Stockert 3T Heater-Cooler Lawsuit - Infections, Recall & Legal Help
Stockert Lawsuit Header

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

Stockert Banner

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

Heater-Cooler Side Effects

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.

 
 
Why Choose Us

Our law firm has been in existence for more than 60 years, and is considered a national leader in this type of litigation. We have received well over 150 jury verdicts throughout the country in the amount of $1 million or more, and achieved verdicts and settlements in excess of $3 billion.

We are the founder of Mass Torts Made Perfect, which is a national seminar attended by approximately 800 lawyers twice per year where we help teach the successful handling of cases against pharmaceutical and medical device companies. For more information, please visit our About Us section.

in business 60 years - $3 billion in verdicts and settlements - listed in Best Lawyers in America, SuperLawyers and Trial Lawyers Hall of Fame
What Does It Cost

Our lawyers provide absolutely free confidential consultations, and if we are fortunate enough for you to hire us, we never will charge you any fees or costs unless you first recover. To review a summary of our fees and costs, click Fees & Costs.

Contact Information

To contact us for a free confidential consult, you can call us at (800) 277-1193 (toll free). You also can request a confidential consultation by clicking Free & Confidential Consult, which form will be immediately reviewed by one of our attorneys handling the Stockert 3T litigation.

Read More

Will the Stockert Lawsuits be Handled as a Class Action

A class action is a type of lawsuit where a few individuals represent the interest of many individuals, even if they don't have a lawyer and are not named in the litigation. The court rulings and jury rulings impact all persons who are considered a member of the class action, most of whom do not even know they are involved.

This is not the type of litigation we will be pursuing for our clients. Instead, we represent each individual based on his/her specific circumstances, and evaluate the recovery for each client based on his or her facts. Each of our clients always has the option of settling or not settling his or her case.

 

Stockert 3T Lawsuit Videos

 
Watch More Videos
 

3T Heater-Cooler System Lawsuit News

Stockert 3T News Banner
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 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 Live

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%. To read more, click MedPage Today

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. To read more, click The Washington Post

Read More
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. To read more, click The Daily Mail

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. To read more, click Becker's Healthcare

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. To read more, click Tech Times

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. To read more, click CNN

For additional news stories, click Levin Law Stockert 3T News

 

3T Heater-Cooler System Claims Information

 Heater-Cooler Compensation

How Much Compensation can be Recovered in a Stockert 3T Lawsuit

We will be seeking the following damages for you:

  1. Past and future medical expenses that result from the infection.
  2. Past and future mental pain and suffering caused by the infection, and the treatment and recovery process.
  3. Past and future wage loss, if any.
  4. Other economic losses you might have sustained as a result of your injuries.
  5. 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

 Stockert 3T FDA Research Banner

The FDA Warns that Mycobacterium chimaera Infections are Linked to the Stockert 3T Heater-Cooler System

On 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:

  1. Remove any 3T devices manufactured before September 2014, and only use in case of emergency.
  2. Remove any heater-cooler devices, accessories, tubing, and connectors that have tested positive for M. chimaera or have been linked with patient infections.
  3. Use new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device.
  4. 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

Read More

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. To read more, click Center for Disease Control - Heater-Cooler Devices

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. To read more, click Center for Disease Control - 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. To read more, click FDA Executive Summary

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. To read more, click United Kingdom Government

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. To read more, click European Center for Disease Control and Prevention