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Prosecutors Must Provide Documents to Civil Claimant in Off-Label Promotion Suit
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Defeating Certification of “No-Injury” Consumer Protection Class Actions
By Steven P. Benenson
In the past several years, plaintiffs’ firms have threatened or brought class actions against different companies under New Jersey’s Truth-in-Consumer Contract Warranty and Notice Act (TCCWNA). Here's what you need to know.
Maximizing Future Medical Damages in Paralysis Cases
By Mitch Warnock
When you take a catastrophic injury case involving paralysis, it is important to have a thorough understanding of the problems and pitfalls. In this article, the author explores, from personal experience, the different types of future expenses the client can expect to incur.
Genetic Labeling: Legal Uncertainty for Pharma Product Liability
By Shannon E. McClure and Whitney Mayer
The FDA’s recent approval of 23andMe’s direct-to-consumer genetic test to identify genes associated with 10 common diseases and disorders could result in a widespread expansion of patients armed with individualized health information. This expansion of genetic information in the hands of consumers potentially impacts regulatory and litigation issues for pharmaceutical companies.
Exclusion of Evidence: The FDA's 510K Process
By Janice G. Inman
In a drug or medical device injury case, one of the defense's most potent arguments often is that the product in question underwent FDA approval. But when a device is approved for sale to the public through the FDA's 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken.
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