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United States v. Guidant, LLC

United States District Court for the District of Minnesota
708 F.Supp.2d 903 (2010)


Facts

Guidant, LLC (defendant) developed, manufactured, and sold implantable cardioverter defibrillators (ICDs), medical devices implanted in a patient to treat abnormal heart rhythms that could result in sudden cardiac death. It was discovered that two of Guidant’s models were defective which could result in the device not working. Although Guidant fixed the defects, it failed to notify the Food and Drug Administration (FDA) in the time and manner required by federal law. Guidant offered to plead guilty to two misdemeanor counts, namely (1) making materially false and misleading statements on reports required to be filed with the FDA, and (2) failing to promptly notify the FDA of a medical device correction. The plea agreement also provided that Guidant would pay a fine of over $250,000 and agree to a criminal forfeiture of over $42 million. However, the agreement did not include a provision that ordered restitution or probation. The district court reviewed the plea agreement.

Rule of Law

Issue

Holding and Reasoning (Frank, J.)

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