A man has filed an NTM infection lawsuit, claiming that the Sorin 3T Heater-Cooler System caused his wife to develop a nontuberculous mycobacteria infection that led to her death.

Plaintiff Gary G. files the NTM infection lawsuit as the anticipated personal representative of the estate of Lois G. The lawsuit was filed on July 31, 2018 demanding jury trial.

According to the NTM infection lawsuit, Gary is a resident of the state of Florida, as was his late wife Lois. Gary is the surviving spouse of Lois who died from alleged complications and injuries in 2016.

According to the NTM infection lawsuit, on July 22, 2015, Lois was admitted for a right lung transplant at Tampa General Hospital. During the procedure, Gary says, the Stockert 3T Heater-Cooler System was used.

On June 22, 2016, Lois was allegedly admitted to Sarasota Memorial Hospital due to feelings of fatigue and being under the weather. She was later transferred to Tampa General after being found to have pulmonary infiltrates of her transplanted lung, according to the NTM infection lawsuit.

During her visit, a respiratory culture was taken for an Acid Fast Bactilli test, the NTM infection lawsuit states. The test allegedly resulted in a positive result for a mycobacterium. Gary says Lois later died from an NTM infection in 2016 at Tampa General Hospital.

The mycobacterium was later identified as M. abscessus and occurred as a “direct and proximate result of Defendants’ negligence and liability.” Gary alleges the acquired infection caused her to undergo medical procedures and treatment through which she suffered from “excruciating and agonizing physical and emotional pain and suffering.”

Gary alleges that due to his wife’s death, he was “deprived of the care, comfort, companionship, services and consortium of his wife…”

The NTM infection lawsuit was filed on multiple counts including negligence, manufacturing defect, warning defects, negligent misrepresentation, and loss of spousal consortium.

Overview: Filing an NTM Infection Lawsuit

A large number of lawsuits have been filed against LivaNova PLC over bacterial infections patients have contracted after their use of the Sorin 3T Heater-Cooler System, also known as the Stockert 3T.

The Stockert 3T device is used to regulate and maintain a patient’s body temperature. It works to keep a patient safe and ensures the proper circulation of blood to vital organs. The device works by and regulates blood temperature by circulating water through tubes into a heat exchanger. The stored water in a tank  can either be heated up or cooled down thus heating a patient’s body as required. However, the tank can become contaminated, especially if it is not cleaned out properly.

“The water tanks and other areas where water pass through aerosolize a vapor containing NTM which exits out of the device and is pushed into the ambient air of the operating room through the System’s exhaust fan,” the NTM infection lawsuit explains. “If placed in the operating room, contaminated vapor from the 3T direct enters the sterile surgical field and the patient’s open body.”

The risk for bacterial infection has become a grave concern. If the inside of the Stockert 3T becomes contaminated, bacteria can then aerosolize into the air of the operating room, potentially causing patient infection.

A Safety Communication was issued by the U.S. Food and Drug Administration (FDA) to healthcare providers informing them of the risks for patient infections linked to the Stockert 3T system on June 1, 2016.

The NTM Infection Lawsuit is Case No. 8:18-cv-01880-EAK-SPF, in the U.S. District Court for the Middle District of Florida.