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Manufacturers Enforcement Actions Department of Justice (DOJ)

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

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?

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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

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 & 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

Dorsey & Whitney LLP

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

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​​​​​​​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

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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

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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

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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

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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...

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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

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“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

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - August 2019

ANTICORRUPTION DEVELOPMENTS - Telecommunications Company Fined $12 Million for FCPA Violations - On August 29, 2019, The Securities and Exchange Commission (SEC) instituted ceaseand-desist proceedings against...more

Robinson+Cole Health Law Diagnosis

DOJ Enters into $225 Million Settlement with Opioid Manufacturer to Resolve Criminal and Civil Investigations

On June 5, 2019, the Department of Justice (DOJ) announced a global settlement with Insys Therapeutics (Insys) that preliminarily resolves criminal and civil cases against the opioid manufacturer in a number of jurisdictions....more

McDermott Will & Emery

Cartel Snapshot - June 2019

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The Department of Justice (DOJ) Antitrust Division announced three new investigations and several developments in its other investigations, including new investigations in the commercial flooring industry, online auctions for...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - September 2018

ANTICORRUPTION DEVELOPMENTS - Petrobras Settles with U.S. Authorities Over Alleged FCPA Violations - On September 27, 2018, the U.S. Department of Justice (DOJ) and the Securities and Exchange Commission (SEC)...more

Foley & Lardner LLP

Know the Risks: Domestic and International Compliance

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An open question coming into 2017 was whether the aggressive enforcement posture that had characterized the Obama and Bush administrations would continue under the Trump administration. Any questions were answered with the...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - August 2015

Welcome to the August 2015 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange...more

Morrison & Foerster LLP

CPSC Could Be Coming Around On A Litigation Strategy

The U.S. Consumer Product Safety Commission continues to escalate its enforcement efforts. Recently, the U.S. Department of Justice, on behalf of the CPSC, filed suit against Spectrum Brands Inc. See United States v. Spectrum...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

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