A nontuberculous mycobacteria lawsuit has been filed alleging that a Sorin cardiac heater cooler caused a life-threatening infection due to contamination.

Plaintiff Vivian S. and her husband Albert S. recently filed a nontuberculous mycobacteria lawsuit against LivaNova Deutschland GMBH, and Sorin Group USA Inc, claiming that the manufacturers’ cardiac heater cooler was contaminated, causing a serious infection.

The couple claims that in January 2014, Vivian underwent open heart surgery. After her surgery, her sternal would allegedly failed to heal properly due to infection and has since opened numerous times.

In July 2016, Vivian had another surgery where the sternal wires were removed and cultures were taken. The samples allegedly showed that Vivian had acquired a nontuberculous mycobacteria infection from which she has still not recovered. Vivian claims that this infection was a result of a Sorin 3T heater cooler device, which has a known risk of contamination.

“As a direct and legal result of the wanton, reckless, tortious and/or negligent conduct of defendants, jointly and severally, [Vivian] experienced multiple injuries and damages,” the nontuberculous mycobacteria lawsuit states. “These injuries have left her disabled, unable to care for herself and have caused substantial pain, suffering, and loss of life’s pleasures.”

Nontuberculous mycobacteria are naturally occurring organisms that are often found in water and soil. They typically pose little threat to human health in their natural form and rarely cause infections. However, when aerosolized through a cardiac heater cooler during surgery, these bacteria can reportedly come into contact with sensitive exposed organs. This exposure can cause a serious postoperative infection that can be life-threatening.

According to the American Lung Association, a nontuberculous mycobacteria infection can be asymptomatic, but common symptoms include a persistent cough, hemoptysis, fatigue, low-grade fever, night sweats, and weight loss.

According to the nontuberculous mycobacteria lawsuit, Sorin knew of the potential mycobacteria contamination as early as 2011. In early 2014, the company allegedly sent out an alert to hospitals that there was a potential risk of a nontuberculous mycobacterium infection when using the Sorin 3T cardiac heater cooler.

In August 2014, Sorin allegedly discovered that the water supply at its manufacturing facility was contaminated with mycobacterium. However, this was reportedly not communicated to the health community and the public until June 2016 when the U.S. Food and Drug Administration released a safety alert.

Vivian argues that Sorin should have communicated the risks to physicians and patients. The nontuberculous mycobacteria lawsuit claims that Sorin had a duty to inform consumers and medical professionals of the infection risk as soon as they knew about it.

“The Sorin defendants knew or should have known, based on their own information, investigation, and/or testing, and based on an outbreak of cases in Europe reported in medical literature as early as 2011, of the association of [nontuberculous mycobacteria] infections with the use of their Sorin [cardiac heater cooler] when used in heart surgery,” the nontuberculous mycobacteria lawsuit states.

Vivian and her husband Albert accuse the defendants of strict products liability – design defect, strict products liability – manufacturing defect, strict products liability – failure to warn, negligence, and loss of consortium. The nontuberculous mycobacteria lawsuit seeks general damages, medical expenses, incidental expenses, punitive damages, court costs, and attorneys’ fees.

The Nontuberculous Mycobacteria Lawsuit is Case No. 8:18-cv-00951-JLS-JDE in the United States District Court for the Central District of California.