Mechanical Heart Valve Patients Try For Class Action StatusJul 17, 2003 | www.cbc.ca When 59-year-old Sharon Frost received her mechanical heart valves in 1998, she believed it would help her heart condition.
Now five years later she finds it difficult to breathe, walk and spend time with her grandchildren.
"It's frustrating. I can't even go up the stairs and carry a glass of water in my hand," she told CBC News.
She is one of a handful of Canadians who claim they received faulty mechanical heart valves.
They are now trying to win the right to launch a class action lawsuit against the manufacturer, St. Jude Medical Inc.
In the late 1990s, surgeons implanted about 2,000 patients across the country with silzone mechanical heart valves made by St. Jude.
The company removed the product from the market about four years ago amid safety concerns that the valve's silver coating— intended to reduce heart infections may cause the valve to leak.
Now the company is facing fresh allegations that it withheld important information from regulatory authorities such as Health Canada.
The lawyers filing for class action status allege the company never told Health Canada that a sheep had died after receiving one of the valves.
If the suit is approved, lawyers for the plaintiffs are vowing to prove St. Jude acted irresponsibly.