Settlement Reached in Suit Over Recalled Heart Valves

Shiley Inc., which recalled a batch of heart valves because of a tendency of the devices to fracture, struck an 11th-hour settlement with 259 valve recipients late Wednesday, including a San Diego County woman who took the company to trial.

Terms of the agreement were not disclosed. The settlement with Ruth Barillas, a 54-year-old former bank clerk from La Mesa, came hours before a 12-person Orange County Superior Court was scheduled to begin deliberations in the 5-week-old trial.

Barillas, who was fitted with a Shiley heart valve in 1980 and discovered in 1991 that it was among valves recalled because of their tendency to fracture, sued Shiley for emotional distress.

The deal also compensates 258 other people, including five people who had separate lawsuits scheduled for trial later this year.

Shiley spokesman Robert Fauteux said Wednesday night that he was unaware of the details of the settlement and declined comment.

The settlement negotiations, which Shiley attorney Pierce O’Donnell said began weeks ago at the request of Barillas’ attorneys, reportedly were hard-fought. One of Barillas’ attorneys, Robert Capretz, declined to say how much money was involved in the settlement.

Such cases have been brought against the onetime medical device-maker by thousands of other heart valve recipients whose valves were working properly but feared that the devices would break.

The Shiley valve, implanted in about 83,000 heart patients worldwide, gained international notoriety because of the relatively high mortality rate of people who had it implanted in their hearts. At least 250 people died when the tiny struts that held their valves together snapped.

During the trial, Barillas’ attorneys attempted to convince the jury that the company had lied to the U.S. Food and Drug Administration and thousands of heart surgeons by downplaying the valve’s potential defects.

The valve was approved for sale by the FDA in 1979, allegedly on data that did not include reports that 18 prototype valves had fractured during testing. Faced with negative publicity, the company pulled them off the market in 1986.

Since then, more than 50,000 heart valve patients have settled out of court with the company.

A class-action agreement in a Pennsylvania federal court--which could cost Shiley as much as $500 million--is currently under appeal.