Zoll Life Vest Lawsuit: Rulings, FDA Recall, and Preemption Split

Lawsuits against Zoll Medical over the LifeVest wearable defibrillator have been filed by families of patients who died while wearing the device, generally alleging that it failed to deliver a life-saving shock during cardiac arrest. Federal courts have split on Zoll’s central defense — that federal law bars state product liability claims over the FDA-approved device — and no reported LifeVest lawsuit has produced a jury verdict or publicly disclosed settlement.¹

What Plaintiffs Are Alleging

The lawsuits share a pattern. A patient wearing the LifeVest suffers a cardiac event. The device either fails to shock at all or shocks inappropriately, and the patient dies. Family members then sue Zoll, typically bringing claims for strict product liability, negligence, breach of warranty, fraudulent or negligent misrepresentation, and wrongful death.

Plaintiffs generally do not attack the LifeVest’s approved design. Instead, they argue Zoll broke its own federally mandated manufacturing standards, and they point to a 2014 FDA warning letter and a 2017 recall as evidence that manufacturing problems were real. Some suits also target statements Zoll representatives allegedly made about the device’s reliability, including claims of a success rate above 98 percent.²

The Godelia Case: The Leading Ruling

The most consequential LifeVest lawsuit arose from the death of Debra Godelia in Florida. On November 18, 2013, Godelia had a cardiac event while wearing the device. The alarm sounded, but no shock was delivered. Her son performed CPR. She died two days later.²

Her husband and son sued, alleging defective soldering caused a cable connecting the rear therapy electrode to the circuit board to separate.³ They brought eight claims covering product liability, negligence, three flavors of fraud, breach of express warranty, negligent misrepresentation, and negligent infliction of emotional distress.

Zoll won an initial dismissal on federal preemption. Because the LifeVest is a Class III device that went through the FDA’s premarket approval process, Zoll argued that state tort claims impose safety requirements “different from, or in addition to” the federal ones, and are therefore blocked under the Medical Device Amendments and the Supreme Court’s decision in Riegel v. Medtronic.⁴

On February 8, 2018, the U.S. Court of Appeals for the Eleventh Circuit largely reversed. Writing for the panel, Judge Beverly B. Martin held that six of the seven remaining claims survived preemption because the plaintiffs were not asking for new safety standards; they were alleging Zoll violated existing federal manufacturing regulations, and those violations also breached Florida common-law duties. The court relied on its earlier decision in Mink v. Smith & Nephew to allow these “parallel” claims to proceed.²

The Eleventh Circuit also ruled that Zoll’s voluntary statements about the device’s success rate could support the misrepresentation and warranty claims, because those promises were the company’s own, not something the state was requiring. Only the negligent infliction of emotional distress claim stayed dismissed.

Back in the trial court, Judge Darrin Gayles denied a renewed motion to dismiss, finding jury questions on whether the cable detached during the cardiac event and whether Zoll’s instructions to bystanders to stay away during an alarm prevented Godelia’s family from performing CPR that might have saved her.³

The Smith Case in Tennessee

Doris Smith sued Zoll in the Western District of Tennessee after her husband Alex Smith died. She alleged the LifeVest failed to shock during an arrhythmia because the battery was disconnected and an alarm failed to sound.⁵

In December 2020, Chief Judge S. Thomas Anderson denied Zoll’s preemption motion, reasoning that Smith was accusing Zoll of failing to follow its own FDA-approved manufacturing requirements, not challenging the approved design.⁶

Smith was representing herself. On December 3, 2021, the court granted Zoll summary judgment because she had no expert witness to establish the device was unreasonably dangerous, an evidentiary requirement in product liability cases.⁵ The case ended on evidence, not on preemption.

The Croci Case: New York Goes the Other Way

In February 2024, the estate of Joann C. Croci sued in New York state court, bringing negligence, strict product liability, breach of warranty, and wrongful death claims. Zoll removed the case to the U.S. District Court for the Southern District of New York, and Judge Nelson Román rejected the plaintiff’s remand attempt in October 2024.⁷

In August 2025, the court dismissed the case, ruling the claims were preempted by federal law.¹ That result put the Southern District of New York on the opposite side of the preemption question from the Eleventh Circuit and the Western District of Tennessee.

The FDA Warning Letter and the Recall

Two regulatory events sit behind most of the lawsuits.

The first is a September 23, 2014 FDA warning letter. After inspecting Zoll’s manufacturing facilities in May and June 2014, the FDA cited failures to document corrective and preventive actions, failures to investigate complaints, inadequate design-validation procedures, and failures to report deaths and serious injuries within the required 30 days. The letter also flagged inappropriate shocks attributed to noise or vibration and declared devices produced at the facilities “adulterated” under federal law.²⁸

The second is the 2017–2018 recall. In September 2017, Zoll initiated a Class 2 recall of the LifeVest Model 4000 because a defect could prevent the device from charging its high-energy capacitors, leaving it unable to shock. Affected units displayed “Message Code 102,” but the FDA found that alert did not tell patients the device was non-functional.⁹ The FDA issued a safety communication in January 2018 disclosing one patient death after the device failed to shock following the error code.¹⁰

The recall covered 33,670 units distributed globally, with about 0.1 percent showing the error code. Zoll committed to replacing affected devices within 24 hours and issued a software update in January 2019 to make the error alert more prominent. The FDA formally terminated the recall on August 10, 2021.¹¹

Adverse event reports have continued. Individual MAUDE reports as recent as 2025 document skin reactions, inappropriate shocks, and deaths where the device’s signal interpretation was questioned. In an October 2024 report, a patient died after receiving three inappropriate shocks; the manufacturer stated its device data did not indicate a malfunction and attributed the false detections to motion artifact and electrode issues.¹²

Why the Preemption Split Matters

Preemption is the fight that decides most of these cases before they ever reach a jury. Zoll’s argument is the same each time: the LifeVest cleared FDA premarket approval, so state tort claims are blocked.

The Eleventh Circuit’s Godelia decision and the Tennessee ruling in Smith read the “parallel claim” exception broadly. If a plaintiff frames the case as Zoll violating federal manufacturing rules, and if those violations also breach state duties, the case can go forward. The Southern District of New York’s Croci ruling reads the exception more narrowly and dismissed on preemption grounds. Which side a court takes will often decide whether a family gets past a motion to dismiss.¹

Even when a case survives preemption, plaintiffs face the ordinary evidentiary burdens of product liability litigation. The Smith case shows what happens without an expert witness: Zoll won summary judgment despite the preemption ruling going against it.⁵

The Separate Data Breach Class Action

Not every lawsuit against Zoll involves the device itself. In January 2023, an unauthorized party accessed Zoll’s internal network and exposed personal information — names, addresses, dates of birth, and Social Security numbers — of more than one million people, including LifeVest users and employees. It was the company’s second breach in four years.¹³

Class actions filed in the U.S. District Court for the District of Massachusetts allege Zoll failed to encrypt sensitive data, train employees, and notify affected people in time.¹⁴ In April 2025, Judge Indira Talwani partially dismissed the consolidated case but let negligence and unjust enrichment claims proceed.¹⁵ This litigation is distinct from the product liability suits and does not involve claims about how the device performed.

1
Mealey’s Litigation Report. N.Y. Federal Judge Finds Claims in Defective Heart Device Case Are Preempted
2
FindLaw. Godelia v. Zoll Services, LLC
3
MassDevice. Zoll Loses Bid to Dismiss LifeVest Lawsuit
4
New York University Law Review. Federal Preemption and Medical Device Litigation
5
Bloomberg Law. Zoll Medical Exits Widow’s Defibrillator Vest Death Lawsuit
6
HarrisMartin. Zoll Loses Bid to Dismiss Defibrillator Vest Lawsuit on Preemption Grounds
7
Justia. Croci v. Zoll Medical Corporation
8
Asahi Kasei. Notice Regarding an FDA Warning Letter
9
DAIC. FDA Issues Safety Communication on Zoll LifeVest 4000 Wearable Cardioverter Defibrillator
10
TCTMD. FDA Warns Certain Zoll LifeVests Might Fail to Deliver Shocks
11
FDA. Recall Z-0353-2018 – LifeVest Wearable Defibrillator Model 4000
12
FDA MAUDE. MDR Report 20612273
13
Milberg. Zoll Data Breach Lawsuit
14
Bloomberg Law. Zoll Medical Hit With Suit Over Data Breach Affecting One Million
15
Law360. Zoll Gets Parts of Data Breach Class Action Tossed