Shiley Ruled Open to Lawsuits in All Suspect Implants : Product Safety: A court finds that the Irvine-based manufacturer can be sued for allegedly hiding information about defective heart valves, even when the valves haven’t malfunctioned.

A state appellate court has ruled that persons implanted 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 4th District Court of Appeal 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 heart valve which 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 against the Irvine-based manufacturer.

In a 17-page decision, the appellate court permits Khan to go to trial with her lawsuit against Shiley and its corporate parent, Pfizer Inc.

Shiley contended in a statement Thursday that it had “scored a major legal victory” in the appellate decision. The company said the court ruled out seven of eight causes of action, including the ability of the plaintiff to sue on grounds of product liability, while only allowing the allegation of fraud 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,” it said.

Shiley said it had not decided whether to appeal the decision.

Khan’s civil suit seeks an unspecified award for damages from emotional distress. It alleges that Shiley and Pfizer concealed problems with valves, of the kind implanted in Khan’s heart, before deciding to completely recall the valves 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 U.S. Food and Drug Administration, there have been 389 reported breakages of the 60-degree and 70-degree valves, in which at least 246 people have died.

Dr. Sidney Wolfe, director of the Public Citizens Health Research Group, which has acted as a resource for those suing Shiley, said wrongful-death lawsuits brought by relatives of the deceased have resulted in some out-of-court settlements, in several cases exceeding $1 million. So far none have been litigated, he said.

Wolfe predicted that the California decision could persuade more people living with valves to file lawsuits.

“It opens the door for massive amounts of litigation which should be brought by all these people who are walking around terrorized in many instances,” he said.

Finzen, however, said he believes the number of pre-fracture lawsuits will be limited because many people who have Shiley valves implanted do not know they may have a problem. “The company never notified any of the patients directly,” he said. Only surgeons and, in some cases, cardiologists were informed of the potential danger, he said.