Sorin Stockert 3T Heater-Cooler Lawsuit
Sorin Stockert 3T heater-coolers can expose patients to the bacteria Mycobacterium chimaera during surgery. Patients are now filing lawsuits against manufacturer LivaNova.
The Sorin Stockert 3T heater-cooler, a common device used for invasive surgeries, can be contaminated with bacteria. Mycobacterium chimaera can grow inside the heater-cooler’s water tanks. The bacteria can be emitted as a vapor into sterile surgical rooms, exposing vulnerable patients to deadly infections.
Between January 2010 and August 2016, the FDA received 91 adverse event reports for the 3T heater-cooler, including 79 incidents of infection and 12 associated deaths. Patients who underwent open-heart surgery that used the 3T device are now filing lawsuits against LivaNova.
Sorin Stockert 3T’s Bacteria Problem
3T heater-coolers left the manufacturer already contaminated.
The 3T heater-cooler uses three water tanks and circuits to simultaneously keep patients warm while also using cold water for cardioplegia—the intentional and temporary cessation of cardiac activity during surgery. The device is primarily used for invasive surgeries involving the heart, lungs, esophagus, and other chest organs.
Research has shown that the bacteria Mycobacterium chimaera (M. chimaera) can grow inside the water tanks. M. chimaera is a bacteria subspecies of nontuberculous mycobacteria (NTM). Exposure to M. chimaera is usually safe for healthy individuals, but patients with vulnerable and compromised immune systems are at risk of developing deadly infections from exposure.
As early as 2002, scientists in Germany discovered that M. chimaera can grow inside 3T water tanks. Contaminated water, they found, could then emit a vapor that the device’s exhaust fan spreads across sterile operating rooms, including even inside a patient’s open heart cavity.
The problem isn’t just that the bacteria tends to grow in the device if left uncleaned—3T heater-coolers left the manufacturer already contaminated. A Euro Surveillance study conducted at LivaNova’s Munich facility found a direct link between clinical samples of infected patients in Europe with samples at the German manufacturing site.
FDA Threatens to Ban Heater-Cooler from the U.S.
On June 15, 2015, the Sorin Group issued a recall of the 3T device, stating that there was “potential colonization of organisms, including Mycobacteria if proper disinfection and maintenance is not performed per instructions for use.”
At the end of 2015, following warnings sent in 2011 after safety and quality inspections at Sorin Group’s manufacturing sites, the FDA warned that the 3T heater-coolers were subject to being banned from the U.S. The FDA said that the 3T heater-coolers were “adulterated” and “misbranded,” and that their “manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements.”
FDA and CDC Warn Hospitals of Infection Risk
60% of hospitals use the 3T device for their heart bypass surgeries.
There are about 250,000 heart bypass surgeries conducted each year, and 60% of those use the 3T device. Because of this, the CDC estimates that there are more than half a million patients at risk of infection.
The chances of patients developing an infection from the bacteria are typically somewhere between 1 in 100 and 1 in 1,000, though the CDC warns that patients who had valves or prosthetics implanted have a higher risk of infection. Infections are difficult to treat and require concoctions of the highest-strength antibiotics. And, even with medication, there is a 50% mortality rate.
On October 27, 2015, the CDC issued an informational toolkit to healthcare providers with tips on spotting incidents of infection. It can take months or even years for patients to develop infections from M. chimaera exposure, though the majority of patients will develop symptoms within four years. Symptoms commonly include fever, muscle aches, weight loss, and draining from the wound.
In June 2016, the FDA issued a formal warning to healthcare providers about the heater-cooler’s infection risk. In October, they updated their statement, strongly recommending that hospitals replace older 3T heater-coolers and only use them if no other devices were available.
York Hospital Faces Infections and Lawsuits
Pennsylvania has particularly been hit hard by the NTM infection. As of October 2016, there were 21 reported cases of infection, resulting in six deaths.
York Hospital in Pennsylvania claims 12 of those cases. Six of their patients have passed away from infections caused by the 3T heater-cooler.
After research discovered a link between the 3T device and NTM infections, York Hospital issued a warning to the 1,300 patients that were potentially exposed in open-heart surgeries between October 1, 2011 and July 24, 2015. The hospital replaced their 3T devices with another company’s and have since improved their standards for heater-cooler inspection, maintenance, and cleaning.
Though the hospital reacted quickly—issuing warnings and precautions before even the CDC or FDA—they haven’t been able to avoid lawsuits for exposing their vulnerable patients to the deadly infection. Six lawsuits have been filed against WellSpan Health (York Hospital’s owner) and LivaNova, including one lawsuit representing 12 York patients and their nine spouses who were exposed to the bacteria.
York isn’t the only hospital with confirmed incidents of infection: Cases have also been reported in Seattle, Michigan, and Iowa. Patients who were exposed to M. chimaera are now filing lawsuits against LivaNova and their health care providers.
Lawsuits allege that LivaNova is responsible for some combination of the following:
- Faulty device design that causes bacterial colonization and/or transmission during invasive surgical procedures.
- Manufacturing and selling the 3T system with NTM contamination that occurred at production facilities.
- Failure to conduct adequate safety testing.
- Failure to provide proper cleaning and disinfection procedures for the 3T system.
- Failure to adequately warn patients or users about the risk of colonization with NTM.
- Failure to alert hospitals and patients to promptly test for NTM infection after invasive surgical procedures using the 3T system.
Lawsuits accuse healthcare providers of recklessness and negligence, specifically over their maintenance and cleaning of the heater-cooler devices and failure to warn patients of the infection risk.
Lawsuit Eligibility and Compensation
If you had invasive surgery that used a 3T heater-cooler, you may be eligible for a lawsuit against LivaNova and/or your healthcare provider. Lawsuits can result in compensation for the following:
- Medical bills—current and future
- Lost wages
- Pain and suffering
- Mental anguish
- Loss of enjoyment of life
Contact Our Attorneys for a Free Legal Review
Undergoing invasive surgery is a difficult process in itself. You or your loved one should not have to worry about contracting deadly bacterial infections because of a company’s negligence.
ClassAction.com’s attorneys will help you hold LivaNova accountable for their actions. Contact us today for a free, no-obligation legal review.