This section contains the nature of the case and procedural background.

Guidant, LLC (D) entered pleas of guilty on two misdemeanor counts charged by P. D developed, manufactured, and sold numerous medical devices. Two of them, subject to this action, the Prizm and Renewal are labeled Class III devices by the FDA. They are subject to the highest level of regulation. A manufacturer may not make any modification to the device that affects the device's safety or effectiveness without receiving prior approval from the FDA. When a correction is made to a device, a medical manufacturer is required to submit a written report to the FDA within a specific amount of time. D is charged with submitting a false and misleading report to the FDA on August 19, 2003, that concerned a change made to the Prizm on or about November 13, 2002. D is also charged with failing and refusing to report to the FDA a medical device correction to the Renewal on or about March 2, 2005. As many as 20,146 patients in the United States may have been implanted with Prizm and Renewal devices between late 2002 and June 2005. D entered pleas of guilty to two misdemeanor counts charged in the Information. At the plea hearing, the Court took under advisement whether it had a right to order restitution and if so, to what victims, if any, and whether to accept the Plea Agreement. The alleged victims urge the Court to reject the Plea Agreement because it does not contain a provision for restitution.

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