On July 16, 2021, Judge Darrin P. Gayles of the Southern District of Florida indicated his intent to grant a new trial to three defendants, Matthew Pisoni, Marcus Pradel, and Victor Ramirez, based on his determination that...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
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
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
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
Federal indictments were unsealed recently against four managers, supervisors, and human resources personnel at Mississippi-based poultry processing plants as a result of an ongoing criminal investigation into company hiring...more
On June 1, 2020, the Criminal Division of the U.S. Department of Justice (“DOJ”) updated its guidance for its evaluation of corporate compliance programs when making charging decisions. The Guidance, first published in...more
On May 19, 2020, President Trump signed the Executive Order “Regulatory Relief to Support Economic Recovery.” The Order seeks “to combat the economic consequences of COVID-19” by directing government agencies to consider...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
Criminal Willie Sutton was once asked why he robbed banks. His response: “Because that’s where the money is.” Introduction - With the enactment of the CARES Act on March 25, 2020, the U.S. government appropriated $2.2...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
This month, Attorney General William Barr issued a memorandum to all U.S. Attorneys to prioritize detection, investigation, and prosecution of all criminal conduct related to the COVID-19 pandemic. The Department of Justice...more
On March 22, 2020, the U.S. Department of Justice (DOJ) announced that the U.S. Attorney’s Office of the Western District of Texas has filed the first action in federal court concerning fraud related to the COVID-19...more
In United States ex rel. Bookwalter v. UPMC, the relators alleged that a number of neurosurgeons employed by the University of Pittsburgh Medical Center, and the Medical Center, submitted false claims for both physician and...more
On October 28, 2019, the Department of Justice announced a $20.25 million settlement of False Claims Act (FCA) allegations. ...more
On May 13, 2019, the Supreme Court handed down its decision in Cochise Consultancy, Inc. v. United States ex rel. Hunt, wherein it recognized a prolonged statute of limitations for a qui tam relator bringing an action under...more
6/19/2019
/ Appeals ,
Cause of Action Accrual ,
Cochise Consultancy Inc v United States ex rel Hunt ,
Dismissals ,
False Claims Act (FCA) ,
Federal Contractors ,
Intervenors ,
Limitation Periods ,
Qui Tam ,
Reaffirmation ,
Relators ,
Reversal ,
SCOTUS ,
Statute of Limitations
On April 30, 2019, the Department of Justice (DOJ) released an updated version of its guidance for evaluating corporate compliance programs....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
When a qui tam relator files a lawsuit alleging violations of the federal False Claims Act (FCA), the statute imposes one of two potential deadlines. Specifically, the FCA’s statute of limitations provisions require that a...more
The Department of Justice (DOJ) filed a motion on November 17, 2017 to voluntarily dismiss its False Claims Act (FCA) case against HCR ManorCare, Inc. (ManorCare). Despite a years-long investigation, coupled with nearly three...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