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
On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more
For years, Department of Justice officials have stressed how important chief compliance officers are as the first line of defense in fighting corporate crimes. While that’s true, compliance programs now have a competitor in...more
Below are noteworthy False Claims Act (FCA) decisions from the third quarter of 2023. The main issues in the cases are: Materiality. The Fourth Circuit held that a pharmacist’s efforts to falsify patient eligibility...more
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more
On March 28, 2023, the Sixth Circuit issued an important False Claims Act (“FCA”) decision in U.S. ex rel. Shannon Martin, et al. v. Darren Hathaway, et al., No. 22-1463, which (1) adopted a “but-for” causation standard for...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
Despite Decrease in 2020 False Claims Act Recoveries, Investigations and Litigation Expected to Rise Under the Biden Administration - As previously detailed by Arent Fox, total False Claims Act (FCA) recoveries for the...more
In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more
A recent decision from the D.C. Circuit Court of Appeals, one of the most important courts in the nation, reaffirmed that a company’s internal investigations—if structured properly—are protected from disclosure in litigation...more
Federal enforcement of False Claims Act (FCA), Stark anti-kickback, and HIPAA/HITECH claims against healthcare companies continues to rise rapidly. FCA recoveries by the U.S. Department of Justice (DOJ) exceeded $9.5 billion...more