The lawsuit involving the Stockert 3T Heater-Cooler System states the manufacturer of this medical product failed to warn hospitals and doctors of a potentially life-threatening infection being caused by the device during cardiothoracic surgeries.
Why are Stockert 3T Lawsuits Being Filed
Claims are being filed against LivaNova PLC, the manufacturer of the 3T heating-cooling system, because the product has been found capable of transmitting a specific type bacteria to patients during surgeries, and especially 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.
What is the Purpose of the 3T Heater-Cooler Systems
Heater-cooler units are machines used during surgeries to control a patient’s body temperature to improve medical care and patient outcomes. These devices have water tanks that provide temperature-controlled water to heat exchangers or blankets, which then provide cooling or warmth to the patient's body.
What is the Concern with the 3T Heater-Cooler Systems
Research has shown that numerous 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.
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.
Stockert 3T Lawsuit Videos
3T Heater-Cooler System Lawsuit News
The CDC posted an alert advising hospitals to notifiy cardiac patients, exposed to the 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. To read more, click Mass LiveHeart 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%. To read more, click MedPage TodayMore 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. To read more, click The Washington Post
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. To read more, click The Daily Mail7 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. To read more, click Becker's HealthcareContaminated 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. To read more, click Tech TimesHeart 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. To read more, click CNN
For additional news stories, click Levin Law Stockert 3T News
3T Heater-Cooler System Claims Information
How Much Compensation can be Recovered in a Stockert 3T Lawsuit
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.
3T Heater-Cooler System Recalls
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 has issued several warnings associated with the use of the 3T, and has recommended detailed safety procedures that hospitals and doctors should take to prevent injuries.
Stockert 3T Settlements
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 cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.
FDA and Scientific Studies Regarding 3T Heater-Cooler Systems
The FDA Warns that Mycobacterium chimaera Infections are Linked to the Stockert 3T Heater-Cooler SystemOn June 1, 2016, the FDA issued a Safety Communication specific to M. chimaera infections associated with the use of the 3T. Testing conducted by the manufacturer in August 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility. The 3T devices manufactured at this facility were distributed worldwide.
The FDA recommends that hospital and doctors take the following steps before using 3T systems:
- Remove any 3T devices manufactured before September 2014, and only use in case of emergency.
- Remove any heater-cooler devices, accessories, tubing, and connectors that have tested positive for M. chimaera or have been linked with patient infections.
- Use new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device.
- Direct and channel the heater-cooler exhaust away from the patient, for example, to the operating room exhaust vent.
To read the complete alert, click FDA Drug Safety Communication