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Government Investigations Team Insights - May 2025

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

DOJ Expands Use of the False Claims Act to Target DEI and DEIA Initiatives

On February 5, 2025, Attorney General Bondi issued a Memorandum, “Ending Illegal DEI and DEIA Discrimination and Preferences,” which was designed to implement President Trump’s Executive Order 14173, “Ending Illegal...more

Limitations to the Anti-Kickback Statute? Seventh Circuit Reverses Conviction Finding “Aggressive” Marketing Tactics Insufficient...

On April 14, 2025, the United States Court of Appeals for the Seventh Circuit reversed the conviction of the owner of a durable medical equipment (“DME”) distributor, ruling that there was insufficient evidence to support a...more

A Constitutional Perspective on False Claims Act Penalties: District Court Finds That Penalties Conflict With Constitution’s...

In a potential watershed decision issued on February 26, 2025, the United States District Court for the Northern District of Texas ruled, in U.S. ex rel. Taylor v. Healthcare Associates of Texas, that the civil penalties...more

Narrowing FCA Cases Based on Kickback Allegations: What Healthcare and Life Sciences Companies Need to Know About the Regeneron...

On February 18, 2025, in a closely watched decision, the United States Court of Appeals for the First Circuit in United States v. Regeneron Pharmaceuticals Inc., No. 23-2086, 2025 U.S. App. LEXIS 3667 (1st Cir. Feb. 18, 2025)...more

Government Investigations Team Insights - February 2025

AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics. Our team, which includes former federal prosecutors and federal agency attorneys, has successfully represented...more

Government Investigations Team Insights - July 2024

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

Government Investigations Team Insights - September 2023

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

Senate Introduces Bill Amending False Claims Act Materiality Element and Anti-Retaliation Provision Expanding Liability

On July 25, 2023, Sens. Chuck Grassley (R-IA), Dick Durbin (D-IL), John Kennedy (R-LA), and Roger Wicker (R-MS) introduced the False Claims Amendments Act of 2023. The proposed amendment to the False Claims Act does not...more

SCOTUS Rejects Objective Knowledge Standard in False Claims Act; Defendant’s Subjective Belief Is Key to Scienter

In a unanimous opinion issued on June 1, 2023, the Supreme Court of the United States clarified the relevant standard for scienter — or knowledge — in False Claims Act (“FCA”) actions by ruling that an objectively reasonable...more

Sixth Circuit Affirms Dismissal of Anti-Kickback Statute-Based False Claims Act Complaint

The United States Court of Appeals for the Sixth Circuit recently affirmed an order dismissing a qui tam False Claims Act (“FCA”) suit based on alleged violations of the Anti-Kickback Statute (“AKS”). The appeals court agreed...more

Government Investigations Team Insights - February 2023

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

DOJ Recovers Over $2 Billion in False Claims Act Cases Last Year, But a Majority of the Funds Were From Cases That the Government...

On February 7, 2023, the Department of Justice released its report on False Claims Act Settlements and Judgments for Fiscal Year 2022, showing that the DOJ recovered over $2.2 billion last year. That same day, in his State of...more

Government Investigations Team Insights - September 2022

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

Eighth Circuit Says “But For” Causation Required in False Claims Act Case Based on an Alleged Anti-Kickback Violation

On July 26, 2022, the Eighth Circuit raised the bar for plaintiffs seeking to allege a violation of the False Claims Act (“FCA”) predicated on the Anti-Kickback Statute (“AKS”). Under this decision, the plaintiff must prove...more

Government Investigations Team Insights - February 2022

AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics.  In this edition, we analyze a recent Eleventh Circuit decision addressing False Claims Act penalties and the...more

Is There a Constitutional Limit to Excessive Fines in False Claims Act Cases? Eleventh Circuit Says a Million Dollar Fine for a...

In late December, the U.S. Circuit Court of Appeals for the Eleventh Circuit issued its decision in Yates v. Pinellas Hematology & Oncology, P.A. The appellate court affirmed the district court’s imposition of damages and...more

Private Equity Investors at Risk: A New Defendant in False Claims Act Cases?

As a generally held principle, mere investment or ownership interest in a company does not expose the investor to liability for acts undertaken by the company. However, that principle is being called into question in the...more

AGG Food & Drug Newsletter - February 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Life Sciences Investigations – 2020 Year in Review and 2021 Outlook

On February 11, 2020, AGG’s Government Investigations practice chairs, Aaron M. Danzig and Sara M. Lord, conducted a webinar, titled “Life Sciences Investigations and Enforcement Actions: 2020 Year in Review and 2021...more

The Beginning of a Wave? First Civil Fraud Settlement Against Recipient of PPP Funds

In a sign of things to come, on January 12, 2021, the Department of Justice (DOJ) announced the first civil settlement to resolve fraud claims involving loan recipients under the Paycheck Protection Program (PPP). We noted...more

2020 Government Investigations Team Insights - October 2020

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

How Much Money Do You Have? DOJ Releases New Guidance on Settling Civil Cases Based on an Ability to Pay

Last month, the Department of Justice released new guidance for assessing a company’s claim that it is unable to pay the amount of money demanded by the DOJ to settle a civil lawsuit. When the DOJ brings a lawsuit seeking...more

“Worthless Services” Theory in False Claims Act Cases Dealt Another Blow

On April 15, 2020, the Eastern District of Pennsylvania issued a defense-favorable order, granting summary judgment in a False Claims Act case brought on a “worthless services” theory. U.S. ex rel. Jackson v. DePaul Health...more

5/13/2020  /  False Claims Act (FCA)

Ninth Circuit Rejects “Objective Falsehoods” Standard and Finds that False Certification of Medical Necessity May Give Rise to FCA...

On March 23, 2020, the Ninth Circuit rejected the conclusion that a mere difference in clinical judgment is insufficient to show “objective falsity.” In issuing this decision, Ninth Circuit joined the Fifth, Tenth, and Third...more

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