Overview
Guidant Corp., a medical device maker based in Indianapolis, did not tell doctors or patients for three years that a unit implanted in 24,000 people that is designed to shock a faltering heart contains a flaw that has caused a small number of the units to short-circuit and malfunction.
The matter has come to light after the death in March of a 21-year-old college student from Minnesota, Joshua Oukrop, with a genetic heart disease. Guidant acknowledges that his device, which is known as a defibrillator, short-circuited. The young man was in Moab, Utah, on a spring break bicycling trip with his girlfriend when he got off his bicycle complaining of fatigue. He then fell to the ground and died of cardiac arrest.
The young man's death is the only known one involving the device.
After Oukrop's death, Guidant told his doctors that it was aware of 25 other cases in which the defibrillator, a Ventak Prizm 2 Model 1861, had been affected or disabled by the same electrical flaw. Guidant said it had changed its manufacturing processes three years ago to fix the problem.
All of the electrical malfunctions involving the particular model occurred in units produced during a two-year period before mid-2002, when the company fixed the flaw.
Oukrop's physicians say that, had they known earlier, they would have replaced the unit in their patient because he was at high risk of sudden death.
A defibrillator is a device about the size of a pager that is surgically implanted in the chest. It sends out a powerful electrical charge to try to shock a chaotically beating heart back into normal rhythm.
In interviews in recent days, a top Guidant executive, Dr. Joseph M. Smith, said the company had not seen a compelling reason to issue an alert to physicians about the defibrillators because their failure rate was very low and replacing them might pose greater patient risks.
Late Monday, after learning that The New York Times was about to publish an article about the device, Guidant issued an advisory to doctors about the problem. In that advisory, which physicians could receive as early as today, Guidant is recommends that the unit not be replaced because of the electrical problem.
The episode highlights an important issue: Doctors and patients are not always told when a medical device maker has data indicating that its product has a flaw which, while rare, poses potential dangers. Also, companies are not required to immediately report all safety modifications to the Food and Drug Administration.
Dr. William H. Maisel, who has studied how doctors respond to device alerts, said that companies considering an alert face competing concerns over the cost of replacement versus harm to their reputations. As a result, Maisel said, there is the potential for a "huge conflict of interest."
Smith, the chief medical officer of Guidant's cardiac rhythm management division, rejected any suggestion that financial or liability concerns had influenced the company's decision. He said that the Model 1861 was among the most reliable defibrillators available, adding that Guidant thought it would cause more harm than good by publicizing the issue because replacement defibrillators might not perform as well and because surgery also posed risks.
While fatalities during defibrillator implantation are extremely rare, the procedure poses an infection rate of 1 percent.
"We choose to extraordinarily communicate when we have a product that does not live up to our expectations," Smith said. He added that issues that could improve patient outcomes would also warrant a doctor's alert. "In this case, neither condition was met," he said.
Doctors in the Minnesota case who treated Joshua Oukrop said they were angeredby Guidant's decision not to notify physicians because they said the company had received enough reports about the flaw to establish a pattern and because high-risk patients could suffer potentially catastrophic results.
Dr. Barry J. Maron of Abbott Northwestern Hospital in Minneapolis said Smith was simply using numbers to support his stance. "It is a statistical argument that has little to do with real people," he said. He also said that the numbers reported to Guidant might understate the situation because, as with any medical device, product problems go undetected or might not be reported.
FDA regulations permit companies to inform the agency in two different ways about manufacturing modifications to improve safety, either while the company is making it or later, when a device maker files its annual report with the agency. A Guidant spokeswoman, Annette Ruzicka, said that it reported the November 2002 change as part of an annual report submitted to the FDA in August 2003.
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