LivaNova Sued Over Infections Linked to 3T Heater-Cooler DevicesMar 2, 2017
Lawsuits Filed Over Contaminated Heater-Cooler Systems
LivaNova (formerly known as Sorin Group) is being sued by patients who developed serious infections allegedly associated with the company's Stöckert 3T heater-cooler device. Heater-cooler systems are used during surgery to maintain a patient's body temperature. Regulators have warned about the possible risk of contamination for the past few years, but recent research findings have provided the strongest evidence to date.
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 is facing lawsuits filed on behalf of patients who suffered infections following surgeries with 3T heater-cooler devices. Typically, plaintiffs are patients who have undergone open heart surgery. The infections are caused by nontuberculous mycobacterium (NTM), mostly a type of NTM called Mycobacterium chimaera (M. Chimaera).
These infections are difficult to diagnose because the bacteria grow slowly. As such, symptoms of an NTM infection may not appear for months or even years following the heart surgery. Regulators have advised heart surgery patients to be screened for NTM infections if they have symptoms such as unexplained fever. Patients may also experience night sweats, muscle aches and weight loss.
According to the U.S. Food and Drug Administration (FDA), contamination occurs when bacteria grow in the water reservoir of the heater-cooler systems. "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," regulators warned in 2015.
LivaNova allegedly failed to warn doctors, patients, hospitals and the medical community about the contaminated 3T heater-cooler devices, according to lawsuits. According to court records, one woman has filed a wrongful death lawsuit against LivaNova. The complaint states that the plaintiff's husband died of an infection linked to the Stöckert 3T heater-cooler device. The system was used during his cardiac bypass procedure in March 2014. Several months later, the hospital sent letters to specific patients informing them of possible NTM infections associated with contaminated heater-cooler devices.
Parker Waichman notes that, in addition to individual lawsuits, LivaNova is also facing a class action lawsuit over its Stöckert 3T heater-cooler device. The complaint was filed on behalf of two patients who suffered an NTM infection after undergoing a cardiac bypass surgery in March 2015. The hospital sent letters to the patients informing them of the possible infection.
Study Shows Worldwide NTM Infections are Associated with Heater-Cooler Devices
The link between contaminated heater-cooler devices and NTM infections has been suspected for some time, but research findings published in November 2016 provided the strongest evidence. The study was published in Infection Control & Hospital Epidemiology, the journal of the Society for Health Epidemiology of America.
The study was led by 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,"
The Centers for Disease Control and Prevention (CDC) issued recommendations in light of new research findings. Heart surgery patients experiencing night sweats, muscle aches, weight loss, fatigue, or unexplained fever should seek medical attention, the agency said. "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 device, 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).