The Guidant Corporation, based in Indianapolis and makers of an internal defibrillator, failed to inform 24,000 patients and their doctors of an internal malfunction it may have cost one young man his life.
According to a New York Times story on Tuesday, Joshua Oukrop, 21, went on a spring bicycling trip in Utah with his girlfriend. He complained of fatigue, then collapsed and died. The young man had a genetic heart defect. He also had one of the Guidant defective defibrillators.
After the fact, Guidant approached his doctors and told them they had 25 other instances, along with Oukrop’s in which the defibrillators had short-circuited and failed. Guidant executive Dr. Joseph M. Smith said the company didn’t have a good reason to tell people about the problem. It was only in a small number of units and might cause more harm than good.
Price of Human Life
The Times went on to report that the Guidant Company issued an advisory after they learned of the story and recommended to doctors not to replace the internal defibrillator.
“It is a statistical argument that has little to do with real people,” Dr. Barry Maron of Abbott Northwestern Hospital told the Times. He also said that the numbers reported to Guidant might understate the situation because product problems could go undetected or might not be reported.
While the device has had widespread success and has saved many lives, most observers say Guidant screwed up when not coming out with the information when they new it. They followed FDA rules by reporting the problems and the corrective changes in the device but they failed to let doctors and patients know what was up and let them make the choice.
In a related BusinessWeek story talked to Indiana University heart expert Dr. Douglas Zipes.
“I don’t think Guidant can be faulted for a design flaw they did not anticipate,” said Zipes, who edits the journal that received the manuscript in which two doctors revealed the flaw. “The issue is, knowing such a defect exists, what do you do about it?”
Oukrop’s father, Lee Oukrop told the Times he hoped Dr. Smith’s son didn’t have the same problems. Oukrop has the same defect as his son. He had his Guidant defibrillator replaced. He also said he was going to talk to lawyer.
Guidant is working on a merger with Johnson and Johnson.
John Stith is a staff writer for Murdok covering technology and business.
