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The Food, Drug, and Cosmetic Act (FDCA) has historically allowed prosecutors to charge corporate employees with misdemeanors without having to prove personal participation or wrongful intent. But, as the use of the statute has become more frequent and penalties have gotten more severe, the constitutionality of such an application of the FDCA has come under heightened scrutiny.
The Food, Drug, and Cosmetic Act (FDCA) has historically allowed prosecutors to charge corporate employees with misdemeanors without having to prove personal participation or wrongful intent. But, as the use of the statute has become more frequent and penalties have gotten more severe, the constitutionality of such an application of the FDCA has come under heightened scrutiny. Until recently, the typical FDCA case has involved an executive who pleaded guilty to one or more misdemeanors in the face of DOJ allegations of felony misconduct. These negotiated resolutions did not raise the same due process concerns posed by cases today where defendants are facing these charges at trial and challenging the constitutionality of their sentences. Until the Supreme Court clarifies the bounds of the FDCA, district courts will struggle with identifying the necessary elements of individual criminal liability.
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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.
By ljnstaff
Discussion of major rulings out of Texas and California.
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