Heater-Cooler Lawsuit

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.

Heater-Cooler Legal Reviews

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: What’s the Problem?

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.

Stӧckert 3T Heater-Coolers

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.”

Heater-Cooler Litigation

  • February 2016: A Heater-Cooler lawsuit  was filed in the U.S. District Court, Middle District of Pennsylvania, by two men who claim to have been exposed to dangerous bacteria while undergoing open heart surgery at Penn State Milton S. Hershey Medical Center and WellSpan York Hospital. According to their class action complaint, the men were allegedly exposed to the bacteria via Stӧckert 3T Heater-Coolers, and are seeking medical monitoring to screen for NTM infections
  • June 2016: the York Dispatch reported that at least two other claims – including a wrongful death suit — had been filed against the manufacturer of the Stӧckert 3T and WellSpan York Hospital as a result of the NMT outbreak.
  • September 2016: A South Carolina man who developed a dangerous bacterial infection following open-heart surgery is pursuing a lawsuit against the manufacturer of the Stöckert 3T Heater-Cooler device. Thomas Fowler underwent a cardiac bypass procedure on April 2, 2014 at the Greenville Health System Hospital (GHS). Two months later, he was diagnosed with an infection at the surgical wound site, forcing Fowler to undergo several more surgeries and antibiotic therapy. On July 21, 2014, GHS outlined safety measures for a “cardioplegia machine” connected to a rare form of NTM that had infected 14 patients during open- heart surgeries. At least four deaths were tied to the infections. Read More
  • January 2017: Plaintiffs pursuing lawsuit over infections allegedly caused by the Stöckert 3T Heater-Cooler System are seeking to have all such federal claims centralized in a single jurisdiction, preferably the U.S. District Court, District of South Carolina. A petition filed with the U.S. Judicial Panel on Multidistrict Litigation indicates that there are currently 15 heater-cooler lawsuits involving the Sorin 3T system pending in the federal courts around the U.S., ten of which have been filed in the District of South Carolina. Read More

Contact an Attorney Today

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.

  1. FDA (2015) “Heater-Cooler Devices: FDA Safety Communication – Use of Devices Associated With Nontuberculous Mycobacteria Infections” http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm467151.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
  2. com (2015) “Penn State Milton S. Hershey Medical Center warns 2,300 open-heart patients of infection risk” http://fox43.com/2015/11/10/penn-state-milton-s-hershey-medical-center-warns-2300-open-heart-patients-of-infection-risk/
  3. com (2016) “Three Philly heart patients among 20 in Pa. diagnosed with rare infection” http://www.philly.com/philly/health/Three-Philly-heart-surgery-patients-diagnosed-with-rare-infections.html
  4. FDA (2016) “Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stӧckert 3T Heater-Cooler System: FDA Safety Communication” http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm504213.htm
  5. FDA (2016) “UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System: FDA Safety Communication” http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/UCM520191.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
  6. York Dispatch (2016) “Suits allege negligence by York Hospital, device manufacturer” http://www.yorkdispatch.com/story/news/health/2016/06/27/lawsuits-negligence-york-hospital-livanova/86436228/
  7. CDC (2016) “Contaminated Devices Putting Open-Heart Surgery Patients at Risk” https://www.cdc.gov/media/releases/2016/p1013-contaminated-devices-.html
Last Modified: February 6, 2017

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