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Much has been written, including by us in January 2016, about the Food and Drug Administration’s (FDA’s) court losses in the area of off-label promotion (e.g., promotion of a pharmaceutical product’s unapproved uses). The agency held a public meeting in November 2016, and it is unclear how and when the FDA will issue any guidance, if at all, on its enforcement policy toward off-label promotion. Nevertheless, companies must remember that the agency will continue to take enforcement action, as appropriate, and FDA enforcement letters are made publicly available on its website. As such, non-compliance with FDA rules increases product liability exposure. In addition, even if the agency does not act, inaction does not preclude a product liability claim if someone is injured as a result of an unapproved use promoted by the company.
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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.