Pfizer Tracks Down Mystery Employee
For more than a year, Employee No. 2832 has taken the rap for repeated problems with a faulty heart valve manufactured by Shiley Inc. in Irvine. Fractures were 12 times more common in devices allegedly rewelded by this so-called phantom worker than in the company’s other valves.
Now there is a name behind the number: Manuel Vizcarra. And he had already left his job at Shiley during the period in the early 1980s that 1,900 valves were signed off under his employee number.
Some lawyers representing heart value patients who have sued Shiley and its parent company, New York-based Pfizer Inc., say the findings should help their cases. Rumors had circulated for months that Employee No. 2832 either never existed or had died; now claimants have a flesh-and-blood witness to back up their accusations that Shiley manufactured the valves under sloppy conditions.
Through an internal investigation, Pfizer tracked down Vizcarra but also learned that he could not have been responsible for problems with valves produced after he left the company, despite continued use of his former worker identification number.
The Wall Street Journal on Thursday reported the identity of Vizcarra, who alleged that data at Shiley often was falsified by employees attempting to meet production quotas. Vizcarra now repairs soft-drink machines in Visalia, Calif.
Shiley said both it and the U.S. Food and Drug Administration were aware of the information. The company said it is not yet clear whether the welding was the cause of the fractures in the devices.
Developed by Donald Shiley in the late 1970s, the company’s “C-C” valve--so named because of its convex-concave shape--has been blamed for nearly 300 deaths. To date, about 450 of the 86,000 valves implanted in patients have fractured--leading to a plethora of lawsuits filed by victims, their families and patients living with the valves. Production of the valves was halted in 1986.
Twenty of the deaths have been attributed to one anonymous plant employee, responsible for rewelding valves that developed hairline fractures during manufacturing. Last April, the FDA ordered Shiley to warn patients who had been implanted with valves signed off by Employee No. 2832 of the higher failure risk.
Attorneys welcomed the identification of Vizcarra. “This verifies what has been suspected for years,” said Irvine attorney James G. Capretz, who represents more than 200 claimants in class-action and individual suits, filed against Shiley. “Before (Vizcarra was identified), we were operating on assumptions and probabilities of what went on (at Shiley).”
Vizcarra’s comments to the media “substantiate our charges that the conduct of the defendants has been egregious,” Capretz added. “Now we have someone who can attest to the fact, in sworn testimony or public statements, that what the company has been saying is incorrect. It should make (Shiley) reflect carefully on whether they should be settling more of these suits out of court.”
But Shiley said its investigation has yet to determine who falsified the production records or why.
“The fact of the matter is, we have not answered or resolved all the questions,” said Shiley spokesman Robert J. Fateaux.
Times Staff Writer Michael Flagg contributed to this story.
