News & Analysis as of

Department of Justice (DOJ) Enforcement Actions Federal Food Drug and Cosmetic Act (FFDCA)

Parker Poe Adams & Bernstein LLP

Is FDA's Civil Money Penalty Authority Dead, and If So, What Does It Mean for Life Sciences Companies?

Does the recent decision in a federal district court in Texas, finding that the U.S. Food and Drug Administration’s tobacco civil money penalty authority is unconstitutional, mean the end of the federal agency bringing...more

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

DarrowEverett LLP

The DOJ’s New White-Collar Agenda: Implications for Businesses

DarrowEverett LLP on

On May 12, 2025, the Department of Justice (the “DOJ”) released its criminal—and, more specifically, white collar crime enforcement—initiatives under the current administration. This is typical each time new leadership...more

Skadden, Arps, Slate, Meagher & Flom LLP

Core False Claims Act Theories Top the List of DOJ Criminal Enforcement Priorities

The May 12, 2025, memo from the head of the Department of Justice’s (DOJ’s) Criminal Division highlights 10 “high-impact” areas as the focus of DOJ’s criminal enforcement efforts. (See our May 14, 2025, client alert “In a New...more

Arnall Golden Gregory LLP

What the Dissolution of DOJ’s Consumer Protection Branch Means for Future Life Sciences and Consumer Protection Enforcement

The Department of Justice’s decision to shutter the Consumer Protection Branch (“CPB”) by September 30, 2025, is sending shockwaves across multiple industries. Known for its unique dual mandate to pursue both civil and...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

Ropes & Gray LLP on

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

Mintz - Health Care Viewpoints

EnforceMintz — Novel Criminal Charges and Emerging Civil Trends from Opioid Enforcement in 2024

In past years we have discussed how opioid-related enforcement efforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcement efforts continued across the entire opioid...more

Alston & Bird

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

Alston & Bird on

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

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

Farrell Fritz, P.C.

Herbal COVID Remedy Is Not The Government’s Cup of Tea

Farrell Fritz, P.C. on

Last week, the EDNY and the DOJ Consumer Protection Branch brought a civil enforcement action against defendants who manufacture and sell an herbal tea product called B4B Earth Tea Extra Strength (“Earth Tea”).  Earth Tea...more

Skadden, Arps, Slate, Meagher & Flom LLP

Recent Enforcement Settlements Highlight Continued Scrutiny of Quality and Manufacturing Issues

Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more

The Volkov Law Group

Avanos Medical Pays $22 Million to Settle Criminal Mislabeling Charges for Surgical Gowns

The Volkov Law Group on

Avanos Medical, a global medical device company, agreed to pay $22 million to resolve criminal charges relating to its fraudulent misbranding of its MicroCool surgical gowns....more

Skadden, Arps, Slate, Meagher & Flom LLP

Joint Promotional Programs With Physicians Raise Compliance Risks

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - Recent settlements between the U.S. Department of Justice (DOJ) and a range of...more

King & Spalding

Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud

King & Spalding on

As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more

Wilson Sonsini Goodrich & Rosati

FDA Announces Unprecedented Recall of Dietary Supplements

Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

Skadden, Arps, Slate, Meagher & Flom LLP

Failure to Report Adverse Events Results in Criminal Misbranding Settlement and Individual Liability

On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

Skadden, Arps, Slate, Meagher & Flom LLP

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

K&L Gates LLP

New DOJ Guidance Sharpens the Focus on Prosecuting and Suing Individuals in Corporate Criminal Investigations

K&L Gates LLP on

On September 9, 2015, the U.S. Department of Justice (“DOJ” or the “Department”) issued a memorandum to its staff revising the principles guiding criminal and, indeed, civil enforcement in corporate criminal investigations...more

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