News & Analysis as of

Whistleblowers Qui Tam Pharmaceutical Industry

Kohn, Kohn & Colapinto LLP

DOJ and Whistleblowers Crack Down on Illegal Kickbacks: Major Qui Tam Settlements from July 2024

In July, the U.S. Department of Justice (DOJ) and U.S. Attorneys Offices announced several large False Claims Act (FCA) settlements stemming from qui tam whistleblower suits....more

ArentFox Schiff

Second Circuit: Whistleblower Must Adequately Allege Willfulness to Assert FCA Claims Based on AKS Violations

ArentFox Schiff on

On March 12, the Second Circuit affirmed in part and reversed in part a district court dismissal of False Claims Act (FCA) claims predicated on alleged Anti-Kickback Statute (AKS) violations. Adam Hart brought the claims...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

Cozen O'Connor

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

Cozen O'Connor on

Summer 2023- 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...more

Morrison & Foerster LLP

DOJ Releases False Claims Act Statistics for Fiscal Year 2022

On February 7, 2023, the U.S. Department of Justice (DOJ) announced its fiscal year (FY) 2022 False Claims Act (FCA) statistics. Utilizing DOJ’s FY 2022 Data Table and comparing back to our FY 2021 coverage, MoFo’s FCA team...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

ArentFox Schiff

Investigations Newsletter: DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller 

ArentFox Schiff on

DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller - On November 8, 2021, the Department of Justice (DOJ) announced that it intervened in a qui tam suit and filed a False Claims Act...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

Bass, Berry & Sims PLC

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more

ArentFox Schiff

Investigations Newsletter: Health Information Technology Developer to Pay $145 Million to Resolve Kickback Allegations

ArentFox Schiff on

In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more

Epstein Becker & Green

Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series

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$3 billion recovered under the False Claims Act (“FCA”). That’s what the US Department of Justice (“DOJ”) reported collecting in FY2019. The health care and life sciences industries accounted for $2.6 billion of the total...more

Baker Donelson

Justice Department Recovers $3 Billion in 2019 from False Claims Act Cases – $2.6 Billion Related to Health Care Industry

Baker Donelson on

This week the Department of Justice reported it recovered $3 billion from False Claims Act cases in 2019. Of that recovery amount, $2.1 billion resulted from whistleblower, or qui tam, actions. In addition, 633 new qui tam...more

The Volkov Law Group

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

The Volkov Law Group on

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

Robinson+Cole Health Law Diagnosis

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more

Saul Ewing LLP

Eastern District of Pennsylvania Rejects Government’s Use of “Unfettered Discretion” to Dismiss Qui Tam Actions

Saul Ewing LLP on

Recently, Judge Timothy J. Savage of the U.S. District Court for the Eastern District of Pennsylvania said the government cannot simply exercise “unfettered discretion” to dismiss a qui tam action. See United States v. EMD...more

Troutman Pepper

When Research Misconduct Violates the False Claims Act: Lessons from Duke's $112.5M Settlement

Troutman Pepper on

On March 25, the U.S. Department of Justice (DOJ) announced that Duke University agreed to settle a False Claims Act qui tam action alleging widespread misconduct in federally funded research. ...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Year End Review: A Look Back…A Look Ahead

Bass, Berry & Sims PLC on

Perhaps the single most appropriate word to describe the current state of the civil and criminal healthcare fraud enforcement environment is uncertainty. From changes in personnel and policy at the highest levels of...more

Mintz - Health Care Viewpoints

Health Care Enforcement Year in Review & 2019 Outlook: Analysis of Health Care FCA Litigation Trends

In 2018, the volume of False Claims Act (FCA) litigation remained high, and health care-related qui tam (i.e., whistleblower) cases continued to lead the way. Using data compiled in the Mintz Health Care Qui Tam Database...more

Burr & Forman

The Causation Trend in Anti-Kickback False Claim Cases: Courts’ Rejection of Relators’ Taint Theory Should “Cause” Them Concern at...

Burr & Forman on

The False Claims Act (“FCA”) permits a person, known as a “qui tam relator” (or more commonly, a “whistleblower”), to bring a lawsuit on behalf of the federal government when that person has information that a healthcare...more

Mintz

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: January 2018

Mintz on

Overview of Qui Tam Activity: ..We identified 47 health care-related qui tam cases that were unsealed in August and September 2017. ..Over those two months, the rate of intervention was relatively high — at least 34%. For...more

Holland & Knight LLP

Healthcare Law Update: December 2016

Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

Saul Ewing LLP

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

Saul Ewing LLP on

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

Faegre Drinker Biddle & Reath LLP

There’s No Such Thing as Bad Publicity

As of March 3, Solvay Pharmaceuticals is ready to second P.T. Barnum’s famous dictum that there’s no such thing as bad publicity. That’s the day a federal court in Texas dismissed a qui tam action against Solvay....more

Foley & Lardner LLP

Whistleblowers Must Have Independent Knowledge to Actually Blow the Whistle

Foley & Lardner LLP on

To bring a valid qui tam action and overcome the so-called “public disclosure bar” under the False Claims Act (“FCA”), a whistleblower must have direct knowledge of the alleged fraudulent activity, independent of already...more

Cooley LLP

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Cooley LLP on

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

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