The national law firm of Baron & Budd is investigating potential lawsuits against the manufacturers of heater-cooler devices used during many open-heart surgeries.
Plaintiffs may be able to file a non tuberculous mycobacteria lawsuit if they developed an infection after undergoing a surgical procedure involving the use of the device.
A heater-cooler device is a piece of equipment used during an open-heart procedure to keep the patient’s organs at a safe temperature, and also to help ensure proper circulation of the blood. However, some of the devices have allegedly become contaminated with nontuberculous bacteria, which have then entered patients’ open chest cavities and led to severe – and potentially fatal – infections.
On October 13, 2016, THe Washington Post reported that as many as 500,000 patients across the U.S. could be at risk.
LivaNova PLC, formerly known as Sorin Group Deutschland GmbH, is one of the companies that manufacture heater-cooler devices. LivaNova’s Stockert 3T Heater Cooler System is used in approximately 60 percent of the estimated 250,000 open-heart surgeries performed in the U.S. each year.
The source of the alleged contamination in heater-cooler devices is the water reservoir, which can spray water into the air of an operating room and enter the patient’s body. The Post reported that 12 patients in one Pennsylvania hospital have developed infections linked to the device and six have died as a result.
On October 14, 2016, the Centers for Disease Control issued a statement that even though thousands of patients have been notified of their potential risk of developing an infection, the number of people who have been exposed could be much larger.
The same day, the US Food and Drug Administration issued a Safety Communication advising healthcare providers on ways to reduce the chances of infections linked to contaminated devices.
“Thousands of patients could have been exposed to a dangerous infection without even knowing it,” said Russell Budd, president and managing shareholder of the national law firm of Baron & Budd.
“We are ready to take action against any companies that negligently manufacture dangerous devices that put people’s lives at risk.”