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FDA ups risk of Guidant defects

2005 analysis released in suit

Jun 23, 2006 | Pioneer Press

A potentially deadly short-circuiting problem with implantable defibrillators made by the former Guidant Corp. may be far more common than initially indicated, according to an analysis by federal regulators.

Guidant's implantable heart devices may fail about 10 times more often than the company had projected last year, according to a U.S. Food and Drug Administration analysis released in a Texas lawsuit. A judge in a product-liability lawsuit involving Guidant's defibrillators recently unsealed the FDA document dated June 16, 2005.

"This doesn't raise my concern level any higher than it already was which was pretty high," said Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute.

In May 2005, Hauser and two Heart Institute colleagues went public after Guidant refused to warn other doctors about its defibrillator. Instead of delivering a sharp jolt to their 21-year-old Minnesota patient's heart, which had gone dangerously out of beat, the $30,000 device apparently short-circuited and the patient died.

Since then, Guidant has been hit by a series of safety alerts, recalls, investigations and lawsuits. The company recalled 109,000 defibrillators because of a variety of problems last year.

Guidant's heart devices are made in Arden Hills. Natick, Mass.-based Boston Scientific bought Guidant earlier this year.

"My major concern is why the FDA didn't release this information at the time, a year ago," Hauser said.

FDA spokeswoman Julie Zawisza declined to say why the agency didn't release its higher estimate. The agency is still evaluating the defect problem, she said.

Officials with what is now Boston Scientific's Guidant unit stood by their original estimates.

"Throughout this period, the observed occurrence rate has remained well within our projection at less than 1 percent," Boston Scientific spokesman Paul Donovan said in a recent interview.

After Guidant began its recall last year, it said no more than 292 of the units were likely to break down. But the FDA said "most" of the 16,000 recalled Contak Renewal defibrillators may have damaged insulation within five years of use, and 40 percent of those damaged devices would fail to produce an adequate electrical shock in a medical emergency. At that rate, at least 3,200 Renewal units would be likely to fail.

The reason there are not more reports of death due to the short-circuiting problem may be that most of these patients die outside the clinic or hospital and their device is not sent back to the manufacturer to be checked out, according to the FDA memo.

"We have no surveillance process for discovering" fatal defibrillator malfunctions, the memo said. "We do not know the death rate associated with this defect. It is probably greater than reported and may be much greater than reported."

The Texas case is one of some 340 product-liability cases in the courts so far, and the company thinks more than 3,000 patients eventually may pursue claims, according to a Boston Scientific filing with securities regulators last month. The FDA's higher projection now may hurt Boston Scientific in lawsuits by patients who received the devices.

"This is as damaging a document as we're going to come across," one of many lawyers representing patients suing Guidant, said in a recent interview. "It flies in the face of all the excuses Guidant has been giving for not telling patients to take these devices out immediately."

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