Two Open-Heart Surgery Outcomes Involving Stockert 3T Heater-Cooler System

April 29, 2022, 9:15AM. By Jane Mundy

LawyersandSettlements receives two open-heart surgery claims involving the Stockert 3T Heater-Cooler

Santa Clara, CAThe chances of developing an infection after cardiac surgery is slim – an estimated 1 in 5,000 patients who had heart valve surgery and even lower for other types of surgery. But that percentage is higher if a Stockert 3T Heater-Cooler was used during surgery. Rod says he hasn’t recovered from his heart surgery and Carol’s husband died from infection. Now they are pursuing a claim against Sorin, the heater-cooler device manufacturer.   

Carol (not her real name pending a lawsuit) and her husband were wintering in Laguna Hills, California (Canadian ‘snowbirds’) when he complained of heart pain. “We rushed him to Saddleback Medical Center where he had open-heart surgery,” says Carol. “While he was recovering in the intensive care unit, my husband developed all kinds of infections, just two days after the procedure. He was in that hospital for 10 days and they moved him to rehab for three weeks. We finally returned home to Edmonton on New Year’s Eve -- soon as he was able to travel -- but he couldn’t shake the infections and he never got better.” Her husband was admitted to the University of Alberta hospital where he passed away. The cause of death was infection of the sternum and outside wall of the heart. Carol says the infectious diseases doctor at U of A is investigating his death because there are also cases of infection involving the heater-cooler device at that hospital.

“No one at the Saddleback hospital mentioned the Stockert 3T Heater-Cooler system and I never even knew about this machine until a year ago – it seems too coincidental,” says Carol. Unless of course, her husband was that one in 5,000 patients. “To make matters worse, he had heart pain when we came back to Canada and the surgeons here think the open-heart operation wasn’t needed.”

Rod, a Wisconsin man, knew the Stockert 3T Heater-Cooler was used during his open-heart surgery. “I received a letter from my doctor soon after surgery explaining about the recall but that’s all I heard,” says Rod, “and I’ve second-guessed my medical issues ever since. I’ve been a truck driver for 15 years and led an active life, until the surgery – it took the wind out of me. Now I can’t work and I’m only 47 years old.” Rod adds that, after he did some research and talked with his doctor, he also developed anger upon discovering that Liva Nova, the heater-cooler manufacturer, knew its device was defective some time before issuing a recall. “As well, my doctor said I could have picked up a nontuberculous mycobacterium (NTM) infection during surgery but I might not have symptoms for years. Meanwhile, I want to file a lawsuit but do I have to be on my deathbed to do so?”

In April 2021, Law360 reported that the Third Circuit revived a heart surgery patient's suit against the former Sorin Group USA over claims that its heating-cooling device put him at risk of contracting bacterial infections, saying a lower court's dismissal wrongly kept him from proceeding with his allegations in any court. A federal court's dismissal of Kyle Hamer's case against Sorin — now known as LivaNova Holding USA Inc.—was reversed. It had been part of multidistrict litigation claiming Sorin failed to warn consumers of risks associated with its 3T heater-coolers during open-heart surgeries. Hamer’s case was tossed because he couldn’t prove that he had NTM, a diagnosis required by the district court. The dismissal, however, was with prejudice. Hamer said it "hobbled his ability to proceed in any court under a theory of injury that, while perhaps too factually distinct from other 3T-related cases to remain in MDL 2816, may still state a prima facie claim against LivaNova," and noted by the appellate panel, which also said Hamer’s dismissal “was an abuse of discretion, finding that the lower court…deprived Hamer of the opportunity to litigate his claims in any venue without consideration of how they might fare outside the MDL context."

In June and October of 2016, the FDA issued a warning about the Stockert 3T Heater-Cooler System after it received reports of Mycobacterium chimaera (M. chimaera) infections linked to use of the devices in cardiothoracic surgeries. Patients who received a heart valve, graft, left ventricular assist device or other prosthetic product during surgery face the highest risk of bacterial infections, the FDA stated.

Carol is finally getting rid of her husband’s belongings, but she is holding on to his medical reports, which she hopes to share with a lawyer willing to take on her case. “It’s been years since he passed and after a while you just say enough already, it’s time to move on with my life,” adds Carol, but if the manufacturer of the device and the hospital were at fault, I want to pursue a lawsuit.”