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Guidant exec says FDA incorrectly told about defibrillator fixes

Feb 22, 2006 | AP A Guidant Corp. executive acknowledged the medical device maker made changes to one of its defibrillators in 2002 and later incorrectly told federal regulators it had no effect on the product's performance.

Still, Fred McCoy, head of Guidant's cardiac rhythm management division, said in a deposition released this week that he didn't think the faulty defibrillator was responsible for patients' deaths.

"This particular failure mechanism does not have the capacity to kill a patient," McCoy said during a January deposition. "It may be unable, as a device, to save the patient."

The defibrillator, a Ventak Prizm 2 Model 1861, was among some 88,000 recalled by the Indianapolis-based company since June. Guidant also recalled or issued safety warnings for more than 200,000 pacemakers. At least seven deaths have been linked to the devices.

The first product liability case stemming from the recalls is set to begin April 10 in Corpus Christi, Texas.

In the 168-page deposition, McCoy said Guidant made two repairs to the Ventak Prizm 2 in 2002 to correct it from short circuiting. But neither modification was approved by the U.S. Food and Drug Administration, and only one was disclosed - in an annual report. In that filing, Guidant said the alteration had no affect on the device's performance.

In a filing two years later, the company incorrectly said it had received FDA approval to make the changes.

Guidant executives waited nearly three years to publicly disclose the flaws, and continued selling some of the defective models.

Bob Hilliard, who is representing two patients in the case, said McCoy's testimony could prove that Guidant sold an unapproved defibrillator - a violation of federal law.

"They've hung out every single doctor in the country if the device was unapproved," Hilliard said Wednesday.

FDA spokesman Stephen King declined to comment.

Guidant, which Boston Scientific officials hope to acquire by the end of next month, faces state and federal regulatory investigations as well as 60 class action lawsuits and another 145 individual suits from its recalls, according to documents filed Wednesday afternoon with the Securities and Exchange Commission.

A message was left by The Associated Press with Guidant spokesman Steve Tragash, who has said previously that the company does not comment on pending litigation.

McCoy, the Guidant executive, said he wasn't told about problems with the devices until May 2005. He also said if he were a patient about to receive one of the devices, he would not want to know if it had a specific problem that could be deadly.

"As an individual, I would not want to know," he said. "But I can concede many would."

Joe Duffey, the Florida-based producer of an online support site for defibrillator patients and their families, said he was surprised by McCoy's statements.

"If someone wants to keep their head in the sand, that's their business," he said. "But personally, I would want all the information available so I could make a reasoned decision with my doctor. Guidant has a responsibility to the end user to tell us what the heck is going on so we can make an informed judgment. That's what they deprived people of.

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