In interviews in May 2005, a top Guidant executive, Dr. Joseph M. Smith, said that 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. But, on May 23, 2005, when told
that The New York Times was preparing an article about the device, the company finally issued an
advisory to doctors about the problems with ICDs.
The problems with Guidant ICDs came to public light after the death, in March of 2005, of a 21-
year-old college student from Minnesota, Joshua Oukrop, who had a genetic heart disease. Guidant
acknowledges that his device short-circuited. The young man was in Moab, Utah, on a spring break
bicycling trip in March with his girlfriend when he complained of fatigue. He then fell to the ground and
died of cardiac arrest. There was evidence of a device malfunction, said Dr. Smith, the Guidant
executive.
Guidant subsequently told Joshua's doctors that it was aware of 25 other cases in which the
defibrillator, a VENTAK PRIZM 2 Model 1861, had been affected by the same flaw. Guidant said it had
changed its manufacturing processes three years ago to fix the problem. Joshua's physicians obviously
replied that had they known earlier, they would have replaced the unit in their patient because he was at
high risk of sudden death. His death is the only one known.
In interviews, doctors in Minnesota who treated Joshua Oukrop said they were angered by
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 that Dr. Smith was simply
using numbers to support his stance. "It is a statistical argument that has little to do with real people", Dr.
Maron said. He also said that the numbers reported to Guidant might understate the situation because
product problems could go undetected or might not be reported.
Dr. Robert G. Hauser, also of Abbott Northwestern Hospital in Minneapolis, said he recently
started alerting cardiologists about the Guidant unit through a database he maintains that collects data
about defibrillator and pacemaker failures. He and Dr. Maron have also submitted an article about their
patient's case to a medical journal. One of those contacted, Dr. David S. Cannom, who sits on Guidant's
board of outside medical advisers, said in an interview that he believed that doctors should have all the
facts. He said that while risks posed by the device were small enough to argue against replacement in
many patients, the calculus could shift substantially for high-risk ones. "At the end of the day, you have to
come down on the side of full disclosure," said Dr. Cannom, the director of cardiology at Good Samaritan
Hospital in Los Angeles.
The Minnesota case appears to illustrate the consequences that can result when company
officials decide not to directly alert doctors to a problem.
