Judge OKs Settlement in Heart Valve Suit : Medicine: Terms of the agreement between 256 people who sued Shiley Inc. in Orange County are undisclosed.
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, in which she claimed she suffered emotional distress caused by fear that the valve implanted in her in 1980 would malfunction.
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, 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.
Although the latest agreement marks a significant victory for Shiley and its parent, New York-based Pfizer Inc., there is no end in sight to the litigation over the valve, which is no longer made.
Twenty-nine other lawsuits remain unsettled, as well as a federal court appeal of a 1992 class-action settlement in Cincinnati, which includes all 83,000 Shiley heart valve recipients around the world.
Attorneys for a group of Pennsylvania plaintiffs argued that the Cincinnati settlement was not sufficient because it only allotted up to $4,000 for those recipients whose valves have not malfunctioned. Surviviors of valves that fractured, or the estates of people with fatal valve breaks, would receive up to $2 million.
Mort Wapner, an attorney who filed the Pennsylvania appeal, said Wednesday’s settlement could be used to bolster his appeal if it was proved that the recipients of normally working valves each received $100,000.
“What is very, very important to all of us,” Wapner said, “is what Shiley paid to working-valve recipients like Barillas. It would certainly say that the class-action suit was fishy.”
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.”
Barillas claimed the company defrauded the FDA and heart surgeons around the world. Shiley 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, she said.
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 of 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, daylong testimony that the family has endured 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 launched a campaign urging federal officials to bring criminal charges 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.
