Irvine Firm Sued on Faulty Heart Valves
A consumer group sued two manufacturers of medical devices today, demanding that about 80,000 people implanted with potentially defective heart valves be individually warned of the risk of life-threatening failures.
The Public Citizen Health Research Group filed its lawsuit in Los Angeles Superior Court on behalf of recipients of the Bjork-Shiley heart valves.
The nonprofit consumer group asked the court to order the maker of the valve, Shiley Inc. of Irvine, and its parent firm, Pfizer Inc. of New York, to notify all people who received the “convexo-concave” mechanical valve of its potential dangers.
Shiley and Pfizer officials today called the suit “completely without merit.” Doctors who implanted the valves “have been notified repeatedly of the very small fracture risk and have been advised to educate and monitor their patients,” they said.
Shiley pulled such valves from the market in November, 1986, more than five years after the first reports of life-threatening valve fractures in patients. Although the valves are no longer available, about 80,000 people--about 40,000 of them in the United States--still have the devices implanted in their hearts, and reports of fractures continue.
As of Feb. 20, Shiley had reported 394 fractures with 252 deaths, one occurring just six months ago, linked to its convexo-concave valves. Congressional investigators say those numbers may be 50% too low.
A report by the Democratic staff of a House subcommittee recently accused Shiley of failing to report valve fractures promptly to the Food and Drug Administration and of playing down the risks in a warning letter sent only to the surgeons who implanted the devices.
“Shiley and Pfizer have engaged in a longstanding and continuing course of deceptive and fraudulent conduct in order to conceal the valve defects and their risks,” said Dr. Sidney Wolfe of Public Citizen.
Besides directly warning valve recipients, the Public Citizen suit demands that Shiley and Pfizer pay for medical consultation so patients can be advised of symptoms of imminent valve failure and benefits of possible valve removal.
