Medtronic Seeks to Dismiss HeartWare HVAD Lawsuit Over Heart Pump Malfunction

Manufacturer argues the lawsuit is preempted by federal law because the Class III heart pump was FDA approved, and not subject to failure to warn claims.

Medtronic is trying to convince a federal judge to throw out a HeartWare HVAD lawsuit, arguing that the case makes few concrete claims or ever identifies a problem with the device.

The complaint (PDF) was originally filed by Richard Ferguson on March 24 in Florida Circuit Court, naming Medtronic Inc. and HeartWare Inc. as the defendants. It was then subsequently removed to the U.S. District Court for the Southern District of Florida on July 31.

Ferguson claims he suffered severe injuries when a Medtronic HeartWare Ventricular Assist Device (HVAD) malfunctioned after being implanted to help pump blood through his body.

Medtronic HVAD Problems

First introduced in 2012, Medtronic’s HVAD system is designed to help pump blood from the heart to the rest of the body for heart failure patients awaiting a heart transplant. The system involves a pump implanted next to the heart and a controller that regulates the pump’s speed and function.

Since the first HVAD systems were approved, the devices have been subject to at least 17 Class I recalls involving defective components, as well as multiple Medtronic HVAD lawsuits.

In June 2021, after reports of more than 3,000 patient deaths and concerns about neurological events and increased mortality, the FDA announced that Medtronic was removing its HVAD systems from the market. However, the agency did not recommend removing the devices from patients who already had them implanted if no problems were detected.

HeartWare Malfunction Allegations

According to his lawsuit, Ferguson was implanted with a Medtronic HVAD in January 2020, and continued using the device until 2026. During that time, he allegedly experienced multiple complications that required several additional medical procedures.

The lawsuit notes that Ferguson experienced post-implant complications that included recurrent fainting and collapsing, blood clots and other problems.

“The device went off at least 11 times without cause, before the end of 2022. Additionally, he had repeated need for invasive evaluation/intervention (multiple right heart caths, thrombolysis). As well, he had chronic anticoagulation management issues and documented LVAD alarms and ER visits with an ongoing dependence on device with progressive complications.”

– Richard Ferguson v. Medtronic Inc. et al.

Ferguson raises allegations of strict liability, negligence, negligent failure to warn, negligence per se and breach of implied warranties of merchantability.

Medtronic Seeks HVAD Lawsuit Dismissal

On August 7, Medtronic and HeartWare filed a motion to dismiss (PDF), asking the court to throw out Ferguson’s lawsuit on several grounds, including arguments that the claims are preempted by federal law.

The preemption defense essentially grants manufacturers immunity from liability in certain situations when the FDA already reviewed and approved a medical device, arguing that state-based failure to warn lawsuits cannot impose different or additional safety requirements. Medtronic and HeartWare therefore claim Ferguson cannot pursue claims that would effectively require the companies to provide warnings beyond those approved by the FDA.

The defendants also argue that Ferguson filed a “shotgun” pleading, meaning the complaint combines allegations and legal claims in a way that allegedly makes it difficult to determine which facts support each cause of action. According to the motion, Ferguson also fails to identify a specific defect in the HVAD that caused his complications and does not provide sufficient factual support for his request for punitive damages.

Medtronic and HeartWare have requested a formal hearing on the motion, which has not yet been scheduled.

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