News & Analysis as of

Healthcare Fraud Supreme Court of the United States Pharmaceutical Industry

A&O Shearman

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

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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

A&O Shearman

Pharma Company Brings Latest Constitutional Challenge To False Claims Act In Third Circuit

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On April 29, 2025, a pharmaceutical company filed the latest constitutional challenge to the qui tam provision of the False Claims Act (“FCA”) when it appealed in the United States Court of Appeals for the Third Circuit a...more

Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

Paul Hastings LLP

The Verdict Is In: SuperValu Wins at Trial Despite Knowingly Submitting False Claims

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In 2023, we wrote about the Supreme Court’s decision in United States ex. rel. Schutte v. SuperValu Inc. interpreting the False Claims Act’s (FCA) scienter standard to require inquiry into a defendant’s subjective knowledge....more

Cozen O'Connor

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

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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

Cranfill Sumner LLP

Kickbacks and Causation: Supreme Court Could Soon Settle the Question of Anti-Kickback Statute and False Claims Act Causation...

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A decision by the First Circuit Court of Appeals has deepened the legal debate surrounding False Claims Act (FCA) actions based on violations of the Anti-Kickback Statute (AKS). This decision has increased speculation that...more

Perkins Coie

First Circuit Imposes Higher “But-for” Causation Standard for False Claims Act Liability Based on Alleged Anti-Kickback Statute...

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On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...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...

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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

Epstein Becker & Green

First Circuit Joins Sixth and Eighth Circuits in Adopting “But-For” Causation Standard Under the Federal Anti-Kickback Statute for...

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In 2010, as part of the Affordable Care Act, Congress resolved a highly litigated issue about whether a violation of the Anti-Kickback Statute (AKS) can serve as a basis for liability under the federal False Claims Act (FCA)....more

Lowenstein Sandler LLP

Circuit Split Deepens on Anti-Kickback Statute’s Causation Standard

Lowenstein Sandler LLP on

Introduction: In its recent decision in United States v. Regeneron Pharmaceuticals, Inc., the United States Court of Appeals for the First Circuit deepened an existing federal circuit court split regarding the causation...more

ArentFox Schiff

Investigations Newsletter: Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions

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Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more

Polsinelli

Supreme Court Declines to Hear “Willfulness” Case

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On Monday, October 7, 2024, the U.S. Supreme Court declined to consider a petition for certiorari in United States ex rel. Hart v. McKesson Corp., Case No. 23-1293, where relator, Adam Hart (“Relator”), sought review of a...more

Morrison & Foerster LLP

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

Morrison & Foerster LLP on

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

Dinsmore & Shohl LLP

The Supreme Court Clarifies the Meaning of “Knowingly” Under the False Claims Act

Dinsmore & Shohl LLP on

On June 1, 2023, the United States Supreme Court issued an important decision addressing the intent element of the False Claims Act (“FCA”) in United States ex rel. Tracy Schutte v. SuperValu Inc. and United States ex rel....more

Bass, Berry & Sims PLC

Supreme Court Rejects Safeco, Holds that FCA Scienter Turns on Defendant’s Subjective Belief

On June 1, the U.S. Supreme Court unanimously refused to apply the Safeco objective knowledge standard to the False Claims Act (FCA), holding instead in U.S. ex rel. Schutte v. Supervalu Inc. that the FCA’s scienter element...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Epstein Becker & Green

Supreme Court Declines to Opine on Circuit Split Over Rule 9(b) Pleading Requirements for FCA Claims

On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more

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