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Faulty jaw implant victims sue Health Canada

http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20070916/Jaw_implants_070916/20070916?
hubÊnada

Faulty jaw implant victims sue Health Canada

Updated Mon. Sep. 17 2007 9:03 AM ET

CTV.ca News Staff

Health Canada is facing an unprecedented class-action lawsuit. An
Ontario judge will allow a suit to proceed, that could involve more
than 2,000 people affected by jaw implants that disintegrated in their
bodies.

It's the first-time such a lawsuit has been given the go-ahead against
the federal department.

The suit alleges that Health Canada approved the Vitek TMJ implants
but failed to warn doctors and patients of potential consequences and
risks.

Alleged victims of the implants had them inserted because of muscular
pain where the jaw bone meets the skull. But some of the implants --
some inserted as long as two decades ago -- shattered, affecting the
patients' autoimmune systems. The broken implants allegedly began to
eat away at the patients' faces.

"It's almost like a flesh-eating disease where it kicks up and starts
eating all the tissue and all you can do is hedge it off where you can
see it," says Geri Templeton, who had the implant inserted in 1985.

Templeton's face has had to be reconstructed with more than 35 metal
pieces because of the defective implant.

"There's a big dent at the top of my skull where it's been eaten
away," she told CTV.

The Food and Drug Administration in the U.S. issued a recall so that
patients like Templeton could have them removed -- something Health
Canada did not do. That was grossly negligent, alleges one of the
lawyers behind the lawsuit, James Newland.

The company that manufactured the device went bankrupt in 1990, so
victims couldn't seek compensation from them. They chose instead to
sue Health Canada, alleging the agency has a responsibility for
protecting Canadians from defective medical products.

Newland says the suit, in addition to seeking compensation for
victims, is meant to send a message: "Health Canada does owe a duty to
Canadians who receive these devices," he said. "It is not enough to
sit back and let others try to warn us about these products. You
should be warning us."

Health Canada denies any negligence, saying: "The Attorney General of
Canada takes the position that no negligence on the part of Health
Canada caused or contributed to the alleged injuries of the
complainants as a result of these devices."

Judi Logan, another patient who had the implant inserted and now takes
more than a dozen pills each day to control chronic pain, wants Health
Canada to take responsibility. She says if the federal department had
taken action, she and others would not be suffering today.

"What happened should never have happened if Health and Welfare Canada
(sic) had been doing their job properly," said Logan.

Health Canada has appealed last week's Ontario Superior Court ruling.
Victims fear that if Health Canada wins the appeal, they'll have to
wait years before the suit is settled. They say they want the lawsuit
to force changes so that others don't suffer the same fate.

With a report from CTV medical specialist Avis Favaro and producer
Elizabeth St. Philip

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