News & Analysis as of

Department of Justice (DOJ) Enforcement Actions Manufacturers

Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

Tucker Arensberg, P.C. on

The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Morrison & Foerster LLP

CPSC Issues Weekly Record Level of Product Safety Notices

As noted in our recent client alert, the U.S. Consumer Product Safety Commission (CPSC) continues to aggressively pursue enforcement actions for violations of the Consumer Product Safety Act (CPSA) against foreign...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Environmental Criminal Enforcement/Clean Air Act: Erie, Pennsylvania Coke Manufacturing Plant Owner Guilty Plea

The United States Attorney’s Office, Western District of Pennsylvania issued a June 20th news release stating that Erie Coke Corporation (“ECC”) has pleaded guilty in federal court to two counts related to alleged criminal...more

Foley & Lardner LLP

Customs Fraud Makes the Big Leagues: DOJ’s New White-Collar Priorities Confirm Heightened Risk

Foley & Lardner LLP on

Last month, the Department of Justice put trade, customs, and tariff fraud squarely in the spotlight. This isn’t just another line item on the compliance checklist, it’s a loud-and-clear signal that import-related enforcement...more

Kelley Drye & Warren LLP

DOJ Intervenes in Customs False Claims Act Case, Consistent with Administration’s Focus on Foreign Trade

The United States has intervened and filed a superseding complaint in a False Claims Act case originally filed by a whistleblower in the Eastern District of California. The Government’s complaint alleges that an importer and...more

Hogan Lovells

Why medical device companies must prioritize compliance with DOJ's Data Security Program

Hogan Lovells on

This regulation is designed to protect U.S. national security by restricting the transfer of bulk sensitive data to foreign entities associated with “countries of concern,” including China, Russia, Iran, North Korea, Cuba,...more

Morgan Lewis

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

Morgan Lewis on

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more

Mintz - Intellectual Property Viewpoints

Regulation, Enforcement, and Associated Challenges of the ENDS Industry: Part I

In 2016, the U.S. Food and Drug Administration (FDA) began regulating all manufacturers, retailers, and distributors of electronic nicotine delivery systems (ENDS) with following the agency’s promulgation of the Final Deeming...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

Foley & Lardner LLP

DOJ to Ramp up Antitrust Enforcement in Agriculture Sector

Foley & Lardner LLP on

On June 21, 2024, Deputy Assistant Attorney General Michael Kades announced the Department of Justice (DOJ) Antitrust Division’s plan to increase both civil and criminal antitrust enforcement in the agriculture sector. As...more

Thomas Fox - Compliance Evangelist

To the DOJ: Think Big and Go Big on the Boeing Monitorship

Perhaps the most significant blog post in the compliance arena was penned by Matt Ellis over 10 years ago when he challenged Walmart to “Go Big” on compliance. (They did.) We are now at another inflection point in compliance...more

ArentFox Schiff

Is the Robinson-Patman Act Returning? Or Was It Never Really Gone?

ArentFox Schiff on

The Federal Trade Commission (FTC) has heralded its increased antitrust scrutiny of price discrimination under the Robinson-Patman Act (RPA), though little has come of it to date. Yet, our review of trends in private...more

Oberheiden P.C.

Whistleblower Claim Leads to Huge Settlement for Unpaid Drug Rebates

Oberheiden P.C. on

A whistleblower action under the federal False Claims Act (31 U.S.C. §§ 3729 et seq.) against a U.S. pharmaceutical company has settled for an amount that can be as high as $50 million. The incident highlights the value and...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more

Dorsey & Whitney LLP

Recent DOJ Settlements Involving DME Manufacturers Highlight Important Anti-Kickback Considerations

Dorsey & Whitney LLP on

​​​​​​​The Department of Justice (“DOJ”) recently announced two settlement agreements, both involving durable medical equipment (“DME”) companies, following allegations that the companies had violated the Anti-Kickback...more

Hinch Newman LLP

FTC Made in USA Lawyer Discusses Latest Agency Enforcement Matter

Hinch Newman LLP on

A proposed FTC settlement that involves alleged false Made in USA representations and alleged deceptive COVID claims was recently filed by the Department of Justice on the FTC’s behalf against an individual and the two...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

Foley & Lardner LLP

Biden’s Executive Order on Competition and What it Means for the Manufacturing Industry

Foley & Lardner LLP on

It seems that hardly a day passes without an antitrust issue ending up on the front page of the newspaper. In the last several months, politicians, government officials, and enforcers alike continue to focus on their desire...more

Foley & Lardner LLP

President Biden’s Executive Order on Competition Could Mean Broad Changes Across a Range of Industries

Foley & Lardner LLP on

On Friday, July 9, 2021, President Biden issued a sweeping Executive Order that could have far-reaching implications for businesses across a broad spectrum of industries. The Executive Order takes a government-wide approach...more

Foley & Lardner LLP

Latest Open Payments Data Released Under Heightened Government Scrutiny

Foley & Lardner LLP on

On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

ArentFox Schiff

Investigations Newsletter: Senior DOJ Official Michael Granston Discusses COVID Relief Enforcement, Granston Memo, and other FCA...

ArentFox Schiff on

Senior DOJ Official Michael Granston Discusses COVID Relief Enforcement, Granston Memo, and other FCA Issues - Michael Granston, the Deputy Assistant Attorney General of the DOJ Civil Division, sat down this week with Jody...more

Morrison & Foerster LLP - Class Dismissed

Consumer Product Safety Enforcement To Heat Up Under Biden Administration

More aggressive enforcement actions and increased regulatory activities under the Biden Administration are here. In President Biden’s first weeks, he is making good on his promise to reverse course from the previous...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

ArentFox Schiff

Deputy Associate Attorney General Sheds Light on DOJ’s FCA Priorities at Annual False Claims Act Conference

ArentFox Schiff on

“Enforcing the False Claims Act is a top priority for the Department—not just for our office,” said Deputy Associate Attorney General Stephen Cox, the Keynote Speaker for the 2020 Advanced Forum on False Claims and Qui Tam...more

American Conference Institute (ACI)

[Virtual Event] 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - July 21st-22nd, 9:00...

Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more

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