Medical Device Legal News with Sam Bernstein: Episode 14
The Justice Insiders: FIFA Corruption Trial – Will the Feds Score Another Goal?
Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more
Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims - Last week, the Second Circuit Court of Appeals affirmed the district court’s ruling that dismissed allegations from a whistleblower who claimed that...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023. Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....more
Whenever new technologies emerge or new pots of government funds for assistance are available, you can count on one thing (as the sun rises and sets) – fraudsters will figure out a way to steal money from innocent persons and...more
On May 3, 2023, the Seventh Circuit Court of Appeals, in Astellas US Holding Inc. v. Federal Insurance Co., held that a liability insurer was required to contribute its limits toward its insured’s payment to settle potential...more
The Biden Administration warned the healthcare industry that it would aggressively prosecute fraud cases. The Justice Department is executing on that promise and doing so with great success. Week after week, we read about...more
On April 20, 2022, the U.S. Department of Justice (DOJ) announced coordinated law enforcement actions targeting various COVID-19 fraud schemes. The law enforcement actions were filed in nine different federal districts...more
Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption developments from the past month, with links to...more
Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and case developments from the past month,...more
The Regulation Process for FinCEN’s New Beneficial Ownership Reporting Requirement Launches - The Financial Crimes Enforcement Network (FinCEN) issued an Advanced Notice of Proposed Rulemaking (ANPRM) on Thursday to solicit...more
Seven Individuals Charged in $16 Million COVID-Relief Fraud Scheme - In an indictment unsealed on November 17, seven individuals were charged with conspiracy to commit wire fraud and wire fraud for allegedly submitting at...more
On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...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
Compliance Today (August 2020) - The Department of Justice’s Criminal Fraud division indicted six Texas-based owners and marketers for a scheme to defraud TRICARE and the U.S. Department of Labor, resulting in more than $14...more
A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more
Enforcement authorities throughout the United States and the Americas continue to aggressively investigate fraud and corruption across the region in the third quarter of 2019. Below, we highlight some recent developments and...more
In a May 17, 2019 press report that has been widely distributed in Brazil and the United States, Brazilian Federal Prosecutor Marisa Ferrari confirmed that the U.S. Federal Bureau of Investigation (FBI), the U.S. Department...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
The 1Malaysia Development Berhad scandal (“1MDB scandal”) has been making headlines for the past few years. The turning point for US prosecutors was the cooperation of Malaysian law enforcement and the corruption allegations...more
The Justice Department added to its roster of criminal FCPA defendants. Going back to 2017, it is clear that the Yates Memorandum requirements have resulted in an increase in criminal FCPA prosecutions....more
On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more
Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s...more
Drugmaker Novartis Pharmaceuticals has agreed in principle to pay $390MM (including $20MM in civil forfeitures) to the Department of Justice. This payment, in addition to modification and an extension of Novartis’s existing...more