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In a drug or medical device injury case, one of the defense’s most potent arguments often is that the product in question underwent U.S. Food and Drug Administration (FDA) approval, so the balance of its safety and efficacy has already been determined by the federal government to warrant distribution of the product. 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. Still, device makers have shown themselves anxious to present evidence of 510(k) approval to juries considering whether their products are safe for patients to use. Is the fact of 510(k) approval a relevant piece of evidence in this regard?
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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.
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.
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.
Discussion of major rulings out of Texas and California.