Guidant Chose Not to Send Defibrillator Warning

By Barry Meier, New York Times News Service

Last year, as executives of Guidant Corp. defended their decision not to tell doctors about significant heart device defects, they cited concerns that doing so could have exposed patients to risks from unnecessary device replacement.

That letter, however, was never sent, and more heart patients kept getting those devices, advanced defibrillators known as the Contak Renewal and Contak Renewal 2.

Since last fall, the Department of Justice and the Food and Drug Administration have been conducting an inquiry into Guidant's handling of safety issues affecting several now-recalled defibrillators, including those models. . .  Both Contak Renewal models and another Guidant defibrillator, the Prizm 2 DR, had insulation flaws that could cause them to short-circuit and catastrophically fail.

A defibrillator is a life-saving device intended to sense and electrically disrupt potentially fatal heart rhythms. The Contak Renewal combines a pacemaker and a defibrillator, a type of unit that is often referred to as a cardiac resynchronization therapy deviced, or CRT-D. Such units cost about $35,000 each.

The latest round of Guidance documents were ordered released on Monday(June 2006) by Judge Jack Hunter of state District Court in Corpus Christi. Hunter is overseeing a lawsuit brought by two patients who both were implanted with a Prizm 2 DR defibrillator.

. . . records (forJanuary 2005) indicate that company officials drafted a "Dear Doctor" letter, which would have disclosed the short-circuiting problem and stated that the company had "removed all non-implanted Renewal and Renewal 2 DRT-Ds from hospital shelves and Guidance inventory" . . . . But the letter was never sent and Guidant officials instead sent doctors a general product update about all its defibrillators that urged them to be on the alert for signs of electrical problems in those devices. It did not single out the Renewal model. . .

This March, an outside panel of experts commissioned by Guidant criticized the company's handling of product safety issues. The experts found that the company's decisions were driven by statistical engineers rather than assessments by doctors about the medical consequences of device failures . . . that Guidant's policy of stopping further factory shipments of the units while continuing to allow implants of devices in inventory was "inconsistent."

"Guidant has stated that the insulation failure rate is small when compared to the overall device attrition rate, and implied there is not a serious risk to health," FDA officials wrote in a June 2005 memorandum. "This analysis minimizes the problem and is incorrect."