Criminal Prosecution, Food and Drug Administration (FDA), Healthcare Fraud

Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases

Cooley LLP on 1/31/2025

Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more

Investigations Newsletter: DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence

ArentFox Schiff on 10/23/2023

DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence - Mark Schena, the former president of Arrayit Corporation, a Silicon Valley-based medical technology company, was...more

Recent DOJ Consumer Protection Branch Cases Highlight the Branch’s Enforcement Priorities

Oberheiden P.C. on 10/6/2022

The U.S. Department of Justice’s (DOJ) Consumer Protection Branch works with other branches and federal law enforcement agencies to investigate and prosecute civil and criminal violations of the nation’s consumer protection...more

Dialysis & Nephrology Digest - August 2022

Benesch on 8/3/2022

DOJ files civil complaint alleging Fresenius performed unnecessary procedures on dialysis patients - In June, it was revealed that DOJ would partially join a whistleblower lawsuit against the dialysis provider. In a civil...more

Fake Histories, Calls by Staff Impersonating Subjects: A Look Inside Two Trial Fraud Cases

Health Care Compliance Association (HCCA) on 1/28/2022

Report on Research Compliance 19, no. 2 (January 27, 2022) - The trial was to be like any other that the clinical research organization (CRO) would oversee. The six-month study, known as VESTRI, would involve pediatric...more

The Convergence: Feds Level First Hybrid Healthcare- and Securities-fraud Charges Arising from COVID-19 Marketing and Sales

Dorsey & Whitney LLP on 6/17/2020

In what may be the beginning of a wave of enforcement actions, the Justice Department charged an organization and its leadership with dual healthcare and securities fraud charges. The prosecution underscores the risks facing...more

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