A New York Stockert infection lawyer can assist people who developed severe infections after having a procedure that used the device. Heater-cooler devices are used to warm and cool patients during certain types of open-chest surgical procedures, such as open-heart surgery. The devices, however, have been linked to an increased risk of potentially dangerous bacterial infections. Affected patients and their families may be able to file a lawsuit and pursue damages with the help of a New York Stockert heater-cooler lawsuit attorney.
For more information, contact the Attorney Group for New York today. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated New York Stockert infection lawyer who can assist you throughout the legal process.
What is a Stockert Heater-Cooler System?
Stockert 3T heater-cooler systems are manufactured by LivaNova PLC, a medical device company based in London, England, that develops medical devices used for cardiac surgery, neuromodulation and cardiac rhythm management. Like most other heater-cooler devices, the Stockert 3T is used to warm or cool a patient during certain surgical procedures, including open-heart surgery and other open-chest procedures.
Stockert 3T Heater-Cooler Infection Risk
According to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), Stockert 3T Heater-Cooler Systems have been linked to severe infections, particularly Mycobacterium chimaera (M. chimaera) infections, a type of nontuberculous mycobacterium (NTM).
Cardiopulmonary bypass procedures in the U.S. utilize heater-cooler devices, and patients who received a heart valve, graft, LVAD or any other prosthetic product or had a heart transplant may be at an increased risk of infection. According to the FDA, possible signs and symptoms of NTM infection include:
- Joint pain
- Abdominal pain
- Difficulty breathing
- Muscle pain
- Weight loss
- Persistent cough or cough with blood
Infections have been linked to heater-cooler devices manufactured by the Sorin Group prior to September 2014, after testing conducted by the manufacturer in August of that year found M. chimaera contamination on the production line at the manufacturing facility. Once this discovery was made, the company added new cleaning and sanitation procedures to the production line, and further testing in June 2015 showed no signs of contamination.
FDA and CDC Warnings
The FDA and CDC have issued a number of safety communications, warning letters, and press releases concerning the risk of NTM infections associated with the use of Stockert 3T heater-cooler devices, including:
- In October 2016, the FDA updated a previous safety communication to provide new information regarding the risk of NTM infections related to the use of Stockert 3T Heater-Cooler Systems in patients who have undergone cardiothoracic surgical procedures, including cardiopulmonary bypass and open-heart surgery.
- Also in October 2016, the CDC issued a report concerning M. chimaera contamination related to heater-cooler devices in addition to a statement advising hospitals to alert potentially at risk patients about the risk of infection linked to heater-cooler devices, including the Stockert 3T.
- In May 2016, the CDC issued a guidance meant to assist health care facilities in identifying patients with NTM infections associated with the use of heater-cooler devices to ensure proper diagnosis and treatment of patients
The FDA also issued a warning letter in December 2015 to LivaNova PLC after inspections conducted at facilities in Germany and Colorado revealed significant issues related to its Stockert 3T Heater-Cooler Systems, including quality systems and premarket clearance violations.
Stockert 3T Heater-Cooler Recall
A New York Stockert heater-cooler lawsuit attorney notes that, although the company has not officially recalled the devices, the Sorin Group (now LivaNova PLC) issued a Field Safety Notice on June 15, 2015 to any and all affected customers who had undergone a cardiothoracic surgical procedure with a Stockert 3T heater-cooler device. According to the FDA recall database, the manufacturer acknowledged that there was a potential contamination of organisms, including Mycobacteria, in the company’s heater-cooler devices if the devices are not properly cleaned and disinfected.
How a New York Stockert Infection Lawyer Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by a defective Stockert Heater-Cooler device may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
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