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
Does the recent decision in a federal district court in Texas, finding that the U.S. Food and Drug Administration’s tobacco civil money penalty authority is unconstitutional, mean the end of the federal agency bringing...more
The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more
On March 27, 2025, the Futures Industry Association hosted a webinar with Brian Young, the director of the U.S. Commodity Futures Trading Commission (CFTC) Division of Enforcement. Although he noted that the opinions...more
On March 20, the Fed announced two enforcement actions against banks last month. On February 24, the Fed issued a civil money penalty order against a state member bank in Hawaii. That bank agreed to pay a $15,500 penalty for...more
On February 21, a group of 23 state attorneys general (AGs) filed an amicus brief in support of the union representing CFPB workers in the union’s request for a preliminary injunction challenging the recent efforts to halt...more
In recent years, the Consumer Product Safety Commission (CPSC) has increased pressure on consumer product companies through various enforcement mechanisms. The increase in the frequency and amount of civil penalties sought by...more
The United States Environmental Protection Agency (“EPA”) and Space Exploration Technologies Corp. (“SpaceX”) entered into a January 15th Consent Agreement and Final Order (“CAFO”) addressing alleged violations of the Clean...more
In Brief - The Australian Competition and Consumer Commission (ACCC) and Australian Securities and Investments Commission (ASIC) continue to be vigilant and seek significant penalties for alleged "greenwashing" (misleading...more
On 12 September 2024, the UK government released the new Trade, Aircraft and Shipping Sanctions (Civil Enforcement) Regulations 2024 (the Regulations), which will come into force on 10 October 2024. The Regulations grant the...more
SEC Loses in ALJ Case, DOL’s Latest Fiduciary Rule Put on Hold, and SEC Reconsiders AI and Custody Rule Proposals - Welcome to our July Regulatory Roundup, where we provide a quick look at the latest regulatory developments....more
Key Takeaways: The Treasury Department is seeking to equip CFIUS with greater enforcement and oversight authority. These new powers include the ability to request more information from transaction parties and also to assess...more
In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers for reportedly selling unauthorized e-cigarette products. Consistent with the Center for Tobacco Products’ (CTP) recent...more
On October 19, Ohio Attorney General (AG) Dave Yost filed a joint motion to enter into a consent order with two Columbus, OH properties, Garrison Southfield Park, LLC, and Olymbec USA LLC, settling claims that Garrison and...more
On July 6, North Dakota Attorney General Drew Wrigley announced a settlement of an administrative complaint, accusing Western Distributing Company and affiliate companies Plains Gaming Distributing Inc. and Midwest Gaming...more
Shipping companies should remain focused on sanctions compliance for 2023. The sanctions space has been bursting with activity as a result of the Russia-Ukraine war, which shows no signs of abating. Companies continue to seek...more
On 28 March 2023, the UK Gambling Commission (the Commission) announced that three gambling businesses owned by William Hill Group would pay a total financial penalty of £19.2 million for social responsibility and anti-money...more
The Federal Trade Commission (“FTC”) recently settled an enforcement action against an advertiser for $753,000 for deceptive “Assembled in USA” product claims, the first such settlement following the FTC’s recent adoption of...more
On August 10, 2021, the Commodity Futures Trading Commission (CFTC) announced that the US District Court for the Southern District of New York entered a consent order against HDR Global Trading Limited, 100x Holding Limited,...more
The Tennessee Department of Environment and Conservation (“TDEC”) issued a proposed April 27th Order and Assessment (“Order”) to Mapco Express, Inc. (“Mapco”) addressing alleged violations of the Tennessee Underground Storage...more
In addition to dramatically changing the policies of former President Trump on the pandemic, the economy, immigration, and other key issues, the Biden Administration is likely to substantially increase the federal...more
Recent and significant regulatory and legislative events in the digital asset space demonstrate the evolving and expanding approach by U.S. and international regulators to the burgeoning digital asset markets. These...more
On August 31, 2020, the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), issued a memorandum to all executive departments and agencies on reforming regulatory enforcement...more
It began as an obscure experiment in unregulated virtual currency. Initially undistinguished from Bitcoin, blockchain evolved to become one of the pillars of web 3.0, enabling new means of trust, transparency, security and...more
Yesterday, I considered five Department of Justice (DOJ) Foreign Corrupt Practices Act (FCPA) enforcement actions. Today, I want to look at key FCPA enforcement actions by the Securities and Exchange Commission (SEC)....more
In a somewhat surprising move, the Securities and Exchange Commission (SEC) entered into a $24 million settlement with Block.one on September 30, 2019, over its unregistered initial coin offering (ICO) that raised upwards of...more