The FDA and clinical studies link heater-cooler devices used during open-heart surgeries to nontuberculous mycobacteria (NTM) infections. Symptoms of NTM infection may not manifest for several weeks or years and may lead to serious illness or death. Heater-cooler lawyers are investigating claims and filing lawsuits on behalf of patients.
Heater-Cooler device lawyers are currently investigating lawsuits against device manufacturers. According to lawsuits already filed, device manufacturers sold defective and “unreasonably unsafe” products that allowed bacteria to grow and spread in patients.
In October 2015, the U.S. Food and Drug Administration warned that heater-cooler devices used in open-heart or cardiopulmonary bypass surgeries may spread nontuberculous mycobacteria (NTM) and cause serious illness or death. Heater-coolers use temperature-controlled water in tanks to heat and cool a patient’s blood or body temperature during surgery. But, if the water is contaminated, the machine can spread bacteria in the air. The bacteria can enter a patient’s open chest cavity and cause infection.
In October 2016, Centers for Disease Control and Prevention and FDA issued a stronger warning for patients and hospitals linked to the Sorin Stockert 3T. Each year, doctors perform about 250,000 heart bypass procedures, and about 60 percent of these procedures use the Sorin Stockert 3T. The risk of contracting an NTM infection from these devices is “between about 1 in 100 and 1 in 1,000,” according to the CDC.
Health officials linked several outbreaks in hospitals to contaminated heater-cooler devices. In October 2015, WellSpan York Hospital in Pennsylvania notified 1,300 patients that they may have been exposed to NTM. In November 2015, Penn State Milton S. Hershey Medical Center notified 2,300 patients of the same risk. So far, the infection has killed a handful of people and sickened others.
NTM infections can be difficult to treat and only have a 50 percent survival rate. The bacteria are slow growing and symptoms of infection can take up to four years to develop after the original surgery. The risk of infection is not limited to Pennsylvania since hospitals across the country use these devices. Some infected patients and their families already filed lawsuits against heater-cooler manufacturers.
Why File a Heater-Cooler Device Lawsuit?
Treatment to eradicate an NTM infection can lead to more complications and medical bills, especially if the patient needs more surgery to remove infected tissue or implants. The FDA noted the design of these machines may be to blame for infection.
“Air filters located on some units are not efficient enough to capture NTM bacteria. An air filter that has the capability to capture NTM bacteria may alter device safety or performance and would therefore need to be evaluated by each manufacturer as a possible mitigation technique before implementation,” the FDA said in a 2016 safety communication on its website.
LivaNova PLC, formerly Sorin Group USA (Sorin Group Deutschland GMBH), manufactures 60 percent of all heater-cooler devices on the market. But attorneys are investigating other device manufacturers.
Some of the claims made in lawsuits against device companies accuse manufacturers of:
- Failure to warn of risks
- Manufacturing a defective product
- Misrepresenting the device’s risk and benefits
- Terumo HX2
- LivaNova/Sorin Stockert 3T
- Cincinnati Sub-Zero 333W and Hemotherm
- Maquet HCU20, HCU30, HCU40
Nontuberculous Mycobacteria Lawsuits & Litigation
So far, a handful of patients have filed lawsuits against LivaNova and Sorin, the manufacturers of the Stockert 3T Heater-Cooler. Court documents claim the defendant manufactured a faulty device and failed to warn them of the risks, among other allegations.
Phillip Lamar West and Karen Austin
Phillip Lamar West and his wife Karen Austin of South Carolina filed a lawsuit in 2016 after West had an aortic valve replacement and cardiac bypass grafting procedure, according to the complaint. West’s surgeon used the Stockert 3T to cool and re-warm his blood. While he did not initially have symptoms, about a month later he ran a high fever, grew weaker and developed pneumonia.
After he developed a rash, swelling and fluid buildup around the incision site, he had to have more surgery to clean out the wound. He tested positive for a NTM called M. abscessus. Unfortunately, the surgeon had to cut muscles that affected use of West’s arm. For the next several months he was in and out of the hospital to treat the infection.
Vincent and Rebecca Karst
Vincent Karst and his wife, Rebecca, sued LivaNova after doctors diagnosed him with an infection six months after open-heart surgery. The suit says that the defendant’s negligence led to medical complications, pain, suffering loss of earnings and chronic illness. He now lives with side effects of medications — including hearing and vision loss from the antibiotics — and is still dealing with the infection.
David Inners and Wendy Woods
David Inners had open-heart surgery in December 2014 and began feeling ill in May 2015, according to the complaint filed by his fiancée, Wendy Woods. He suffered from fatigue and fevers, but multiple blood tests came out negative. His health deteriorated in June 2015 and he lost weight, had no appetite and had a low white-blood cell count. Another blood test and a bone marrow biopsy revealed NTM. In October, York Hospital informed Inners that his infection was connected to the heater-cooler device. He died two weeks later.
Heater-Cooler Device Class Action
Because the litigation is in the beginning stages, there is no class action for these lawsuits. Instead, patients are filing individual lawsuits. Heater-cooler lawyers are investigating lawsuits on behalf of patients who had heart problems and needed cardiopulmonary bypass surgery and suffered an NTM infection. There are no settlements or jury verdicts to report, and the litigation is ongoing.
FDA Actions Related to Heater-Coolers
The FDA released its first warning about heater-cooler devices and NTM infections in October 2015. But, before that, the agency sent a warning letter to Stockert 3T manufacturer Sorin in August 2011. The letter detailed Sorin’s deficiencies related to water quality and cleanliness criteria. In 2012, Sorin changed the design of its heater-cooler device and failed to update its cleaning instructions, the agency said.
In August 2014, The FDA announced Sorin found its heater coolers were contaminated with M. chimaera on the production line. In June 2015, Sorin recalled the devices to update cleaning instructions. But, according to the FDA, the company failed to provide proof that its new cleaning procedures were adequate.