News & Analysis as of November 15, 2024

Whistleblowers

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

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

Kohn, Kohn & Colapinto LLP on 8/14/2024

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

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

ArentFox Schiff on 3/19/2024

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

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

American Conference Institute (ACI) on 11/22/2023

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

True Facts About False Claims: MoFo's FCA Newsletter - October 2023

Morrison & Foerster LLP on 10/11/2023

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

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

Cozen O'Connor on 8/9/2023

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

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

Health Care Compliance Association (HCCA) on 8/8/2023

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

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

Bass, Berry & Sims PLC on 11/15/2022

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

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

Robinson+Cole Health Law Diagnosis on 9/28/2022

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

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

Robinson & Cole LLP on 12/20/2021

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

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

ArentFox Schiff on 11/15/2021

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

How The Truth Is False: Accurate Prescription Drug Event Data Can Trigger False Claims Act Liability

McCarter & English Blog: Government Contracts... on 5/12/2021

In United States ex rel. Silver v. Omnicare, Inc., et al. (D.N.J. No. 11-cv-01326), a whistleblower relator consistently alleged that certain pharmaceutical service providers have engaged in an illegal kickback arrangement...more

Novartis US Corruption Settlements: Part 3 – Compliance Failures

Thomas Fox - Compliance Evangelist on 7/22/2020

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Pharmaceutical company pays $54 million in settlement for FCA violation

Society of Corporate Compliance and Ethics... on 3/24/2020

CEP Magazine (March 2020) - On January 6, Teva Pharmaceuticals agreed to pay $54 million to settle allegations that the company violated the False Claims Act and the Anti-Kickback Statute by providing unlawful compensation...more

Teva Pharmaceuticals to Pay $54 Million to Settle Healthcare-Based FCA Claims

PilieroMazza PLLC on 2/12/2020

A qui tam False Claims Act (FCA) action brought by two whistleblowers alleging violations of the Anti-Kickback Statute (AKS) has resulted in a $54-million settlement from Teva Pharmaceuticals USA, Inc. and two subsidiaries...more

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

Bass, Berry & Sims PLC on 2/4/2020

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

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

ArentFox Schiff on 2/3/2020

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

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

The Volkov Law Group on 10/23/2019

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

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

Robinson+Cole Health Law Diagnosis on 9/18/2019

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

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

Saul Ewing LLP on 5/20/2019

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

DOJ moves to dismiss 11 False Claims Act cases

Bricker Graydon LLP on 1/17/2019

On December 17, 2018, the Department of Justice (DOJ) moved to dismiss 11 False Claims Act (FCA) cases brought by whistleblowers against pharmaceutical manufacturers and their commercial outsourcing vendors, alleging that...more

Management Alert: DOJ Files Motion To Dismiss Eleven False Claims Act Suits

Seyfarth Shaw LLP on 12/24/2018

Seyfarth Synopsis: The United States Department of Justice recently filed a seismic motion to dismiss in a series of healthcare fraud-related cases. ...more

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

Skadden, Arps, Slate, Meagher & Flom LLP on 12/13/2018

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

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

Burr & Forman on 11/28/2018

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

Recent Fraud Settlements Illustrate Current Compliance Risk Areas

Ruder Ware on 5/18/2018

One of the reasons compliance officers and health care attorneys read fraud settlements is to identify issues the government is focused on. The cases the government decides to pursue are very indicative of the areas of fraud...more

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

Skadden, Arps, Slate, Meagher & Flom LLP on 3/30/2018

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

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Anti-Kickback Statute › Pharmaceutical Industry › Whistleblowers

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