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
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
On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more
The United States Environmental Protection Agency (“EPA”) and Allnex USA Inc. (“Allnex”) entered into a June 11th Consent Agreement (“CA”) addressing alleged violations of an Air Permit. See Docket No. CAA-03-2025-0036....more
The Arkansas Department of Energy and Environment - Division of Environmental Quality (“DEQ”) and Acme Brick Company (“ABC”) entered into a Consent Administrative Order (“CAO”) addressing an alleged violation of an Air...more
The United States Environmental Protection Agency (“EPA”) and Wieland Rolled Products (“WRP”) entered into a June 9th Consent Agreement and Final Order (“CAFO”) addressing alleged violations of the Clean Air Act New Source...more
The Alabama Department of Environmental Management (“ADEM”) and AMVAC Chemical Corporation (“AMVAC”) entered into a June 11th Consent Order (“CO”) addressing an alleged violation of ADEM Admin. Code Div. 14. See Consent Order...more
The Mississippi Commission on Environmental Quality (“MCEQ”) and Calgon Carbon Corporation (“Calgon”) entered into a May 12th Agreed Order (“AO”) addressing alleged violations of an air permit. See Order No. 7491 25....more
The Alabama Department of Environmental Management (“ADEM”) and Kronospan, LLC (“Kronospan”) entered into a May 28th Consent Order (“Order”) addressing an alleged violation of the Alabama Air regulations. See Consent Order...more
The Missouri Department of Natural Resources (“MDNR”) and Huggins Metal Finishing, Inc. (“Huggins”) entered into an April 22nd Administrative Order on Consent (“AOC”) addressing an alleged violation of an Air Permit. See No....more
The United States Environmental Protection Agency (“EPA”) and Vibracoustic USA, Inc. (“VUI”) entered into an April 21st Consent Agreement (“CA”) addressing alleged violations of the Comprehensive Environmental Response,...more
On May 5, 2025, the U.S. Environmental Protection Agency (EPA) Environmental Appeals Board (EAB) issued a consent agreement and final order between EPA and Cytonix, LLC (Cytonix). According to the consent agreement, in 2022,...more
The United States Environmental Protection Agency (“EPA”) and Owens-Brockway Glass Container Inc. (“OB”) entered into an April 8th Consent Agreement (“CA”) addressing alleged violations of the Resource Conservation and...more
The Mississippi Commission on Environmental Quality (“MCEQ”) and USG Interiors, LLC (“USG”) entered into a March 14th Agreed Order (“AO”) addressing an alleged violation of an air permit. See Order No. 7466 25....more
The California Energy Commission (“CEC”) and Sceptre, Inc. (“SI”) entered into an March 24th Settlement Agreement and Release (“Settlement”) addressing alleged violations of Appliance Efficiency Regulations at California Code...more
The Alabama Department of Environmental Management (“ADEM”) and Sanmina Corporation (“SC”) entered into a Consent Order (“CO”) addressing alleged violations of the Alabama Hazardous Waste Regulations. See Consent Order No....more
Alaska’s Department of Law’s Consumer Protection Unit recently announced it obtained a Superior Court order issuing a $250,000 civil penalty against B. Merry Studio, which the state alleged to have marketed products as being...more
The Alabama Department of Environmental Management (“ADEM”) and Pinnacle Manufacturing, LLC (“Pinnacle”) entered into a March 5th Consent Order (“CO”) addressing alleged violations of the Alabama Hazardous Waste regulations....more
On November 1, 2024, the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) imposed a $500,000 monetary penalty on GlobalFoundries U.S. 2 LLC and its parent, GlobalFoundries U.S. Inc., for a series of...more
As previously reported by Home Textiles Today, the Federal Trade Commission (FTC) has announced a “record civil penalty” of $3.175 million against a retailer who failed to tell the truth about whether the products it sells...more
Tractor maker Kubota North America Corporation will pay a $2 million civil penalty for falsely labeling its replacement parts as “Made in USA,” the largest civil penalty ever in a Federal Trade Commission (FTC) Made in USA...more
The Arkansas Department of Energy & Environment – Division of Environmental Quality (“DEQ”) and The Bryce Company, LLC (“Bryce”) entered into an October 3rd Consent Administrative Order (“CAO”) addressing alleged violations...more
The United States Environmental Protection Agency (“EPA”) and Sigmapharm Laboratories LLC (“SLL”) entered into a May 3rd Expedited Settlement Agreement and Final Order (“ESA”) addressing alleged violations of the Resource...more
The interconnectedness of the global economy has resulted in consumers being faced with a wide selection of substitute products from many different countries. A ”Made in the United States” claim could be, and often is, a...more
On August 30, the Federal Trade Commission announced a complaint and proposed order for Ohio-based Electrowarmth Products, LLC and its owner, alleging they improperly claimed that their heated fabric truck bunk...more
A proposed FTC settlement that involves alleged false Made in USA representations and alleged deceptive COVID claims was recently filed by the Department of Justice on the FTC’s behalf against an individual and the two...more