An article published in the May 24, 2005, edition of the New York Times tells the story of 21-year old college student Joshua Oukrop, who was afflicted with a genetic heart disease and implanted with a defibrillator made by Guidant Corporation. In March Oukrop died on a bicycling trip when, after complaining of fatigue, he suddenly fell to the ground and died of cardiac arrest. Guidant acknowledges that its implanted device was responsible.

The defibrillator, marketed under the brand Ventak Prizm 2 Model 1861, is surgically implanted in the chest under the skin and sends out an electrical charge to try to shock a chaotically beating heart back into normal rhythm when it becomes erratic. Guidant’s defibrillators are implanted in an estimated 24,000 people in the United States.

A flaw in the device has caused a small number of those units to short-circuit and malfunction. Guidant said it had changed its manufacturing processes over three years ago to fix the problem but did not notify physicians about the defibrillators because the failure rate was “very low and replacing the devices might pose greater patient risks.” The short circuit problem was fixed in 2002. The problem has not appeared in devices manufactured since then.

In interviews, doctors who treated Oukrop were angered by Guidant’s decision not to notify physicians. They felt the company had received enough reports about flaws to establish a pattern, and because high-risk patients could suffer potentially catastrophic results. When told the New York Times was preparing to release an article about the device, Guidant suddenly issued an advisory to doctors.

Guidant is one of the largest makers of medical devices with a reported $3.8 Billion in sales, almost half of that coming from implantable defibrillators. One defibrillator can cost up to $25,000, and doctor and hospital costs for the surgery can run another $15,000. Defibrillators also need to be replaced every five or six years because their batteries drain.

Implantable defibrillators are among the fastest-growing group of medical devices. The New York Times reported that more than 200,000 patients are expected to receive the implant this year. In December of 2004, Johnson & Johnson announced plans to purchase Guidant in a deal worth over $25 Billion. Mr. Oukrop’s father said he is likely to hire a personal injury lawyer to redress his son’s death.

Source: Barry Meier, “Maker of Heart Device Kept Flaw From Doctors,” New York Times, May 24, 2005.