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Drug and Medical Device Product Liability Deskbook

  • ID: 3511157
  • Book
  • Region: United States
  • ALM Media, LLC
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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
The Drug and Medical Device Product Liability Deskbook includes: detailed coverage of: warning-related claims and defenses; other information-based theories; strict liability; FDA-related per se liability; preemption of common law tort claims by the Food, Drug & Cosmetic Act and FDA regulations; class actions in drug and medical device litigation; theories of liability asserted against entities other than manufacturers; practical issues involving litigation management; the use of expert witnesses; and many other important topics. The authors include practical coverage of “what a litigator needs to know about the FDA.” You'll also find out how plaintiffs and defendants can enhance their chances for success before litigation even commences.

Book #00674; looseleaf, one volume, 1,158 pages; published in 2004, updated as needed; no additional charge for updates during your subscription. Looseleaf print subscribers receive supplements. The online edition is updated automatically. ISBN: 978-1-58852-121-7.
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James M. Beck
James M. Beck is counsel in the mass torts and product liability group of Dechert LLP in Philadelphia. In addition to handling cases at the trial and appellate level, he is a frequent lecturer and writer on product liability issues. His article, FDA, Off-Label Use and Informed Consent: Debunking Myths and Misconceptions for the Food and Drug Law Journal, has been cited by the U.S. Supreme Court and by other appellate courts. He is also the editor of a 50-state ABA survey on FDCA-related tort causes of action and the ABA Mass Tort Subcommittee newsletter. Mr. Beck operates (with another attorney) the widely read Druganddevicelaw blog, devoted to the defense of product liability litigation involving FDA-regulated products. He is a member of the Product Liability Advisory Committee (PLAC), the Pennsylvania Defense Research Institute, the American Law Institute, and the American, Pennsylvania, and Philadelphia Bar Associations. A graduate of Princeton University (B.A., cum laude, 1978) and the University of Pennsylvania Law School (J.D., 1982), Mr. Beck is admitted to practice in federal and state courts in Pennsylvania, in the Supreme Court of the United States, and has been admitted in various federal and state courts pro hac vice.
Anthony Vale
Anthony Vale is a partner in the Litigation Department of Pepper Hamilton LLP in Philadelphia. He has wide experience in mass tort litigation involving drugs, devices and chemicals. He has written and lectured widely on these topics at ABA, IADC, ACI, and DRI meetings. Mr. Vale was chair of the Class Action and Multiparty Litigation Committee of the International Association of Defense Counsel, chair of the Toxic Tort and Environmental Law Committee of ABA/TIPS, and a member of the CLE board of the American Bar Association's Tort and Insurance Practice Section (ABA/TIPS). He has also served as president of the British American Chamber of Commerce of Greater Philadelphia. Mr. Vale received his LL.B. in 1972 from the University of Exeter in England and attended University of Pennsylvania Law School. He is admitted to practice in Pennsylvania and before the United States Supreme Court, the Third, Fifth and Eleventh Circuit Courts of Appeal, and several federal district courts.
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