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BEHIND THE NEWS: Guidant defibrillator flap spawns disclosure debate

May 30, 2005

Early this year, when Minnesotabased Medtronic Inc. was deciding how to respond to a battery defect in its defibrillators, it contacted prominent Indianapolis cardiologist Douglas Zipes.

"You absolutely go public with this," Zipes, a longtime consultant for the Minnesota company, recalled saying. "You take your hit, you let the physicians know what is happening, and let them decide what to do with their individual patients."

Remaining silent, he said, carried worse risks, even though reported failures were rare.

"The last thing you want is a headline in The New York Times stating a patient died because of a device failure," he recalled saying.

How prophetic he was. Following the advice of Zipes and others, Medtronic notified doctors, who after consulting with patients replaced more than 13,000 defibrillators. The company has so far rung up $18 million in expenses footing the bill for replacements.

But the problem proved manageable for Medtronic, which has reported no patient deaths from the battery flaw. And it has avoided the PR nightmare that now faces Guidant Corp., which found itself the subject of a front-page story in The New York Times May 24 headlined, "Maker of Heart Device Kept Flaw from Doctors."

The story reported that the Indianapolis company did not tell doctors for three years that a defibrillator model implanted in 24,000 people contained a flaw that caused a small number of those units to short-circuit.

The issue surfaced publicly after a 21-year-old Minnesota college student with a genetic heart disease died during a spring break bicycling trip in March. According to the newspaper, Guidant acknowledged the student's defibrillator short-circuited and told his doctors it was aware of 25 other cases where the device had been affected by the same flaw, though none of those involved a patient death.

The company's defense: The risk of failure was very low and replacing the devices might pose a greater risk to patients. About 1 percent of defibrillator surgeries lead to major infections.

Paternal behavior?

"I sort of can see both sides," said Dr. Eric Prystowsky, director of the Clinical Electrophysiology Laboratory at St. Vincent Hospital, who is a consultant to Guidant but wasn't involved in discussions on whether to go public.

"You have to judge the extent of potential harm to allow these to stay in vs. the harm letting people know and having irrational behavior take place," said Prystowsky, who also edits the Journal of Cardiovascular Electrophysiology.

After Medtronic revealed its battery problem, Prystowsky said, doctors in his group scheduled meetings with all of the more than 100 affected patients and ultimately replaced the devices in about 35 percent of the cases.

"To me, that's rational behavior," Prystowsky said. "But some places, every defibrillator got changed. To me, that was grossly irrational behavior."

Even so, Prystowsky said, "I as a physician would like to know. ... The question is, 'Who is the daddy?' Should Guidant or Medtronic be paternalistic and tell me what is right or wrong? I don't think it is their responsibility to worry about a superspecialist who doesn't act in a rational manner."

Zipes, a distinguished professor emeritus of medicine at the IU School of Medicine who edits the journal Heart Rhythm, agreed. "What [Guidant] was doing was playing the numbers game, feeling the odds of failure of a device was very remote, and for it to fail at the time a patient needed it was even more remote," he said. "The problem with that scenario is the worst-case scenario did happen."

Armed with the information from Medtronic, Zipes and his IU colleagues replaced the device in all 75 of their patients who had it. What Prystowsky considers an irrational response was justified, Zipes said, because "the people in my group are so good I figured the complication rate would be nonexistent or very small."

Assessing fallout

Hours after The Times printed its Guidant story, New Jersey-based Johnson & Johnson released a statement saying it "continues to be confident in its decision to acquire Guidant." The $25 billion deal, announced late last year, is expected to close in the fall.

Wall Street analysts believe publicity about the defibrillator defect will spawn lawsuits against Guidant. But because the number of malfunctions has been small, the financial exposure should be minor compared with the company's last highprofile flap over a flawed product.

In 2003, Guidant acknowledged that a California subsidiary covered up thousands of serious medical problems, including 12 deaths, related to installation of an aortic-aneurysm device.

Guidant pleaded guilty to 10 felony counts and paid a $92 million fine. The controversy spawned a mountain of lawsuits, some of which the company later resolved through confidential settlements.

Whatever the cost this time around, it surely would have been smaller had Guidant informed doctors of the flaw before a patient died, said Henry Price, an attorney with Price Waicukauski Riley & DeBrota, an Indianapolis firm that litigates lawsuits against medical companies.

Price called Guidant's handling of the matter "corporate callousness." Without disclosure by Guidant, he said, "the doctor and patient have no opportunity to assess the relative risk. It's the [patient's] life. Why should the company make the decision for them?"
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