CRM/LAW C144 Chapter Notes - Chapter UNITED STATES V GUIDANT LLC: Implantable Cardioverter-Defibrillator, Guidant, Asset Forfeiture
20 Jun 2017
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Punishing the corporate entity: the problem of sanctions. Underlying facts, the actual crime that took place. On april 2010, guidant entered pleas of guilty. Two misdemeanor counts: (1) making materially false and misleading statements on reports required to be filed with the fda, (2) failing to promptly notify the fda of a medical device correction. For the reasons set forth below, the court declines to accept the plea agreement as currently drafted. Hauser and maron urge the court to reject any plea agreement that does not contain a probation provision: also at issue in this case is the safety of future generations of patients who receive medical devices. Manufacturers are the first to know when a medical device is dangerous or underperforming. Thus, it is in the best interest of patients, and society in general, for manufacturers to be liable for the safety and effectiveness of their products.
