Thompson’s Drug & Device Enforcement & Litigation: Impact on 2008 and Beyond gives you in-depth analysis of the major legal, regulatory, enforcement and litigation events through early 2008 affecting the drug and medical device industries. This book will help attorneys and the industry:

• Plan legal strategy in 2008 and beyond,
• Avoid lawsuits,
• Save money, and
• Prevent costly mistakes

The book includes insights from leading attorneys; essential summaries of major cases and court decisions; practice tools; and a case index of nearly 275 cases.

The chapters are divided into six broad areas for easy reference – Product Liability; Enforcement and Compliance; Sales & Promotion Compliance; Medical Device Compliance; Food and Drug Administration Amendments Act of 2007; and Clinical Trials.

• thorough reporting of important developments
• commentary and analysis from prominent attorneys who offer valuable expertise and insight
• practical tips that can give you a heads-up on likely future developments – as well as guidance on best practices that can help you face the challenges confronting FDA-regulated companies and their counsel
• table of cases with nearly 275 case references and a table of practice tools

New for the 2008 Edition:

• The $4.85 billion Vioxx settlement, and what it means for product manufacturers, consumers, and mass product liability settlements.
• Important decisions from the U.S. Supreme Court and other federal and state courts on the federal preemption of state law liability claims brought against drug and device manufacturers.
• Sweeping new legislation boosting the FDA’s enforcement powers and new requirements for drug manufacturing, clinical trials and device regulation.
• The latest developments involving the regulation of direct-to-consumer advertising.
• Expanded use of the federal False Claims Act and the growing role of state false claims acts in the face of alleged fraud and abuse involving FDA-regulated products.

Nothing can help drug and device company officials and their counsel deal with these challenging times more than a clear understanding of the latest legal and regulatory developments and their likely effect during the years to come. Thompson’s Drug & Device Enforcement & Litigation: Impact on 2008 and Beyond will help you gain that understanding and prepare you for future events that will profoundly affect the drug and medical device industries.

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