 13 (citing, inter alia, Gelber v. Stryker Corp., 788 F. Supp. 2d 145, 157-58 (S.D.N.Y. 2011) (describing letter from FDA warning that manufacturer failed to comply with CGMP requirements, and notice from manufacturer accompanying recall acknowledging manufacturing defect)). Having reviewed that authority, this Court agrees with the Report that these cases are inapposite.

recall, combined with a study showing that the HiRes Ultra 3D line of implants was subject to a high failure rate, could support their negligence claims, but not their manufacturing defect claim. See

7

establish a violation of federal regulations (for purposes of claim), but that they could establish that the implant should have been explanted (for purposes of their negligence claim).

manufacturing defect claim should be dismissed are overruled.

II. Count Two: Design Defect The MDA preempts state law claims for a design defect regarding a device that has received Premarket Approval (PMA). See Simon, 990 F. Supp. 2d at 405. The Report noted, however, that the FDA approved both the HiRes Ultra 3D implant line and its PMA supplement. See R. & R. at 15 (citing FAC ¶¶ 55, 296). Accordingly, the design defect claim is preempted. Here, the Wieders raise two objections. First, they assert that their device must have differed from the design approved by the FDA in the PMA supplement, but that they cannot acknowledged the difficulties for plaintiffs in

attempting to allege specific defects or deviations from federal regulatory requirements without access to confidential PMA documents, see, e.g., Gelber, 788 F. Supp. 2d at 157, Plaintiffs do not cite authority for the proposition that they need not allege a specific deviation from FDA requirements in order to avoid pr f bears the burden of alleging

deviations from [applicable FDA] safety standards in order to avoid preemption and assert state McConologue v. Smith & Nephew, Inc., 8 F. Supp. 3d 93, 105 (D.

Conn. 2014) (citing Riegel, 552 U.S. at 322-23). Indeed, in Rosen v. St. Jude Medical, Inc., 41 F. Supp. 3d 170 (N.D.N.Y. 2014), which the Wieders cite for the proposition that courts must be mindful of the fact that plaintiffs often do not have access to confidential PMA documents, see

8

allegations with two FDA enforcement letters and other materials indicating a specific violation of applicable federal requirements. See Rosen, 41 F. Supp. 3d at 183. The Wieders have not pointed to anything comparable here.

Next, the Wieders argue that, by permitting hand application of silicone, the design of the device necessarily deviated from applicable CGMPs ariability and lacked of a hand application process inevitably results in deviations from the specifications approved by the FDA, this is not a design defect claim, which, under New York

product flaw arises from an intentional decision by the manufacturer to configure the product in a Denny v. Ford Motor Co., 662 N.E.2d 730, 735 n.3 (N.Y. 1995) (emphasis added). Rather, this argument sounds in the form of a manufacturing defect, which alleges that Gelber, 788 F. Supp. 2d at 155.

And for the reasons explained above, Plaintiffs have failed to state a manufacturing defect claim. defect claim be dismissed are overruled.

III. Count Three: Breach of Implied Warrant of Merchantability The Report recommended that, in light of the recommendations discussed above, the claim for breach of implied warranty of merchantability rises or falls with their manufacturing defe R. & R. at 17. The Wieders and citing various cases holding that a breach of

warrantability claim can survive even where a strict liability claim (like the manufacturing and

9

design defect claims here) fail. See inter alia, Denny, 662 N.E.2d at 736).⁴ Advanced Bionics argues that the Weiders did not make this argument on the underlying motions, but more importantly notes that the cases cited by the Wieders do not take into account the federal preemption principles at issue in this case. See

Advanced Bionics is correct. In the Denny case, cited by the Wieders, the New York Court of Appeals held that, as a matter of New York state law, the elements of claims for strict products liability and breach of implied warranty are not coexte

breach of implied warranty even though a claim of strict products liability has not been .2d at 731. But that is not the issue here. As Advanced Bionics

notes, the MDA preempts any state law claim for breach of implied warranty when the FDA has approved the device at issue. See, e.g., Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 252 breach of implied warranty fails for the same

reason that its design defect claim fails: the HiRes Ultra 3D implant was approved by the FDA. breach of implied warranty be dismissed is overruled.

IV. Count Four: New York General Business Law §§ 349-50 claims under the New York General Business mption grounds. The Report noted that, where a plaintiff challenges under state law labelling, marketing, or other consumer-oriented materials approved by the FDA, such claims are preempted unless the materials were inconsistent with FDA-

10

approved language or labelling. See R. & R. at 19 (citing Tillet v. CooperSurgical, Inc., No. 23 Civ. 6031, 2023 WL 4704091, at *6 (W.D.N.Y. July 24, 2023)). The Report concluded that, here, because the Wieders have made no such allegation, their GBL claim is preempted. See id. at 20. The Wieders object, noting that they have pled the elements of a GBL claim, and again protest that they cannot allege whether the materials in question deviate from those approved by the FDA, because they lack access to the relevant PMA documents. See that product-specific information is confidential

under federal law, the standard notice pleading requirements of federal law still apply in this context. Croci v. Zoll Med. Corp., No. 24 Civ. 2137, 2025 WL 2307728, at *3 (S.D.N.Y. Aug. 11, 2025). Plaintiffs have not pled that any of

Ultra 3D implant are inconsistent with what the FDA has approved. See Horowitz v. Stryker Corp., ation of applicable federal safety rules in order to avoid

preemption under the MDA. See McConologue, 8 F. Supp. 3d at 105. The Wieders have not done so here.

be dismissed is overruled.

V. Count Five: Fraud As with the other claims disc claim be dismissed as preempted. See R. & R. at 20-21. The Wieders object that they have ts went beyond the scope of FDA approval and

presented misleading assurances of safety and performance not contained in the PMA, which, if at 13-14. But they do not support this conclusory

11

assertion by pointing to any specific statements that were allegedly fraudulent; nor do they describe concerned safety or performance Id. They have therefore not

established that these claims escape preemption. As the Report noted, the authority that the Wieders cited in their opposition brief, , 564 F. Supp. 3d 58, 73

(E.D.N.Y. 2021), involved allegations that the defendant made fraudulent representations to the FDA itself, which is not the case here. And, to the extent the Wieders allege that Advanced Bionics should have issued warnings that go beyond those required by the FDA, that is precisely the kind of claim that is preempted by the MDA. See Dains v. Bayer HealthCare LLC, No. 22 Civ. 208, 2022 WL 16572021, at *2, 5 (N.D.N.Y. Nov. 1, 2022).

that their fraud claim

be dismissed is overruled.

VI. Count Six: Negligent Failure to Warn l 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 State Farm Fire & Cas. Co. v. Nutone, Inc.

(2d Cir. 2011). The Wieders appear to press multiple theories with respect to their negligent failure ings deviated from language approved by the FDA;

that Defendant should have included language going beyond FDA-approved labeling; and that Defendant failed to inform the Wieders, their doctors, and the medical community at large, of the risks associated with the implant, including through non-compliance with federal reporting requirements. See R. & R. at 22-23. The Report recommended dismissing this claim as asserted under each of these various theories of liability. See id. at 22-25.

12

compliance with federal PMA monitoring and reporting requirements. See⁵With respect to that theory, the Report recommended dismissal on two grounds. First, the Report recommended it be dismissed as preempted because New York law does not provide

to report adverse events to the FDA. R. & R. at 23-24. Second, the Report recommended it be at Advanced Bionics failed to make required

reports to the FDA are conclusory Id. at 24-25.

ecommendation to dismiss this claim based solely on the

s have failed to state this claim due to contradictory (or

otherwise insufficient) factual allegations. The Report noted that the Wieders made contradictory allegations with respect to the th , a failure to provide a warning. See R. & R. at 24-25. In their objections, the Wieders argue that the Report erroneously resolved factual ambiguities against them, and note that they have the right to plead alternative theories. See vanced Bionics improperly reported incidents to

order to evade scrutiny or FDA

was flatly contradicted by other allegations in the FAC that

gs that are directly contradicted by other factual

Barberan v. Nationpoint, 706 F. Supp. 2d 408, 424

(S.D.N.Y. 2010).

13

The Wieders protest that inconsistencies in th xplain away their plainly contradictory factual allegations, which need not be credited by the Court. The Wieders also object that the Report discounted their allegations that prior cochlear implant lines manufactured by Advanced Bionics e., moisture intruding into the device. See id. at 18. But

those allegations do not establish that Advanced Bionics had a duty to warn about the implant line at issue in this case.⁶

are contradictory and/or otherwise

14

insufficient to state a claim for negligent failure to warn, and the Court therefore adopts the

VII. Counts Seven through Nine: Negligence and Loss of Services No party has objected to the portions of the Report recommending that the Motion to Dismiss be denied as to these counts. Notably, Advanced Bionics did not argue that these claims are preempted. The Court has reviewed these portions of the Report, and has found no error, clear or otherwise. Accordingly, these portions of the Report are adopted in full.

CONCLUSION

For the reasons given above, the ADOPTED IN FULL. The Motion to Dismiss as to Counts One through Six is GRANTED; the motion is DENIED as to Counts Seven through Nine.

exercises discretion to release re ssively by uploading the reports But this is a rather limited description of the role of the FDA plays in promoting safety. As DA has the power to recall medical devices . . . , to order

manufacturers to cease distribution, to notify healthcare professionals and device users, and to take other corrective actions when it finds a reasonable probability that the device would cause serious adverse health consequences or deat see also Rosen, 41 F. Supp. 3d at

nd [Medical Device Reportings] in a public,

searchable database called the Manufacturer an

which physicians and the general public may access to view safety data on me Anyone who has had to throw away a food item like a bag of contaminated lettuce due to an FDA recall understands that the reach of FDA warnings can be, and often is, quite broad. See, e.g., Jin Yu Young, F.D.A. Orders Recall of More than 1.5 Million Bags of Shredded Cheese, N.Y. Times (Dec. 4, 2025), https://nytimes.com/2025/12/04/us/cheese-recall.html [https://perma.cc/XT5T-

JAC7].

and safety information, this Court is persuaded by the reasoning of the various courts that have held that the duty to take adequate steps to notify medical professionals extends to providing notice the FDA, see supra, and therefore declines to adopt a rule that New York law does not provide a cause of action for a

15