News & Analysis as of

Whistleblowers Prescription Drugs False Claims Act (FCA)

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

Oberheiden P.C.

A 4-Point Guide for Pharmaceutical Whistleblowers

Oberheiden P.C. on

There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more

Cozen O'Connor

Supreme Court Confirms: Subjective Beliefs of Falsity are Fair Game in FCA Lawsuits

Cozen O'Connor on

On June 1, 2023, the Supreme Court unanimously held in two consolidated landmark cases, U.S. ex rel. Proctor v. Safeway Inc. and U.S. ex rel. Schutte et al. v. SuperValu Inc., that a defendant’s subjective beliefs must be...more

Burr & Forman

Do I Believe You? Scienter Standard in a FCA Case

Burr & Forman on

Two False Claims Act (“FCA”) cases have recently been decided by the United State Supreme Court, further clarifying one aspect of the FCA. In the recent decisions in U.S. ex rel Proctor v. Safeway, Inc. and U.S. ex rel....more

Stevens & Lee

Supreme Court’s Decision in SuperValu May Benefit Defendants in False Claims Act Cases

Stevens & Lee on

Last month in United States ex rel. Schutte, et al. v. SuperValu Inc. et al, the Supreme Court unanimously held (with Justice Thomas writing the opinion) that the False Claims Act’s (“FCA”) scienter element refers to a...more

BCLP

U.S. Supreme Court Explains Meaning of “knowingly” Under the False Claims Act

BCLP on

In its recent unanimous and significant decision in the consolidated cases of United States ex rel. Schutte v. SuperValu, No. 21-1326 (6-1-23), and United States ex rel. Proctol v. Safeway, Inc., No. 22-111 (6-1-23), the...more

Ballard Spahr LLP

Supreme Court’s SuperValu Decision: a Game-Changer for Assessing FCA Violations

Ballard Spahr LLP on

Summary - On June 1, 2023, the Supreme Court issued a landmark decision in False Claims Act cases. In United States ex rel. Schutte v. SuperValu Inc., it unanimously held that liability under the False Claims Act depends...more

ArentFox Schiff

Investigations Newsletter: Supreme Court Again Tightens FCA Intent, But Tricky Questions Linger

ArentFox Schiff on

The US Supreme Court brushed aside novel assertions from two pharmacy retailers on June 1 and ruled unanimously that False Claims Act liability hinges on whether defendants subjectively believed their claims were “false.” In...more

Sherman & Howard L.L.C.

SCOTUS Pro-employer Pendulum Swings When It's the Fed's Ox Getting Gored

The False Claims Act ("FCA") imposes liability on anyone who "knowingly" makes a false claim to the Federal Government. This includes making false claims for reimbursement from the government under federal programs. As part...more

Clark Hill PLC

The U.S. Supreme Court Hands Down Decision That May Cool Pharmacy or Provider Discount, Coupon, or Financial Assistance Patient...

Clark Hill PLC on

Pharmacies and Healthcare Providers May Be Impacted - A June 1st U.S. Supreme Court (SCOTUS) decision on two whistleblower cases may have far reaching consequences for pharmacies or healthcare providers that charge a discount...more

WilmerHale

High Court Hears Important Case on False Claims Act’s Scienter

WilmerHale on

On April 18, the Supreme Court heard oral argument and what has been billed as the most important False Claims Act (FCA) case in a decade. Since the FCA was enacted in the Civil War era, it has been the primary tool for the...more

Morrison & Foerster LLP - Government...

Supreme Court Weighs In On The Role Of Subjective Intent Under The False Claims Act

On Tuesday, April 18, 2023, the Supreme Court heard argument in the consolidated cases of United States ex rel. Schutte v. SuperValu, Inc., and United States ex rel. Proctor v. Safeway, Inc., to consider whether subjective...more

Kohn, Kohn & Colapinto LLP

The Government’s Ability to Combat Fraud is on the Line in False Claims Act Supreme Court Case

Oral arguments are scheduled for April 18, 2023, in the Supreme Court case combining two Seventh Circuit Court of Appeals cases U.S. ex rel. Schutte v. SuperValu, Inc. (“SuperValu”) and U.S. ex rel. Thomas Proctor v. Safeway,...more

Fox Rothschild LLP

Is it Really Fraud? The Supreme Court Will Decide

Fox Rothschild LLP on

Two landmark cases fraught with False Claim Act (“FCA”) allegations of fraudulent billing for prescription drugs against food and pharmacy chains are making their way from the Seventh Circuit to the Supreme Court....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

Bradley Arant Boult Cummings LLP

Recent $900 Million FCA Settlement Highlights Risks in Speaker Programs

Several days ago, Biogen Inc. announced that it had reached a settlement to resolve a whistleblower lawsuit under the False Claims Act (FCA). Relator’s claims were based on allegations that Biogen’s speaker and consultant...more

Health Care Compliance Association (HCCA)

DOJ Intervenes in FCA Case Over Hospital Alliance With Doctors; 340B Drugs Are an Issue

Report on Medicare Compliance 31, no. 14 (April 18, 2022) - The Department of Justice (DOJ) said April 11 it has intervened in a whistleblower lawsuit against Methodist Le Bonheur Healthcare (MLH) in Memphis, Tennessee,...more

McCarter & English Blog: Government Contracts...

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

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

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

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

ArentFox Schiff

Investigations Newsletter: Major Retail and Health Care Company Faces Fraudulent Billing Lawsuit

ArentFox Schiff on

Omnicare and CVS Face Fraudulent Billing Lawsuit - On Tuesday, the US Attorney’s Office for the Southern District of New York announced a False Claims Act lawsuit against Omnicare, Inc. and its parent company, CVS Health...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

Dorsey & Whitney LLP

Relator Strikes Twice Against Walgreens

Dorsey & Whitney LLP on

For those who pay close attention to FCA settlements, the January 22 press release from the United States Attorney for the Southern District of New York of a $60 million settlement against Walgreens related to its...more

Bricker Graydon LLP

DOJ moves to dismiss 11 False Claims Act cases

Bricker Graydon LLP on

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

44 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