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Drug & Device News
More Cases Link Meningococcal Vaccine and Guillain Barr' Syndrome
On Oct. 20, the FDA and the Centers for Disease Control and Prevention (CDC) updated a previous alert to consumers and health care providers regarding reports of Guillain Barr' Syndrome (GBS) following administration of Meningococcal Con-jugate Vaccine A, C, Y, and W135 (trade name Menactra'), manufactured by sanofi pasteur. In addition to the five cases the FDA reported in October 2005, the new alert announced that 12 more such cases have developed. Fifteen of the 17 cases reported to date involved children 11-19 years old, and all these subjects developed GBS within six weeks of vaccination.
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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.