Originally published November 4 2005
Manufacturer of heart defibrillators sued for concealing safety facts
by Mike Adams, the Health Ranger, NaturalNews Editor
New York Attorney General Eliot Spitzer has filed suit against Guidant Inc., the second-largest manufacturer of implantable defibrillators, on charges that the company concealed a mechanical flaw in the device from doctors.
Guidant Corp., the second-biggest maker of implantable defibrillators, was sued by New York Attorney General Eliot Spitzer, who said the company misled doctors about a design flaw in a heart defibrillator.
The lawsuit claims Guidant Corporation failed to inform doctors about a mechanical problem that could cause the implanted device to malfunction with potentially fatal consequences, according to a statement today by Spitzer.
``Concealment of negative facts that might influence a consumer to purchase another manufacturer's product is the essence of fraud,'' Spitzer said in the statement.
The suit comes a day after Johnson & Johnson said it may abandon its $25.4 billion acquisition of Guidant Corp. because the company refused to accept revised terms after it recalled faulty heart defibrillators in June.
Guidant wouldn't agree to a restructuring of the proposed transaction, Johnson & Johnson said.
Guidant, based in Indianapolis, recalled 109,000 defibrillators, setting off regulatory probes and giving competitors an advantage.
Spitzer said in the statement that he is seeking any profits Guidant made from the sale of the implantable defibrillator in question, identified as a Ventak Prizm 2 DR Model 1861.
He also seeks restitution for any patient who wishes to replace any of that model made before manufacturing changes in 2002.
The defibrillator is designed to be surgically implanted in the body of a patient at high risk of sudden death due to an abnormal heart rhythm.
It is supposed to deliver a controlled electric shock to restore normal functioning of the heart muscle.
Spitzer claims in his suit that the model had a design flaw that caused it to short out.
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