November 4, 2005
New York Attorney General Eliot Spitzer has filed a lawsuit against one of the worlds leading manufacturers of medical devices for concealing information about a design flaw in a heart defibrillator.
The lawsuit alleges that the Guidant Corporation failed to inform doctors about a mechanical problem that could cause the implanted device to malfunction with potentially fatal consequences.
"Concealment of negative facts that might influence a consumer to purchase another manufacturers product is the essence of fraud," Spitzer said. "We wouldnt permit this type of conduct in connection with the sale of cars or washing machines. It is simply unconscionable that it occurred with a critical medical device."
The lawsuit filed November 2, 2005, in New York State Supreme Court in Manhattan alleges that the Indianapolis-based company engaged in fraud by failing to disclose to physicians information about a flaw in its implantable cardio defibrillator -- the Ventak Prizm 2 DR Model 1861.
The device is surgically implanted in the body of a patient at high risk of sudden cardiac death due to an abnormal heart rhythm. Its supposed to deliver a controlled electric shock to restore normal functioning of the heart muscle. But if the device fails, the normal rhythm may not be restored, the heart may stop and the patient may die.
The lawsuit contends that in February, 2002, Guidant discovered a design flaw that caused some Prizm 1861 models to short out. It further states that between April and November of 2002, Guidant made certain engineering changes to correct the flaw.
The company, however, continued to sell Prizm 1861 defibrillators in which the design flaw had not been corrected. And for more than three years, Guidant failed to notify doctors of the defect in the older models.
In fact, Guidant did not reveal the facts about the Prizm 1861 defibrillator until May, 2005, on the day before the information was to be revealed in a news article in The New York Times.
The electrical short has been implicated in at least 28 failures of the Prizm 1861 defibrillator, including one that resulted in the death of a patient.
Through the lawsuit, the attorney general is seeking:
• a court order that will require Guidant to fully disclose to medical professionals relevant design and performance information about its medical devices.
• restitution for any patient who wishes to replace a Prizm 1861 defibrillator made before the 2002 manufacturing changes.
• disgorgement of Guidants profits from the sale of defective Prizm 1861 defibrillators.
In June of this year, Guidant voluntarily recalled Prizm 1861 defibrillators manufactured before April 2002.
At the time Guidant issued its recall, approximately 13,900 defibrillators made before the April 2002 were still in use by patients in the U.S.
