Many Recipients of Heart Valves Reject Settlement : * Litigation: Consolidated suit against Irvine-based manufacturer of potentially defective valves will proceed in Orange County.

Hundreds of recipients of potentially defective Shiley heart valves have rejected the manufacturer’s offer to settle their cases, saying that it fails to compensate them fully for their fear that the devices might fracture.

Nearly 450 valve recipients worldwide have told or plan to tell a federal court in Cincinnati that they will not accept the $455-million offer from Shiley Inc. and its parent company, Pfizer Inc. in New York.

Plaintiffs were given until today to decide whether to join the settlement proceedings, scheduled to begin on June 5. Having rejected the offer, they will proceed with a consolidated suit in Orange County Superior Court. Shiley is based in Irvine.

Since the U.S. Food and Drug Administration approved the device in 1979, the agency has received reports of more than 350 strut fractures in the valves. The device was implanted in about 82,000 people worldwide.

About 265 people whose valves have malfunctioned have died, most within hours. The device was recalled after several reports that the struts, which hold the valve together, came apart. Shiley took the device off the market in 1986.

The settlement offered “doesn’t pay for the lifelong terror that a valve will kill them at any time, day or night,” said Vance Simonds, a lawyer with the Irvine firm of Capretz & Kasdan, which represents about 90 valve recipients who have rejected the settlement. “It is a clever attempt on the part of Pfizer not to pay for emotional distress.”

Another 200 of Simonds’ clients have claims against the manufacturer, but lawsuits have not been filed as part of an agreement with Shiley, he said. Three of his clients will join the settlement conferences in Cincinnati “for the express purpose of objecting to how repugnant the plan is,” he said.

Shiley spokesman Robert Fauteux said the federal court has received thousands of inquiries about the settlement offer.

“The vast majority of them indicate a positive response,” he said.

It was not clear Thursday what effect the rejections of the settlement will have on Pfizer’s offer. Fauteux said Shiley will not know until the first hearing how many recipients will accept the settlement. If too few accept, Pfizer officials have said, they will withdraw the offer.

There “must be assurance that there is a sufficient number of participants to resolve the claims,” Fauteux said.

On Wednesday in Cincinnati, 341 valve recipients gave notice to the court that they will opt out of the settlement proceedings, said their attorney, Bruce Finzen of Minneapolis.

“We believe it is in our clients’ best interests that they continue their lawsuits in California,” Finzen said. His law firm has an office in Newport Beach.

Earlier this year, Pfizer offered to settle hundreds of lawsuits filed by recipients and by some of the survivors of those who died when the valves cracked.

Shiley has offered to pay $75 million to develop a diagnostic device that would determine the condition of a heart valve. An advisory panel of experts would then weigh the risks and recommend whether a recipient should have a valve replaced, a procedure the company would pay for. The company also offered to spend as much as $80 million to cover recipients’ costs for physician consultations and anxiety-related medical expenses.

Pfizer said it would set aside $300 million to settle future patient or survivor claims.

Earlier this week, U.S. District Judge S. Arthur Spiegel rejected a support group’s request to extend the deadline for valve recipients to decide whether to join the settlement.

In a letter to Spiegel, the group, Victims Against Lethal Valves, called the compensation offer “inadequate and unfair.” The 200-member group, based in Pittsburgh, also expressed its doubts about the neutrality of the advisory panel and a Pfizer-led effort to develop a diagnostic device.

A decision to have the valve replaced “should be a free choice taken up by the implantee along with their cardiologist and surgeon,” the group wrote. Shiley and Pfizer should pay “all the medical and related costs for those recipients who choose to have the potentially defective valve replaced.”

Shiley officials say the risks of having a valve removed by open-heart surgery are far greater than those of leaving it in place.