Three former employees of Shiley Inc., the onetime Irvine medical device manufacturer, have accused the company of recycling thousands of poorly manufactured heart valves--and altering their serial numbers--to save money.
The allegations were made by former Shiley welders in affidavits filed in connection with a Texas lawsuit that Shiley settled in 1991. But the charges, denied by Shiley officials, are receiving attention as Shiley continues to battle lawsuits pressed by recipients of the valves, which have fractured in some patients and have been cited as the cause of at least 250 deaths.
Currently, Shiley and its parent company, Pfizer Inc., are defendants in Orange County Superior Court in a suit filed by a 54-year-old San Diego woman who claims she has suffered emotional distress because she fears the valve she received in 1980 may malfunction.
The allegations in the affidavits raise questions about whether Shiley could face a wave of potentially more damaging lawsuits focusing on safety and the integrity of its manufacturing procedures.
Shiley spokesman Robert Fauteux recently denied the allegations in the affidavits. He added that the former employees had not been cross-examined by company attorneys.
“We question the propriety of publicizing materials that have not been admitted in court,” Fauteux said, referring to the Orange County lawsuit.
During the four-week trial, the company has defended the reliability of the heart valve. Shiley attorneys argued that the valve, while in production, was the safest such device on the market, even considering the occasional strut fractures that still occur at a rate of three a month.
About 83,000 Shiley valves were implanted in heart patients beginning in 1979, when the company received federal approval to sell them, until it ceased making them in 1986. Government regulators say they know that 501 of the valves have fractured.
After three recalls of the valve and numerous attempts to solve the strut fracture problem, Shiley was forced to stop selling them seven years ago because of “negative publicity,” the company said at the time.
The company denies that it ever permitted substandard manufacturing processes at its Irvine facility.
In a separate product liability suit against Shiley, however, a Huntington Beach man claims the company was guilty of shoddy manufacturing.
Shiley critics say the affidavits represent a small portion of the voluminous documents that point to scores of misdeeds allegedly committed by Shiley and Pfizer.
For instance, the affidavit of one Shiley worker said Shiley welders were originally instructed to inspect all valves with microscopes for cracks or bad welds as the valves came off the assembly line. Rejected valves were placed in small plastic bags with red tags and stored in a separate area, ostensibly to be discarded later.
“When a valve was red-tagged, this meant it was scrapped and would not be used anymore,” former Shiley welder Wayne Runnells wrote. But in 1979, Runnells said, “thousands of scrapped Bjork-Shiley Convexo-Concave heart valves were brought back to the welding room for rework(ing) by me.”