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Department of Justice (DOJ) First Amendment False Claims Act (FCA)

ArentFox Schiff

Investigations Newsletter: Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict

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Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict - Following a record $1.6 billion jury verdict for off-label promotion of HIV drugs Prezista and Intelence, Johnson & Johnson (J&J) subsidiary...more

McGuireWoods LLP

Fourth Circuit Allows Anti-DEI Executive Order Provisions Involving Federal Contractors and Grantees to Proceed

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On March 14, 2025, a three-judge panel of the U.S. Court of Appeals for the Fourth Circuit lifted a nationwide preliminary injunction that previously halted parts of two DEI-related executive orders signed by President Donald...more

Womble Bond Dickinson

Appeals Court Lifts Injunction on Pair of DEI-Targeting Executive Orders: What It Means for Federal Contractors and Grantees

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A panel of the United States Court of Appeals for the Fourth Circuit lifted a nationwide injunction, allowing the Trump administration to resume implementation of a pair of executive orders targeting diversity, equity, and...more

Dinsmore & Shohl LLP

Court Blocks Enforcement of Anti-DEI Executive Orders

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What, exactly, is “illegal” Diversity, Equity and Inclusion (“DEI”)? As we previously reported, two recent Executive Orders (“EO”) prohibit “illegal” DEI practices that violate longstanding civil rights laws, but fail to...more

Smith Anderson

Court Puts Key DEI Executive Order Provisions on Indefinite Hold

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On February 21, 2025, a federal court in Maryland issued a nationwide preliminary injunction temporarily blocking the administration from carrying out key provisions in two of President Trump’s Executive Orders on Diversity,...more

Shipman & Goodwin LLP

Federal Court Injunction Pauses Key Provisions of President Trump’s DEI Executive Orders

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On February 21, 2025, the U.S. District Court for the District of Maryland issued a preliminary injunction that significantly impacts two of President Trump’s executive orders targeting Diversity, Equity, and Inclusion (DEI)...more

Morgan Lewis

Federal Judge Temporarily Halts Enforcement of Executive Orders Related to DEI

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A federal district court in Maryland issued a preliminary nationwide injunction on February 21 that temporarily halts enforcement of elements of Executive Orders 14151 and 14173. Most notably for federal contractors and...more

Davis Wright Tremaine LLP

New Administration Outlook: Key Provisions of Trump DEI Orders Blocked

On Friday, the U.S. District Court for the District of Maryland issued a preliminary injunction against several provisions of two executive orders signed by President Trump that sought to dismantle diversity, equity, and...more

Foley Hoag LLP

Court Blocks Key Provisions Under Trump Administration’s Anti-DEI Executive Orders

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On Friday, February 21, 2025, the United States District Court for the District of Maryland issued a preliminary injunction against key provisions of executive orders issued by President Trump that are aimed at curtailing the...more

Bond Schoeneck & King PLLC

Federal District Court Issues Partial Injunction of DEI Executive Orders

On Feb. 21, 2025, the federal district court for the District of Maryland issued a preliminary injunction partially enjoining two of President Trump’s executive orders: Ending Radical and Wasteful Government DEI Programs and...more

Hogan Lovells

Executive Orders targeting DEI partially blocked by court

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On February 21, a federal court in Maryland preliminarily enjoined three components of Executive Order (EO) 14151 (Ending Radical and Wasteful Government DEI Programs and Preferencing) and Executive Order 14173 (Ending...more

Nelson Mullins Riley & Scarborough LLP

Maryland Federal Court Enjoins Implementation and Enforcement of Two Trump Executive Orders Directed at DEI

On February 20, 2024, a Federal District Court in Baltimore preliminarily stopped the Trump DEI Executive Orders from going into effect until further legal proceedings occur. This abrupt halt of the Executive Orders will...more

PilieroMazza PLLC

DEI Executive Orders Partially Blocked: What’s In and What’s Out, For Now . . .

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On February 21, 2025, a federal court preliminarily blocked the Trump administration from enforcing key provisions of the recent executive orders (EOs) to eliminate “illegal” diversity, equity, and inclusion (DEI) programs...more

Morrison & Foerster LLP

What Now? President Trump's DEI Executive Orders Temporarily Paused

On February 21, 2025, a federal district court in Maryland issued a nationwide injunction, temporarily preventing enforcement of three key provisions of President Trump’s executive orders targeting DEI programs. Specifically,...more

Baker Donelson

Federal Crackdown on DEI Programs Intensifies – Government Enforcement and Investigations Risks

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In our prior Baker Donelson Client Alert, we examined the labor and employment implications of Attorney General Pam Bondi's Ending Illegal DEI and DEIA Discrimination & Preferences memorandum. This alert focuses on the...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more

Wilson Sonsini Goodrich & Rosati

DOJ Acknowledges in Proposed Jury Instructions That Dissemination of Truthful and Non-Misleading Off-Label Use Information Is Not...

For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more

Saul Ewing LLP

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

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Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

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