Heart Valve Patient Can Sue Before Unit Fails, Court Says
A state appellate court has ruled that persons with certain heart valves made by Shiley Inc.--a type with a history of life-threatening failures--may sue the manufacturer for fraud even though their valves have not malfunctioned.
The Fourth Appellate District Court in Santa Ana on Wednesday reversed the opinion of an Orange County Superior Court judge that Judy Khan of Roanoke, Va., had filed her grievances prematurely because the valve she received in 1983 has not malfunctioned.
Bruce Finzen, Khan’s attorney, said the California appellate court was the first court in the country to allow persons with functioning Bjork Shiley Convexo-Concave valves to litigate claims against the Irvine-based manufacturer.
In 17-page written decision, the appellate court gave Khan permission to go to trial with her lawsuit against Shiley and its corporate parent, Pfizer Inc.
However, the company claimed “a major legal victory” in the appellate court decision, saying the court had dismissed seven of the eight grounds for action, including product liability, while allowing only the fraud allegation to be litigated.
The company denied that it had acted fraudulently. “Shiley firmly believes there is no basis to this claim and that after further litigation proceedings . . . the plaintiff will be unable to recover on such a claim,” the company said.
Shiley said it had not decided whether to appeal the decision. Khan’s civil suit, which seeks an unspecified amount of damages for emotional distress, alleges that Shiley and Pfizer knowingly concealed problems associated with valves of the kind implanted in Khan’s heart before it decided to completely recall the valves from the market in 1986.
The appellate court said it was confirming that “a manufacturer of a product may be liable for fraud when it conceals material product information from potential users. This is true whether the product is a mechanical heart valve or frozen yogurt.”
Finzen said his law firm, Robins, Kaplan, Miller & Ciresi, currently represents 140 other people who, like Khan, still have the valve implanted and have filed suit in California.
From 1979 to 1986 more than 85,000 Bjork Shiley Convexo-Concave heart valves were sold worldwide, about half in the United States. According to the Food and Drug Administration, there have been 389 reported breakages of the valves and at least 246 deaths.
