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AGG Food and Drug Newsletter - September 2017

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 Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and...

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

State Official Charged With Taking Bribes In Connection With $1 Billion Healthcare Fraud Scheme

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

AGG Food and Drug Newsletter - May 2017

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

California Regents File State False Claims Act Case Against Healthcare Providers And Pharmacies For Allegedly Defrauding UC...

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

Legal Issues Business Leaders Need to Know in 2017

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

Taking Shape: Influential D.C. Circuit Court Continues the Expansion of Escobar’s “Materiality” Standard

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

Key Legal Issues Business Leaders and In-House Counsel Need to Know for 2017

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

OIG Implements New Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Regulations

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

Department Of Justice Announces The Indictment Of 21 Individuals Affiliated With Forest Park Medical Center

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

The First Circuit Rules On Materiality And Rule 9(b) In Two FCA Opinions

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

AGG Food and Drug Newsletter - October 2016

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 Will Pay $513 Million To Resolve Criminal Charges And Civil Claims

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

AGG Food and Drug Newsletter - September 2016

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

Government Charges Sixteen In $175 Million Pharmacy Fraud

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

AGG Litigation Insights Newsletter - Summer 2016

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

False Claims Act Cases: With No End In Sight, Why You Should Consider Litigating And How To Maximize Your Litigation Advantages

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

AGG Food and Drug Newsletter - August 2016

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

Federal Jury Convicts Two Former Acclarent, Inc. Executives on Misdemeanor Charges Related to Off-Label Marketing of Medical...

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

AGG Food and Drug Newsletter - May 2016

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

Pharmaceutical Company Reaches Preliminary Agreement in Principle to Resolve DOJ and SEC Investigations

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

Implied Fraud Under the False Claims Act Hangs in the Balance

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

AGG Food and Drug Newsletter - April 2016

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

OIG Continues its Focus on GIP Abuse: What Hospice Providers Need to Know

On March 31, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a report on hospice billing for general inpatient care (GIP). According to the OIG, hospices billed Medicare for...more

Abbott Laboratories Prevails in False Claims Act Case

On April 7, 2016, following a three-week trial and after only three hours of deliberations, a federal jury in Dallas, Texas found that Abbott Laboratories had not violated the False Claims Act (FCA) when it marketed bile duct...more

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