Contaminated medical devices used in open-heart surgery caused severe infection in patients
Class-action lawsuit alleges device manufacturer failed to adequately warn hospitals of risk
Paul Johnson always knew he'd need surgery on his heart after doctors discovered a defect in his aortic valve when he was 15 years old. In October 2015, at the age of 62, he finally had that procedure at the Mazankowski Heart Institute in Edmonton.
Now, the 68-year-old sits in constant pain, unable to move freely around his house on his own. He takes a cocktail of antibiotics and painkillers every day, and his wife, Cathy Johnson, has become his full-time caregiver.
During that open heart surgery in 2015, Johnson was exposed to a slow-growing bacteria, called M. chimaera, that has ravaged his body.
"The hardest thing is seeing somebody you love in a lot of pain and not being able to do the things that they want to do in life," said Cathy.
Johnson is part of a class-action lawsuit that was launched because contaminated medical devices used in open heart surgeries led to serious, and in some cases deadly, M. chimaera infections.
Approximately a dozen former patients with confirmed infections or their families are part of the suit against LivaNova, formerly known as Sorin, the manufacturers of the Sorin 3T Heater-Cooler System, a medical device used to regulate the temperature of fluids during open heart surgeries.
The water tanks on the Sorin 3T Heater-Cooler System were contaminated with M. chimaera at the manufacturing facility in Germany, according to the lawsuit, which has been certified by an Ontario Superior Court judge.
M. chimaera is a common bacteria found in the environment, in soil and water. Although it rarely leads to infection in humans, when it does, it can be deadly.
"It's an incredibly serious infection,'' said Dr. Stephanie Smith, director of infection prevention and control at the University of Alberta. "The mortality [rate] is incredibly high."
The heater-cooler medical device, which is essential in open heart surgeries, did not come into contact with patients.
Instead, the lawsuit alleges, a fan on the machine aerosolized contaminated water from the device's tanks into the operating rooms.
"[The bacteria] landed in the open chest of patients, or on some kind of prosthetic material that was being put into the patient at the time of their surgery," said Smith, who's part of the team overseeing the treatment of infected patients in Alberta.
Number of cases in Canada still unknown
The number of M. chimaera infections related to the heater-cooler devices in Canada is unknown, although there are confirmed cases in Alberta, Ontario and Quebec.
According to the lawsuit, the last device with a risk of contamination was pulled from service in July 2018, but symptoms can take up to five years before they begin to show.
"There's still the possibility of more people becoming infected," said Margaret Waddell, one of the lawyers in Toronto leading the class action.
The action covers plaintiffs who may have been infected between January 2010 and July 2018, when the devices were used in 35 hospitals across Canada.
In March 2019, LivaNova paid $225 million to settle similar lawsuits in the United States. Under the agreement, LivaNova made "no admission of liability."
In a statement to CBC News, LivaNova said over the past several years it has "implemented a device remediation plan to address the use of heater-coolers during open-heart surgery to further mitigate the already low risk of contamination."
But Waddell said the company downplayed the risk of harm.
"If they had said to pull the machines sooner, there would have been a year and a half of people that weren't exposed to infection,'' said Waddell.
"There could have been fewer deaths … but now we have to deal with the consequences of that not happening."
Infections rare, but deadly
One of those deaths was Sheila Hagan-Bloxham's husband of 52 years, John Bloxham.
"John was not a person who had a vengeful bone in his body. He would not like the idea of being involved in a lawsuit," said Hagan-Bloxham. "But he would be adamant that he did not want this to happen to anybody else."
Bloxham had surgery for an aortic valve replacement in April 2016 at the Mazankowski. He died as a result of M. chimaera infection in January 2018, two months after doctors confirmed he'd been infected. By then, it had spread to his bone marrow and his brain.
WATCH | Sheila Hagan-Bloxham recounts some of her final moments with her husband:
M. chimaera is a difficult infection to diagnose. Initial symptoms are generally nonspecific, such as fatigue, fever and night sweats. Because it can take years for symptoms to present, the infection has often already spread by the time it is discovered.
"And then it can be incredibly difficult to treat and to cure," said Smith.
In Alberta, there have been 10 confirmed cases of M. chimaera infection related to open heart surgeries. Eight of the patients have died, said Smith. The surviving two spoke to CBC News.
2 Alberta patients still alive
Initially, Paul Johnson's recovery after his surgery was going well.
"I met with my cardiologist on a regular basis doing stress tests. Everything seemed to be progressing nicely."
He stayed active, biking to work and spending his free time building a small lakefront cabin.
But four years after his surgery, that started to change. Johnson was short of breath and stamina and developed inexplicable tremors.
It didn't take long for doctors at the Mazankowski to link his symptoms to his 2015 surgery. Johnson was put on several antibiotics and underwent surgery to remove the infected tissue from his heart.
But it was too late. The M. chimaera had spread to his bloodstream, his brain, his spleen and his spine.
"It's a devastating infection," said Cathy.
Johnson has had two spinal surgeries to remove the infection, but his most recent PET scan showed the surgeries didn't work. The Johnsons are hoping doctors can find another treatment.
"To find anything new is kind of a Hail Mary at this point," said Cathy.
WATCH | Paul Johnson is living in chronic pain from M. chimaera infection:
Parker Schmidt, a 27-year-old farm worker from Barrhead, Alta., was the first confirmed case of M. chimaera in Alberta, after having surgery in 2015 to fix an aortic valve.
He's since had two additional surgeries to remove infected tissue from his heart. For now, the infection is at bay with antibiotics. But his fears for the future led him and his wife Jill to join the class-action lawsuit.
"No insurance company will touch me with a 10-foot pole," he said. "If I were to die tomorrow, Jill's not left with anything really. And our kids are left with nothing."
Company issued notice in 2015
LivaNova became aware of the contamination at the manufacturing facility in 2014, according to the class action.
In June 2015, the company told hospitals and Health Canada that bacteria could be aerosolized when the device was in operation.
LivaNova said the "disinfection practices … that some users have been performing are not always conducted according to our instructions."
The notice advised hospitals to change the water tanks daily, disinfect the equipment and test the water for bacteria.
"They breached their duty to warn by underplaying the risks of harm, by saying you're not cleaning the machines properly, it's not us, it's you," said Waddell.
Emails obtained by CBC News show that two months later, the company wrote to Health Canada saying it had contacted all hospital customers and considered the matter closed.
A Health Canada compliance officer agreed, writing: "I agree that this recall can be considered closed at this time."
But further emails show that various health regions wrote to Health Canada, raising issues with the practicality of LivaNova's recommendations. They said the process for decontaminating the devices was not working and they were having difficulty finding a lab to test the water.
Internal emails show the Health Canada compliance officer dismissed the latter complaint, writing: "I can only assume [the health region] didn't ask the company."
In a statement to CBC News, Health Canada said "directing health regions to the manufacturer was necessary to ensure that the manufacturer could investigate customers' concerns and support them in resolving contamination issues."
On Oct. 21, 2016, Health Canada sent out a "risk communication" warning of infections linked to various heater-cooler devices.
Health Canada reminded hospitals to follow the manufacturer's cleaning instructions, and advised that any devices suspected of contamination should be removed "from the operating room, or if feasible, from service as soon as practical."
A week prior, the U.S. Food and Drug Administration had sent out a notice telling hospitals to immediately pull any device that had tested positive for M. chimaera, and urging them to "strongly consider" not using the devices for open chest cardiac surgery.
That was, at that point, the fourth notice issued by the FDA, after it inspected the manufacturing facility in Germany and previously warned surgeons to remove devices that "may indicate bacterial growth."
WATCH | LivaNova didn't provide adequate warning soon enough, says lawyer:
"Health Canada, certainly in this case, was not proactive in the same way that the FDA was," said Waddell.
"They expect the manufacturers to be honest, and truthful and forthcoming," said Waddell.
"But all it takes is any particular manufacturer to downplay, underplay or not disclose an issue and Health Canada doesn't have the ability to double check what they're hearing."
In February 2017, Health Canada issued a second, stronger notice, saying any LivaNova heater cooler devices manufactured before 2014 should be removed from service altogether.
"The regulated party is responsible for initiating all aspects of the recall, including notifying customers," a spokesperson for Health Canada told CBC News. "Health Canada oversees and monitors recalls to ensure that all regulatory requirements are being met."