Croci v. Zoll Medical Corporation

Background

Robert Croci, acting as administrator of the estate of Joann C. Croci, sued Zoll Medical Corporation and Zoll Services LLC under New York law. The complaint asserted negligence, strict products liability, breach of express and implied warranties, and pecuniary losses to the estate.

The claims arose from Joann Croci’s use of a Zoll LifeVest, a wearable defibrillator. She received the device after a heart attack. The complaint alleged that she contacted the defendants about alerts, a red light, and sound warnings from the device. A defendants’ representative later visited her home. On April 8, 2023, she suffered cardiac arrest and died. The complaint alleged that the LifeVest failed to detect dangerous heart rhythms or automatically deliver a treatment shock.

The defendants moved to dismiss the entire complaint under Federal Rule of Civil Procedure 12(b)(6), which permits dismissal when a complaint does not state a legally sufficient claim. They argued that federal law preempted the claims and that the complaint failed to satisfy the requirement that its factual allegations make liability plausible.

Federal Preemption Framework

The court applied the Medical Device Amendments’ express-preemption provision, 21 U.S.C. § 360k(a), and the two-part framework from Riegel v. Medtronic, Inc. First, the device must be subject to device-specific federal requirements through the Food and Drug Administration’s premarket-approval process. The court found that this requirement was met because the LifeVest was a Class III medical device that had received premarket approval.

Second, the court considered whether the New York claims would impose safety or effectiveness requirements different from or additional to the federal requirements. A state-law claim may proceed as a parallel claim if it relies on a state-law duty identical to a specific federal requirement, alleges a violation of that federal requirement, and provides facts plausibly linking the violation to the injury. A claim based only on an alleged violation of federal law is also barred because private parties may not use state claims to enforce the Federal Food, Drug, and Cosmetic Act directly.

Negligence and Strict Products Liability

The court held that the complaint’s general negligence and strict-liability theories were preempted. The allegations challenged the LifeVest’s design, testing, inspection, distribution, labeling, servicing, and staff training, but did not identify an identical state-law duty and a specific federal violation supporting a parallel claim.

The design-defect claims were expressly preempted because the complaint alleged that the FDA-approved design itself was unreasonably dangerous or defective. The court reasoned that such a claim would ask a jury to impose a different or additional safety standard than the one approved by the FDA.

The manufacturing-defect claims also failed. Although a manufacturing-defect theory could potentially parallel a federal requirement, the complaint only alleged, in general terms, that the defendants failed to assemble the device properly. The court found that this conclusory allegation did not provide enough detail to plausibly show that the particular LifeVest was defective because of a manufacturing mishap, improper workmanship, or defective materials, or that the defect caused the injury.

The failure-to-warn claim was preempted because the complaint did not identify a specific federal warning or labeling requirement that the defendants violated, and it did not allege that the defendants departed from federal standards. The court concluded that a claim asserting that FDA-approved warnings were inadequate would impose additional state-law warning obligations.

Warranty Claims

The implied-warranty claim was expressly preempted because determining that the FDA-approved LifeVest was not reasonably fit for its intended purpose would conflict with the FDA’s safety and effectiveness determination.

The express-warranty claim also failed. The court explained that such a claim could avoid preemption only if it were based on specific voluntary representations by the manufacturer that went beyond what the FDA approved. The complaint did not identify any such representations.

Pecuniary-Loss Claim

The complaint’s fourth claim sought pecuniary losses to the estate. The court found that Croci abandoned this claim by failing to respond to the defendants’ arguments for dismissal.

Disposition

Judge Nelson S. Roman granted the defendants’ motion to dismiss under Rule 12(b)(6). The court dismissed the claims without prejudice and granted Croci leave to file an amended complaint by September 15, 2025. The court stated that the amended complaint would replace, rather than supplement, the original complaint. If Croci did not file an amended complaint by the deadline, claims dismissed without prejudice would be deemed dismissed with prejudice. The defendants were directed to answer or otherwise respond by October 15, 2025, if an amended complaint was filed.