Health Care Law News and Insights

Supreme Court Ruling Finds “Strong” Mens Rea Requirement For Prosecution Under The CSA

Published: Jul 07, 2022
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Highlights In Ruan v. United States, the U.S. Supreme Court on June 27, 2022, dealt a blow to the U.S. Department of Justice by vacating convictions of two physicians convicted of violating 21 U.S.C. §841(a) of the Controlled Substances Act (CSA), which proscribes the illegal manufacture, distribution or dispensing of controlled...

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DOJ Clarifies Position On Fraud-On-The-FDA Theory Of False Claims Act Liability

Published: Jun 28, 2022
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On June 3, 2022, the Washington, D.C., office of the Civil Division of the Department of Justice (DOJ) filed a statement of interest in a relator's action in the Southern District of Florida, captioned U.S. ex rel. Patricia Crocano v. Trividia Health Inc., arguing that "[c]onduct giving rise to a regulatory violation can...

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Smart Baby Monitors May Be Considered Medical Devices By FDA

Published: Jun 18, 2022
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In 2018, Apple made headlines when it released a new version of its smartwatch that included an FDA-cleared electrocardiogram feature. Conor Hale, New Apple Watch receives FDA clearance for built-in ECG, Fierce Biotech (Sept. 12, 2018). This feature cemented the smartwatch's classification as a medical device. With the popularity of wearable health...

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