Day on Torts

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.

Since this report, my family has been trying to check on the model, etc. My father had, what we know so far is a Guidant Defribrillator that was put in in August of 2003. He died in his apartment, apparently after a bike ride and was taking a shower. Because he was found 3-4 days after he died, the medical examiner did not recommend an autopsy and I believe the final listing on his death certificate was heart failure. How could we ever know if it was defective and didn't save him like it was supposed to? After all, that's why it was installed.

I think it would be very difficult to link your father's death with the pacemaker, but the way to get some peace is to talk with a good lawyer in your community and get his or her advice. I would recommend looking for a board-certified lawyer. Go to www.nbtanet.org and look for a lawyer in or near your community. Ask the lawyer whether he or she has experience in products liability cases in general and medical device cases in particular. You should take this action as soon as possible because each state has time limits for filing lawsuits of this type; the failure to file a lawsuit on time bars your right to ever do so.

You should also contact the FDA with your concern. That effort may not help your family, but it could help some other family. Go to http://www.fda.gov/medwatch/.

I am sorry for your loss.

My dad had the Guidant 1861 implanted 8/02. He always said something didn't feel right about it. Once the monitoring technician seemed quite surprised/concerned as he read the display during a visit, the tech quickly left the room and got the doctor to see it. The doctor was also visibly surprised when he came in though neither said much. I don't recall the date now, but by 1/03 the doctor removed the device and implanted another model. By 8/03 my dad had died, but since he had CHF we always assumed that was the cause and never requested an autopsy. Then yesterday, my family hears about the class action suit starting against Guidant.
Is it possible the original device could have contributed to his eventual death? It did shock him several times in a row once when he said he felt fine, he ended up falling and splitting his head open on a marble statue and was taken by ambulance to the hospital.

My father had a Guidant implant put in on November 2, 2004. He always said that he did not think it helped him one bit, and when the $120,000.00 bill arrived , we were shocked! By january 27, 2005, two months later, my father died of heart failure in his assisted living apartment. The nurse had taken his blood sugar and vitals 15 minutes prior to his death, and all was fine. He took a bath, got out and dried off and died.
His pacemaker was a ACID product, Model H177, Serial number 503940. Is this one of the pace maker/defibrilators recalled?

Sorry to hear about your father.

Here is a copy of a press release. The device you mention does not appear on the list. Your father should check with his doctor to make sure that this information is correct.

Indianapolis, Ind. - July 1, 2005 - Guidant Corporation (NYSE: GDT) said today that FDA has classified its June 17, 2005 and June 24, 2005 physician communications regarding certain devices.

FDA has designated as "Class I" the previously announced physician communications concerning:

VENTAK PRIZM 2 DR (manufactured on or before April 16, 2002)
CONTAK RENEWAL 1 and 2 devices (manufactured on or before August 26, 2004)
A "Class I" recall is the highest priority recall. This recall, which consisted of a letter to physicians and patients, was sent out on June 17. A Class I recall is one in which there is a reasonable probability that, if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death.

FDA has designated as "Class II" the previously announced physician communications concerning:

VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL AVT devices
RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF devices
A Class II recall is one in which the malfunctioning product may cause temporary or medically reversible adverse health consequences, however the probability of serious adverse health consequences is remote.

It is absolutely wrong that our federal government simply cannot classify said implants before they hit the public market full bore. As far as myself and many of my associates are concerned, the fda needs an overhaul in the worst way to shore up all the screening issues it has so our legal system doesn't get anymore overloaded with these unbelievable claims.
Take Care,
Love your writing and blog,
Pat