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
On October 5, 2017, in United States of America ex rel. Swoben v. Scan Health Plan, et al. (“Swoben”), Judge John F. Walter of the United States District Court for the Central District of California granted United Health...more
In June 2017, a bipartisan group of state attorneys general announced that they were jointly investigating the marketing and sales practices of opioid manufacturers. While the group initially did not identify any targets of...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
On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....more
On July 22, 2016, the Department of Justice announced the indictment of the owner of more than 30 Miami-area skilled nursing and assisted living facilities, a hospital administrator, and a physician’s assistant in connection...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
5/22/2017
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Domain Names ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Mobile Health Apps ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Trademarks
The Regents of the University of California (UC) have filed a lawsuit against Studio Pharmacy, Excel Care Pharmacy, Pharma Pro Solutions, California Clinical Trials, and 17 individual defendants, including four physicians and...more
Expanding wage and hour obligations will continue to be a top concern for employers in 2017. As most employers are aware, in May 2016, the United States Department of Labor issued its long-awaited final rule regarding the...more
3/27/2017
/ Affordable Care Act ,
Ban the Box ,
Blockchain ,
Corporate Counsel ,
Cybersecurity ,
E-Verify ,
Employer Liability Issues ,
EU-US Privacy Shield ,
Federal Trade Commission (FTC) ,
Form I-9 ,
Non-GAAP Financial Measures ,
Popular ,
Securities and Exchange Commission (SEC) ,
Wage and Hour ,
Young Lawyers
In June 2016, the Supreme Court’s decision in Universal Health Services, Inc. v. United States ex rel. Escobar confirmed the viability of the “implied false certification” theory of liability under the False Claims Act (FCA)....more
1. With Wage and Hour Rules in Flux, Employers Need to Remain Vigilant -
Expanding wage and hour obligations will continue to be a top concern for employers in 2017. As most employers are aware, in May 2016, the United...more
1/26/2017
/ Affordable Care Act ,
Americans with Disabilities Act (ADA) ,
Ban the Box ,
Blockchain ,
Consumer Financial Protection Bureau (CFPB) ,
Copyright Infringement ,
Cybersecurity ,
Department of Labor (DOL) ,
Dodd-Frank ,
E-Verify ,
Employer Liability Issues ,
EU ,
EU-US Privacy Shield ,
European Court of Justice (ECJ) ,
Federal Trade Commission (FTC) ,
Form I-9 ,
Non-GAAP Financial Measures ,
Popular ,
Securities and Exchange Commission (SEC) ,
Tax Reform ,
UDAAP ,
USCIS ,
Wage and Hour ,
Wellness Programs
On December 7, 2016, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued a final rule to implement revisions to certain Anti-Kickback Statute (AKS) safe harbors, as well as revisions to...more
On December 1, 2016, the United States Attorney’s Office for the Northern District of Texas announced the indictment of 21 executives, physicians, surgeons, and others affiliated with Forest Park Medical Center (FPMC) in...more
On November 22, 2016, the United States Court of Appeals for the First Circuit issued two False Claims Act (FCA) opinions in the continuing debate over the parameters of the FCA. In United States ex. rel. Escobar et al. v....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
Tenet Healthcare Corporation, an investor-owned healthcare services company based in Texas, and two of its Atlanta-based subsidiaries have entered into an agreement with the government to resolve criminal charges and civil...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
On September 1, 2016, the United States Attorney’s Office for the Southern District of Florida filed a five-count information, variously charging sixteen individuals, including three physicians, in connection with a scheme to...more
Even for companies accustomed to civil lawsuits, when the government is on the other side of the “v,” the prospect of litigation can be intimidating and unfamiliar. In this issue of the Litigation Newsletter, we explore how...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
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
8/23/2016
/ 510(k) RTA ,
Advertising ,
Draft Guidance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
LabMD ,
Medical Devices ,
Pharmaceutical Industry ,
Social Media ,
Software
On July 21, 2016, two former executives of Acclarent, Inc., a medical device company owned by Johnson & Johnson, Inc., were found guilty of ten misdemeanor violations of the Food, Drug and Cosmetic Act (FDCA), following a...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
So On May 12, 2016, Aegerion Pharmaceuticals, Inc., announced that it has reached “preliminary agreements in principle” with the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) to resolve the...more
On April 19, 2016, the United States Supreme Court heard oral arguments in a hotly anticipated False Claims Act (FCA) case: Universal Health Services, Inc. v. United States ex rel. Escobar. The Court will decide whether the...more