What was this company thinking?
The Guidant Corporation said yesterday that it was recalling about 29,000 implanted heart devices because of flaws that might cause them to short-circuit when they are supposed to deliver a potentially life-saving shock.
The recall, which comes at the urging of the Food and Drug Administration, involves three models of defibrillators made by Guidant. In the case of one model, the Ventak Prizm 2 DR Model 1861, Guidant did not tell doctors for more than three years that it was prone to electrical failure because of a design flaw. The company also disclosed yesterday for the first time that two other Guidant units had also repeatedly short-circuited.
The company said it was aware of two recent deaths involving the units at issue. It is not clear how much the recalls may cost Guidant.
Goodness. This is like the kind of perfidy you read about in a John Grisham novel. Why did they finally decide to do something now? Oh:
But yesterday’s disclosure that Guidant also knew that other popular company models beside the Prizm 2 were prone to short-circuiting raises further questions about how the company handled such issues.
An F.D.A. official also questioned whether Guidant had acted properly when it recently rushed out a letter to doctors notifying them that the Prizm 2 had short-circuited in over 25 known cases, including the March death of a 21-year-old student.
The company took the action late last month when it became aware that problems with the device, which date back to 2002, were going to be publicized in other forums…
After the March death of a college student, Joshua Oukrop, doctors in Minnesota learned from Guidant that the Prizm 2 defibrillator they had implanted in him in 2001 had a history of electrical failures related to a design flaw.
The physicians, who had been treating Mr. Oukrop for a genetic heart disease that put him at risk of sudden cardiac arrest, said they urged Guidant at that time to notify other doctors. But company officials said they did not plan to do so because they did not see the problem as significant. The company did send a letter to doctors about the device in late May just as The New York Times was publishing an article about the Prizm 2.
The families of anyone who died should be able to sue this company out of existence and the executives responsible should be charged criminally if this is true.
John, John, John. Not very tort reform-y of you.
Tell me about it.
ed in texas
It was part of a subtle plot to sell a defective medical device via incompetent doctors, and hope the quacks killed ’em before the product failed. Failing that they were gonna take the patients on a fifth anniversary trip to Aruba.
J. Michael Neal
John, is it possible to give block quotes a darker background? I frequently have difficulty telling the quotes from your comments.
I mean, I wouldn’t want to mistake you for a Guidant spokesman.
Q: Why don’t polish girls use vibrators?
A: It chips their teeth.
They were thinking of their bottom line, of course, the next quarter and their investors. John, there is a left because we cannot count on the goodwill and ethics of the powerful. Surely you are aware of this? Surely? Please tell me you are.
Wasn’t this an early episode of Law and Order?
This is why I don’t support tort reform. Suing is how we keep companies from producing garbage. Its how a free market polices itself. If they can be sued, painfully, companies will spend the extra time and cash to make sure their products won’t hurt their consumers.
Is that brand the kind Cheney has installed?
Hard to judge this without more facts. One or two deaths in 29,000 people having heart attacks or heart problems. Sounds like a successful product to me.
We have deaths on a regular basis from Coke machines. One cannot build perfect medical electroncis that will keep the heart beating properly in all cases forever – any lawyer who says it can be done is just being a sophist.
It takes time to identify a defect and find a cure that would justify a recall. Three years does not shock me. Until one knows the defect and the cure, what good comes from writing to MD’s?
A patient who takes such a device is informed that it can and will fail.
Asking for perfection now is a great way to squash innovation, no?
It is the knowing there is a fult and not doing anything about it that kind of has my knickers in a twist.
The fault was in 27 of the 50,000 devices. This story is so not a story. It’s a medical device there might be a fault, oh and it’s .001% chance. What is the chance they might die without it?60, 65% Barry Meier, liberal douchebag
Josh was a friend of mine from High School. Obviously medicine is not without it’s flaws and no procedures are 100% guaranteed, but the patient deserves to know whatever the company and the doctors know about the product(s) being placed in their body and supposedly sustaining their lives. It is very easy to look at a story like this and say “only 27 of 50,000” but when that person is someone who has touched your life they are no longer just a number. Josh was a young adult with a bright future ahead of him and had he or his doctors known everything that the people at Guidant knew he would most likely still be with us today. How dare anyone turn him into just another number – no one deserves that.