The latest medical device express preemption decision, Wieder v. Advanced Bionics LLC, 2026 U.S. Dist. LEXIS 70645, 2026 WL 880370 (S.D.N.Y. Mar. 31, 2026), comes out of the Southern District of New York and involves a Class III, PMA‑approved cochlear implant. 

Fluid allegedly worked its way into the device and caused a short‑circuit and device failure.  Then, a replacement surgery only partially succeeded because of scarring attributed to the original device, allegedly leading to permanent impairment of the infant patient’s ability to hear, speak, and learn.

In this opinion, the District Court adopted almost all of a solid Report and Recommendation by Magistrate Judge Gorenstein, and the result is that all the classic product‑liability theories—manufacturing defect, design defect, implied warranty, consumer protection, fraud, and failure to warn—were dismissed, largely on preemption grounds, while three negligence‑based counts and derivative loss‑of‑services claims live on.

The court followed the familiar Riegel v. Medtronic, Inc. framework:  For PMA‑approved Class III devices, state‑law claims are expressly preempted if they would impose requirements “different from, or in addition to” the federal requirements.  To escape preemption, plaintiffs must plead a “parallel” claim: a traditional state‑law duty that mirrors a federal requirement applicable to the device without imposing anything more or different.  (We realize the parallel terminology is de rigueur, but would not mind if more courts adopt the “mirror and ceiling” framework instead.)

We heartily approve of some themes that run through the opinion:

• It is plaintiffs’ burden to allege a specific deviation from applicable FDA requirements.

• General references to Current Good Manufacturing Practice regulations (or “CGMPs”) do not supply the needed specificity.

• Voluntary recalls, alleged high failure rates, and alleged under‑reporting to FDA also are not, without more, enough either.

As to strict liability manufacturing defect, the plaintiffs did not merely regurgitate the elements in a conclusory way.  They at least added some alleged facts to the mix—that the manufacturing defect resulted from hand-application of a silicone sealant around the implant’s electrode, which allegedly was not subject to proper quality control, as the CGMPs allegedly require and as a voluntary recall and high failure-rate study allegedly established.

While that perhaps would be enough to state an ordinary manufacturing defect claim for a regular product, it was not enough to plead and adequate, non-preempted one for a PMA medical device.  The complaint did not allege any specific  CGMP violation, it wasn’t clear that hand application was a CGMP violation, and asserting “no quality control” is too conclusory to withstand our old friend Twiqbal.

In objecting to the Magistrate Judge’s Report and Recommendation, Plaintiffs did raise a specific alleged CGMP violation for the first time (21 C.F.R. § 820.70(a) regarding process validation and reproducibility), but the District Court refused to consider arguments not presented to the magistrate judge. 

Nevertheless, we will raise another CGMP argument of our own here for the first time in response.  PMA applications “are required to include” descriptions of their compliance with Current Good Manufacturing Practices (“CGMP”) requirements, which are promulgated in the Quality System Regulation (“QSR”), and “approval of a PMA application for a device can be denied if a manufacturer does not conform to the QS regulation requirements.”   See FDA’s Compliance Program Guidance Manual related to Medical Device PMA Preapproval and PMA Postmarket Inspections, at Part I, p. 1-2.

Putting it another way, the FDA reviewed and approved the hand-painted silicone step and the quality control procedures as part of the PMA process.  Therefore, a plaintiff claiming that the quality control process didn’t measure up, or that the manufacturer’s systems did not satisfy 21 C.F.R. § 820.70(a)’s process validation and reproducibility requirements, necessarily is using a state law claim to second-guess the FDA’s grant of premarket approval and inherent determination that the manufacturer’s processes were appropriate.  Preemption should result regardless.

Anyway, next up was the design‑defect claim, and that was quickly dispatched.  State‑law design‑defect claims challenging the safety or efficacy of the PMA‑approved design are categorically preempted because they would impose different design requirements than those the FDA approved.  Even though a plaintiff lacks access to confidential PMA documents at the motion to dismiss phase, those practical difficulties do not excuse plaintiffs from meeting their burden of alleging a specific deviation from PMA requirements. 

The New York implied warranty of merchantability claim went the same way.  Such claims also necessarily second‑guess the FDA’s safety and effectiveness determination by asserting the product was not “merchantable” (i.e., not fit for its ordinary purpose) despite being approved.

Plaintiffs’ New York consumer protection and fraud claims, and part of their failure to warn claim, targeted the device’s labeling, marketing, or promotional materials as deceptive and misleading.  But those materials were FDA‑approved, so these theories were preempted.  (Plaintiffs also failed to identify the allegedly fraudulent statements, which itself is always a problem.)

Weider also addressed a failure to warn claim premised on an alleged failure to report adverse events to the FDA.  The Magistrate Judge, quite correctly, recommended dismissal of this claim because New York law does not recognize a state law duty to report adverse events to FDA. 

The District Court unfortunately disagreed on this point, concluding that New York law might allow this theory in some circumstances.  In particular, because the learned intermediary doctrine requires manufacturers to take “adequate steps” to alert prescribing or implanting physicians to device risks, those steps may include notifying the FDA of adverse events, which the FDA may then disseminate to the universe. 

That allowance did not save plaintiffs’ claim here, however, because these plaintiffs alleged that the FDA received “multitudes of adverse event reports,” undermining the whole “there was a failure to report” idea.  

The claims that made it through were narrower negligence and loss of consortium-type claims that the manufacturer did not attack with preemption. 

The District Court’s order smartly closed the door on further amended complaints, and directed the parties to get to work on a discovery and case management plan for the case as narrowed.