Ottawa knew implants harmful, case alleges
AARON VINCENT ELKAIM/TORONTO STAR
Joyce Attis, who received a silicone gel breast implant in 1972 due to a medical condition, says the implant, which she had removed in 1992, ruined her health.
Health Canada wanted to ban silicone gel devices in 1978, but they stayed in use until 1992
May 28, 2008

Legal Affairs Reporter

The federal government knew as early as 1962 that silicone gel breast implants posed serious health hazards but did nothing for 30 years while Canadian women were fitted with them, the Ontario Court of Appeal heard yesterday.

Health Canada's own scientists examined Dow Corning implants and recommended they be pulled from the market in 1978, but they remained in use until 1992 – despite studies showing they ruptured between 5 and 32 per cent of the time, a three-judge panel was told.

"At the very least, they (federal officials) could have issued a warning," said Kirk Baert, a lawyer representing women who say they became severely disabled after being fitted with implants.

Among them was Joyce Attis, who was in the province's highest court yesterday while Baert and other lawyers tried to resurrect a proposed class action lawsuit against the federal government for failing to regulate the implants.

The case is one of a series of lawsuits launched around the world over alleged breast implant failures. Ten years ago, a civil suit against Dow Corning settled in Ontario.

Attis, who suffers from a medical condition that prevented her right breast from developing, received a silicone gel implant in 1972.

Her breast later hardened and became deformed. The North York woman developed a long list of physical ailments, including connective tissue disease, rheumatoid arthritis and chest pain, according to allegations in an affidavit filed with the court.

"Health Canada owes it to its constituents to protect us and it's up to them to ensure what it puts on the market is safe," said Attis, who now walks with a cane.

Her implant was leaking when she had it surgically removed in 1992, she alleged in court documents.

Baert argued the health department's failure to ban Dow Corning implants or warn of their dangers amounts to negligence.

But last year, a lower court disagreed and threw out the case. Justice Warren Winkler of the Superior Court of Justice said allowing breast implants to remain on the market was a government policy decision and immune from lawsuit.

That's now the case's key issue.

In essence, the proposed class action lawsuit accuses Ottawa of "failing to govern" by failing to pass regulations to prevent implants from being used, Winkler said in his May 2007 ruling.

Since then, he's been elevated to Ontario chief justice. So it fell to Baert and co-counsel John Legge yesterday to persuade the panel that Winkler got it wrong.

The panel pressed him to point to a single federal regulation or statute that required Health Canada to issue a public warning about unsafe products or remove them from the market, as opposed to having that duty fall to the manufacturer.

The Food and Drugs Act stipulates that nobody can sell a device that causes health injuries through normal use, Baert said.

But that clearly puts the onus on manufacturers, such as Dow Corning, not the government, argued federal justice department lawyer Paul Evraire.

"Regulation by Health Canada is at a sky-high level," Evraire told the panel.

Some estimates say up to 200,000 Canadian women received breast implants between 1969 and 1992, from various manufacturers, although the proposed class action is against Dow Corning.

Only saline gel implants were authorized for use in Canada after silicone gel implants were pulled from the market in 1992.

The Appeal Court panel reserved its decision.