Family blames KU Med and maker of heart surgery device in deadly infection trial
AI-generated summary reviewed by our newsroom.
- Plaintiffs allege a heater‑cooler device at KU Med was contaminated and caused infections.
- About 17 lawsuits have resulted in confidential settlements with the hospital.
- LivaNova's defense says KU Med stopped disinfecting units, causing the outbreak.
Attorney Lynn Johnson stood before jurors in a Kansas City, Kansas, courtroom Tuesday afternoon and motioned to a metal device on wheels that was sitting in front of them.
“You’re probably wondering what this is doing here,” he said of the box-shaped unit that stood about 3 feet tall. “This is a 3T Heater-Cooler device.”
It’s in the courtroom, Johnson said, because during Stephen Nolte’s open-heart surgery at The University of Kansas Hospital in 2019, a device just like it emitted deadly bacteria that had been in the machine since it was manufactured and then delivered to KU Med in 2017.
As a result, Johnson said, Nolte developed a deadly infection called Mycobacterium chimaera, or M. chimaera. After enduring a long list of health complications, Johnson said, Nolte died on July 8, 2020.
Johnson was presenting the opening statements in Wyandotte County District Court in a trial over the allegation that a contaminated heater-cooler device used during Stephen Nolte’s surgery led to the infection that claimed his life.
The trial, which is expected to last about three weeks, got underway on Monday, with attorneys selecting the jury from a pool of about 100. The plaintiffs’ first witnesses will begin testifying on Wednesday.
Nolte’s widow, Christine, and their son, Christopher, filed a lawsuit in 2021 against The University of Kansas Hospital Authority and LivaNova USA Inc., the med-tech company that manufactured the heater-cooler device.
The lawsuit alleged wrongful-death and personal injury claims against The University of Kansas Hospital Authority and negligence and product liability claims against LivaNova USA Inc.
The University of Kansas Hospital Authority settled with the Noltes last week, and District Court Judge Courtney Mikesic approved the confidential settlement on Monday, dismissing KU Med as a defendant. According to a court filing, no admission of liability was made.
Johnson told jurors Tuesday that his firm was representing Christine and Christopher Nolte in the lawsuit. Both were sitting with the attorneys in the courtroom. But the law firm also is representing Stephen Nolte, Johnson said.
“Steve went through hell for about eight months before he died,” he said.
Attorney says 30 KU Med patients infected
Nolte wasn’t the only KU Med patient who contracted the infection, Johnson said. Twenty-nine more patients developed M. chimaera in the same time frame. And all, he said, were found to have the same point source of contamination.
“That point source is from the manufacturing plant at LivaNova,” he said.
Nolte’s case is among more than two dozen lawsuits that The Star reported last month have been filed in Wyandotte County District Court against The University of Kansas Hospital Authority and LivaNova.
The lawsuits allege that 25 patients at The University of Kansas Hospital contracted the M. chimaera infection after undergoing open-heart surgery involving a heater-cooler device that hadn’t been properly disinfected.
In those cases, 11 of the patients died, and others are living with life-altering health problems, according to the lawsuits. About 17 of the cases have resulted in confidential settlements with The University of Kansas Hospital Authority, court filings show.
During Johnson’s hour-long opening statement, jurors got a crash course on heater-cooler devices. A heater-cooler device contains pumps that circulate water during bypass procedures to regulate a patient’s temperature.
The units are used in conjunction with a heart-lung machine, which takes over the function of the heart and lungs during surgery. Studies found that in contaminated heater-cooler devices, the aerosolized vapor is pushed out of the water tanks by exhaust fans, spreading bacteria through the air in the operating room. That bacteria can then enter a patient’s open cavity, leading to infection.
Nolte, of Raytown — a U.S. Navy veteran and electrician — underwent an aortic valve replacement at The University of Kansas Hospital on March 6, 2019, Johnson said.
He said that the heater-cooler device used in his surgery was contaminated with M. chimaera when it was manufactured in Germany and that the hospital’s perfusion staff — those in charge of operating the units — had failed to disinfect it since October 2018.
“Was that negligence?” Johnson asked. “Yes.” But KU Med wasn’t the only entity at fault, he said.
In 2014, he said, a doctor in Switzerland first reported that airborne infections could be traced to the heater-cooler devices. In October 2016, reports surfaced in the U.S. about contamination in Pennsylvania and Iowa.
Since then, Johnson told jurors, “There has been worldwide reporting in peer-reviewed literature of M. chimaera infections from people exposed to heater-cooler devices.”
“This is something that’s happening all over the world.”
LivaNova gives KU Med 5 new heater-cooler units
To reduce the risk of spreading M. chimaera, LivaNova developed a vacuum seal upgrade for the heater-cooler units. The upgrades were available in Europe as early as May 2017, Johnson said, but not in the U.S. until October 2018.
In late June 2017, Johnson said, LivaNova gave KU Med five new “loaner” heater-cooler devices. They came with detailed instructions for use that included adding hydrogen peroxide to the water in the tanks and disinfecting them with bleach every two weeks. The hospital staff followed those instructions until October 2018, Johnson said, then stopped.
And in the spring of 2019, the hospital had an M. chimaera infection in a heart surgery patient. Then another, and another. The hospital contacted the Kansas Department of Health and Environment, Johnson said, which in turn called in the Centers for Disease Control and Prevention. In December 2019, they conducted an inspection at The University of Kansas Hospital, taking samples from two heater-cooler devices — including one used in Nolte’s surgery.
That unit had been fitted with the vacuum seal upgrade in the months after Nolte’s surgery, Johnson said, but KU Med’s other four units did not receive the seals.
The investigators found M. chimaera in the water tanks and in the operating room air in the device without a vacuum seal. But in the device with a vacuum seal, Johnson said, they found M. chimaera only in the water tank — it hadn’t spread into the air.
He said the CDC found that the M. chimaera in the water tank, the air in the operating room and in the patients was all the same kind — and the source was the LivaNova 3T Heater-Cooler Device made in Germany.
Johnson told jurors that three experts would testify that the M. chimaera strain at KU Med came from the LivaNova manufacturing plant.
Johnson said the Noltes are claiming that the design of LivaNova’s heater-cooler device was dangerous because it allowed the release of M. chimaera into the operating room, “which caused or contributed to cause” Stephen Nolte’s death. They also are claiming that the defect was in the manufacturing process, Johnson said.
In addition, the Noltes allege that LivaNova was negligent because when it loaned the devices to KU Med, it knew that strict adherence to the water tank cleaning process was necessary to lower the risk of infection, Johnson said. But the company did not implement any kind of monitoring or quality control to ensure the loaners were being properly maintained by KU Med, he said.
And when the vacuum seals were available, Johnson said, LivaNova did not install them on four of the five loaner devices at KU Med.
Those “acts of negligence,” he said, caused or contributed to the cause of Nolte’s death. He said jurors would decide what percent KU Med and LivaNova contributed toward the death.
LivaNova denies fault, blames KU Med
As LivaNova attorney David Gross began his 90-minute opening statement, he told jurors that the plaintiffs and defendants were in agreement on one key issue: KU Med was at fault.
“KU is negligent,” he said. “That’s established.”
Gross said the Noltes’ contention that LivaNova’s problems with the aerosol emissions in their heater-cooler devices were unique was inaccurate. He named three other companies that have come under fire from the Food and Drug Administration for failing to resolve problems with their heater-cooler devices.
The only thing unique about LivaNova, Gross said, is that unlike other companies’ devices, it’s approved by the FDA.
Gross also told jurors that KU Med is still working with LivaNova and using its units.
He said the heater-cooler units were released in the United States in 2006 and have been used in hospitals for years. The devices work with the heart-lung machines during surgeries to extend or save people’s lives, he said, adding that “LivaNova is one of the leaders of heart-lung machines.”
He noted that when LivaNova learned of the concerns with its heater-cooler units, it notified the FDA. He said the FDA investigated the matter and in June 2016 issued a notice saying there was a possibility of infection from the water tanks, but that the benefits of the devices outweighed the risks. The FDA told hospitals they could continue using the units but needed to strictly follow the cleaning instructions, he said.
Gross disputed the plaintiffs’ allegations that the new loaner machines it provided to KU Med were contaminated. He said LivaNova had improved its manufacturing process in September 2014, disinfecting the units with ethanol and drying them before they were shipped to hospitals. Gross added that the device used in Nolte’s surgery was brand new.
“We don’t think there’s evidence that these new machines were contaminated,” he said.
Gross placed the blame on KU Med, saying it failed to follow the specific instructions for using the devices.
Years before Nolte’s surgery, LivaNova — then called the Sorin Group — told hospitals that there was a possibility of bacteria being emitted into the air and that it was crucial to keep the water clean, Gross said.
In June 2015, he said, The University of Kansas Hospital’s chief perfusionist, Jamie Newberry, signed a document saying the staff understood the instructions. LivaNova sent KU Med a notice in August 2015, Gross said, reminding them that M. chimaera can be emitted into the air and to follow the instructions for cleaning. Another notice went out in January 2016, Gross said, and another in October 2016.
In addition, Gross said, the FDA had told KU Med in October 2015 that it was critical to disinfect the units to minimize the risk of bacterial growth and patient infection. He said the FDA told the hospital to develop a monitoring program to ensure the cleaning was being done properly.
Gross said the CDC also told KU Med to make sure to follow the instructions for disinfecting.
When LivaNova gave the hospital the new loaner units, Gross said, Newberry signed a contract agreeing to clean them according to the instructions.
From July 1, 2017, through Oct. 16, 2018, Gross said, KU Med carefully followed the cleaning instructions and kept meticulous records about the process. And during that period, he said, there were no confirmed cases of M. chimaera infections from open-heart surgeries.
But then the hospital stopped disinfecting the units, Gross said. Once that happened, he said, “they had an outbreak” of M. chimaera infections. Nolte’s was among them.
It was, Gross said, a “complete system breakdown.” He said Newberry’s response to the outbreak was, “‘This is truly confounding. We haven’t changed anything on our end.’”
But when KU Med began disinfecting the heater-cooler units again, Gross told jurors, “They had to reorder bleach.”
“It was gone.”
