Features
'Failure to Warn' Claims Against Generic Manufacturers Not Preempted By Federal Law
The U.S. Court of Appeals for the Eighth Circuit recently held that "failure to warn" claims brought against generic manufacturers of Reglan' (a prescription drug used to treat certain gastric disorders) were not preempted by federal law and could, therefore, proceed to discovery.
Features
Practice Tip: FDA Issues Draft Guidance for REMS
The first part of this article discussed the background of REMS (Risk Evaluation and Mitigation Strategies) and provided a summary of the Draft Guidance. The conclusion herein explains the second part of the procedure, including proposed modifications and communicating with the FDA.
When Attorneys Ghostwrite Experts' Reports
How much attorney involvement in the drafting of experts' reports is permissible? Must the entire work product be that of the expert? Or, at the other extreme, would it be acceptable for an attorney to draft the entire expert's report with the expert "adopting" it?
Enhance Associates' Success by Managing Conditioned Responses
Habitual responses quickly turn into behavioral practices. Too frequently, inappropriate conditioned responses escalate to bad habits due to frequency of use and lack of awareness. What can be done?
How Consensus Management Threatens Profitability
Firms of all sizes are faced with increased competition and increased client demands ' and consensus management is ill-equipped to deal with the new environment. There are several reasons for this, discussed herein.
Features
Constructing an In-House Training Program
This article outlines some of the essential advantages, and the challenges, in constructing an effective in-house training program.
Features
Powering Your Way Out of the Recession
The vision of this article is to provide a model that may be used in discussing how a firm can power into the next few years. It uses a watershed analogy to demonstrate drivers for higher margins and the skills required to maximize each stream of effort running toward the earnings "lake."
Features
Child Abuse Registry
Federal district court judge Shira A. Scheindlin has given preliminary approval to a settlement between a class of plaintiffs whose names are on the state's child abuse registry and the New York State Office of Children and Family Services.
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MOST POPULAR STORIES
- Use of Deferred Prosecution Agreements In White Collar InvestigationsThis 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.Read More ›
- The DOJ's Corporate Enforcement Policy: One Year LaterThe 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.Read More ›
- Surveys in Patent Infringement Litigation: The Next FrontierMost experienced intellectual property attorneys understand the significant role surveys play in trademark infringement and other Lanham Act cases, but relatively few are likely to have considered the use of such research in patent infringement matters. That could soon change in light of the recent admission of a survey into evidence in <i>Applera Corporation, et al. v. MJ Research, Inc., et al.</i>, No. 3:98cv1201 (D. Conn. Aug. 26, 2005). The survey evidence, which showed that 96% of the defendant's customers used its products to perform a patented process, was admitted as evidence in support of a claim of inducement to infringe. The court admitted the survey into evidence over various objections by the defendant, who had argued that the inducement claim could not be proven without the survey.Read More ›
- The DOJ's New Parameters for Evaluating Corporate Compliance ProgramsThe 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.Read More ›
- In the SpotlightOn May 9, 2003, the U.S. Attorney's Office for the District of Massachusetts announced that Bayer Corporation, the pharmaceutical manufacturer, had been sentenced and ordered to pay a criminal fine of $5,590,800 stemming from its earlier plea of guilty to violating the Federal Prescription Drug Marketing Act by failing to list with the FDA its drug product, Cipro, that was privately labeled for an HMO. Such listing is required under the federal Food, Drug & Cosmetic Act. The Federal Prescription Drug Marketing Act, Pub. L. 100-293, enacted on April 22, 1988, as modified on August 26, 1992 by the Prescription Drug Amendments (PDA) Pub. L. 102-353, 106 Stat. 941, amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. '' 331, 333, 353, 381, to establish requirements for distributing prescription drug samples.Read More ›
