Guidant LLC has pleaded guilty to withholding information from the U.S. Food and Drug Administration regarding failures in some of defibrillators, a criminal violation of the Federal Food, Drug and Cosmetic Act, according to the U.S. Department of Justice. It has agreed to pay $296 million as part of a plea deal, which still needs to be approved.
The admission by the medical device manufacturer, a subsidiary of Boston Scientific Corp., which is based in Natick, Mass., comes after a four-year investigation into Guidant’s handling of short-circuiting failures of three models of its implantable cardioverter defibrillators: the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Guidant’s Cardiac Rhythm Management division, which produced the defibrillators, is headquartered in Arden Hills, Minn.
Under the terms of the plea agreement with the Justice Department to resolve the charges, which must still be approved by a judge, Guidant admitted to making a false statement in a submission to the FDA with regard to the Ventak Prizm 2DR device; and failing to notify the FDA of a correction to Contak Renewal devices.
Said FDA Commissioner Margaret Hamburg, M.D.: “Today's entry of a guilty plea by Guidant LLC and the proposed resolution would represent the largest criminal penalty ever imposed on a device manufacturer for violating the Food Drug and Cosmetic Act.”
“This successful prosecution serves as an important wake up call to all those who seek to withhold vital information about public health and safety,” said Assistant Attorney General Tony West, who heads the Justice Department's Civil Division.
Boston Scientific wasn’t immediately available for comment.
Guidant Pleads Guilty to Not Reporting Defibrillator Problems to FDA; Plea Deal Calls for $296 Million Penalty
Published April 7, 2010
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