Sorin Heater-Cooler Devices – Healthcare Provider Class Action Investigation
Chimicles & Tikellis is investigating a potential class action lawsuit on behalf of hospitals and healthcare providers who purchased heater-cooler devices manufactured by LivaNova (formerly the Sorin Group). Heater-cooler devices are used during cardiothoracic, open-heart and other surgeries to warm or cool a patient’s body to optimize medical care. The devices do this by using temperature controlled water. While the water itself does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or to transmit bacteria through the air.
The Food and Drug Administration (FDA) has recently stated that it is “aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.” NTM infections can cause serious health complications, including death. The Penn State Milton S. Hershey Medical Center recently notified approximately 2,300 patients who had surgeries at the hospital between November 5, 2011 and November 5, 2015 that they may have been exposed to the bacteria. The hospital has already confirmed that three of its heart surgery patients have acquired NTM, two of whom have died. Similarly, WellSpan York Hospital has been sending similar notifications to its surgery patients. That hospital reportedly identified eight open-heart patients who have been infected with NTM; five of those patients have died. These incidents may subject these and other hospital systems to significant liability.
In October of 2015, the FDA sent a notice to hospitals and healthcare providers to provide them with “heightened awareness about infections associated with heater-cooler devices and steps health care providers and health facilities can take to mitigate risks to patients.” Among other things, the FDA recommended a series of disinfection and cleaning protocols for healthcare providers to follow. The original cleaning processes consisted of about six steps; the new process is approximately 56. More recently, the FDA sent LivaNova a Warning Letter indicating that the company did not provide adequate information about how its new cleaning procedures prevent biofilm from growing in the devices or causing waterborne infections. The FDA also told the company that it may prevent the entry of new heater-cooler devices into the country until these issues are corrected.
C&T is investigating whether providers that purchased these machines may have a cause of action against the manufacturer, LivaNova. If you have purchased one of these heater-cooler devices please contact us to discuss this investigation.