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
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
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 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
In a continuation of its annual rite, the Department of Justice (“DOJ”) on July 20, 2022, announced healthcare-related criminal charges against 36 defendants in 13 federal districts around the U.S. The charges allege more...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)
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
On November 24, 2020, the Eleventh Circuit issued an opinion in U.S. v Shah (Case No. 19-12319), in which it disposed of the Anti-Kickback Statute’s (AKS or the “statute”) “one purpose” rule in certain circumstances. In this...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 October 28, 2019, the Department of Justice announced a $20.25 million settlement of False Claims Act (FCA) allegations. ...more
Over the past few years, the government’s emphasis on conducting fraud and abuse investigations – especially in the healthcare industry – has resulted in scores of settlements and billions of dollars paid to the government...more
Back in March of this year, in U.S. ex rel. Paradies v. AseraCare, Inc., a district court in Alabama granted summary judgment to a defendant hospice finding that an expert physician’s disagreement with a certifying...more