A South Carolina couple recently filed a lawsuit against LivaNova, alleging that the company’s cardiac heater-cooler system caused an open heart surgery infection in one of the plaintiffs.

The couple, Ennis and Vickie B., filed this lawsuit after Ennis underwent a coronary artery bypass graft in March 2014 that used the Sorin 3T System, a kind of cardiac heater-cooler.

Later, the lawsuit alleges, Ennis developed an open heart surgery infection. According to the lawsuit, Ennis was exposed to nontuberculosis mycobacteria.

As a result, the plaintiff began experiencing chest pain in April, and went to the emergency room on both April 2 and April 9, 2014, though he was not admitted.

The plaintiff returned to the ER on April 14 complaining of both chest pain problems and skin redness around the site of the incision.

Finally, after chest pain continued and the cellulitis surrounding the incision worsened, Ennis was admitted in May 2014.

He underwent multiple procedures, including irrigation, sternal debridements, and a wound flap procedure. At the time, physicians were not aware of the cause of his infection.

Ennis and Vickie’s open heart surgery infection lawsuit was filed on multiple counts including negligence, strict products liability, breach of express and implied warranties, and misrepresentation by omission.

Device Linked to Open Heart Surgery Infection

Cardiac heater-cooler devices are intended to supply temperature-controlled water to heating devices such as heat exchangers and thermal regulating blankets, which are used to control a patient’s temperature during a cardio-pulmonary bypass procedure.

The Sorin 3T System, manufactured by LivaNova PLC, is a device used during heart surgeries to warm and cool a patient’s blood and organs as necessary. However, the CDC warns that during the manufacturing process, each Sorin 3T System device may have been contaminated with a species of nontuberculous mycobacterium (NTM).

An NTM infection is a serious pulmonary illness that, even with antibiotic treatment, can take over a year to subside. It carries specific symptoms, including night sweats, aching muscles, joint pain, weight loss, fatigue, and fever.

Symptoms can take months to surface after initial infection, which often means that patients have no idea what caused the problem in the first place. This can lead to missed or delayed diagnosis for up to several years.

Both the CDC and the U.S. Food and Drug Administration have published alerts about the Sorin 3T System device and others like it.

The U.S. Food and Drug Administration (FDA) released a warning letter to LivaNova in December 2015, indicating that inspection of certain facilities had shown Sorin 3T systems could become contaminated or damaged.

Cardiac Heater-Cooler Lawsuits

A class action lawsuit against LivaNova over infection from cardiac heater-cooler devices was filed in February 2016 in Pennsylvania. The patients involved in the LivaNova class action lawsuit had undergone open heart surgeries in 2015.

If you or someone you love has suffered from an open heart surgery infection after undergoing heart surgery with the use of a Sorin 3T System or similar device, you may be able to file a Sorin lawsuit or join a Sorin class action lawsuit.

The Cardiac Heater-Cooler Open Heart Surgery Infection Lawsuit is Case No. 6:16-cv-02308 in the U.S. District Court for the District of South Carolina, Greenville Division.