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 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
The federal False Claims Act (“FCA”) is the United States’ primary civil tool for prosecuting fraud against the government. It was enacted in 1863 during the Civil War and, from its inception, has included qui tam provisions...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
The United States Court of Appeals for the Seventh Circuit recently considered a district court’s nearly $6 million judgment in a qui tam False Claims Act (“FCA”) suit based on Anti-Kickback Statute (“AKS”) violations. The...more
On March 27, 2020, the CARES Act was signed into law to provide emergency financial assistance to Americans suffering the economic effects caused by the COVID-19 pandemic, including in the form of forgivable loans to small...more
News Briefs - State AGs Urge Congress to Reform Pharmacy Benefit Managers - A bipartisan group of 39 state attorneys general sent a letter to Congress urging lawmakers to take "decisive action" to reform pharmacy benefit...more
3/4/2024
/ Biotechnology ,
Digital Health ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Healthcare Workers ,
Home Health Care ,
Hospice ,
Hospitals ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Settlement ,
Telehealth
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
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
The United States Court of Appeals for the Ninth Circuit recently considered an Order of the Central District of California dismissing a qui tam False Claims Act (FCA) suit against a medical device manufacturer based on...more
On July 9, 2018, in United States ex rel. Polukoff v. St. Mark’s Hosp., the Tenth Circuit Court of Appeals added to the debate over the role of the False Claims Act in policing medical necessity. ...more
On January 11, 2018, the United States District Court for the Middle District of Florida set aside a nearly $350 million False Claims Act (FCA) jury verdict rendered in February 2017 against a group of fifty-three skilled...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
The United States Court of Appeals for the Second Circuit recently affirmed an Order of the Eastern District of New York dismissing a qui tam False Claims Act (FCA) suit based on “off-label” marketing of prescription drugs....more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
5/20/2016
/ Abbreviated New Drug Application (ANDA) ,
App Developers ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Medical Foods ,
OIG ,
Pharmaceutical Industry ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
4/22/2016
/ Abbott Laboratories ,
All Natural ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Co-payments ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Investors ,
Medicare Part B ,
Misleading Impressions ,
Natural Products ,
Personal Care Products ,
Pharmaceutical Industry ,
Prescription Drugs ,
Securities and Exchange Commission (SEC) ,
Securities Fraud
On January 7, 2016 the United States District Court for the Middle District of Florida took the rare step of dismissing (with leave to amend) the government’s Complaint in Intervention in a False Claims Act Case. This case...more
Principal Deputy Assistant Attorney General Benjamin C. Mizer’s remarks at the 16th Pharmaceutical Compliance Congress and Best Practices Forum highlighted the Department of Justice’s “renewed commitment to ensuring that...more