News & Analysis as of

Criminal Prosecution Food and Drug Administration (FDA)

Latham & Watkins LLP

Key Insights on President Trump Executive Order Limiting Criminal Enforcement of Regulatory Offenses

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The executive order shifts policy on enforcement of criminal regulatory offenses, steering away from criminal enforcement of strict liability offenses in regulatory matters....more

Hogan Lovells

White House Issues Executive Order Limiting Criminal Enforcement of Regulatory Offenses

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On May 9, 2025, the White House issued an Executive Order, “Fighting Overcriminalization in Federal Regulations,” that seeks to place limits on the criminal enforcement of regulatory offenses, particularly those that impose...more

Cooley LLP

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

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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

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

ArentFox Schiff

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

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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

Foley Hoag LLP

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...more

Oberheiden P.C.

SARMs Enforcement and FDA Escalation

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Always on the lookout for unapproved drugs and supplements being sold, the U.S. Food and Drug Administration (FDA) has ramped up its enforcement actions against selective androgen receptor modulators (SARMs), which are banned...more

Oberheiden P.C.

The FDA’s Scrutiny of Novo Nordisk is Likely to Trigger Additional Semaglutide Investigations

Oberheiden P.C. on

Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more

Alston & Bird

$19 Million Criminal Penalty Levied Against Food Manufacturer Serves as a Stark Reminder of the Importance of Food Safety...

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A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more

BakerHostetler

AD-ttorneys@law - January 2023 #2

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Introducing Our Secret Plan to Fight Inflation - It’s simple: Don’t fall afoul of the FTC - ’Twas Ever Thus - Every year, like the swallows returning to Capistrano, the Perseid meteor shower, or a Real Housewives...more

BakerHostetler

Note of Caution to Compounding Pharmacies

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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

Oberheiden P.C.

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

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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

Skadden, Arps, Slate, Meagher & Flom LLP

Deputy Attorney General Monaco Announces Additional Measures Targeting Corporate Criminal Conduct: The Impact for Life Sciences...

In a speech on September 15, 2022, Deputy Attorney General (DAG) Lisa Monaco announced several important updates to the U.S. Department of Justice’s (DOJ’s) approach to investigating and prosecuting corporate crimes. These...more

Benesch

Dialysis & Nephrology Digest - August 2022

Benesch on

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

Benesch

Dialysis & Nephrology Digest - May 2022

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Denver jury acquits DaVita, former CEO, of all charges in antitrust trial - After two days of deliberations, a Denver jury found DaVita and former CEO Kent Thiry not guilty of all charges relating to charges they...more

Oberheiden P.C.

Did You Receive an FDA Warning Letter? Here's What to Do Next

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What is an FDA Warning Letter? Did you receive an FDA warning letter? If so, then there are critical steps you can take today to prepare and to be able to respond promptly to the warning letter. The FDA will issue a...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 4. In This Month's E-News: April 2022

Report on Research Compliance 19, no. 4 (April, 2022) - A six-year review of the institutional review board (IRB) at National Jewish Health (NJH) of Denver has been resolved, with the organization outsourcing the...more

Oberheiden P.C.

Prescription and Medication Counterfeiting Defense

Oberheiden P.C. on

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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 2. In This Month's E-News: February 2022

Report on Research Compliance 19, no. 2 (January 27, 2022) - While expressing their “great disappointment,” the University of Michigan (U-M) Board of Regents on Jan. 16 announced the immediate removal of Mark Schlissel as...more

Health Care Compliance Association (HCCA)

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

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

Oberheiden P.C.

The FDA is Investigating Companies that Produce and Sell Poppy Seeds Due to Suspected Contamination

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The U.S. Food and Drug Administration (FDA) is investigating companies that produce and sell poppy seeds due to growing concerns over contamination with a controlled substance. In doing so, it is collaborating with the Drug...more

Vinson & Elkins LLP

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

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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

Rivkin Radler LLP

CBD Health Claims Raise FTC’s Hackles (And Prompt Class Action Suits)

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Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could...more

Saul Ewing LLP

The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know

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In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with colleague Justin Danilewitz, a litigator in the Firm’s White Collar and Government...more

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