United States v. Elizabeth Holmes and Ramesh Balwani

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I. WHY THIS CASE MADE THE LIST -

A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions last year against both executives for their roles in deceiving investors, doctors, and patients about the Company’s failed diagnostic tests. While this case is not premised upon violations of the Federal Food, Drug, and Cosmetic Act (FDCA)—and might even be considered by some industry observers to be ancient history at this point—the case is nevertheless important, and not only because the individuals at the helm were held personally and criminally accountable for their conduct...

Originally published in Food and Drug Law - May 2023.

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