UNITED STATES V. GUIDANT LLC
708 F.Supp.2d 903 (2010)
NATURE OF THE CASE: This was a hearing to accept a plea agreement by a corporation.
FACTS: 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.
ISSUE:
RULE OF LAW:
HOLDING AND DECISION:
LEGAL ANALYSIS:
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