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
The U.S. Court of Appeals for the Ninth Circuit has held that a laboratory owner’s payments to marketing intermediaries violated the Eliminating Kickbacks in Recovery Act (EKRA)—in its first interpretation of the statute...more
The Eliminating Kickbacks in Recovery Act, enacted in 2018, was a bombshell for the addiction treatment and diagnostic laboratory industries. For the first time, paying commissions for sales and marketing services was...more
In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...more
On July 11, 2025, the Ninth Circuit Court of Appeals affirmed the criminal conviction of laboratory operator Mark Schena for violations of the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220 (EKRA) based on...more
On December 4, the U.S. Court of Appeals for the Seventh Circuit heard oral arguments in USA v. Mark Sorensen, case number 24-1557, and it is now taking under advisement a case that could have widespread effects as to what...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
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
In Brasko v. Howard Bank, 2022 WL 951771 (D. Md. Mar. 29, 2022), a district court recently certified a subclass of residential mortgage borrowers who alleged that First Mariner Bank, a predecessor of Howard Bank, violated...more
The U.S. Department of Justice (DOJ) announced on January 28 that athenahealth Inc., a Massachusetts-based electronic health records (EHR) technology vendor, has agreed to pay $18.25 million to resolve allegations that it...more
The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more
On June 5, 2019, the Department of Justice (DOJ) announced a global settlement with Insys Therapeutics (Insys) that preliminarily resolves criminal and civil cases against the opioid manufacturer in a number of jurisdictions....more
Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more
In 1996, the Food and Drug Administration (“FDA”) approved Taxotere “for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.” However, women claim that Sanofi-...more
Healthcare providers of all kinds, as well as medical equipment suppliers, have traditionally relied upon discounts as a legitimate means of attracting patients and commercial clients without running afoul of the federal...more
Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more
On October 8, 2015, the Consumer Financial Protection Bureau (CFPB or Bureau) issued a Compliance Bulletin on RESPA Compliance and Marketing Services Agreements (“MSAs”)(“Compliance Bulletin”). The Compliance Bulletin’s...more
In this issue: - Private Civil Enforcement Actions Increasing: The Ameritox vs. Millennium Lawsuit By L. Pahl Zinn, and Christian G. Ohanian As healthcare and antitrust enforcement by governmental agencies...more