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Drug & Device News
Employees Plead Guilty to Charges Company Misbranded Medical Devices
Two employees of AM2PAT Inc., which manufactured pre-filled syringes containing heparin and saline, have pleaded guilty to various charges stemming from the shipment of the company's products, which were misbranded as “sterile.” The company did not, in fact, test the syringes for sterility. Once they were shipped, the company then falsified device history reports to make it appear that sterility testing had been accomplished on the syringes prior to shipment. According to the U.S. Attorney's release announcing the guilty pleas, as a result of the scheme “between 200 and 300 medical patients around the country developed bacterial infections after having been injected with syringes from AM2PAT, Inc. Some of these infections resulted in serious illness such as spinal meningitis and permanent brain damages, while other infections led to death.”
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.