Ex-Shiley Chief Would Not Fear Valve Implant : Suit: Former president, now a consultant, testifies that data was not knowingly withheld during safety tests.

The former president of Shiley Inc., the Irvine medical manufacturer whose heart valves are the subject of a lawsuit challenging their safety, told jurors Monday that his company did not knowingly withhold information during government safety tests and that he would have no fear if one of the company’s products were implanted in his chest.

Bruce E. Fettel, the company’s president from April, 1980, to April, 1985, and now a $1,200-a-day consultant to Shiley, said that while he was unsure of some specific operational details from eight years ago he was confident in the safety of the Bjork-Shiley Convexo-Concave Heart Valves.

If one was in his heart, he said, “I’d be very happy. I would feel very confident that it wouldn’t break.”

Fettel’s testimony kicked off the second week in the trial of a multimillion-dollar damage suit against Shiley and its former parent company, Pfizer Inc. San Diego resident Ruth Barillas, one of about 50,000 people worldwide with a Shiley heart valve implant, has alleged emotional and psychological stress because she doesn’t know if the valve she has had for 13 years will malfunction.

As of January, the most recent month for which figures are available, 501 fractures of the Shiley valve had been reported to the FDA, with 164 recipients surviving those fractures, according to attorneys

The lawsuit by Barillas, 54, alleges that Shiley, which made and sold the artificial heart valves from 1976 to 1986, lied to the U.S. Food and Drug Administration about the safety of the device.

In the courtroom last week, attorneys for the plaintiff charged that Shiley withheld important test result information from the FDA when it applied for approval to sell the valves. The lawyers said that of the 21 valve tests performed before FDA approval in 1979, 18 valves showed fractures of some kind. That information was not given to the FDA until the mid-1980s, years after the FDA approved the valve, lawyers said.

Former Shiley engineer Paul Morris testified last week that the results were not given to the FDA because the tests were performed on “prototype” valves. Plaintiff’s lawyers have argued that the prototype valves were implanted in humans.

Fettel said he could not remember whether all the test results were reported to the FDA.

“I can’t tell whether it was or not,” said the silver-haired consultant, when asked about the status of a certain test. “I think all the data was.”

Fettel was repeatedly asked about his February, 1979, testimony before an FDA panel, where he told representatives that Shiley had broken at least one valve in pre-market testing.

Kenneth S. Kasdan, the plaintiff’s attorney, charged that Shiley had broken not one, but at least four valves in pre-market tests, which was not reported to the FDA until much later.

“I was only aware of one at the time. That’s what I believed,” said Fettel, who will be cross-examined by lawyers for Shiley later this week.

Of six lawsuits pending against Shiley, Barillas’ is the first to go to trial and is meant to be a bellwether in the long-running dispute. There have been about 300 individual and class-action settlements.