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Enforcement Actions Department of Justice (DOJ) Pharmaceutical Industry

Troutman Pepper Locke

State AGs Join $202M Settlement Over HIV Drug Kickback

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On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more

Cozen O'Connor

AGs Inject Accountability into Pharma Practices via $202M Gilead Settlement

Cozen O'Connor on

New York AG Letitia James, along with a bipartisan coalition of 48 other AGs and in coordination with the U.S. DOJ, announced a $202 million settlement in principle with Gilead Sciences, Inc. (“Gilead”), to resolve...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

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments for June 2025

Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more

Tucker Arensberg, P.C.

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

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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

Husch Blackwell LLP

False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement

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Host Jonathan Porter welcomes back to the show Husch Blackwell attorney Abe Souza to discuss False Claims Act (FCA) enforcement in the pharmacy context. Pharmacies face multiple pressures, from disruptive online enterprises...more

Cozen O'Connor

Whistleblower Watch - A quarterly update on FCA Enforcement and Qui Tam Litigation - June 2025

Cozen O'Connor on

Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the most notable...more

Epstein Becker & Green

DOJ Civil Division Announces 2025 Priorities: Promises “Aggressive” False Claims Act Enforcement of Civil Rights Violations and...

Epstein Becker & Green on

On June 11, 2025, Assistant Attorney General Brett A. Shumate issued an internal memorandum (the “Shumate memo”) to all Civil Division employees of the U.S. Department of Justice (“DOJ”), describing the Division’s enforcement...more

Husch Blackwell LLP

Attorney General Pam Bondi’s Memo Concerning Healthcare Treatment for Transgender Minors: Implications for Providers

Husch Blackwell LLP on

Recently, Attorney General Pam Bondi purportedly issued an internal memorandum in response to Executive Order 14187 (“Protecting Children from Chemical and Surgical Mutilation”) concerning the treatment of transgender minors...more

Ropes & Gray LLP

DOJ Is Not Taking Its Foot Off the Gas in Health Care Fraud Enforcement: What DOJ’s New White-Collar Enforcement Plan Means for...

Ropes & Gray LLP on

On May 12, 2025, the Head of the US Department of Justice’s Criminal Division, Matthew R. Galeotti (“Galeotti”), announced DOJ’s first ever White-Collar Enforcement Plan (the “Plan”), which directs prosecutors to: (1) focus...more

Mintz - Health Care Viewpoints

Speaker Programs: Two Recent Enforcement Actions Serve as a Reminder of the Government's Longstanding Scrutiny

The pharmaceutical and medical device industries have long utilized speaker programs, which typically involve retaining health care professionals to speak or present on the companies’ products to educate their peers. Speaker...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

Skadden, Arps, Slate, Meagher & Flom LLP

Speaker Program Settlement Highlights Compliance Risks for Life Sciences Companies

On April 29, 2025, the U.S. Attorney’s Office for the Southern District of New York (SDNY) announced a $202 million civil False Claims Act (FCA) settlement with Gilead based on allegations that the company’s speaker program...more

ArentFox Schiff

Investigations Newsletter: Gilead to Pay $202 Million to Settle DOJ Claims Over Speaker Program Kickbacks

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Gilead to Pay $202 Million to Settle DOJ Claims Over Speaker Program Kickbacks - Gilead Sciences, Inc. has agreed to pay $202 million to resolve allegations brought by the US Department of Justice (DOJ) that it violated...more

ArentFox Schiff

Investigations Newsletter: Walgreens to Pay $300 Million to Settle DOJ Claims Over Invalid Opioid Prescriptions

ArentFox Schiff on

Walgreens to Pay $300 Million to Settle DOJ Claims Over Invalid Opioid Prescriptions - Walgreens Boots Alliance has agreed to pay more than $300 million to resolve allegations brought by the US Department of Justice (DOJ)...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

Morrison & Foerster LLP

Sights and Sounds from the Antitrust Section’s 2025 Spring Meeting

Antitrust experts from across the globe convened in Washington, D.C. on April 2–4, 2025 to discuss new enforcement policies and share updates on current issues in antitrust. We provide the key highlights from numerous panels...more

A&O Shearman

First Circuit Ruling Requiring “But-For” Causation In FCA Kickback Claims Deepens Circuit Split

A&O Shearman on

In an opinion that may complicate the U.S. Department of Justice’s (“DOJ”) efforts to enforce the False Claims Act (“FCA”), the U.S. Court of Appeals for the First Circuit held in a unanimous opinion on February 18, 2025 that...more

Latham & Watkins LLP

First Circuit Reins In Broad Theory of Liability Under AntiKickback Statute by Adopting “But-For Causation” Standard

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The First Circuit joins the Sixth and Eighth Circuits in adopting a more exacting causation standard for False Claims Act liability premised on Anti-Kickback Statute violations. In a victory for False Claims Act (FCA)...more

Womble Bond Dickinson

For Whom the Bell Tolls? The Impact of Wisconsin Bell v. United States ex rel. Todd Heath and United States v. Regeneron...

Womble Bond Dickinson on

The Supreme Court’s decision in Wisconsin Bell v. United States ex rel. Todd Heath clarifies what constitutes a “claim” under the federal False Claims Act (FCA). ...more

ArentFox Schiff

Investigations Newsletter: FCA Enforcement & Compliance Digest — Winter 2025 False Claims Act Newsletter

ArentFox Schiff on

Welcome to the Winter 2025 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more

K&L Gates LLP

First Circuit Adopts But-For Causation Standard for Kickback-Premised False Claims Act Actions

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On 18 February 2025, the First Circuit Court of Appeals issued its decision in United States v. Regeneron Pharmaceuticals, Inc., determining that “but-for” causation is the proper standard for False Claims Act (FCA) actions...more

Bass, Berry & Sims PLC

13th Annual Healthcare Fraud & Abuse Review - 2024

Bass, Berry & Sims is pleased to announce the release of the 13th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2024. Compiled by the firm's Healthcare Fraud & Abuse Task Force,...more

Harris Beach Murtha PLLC

First Circuit Decision Raises Bar on Anti-Kickback Statute-Premised Liability Under the False Claims Act

The United States Court of Appeals for the First Circuit recently joined the Sixth Circuit (2023) and Eighth Circuit (2022) in holding that the term “resulting from” in the Federal Anti-Kickback Statute (“AKS”) (as amended in...more

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