New Heater-Cooler Class Action Filed in South Carolina

A new class action lawsuit was filed against 3T heater-cooler device manufacturer LivaNova, formerly Sorin Group Deutschland GMBH, on January 24, 2017. The case was filed in the U.S. District Court for the District of South Carolina, Columbia Division.

The plaintiff asserts that he and other class action members were unknowingly exposed to a potentially fatal bacteria during open chest surgery from the use of the 3T heater-cooler. He seeks class action certification, and actual and punitive damages.

Plaintiff Exposed to Potentially Deadly Bacteria During Open-Chest Surgery

The plaintiff who filed the case is a South Carolina resident. On March 13, 2014, he underwent an open-heart surgery. A Sorin 3T heater-cooler device was used during his surgery, which regulates body temperature in the patient during the procedure. The plaintiff alleges that device exposed him to a nontuberculous mycobacterium (NTM), a serious and potentially deadly bacteria that can cause antibiotic-resistant infections.

The Sorin 3T system came onto the market in 2006, and was designed to provide temperature-controlled water to heat exchanger devices, like thermal regulating blankets, which warm or cool a patient during bypass procedures lasting six hours or less. Not long after it was released on the market, however, hospitals began to report problems with the device.

South Carolina Patients at Risk for NTM Infection

The representative plaintiff in this case underwent surgery at Palmetto Health Richland Hospital, and seeks class members who had surgery at this hospital or at Greenville Health Hospital System.

In around June 2014, Greenville Health announced that about 14 patients had tested positive for a rare NTM infection, known as M. abscessus. Most of those patients were exposed to the bacteria during open chest surgeries. The hospital added that there had been three deaths resulting from the same infection.

That same month, the hospital released a second statement indicating there were 15 confirmed cases of patients with the infection, and that the patient death toll had increased to four. In July 2014, it sent out letters to about 180 patients notifying them of a potential risk of infection from the heater-cooler device.

FDA Warns of Potential Infection Risk

As news of these potential infections spread, additional hospitals became aware of the risks associated with the 3T heater-cooler device. Several hospitals sent out warning letters, notifying patients to watch for symptoms like night sweats, muscle aches, weight loss, unexplained fever, and difficulty breathing.

In October 2016, the FDA released a safety communication warning that surgery with the 3T heating-cooling devices had been linked with M. chimaera infections, and warned doctors and hospitals to immediately remove any of the devices that tested positive for the bacteria.

Then, in December 2016, the plaintiff’s hospital, Palmetto Health, announced that hundreds of its patients were potentially exposed to the rare bacteria during open-chest surgeries. They also sent letters to individual patients to inform them that they may be at risk.

The NTM is a slow-growing bacterium that can take from a few weeks to four years to manifest into a diagnosable infection. These infections can cause pulmonary or cardiovascular disease. The heating-cooling devices were initially linked to the infections via tests that confirmed that the bacteria came from one particular manufacturing site.

The plaintiff seeks class action certification to include all individuals in the state of South Carolina who went through an open-chest surgery at Greenville Health or Palmetto Health since January 1, 2011, and who are currently asymptomatic for an NTM infection. Claims of actual injury from the infection are excluded from this class action.