MEDICAL : Irvine Manufacturer Sued Over Lack of Disclosure That Heart Valves Break
The Irvine law firm of Capretz & Kasdan said it has filed its 10th product liability lawsuit against Shiley Inc., alleging that the Irvine maker of valves for artificial hearts did not tell patients that its Bjork-Shiley mechanical valve could break.
The suit was filed in U.S. District Court in Washington state on behalf of Robert Cloquet, 62, a Burlington, Wash., resident who received a Bjork-Shiley valve during open-heart surgery in 1984.
The suit alleges that recurring troubles forced Cloquet to undergo exploratory surgery twice before doctors found that part of the valve had broken, which caused it to malfunction.
“Though defects of certain models . . . have been documented for several years, Shiley decided to not warn those patients directly about the risk of fracture,” said James T. Capretz, a managing partner in the law firm.
Shiley voluntarily withdrew the Bjork-Shiley valve from the market in 1986.
Shiley now sells an improved version of the valve outside the United States and is seeking Food and Drug Administration approval to market the new valve in America, company spokesman Robert Fauteux said.
Fauteux said his company would not comment on the lawsuit.
Capretz said seven lawsuits filed by his firm against Shiley have been settled. In all, Capretz said more than 100 suits have been filed against Shiley involving the Bjork-Shiley valve.