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
State and local governments have long participated in toxic tort litigation against manufacturers whose products are claimed to have driven up government healthcare costs. Now, the Texas attorney general has staked out a new...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
Proposition 65 warnings are now required for products containing BPS sold in California. BPS is one of several organic compounds known as bisphenols, which are chemical substances used in the production of plastics....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
The United States Environmental Protection Agency (“EPA”) and Griswold Industries (“GI”) entered into a January 3rd Expedited Settlement Agreement (“ESA”) addressing alleged violations of the Resource Conservation and...more
Texas AG Ken Paxton has announced a settlement with TPC Group, Inc. and TPC Group LLC (collectively, “TPC”), to resolve lawsuits alleging that TPC violated Texas law through conduct that resulted in an explosion that leveled...more
In late June 2024, Rhode Island joined the growing list of states that have enacted phased bans on the manufacture, sale, and distribution of various types of products containing PFAS. Rhode Island’s statute, entitled the...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
The United States Environmental Protection Agency (“EPA”) and Mr. Mulch, LLC (“Mr. Mulch”) entered into a July 11th Expedited Settlement Agreement (“ESA”) addressing alleged violations of the Clean Water Act Stormwater...more