A recent preemption decision out of the Southern District of New York offers encouraging news for medical device manufacturers. In Wieder v. Advanced Bionics LLC, 2025 WL 3237257 (S.D.N.Y. Nov. 20, 2025), the magistrate judge has recommended that most of the state law claims asserted against a cochlear implant manufacturer be dismissed as preempted by federal law under the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act (FDCA). While this is not a final decision yet, should the report and recommendation be adopted, it will be a welcome decision for device manufacturers because it reaffirms that state law claims challenging the safety or effectiveness of a pre-market approved (PMA) medical device are broadly preempted.
Weider involved allegations against the manufacturer of a Class III PMA cochlear implant. The plaintiffs alleged the device, which was implanted in their young child, was defectively manufactured and designed, citing issues with a silicone seal and alleging the manufacturer knew of a design flaw that was revealed by a company-backed clinical study. The manufacturer moved to dismiss the case in its entirety, arguing that federal preemption barred the claims or, alternatively, that the claims were inadequately pleaded.
Addressing preemption, the court reaffirmed that PMA devices are subject to “rigorous” federal oversight and that state-law claims imposing requirements “different from or in addition to” federal obligations are preempted. Weider, 2025 WL 3237257 at *4 (citing Riegel v. Medtronic, 552 U.S. 312, 317-18 (2008)). The court also noted that to avoid preemption, claims must be based on conduct that violates the FDCA, but plaintiffs must not be suing solely because the conduct violates the FDCA. Weider, 2025 WL 3237257 at *5. This leaves what has been described as a “narrow gap” for pleading a viable state law claim.
The court dismissed the bulk of the claims on preemption grounds because they were found to impose requirements that would differ from or add to federal requirements for the PMA device. The court emphasized that to escape preemption, a plaintiff must plead a “parallel” state law claim based on violation of an actual federal requirement applicable to the device. Weider, 2025 WL 3237257 at *4. Here, the plaintiffs struggled to do so.
In dismissing the manufacturing defect claims, the court rejected as conclusory the plaintiffs’ allegations that the defendant violated current good manufacturing practices (CGMP) and that the manual application of the silicone seal is not subject to a quality control process, because the naked allegations did not provide any factual explanation or detail about how the manufacturing process violated federal requirements. The court also held that the plaintiffs’ citation to a voluntary recall notice was insufficient to avoid preemption.
The court likewise dismissed the design defect claim as a squarely preempted claim challenging the device’s PMA. To the extent the plaintiffs alleged the device deviated from the approved design, those allegations were conclusory and sounded in manufacturing defect rather than design. Without the manufacturing and design defect claims, the plaintiffs’ implied warranty claims also failed to state a claim.
The court also dismissed the plaintiffs’ negligent failure to warn claim on preemption grounds. In so doing, the court rejected the approach taken in some other New York cases which permitted failure to warn claims to proceed on the theory that the manufacturer’s state law duty to warn the medical community could encompass the duty to warn the FDA. The court dismissed allegations that the manufacturer failed to warn “the [plaintiffs], the medical community at large, and the general public” of the device’s dangers, finding that to the extent they challenged the adequacy of the FDA-approved labeling and instructions, the claim was expressly preempted. Contrary to the plaintiffs’ assertion, the court found there is no duty to warn the medical community under New York law that parallels federal reporting requirements. Further, under New York’s learned intermediary doctrine, a device manufacturer’s duty runs only to the treating physician, not to the FDA. The court also noted that even if there was a parallel duty to report, the plaintiffs’ allegations here were too conclusory and internally inconsistent to support it.
The court also dismissed plaintiffs’ fraud and consumer protection claims under the New York General Business Law, emphasizing that statements consistent with FDA-approved labeling or marketing are protected and preempted in the absence of allegations that the manufacturer made representations beyond those the FDA approved.
The only claims that survived the motion to dismiss were claims for negligent undertaking and loss of services, which the defendant did not argue were preempted. The court found that the plaintiffs stated a plausible claim by alleging that a company representative assumed and breached a duty to the plaintiffs by testing the device and concluding, incorrectly in the face of other evidence to the contrary, that the device was working properly and did not need to be explanted.
All in all, the Weider decision underscores the difficult hurdles plaintiffs face in trying to plead a viable parallel claim against PMA devices and illustrates the value of an early, aggressive motion to dismiss on preemption grounds.
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