Engineer Says Tests Proved Shiley Valve’s Value : Courts: Despite ‘devastating’ results, the device was not a medical failure, he tells jurors hearing recipient’s lawsuit.

The engineer who oversaw testing of a controversial artificial heart valve told a jury Friday that putting the device on the market has been “devastating” for Shiley Inc., the Irvine company that made it.

“The company would have been better off without it,” Daniel Johnston said of the Bjork-Shiley Convexo-Concave Heart Valve, once billed as a life-saving innovation. Shiley, Johnston’s employer, manufactured the device from 1979 to 1986.

Johnston also said he has given depositions in more than 20 lawsuits related to the valve, which has been implanted in more than 86,000 people worldwide and has been suspected as a factor in as many as 900 deaths.

The suit that brought Johnston to Orange County Superior Court in Santa Ana was filed against Shiley and its parent company, Pfizer Inc. in New York, by a San Diego County woman seeking damages for emotional trauma.

Ruth Barillas, 54, was implanted in 1980 with a Shiley valve that has functioned without incident. But the former bank clerk says the quarter-sized device’s well-publicized failures have left her tormented by anxiety.

In five hours of testimony, Johnston detailed the tests that Shiley researchers used to determine the valve’s durability, effectiveness and safety before and during its sale worldwide. Despite documented incidents of valve malfunction, Johnston told jurors, the device was not a medical failure.

“Our efforts were very successful,” he said of design refinements that followed the initial spate of malfunctions. “We solved strut fracture problems and we learned what was causing strut fracture.”

One of two miniature struts that hold the device together has snapped at a weld point in 501 of the 86,000 implanted heart valves as of January, 1993, U.S. Food and Drug Administration statistics show. Of those malfunctions, 337 led to the recipient’s death.

Johnston’s accounts of valve test procedures and findings may be vital to the plaintiff’s attorneys, who hope to show that Shiley committed fraud or acted negligently by misleading federal officials and the medical community about the device’s risks.

Barillas’ attorney Kenneth S. Kasdan pushed Johnston to explain why certain test results--specifically, those charting seven valves that fractured in lab trials--were not included in the initial application for product marketing sent to the FDA.

Johnston said the omitted results were from studies that had little bearing on the valve’s performance or did not pertain to the application. He said that the structural breakdowns came during intensive endurance trials in which the Shiley valve fared far better than similar devices considered to be the industry standard at the time.

Much of the verbal duel between Kasdan and Johnston revolved around one group of lab documents written by Shiley researchers in the late 1970s and early 1980s, then turned over to the FDA during product investigations in 1985.

Kasdan said the documents demonstrate Shiley’s willful attempt to bury unfavorable test results. He cited one particular case in which a valve was categorized as “functional,” even though handwritten lab logs showed that the device broke, was repaired and returned to the test.

But Johnston told jurors that the papers in question were a jumble of test results that were being pulled out of context and presented without benefit of their scientific frame of reference.

That collection of documents, Johnston said, “was not meaningful to me. It was, as I said, a hodgepodge of things that were unrelated.”

Johnston is scheduled to continue his testimony Monday.