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
As of February 18, 2025, the First Circuit Court of Appeals requires the government to prove “but-for” causation in Anti-Kickback Statute (AKS)-based False Claims Act (FCA) cases. The court reasoned in United States v....more
President Trump Puts a “Pause” on FCPA Enforcement - On Monday, President Donald Trump signed an executive order (EO) pausing the enforcement of the Foreign Corrupt Practices Act (FCPA). According to the EO, the pause will...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
Seventh Circuit Considers When Legal Marketing Transforms Into Illegal Kickbacks - On December 4, the US Court of Appeals for the Seventh Circuit heard oral arguments regarding whether the January 2023 jury conviction of...more
Owner, Operator of Texas Lab Charged for $79 Million Medical Testing Fraud Scheme - On November 20, Osman Syed, the owner and operator of a laboratory in Texas, was charged with three counts of health care fraud,...more
Judge Orders Government to Pay Relators a Cut of FCA Settlement - On November 4, a federal judge from the US District Court for the District of Massachusetts ordered the government to pay the relators’ share of a...more
Intensifying international crises, increasing regulatory burdens, and uncertain macroeconomic conditions have led to an era of caution for manufacturers, but hidden among those challenges are exciting opportunities for...more
Corporate Whistleblower Awards Pilot Program (“Pilot Program”), aimed at incentivizing whistleblowers to report potential criminal conduct. The announcement was anticipated, having been previewed in March 2024 by Deputy...more
Precision Lens Pays $12 Million to Resolve FCA and AKS Violations - Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more
Teva and DOJ May Reach Settlement in Closely Watched AKS Lawsuit - On June 16, Teva Pharmaceuticals filed a request with the First Circuit Court of Appeals seeking to hold in abeyance its interlocutory appeal concerning...more
Chicago Laboratory Owner Charged with Defrauding Medicare in $60 Million COVID-19 Test Kit Scheme - The Chicago-based owner of two laboratories, Zoom Labs Inc. and Western Labs Co., has been charged with health care fraud...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
Cooperation Spares Former NBA Shooting Guard From Prison - Former National Basketball Association (NBA) shooting guard, Antoine Wright, was sentenced to time served after he pled guilty to conspiracy and aggravated...more
The U.S. Department of Justice (“DOJ”) announced its False Claims Act (“FCA”) enforcement statistics for FY 2023 and identified key priorities for FCA enforcement in 2024 and beyond. The DOJ continues to pursue FCA...more
As we do every year, this issue revisits the key cases and other developments from the year gone by. And by most metrics, 2023 was a notable year for the False Claims Act (FCA). We start with the numbers: The Department...more
This year will see a continued proliferation of enforcement against health-care fraud, with old and new theories. Some hot spots for enforcement will involve cases about new technologies; data outliers; entities perceived as...more
Binance to Pay Historic $4 Billion Fine - Binance Holdings Limited, the operator of the world’s largest cryptocurrency exchange, agreed to pay $4.3 billion to resolve allegations that it violated the Bank Secrecy Act (BSA)...more
Three Men Sentenced for $54 Million TRICARE Fraud Scheme - Three men were sentenced in connection with a $54 million bribery and kickback scheme involving TRICARE, a federal program that provides health insurance benefits...more
Nevada Man Sentenced to 51 Months Imprisonment for Prize-Notification Fraud Scheme - Earlier this week, a Nevada man was sentenced to 51 months in prison for perpetrating a prize-notification scheme that defrauded...more
Medical Marketer Convicted of $55 Million Fraud Scheme - Late last week, a federal jury in the Northern District of Texas convicted Quintan Cockerell for his role in a $55 million fraud conspiracy involving TRICARE, a...more
Earlier this month, a federal judge vacated two convictions related to the Department of Justice’s (“DOJ”) investigation into corruption in international soccer, widely known as the “FIFA Case.” Despite the jury’s findings...more
DOJ Announced Results of Nationwide COVID-19 Fraud Enforcement - On Wednesday, August 23, 2023, the US Department of Justice (DOJ) announced the results of a coordinated, nationwide enforcement action to combat COVID-19...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
$140 Million Healthcare Fraud Case to Be Retried - On June 27, a Houston federal district court judge indicated that a $140 million healthcare fraud case, which ended in mistrial in December 2022 due to allegations of...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for April 2023. We discuss several criminal and civil enforcement actions related to the Anti-Kickback Statute (AKS) and the...more