Medtronic Heart Pump Lawsuit Alleges HVAD Malfunctions Required Multiple Surgeries, Transplant

Device suffered repeated failures, leading to fainting, low blood-oxygen levels and eventually needing to be removed.

A Virginia man has filed a lawsuit claiming that systemic and repeated failures of a Medtronic heart pump caused severe complications, hospitalization and the need for additional surgeries, resulting in permanent injuries.

The complaint (PDF) was originally brought by Chad Clark in Florida state court on September 23, naming Medtronic Inc. and HeartWare Inc. as the defendants. It was removed to the U.S. District Court for the Southern District of Florida on October 28.

Clark indicates his Medtronic HeartWare Ventricular Assist Device (HVAD) failed repeatedly, causing fainting spells, thrombosis and the need for revision surgery. He alleges that the HVAD was defectively designed, highlighting numerous problems with the devices, including how his own HVAD was subject to a medical device recall and eventual removal from the market.

HeartWare Heart Pump Problems

The Medtronic HVAD system was approved in 2012 for the purpose of helping pump blood from the heart to the rest of the body while patients suffering from heart failure wait to have a heart transplant. The pump itself is implanted next to the heart, and an external controller regulates its speed and function.

Over the years, more than 3,000 patient deaths have been linked to HeartWare problems. Since they were first approved by the U.S. Food and Drug Administration (FDA), Medtronic has issued 17 Class I HVAD recalls. The Class I designation is the most serious label the agency can give a recall, meaning problems with the product carry a high risk of serious injury or death.

The HVAD has been linked to more Class I recalls than any other high-risk medical device, and an August 2021 ProPublica investigation revealed that FDA inspectors had been raising concerns about the devices since January 2014, following a HeartWare recall in late December 2013, over pump failures and patient deaths.

Finally, in June 2021, 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.

HVAD Implant Malfunction Allegations

According to the complaint, Clark was implanted with a Medtronic HVAD system in November 2013, which he used until March 2022. He notes that throughout that time, his heart pump suffered multiple failures and problems.

The lawsuit indicates that Clark was hospitalized for complications due to the failure of the HVAD implant in March 2022. It states that he underwent multiple medical procedures after experiencing fainting episodes and severely reduced levels of oxygen-rich blood.

Doctors determined that the HVAD had failed, and Clark was hospitalized from June 7, 2022, to July 25, 2022. During that time, he underwent several additional surgeries, including removal of the failed HVAD system.

“HVAD malfunction caused and/or contributed to cause significant decrease in Mr. Clark’s ability to carry on normal daily activities of life, impaired his ability to thrive as a normal adult, prevented his ability to perform normal work functions, impaired his ability to live a life free from significant pain and suffering.”

– Chad Clark v. Medtronic Inc. et al.

The lawsuit presents claims of strict liability, negligence, negligent failure to warn, negligence per se and breach of implied warranty. It seeks both compensatory and punitive damages.

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