Wednesday, April 28, 2010

Guidant Plea Deal on Defibs Rejected

Boston ScientificImage via Wikipedia

U.S. District Judge Donovan Frank in St. Paul, Minnesota, gave the judicial thumbs down to a plea agreement with prosecutors. He said the company should be placed on probation for failing to disclose defects with its heart devices to regulators. Boston Scientific had agreed to plead guilty to two misdemeanors and pay $296 million to settle a U.S. Justice Department probe.

On February 25, 2010, the United States of America charged Guidant LLC (formerly known as Guidant Corporation and hereinafter referred to as “Guidant”) with two misdemeanor violations of the FDCA pursuant to 21 U.S.C. § 333.

The filing of the Information was pursuant to a plea agreement that was
reached following a lengthy criminal investigation. As described more fully in the plea agreement, Guidant will plead guilty 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.


“At a minimum, the public’s interest in accountability would be served by Guidant and Boston Scientific being placed on probation,” Frank said in his 37-page ruling.

Link here.

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