HAVERFORD, PA (January 31, 2017) — ATTORNEY ADVERTISING — Chimicles & Tikellis LLP, with offices in Haverford, Pennsylvania and Wilmington, Delaware, is investigating a potential class action lawsuit on behalf of hospitals and healthcare providers that purchased heater-cooler devices manufactured by LivaNova (formerly the Sorin Group). Heater-cooler devices use temperature-controlled water to heat or cool a patient’s body during cardiothoracic, open-heart and other surgeries. While the water itself does not come into direct contact with the patient, there exists the potential for contaminated water 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. 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.”
In October 2016, the Centers for Disease Control and Prevention released a Health Alert Network Advisory that instructed hospitals to notify patients who underwent surgery where a Sorin 3T System was utilized of their increased risk of infection. It has been reported that at least sixteen hospitals in ten states have identified NTM infections among patients exposed to the heart surgery device. These incidents may subject these and other hospital systems to significant liability.
C&T is investigating whether hospitals and healthcare providers that purchased these machines have a cause of action against LivaNova to recover damages, including the costs associated with purchasing a replacement device, notifying patients of their potential exposure to infection, providing patient or medical monitoring, maintaining and cleaning the devices, and defending lawsuits filed against hospitals and healthcare providers by patients who were exposed to NTM. C&T successfully prosecuted a similar class action lawsuit on behalf of hospitals and healthcare providers that had to purchase replacement medical devices in light of their uncertain status before the FDA. In that case, Physicians of Winter Haven LLC, d/b/a Day Surgery Center v. STERIS Corporation, No. 1:10-cv-00264 (N.D. Ohio), C&T obtained a settlement valued at approximately $20 million on behalf of hospitals and surgery centers that purchased a sterilization device from STERIS that allegedly did not receive the required pre-sale authorization from the FDA.
Any hospitals or healthcare providers that purchased a Sorin 3T System can learn more about C&T’s investigation by contacting the attorneys below.