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Guidant pleads guilty to withholding information from the FDA
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Device manufacturer Guidant recently pleaded guilty to criminal violations of the Federal Food, Drug and Cosmetic Act before a U.S. District Court judge.
Guidant admitted to criminal wrongdoing in its handling of short-circuiting failures in three models of its implantable cardioverter defibrillators, according to a press release. The affected models include the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Specifically, Guidant “admitted to making a materially false statement in a required submission to the FDA with regard to the Ventak Prizm 2 DR device” and also admitted to failing to notify the FDA of a “correction” to information on the Contak Renewal devices. The legal arrangement calls for Guidant to pay a combined criminal penalty of $296 million.
“Today’s entry of a guilty plea by Guidant and the proposed resolution would represent the largest criminal penalty ever imposed on a device manufacturer for violating the Food, Drug and Cosmetic Act,” FDA commissioner Margaret A. Hamburg, MD, said in the press release. “The FDA will continue to commit enforcement resources to seeking this type of criminal resolution and stiff sanctions when device manufacturers fail to adhere to the statutory and regulatory requirements that exist to ensure the safety and efficacy of their products.”
Guidant, a subsidiary of Boston Scientific Corporation, was charged in February 2010 and filed its guilty plea with the court on March 11, 2010. The devices were manufactured by Guidant’s cardiac rhythm management division headquartered in Arden Hills, Minn.
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