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Deposition sheds light on Guidant defibrillator case

Feb 22, 2006 | www.indystar.com

After a Guidant Corp. defibrillator failed to jolt a Minnesota student's heart back to life during cardiac arrest last year, the victim's doctors demanded an explanation from the Indianapolis medical device maker.
   
It offered one, saying its implantable defibrillator suffered from a short-circuiting glitch that the company fixed in 2002 by "rerouting" a wire in the tiny, battery-powered device. A top Guidant executive now tells what that repair entailed: applying some medical glue to the electrical wire.

"Sounds like rerouting to me," said Fred McCoy, the president of Guidant's cardiac rhythm management division in St. Paul, Minn., in a recent court deposition, according to legal documents provided to The Indianapolis Star.

McCoy's deposition, conducted by an attorney who is suing Guidant on behalf of defibrillator patients, contains the first lengthy comments to become publicly available from any Guidant executive about the series of quality problems that hit its defibrillator and pacemaker lines last year.

The problems prompted federal investigations of Guidant's handling of the incidents and nearly derailed the company's attempt to sell itself, although it now has lined up a new buyer. The product recalls also gave rise to dozens of lawsuits against Guidant by patients, including the first case scheduled for trial, on April 10 in Neuces County, Texas.

McCoy, a former Eli Lilly and Co. executive who has headed Guidant's defibrillator and pacemaker business since 2000, defended Guidant's actions under questioning from Robert Hilliard, the Corpus Christi attorney who is representing two defibrillator users in the upcoming jury trial.

Hilliard released the deposition this week. Some of the questions and answers were blacked out by Guidant in court-allowed editing. Some of McCoy's comments are likely to become points of contention in the trial, at which Guidant will face charges it failed to tell patients about potentially fatal flaws in defibrillators they relied on to help shock their weakened hearts into regular rhythm. Plaintiffs are expected to ask for a large damage award, possibly running into the millions of dollars.

The rerouting issue is significant because Guidant documents suggest the company didn't actually do a formal rerouting of the wire found to have short- circuited in its Prizm 2 defibrillators, a once-popular defibrillator that no longer is sold. Guidant told two Minnesota doctors last spring it did a rerouting of the wire, Hilliard said, citing a company presentation to the doctors.

Despite the claim, "Changes to route the feedthrough wire away were determined to be not cost-effective," an April 2005 Guidant memo obtained by Hilliard said.

McCoy, however, argued in his deposition that some glue the company applied to the wire amounted to rerouting it. "Patient safety is more important than cost considerations" at Guidant, McCoy said, downplaying the memo that referred to the fix not being cost-effective.

Guidant spokesman Steven Tragash said the company does not comment on litigation in which it is involved, so it had no comments on the deposition.

In other comments made in the deposition, taken Jan. 4, McCoy:

Denied any personal knowledge of the short-circuiting problem until May 2005, when the company finally revealed it to doctors and patients.

Couldn't say what was meant by "random event," a term Guidant used in an internal document to describe the short- circuiting problem and partially justify its decision to not issue a public alert.

"It's a troublesome term," McCoy said. He said the company also opted not to issue a public alert because the Prizm 2's reliability was still better than expected, despite at least two deaths from the short-circuiting problem.

Insisted he wouldn't want to be told about a rare but potentially fatal flaw in a defibrillator if it were implanted in his own chest. "The answer would be no," McCoy said. "But I appreciate that some (people) would (want to be told)."

Couldn't explain why Guidant claimed in a medical device report filed with the Food and Drug Administration in 2004 that it had gotten FDA approval for fixing the short-circuiting problem. "That seems to be in error," McCoy said of the claim.

Guidant fixed the problem in 2002 without obtaining FDA approval, he said.

Hilliard said he believes the law required Guidant to get FDA approval for making design changes in its Prizm 2 defibrillator, and he aims to make that argument in the trial. If Guidant didn't get FDA approval for the redesigned Prizm 2s, that means it was illegally selling an unapproved medical device, he said.

Hilliard said he also intends to highlight McCoy's comment that he wouldn't want to know about a rare fatal flaw in a defibrillator he himself was using.
 
"I lost my respect for him when he said that. Even the president of Ford would want to know if his Pinto would explode if hit from behind," Hilliard said.

He said Guidant has shown "no serious indications" it wants to settle the case before trial.


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