Plaintiff Richard D. has filed an NTM infection lawsuit in New York federal court against LivaNova Deutschland Gmbh, the manufacturers of a cardiac heater-cooler system .

The defendant LivaNova Deutschland Gmbh also does business as Sorin Group Deutschland Gmbh and Sorin Group USA Inc. Richard is a resident and citizen of Queens County in New York state.

He alleges, according to the NTM infection lawsuit, that he was hospitalized at New York University Langone Medical Center in New York, N.Y. on Jan. 22, 2016. At the time he was 57 years old.

He was admitted to address the failure of his left ventricular assist device. Once hospitalized, he underwent replacement surgery for his LVAD.

Throughout the treatment, the Sorin 3T System was used in order to provide temperature regulation for the plaintiff’s body.

He was later readmitted to the hospital in January 2017 for treatment of gastrointestinal bleeding. There, he received antibiotics for the diagnosis of a bacterial infection. Laboratory cultures, according to the NTM infection lawsuit, showed that he was tested positive for the acid-fast bacilli (AFB) test, which indicated the presence of an NTM infection.

Richard files the following counts against the defendant: 1) Negligence; 2) Strict Products Liability; 3) Failure to Warn; 4) Breach of Implied Warranty; and 5) Violation of New York’s General Business Law.

Sorin 3T Heather-Cooler System Facts

According to the NTM infection lawsuit, throughout the plaintiff’s surgery the Sorin 3T Heater-Cooler System was used. This device was designed and manufactured by LivaNova.

The Sorin 3T System provides temperature controlled water that warms or cools a patient’s blood during surgery. The heater cooler unit works by storing water in a tank, which can, therefore, decrease or increase a patient’s body temperature.

The water doesn’t come into contact with the patient during surgery. However, if the interior of the unit is not properly cleaned, it can therefore become contaminated with bacteria that can be driven out of the unit through its exhaust vent. The bacteria can then reach the patient and allow the development of a bacterial infection.

Nontuberculous mycobacteria occurs naturally in the environment, and it doesn’t present much threat of infection in healthy persons. However, the contamination of the heater-cooler unit, for an insufficient lack of sterilization and cleanliness will put a surgical patient at risk for the development of an NTM infection.

While a patient is undergoing open heart surgery, this puts the patient’s organs and chest cavities at risk for the development of such an infection from the heater-cooler units.

U.S. Food and Drug Administration Warnings of Heater-Cooler Units

According to the FDA, the heater-cooler unit system that is used throughout cardiothoracic and other surgical or medical procedures assist in maintaining a patients blood temperature and helps to improve patient outcomes.

However, the federal agency does contend that, “through the FDA’s analysis of adverse event reports, the medical literature, and information from national and international public health agencies, we are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.”

The NTM Infection Lawsuit is Case No. 1:17-cv-06026-DLI-RLM, in the U.S. District Court for the Eastern District of New York.