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Post date: November 3 2005

Medical Device Maker Sued For Hiding Defibrillator Defect

Attorney General Spitzer today announced a lawsuit against one of the world’s 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 manufacturer’s product is the essence of fraud," Spitzer said. "We wouldn’t 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. The device is 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 alleges that in February 2002, Guidant discovered a design flaw that caused some Prizm 1861 models to short out. The lawsuit alleges 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.

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.

The lawsuit seeks restitution for any patient who wishes to replace a Prizm 1861 defibrillator made before the 2002 manufacturing changes.

The lawsuit also seeks disgorgement of Guidant’s 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.

The case is being handled by Assistant Attorneys General Shirley Stark and Rose Firestein, under the supervision of Thomas Conway, Chief of the Consumer Frauds Bureau, and Joseph Baker, Chief of the Health Care Bureau.


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