A certified class action lawsuit has been filed against Health Canada for allegedly approving the use of Vitek TMJ implants without warning doctors and patients of potential consequences and risks. More than 2,000 people have had the jaw devices implanted over the past two decades due to muscular pain where the jaw bone meets the skull. The lawsuit was filed in Ontario Superior Court and claims Vitek TMJ implants shattered and began to disintegrate into patients bodies, sometimes eating away at their faces.
The United States Food and Drug Administration issued a recall so that patients could have them removed, but Health Canada has not done the same. The company that manufactured the device went bankrupt in 1990, so victims were not able to seek compensation from them. Victims chose to sue Health Canada, alleging the agency has a responsibility for protecting Canadians from defective medical products.
"Health Canada has filed a notice for leave to appeal and the application will be heard at the end of November," says Toronto lawyer James Newland. "If the application is denied, the class action will proceed to trial and I am confident it will proceed. Assuming the leave is denied, then notification will go out to the entire classâ"within the next few months.
Currently, Newland knows of several hundred people who have been affected by these implants and is in direct communication with them. After notification, he expects more people to come forward.
The Vitek implants were employed by some oral surgeons throughout the 1980s. "What is unusual about these implants is that they had a 100% failure rate, and that in many cases, the consequences of the failure were catastrophic," says Newland.
How long did it take the dental community to realize these failures? "It depends on the specific patient," says Newland. "However, the devices started to fragment shortly after implant." The device was made from a combination of Teflon and Proplastâ"a deadly combination. The small microparticles set off a foreign body that caused a giant cell reaction and it is that particular reaction that led to the catastrophic consequences.
"A lot of people lost their skull bases," adds Newland. "The implant won't kill you per se but the pain involved is extremely debilitating so a lot of these victims have been left totally disabled." In the US there were about 12,000 Vitek implants before the company filed bankruptcy.
There were a number of lawsuits against Vitek, based in Texas, before they went bankrupt. "There was a settlement in the Methodist Hospital class actionâ"they were involved in the R&D and design of the implants, says Newland, "and there was a successful class action settlement in Canada against the Canadian distributorâ"Instrumentarium--in the late 1990s.
