A man is filing a lawsuit on behalf of his deceased father against LivaNova PLC, manufacturers of the Stockert 3T Heater-Cooler System.

Plaintiff James J. is filing the heart valve replacement infection lawsuit on behalf of his father Kevin J.

According to the heart valve replacement lawsuit, James is a resident and citizen of Syracuse, N.Y. He says that on Nov. 2, 2011, Kevin underwent replacement of his aortic valve, ascending aorta, and a redo Bentall procedure with bioprosthetic valve at St. Joseph’s Health Center.

During the procedure, Kevin’s surgeon allegedly used a Sorin 3T Heater-Cooler System to provide re-warming and cooling to his blood.

However, James says Kevin later became hospitalized at St. Joseph’s Hospital on March 5, 2014 for a mediastinal pseudoaneurysm. That week he also underwent multiple surgical procedures that included a “redo sternotomy, redo Bentall procedure, and reimplantation of right and left coronary ostium,” the lawsuit maintains.

During his admittance, a large aortic root abscess with pus was found. Upon analysis of a culture that was taken from the abscess, James says Kevin’s infection was diagnosed as Mycobacterium avium-intracellulare complex.

In October 2015, after being transferred to St. Joseph’s Hospital emergency department due to septic shock, Kevin passed away following final diagnoses that included but was not limited to “infection and inflammatory reaction due to cardiac valve prosthesis, other mycobacterial infections, sepsis unspecified organism (Primary) and severe sepsis with septic shock,” the lawsuit states.

The lawsuit was filed on multiple counts including negligence, strict products liability, failure to warn, breach of implied warranty, violation of New York’s general business law, wrongful death and survival action.

Overview: Heart Valve Replacement Infection Lawsuit

Thousands have filed lawsuits against LivaNova PLC, manufacturers of the Stockert 3T Heater-Cooler System.

The company is being held liable for failing to warn of the dangers and side effects associated with using the Stockert 3T device; of manufacturing an allegedly defective device; of failing to avoid causing patients unreasonable harm; and of breaching other duties held by medical device manufacturers.

Allegations against the company state that the device causes patients, like Kevin, to contract a subspecies mycobacteria (NTM) known as M. Chimaera and M. Abscessus.

Although these subspecies are relatively harmless and rarely cause illness in the outside environment, patients under hospital care faced unique risks especially when undergoing invasive and critical surgical procedures.

The Stockert 3T Heater-Cooler device stores water in a tank that can be regulated to re-warm or cool a patient’s body down as needed. However, researchers believe bacteria inside the system can be ejected through its exhaust vent and into the operating room, possibly causing patient infection.

Patients who have contracted an illness or NTM infection following Stockert 3T heater-cooler use may be eligible to file infection lawsuits against LivaNova PLC. Filing a lawsuit can help a patient recover damages for permanent impairment, mental anguish, permanent scarring, medical expenses and pain and suffering.

The Heart Valve Replacement Infection Lawsuit is Case No. 5:18-cv-00556-GTS-ATB, in the U.S. District Court for the Northern District of New York.