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Cases in Court
California Medical Device Maker Pleads Guilty in Cover-up of Malfunctions
Endovascular Technologies, Inc., a wholly owned subsidiary of Guidant Corporation, based in Menlo Park, CA, pled guilty to a criminal information with ten felony counts, and agreed to pay $92.4 million to settle criminal and civil charges for covering up thousands of incidents involving the malfunction of a medical device (the 'Ancure device') used to treat aneurysms in the aorta. The incidents involved 12 deaths and dozens of invasive surgeries, according to a June 12, 2003, announcement by the U.S. Attorney's Office for the Northern District of California. Because the company knowingly failed to file required Medical Device Reports with the FDA, which the company knew about since it had a sales representative present in the operating room each time one of these devices was surgically implanted in a patient, it violated 21 U.S.C. ” 331(a) and 333(a)(2) ('Interstate Shipment of Misbranded Devices'). According to investigators, the government may charge company executives. The press release is available at www.usdoj.gov/usao/can/press/html/2003_06_12_endovascular.html
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.
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.
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.
CLE Shouldn't Be the Only Mandatory Training for Attorneys
Each stage of an attorney's career offers opportunities for a curriculum that addresses both the individual's and the firm's need to drive success.
Discovery of Claim Construction and Infringement Analysis May be Compelled Prior to a Markman Hearing
A defendant in a patent infringement suit may, during discovery and prior to a <i>Markman</i> hearing, compel the plaintiff to produce claim charts, claim constructions, and element-by-element infringement analyses.