Why are there lawsuits involving heater-cooler devices?

The heater-cooler device is linked to causing Nontuberculous Mycobacteria (NTM) Infections in patients where the device was used during surgery. NTM infections can cause serious illness and potentially even death. LivaNova PLC (formerly Sorin Group), a manufacturer of the 3T heater-cooler device, are accused of negligence, failing to warn hospitals and doctors of the risks, manufacturing a defective product and misrepresenting the device’s risk and benefits.

Where are heater-cooler devices being used?

The heater-cooler device is most often used in open-chest cardiac procedures keep the patient’s body at the optimal temperature.

Where are these outbreaks being reported?

The FDA has received complaints about NTM infections and the devices dating back to January 2014.

In July 2015, WellSpan York Hospital was the first to identify NTM infections and informed 1,300 patients who were possibly exposed. To date, twelve of the patients have infections most likely linked to the heater-cooler device, including six who have died, but they also had other medical conditions.

Six hospitals have reported 28 cases of NTM infections due to the the heater-cooler devices in Pennsylvania, Iowa and Michigan since October 2011.

How many people are at risk?

Federal health officials are estimating that more than half a million patients who had open-heart surgery in the US since 2012 could be at risk. According to an article by the Washington Post, the heater-cooler device is used in an estimated 250,000 heart-bypass procedures each year, and 60 percent of these procedures use the model linked to NTM infections.

The CDC deputy director of healthcare quality promotion, Mike Bell, estimates between 1 in 100 and 1 in 1,000 patients are at risk. Although infections can be rare and slow to develop, the mortality rate is around 50%.

Lawsuits involving the heater-cooler devices:

  • York Hospital in Pennsylvania: Currently facing 4 lawsuits by patients who had open-heart surgery where heater-cooler devices were used and developed NTM infections.
  • Penn Presbyterian Medical Center in Philadelphia: Currently facing a lawsuit by an aortic valve-replacement surgery patient in 2014 where a heater-cooler device was used and had developed an NTM infection.

Many more lawsuits are expected to be filed due to the link between heater-cooler devices and NTM infections.