P.M. BRIEFING : Group Asks Heart Valve Warning
A private health watchdog group asked the government today to force the maker of a flawed artificial heart valve to inform those fitted with the device of its potential for failure.
The Public Citizen Health Research Group said it petitioned the Food and Drug Administration on behalf of those who have had the potentially defective and lethal Shiley artificial heart valve implanted in their chests and who may be unaware of its troubled history.
The valve was implanted in an estimated 86,000 Americans between the time it was first approved by the FDA in April, 1977, and November, 1986, when its maker, Pfizer Inc., pulled it off the market.
Though it has helped thousands of heart patients to regain their health, Pfizer has also reported that it knows of at least 394 instances of valve failures and 252 deaths linked to the device.
With the FDA’s backing, Pfizer has argued that the best way to let patients know about the risks of the valve is through the doctors who implanted the device.
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