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Daily Compliance News: August 1, 2025, The All AI Edition
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Solicitors General Insights: The Tale of Two Washingtons — Regulatory Oversight Podcast
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Understanding the Impact of IPR Estoppel and PTAB Discretionary Denials — Patents: Post-Grant Podcast
The Presumption of Innocence Podcast: Episode 64 - Cages We Built: The Making of Mass Incarceration in America
Solicitors General Insights: The Legal Frontlines in Iowa and Indiana — Regulatory Oversight Podcast
(Podcast) The Briefing: The Ninth Circuit Puts the Brakes on Eleanor’s Copyright Claim
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Solicitors General Insights: A Deep Dive With Mississippi and Tennessee Solicitors General — Regulatory Oversight Podcast
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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
Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict - Following a record $1.6 billion jury verdict for off-label promotion of HIV drugs Prezista and Intelence, Johnson & Johnson (J&J) subsidiary...more
On June 23, 2025, the United States Court of Appeals for the Ninth Circuit affirmed a district court judgment in a case in which the jury found the defendant knowingly made false statements on customs forms to avoid paying...more
On May 22, 2025, in a significant decision that clarifies the scope of the federal wire fraud statute and resolves a circuit split, the U.S. Supreme Court upheld a pair of wire fraud convictions that had been premised on a...more
AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics. Our team, which includes former federal prosecutors, SEC enforcement attorneys, and federal agency attorneys, has...more
The US Court of Appeals for the First Circuit’s landmark decision in United States v. Regeneron Pharmaceuticals will have some implications for healthcare compliance and defense strategies. In the case, the First Circuit...more
In October 2024, we wrote about U.S. District Judge Kathryn Kimball Mizelle’s dismissal of a whistleblower action, deeming the qui tam provisions of the False Claims Act (FCA) unconstitutional. The Department of Justice (DOJ)...more
Seventh Circuit Reverses AKS Conviction Involving Allegations of Illegal Marketing and Advertising - On April 14, the US Court of Appeals for the Seventh Circuit reversed the criminal conviction of Mark Sorensen after a...more
In the summer of 2023, Justice Thomas suggested in a dissenting opinion in U.S. ex rel. Polansky v. Executive Health Resources that Article II of the Constitution might not permit a qui tam relator to sue in the name of the...more
On March 14, 2025, a three-judge panel of the U.S. Court of Appeals for the Fourth Circuit lifted a nationwide preliminary injunction that previously halted parts of two DEI-related executive orders signed by President Donald...more
On March 14, 2025, the Fourth Circuit Court of Appeals stayed the nationwide preliminary injunction previously issued by the District of Maryland, which had enjoined certain aspects of Executive Order No. 14173, President...more
On March 14, 2025, the U.S. Court of Appeals for the Fourth Circuit granted the government’s request to stay a Maryland federal judge’s nationwide preliminary injunction that temporarily stopped three key provisions of...more
Recent legal and political False Claims Act (“FCA”) developments signal a potentially turbulent time for the defense of investigations and lawsuits brought under the FCA...more
The United States Court of Appeals for the First Circuit recently joined the Sixth Circuit (2023) and Eighth Circuit (2022) in holding that the term “resulting from” in the Federal Anti-Kickback Statute (“AKS”) (as amended in...more
On February 18, 2025, the First Circuit joined the Sixth and Eighth Circuits in adopting a “but for” causation standard in cases involving per se liability under the federal Anti-Kickback Statute (AKS) and the False Claims...more
On Feb. 18, 2025, the U.S. Court of Appeals for the First Circuit adopted the “but for” causality standard for violations of the federal Anti-Kickback Statute (AKS) that give rise to violations of the federal False Claims Act...more
The First Circuit has issued its long-anticipated opinion in United States v. Regeneron Pharmaceuticals, Inc., clarifying the standard for establishing False Claims Act (“FCA”) liability based on Anti-Kickback Statute (“AKS”)...more
On February 18, 2025, a panel of the U.S. Court of Appeals for the First Circuit unanimously decided that in order to transform an Anti-Kickback Statute (AKS) violation into a false or fraudulent claim for purposes of False...more
In its most recent False Claims Act decision, the US Supreme Court opted for a narrow “claim” definition analysis, limiting its impact to those involved in the E-Rate program, but signaled interest in addressing the...more
On February 21, 2025, a federal district court in Maryland issued a nationwide injunction, temporarily preventing enforcement of three key provisions of President Trump’s executive orders targeting DEI programs. Specifically,...more
The Supreme Court of the United States issued three decisions today: Wisconsin Bell, Inc. v. United States, ex rel. Heath, No. 23-1127: This case considers whether reimbursement requests submitted to the Federal...more
On Feb. 18, in U.S. v. Regeneron Pharmaceuticals, the First Circuit Court of Appeals joined the Sixth Circuit and the Eighth Circuit in holding that, for purposes of establishing that a claim for payment of items or services...more
It’s now 3–1, with the First Circuit (2025) aligning with the Sixth (2023) and Eighth (2022) Circuits finding the meaning of the words “resulting from” — as used in a 2010 amendment to the federal Anti-Kickback Statute (AKS)...more
On September 30, 2024, a federal district court in the Middle District of Florida dismissed a qui tam action under the False Claims Act (“FCA”) on the basis that the FCA’s qui tam provision – which allowed individuals to sue...more
The qui tam provisions of the False Claims Act allow individuals to file suit on behalf of the United States and to receive a share of the resulting financial settlement or judgment. Filing a qui tam case is not just a formal...more