Is a 1/10% failure rate too high?

Another company has joined Boston Scientific in the spotlight for providing faulty equipment. Guidant Corp., #2 maker of heart defibrillators, has acknowledged the existence of 49 reports of short circuits occuring in two models of its defibrillators, of which 42,000 units of both models had been produced.

Okay, it's not a perfect world, accidents happen. But, the issue here is that Guidant knew about the failure for three years and did not deign to tell doctors about the problem apparently because, in Guidant's eyes, the doctors were not capable of deciding whether the risks of removing the device outweighed the risks of keeping it implanted. Furthermore, rather than throwing out the devices it had in inventory, it sold them. That's right, it knew that at least 1/10% of the devices would short circuit and very likely kill someone but still they sold the devices and told no one of the risk. Adding insult to real injury, knowing what they knew about the risks inherent in one device, the Prizm 2 DR, they used the same technology in another device, Contak Renewal.

This is not the first time Guidant has adopted a "we know best' attitude. In 2001 one of the leading cardiologists in the US published an article about electrical failures in some other Guidant devices. The company's response? Silence.

Could it be that Guidant's judgment is being clouded by the $25.4 billion merger agreement that signed with Johnson & Johnson last December? Of course not, as the head of Guidant's cardiac implant unit says, "At this company, the quality culture is absolutely apparent." I'm not sure J&J believes that as they are taking another look at the merger agreement.