Report: Guidant knew of device's faultsDec 24, 2005 | UPI
Flaws in a heart defibrillator were known by manufacturer Guidant, but were viewed as acceptable within a statistical realm, the New York Times reports.
The Indianapolis-based company filed papers in a Texas court indicating officials were aware in 2002 that the consequences of the defibrillator's electrical failure were rare, but could be "life threatening." Despite that assessment, Guidant kept selling potentially flawed devices and did not notify doctors about the defect until last spring, when the problem was about to be made public by the Times, the newspaper said.
At least seven people have died because of the flaw, and Guidant has since recalled 80,000 implantable defibrillators in June. In September, Guidant recalled 380,000 pacemakers.
A chart on the document submitted to the court shows the company's acceptable failure rate was about 15 devices a year, a rate of slightly more than one a month.
"For Guidant, these people are numbers," said Dr. William Maisel, chairman of the Food and Drug Administration advisory committee that reviews heart devices. "Their descriptions are full of numbers. But for me, these patients are people."