Settlement Reached in Heart Valve Suit : Medicine: An undisclosed offer is accepted by 256 people who sued Shiley Inc. in Orange County.

An Orange County judge Thursday accepted an eleventh-hour settlement between Shiley Inc. and 256 recipients of a potentially fatal artificial heart valve once manufactured by the Irvine company.

The Wednesday night out-of-court settlement in the cases of Ruth Barillas, 54, of La Mesa, Calif., and others who separately sued Shiley in Orange County came just as the jury prepared to deliberate in Barillas’ 5-week-old trial on claims that she suffered emotional distress because she feared a malfunction in the valve implanted in her in 1980.

None of the parties to the agreement would disclose its terms.

But legal experts familiar with ongoing Shiley litigation said the settlement is most likely worth about $26 million and computed under a formula similar to one used to award about $35 million to 333 heart valve recipients last November in Orange County Superior Court.

In the earlier settlement, Shiley heart valve recipients or their surviving family members were also given the right to sue again if their heart valves fracture in the future, sources said.

Jurors in the Barillas trial were dismissed Thursday morning, although it appeared that many of them may have been willing to hand over a verdict in favor of Shiley, which has come under fire for years for allegedly lying to the U.S. Food and Drug Administration.

Although some jurors sympathized with Barillas’ plight, they said they believe the company is not guilty of wrongdoing.

“I didn’t feel Mrs. Barillas had been injured, she’d only been helped,” said juror Nancy Williams, 56, of Mission Viejo. “Everybody has problems and illnesses, and you just live with it. I thought she might have been depressed, but that wasn’t Shiley’s fault. All they did was put a little valve in.”

Jurors were expected to begin deliberating Thursday morning on Barillas’ charges that Shiley had defrauded the FDA and heart surgeons around the world.

She claimed the company did not properly warn her cardiologist when he implanted a Shiley valve into the left side of her heart that the controversial device had a tendency to break down.

Fears that her heart valve would one day “explode” have caused her to suffer depression and vivid nightmares, she said. She and her husband, Constantino, had asked for $450,000 and an undetermined amount in punitive damages.

Before approving the settlement, Superior Court Judge William F. Rylaarsdam, who is in charge of all of the Orange County cases, asked Barillas if she understood the implications of her decision to accept an undisclosed amount of cash instead of betting on a favorable jury verdict.

Answering with a simple “Yes” to his series of questions, Barillas then sat down, and her husband, visibly emotional, stood.

“It was very hard,” he said, referring to the grueling testimony that the family has endured daily since the Aug. 4 opening of the trial. “But we thank God.”

News of the settlement quickly flashed around the nation as Shiley critics, hopeful of a verdict in Barillas’ favor, learned that the trial had been settled.

“I can’t believe it,” said Eric Adam, a U.S. Department of Veterans Affairs employee in Arizona, who has launched a letter-writing campaign to federal officials urging that criminal charges be brought against Shiley. “They always pay up because they know they are wrong.”

Dr. Sidney Wolfe, co-founder of Ralph Nader’s Public Citizen, a nonprofit consumer advocacy organization in Washington, said he is disappointed in the settlement but that he doubts any jury will ever get a chance to decide whether Shiley committed fraud by selling the valves and allegedly downplaying the rate of fractures.

“It will take somebody of extraordinary wealth to withstand Pfizer,” he said.

Shiley attorney Pierce O’Donnell said he is confident that he provided a solid enough case for a verdict in favor of his client.

When asked whether it would have been better for Shiley if the jury had returned a verdict in the company’s favor, O’Donnell said: “I think the jury did speak. I could see it in their eyes, no doubt about it.”

Still, he said, “I feel like I’m on the 1-yard line and somebody says the game is over.”