The lawsuit involving the Sorin Stockert 3T Heater-Cooler System claims the maker of the medical product failed to warn hospitals that patients could suffer a potentially life-threatening infection caused by the machine during cardiothoracic surgeries.
As of December 2018, 86 lawsuits have been filed in federal court against the manufacturer of the Stockert 3T. Our law firm is accepting clients who suffered a nontuberculous mycobacteria infection linked to the Stockert 3T.
What Do We Know About the Sorin Stockert 3T Lawsuits
Claims are being filed against LivaNova PLC, the manufacturer of the 3T heater-cooler system, because the product has been found capable of transmitting a deadly bacteria to patients during surgeries, and especially during open-chest cardiac procedures.
The bacterium is called Mycobacterium chimaera, and can result in nontuberculous mycobacteria infections (NTM), which are extremely serious, capable of causing death even after years of antibiotic treatment.
Stockert 3T Heater-Cooler Injuries
Heater-cooler machines are used during surgeries to control a patient’s body temperature to improve medical care and patient outcomes. These machines have tanks that provide temperature-controlled water to heat exchangers and blankets, which then provide cooling or warmth to a patient's body.
Research has shown that numerous Sorin Stockert 3T systems are using water contaminated with Mycobacterium chimaera, and that this bacterium is being released into the air through the device's exhaust vent, which bacteria then is coming in contact with patients.
While the bacteria occurs naturally in the environment, and rarely causes problems, it presents a serious risk to individuals with a weakened immune system, including those who have undergone invasive surgeries. Unfortunately, there can be a very long delay (up to seven years) between the time a patient is exposed to the bacteria and an infection occurring.
Symptoms of Nontuberculous Mycobacteria Infections
Patients who have undergone cardiac surgery should be very careful to look for signs of endocarditis, surgical site infection, abscess, bacteremia, hepatitis, renal insufficiency, splenomegaly, pancytopenia, and osteomyelitis.
These are potential symptoms and complications from nontuberculous mycobacteria infections, and can occur up to several years after surgery. Other common symptoms include fever of undetermined origin, night sweats, joint pain, weight loss, myalgia, and malaise.
If you experience any of the above symptoms, it's crucial that you notify your treating physician that you might have a nontuberculous mycobacteria infection, such as Mycobacterium chimaera, and that special cultures and molecular diagnostics need to be performed to help diagnose and treat.
The infection that is being caused by the Stocker 3T is not contagious and does not spread from an infected person to other people. Potential treatment most often involves an intense regimen of several different antibiotics over a long time period. The earlier the infection is treated, the better the potential outcome.
Compensation in a Sorin Stockert 3T Lawsuit
If you suffered a nontuberculous mycobacteria infection as a result of the Stockert 3T heater-cooler machine, we will be seeking the following damages for you:
- Past and future medical expenses that result from the infection.
- Past and future mental pain and suffering caused by the infection, and the treatment and recovery process.
- Past and future wage loss, if any.
- Other economic losses you might have sustained as a result of your injuries.
- Punitive damages, if appropriate.
Stockert 3T Lawsuit Settlement Amounts
As of this time, there have been no large group settlements involving Stockert 3T and its potential link to surgical infections. Generally, however, large groups of settlements do not occur until such time as a few lawsuits are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.
Attorney Mike Papantonio Discusses the Stockert 3T Lawsuits
Stockert 3T Heater-Cooler System Recalls & Warnings
On June 15, 2015, LivaNova (formerly known as Sorin Group) issued a Class 2 recall of the Stockert 3T, acknowledging the potential dangers of nontuberculous mycobacteria infections.
Additionally, the FDA and the Centers for Disease Control and Protection has issued several warnings associated with the use of the 3T and the link to nontuberculous mycobacteria infections, and has recommended detailed safety procedures that hospitals and doctors should take to check their Stockert machines for possible contamination and to monitor and treat patients.
Sorin Stockert 3T Lawsuit News
Baystate Medical Center to notify at least 1,500 cardiac surgery patients of potential infection risk
The CDC posted an alert advising hospitals to notifiy cardiac patients, exposed to the Sorin Stockert 3T during open heart surgery as far back as at least 2012, that they may be at risk for developing symptoms indicative of a potentially deadly bacterial infection as a result of such exposure. Reported in Mass Live - Baystate Medical Center Surgical Infects
Heart Surgery Machines Tied to M. chimaera Outbreak
Twenty-four cardiac surgery patients became ill with a mycobacterium infection after cardiothoracic surgery using a contaminated heater-cooler device and nearly half died. These are very serious infections. They are very rare and slow to develop. The mortality rate approaches 50%. Reported in MedPage Today - Stockert 3T M. chimaera Outbreak
More than half a million heart surgery patients at risk of deadly infection
More than half a million patients who had open-heart surgery in the United States since 2012 could be at risk for a deadly bacterial infection linked to a device used during their operations, federal health officials said Thursday. Reported in The Washington Post - Heart Surgery Patient Infections
One in three devices used in NHS valve surgery is contaminated
The number of victims is unknown, forcing the NHS to embark on a mammoth project to trace the 47,000 people who have had surgery since 2013. The Medicines and Healthcare Products Regulatory Authority revealed that in the past two years it has received reports of the bacteria being found in more than one in three machines used to heat and cool blood in use in NHS hospitals nationwide. Reported in The Daily Mail - Contaminated Surgical Devices
7 hospitals notifying patients of heater-cooler infection risks
The following is a list of seven hospitals that have issued warnings to their patients about the risk of nontuberculous mycobacterium infections linked to the device, which is used during open-heart surgery: WellSpan York (Pa.) Hospital; Penn State Hershey Medical Center; Mercy Medical Center-Des Moines (Iowa); Penn Medicine; Mayo Clinic in Rochester, Minn.; Baystate Medical Center in Springfield, Mass.; and St. Francis Hospital & Medical Center in Hartford, Conn. Reported in Becker's Healthcare - Hospitals Notifying Patients Infection Risks
Contaminated LivaNova Heater-Cooler Heart Devices Ups Infection Risk In Open-Heart Surgery Patients
According to the CDC report, some Stöckert 3T heater-cooler devices manufactured by LivaNova PLC could have been contaminated with bacteria named Mycobacterium chimaera during production. The infection could be fatal. Reported in Tech Times - Heater-Cooler Infection Risk
Heart surgery patients at risk for deadly infection, CDC warns
Patients who have had valve implants are at higher risk of infection with a bacterial species of nontuberculous mycobacterium (NTM). Based on the number of surgeries conducted over the past four years, an estimated 600,000 patients are at risk for a potential infection. Reported in CNN - Heart Surgery Infection Warning
For additional news stories, click Levin Law Stockert 3T News
FDA and Scientific Studies Regarding the Sorin Stockert 3T
FDA's Ongoing Investigation of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices
Through the FDA’s analysis of adverse event reports, the medical literature, and information from national and international public health agencies, we are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures. NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in some patients. Reported in FDA Heater-Cooler Investigation
Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery
Over 250,000 procedures using cardiopulmonary bypass are performed in the United States each year. Stockert 3T heater-cooler devices represent approximately 60% of the U.S. market. Testing by the CDC shows that the heater-cooler devices can cause M. chimaera infections in patients undergoing surgery. Reported in Center for Disease Control - Heater-Cooler Device Bacteria
Non-tuberculous Mycobacterium Infections and Heater-Cooler Devices:
Recent reports have suggested an association between heater-cooler devices and NTM infections among patients undergoing cardiac surgery potentially through the aerosolization of bacteria from contaminated water used in these devices. Reported in Center for Disease Control - Stockert 3T Non-tuberculous Mycobacterium
Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices during Cardiothoracic Surgery:
Nontuberculous mycobacteria infections have been identified in patients in Europe and the US that previously underwent cardiothoracic surgeries. Studies have found an association among patients who were exposed to a heater-cooler device utilized during cardiopulmonary bypass surgery. Reported in FDA Executive Summary - Stockert 3T Mycobacterium Infections
Heater-cooler devices used in cardiac surgery - risk of infection with Mycobacterium species:
Low risk of Mycobacterium infection in patients undergoing cardiac surgery, associated with heater-coolers used with cardiopulmonary bypass machines. Reported in United Kingdom Government - Heater-Cooler Infections
Invasive cardiovascular infection by Mycobacterium chimaera potentially associated with heater-cooler units used during cardiac surgery:
Since 2011, cases of infection caused by Mycobacterium chimaera have been detected in patients having previously undergone cardiac surgery in Europe. Reported in European Center for Disease Control and Prevention - Heater-Cooler Mycobacterium Chimaera Infection