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
The Tennessee Air Pollution Control Board (“Board”) issued a July 31st Proposed Technical Secretary’s Order and Assessment of Civil Penalty (“Order”) to Lodge Manufacturing Company (“Lodge”) addressing alleged violations of a...more
The Mississippi Commission on Environmental Quality (“MCEQ”) and Oxbow Greenwood, LLC (“OG”) entered into a July 3rd Agreed Order 9 (“AO”) addressing alleged violations of an Air Permit. See Order No. 7520 25....more
The United States Environmental Protection Agency (“EPA”) and Gallade Chemical, Inc. (“GCI”) entered into a July 11th Expedited Settlement Agreement (“ESA”) addressing alleged violations of the regulations implementing...more
The Arkansas Department of Energy and Environment - Division of Environmental Quality (“DEQ”) and Lakeside Gardens Horizontal Property Regime (“Lakeside”) entered into a February 4th Consent Administrative Order (“CAO”)...more
The Arkansas Department of Energy and Environment – Division of Environmental Quality (“DEQ”) and Stella-Jones Corporation (“SJC”) entered into a May 21st Consent Administrative Order (“CAO”) addressing alleged violations of...more
The Offence and Penalty - On 8 May 2025, the UK’s Office of Financial Sanctions Implementation (OFSI) published its 11 April 2025 notice of its first-ever monetary penalty for an information offence relating to financial...more
The United States Environmental Protection Agency (“EPA”) and Gold Medal Service (“GMS”) entered into an April 7th Consent Agreement and Final Order (“CAFO”) addressing an alleged violation of the Clean Air Act regulations 40...more
As previously advised, the first compliance report required under New York City’s Local Law 97 (LL97) is due by May 1, 2025. LL97 requires most buildings over 25,000 square feet to limit carbon emissions or face significant...more
The Arkansas Department of Energy and Environment - Division of Environmental Quality (“DEQ”) and City of Bauxite, Arkansas entered into a March 10th Consent Administrative Order (“CAO”) addressing alleged violations of the...more
The Arkansas Department of Energy and Environment - Division of Environmental Quality (“DEQ”) and Northeast Arkansas Public Water Authority (“NAPWA”) entered into a March 10th Consent Administrative Order (“CAO”) alleging a...more
The Arkansas Department of Energy and Environment - Division of Environmental Quality (“DEQ”) and Newly Weds Foods, LLC (“NWF”) entered into a March 25th Consent Administrative Order (“CAO”) addressing and alleged violation...more
The Missouri Department of Natural Resources (“MDNR”) and Mac’s Convenience Stores LLC (“Mac’s”) entered into a February 26th Administrative Order on Consent (“AOC”) addressing an alleged violation of the Missouri Air...more
New York Local Law 97 (“LL97”) is a landmark piece of climate legislation enacted as part of New York City’s broader Climate Mobilization Act. Passed in 2019, LL97 aims to drastically reduce greenhouse gas emissions from...more
During her keynote address at the Futures Industry Association’s International Futures Industry Conference, BOCA50, CFTC Acting Chairman Caroline D. Pham announced a new effort to encourage market participants to resolve open...more
On February 14, the Governor of New York signed into law AB 431 (the “Act”), amending Article 9, Sections 901, 902 and 904 of the financial services law relating to private education debt reporting. The Act requires student...more
The Alabama Department of Environmental Management (“ADEM”) and Crimson Oak Grove Resources, LLC (“Crimson”) entered into a February 13th Consent Order (“CO”) addressing alleged violations of the clean water act national...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 US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice...more
Córdoba Music Group LLC (Córdoba), a manufacturer of musical instruments based in California, has agreed to pay $41,591 to settle its civil liability for violations of sanctions on Iran. On nine occasions, Córdoba shipped...more
The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more
The Federal Trade Commission (FTC) announced the annual changes to the Hart-Scott-Rodino (HSR) Act notification and filing fee thresholds, expected to go into effect in February 2025. The FTC is required by law to revise...more
On December 17, 2024, the National Highway Traffic Safety Administration (“NHTSA” or “Agency”) adopted a final rule to formalize its whistleblower program under the Motor Vehicle Safety Whistleblower Act (Whistleblower Act). ...more
Every health care provider has “credit balances,” which occur when a provider receives more money than it is owed for services rendered. Credit balances can be caused by a number of factors, including incorrect coding,...more
On December 20, 2024, the Securities and Exchange Commission (SEC or the “Commission”) announced charges against several entities that failed to file a Form D within 15 days of a private sale of securities. These entities,...more
On December 4, 2024, the Commodity Futures Trading Commission (“CFTC”) released its enforcement results for Fiscal Year 2024 (“FY 2024”), showcasing record awards of monetary relief totaling more than $17.2 billion....more