Last week a judge in Canada ruled that two women have no legal rights sue Health Canada over implants that leaked, ruptured and caused them catastrophic medical conditions and permanent health disabilities.

Alexandra Tesluk and Joyce Attis were implanted with Dow Corning silicone gel breast implants. Tesluk received two implants in 1980 that were removed in 1994. Attis received one implant in 1972 and it was removed in 1992.

The two ladies claim that the government was negligent in the regulation of breast implants and liable for their resulting 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, when 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 medical 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 $3.2 billion, US, to settle claims from more than 300,000 North American women who said they had been harmed by the product. According to those court proceedings, Tesluk only received nominal damages from the settlement.

After the settlement, Attis and Tesluk began the action against Health Canada on behalf of a reputed class consisting of plastic surgery patients of Canada — excluding 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 plaintiffs about the potential risks and side effects of the breast implants. But the Appeal Court ruled regulatory governing bodies should not be held liable for a private company’s negligence.

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

“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.”