As most of us have already heard, last week a judge in Canada ruled that two women cannot sue over implants that leaked, ruptured and caused them catastrophic medical conditions and permanent disabilities.

Joyce Attis and Alexandra Tesluk were implanted with silicone gel Dow Corning breast implants.

Attis received one implant in 1972 and it was removed in 1992.

Tesluk received two implants in 1980 that were removed in 1994.

Both allege that their implants leaked or ruptured, causing them catastrophic medical consequences and permanent disabilities.

They allege the government was negligent in the regulation of breast implants and liable for their injuries.

Justice Warren Winkler of the Superior Court of Justice ruled against the suit on May 3, 2007, and awarded the women $125,000 in court costs.

Health Canada did not directly misrepresent or assure the long-term safety of the breast implants to individual consumers, the Ontario Court of Appeal said in rejecting the case.

“This is a case where Health Canada acted within its mandate in exercising its discretion regarding the enforcement of its regulatory regime,” the judges wrote. “It had no interaction with the appellants in the course of that role.”

The Appeal Court upheld the awarded costs.

Attis and Tesluk had claimed costs of more than $1 million.

Both women were members of a class of plaintiffs that sued Dow Corning Corp. and other breast implant manufacturers in an earlier and separate class proceeding.

Attis opted out of that proceeding in 1994.

Dow Corning was granted bankruptcy protection in 1995.

The manufacturer agreed to pay up to US$3.2 billion to settle claims from more than 300,000 women — including Canadians — who said they had been harmed by the product.

Tesluk only received nominal damages from the settlement, court heard.

After the settlement, Attis and Tesluk began the action against Health Canada on behalf of a putative class consisting of residents of Canada — except British Columbia — who received Dow Corning breast implants between 1962 and 1992.

This class is said to include approximately 29,500 individuals.

They had claimed Health Canada failed to test, ban, recall or warn the appellants about the hazards of the implants.

But the Appeal Court ruled regulatory bodies should not be held liable in negligence.

“This could lead to decreased vigilance by the regulated entity, in this case the manufacturer, importer, and distributor of the product,” the judges said. “Diminished deterrence for a regulated industry is to be avoided particularly when it is the industry, and not the regulator, that holds critical knowledge regarding product safety.”

This is a very disheartening story. The courts are basically saying that it is not the job of the government to govern product safety and reliability, but instead it is the responsibility of the manfacturer of the device.

The Court of Appeal for Ontario also tossed out a separate class action by people whose jaw implants disintegrated. Thousands of people suffering from chronic pain argued Health Canada had failed to issue warnings or take action to get the jaw implants off the market, even though the plaintiffs acknowledged being told the implants could break down and “cannibalize” bone and soft tissue at the base of their skull.

Manufacturers, not government officials, are responsible for product safety and reliability, the court said in both instances.

Now, I am not claiming to understand how “things” work in Canada, but as a U.S citizen, I sure as hell expect the government to insure that medical devices are safe and reliable. If we leave it up to the manufacturers to decide if something is safe or not, we are basically handing our health and possibly even our lives over to companies who just want to make money off of us, but do not have our best interest in mind. How wonderful.