News & Analysis as of

Whistleblowers Enforcement Actions Pharmaceutical Industry

A&O Shearman

Pharma company challenges the US False Claims Act: what’s at stake for whistleblowers and government enforcement?

A&O Shearman on

A pharmaceutical company is currently appealing a record USD1.6 billion judgment in the US, arguing that a key part of the US False Claims Act (FCA) is unconstitutional. This case, now before the Court of Appeals for the...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

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

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

Morgan Lewis

China’s First Antitrust Enforcement Case Targeting Individual Liability: Strategic Guidance for Multinational Corporations

Morgan Lewis on

The Administration for Market Regulation of Shanghai recently finalized penalties totaling RMB 223 million (approx. $31 million) against three pharmaceutical companies for colluding to fix prices and divide markets for...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

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

Patterson Belknap Webb & Tyler LLP

The First Circuit Requires But-For Causation in False Claims Act Cases Predicated on Violations of the Anti-Kickback Statute,...

On February 18, 2025, in United States v. Regeneron Pharmaceuticals, the First Circuit held that to establish civil liability under the False Claims Act (“FCA”) premised on violations of the Anti-Kickback Statute (“AKS”), the...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

Robinson+Cole Health Law Diagnosis

First Circuit Makes Historic Decision: “But-For” Causation is the Majority Standard in AKS-Based FCA Claims

In a much-anticipated decision, the First Circuit unanimously ruled the government and relators must prove that a violation of the federal Anti-Kickback Statute (AKS) was the “but-for” cause of a false claim under the False...more

Arnall Golden Gregory LLP

Narrowing FCA Cases Based on Kickback Allegations: What Healthcare and Life Sciences Companies Need to Know About the Regeneron...

On February 18, 2025, in a closely watched decision, the United States Court of Appeals for the First Circuit in United States v. Regeneron Pharmaceuticals Inc., No. 23-2086, 2025 U.S. App. LEXIS 3667 (1st Cir. Feb. 18, 2025)...more

Troutman Pepper Locke

DOJ and 18 States Reach False Claims Act Settlement with QOL

Troutman Pepper Locke on

The U.S. Department of Justice (DOJ) and 18 state attorneys general (AG) announced a settlement with Boston-based QOL Medical, LLC (QOL) and its CEO, Frederick Cooper, to resolve allegations that the company provided unlawful...more

Cranfill Sumner LLP

Record Number of Qui Tam Actions Filed in Fiscal Year 2024

Cranfill Sumner LLP on

The U.S. Department of Justice (“DOJ”) recently announced that in fiscal year 2024 (“FY2024”), settlements and judgments under the False Claims Act (“FCA”) exceeded $2.9 billion. Over $2.4 billion of such settlements and...more

Health Care Compliance Association (HCCA)

Delayed Action on Misconduct Costs Firm $4M; FCA Whistleblower Flagged Earlier Application

Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Bass, Berry & Sims PLC

[Virtual Conference] Nashville Healthcare Fraud Conference - December 15th - 16th, 8:00 am - 1:00 pm CST

Bass, Berry & Sims PLC on

Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more

Robinson+Cole Health Law Diagnosis

DOJ Announces $900 Million Settlement Tied to Speaker Bureau Payments to Physicians

On September 26, 2022, the United States Department of Justice (DOJ) announced a $900 million settlement with pharmaceutical company Biogen Inc., which arose from alleged violations of the federal False Claims Act (FCA) and...more

Robinson & Cole LLP

Department of Justice and State Attorneys General Pursue Private Equity Firms Under the False Claims Act

Robinson & Cole LLP on

On October 14, 2021, the Massachusetts Attorney General (MA AG) announced a $25 million settlement with South Bay Mental Health Center, Inc.’s (SBMHC) private equity owner and two former executives for allegedly causing false...more

Bass, Berry & Sims PLC

Trio of False Claims Act Retaliation Rulings from September

Bass, Berry & Sims PLC on

The False Claims Act (FCA) prohibits employers from retaliating against whistleblowers who report FCA violations. 31 U.S.C. § 3730(h). To plead a claim under this anti-retaliation provision of the FCA, an employee must show...more

The Volkov Law Group

St. Jude Agrees to Pay $27 Million to Settle False Claims Act Charges for Selling Defective Heart Devices (Part III of V)

The Volkov Law Group on

St. Jude Medical agreed to pay $27 million to settle False Claims Act charges that it knowingly sold a defective heart device to health care facilities.  St. Jude was acquired by Abbott Laboratories in early 2017....more

Morgan Lewis

Seventh Circuit Creates Third Standard in FCA Dismissal Authority Circuit Split

Morgan Lewis on

The Seventh Circuit’s novel statutory interpretation of the government’s dismissal authority under 31 USC § 3730(c)(2)(A) may have unintended consequences. ...more

40 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide