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
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
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
5/13/2025
/ Anti-Kickback Statute ,
Appeals ,
Criminal Prosecution ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Marketing ,
Medical Devices ,
Medicare ,
Physicians ,
Whistleblowers
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
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
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
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
7/23/2024
/ Administrative Authority ,
Administrative Law Judge (ALJ) ,
Artificial Intelligence ,
Drug Trafficking ,
Expert Testimony ,
Expert Witness ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
Fraud ,
Government Agencies ,
Government Investigations ,
Health Care Providers ,
Jury Trial ,
Medicare ,
Qui Tam ,
Regulatory Authority ,
SCOTUS ,
SEC v Jarkesy ,
Securities and Exchange Commission (SEC) ,
Statutory Authority ,
Whistleblowers
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
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
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
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
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
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
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
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
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
2/28/2022
/ Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Discount Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Government Investigations ,
Healthcare ,
Healthcare Fraud ,
Infectious Diseases ,
OIG ,
Paycheck Protection Program (PPP)
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
2/2/2022
/ Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Certification Requirements ,
CLIA ,
Clinical Laboratory Testing ,
Damages ,
Eighth Amendment ,
Excessive Fines Clause ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Penalties ,
Reimbursements ,
Statutory Violations
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
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
2/25/2021
/ Advertising ,
Anti-Kickback Statute ,
Biologics ,
Biotechnology ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Investigations ,
Life Sciences ,
Marketing ,
OPDP ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Warning Letters
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
2/19/2021
/ Anti-Kickback Statute ,
Biotechnology ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Investigations ,
Life Sciences ,
OIG ,
Penalties ,
Pharmaceutical Industry ,
Speaker Programs
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
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
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
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
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