Manufacturer on trial over fatal infection linked to surgery device at KU Med
A trial got underway on Monday in Wyandotte County District Court in a case involving a family’s allegation that a contaminated device used during open-heart surgery at The University of Kansas Hospital led to an infection that killed their loved one.
About 100 potential jurors packed the Kansas City, Kansas, courtroom Monday afternoon for the jury selection process. The trial is expected to last three weeks.
Christine Nolte, the widow of Stephen Nolte, along with the couple’s son, Christopher, filed a lawsuit in 2021 against The University of Kansas Hospital Authority and LivaNova USA Inc., the 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 prior to the trial. District Court Judge Courtney Mikesic approved the settlement on Monday and dismissed The University of Kansas Hospital Authority as a defendant. The dismissal was issued “with prejudice,” meaning the case is permanently closed and can’t be refiled. Each side is to bear its own costs, the order said.
LivaNova has declined to settle and told The Star last month that “we are vigorously defending the product and company actions in these cases.”
The lawsuit is among more than two dozen that The Star reported last month have been filed in Wyandotte County District Court against The University of Kansas Hospital Authority and LivaNova. The Star found 31 lawsuits alleging that 25 patients at The University of Kansas Hospital contracted the infection — which is caused by a bacterium called Mycobacterium chimaera, or M. chimaera — 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.
An additional lawsuit was filed in January in federal court in Kansas City, Kansas, against LivaNova and an employee at The University of Kansas Hospital, called a perfusionist, who was in charge of the heater-cooler device during the surgery of a patient who later died.
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 heart 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.
Settlement with KU Med
Stephen 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, the lawsuit said.
It said that the heater-cooler device used in his surgery was contaminated with M. chimaera when it was installed at the hospital on June 28, 2017. The hospital, the lawsuit said, failed to follow “the specific recommendations to minimize or eliminate the unreasonable risk of airborne transmission” of M. chimaera through the heater-cooler device used during Nolte’s surgery.
As a result, the lawsuit alleged, Nolte contracted M. chimaera infection and died on July 8, 2020.
The confidential settlement agreement between the Noltes and the University of Kansas Hospital Authority was confirmed in court documents and during a hearing last week in Wyandotte County District Court.
“Plaintiffs have agreed to dismiss all claims against Defendant UKHA with prejudice pursuant to the terms of the Agreement,” said a motion filed April 7. “No admission of liability is made.”
Lynn Johnson and Matt Birch, attorneys with the Shamberg, Johnson & Bergman law firm in Kansas City, which is representing plaintiffs in eight ongoing infection cases in Wyandotte County District Court, declined to comment on the settlement agreement.
