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Features

'Failure to Warn' Claims Against Generic Manufacturers Not Preempted By Federal Law

David M. Gossett, Henninger S. Bullock & Daniel L. Ring

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Practice Tip: FDA Issues Draft Guidance for REMS

Alan Minsk

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this article discussed the background of REMS (Risk Evaluation and Mitigation Strategies) and provided a summary of the Draft Guidance.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

Michael Hoenig

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

Debra Forman

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

Robert W. Denney

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

Steven C. Bennett

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

William C. Cobb

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."

NJ & CT News

ALM Staff & Law Journal Newsletters

What's happening in neighboring states.

Features

Decisions of Interest

ALM Staff & Law Journal Newsletters

A review of recent case law.

Features

Child Abuse Registry

By Janice G. Inman

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

  • Surveys in Patent Infringement Litigation: The Next Frontier
    Most 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.
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  • In the Spotlight
    On 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 &amp; 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.
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