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September 19, 2007

Jaw-implant class action given the go-ahead

An Ontario Superior Court judge has given an unprecedented green light to a class-action lawsuit against the federal government over jaw implants that disintegrated, leaving an estimated 2,600 people suffering a lifetime of intense, chronic pain. The case, which could result in settlements worth hundreds of millions of dollars, is the first in which a court has penetrated a seemingly impregnable immunity enjoyed by Health Canada regulators when it comes to faulty medical devices. The implants were manufactured in the U.S. and marketed under the trademark Proplast. A lawyer for the plaintiffs, John Legge, said in an interview that Parliament has a moral obligation to move quickly to settle the case and compensate the victims. The conduct of senior Health Canada officials in the case was unconscionable, Mr. Legge said. Despite being told the implants could break down and "cannibalize" bone and soft tissue at the base of each victim's skull, Health Canada failed to issue warnings or take action to get the devices off the market, he said. The lawsuit specifically alleges that the Health Canada employees negligently approved the Vitek TMJ implants under the Food and Drugs Act, and that they failed to warn doctors and patients of potential risks.

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