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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 April 2019, 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.
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.
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.
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:
As of April 2019, 86 lawsuits were pending in federal court against the manufacturer of the Sorin Stockert 3T by individuals who claim to have experienced injuries because of the heater-cooler device. The cases are being heard by John E Jones, III in the Middle District of Pennsylvania.
Our law firm started handling personal injury cases in 1955. Today, we are recognized as a national leader in lawsuits involving medical device injuries. We have received over 150 jury verdicts for $1 million or more, and have won jury verdicts and settlements in excess of $4 billion.
We are one of a very few law firms that have been appointed to the Plaintiffs Executive Committee by the judge handling all of the federal lawsuits involving the Sorin Stockert 3T system and the connection to nontuberculous mycobacteria infections. This means that we are directly involved in the national investigation against the manufacturer that will hopefully result in compensation for the individuals injured by this medical product.
We are the founder of Mass Torts Made Perfect. This is a national conference attended by 1,500 lawyers each year where we teach how to successfully handle lawsuits against medical device manufacturers. For more information, please visit our About Us section.
Our lawyers provide free confidential case evaluations, and we never charge any fees or costs unless you first recover.
The contingency fee we charge ranges from 20% to 40%. The amount we charge is based on how much we recover for you. To review a summary of our fees and costs, click Fees & Costs.
To contact us for a free case evaluation, you can call us at (800) 277-1193. You also can request an evaluation by clicking Free & Confidential Stockert 3T Evaluation Form. This form will be immediately reviewed by one of our attorneys handling the Stockert 3T litigation.
A class action is a lawsuit where a few individuals represent the interest of many individuals. The court rulings are binding on all persons who are a part of the class action. All class members are required to accept the settlement, even if an individual is going to receive little or no compensation.
Our Stockert 3T attorneys will not be pursuing class actions for our clients. Instead, we represent each client on his/her specific facts, and we evaluate each client’s damages on his/her specific facts. Each of our clients has the option of settling or not settling his/her case.
For a detailed discussion on class actions, mass torts, and multidistrict litigation, please visit our Class Action Mass Torts Page.
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.
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.
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
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 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
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
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
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
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
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
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
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 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
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
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
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