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 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
Under the Fair Labor Standards Act, violations of overtime or minimum wage requirements can result in assessment of liquidated damages equal to the amount of unpaid wages. ...more
The Commodity Futures Trading Commission (CFTC) recently issued a significant Enforcement Advisory detailing how companies and individuals can earn Mitigation Credit....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
Section 311/Clean Water Act Enforcement: U.S. Environmental Protection Agency and Laconia, New Hampshire Car Care Center Enter into Expedited Settlement Agreement - The United States Environmental Protection Agency (“EPA”)...more
The United States Environmental Protection Agency (“EPA”) in IMMCO Diagnostics (“ID”) entered into an October 3 expedited settlement agreement (“ESA”) addressing an alleged violation of the Resource Conservation Recovery Act...more
The Tennessee Department of Environment and Conservation (“TDEC”) issued a January 17th Proposed Director’s Order and Assessment (“Order”) to Sherwin-Williams Company (“Sherwin-Williams”) addressing alleged violations of the...more
On January 17, 2025, the Environmental Protection Agency (EPA) and the Department of Justice (DOJ) announced a $9.5 million settlement with Stericycle, Inc. for Hazardous Waste Management Violations. The settlement resolves...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 Department of Justice (DOJ) and the Office of the Inspector General for the Department of Health and Human Services (OIG) have historically focused their virtual health care enforcement efforts on “traditional”...more
On January 13, 2025, the Federal Trade Commission announced that it is seeking comment on proposed changes to the Business Opportunity Rule and a proposed new Earnings Claim Rule. According to the FTC, the two, taken...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 Louisiana Department of Environmental Quality (“LDEQ”) and Cameron Interstate Pipeline, LLC (“Cameron”) entered into a settlement agreement (“SA”) addressing violations of the Louisiana Air regulations....more
The Arkansas Department of Energy and Environment - Division of Environmental Quality (“DEQ”) and City of Jasper, Arkansas entered into a December 4th Consent Administrative Order (“CAO”) addressing alleged violations of a...more
The nine judges that finally coalesced over the decision of affirmance voted for two inconsistent judgments and provided no explanation for this result. The judges held that, under Laidlaw, civil penalties which must be...more
The Tennessee Department of Environment and Conservation (“TDEC”) issued a Proposed Order and Assessment (“Order”) for alleged violations of the Tennessee Petroleum Underground Storage Tank Act and relevant rules. See Case...more
The Federal Energy Regulatory Commission’s (“FERC” or “Commission”) Office of Enforcement (“Enforcement”) continues to focus on enforcing its duty of candor rules, with a recent action resulting in a $6.6 million civil...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
The Alabama Department of Environmental Management (“ADEM”) and City of Selma entered into a December 11th Special Order by Consent (“Order”) addressing alleged violations of a Solid Waste Disposal Permit. See Order No....more
The Mississippi Commission on Environmental Quality (“MCEQ”) and Hunt Southland Refining Company LLC (“Hunt”) entered into a November 18th Agreed Order (“AO”) addressing alleged violations of a Clean Water Act National...more
The Tennessee Department of Environment and Conservation (“TDEC”) issued on November 15th a Proposed Director’s Order and Assessment (“OA”) to Tradebe Treatment and Recycling of Tennessee, LLC (“TTRT”) addressing alleged...more
The United States Environmental Protection Agency (“EPA”) and DTE Electric Company (“DTE”) entered into a Consent Agreement and Final Order (“CAFO”) addressing alleged violations of Clean Water Act National Pollutant...more
Wastewater Enforcement: Arkansas Department of Energy and Environment - Division of Environmental Quality and City of Glenwood Enter Into Consent Administrative Order - The Arkansas Department of Energy and Environment –...more
The Tennessee Department of Environment and Conservation (“TDEC”) issued a December 16th Proposed Order and Assessment (“Order”) to Cymer-Dayton, LLC (“CD”). See Case No. HWM 24-0022. The Order provides that CD conducts...more
The Alabama Department of Environmental Management (“ADEM”) and Scotch and Gulf Lumber, LLC (“Scotch”) entered into a December 11th Consent Order (“CO”) addressing an alleged violation of a Clean Air Act Title V Major Source...more