Guidant Decides Not to Warn About Manufacturing Defect in Defibrillator

Guidant Corporation, a medical device manufacturer, did not tell doctors or patients for three years that a unit implanted in an estimated 24,000 people that is designed to shock a faltering heart contains a flaw that has caused a small number of those units to short-circuit and malfunction.

Defibrillators are put in people whose heart cannot be relied upon to operate consistently on its own. Of course, if your heart does not maintain an appropriate rhythm over a given period of time, you can die.

According to the New York Times, Dr. Joseph Smith, a corporate representative, said “We choose to extraordinarily communicate [to doctors or patients] when we have a product that does not live up to our expectations.” Apparently, then, Guidant expected that at least 26 of the units it manufactured with the expectation of helping people to live would short-circuit and malfunction and determined that that risk was not a significant one (at least for its company). Guidant knew that twenty-five of those units failed before the death of a 21-year old college student from Minnesota, who died when his device failed. His death is the only known death from the malfunction of the device.

My guess is that Joshua Oukrop (the young man who died) and his family had different expectations than Guidant. My guess is that they thought device implanted in Joshua’s chest would work. My guess is that they thought if the company knew of a defect in the device they would let him or his doctor know. My guess is that Dr. Smith would have a different point of view if the device was implanted in the chest of his child.