Defense witness denies factory that made KU Med surgery device was source of infection
AI-generated summary reviewed by our newsroom.
- Defense witness said he didn’t believe the LivaNova factory was the source of infection.
- Nolte’s family alleged his 2019 open‑heart surgery led to infection; he died in July 2020.
- The University of Kansas Hospital Authority settled suit with no admission of liability.
The factory that manufactured the device used during a Raytown man’s heart surgery at The University of Kansas Hospital was not the source of the deadly infection that his family alleges claimed his life, a defense witness testified at a trial on Friday.
Robert Hancock, a researcher and professor in the Department of Microbiology and Immunology at the University of British Columbia, told jurors he reviewed stacks of scientific literature on M. chimaera along with the opinions of some doctors who said the “point source” of patient Stephen Nolte’s infection was the LivaNova plant in Germany where the heater-cooler devices were made.
Tim Grimsrud, an attorney for the medtech company, asked Hancock if he believed the theory that the Mycobacterium chimaera, or M. chimaera, came from the LivaNova factory.
“I do not believe that,” Hancock said.
Did Hancock hold his opinions on the matter “to a reasonable degree of scientific certainty?” Grimsrud asked.
“I do indeed,” Hancock replied.
Hancock’s testimony came on the 10th day of a trial in Wyandotte County District Court over the allegation that a contaminated heater-cooler device used during Nolte’s 2019 open-heart surgery was responsible for his death. Nolte died on July 8, 2020, at 71.
Hancock was the final witness for the defense, which wrapped up its case on Friday afternoon.
Closing arguments are planned for Tuesday. Jurors were given Monday off so attorneys could work with the judge on a lengthy set of instructions the jury will receive prior to deliberations.
University of Kansas Hospital lawsuit
Nolte’s wife, Christine, and the couple’s son, Christopher, filed a lawsuit in 2021 against The University of Kansas Hospital Authority and LivaNova USA Inc.
The lawsuit alleged wrongful death and personal injury claims against The University of Kansas Hospital Authority and negligence and product liability claims against LivaNova.
The University of Kansas Hospital Authority settled shortly before the trial, and District Court Judge Courtney Mikesic approved the confidential settlement on April 13, dismissing KU Med as a defendant. According to a court filing, no admission of liability was made.
LivaNova has denied it was at fault and said any damages sustained by the Noltes were caused by the negligence of KU Med, whose perfusionists failed to disinfect the heater-cooler units according to the specific instructions the company provided. The company also argued that Nolte had multiple underlying health issues that contributed to his death.
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.
Dozens of lawsuits filed over heart surgery problems
Nolte’s case is among more than two dozen lawsuits 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 heater-cooler devices 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.
The Noltes contended that the heater-cooler device had a defective design that made it possible for M. chimaera to be aerosolized into the operating room. They also alleged that the manufacturing process was defective because the device was contaminated with M. chimaera when it was delivered to KU Med.
LivaNova denied that the design was defective and said the Food and Drug Administration and the Centers for Disease Control and Prevention had concluded that the benefits the devices provided outweighed any risks. The agencies also said the heater-cooler devices were appropriate for continued use when its instructions for use were followed.
LivaNova said there was no evidence that the unit used in Nolte’s surgery was contaminated at the time of delivery. And it argued that there could have been other sources of M. chimaera, including the water at the hospital.
Witness cites other possible sources of infection
On Friday, Hancock — who said he was an expert in bioinformatics and has more than 80 patents based on his research — testified that there were “quite a few” scientific publications that disagreed with the theory that LivaNova was the source of the M. chimaera contamination.
He said that water samples taken at LivaNova’s manufacturing plant found a subgroup called 1.8 M. chimaera, not the subgroup 1.1 that has been connected to the infection outbreak.
One sample did contain subgroup 1.1, he said, but it was a mixed sample.
Hancock said a massive study on lung infections at a hospital in the United Kingdom showed that prior to the M. chimaera outbreak in heart surgery patients at KU Med, a strain closely related to the outbreak strain was circulating in patients with respiratory diseases.
He also cited a study that said the water used in hospitals for filling the heater-cooler tanks couldn’t be excluded as a source of the bacteria.
Cross-examination
During cross-examination, Nolte attorney Lynn Johnson asked Hancock if he believed that it was the patients who had contaminated the heater-cooler machines, not that the machines contaminated the patients.
Hancock said it was “quite possible that the patients contaminated the machines.”
He also said that M. chimaera subgroup 1.1 had been found in other heater-cooler brands and in non-cardiac surgery patients.
Johnson asked Hancock if he’d published a peer-reviewed article on his opinions expressed during his testimony. Hancock said he had not.
Johnson referred to an article written by numerous scientists about a study that said the M. chimaera contamination most likely occurred during the manufacturing process at LivaNova’s production site in Germany.
“I just cannot agree with this statement,” Hancock said, adding that “most likely” means it’s open for scientific interpretation.
When Johnson said that a medical doctor and infectious disease expert had testified that there were at least 29 patients who were infected with M. chimaera after their cardiothoracic surgeries at The University of Kansas Hospital, Hancock countered that one patient had become infected who hadn’t used a heater-cooler device.
He said that showed M. chimaera could come from other sources.
As the questioning was winding down, Johnson asked Hancock if he had been hired by LivaNova. Hancock acknowledged that he had. Then Johnson asked Hancock when he was first hired by LivaNova.
“About five years ago,” he said.
