Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
A federal district court recently granted the unopposed motion of the Department of Justice (DOJ) and the Consumer Financial Protection Bureau (CFPB) to terminate their October 2021 consent order with Trustmark National Bank...more
Over the last 15 years, private equity (“PE”) firms have invested hundreds of billions of dollars in the healthcare sector, infiltrating every corner of the industry from emergency rooms and labs to billing providers and...more
On January 17, 2025, the Environmental Protection Agency (EPA) and the Department of Justice (DOJ) announced a $9.5 million settlement with Stericycle, Inc. for Hazardous Waste Management Violations. The settlement resolves...more
Following our annual tradition — which started over a decade ago — we are analyzing the year's 10 most significant whistleblower and retaliation events. As you'll see, in 2024, actions taken by a range of courts and...more
On August 30, 2024, the Federal Trade Commission announced that the Department of Justice filed a complaint upon notification and referral from the FTC against a surveillance camera company that allegedly failed to provide...more
On August 5, 2024, the United States Department of Justice (“DOJ”) filed a rare[1] gun jumping[2] civil lawsuit and proposed settlement in the United States District Court for the Southern District of New York against Legends...more
The Commodity Futures Trading Commission (CFTC) has joined the list of federal agencies targeting employment nondisclosure agreements and other restrictive covenants that allegedly restrict employees from making reports to...more
The United States Environmental Protection Agency (“EPA”) and PMA Industries, Inc. (“PMI”) entered into a May 9th Expedited Settlement Agreement (“ESA”) addressing alleged violations of the Federal Hazardous Waste...more
The Department of Justice’s blockbuster FCPA settlement with Gunvor restores the credibility of DOJ’s pronouncements of DOJ’s commitment to aggressive FCPA enforcement. While I have questioned DOJ’s commitment to its...more
On December 14, 2023, the Commodity Futures Trading Commission (“CFTC”) and Department of Justice (“DOJ”) Fraud Section announced the settlement of insider trading fraud charges and Foreign Corrupt Practices Act (“FCPA”)...more
On November 21, 2023, the U.S. Office of Foreign Assets Control (OFAC) announced its largest settlement in history with the virtual currency exchange Binance. This almost-billion dollar settlement is a part of a larger...more
Although the SEC has long adhered to its Seaboard Report of Investigation to outline the analytical framework for the agency's cooperation program for companies, the exact benefits of self-policing, self-reporting,...more
The United States Environmental Protection Agency (“EPA”) and Austin Powder Company (“APC”) entered into a June 8th Expedited Settlement Agreement (“ESA”) addressing an alleged violation of the Comprehensive Environmental...more
The United States Environmental Protection Agency (“EPA”) announced in a June 5th news release a settlement with Anheuser-Busch, LLC (“AB”) addressing alleged violations of the following programs: Clean Air Act chemical...more
A laboratory company based in Texas, Genotox Laboratories Ltd., recently reached an agreement with the federal government to resolve False Claims Act and Anti-Kickback Statute violations, stemming from allegations related to...more
The Federal Trade Commission’s recent settlement with Dalal A. Akoury and AWAREmed Health & Wellness Resource Center provides a good overview of how today’s FTC approaches medical claims it believes are unsubstantiated. The...more
The Department of Justice (DOJ) announced on September 12, the first-ever False Claims Act (FCA) settlement with a Paycheck Protection Program (PPP) lender. Prosperity Bank, a Texas-based regional bank, agreed to pay...more
DC Circuit Adopts Pro Tanto Approach to False Claims Act Settlement Offsets - In an opinion issued on August 30, 2022, the US Court of Appeals for the DC Circuit held in United States v. Honeywell International, Inc., ---...more
The Federal Trade Commission (FTC) reached a settlement with WW International Inc., formerly known as Weight Watchers (WW), over allegations that the company collected children’s information without parental consent in...more
The U.S. Department of Justice (DOJ) recovered more than $5.6 billion in civil False Claims Act (FCA) judgments and settlements in fiscal year (FY) 2021, the second largest ever annual total in FCA recoveries and the largest...more
For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other...more
On September 20, 2021, the Department of Justice (DOJ) announced that it reached a settlement with the New Jersey Higher Education Student Assistance Authority (HESAA), resolving allegations that the state...more
On April 29, 2021, the Office of Foreign Assets Control (“OFAC”) of the U.S. Department of Treasury, and the Bureau of Industry and Security (“BIS”) of the U.S. Department of Commerce announced settlements with German...more
Sales of your software are robust around the globe. You have a network of third-party resellers, distributors or implementation partners that are driving international growth. Your customers praise your efficient maintenance...more
On April 29, 2021, the US Department of the Treasury’s Office of Foreign Assets Control (OFAC) announced two settlements of potential civil liability with two companies over their apparent violations of its regulations. The...more