This discovery sparked numerous Sorin Stöckert 3T lawsuits against the device manufacturers. The lawsuits claim the manufacturers should have known about the risks of deadly infections.
If you or your loved one suffered life-threatening infections after using the Sorin 3T System during surgery, you deserve justice and compensation for your injuries. Join the Many will help you every step of the way, beginning with a free case review to determine your eligibility.
A Brief History of the Sorin Stöckert 3T Heater-Cooler Device
The Sorin Stöckert 3T device is standard in healthcare facilities. These devices control the patient’s blood and organ temperature during open cardiothoracic surgeries. Heater-cooler units are vital in procedures where the lungs and heart often cease function, such as:
- Lung transplant
- Heart transplant
- Pulmonary artery banding
- Cardiopulmonary bypass surgeries
- Heart valve replacement
- Aortic anomaly surgery
- Lung resection
- Extracorporeal membrane oxygenation or ECMO
- Coronary artery bypass graft or CABG
- Left ventricular assist device (LVAD) implant
According to data from the CDC, heater-cooler devices are vital in over 250,000 heart surgeries in the US. Nearly 60% of these surgeries rely on Stöckert, a 3T device, which raises serious concerns about bacterial infections.
In 2015, the CDC and FDA issued warnings about contamination from Sorin Stöckert 3T devices. The agencies highlighted the increased risk of severe mycobacterial infections.
These alerts followed a study by researchers from Switzerland on cardiac surgery patients. The team identified two patients suffering from infective endocarditis after using the device.
The FDA launched investigations and discovered three potential risk areas in the device, including:
Laminar Airflow Interruption
The laminar airflow technique sterilizes the area above the surgical table. The heater-cooler system’s exhaust can interrupt the laminar, allowing bacteria into the sterile space.
Airborne Bacteria
The heater-cooler device has water tanks that assist in regulating the temperature. The NTM bacteria (Nontuberculous mycobacterial) can indirectly contaminate water and other equipment.
Heater-cooler Filters
Although most heater-cooler devices have water or air filters, some filters are ineffective against NTM bacteria that contaminate the system.
The FDA released a warning in 2016, cautioning that the Sorin 3T System posed severe health risks. The device increased the risk of NTM and Mycobacterium chimaera infections after surgery.
Overview of Research Findings
The Sorin Stöckert 3T Heater-Cooler device is a product of LivaNova. The device has three circuits that heat and cool simultaneously and a sub-divided water tank.
It has a cooling and heating unit for air circulation while heating or cooling the water. The water flows through the closed circuits to heating or cooling blankets or an exterior heat exchanger.
The cold water ensures cardioplegia when the surgeons need to halt the heart and blood flow temporarily. At the same time, hot water ensures the patient remains warm during the procedure.
Although the patient doesn’t have direct contact with the water, the device has exhaust vents and fans. The fans and vents can vaporize contaminated water as it moves through the device’s circuits. The contaminated air can enter the operating room, putting the surgery patient at high risk of infection. Cases of bacterial infections after invasive surgeries first caught the attention of the CDC and FDA in 2010.
The infections involved bacteria are known as Mycobacterium chimaera, a rare NTM (nontuberculous mycobacterium) species. In 2015, European researchers studied post-surgery patients and discovered several Mycobacterium chimaera cases.
The FDA and CDC issued warnings about the risk of infections after cardiothoracic surgery later that year. The agencies mentioned the Sorin 3T Heater-Cooler, prompting the recall in 2015.
The Link between M. Chimaera Infections and the 3T Heater-Cooler Device
The symptoms of NTM and M. chimaera infections often take time to manifest. Some patients don’t experience any symptoms for up to four years.
This slow progression exposes more people to life-threatening conditions. They remain unaware of the infection until it’s too late. The CDC cautions that people with valve implants or prosthetic devices have a higher risk of infection.
It’s essential for anyone who underwent open surgery with the Sorin device in use from 2012 to watch out for symptoms such as:
- NTM infection
- Surgical Wound Infection
- Heat, redness, or pus around the surgical area
- Endocarditis
- Joint or muscle pain
- Sepsis
- Fatigue
- Abdominal pain
- Fever
- Night sweats
- Persistent cough with blood
- Weight loss
- Vomiting
- Difficulty breathing
- Nausea
- General Malaise
As the infection progresses, you may notice more severe symptoms like:
- Osteomyelitis or inflammation in the bones
- Pancytopenia
- Abscesses
- Splenomegaly
- Signs of organ dysfunction
- Renal insufficiency
- Bacteremia or bacteria in the blood
- Endocarditis or the inflammation of the heart’s inner lining
Such complications require ongoing treatment for several months or years. Failure to seek treatment for NTM infections can be fatal.
If you or someone you care about experiences these symptoms, ensure you seek medical assistance immediately. While no amount of money can undo the trauma and fear caused by these machines, you should also consider seeking compensation from the manufacturer to cover your medical bills. Join the Many to learn about your options and how we can make sure your voice is heard.
Lawsuit History
Sorin Stöckert 3T Heater-Cooler lawsuits are claims against Sorin Group and affiliates. This includes LivaNova PLC and Cyberonics Inc. The basis of these lawsuits is that the manufacturer should have known their device could potentially disperse bacteria, causing deadly infections.
There’s no excuse for these manufacturers since research linking the 3T water tank to M. chimaera has been available since 2012. German researchers determined that the water tank provided an ideal environment for the bacteria to thrive.
Generally, M. chimaera bacteria are harmless to healthy patients. However, it affects people with weakened immune systems, such as patients undergoing open heart surgery.
Euro Surveillance also conducted another study. They noted that the devices leaving the Munich manufacturing facility already had contamination.
Any manufacturer whose product is potentially dangerous must inform the FDA and consumers of the risks. Once LivaNova PLC discovered their 3T device could cause fatal injuries, they took no immediate action.
They did not warn the medical community of the possible dangers or recognize the defect, which amounts to negligence. According to the lawsuits, LivaNova also did not:
- Execute quality safety tests on the devices
- Ensure proper sanitization to sterilize the 3T system regularly
- Adequately warn patients about the possible risks of bacterial infection
- Warn patients and the medical community to undergo tests for NTM after surgery
Examples of Sorin Stöckert 3T Heater-Cooler Lawsuits
The Stöckert 3T device caused numerous infections, which continue to emerge as time goes by. The manufacturers are now facing thousands of lawsuits across the US.
The first 3T heater-cooler lawsuit was by Lori Weinacker on behalf of her husband, Henry Weinacker. Lori filed the lawsuit in South Carolina’s federal court on 27th June 2016. According to the case, her husband underwent a heart bypass surgery in 2014 and used a Sorin 3T device during the procedure.
Henry’s surgery was in South Carolina at the Greenville Health System (GHS) Hospital. Around the time of his surgery, the hospital saw an influx of an NTM infection known as M. abscessus.
The hospital contacted about 180 patients they believed may have come into contact with the bacteria, including Henry.
Unfortunately, he developed other complications that required antibiotic treatments and additional surgery. He succumbed to infection only three months after the invasive surgery.
Armando Lopez’s 3T Heater-Cooler Lawsuit
Armando Lopez submitted his Sorin 3T heater-cooler lawsuit to a federal court in south Florida on 19th September 2018. The lawsuit alleged that the device caused him to develop a deadly infection that damaged his organs.
Armando was a patient at the Westside Regional Medical Center (WRMC) in Florida. He underwent heart bypass surgery in June 2014 and discovered symptoms of infection a few weeks later.
Lopez received treatment for a persistent cough and other related issues until 2016. He became aware of NTM exposure in January 2017 after receiving a letter from WRMC.
He was among the patients affected by M. chimaera bacterial infection due to the Sorin 3T heater-cooler machine.
Armando shared the information with his doctor, prompting him to prescribe M. chimaera treatment. The potent antibiotics caused damage to his kidneys, liver, and lungs, and he lost his hearing.
Sorin Stöckert 3T Heater-Cooler Class Action Lawsuits
We’ve seen at least three class action lawsuits seeking compensation from Sorin.
Pennsylvania Class Action Lawsuit
Jack Miller and Edward Baker from York County in Pennsylvania submitted a class action lawsuit against the Sorin Group and affiliates in February 2016. The two gentlemen got exposed to NTM bacteria after using Sorin’s Heater-Cooler System during open heart surgery.
The lawsuits cite the two hospitals in Pennsylvania warning of NTM bacteria exposure in 3,600 patients. These patients underwent cardiac surgeries between 2011 and 2015.
The York Hospital contacted about 1,300 patients, while the Penn State Hershey Medical Center alerted 2,300 patients.
The District Court for the Middle District of Pennsylvania approved the class action in October 2017.
Iowa Class Action Lawsuit
Jeri Pickrell from Iowa filed a class action lawsuit against Sorin in May 2017. The class action included other people with similar complications after exposure to NTM bacteria.
The lawsuit cites that the University of Iowa Hospitals and Clinics contacted over 1,700 patients in February 2016.
The Mercy Medical Center in Iowa also warned 2,600 patients who underwent open-heart surgery about the risk of infection.
South Carolina Class Action Lawsuit
In January 2017, Steven Foster from South Carolina also filed a Stöckert 3T Heater-Cooler class action.
The lawsuit cited that the Greenville Health Hospital and Palmetto Health Richland Hospital reported two fatalities and hundreds of NTM cases. However, Foster later decided to withdraw the class action lawsuit without disclosing the reasons behind his decision.
Sorin Stöckert Federal Multidistrict Litigation
As more cases emerged, the US Judicial Panel on Multidistrict Litigation combined the lawsuits into one MDL (No. 2816) in February 2018.
The MDL is before the federal court in the Middle District of Pennsylvania. An MDL is different from a class action lawsuit, but there are some similarities. For instance, both involve people who suffered similar injuries, and the cases appear before one judge.
However, in a class-action lawsuit, the participants agree on one case that proceeds to trial on behalf of others. If the case has a positive outcome, everyone receives an equal share of the settlement amount.
In an MDL, the cases remain independent but under various categories or groups. This grouping allows the court system to use the evidence or arguments in one case to make multiple decisions.
Everyone receives a different amount in case of a positive outcome, depending on their injuries and case.
What Compensation Can I Expect in a Sorin Stöckert 3T Lawsuit?
If you or someone you care about developed deadly NTM bacterial infections after using LivaNova’s 3T device in surgery, you may have a valid case.
Talk to the Join the Many experts and share your details to see if you qualify. Depending on the extent of your injuries, you might receive compensation for the following:
- Medical bills incurred due to post-surgery complications
- Economic damages for your injuries
- Lost wages due to medical appointments and hospital stays
- Loss of enjoyment of life and emotional distress
- Pain and suffering due to the infection
If you lost a loved one due to NTM infection, you could recover damages such as:
- Loss of consortium
- Lost inheritance rights
- Loss of your family member’s income
- Costs of medical care incurred until they passed away
- Mental anguish
- Pain and suffering your dear one experienced before passing away
- Reasonable burial and funeral expenses
Sometimes juries award punitive damages to admonish the company and discourage similar actions in the future.
Take the Bold First Step: Join the Many
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We understand that taking action against established businesses can be intimidating, so we empower you with the best of the best. We’ll connect you with experienced attorneys to fight for the compensation you deserve at no upfront costs. It’s time to take action and Join the Many.
