Contaminated surgical devices subject of class-action lawsuit
By Colin Slark
A class-action lawsuit in the Superior Court of Ontario is in the works against the manufacturer of medical heater-cooler machines. The machines, made by the Sorin Group, maintain blood temperature for patients undergoing open heart surgery. Some machines were found to be contaminated with a form of potentially harmful non-tuberculous mycobacteria (NTM) that can lead to fatal infections.
Health Canada issued a warning on October 21, 2016 stating that heater-cooler devices of several makes and models were being investigated for links to NTM. The report says that NTM infection could appear “… months to years after cardiothoracic surgery.”
On February 17, 2017, Health Canada issued another alert specifically listing Sorin 3T devices manufactured before Sept. 2014 at Sorin’s Munich, Germany factory as being “at an increased risk of contamination with Mycobacterium chimaera.”
Health Canada says NTM are “… typically not harmful but in rare cases, they can cause infections in very ill patients, including those with compromised immune systems, and chronic diseases or health conditions.”
The Special Pathogens Laboratory (SPL) of Pittsburgh, Pennsylvania, that specialize in testing for waterborne pathogens, tested 89 Sorin 3T machines in the United States and Canada for NTM between June 2015 and December 2016. 33 out of 89 machines, or 37 per cent, tested positive for NTM.
With heater-cooler machines, the patient’s blood is circulated through temperature-controlled water tanks during surgery to keep warm. On some machines, these tanks were contaminated with NTM.
According to Jack Rihs, vice-president of laboratory services at SPL and author of the lab’s report on the tests on Sorin 3T devices, the machines’ fans were aerosolizing the contaminated water and spreading through the operating room.
“It was never intended for the water in these instruments to come in contact with the patient at all,” says Rihs, Rihs also says that other types bacteria were found in the water in 3T devices, but those have not been linked to cases of illness.
Sorin Group Deutschland GMBH, the devices’ manufacturer and LivaNova Canada, the Canadian branch of the company that owns Sorin are named as defendants in the suit. Law firms Flaherty McCarthy LLP and Waddell Phillips P.C., both located in Toronto, are representing the plaintiffs.
Speaking on behalf of Flaherty McCarthy LLP, Candace Mak says “When (Sorin) realized something was going on, our allegation is that they still didn’t deal with that situation.”
According to the Statement of Claim filed by the plaintiffs’ counsel and a 2015 United States Food and Drug Administration letter, LivaNova was first made aware of NTM infections following open heart procedures where Sorin 3T machines were used in 2014. LivaNova issued a recall for the 3T machines in June 2015.
In the most recent Statement of Claim, the plaintiffs are listed as looking for over $750 million in damages for past and future costs associated with NTM infection. The bacteria can lie dormant for some time before an illness manifests.
LivaNova and Sorin have yet to respond with a Statement of Defence. A request to LivaNova for comment was not answered by production time.
The class action suit was first filed on July 19, 2017 and is waiting until May of 2019 to see if it will be officially certified. On April 18, 2018, the suit was approved for funding by the Ontario Class Proceedings Fund, which helps those normally unable to afford joining a class action lawsuit the ability to join in exchange for the law firms representing the plaintiffs receiving a portion of the judgement.
Class action lawsuits are also being brought against LivaNova by patients in the United States, and by certain patients of the Montreal Heart Institute in Quebec. Allegations from the Statement of Claim have yet to be proven in court.