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 CFPB has filed a complaint against Synapse Financial Technologies Inc, alleging that the company engaged in unfair acts and practices in violation of the Section 1036(a)(1)(B) of the CFPA by failing to maintain sufficient...more
The United States Environmental Protection Agency (“EPA”) and City of Dallas, Oregon entered into a July 25th Expedited Settlement Agreement (“ESA”) addressing an alleged violation of the Clean Air Act. See DOCKET NO....more
Last week, TZP Management Associates, LLC (TZP), a New York-based private equity investment adviser, agreed to pay more than $680,000 in monetary relief to settle charges brought by the Securities and Exchange Commission...more
The Tennessee Air Pollution Control Board (“Board”) issued a July 31st Technical Secretary’s Order and Assessment of Civil Penalty (“Order”) to Colortech, Inc. (“CI”) addressing an alleged violation of an Air Permit. See Case...more
The Alabama Department of Environmental Management (“ADEM”) and Sun Coast Resources, LLC (“SCR”) entered into an August 7th Consent Order (“CO”) addressing the violation of certain Alabama regulations concerning...more
In 2020, California was the first mover in state comprehensive privacy law legislation, a distinction it held for approximately three years before other states took similar action. Indeed, eighteen additional states have...more
The Mississippi Commission on Environmental Quality (“MCEQ”) and Niteo Products LLC (“NP”) entered into a June 17th Agreed Order (“AO”) addressing alleged violations of the Mississippi Hazardous Waste Regulations. See Order...more
The Alabama Department of Environmental Management (“ADEM”) and Frit Car, Inc. (“FCI”) entered into an August 6th Consent Order (“CO”) addressing alleged violations of the Alabama Hazardous Waste Regulations. See Consent...more
The United States Environmental Protection Agency (“EPA”) filed a Complaint and Notice of Opportunity for Hearing (“Complaint”) against Unitek Solvent Services, Inc. (“Unitek”) on August 6th alleging violations of the Hawaii...more
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
On July 23, 2025, the White House issued an Executive Order titled “Accelerating Federal Permitting of Data Center Infrastructure.” Released alongside “America’s Artificial Intelligence (AI) Action Plan,” the Order reflects a...more
In early August, the U.S. District Court for the Northern District of Texas ruled that the civil money penalty (CMP) provision in the Food, Drug, and Cosmetic Act (FDCA) for tobacco products, 21 U.S.C. § 333(f)(9), is...more
In July 2025, the European Competition Commission imposed a EUR 489,000 fine on Alchem International Pvt. Ltd. and its Hong Kong subsidiary for their involvement in a pharmaceutical cartel involving the active ingredient used...more
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 Administrative False Claims Act (AFCA), enacted in December 2024, expands agency authority and recovery limits, making the AFCA a more powerful tool for recouping government funds lost to alleged false claims—a...more
On July 18, the CFPB terminated a consent order against a credit union after confirming that the credit union fulfilled “certain obligations” under the original consent order, including paying a $1.5 million civil money...more
The Mississippi Commission on Environmental Quality (“MCEQ”) and Hankins Lumber Company Inc. (“Hankins”) entered into an April 30th Agreed Order (“AO”) addressing alleged violations of a Title V Operating Permit. See Order...more
A federal appeals court just ruled that the Department of Labor’s administrative system for imposing civil penalties on agricultural employers for H-2A violations is unconstitutional, handing businesses across all industries...more
The Arkansas Department of Energy and Environment - Division of Environmental Quality (“DEQ”) and the Hounds’ Hideaway Rogers, LLC (“Hounds”) entered into an April 9th Consent Administrative Order (“CAO”) addressing an...more
On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and...more
On July 21, 2025, the Consumer Financial Protection Bureau (CFPB) announced that it had terminated its October 2024 consent order with a Florida-based credit union....more
The United States Environmental Protection Agency (“EPA”) and Nevada Tri Partners, LLC (“NTP”), and Damonte Ranch Commerce Center, LLC (“Damonte”) entered into a July 1st Consent Agreement and Final Order (“CAFO”) addressing...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
On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released an Audit and Enforcement Report summarizing its annual Medicare Advantage (Part C) and Prescription Drug (Part D) program audits and enforcement...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