2 Canadian Provinces Sue Shiley Over Valves : Courts: Manitoba and Ontario seek to recover costs for surgical replacement of the heart devices in 2,000 citizens.
IRVINE — The Canadian provinces of Manitoba and Ontario have joined those taking legal action against the maker of the potentially defective Bjork-Shiley heart valve.
Representing about 2,000 Canadian citizens who have been implanted with the valves, the provincial governments are seeking to cover medical costs for surgical replacement of the devices. The suit against Irvine-based Shiley Inc. and its parent company, Pfizer Inc. in New York, was filed Thursday in U.S. District Court in Santa Ana.
“This is the first time we know of that a governmental agency has made a claim against a potentially defective Shiley heart valve in a U.S. court,†said attorney James Capretz, whose Irvine firm is representing the Canadian provinces as well as about 270 individuals who chose earlier not to take part in a class-action suit against the heart-valve maker.
Canadian citizens, some of whom have sued on their own, are more likely than Americans to require replacement of the valves, Capretz said. A higher-risk valve was used in most of the operations in that country, he said, while the U.S. Food and Drug Administration prohibited the use of any but the lower-risk device in this country.
A spokesman for the valve-maker, Robert Fauteux, said the suit by the Canadian provinces is without merit.
“Pfizer believes there isn’t any basis for any claim by the provinces against the company,†he said. “The health authorities there, when they underwrote medical coverage to implant the heart valves, also accepted responsibility for any re-operation contingencies.â€
Mechanical heart valves require replacement for any number of other complications, Fauteux said, including clotting, strokes or rejection by the body.
The convexo-concave valves, made by Shiley in Irvine, were implanted in about 51,000 people worldwide before the company stopped making them in 1986. Of those patients, at least 300 have died when the struts holding the valves together came apart.
Shiley and Pfizer agreed to pay more than $215 million in a class-action settlement approved by a federal judge in Cincinnati last summer. The settlement provides heart-valve recipients with a total of $90 million to $140 million for medical or psychological consultations, which works out to about $2,500 to $4,000 each.
The settlement also designates $75 million for research on procedures to detect flawed valves, and it sets aside $300 million--which is not part of the settlement money--for patients whose heart valves may fracture in the future.
Opponents of the class-action settlement--including Capretz and his clients--argued that the compensation was unfair, given their anxiety about the safety of the valves. A Philadelphia lawyer has appealed the class-action settlement on the basis that not enough consideration was given to the heart-valve recipients who decided not to take part.
About 850 individuals, including 44 Californians, are pursuing claims on their own.
Manitoba and Ontario had sought to join that suit, Capretz said, but the judge ruled that they could not and that their claim was a separate matter.
The class-action lawsuit alleged that the companies knew that the heart valves, sold from 1979 to 1986, could fracture and possibly kill the recipient.
Pfizer’s chairman and chief executive, William C. Steere Jr., said at the time that the company still believes complaints about the valve lack merit, but he accepted the settlement to end the court battle.
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