Medical Device Manufacturer Lied About Internal Heart Defibrillators, Will Pay Over $296 Million

On April 5th, 2010, the Department of Justice reported the settlement of a False Claims Act involving Guidant LLC.  The medical device manufacturer has agreed to pay over $296 million to resolve allegations that it lied to the Food & Drug Administration (FDA) to cover up fatal errors in three of its implantable cardioverter defibrillators. These lifesaving devices are used to detect and respond to abnormal hearth rhythms that, if left untreated, can result in death within minutes.

Guidant pleaded guilty to withholding information from the FDA regarding catastrophic failures in three of its devices: the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Specifically, Guidant admitted to: (1) making a materially false statement in a required submission to the FDA with regard to the Ventak Prizm 2DR device; and (2) failing to notify the FDA of a “correction” to the Contak Renewal devices, which the company made to reduce a risk to health caused by the devices. As a result of these offenses, the agreement calls for Guidant to pay a combined criminal penalty in excess of $296 million.

“The guilty plea today should serve as a reminder and deterrent to those who would break the laws requiring honesty and cooperation with government regulators whose mission is to protect the health and safety of the public,” said Frank J. Magill, Acting U.S. Attorney in this case for the District of Minnesota . “The health care laws are as important as ever. When medical device and pharmaceutical companies fail to live up to their legal obligations, serious criminal consequences will follow.”

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,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “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.”

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