Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Cases in Court

By ALM Staff | Law Journal Newsletters |
August 26, 2003

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

Read These Next
The DOJ's New Parameters for Evaluating Corporate Compliance Programs Image

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.

The DOJ's Corporate Enforcement Policy: One Year Later Image

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 Image

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.

A Lawyer's System for Active Reading Image

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.

Bankruptcy Sales: Finding a Diamond In the Rough Image

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.