United States v. Guidant, LLC
United States District Court for the District of Minnesota
708 F.Supp.2d 903 (2010)
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
Holding and Reasoning (Frank, J.)
What to do next…
Unlock this case brief with a free (no-commitment) trial membership of Quimbee.
You’ll be in good company: Quimbee is one of the most widely used and trusted sites for law students, serving more than 97,000 law students since 2011. Some law schools—such as Yale, Vanderbilt, Berkeley, and the University of Illinois—even subscribe directly to Quimbee for all their law students. Read our student testimonials.
Learn more about Quimbee’s unique (and proven) approach to achieving great grades at law school.
Quimbee is a company hell-bent on one thing: helping you get an “A” in every course you take in law school, so you can graduate at the top of your class and get a high-paying law job. We’re not just a study aid for law students; we’re the study aid for law students. Read more about Quimbee.
Here's why 170,000 law students have relied on our case briefs:
- Written by law professors and practitioners, not other law students. 13,800 briefs, keyed to 187 casebooks. Top-notch customer support.
- The right amount of information, includes the facts, issues, rule of law, holding and reasoning, and any concurrences and dissents.
- Access in your classes, works on your mobile and tablet. Massive library of related video lessons and high quality multiple-choice questions.
- Easy to use, uniform format for every case brief. Written in plain English, not in legalese. Our briefs summarize and simplify; they don’t just repeat the court’s language.