Heart Valve Use Backed by Surgeon : Trial: Professor defends disputed device. He tells the jury that plaintiff has serious medical problems unrelated to it.

A cardiac surgeon told jurors Wednesday in an Orange County Superior Court fraud case that a woman seeking damages for a potentially dangerous artificial heart valve is a “challenging patient” whose other health problems present far more problems than the device.

Dr. Anthony Moulton, a professor at Brown University in Rhode Island, testified that the San Diego County woman’s Bjork-Shiley Convexo-Concave Heart Valve has worked without incident since it was implanted in February, 1980.

“This valve has functioned flawlessly through a number of life-threatening episodes in her life,” Moulton testified as the plaintiff, former bank clerk Ruth Barillas, 54, looked on.

Barillas is suing the valve manufacturer, Shiley Inc. in Irvine, and its former parent, Pfizer Inc. in New York. Her suit claims Shiley was fraudulent or negligent when it gave surgeons and federal officials false or understated information about the controversial valve’s tendency to malfunction.

Barillas testified last week that the presence of the widely criticized valve in her chest has led to constant anxiety and a parade of nightmares in her life.

Introduced in 1979 and discontinued in 1986, the Shiley valve was billed as a device designed to help valve recipients avoid the common threat of clotting. But the same innovation that allowed blood to flow easier through the valve also created a weak point in the quarter-size device.

A small wire strut that holds the valve together has snapped at the weld point in 501 cases reported to the U.S. Food and Drug Administration as of January, with 164 of those patients surviving the mishap. Some critics of Shiley estimate that 900 of the 86,000 valve recipients worldwide have died because of the failure.

But Moulton told jurors Wednesday that the remote chance of the valve’s highly publicized flaw developing in her case is a danger that is minuscule in comparison to Barillas’ other maladies.

“She has had long-term problems that presented a much greater danger than the risk of strut failure,” Moulton said.

Moulton testified that during the 1980s, when he was at the University of Maryland hospital, he and his colleagues implanted 285 Shiley valves in 259 patients from April, 1980, through April, 1985. He said the staff’s use of the valve was discontinued in the wake of national media reports that raised patient anxiety about the device.

Despite abandoning the Shiley device, Moulton said the valve’s benefits far outweighed any of its dangers. He agreed with defense attorney statistics showing clotting threats to be 10 times more likely to endanger patients than device failure.

“That would have been my choice for a valve for Mrs. Barillas if I was handling her case,” Moulton said. Later, when asked how he would feel if all his valve patients had fared as well as Barillas, he said, “I would be delighted.”

On cross examination, Moulton conceded that though he and his colleagues lauded the valve for reducing the threat of clotting, there was little in the way of statistical proof to support that belief.

Moulton also agreed that the Shiley valve indeed had more structural malfunctions than most other leading valves available at the time, and that revised designs by the manufacturer did little to reduce the number of flaw incidents.

“I don’t know that anybody has said (the malfunctions) were a fluke,” he said. “There was obviously a problem.”