Sorin Stockert 3T Heater-Cooler Lawsuit - Settlements & Recalls
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The lawsuit involving the Sorin Stockert 3T Heater-Cooler System states the manufacturer 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 May 2018, more than 100 lawsuits have been filed against the manufacturer.

Our law firm is accepting clients who suffered a nontuberculous mycobacteria infection linked to the Stockert 3T. We have been handling lawsuits against medical device manufacturers since 1955, and we are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.

 

Why are Sorin Stockert 3T Lawsuits Being Filed

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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.

The Key Legal Issues
  • The Stockert 3T manufacturer knew, or should have known, that its machines had become contaminated with Mycobacterium chimaera. Yet, it still sold the machines to hospitals and physicians.
  • The Stockert 3T manufacturer failed to remove the machines from the market even after becoming aware of the contamination.
  • The Stockert 3T manufacturer failed to warn hospitals and physicians of the contamination, and the need to remove the machines from use.
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    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.

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    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:

    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.
     
     
    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 $4 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 lawsuits against medical device manufacturers. For more information, please visit our About Us section.

    in Business 63 years * $4 Billion in Verdicts & Settlements * Best Law Firms: U.S. News & World Reports * Trial Lawyers Hall of Fame * SuperLawyers
     
    Our Fees & Costs

    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.

    The contingency fee we charge ranges from 20% to 40% depending upon how much we recover for you. To review a summary of our fees and costs, click Fees & Costs.

     
    Free Case Consultation

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

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    Will My Stockert 3T Case be Handled as a Class Action

    A class action is a type of lawsuit where a few individuals represent the interest of many other individuals. The court rulings are binding on all persons who are considered a member of the class action. All class members are required to accept the settlement approved by the court, even if an individual class member is going to receive little or no compensation.

    This is not the type of litigation that our Stockert 3T attorneys 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/her facts. Each of our clients always 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.

     

    Stockert 3T Lawsuit Settlement Amounts

    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 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

     
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    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

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    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

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    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

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    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

     
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