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.
Yesterday's ruling granted legal "certification" to the plaintiffs, a major hurdle in a class action that usually results in the defendant offering a settlement.
In his decision, Mr. Justice Maurice Cullity was quick to dismiss as "fanciful" federal arguments that he has left government regulators vulnerable to a flood of future litigation.
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.
It took a half-dozen junior "whistle-blowers" to leak the fact that their department was ignoring their warnings before the faulty implants were withdrawn, Mr. Legge said. "Most of the doctors and hospitals involved are effectively supporting this action, because they didn't know about the risk either," he added.
In his ruling, Judge Cullity noted that, should the case go to trial, it could be possible for the plaintiffs to argue that Health Canada's inaction "could only have encouraged the importer/distributor to believe that it could ignore its statutory obligations. ..."
The vast majority of the plaintiffs in the class action are women. They chose to have the implants inserted because they had been clenching their jaws in a way that caused them muscle pain.
"The implants sent their autoimmune system into chaos," Mr. Legge said. "The body started to destroy itself. Their best day is like undergoing a dental drill without an anesthetic."
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.
The lead plaintiff in the case, Kathryn Taylor, received her implant in 1988. The lawsuit was launched 11 years later. "She claims to have suffered catastrophic and irreversible adverse biomedical consequences that resulted in permanent total disability and loss of enjoyment of life," Judge Cullity said.
The implants were manufactured in the U.S. and marketed under the trademark Proplast.