Filing a Heater-Cooler lawsuit may be an option for patients who were diagnosed with a Nontuberculous Mycobacteria (NTM) infection following cardiothoracic surgery or other procedures that involved the use of a Stӧckert 3T or other Heater-Cooler device.
A number of Heater-Cooler lawsuits have already been filed in U.S. courts on behalf of patients who allegedly suffered harm due to bacterial contamination of a Stӧckert 3T or similar device. To learn more, please call (888) 994-5118 to discuss your case with a member of Bernstein Liebhard LLP’s legal team.
Heater-Cooler devices are used to warm and cool patients undergoing cardiac thoracic surgery and other medical procedures. These systems include tanks that provide temperature-controlled water via closed circuits to external heat exchangers or warming/cooling blankets. While the water never comes into direct contact with the patient, there is the potential for contaminated water to enter other parts of the apparatus. Bacteria may also travel via the exhaust vent into the air, where it could come into contact with the patient.
In October 2015, the U.S. Food & Drug Administration (FDA) issued a Safety Communication regarding a possible association between the use of Heater-Cooler devices and Nontuberculous Mycobacteria (NTM) infections. In November, Pennsylvania’s WellSpan York Hospital notified 1,300 former patients of possible NTM exposure related to these devices. A month later, Penn State Milton S. Hershey Medical Center notified 2,300 patients of the same risk. Similar outbreaks have since been reported at other facilities.
The FDA issued a new alert in June 2016, following publication of a study that suggested a direct link between Stӧckert 3T Heater-Coolers and a specific type of NTM infection (M. chimaera) that had been reported among open-chest cardiac surgery patients in Europe. The FDA noted that tests conducted at the Stӧckert 3T manufacturing facility in 2014 had detected M. chimaera bacteria on the production line and in the water supply. The FDA was trying to determine whether or not the same devices played any role in M. chimaera infections that had recently been reported among cardiothoracic surgery patients in the U.S.
The FDA issued a second alert in October 2016, after testing conducted by the U.S. Centers for Disease Control and Prevention (CDC) suggested a link between the U.S infections and the Stӧckert 3T Heater-Coolers. According to the CDC, about 60%, or 250,000, of all heart bypass procedures performed each year in this country utilize a Heater-Cooler device like the Stӧckert 3T system. The risk of contracting an NTM infection from these devices is “between about 1 in 100 and 1 in 1,000.”
Individuals who developed M. chimaera or other Nontuberculous Mycobacteria infections following surgery with the Stӧckert 3T or similar Heating-Cooing device may be entitled to compensation for medical bills, lost wages, pain and suffering, and more. To discuss filing a Heater-Cooler lawsuit with a member of our legal team, please call (888) 994-5118 to arrange for your free, no-obligation case review.
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