Heart Valve Patients Can Sue Maker: JudgeSep 24, 2003 | www.cbc.ca
An Ontario judge has ruled that Canadians who received certain silver-coated heart valves can sue the company that made them.
Silzone mechanical heart valves, by St. Jude Medical, were coated in silver, the company says, to reduce the rate of infection in patients.
Three years after the company introduced them, they recalled the valves because they were making too many people sick.
Eric Anderson received Silzone heart valves in 1998, one of about 2,300 Canadians who were implanted with the devices between 1997 and 2000, the year the valves were recalled.
In Anderson's case, the sutures on one of the valves tore away from the heart muscles, causing a leak that made his heart work harder than it should have.
"It's a terrible feeling always to be scared that something can happen tomorrow," said Anderson.
St. Jude Medical has insisted that it acted responsibly, but the company now faces a class action lawsuit.
The lawyer for Anderson and others in the lawsuit, says the company was negligent in its research and development of the valve.
Anderson's attorney says the company should have known there would be problems with the valve before it sought approval from government regulators.
And he says the company vigorously marketed the product without proper testing.
Health Canada approved the Silzone valve in 1997, despite internal documents questioning the company's claim that the silver reduced infection rates.
A spokesman for St. Jude Medical said the company acted responsibly in recalling the valve.
"We did a voluntary recall of this valve back in January 2000 and we've been responding to claims from litigants and their attorneys since then," said Peter Gove.
Gove said the company opposes class action status because each patient's history and experience is different.
St. Jude has until next week to appeal the decision to allow the suit to go forward as a class action.