Lawyers predicted Friday that Pfizer Inc. would get hit with another rush of lawsuits over an allegedly faulty heart valve, after the government warned that patients should consider having the devices removed.
On Thursday the Food and Drug Administration, citing a Dutch study, said the Bjork-Shiley heart valve made by Shiley Inc., an Irvine-based subsidiary of Pfizer, has such a high rate of sudden, fatal failure that patients should talk to their doctors about having it surgically removed.
Pfizer, which disputes the finding, said it was surprised the FDA would rely on only one study. It said most clinical reports show the mortality rate from operations to replace valves averages at least 5%, which is higher than the risk of death from valve failure.
More than 20,000 valves have been implanted through open heart surgery in the United States, and at least 30,000 have been implanted in operations overseas.
Pfizer has reported that the valve failed in about 500 patients worldwide, resulting in the deaths of two-thirds of those cases.
The Shiley valves were marketed in several sizes, but researchers said the larger ones had a higher risk of failure. The valves are no longer sold in the United States.
Researchers have said the valves fail with little warning. The symptoms are similar to those of a heart attack, including dizziness, shortness of breath and fainting.
In some cases, patients have as little as 30 minutes to receive medical help before the failure is fatal, said New York lawyer Paul Rheingold.
Even before the FDA's warning on Thursday, hundreds of lawsuits had been filed in the United States. In California alone, more than 500 cases have been consolidated in a state court in Orange County.
The suits allege that Shiley lied to doctors about the safety of the devices and that it and Pfizer minimized the risk of valve failure.
"We expect many more (plaintiffs) will come forward" as a result of the FDA advisory, said Vance Simonds, an Irvine lawyer whose firm represents more than 90 plaintiffs.
But at least one financial analyst who follows Pfizer disputed the predictions about calls for open heart surgery to replace valves.
"We doubt that many physicians will recommend this procedure," said Ronald Nordmann, an analyst with PaineWebber.
The FDA based its finding on a Dutch study published in the Feb. 1 issue of The Lancet, a British medical journal. The Dutch researchers studied all 2,303 patients in the Netherlands who had received a Shiley valve. The failure rates were five times higher than earlier FDA estimates.