Guidant Faces More Legal Action in False Claims Lawsuit

Cheryl Clark, January 31, 2011

Two weeks after it was formally convicted and fined $296 million by a federal judge for criminally failing to report life-threatening defects in its cardioverter defibrillators, Boston Scientific and its subsidiary Guidant find themselves again facing federal legal action, this time in the form of a civil False Claims Act lawsuit.

The U.S. Department of Justice joined litigation filed by a patient, James Allen, who allegedly received one of the defective devices. Under the whistleblower or qui tam provisions of the False Claims Act, a private citizen can sue on behalf of the U.S. and share in any recovery.

In a statement, Justice officials allege that Guidant sold the Ventak Prizm 2 and the Renewal 1 and 2, even though Guidant knew the devices were defective. Despite Guidant's fixing the defect in these lines of devices, the company continued to sell their remaining stock of defective devices anyway, the government charges.

In mid-January, Guidant was fined $296 million for failing to notify the U.S. Food and Drug Administration about short-circuiting failures in three models of its implantable cardioverter defibrillators. They include the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155).

In the latest case, federal officials charge that Guidant "hid the problems with their defibrillators form patients, doctors and the FDA." In February, 2010, Guidant pleaded guilty to misleading the FDA about the problems in the devices. A district court in Minnesota accepted the company's plea on Jan. 12, 2011.

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