News & Analysis as of

Department of Justice (DOJ) Manufacturers

Thomas Fox - Compliance Evangelist

The Boeing Monitorship: Memo to Attorney General Garland and Kelly Ortberg

Gentlemen - I have written blog posts and articles about the proposed Plea Agreement negotiated between Boeing and the Department of Justice (DOJ). As the leaders of both organizations, I wanted to address you both...more

Thomas Fox - Compliance Evangelist

Boeing: Accept the Omnibus Monitor Approach

I recently wrote a series of blog posts and articles on why the Department of Justice (DOJ) should think big and go big with a completely new approach to the monitorship for Boeing under its agreement to take a guilty plea....more

Foley & Lardner LLP

DOJ to Ramp up Antitrust Enforcement in Agriculture Sector

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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

Troutman Pepper

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

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In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...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

Fisher Phillips

Snapshot on Manufacturing Industry: New Program Encouraging Corporate Whistleblowing Puts Manufacturers on Notice

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Welcome to this edition of the FP Snapshot on the Manufacturing Industry, where we take a quick snapshot look at a recent significant workplace law development with an emphasis on how it impacts employers in the manufacturing...more

Adams and Reese LLP

International Compliance Digest – May 2024

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May saw the long-awaited release of the USTR’s Section 301 review. USTR confirmed that the Trump-era tariffs will remain in place, and raised those tariffs by another $18 billion on manufacturing, critical minerals, solar...more

ArentFox Schiff

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

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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

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

Oberheiden P.C.

A 4-Point Guide for Pharmaceutical Whistleblowers

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There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more

Fox Rothschild LLP

New Comment on Right to Repair Products

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This week, the Federal Trade Commission (FTC) and Department of Justice (DOJ) submitted a comment to the U.S. Copyright Office to advocate for renewed and expanded exemptions to the Digital Millenium Copyright Act (DCMA),...more

Maynard Nexsen

Recent FCA Settlement Highlights Small Business Certification Issues in Private Equity Transactions

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The Department of Justice ("DOJ") recently announced a $1.75 million false claims settlement with a contractor that "improperly obtained government contracts that were set-aside for small businesses." The DOJ settlement...more

Troutman Pepper

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

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The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...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

American Conference Institute (ACI)

Navigating U.S. Sanctions and Export Control Restrictions

Over the last several months, companies have become entangled in an increasingly complex web of new and expanded sanctions and export control restrictions related to Russia in response to its war on Ukraine. The current...more

Husch Blackwell LLP

Legal Insights for Manufacturing: Outlook for 2024

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Our downloadable report, Legal Insights for Manufacturing, explores how the business, legal, and regulatory framework is evolving—and will evolve—to address the large generational shifts taking place. This year, our report...more

Fisher Phillips

White House Issues Sweeping AI Executive Order: 10 Things Employers Need to Know

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The executive order on artificial intelligence issued by the White House yesterday is the federal government’s most ambitious attempt to date to corral this burgeoning technology – and contains numerous items of interest for...more

Ankura

eDiscovery and Life Sciences Industry - Challenges and Solutions

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The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2023

On February 7, the Department of Justice (DOJ) issued a press release indicating that settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending September 30, 2022. Of this...more

Foley & Lardner LLP

Antitrust: Heightening Expansion, Review, and Enforcement

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Manufacturing companies should actively prepare for heightened antitrust scrutiny of their business practices in 2023, including practices that have not traditionally garnered the focus of the federal antitrust enforcers. ...more

McDermott Will & Emery

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

King & Spalding

DOJ Announces False Claims Act Recoveries for FY 2022

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On February 7, 2023, the Department of Justice (DOJ) announced its annual False Claims Act (FCA) recoveries for fiscal year 2022. DOJ recovered $2.2 billion from a total of 351 settlements and judgments—the second-highest...more

Husch Blackwell LLP

Legal Insights for Manufacturing

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We are pleased to announce that Husch Blackwell has published its inaugural “Legal Insights for Manufacturing” report, which provides a look ahead to 2023 and explores the key trends and issues that will shape the coming year...more

Hogan Lovells

FTC seeks to reinvigorate enforcement of Robinson-Patman Act

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The US Federal Trade Commission’s (“FTC”) reported investigations of Coca-Cola Co. and PepsiCo. Inc. for price discrimination are a significant step toward the agency’s revival of enforcement under the Robinson-Patman Act...more

Foley & Lardner LLP

Migraine Company Fails to Avoid Own Headache: Jet Medical and Others to Pay $745,000 to Resolve Allegations that Medical Device...

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On January 4, 2023, the Department of Justice issued a press release stating that Jet Medical Inc. has agreed to pay $200,000 to resolve criminal allegations relating to a migraine headache treatment. Jet Medical and two...more

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