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Editor’s Note: The author has a unique and personal perspective on this issue. He is a C6, C7 quadriplegic who has been paralyzed from his chest down since 1989, and went from a seemingly hopeless situation in a hospital bed to intense therapy to the courtroom.
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 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.
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.