Overview

This 35-page Executive Report written for food and drug attorneys and their clients features strategies for companies or individuals defending food and drug cases and determining factors for whether or not to litigate. Described are examples of common litigation matters that food and drug attorneys face and FDA's judicial enforcement mechanisms to deal with these matters. Whether a civil injunction proceeding or the more severe enforcement of criminal prosecution, devastating economic consequences are a definite possibility for any company. Selecting a knowledgeable attorney who will handle the matter with extreme care is crucial. In this Executive Report , these top food and drug attorneys demonstrate how to analyze the facts in a dispute and assess the pros and cons to a strategy before deciding upon a resolution that will best suit the client. Other topics include the first step in developing a strategy, step-by-step case development, damages normally sought, DEA enforcement, the FDA's two primary goals in regulating clinical research, the Hatch Waxman Act, warrant to seize goods, in rem proceeding, civil money penalties (CMPs), the Administrative Procedures Act, Federal Sentencing Guidelines, settling out of court versus going to trial, frivolous cases, trouble signs for defendants, financial exposure for companies, staying innovated in the field, false advertising, patent and trademark infringement, imprisonment of company officials, and class action suits. This Executive Report is written by: Frederick A. Stearns, Partner, Keller and Heckman LLP - Understanding FDA Oversight ; John A. Gilbert Jr., Director, Hyman, Phelps & McNamara PC - The Basics of DEA Enforcement ; Marsha C. Wertzberger and Wayne H. Matelski, Members, Arent Fox - The ABCs of FDA Oversight ; Robert B. Nicholas, Partner, Chair, FDA Practice Group, McDermott Will & Emery LLP - Understanding the FDA's Goals, Tactics and Motivations ; Charles R (Bob) McConachie, Partner, Simpson Woolley McConachie - Defending Litigation: Case by Case ; William W. Vodra, Esq.,Senior Partner, Arnold & Porter LLP - How FDA Cases and Class Action Suits Come About ; and Stanley H. Abramson, Life Sciences Co-Chair, Arent Fox PLLC - Defending Food and Drug Litigation. Executive Reports offer focused, hard-hitting advice from the leaders of some of America's top companies, packaged in a concise, readable format. Each research report provides readers with 3 to 5 strategies that will have a direct financial impact on their business. While not meant as a comprehensive guide, each report includes quick-hit items that can immediately impact specific business strategies. Executive authors drill down to the central issues surrounding each topic area and dispense expert advice in concise, direct language. Executive Reports feature leading professionals selected by the Aspatore Editorial Board based on their experience, research, and standing within the professional community.

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9781596225282

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