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Press Releases 2006

For immediate release

May 11, 2006

Heart Valve Recall

(Queen's Park)   Oak Ridges MPP, Frank Klees asked Ontario 's Health Minister today why patients are finding out about a heart valve recall from lawyers rather than from their doctors.

Klees raised the issue during Thursday's Question Period citing the fact that he became aware of the issue through a patient who was distraught to get a call from a lawyer's office soliciting his support for a class action law suit against

St. Jude Medical Inc. of St. Paul Minnesota .

"I could not believe that the first time a patient would hear that his implanted heart valve has had a recall, is from a lawyer and not his doctor," said Klees. "I cannot believe that there is not a protocol that requires the surgeon or attending physician to advise a patient when there is a recall of an implanted medical device. To hear that your heart valve may be faulty from a lawyer rather than your doctor, is at best disturbing."

The Minister of Health was not aware of either the recall or the class action law suit when questioned by Klees, but he undertook to look into the matter. When asked whether he believed it was appropriate that patients were not being advised of the recall by their doctors, the Minister refused to respond directly, stating that he would have to look into issue first.

The recall was first announced by St. Jude Medical, Inc. on January 24, 2000 in a News Release advising that the company had initiated a worldwide voluntary recall of all field inventory of heart valve replacement and repair products incorporating its proprietary Silizone coating. The company ceased distribution of the product.

There are 36,000 patients worldwide who received the valves and over 2000 of those patients live in Canada .


For further information

Frank Klees , MPP