The case was filed by Dennis Godelia, remaining son of deceased Debra Godelia, who died in 2013 after the LifeVest allegedly did not function correctly during a “defibrillation event,” court documents report.
Mr. Godelia claims that the LifeVest made an audible alarm, but did not shock Ms. Godelia, who lost consciousness and died two days later. He proceeded to file a complaint in Florida state court relating to the malfunction, according to court documents.
Zoll, after moving the case to federal court, moved to dismiss the case arguing that claims in the case were pre-empted by the Medical Device Amendments identified in an FDA warning letter the company received.
The District Court eventually granted a request from Zoll to dismiss in full, saying that “claims of defects in the LifeVest would be at odds with the FDA’s determination that LifeVests were safe, and that Mr. Godelia “failed to allege a parallel claim, as is required in order to avoid preemption,” according to court documents.
The three judges on the panel in the case disagreed, saying that the plaintiff’s claims were not preempted simply because he alleged the defect was due to compliance issues, and reversed all claims but the negligent infliction of emotional distress.
The US Court of Appeals for the Eleventh Circuit affirmed a lower courts dismissal of plaintiff’s “negligent infliction of emotional distress claims” but reversed the dismissal of the remaining six claims.
Reversed claims include strict product liability, negligence, fraudulent misrepresentation, fraudulent marketing and promotion, breach of express warranty and negligent misrepresentation, which Judges said the lower court unnecessarily dismissed as being preempted by federal law, according to court documents.
Last month, Zoll Medical and the FDA began warning about an error code displayed by a model of its LifeVest wearable automatic external defibrillator that was involved in a patient’s death.