Quadrupled Failure Rate Seen for Shiley Valves : Medicine: Health research group Public Citizen bases warning on a Dutch study of 2,303 patients whose heart devices were made by the Irvine-based firm.

A defectively designed heart valve fails about four times more often than previously thought, and younger patients with no apparent problems may want to have those valves replaced, a consumer group said Thursday.

A Dutch study of 2,303 patients with this heart valve, manufactured by the Irvine-based Shiley unit of Pfizer Inc., found the cumulative failure rate over eight years was 4.2%. Among younger patients, that rate was 6.3%.

The 4.2% rate is about four times higher than previously thought, according to the health research group Public Citizen, founded by Ralph Nader.

The study, which has been questioned by Shiley, was outlined earlier this month in a British medical journal, the Lancet.

There is no reason to believe that the U.S. failure rate would be different from that documented in the Dutch study, said Dr. Sidney Wolfe, director of Public Citizen. “The valves that were implanted in Holland were pretty representative,” Wolfe said.

Wolfe said the company and the government should advise younger patients that they may want to have the device removed.

About 400 patients are suing the Shiley unit, alleging fraud and emotional distress because they must live with the fear that their valves could fail. The product liability case is expected to come before Orange County Superior Court later this year.

Pfizer has withdrawn the valve from the market. In January, the company announced that it would spend up to $205 million to settle anxiety lawsuits.

Pfizer responded by repeating that it would not advise patients without problems to have the valves removed. The company issued a statement that did not dispute the Dutch report and called it a “valuable single study, and its data must be considered in light of all available information.”

However, Pfizer said, the statistical methods used by the company and the Dutch study both are valid but are not directly comparable.

“It is not appropriate to single out one article as definitive when other equally valuable studies have found somewhat different results with regard to the implications of patient age and valve position,” said physician Roger Sachs, president of the Shiley Heart Valve Research Center.

He said Shiley provided the federal Food and Drug Administration with a copy of the Dutch study in October.

Public Citizen’s call for a notification of doctors and valve patients was in a letter sent to Dr. David Kessler, commissioner of the Food and Drug Administration.

About 25,000 of those valves have been implanted worldwide, about half in U.S. patients, Wolfe said.

The FDA has received reports of 222 deaths.