Injury Lawsuits Filed over Stockert 3T Heater-Cooler Devices

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

LivaNova Faces Litigation over Infections Allegedly Caused by Stockert 3T

Lawsuits are mounting against LivaNova (formerly known as Sorin Group) over the company’s Stöckert 3T heater-cooler device, a system used to maintain a patient’s body temperature during surgery. The 3T has been linked to a global outbreak of infections caused by nontuberculous mycobacterium (NTM), a type of slow-growing bacterium. Plaintiffs in the litigation are open heart surgery patients who suffered an NTM infection. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have both warned about the risk of NTM infection associated with contaminated heater-cooler devices.

Parker Waichman LLP is a national law firm with decades of experience representing clients in medical device injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a LivaNova (formerly known as Sorin Group) Stöckert 3T heater-cooler device lawsuit.

LivaNova’s Stöckert 3T heater-cooler device utilizes water circuits to keep a patient warm while under anesthesia. The water reservoirs are believed to house the bacteria in the contaminated systems. The FDA has warned that, even though the water does not make direct contact with patients, it can spread contaminants through the air (aerosolize).

“Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient,” the agency said in 2015.

Between January 2010 and August 2015, the FDA received 32 reports of NTM infections associated with heater-cooler devices. The agency said it received 25 reports in 2015 alone. Regulators have been issuing warning on the issue since at least 2014.

Reports of infection associated with heater-cooler devices mostly cite infection by Mycobacterium chimaera (M. Chimaera), a type of NTM. Since these bacteria grow slowly, infections can be hard to diagnose since symptoms may not appear for long periods of time. Some patients did not develop symptoms for months or even years. Because of this, regulators have advised heart surgery patients to seek medical attention if they have certain symptoms, such as unexplained fever. Other symptoms may include night sweats, muscle aches and weight loss.

Plaintiffs allege that LivaNova failed to adequately warn hospitals, doctors, and the medical community about the risks associated with contaminated 3T heater-cooler devices.

LivaNova is facing both individual lawsuits and class action litigation over its 3T heater-cooler device. In a class action lawsuit, one complaint represents numerous plaintiffs (known collectively as a “class”). Court records show that a 3T heater-cooler class action was recently filed. The first two plaintiffs are heart surgery patients who underwent cardiac bypass surgery in March 2015. Both patients received a letter from the hospital warning them of potential NTM infections associated with heater-cooler systems.

Court documents also show that an individual wrongful death lawsuit was filed against LivaNova. The plaintiff is a woman whose husband died of a fatal infection, allegedly due to the Stöckert 3T heater-cooler device. According to the lawsuit, he underwent a cardiac bypass procedure in March 2014. The plaintiff alleges LivaNova knew or should have known about this risk but failed to warn the medical community.

The complaint states that in June 2014, the hospital that performed the surgery publicly announced that 14 of its patients tested positive for mycobacterium abscessus. The infections were linked to three deaths, the hospital said at the time. The following month, the suit states, the hospital reported 15 infections and four deaths. After this announcement, 180 letters were submitted to patients who may have been exposed to bacterial infections following heart surgery with the 3T heater-cooler.

Research Provides Strong Evidence Showing Infections are Caused by Contaminated 3T Heater-Cooler Systems

Parker Waichman notes that research has provided strong evidence showing that contaminated heater-cooler devices are the source of a global outbreak of M. Chimaera. Specifically, a November 2016 study was published in the Infection Control & Hospital Epidemiology, the journal of the Society for Health Epidemiology of America.

The lead author is Rami Sommerstein, MD, of Inselspital, Bern University Hospital in Switzerland. “It is surprising that a global outbreak like this could go unnoticed for years. This dangerous infection has put many patients at risk all over the world,” Dr. Sommerstein said. “Now that we know HCDs are the source, individual action from the different players (healthcare institutions, manufacturers, etc.) is needed to contain the ongoing patient risk. The most important action a hospital can take is to remove contaminated HCDs from the operating room and other critical areas. That is the only way to ensure that patients are protected from this infection moving forward.”
“While our understanding of the causes and the extent of the M. chimaera outbreak is growing, several aspects of patient management, device handling and risk mitigation still require clarification,”

In light of these findings, researchers said that patients who have undergone heart surgery in the past should be screened for NTM infection if they have an unexplained fever. The risk of infection can also be lowered by removing heater-cooler devices from critical medical areas.

Following new research findings, the CDC issued a recommendation for heart surgery patients. The agency said that patients experiencing night sweats, muscle aches, weight loss, fatigue or unexplained fever should seek medical attention. “This advice follows new information indicating that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, used during many of these surgeries, might have been contaminated during manufacturing which could put patients at risk for life-threatening infections,” the CDC said in October 2016.

Filing a Stöckert 3T Heater-Cooler Lawsuit

If you or someone you know suffered an infection after undergoing surgery involving a LivaNova (formerly Sorin Group) Stöckert 3T heater-cooler system, you may have valuable legal rights. Parker Waichman offers free, no-obligation case evaluations. For more information about filing a Stöckert 3T heater-cooler lawsuit, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).