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.
"synopsis" may belong to another edition of this title.
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.
"About this title" may belong to another edition of this title.
(No Available Copies)
If you know the book but cannot find it on AbeBooks, we can automatically search for it on your behalf as new inventory is added. If it is added to AbeBooks by one of our member booksellers, we will notify you!Create a Want