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

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

United States v. Elizabeth Holmes and Ramesh Balwani

Foley Hoag LLP on 5/24/2023

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...more

Note of Caution to Compounding Pharmacies

BakerHostetler on 12/6/2022

Key Takeaways: ..FDA created a new category for voluntary firm registration after NECC compounding fungal meningitis outbreak in 2012. ..Individuals face criminal liability for misrepresentations made to FDA. ...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

Prescription and Medication Counterfeiting Defense

Oberheiden P.C. on 2/22/2022

21 U.S.C. § 331: Selling Counterfeit Drugs - Under Section 331, it is illegal to sell counterfeit drugs in interstate commerce. Because this includes online sales, the “interstate commerce” element is very easy to...more

Data Corruption: DOJ Targets Fraud In Medical Research Trial In The Era Of COVID-19

Vinson & Elkins LLP on 3/23/2021

In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...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

Food & Beverage Litigation Update l February 2020 #2

Shook, Hardy & Bacon L.L.P. on 2/18/2020

LEGISLATION, REGULATIONS & STANDARDS - France to Ban Mass Culling of Male Chicks - France’s agriculture minister has reportedly announced that the country will prohibit the mass culling of male chicks shortly after they...more

The Delaware Court of Chancery Rejects Termination of Merger Agreement Based on Material Adverse Effect

Cadwalader, Wickersham & Taft LLP on 1/8/2020

In Channel Medsystems, Inc. v. Boston Scientific Corporation, the Delaware Court of Chancery rejected an attempt by Boston Scientific to terminate and thus avoid consummating a merger agreement with Channel on the grounds...more

Criminal Prosecution › Fraud › Food and Drug Administration (FDA)

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