A new lawsuit has been filed in Connecticut over a bypass surgery infection.

The plaintiff, Debra S., is holding LivaNova PLC, Sorin Group USA Inc., and Sorin Group Deutschland GMBH liable for an infection she sustained after surgery. She believes her infection was a result of the use of a Stockert 3-T Heater-Cooler in her bypass surgery.

Debra says she had a quadruple bypass procedure on her heart on Oct. 5, 2012 at Hartford Hospital. She claims that a Stockert 3-T Heater-Cooler device was used during the surgical intervention to regulate her body temperature. This device provides temperature-controlled water that doesn’t come in contact with the patient but is funneled to a heat exchange device to warm or cool a patient as needed.

Within a 14-day time window of the quadruple bypass surgery, Debra says she was readmitted to the hospital and subjected to a second surgery because of a bypass surgery infection. The bypass surgery infection allegedly reappeared after this surgery and required yet another medical intervention towards the end of December of the same year.

Debra says that the heater cooler device manufacturer knew about the risk of infection, but failed to warn patients and the medical community. She is asking for a trial by jury, compensatory damages and assessment of punitive damages against all the named defendants.

The History of the Stockert 3T Heater Cooler Device

The Stockert 3T heater cooler was essentially given approval to enter the market based upon the track record of a previously proven and substantially similar device through the U.S. Food and Drug Administration’s (FDA) section 510(k) program. This program is highly controversial because the process does not subject the device to same safety trials as a new device.

In the case of the 3T, Sorin used the 510(k) process and was notified of approval in the early summer of 2006. Five years later, inspectors visited the facilities in Germany where the device is manufactured and discovered several anomalies. These anomalies related to the way the device was designed that could result in the development of bacteria in the water tank. Sorin had also created cleaning protocols that weren’t based upon U.S. availability of products or water conditions.

A subsequent investigation of the manufacturing site in 2014 revealed the presence of mycobacteria in the facility. Mycobateria infections are difficult to resolve and present an extreme risk to surgery patients. Information regarding these results were released in a safety communication from the FDA a full two years later in early summer 2016.

In the fall of that same year, the Centers for Disease Control and Prevention identified the Stockert (Sorin) 3T heater cooler as a risk for infection after cardiac surgery.

According to Debra’s lawsuit, the defendants knew or should have known of the potential for their device to promote water tank bacterial growth and recalled the design. Instead, Sorin continued to promote and sell the device in the United States.

The Stockert 3T Lawsuit is Case No. 3:18-cv-01446-RNC in U.S. District Court for the District of Connecticut.