Files Show Guidant Foresaw Some Risks
January 8, 2006 08:21

NY TIMES: "Officials of the Guidant Corporation projected in an internal report that some patients might die as a result of short circuits in a company heart device, but it did not publicize the flaw because it apparently viewed the overall failure rate as acceptable, company records filed in connection with a lawsuit show. Guidant had also determined in mid-2002, a company report shows, that the consequences of the defibrillator's electrical failure, while rare, 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."

NY TIMES By BARRY MEIER
Published: January 20, 2006

Six months before the Guidant Corporation publicly disclosed short circuits in its heart devices, a debate may have been going on within the company over whether to alert doctors about such failures, internal company documents released yesterday suggest.