FDAnews Device Daily Bulletin


Nov. 7, 2005

Embattled heart devicemaker Guidant faced new legal troubles last week after New York Attorney General Eliot Spitzer filed a lawsuit alleging the firm concealed information about a design flaw in its heart defibrillator.

The lawsuit, filed in New York State Supreme Court in Manhattan, alleges Guidant engaged in fraud by failing to disclose to physicians information about a flaw in its Ventak Prizm 2 DR Model 1861 implantable cardioverter defibrillator (ICD).

"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."

Guidant has recalled or issued warnings on tens of thousands of its ICDs and pacemakers in recent months. The firm is facing a wave of liability lawsuits and a reported FDA criminal investigation. In addition, Guidant was one of three devicemakers targeted by a Justice Department probe into the sales practices of cardiac device manufacturers.