United States v. Guidant, LLC

Guidant, LLC (defendant) manufactured implantable cardioverter defibrillators (ICDs) used to treat abnormal heart rhythms, and discovered defects in two of its models that could cause the devices to fail; although Guidant fixed the defects, it failed to timely notify the FDA as required by law. Guidant offered to plead guilty to two misdemeanors — filing false statements with the FDA and failing to promptly report the device correction — agreeing to pay a fine over $250,000 and forfeit over $42 million, but the plea agreement included no term of probation or restitution. Victims and physicians urged the court to reject the plea for omitting probation, while the government argued probation would waste taxpayer resources.