Health Law Daily Wrap Up, MEDICAL DEVICES—S.D.N.Y.: General allegations as to manufacturer’s service, training failures insufficient to evade preemption, (Aug 19, 2025)

By Jeffrey H. Brochin, J.D.

Allegations that the manufacturer failed to service the device and train its staff adequately were insufficient to evade preemption.

A federal district court in New York has granted the motion to dismiss filed by Zoll Medical Corporation in a negligence and strict liability lawsuit filed by the administrator of the estate of a patient whose defibrillator allegedly failed. The manufacturer’s “Zoll Life Vest” (LifeVest), a wearable defibrillator, had pre-market approval (PMA) by the FDA, and by allowing the administrator’s claims—which were rooted in generalized duties derived from state negligence and strict liability law—to proceed would directly regulate the device’s operation and use, thereby conflicting with federal law (Croci v. Zoll Medical Corporation, No. 24-CV-02137-NSR (S.D.N.Y. Aug. 11, 2025)).

Zoll Life Vest device. Physicians prescribe LifeVest to patients who are at risk of sudden cardiac death. It is worn externally and continuously monitors the wearer’s heart rate and rhythm, and it incorporates built-in hardware and software to detect potentially life-threatening fast heart rhythms, specifically, ventricular tachycardia and ventricular fibrillation. If necessary, LifeVest delivers a therapeutic shock to restore normal cardiac rhythm. Since its approval by the FDA in 2001, the LifeVest has been used by thousands of patients worldwide.

On March 16, 2023, the patient received a LifeVest and its accompanying components following a heart attack. Several days later, she contacted the manufacturer’s service line to report that the device was issuing alerts and was instructed to clean the sensors. Approximately two weeks before her death, the patient again contacted the manufacturer service line to report that the device was displaying a red light and emitting sound alerts. Three days later, a representative from the manufacturer visited her home to “purportedly desensitize the device.” On April 8, 2023, the patient suffered a cardiac arrest and passed away. Her estate’s administrator filed suit alleging that the patient’s death was a direct result of the LifeVest’s failure to function as intended. Presently before the court were the manufacturer’s motion to dismiss on two grounds: (1) the claims were preempted by federal law; and (2) the claims did not meet the minimum pleading standards and therefore must be dismissed pursuant to Rule 12(b)(6).

1976 MDA. At issue before the court was whether the express preemption clause contained in the Medical Device Amendments of 1976 (MDA) precluded the administrator’s claims. In enacting the MDA, Congress sought to address the growing complexity of medical devices and the inadequacy of state tort law to regulate their risks. The MDA established a comprehensive federal framework to ensure the safety and effectiveness of medical devices and to ensure uniformity in device regulation. Congress included an express preemption clause for product liability claims against manufacturers of Class III medical devices. The clause provided that “no state may establish or continue in effect with respect to a device intended for human use any requirement—(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or any other matter included in a requirement applicable to the device.”

However, the MDA’s preemption clause is not absolute: the Supreme Court has clarified that §360k(a) protects a medical device manufacturer from liability to the extent that it has complied with federal law, but it does not extend protection from liability where the claim is based on a violation of federal law. Put differently, where state law is parallel to federal law, §360k does not preempt the claim.

Two-step test. Preemption is overcome only when a complaint alleges a state claim that is based on a violation of FDA regulations, and such claims qualify as parallel claims that, when properly pleaded, provide an exception to federal preemption under the MDA. The preemption analysis under the MDA has two steps: first, a court must determine whether the federal government has established requirements applicable to the particular medical device; and, second, if such requirements have been established then the court must determine whether the state-law claims would impose requirements with respect to the device that are “different from, or in addition to” the federal requirements, and relate to either the “safety or effectiveness” of the device. As an initial matter, it was undisputed that LifeVest is a Class III medical device subject to device-specific federal requirements, and that it had received FDA PMA.

Pleading a parallel claim. The court noted that district courts are in nearly complete agreement on the degree of specificity required to plead a parallel claim. Crucially, pleadings must meet the Twombly and Iqbal standard governing the sufficiency of pleadings to avoid preemption, and a party suing with regard to a PMA-approved device cannot simply make the conclusory allegation that a manufacturer’s conduct violated FDA regulations. Furthermore, to successfully plead a parallel claim, the complaint must: identify a state-law duty that is identical to a particular federal requirement; allege a violation of that federal requirement; and present facts plausibly linking that violation to the injuries.

Here, the court found that to the extent that the administrator relied on catch-all theories of negligence and strict liability, those claims failed. They amounted to generalized duties derived from state negligence and strict liability law and allowing them to proceed would directly regulate the device’s operation and use, thereby conflicting with federal law. (General common law duties are expressly preempted as they directly regulate a device.) The allegations were therefore insufficient to evade preemption without a state law duty to support a parallel claim. Specifically, the allegations that the manufacturer failed to service the patient’s LifeVest and train its staff adequately were insufficient to evade preemption.

Based on the foregoing, the court granted the manufacturer’s motion to dismiss, but with leave to amend.

The case is No. 24-CV-02137-NSR.

Judge: Román, N.

Attorneys: George A. Smith (Murphy & Lambiase) for Robert Croci. Jenny A. Covington (Carlton Fields, P.A.) for Zoll Medical Corp.

Companies: Zoll Medical Corp.

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