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 U.S. Securities and Exchange Commission (SEC) brought more actions targeting regulated entities for recordkeeping violations related to employees using noncompany communications platforms, and both the SEC and the U.S....more
On August 30, 2024, the Federal Trade Commission announced that the Department of Justice filed a complaint upon notification and referral from the FTC against a surveillance camera company that allegedly failed to provide...more
Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more
The United States Department of Justice on behalf of the United States Environmental Protection Agency (“EPA”) and Gershow Recycling Corporation (“GRC”) entered into an August 20th Consent Judgment (“CJ”) addressing alleged...more
On August 5, 2024, the United States Department of Justice filed a rare gun jumping civil lawsuit and proposed settlement in the United States District Court for the Southern District of New York against a global sports and...more
Earlier this month, the Department of Justice (DOJ) Antitrust Division filed a consent decree fining venue management firm Legends Hospitality $3.5 million over allegations that Legends improperly coordinated with an...more
On August 5, 2024, the United States Department of Justice (“DOJ”) filed a rare[1] gun jumping[2] civil lawsuit and proposed settlement in the United States District Court for the Southern District of New York against Legends...more
The Commodity Futures Trading Commission (CFTC) has joined the list of federal agencies targeting employment nondisclosure agreements and other restrictive covenants that allegedly restrict employees from making reports to...more
The United States Department of Justice (“DOJ”) and Wafler Farms, Inc., doing business as Wafler Nursery & Orchards (“WFI”) entered into a July 23rd Consent Decree (“CD”) addressing alleged violations of the Clean Water Act....more
On June 27, the US Supreme Court issued an opinion in SEC v. Jarkesy that limits the US Securities and Exchange Commission’s (SEC) ability to administratively seek civil penalties against defendants for securities fraud....more
The United States Environmental Protection Agency (“EPA”) and PMA Industries, Inc. (“PMI”) entered into a May 9th Expedited Settlement Agreement (“ESA”) addressing alleged violations of the Federal Hazardous Waste...more
The United States Department of Justice (“DOJ”) on behalf of the U.S. Environmental Protection Agency (“EPA”) entered into a July 1st Consent Decree (“CD”) with Gristede’s Foods NY, Inc. (“GFNI”) addressing alleged violations...more
In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more
At the end of June, the U.S. Supreme Court issued major decisions on the enforcement power of the Securities and Exchange Commission, what does or doesn’t qualify as a bribe of government officials, and on federal judges’...more
The United States Department of Justice (“DOJ”) and State of New York (“NY”) entered into a Consent Decree (“CD”) addressing alleged violations of the Safe Drinking Water Act (“SDWA”) with the following: Westchester Joint...more
The United States Environmental Protection Agency (“EPA”) and Bob Evans Farms, Inc. entered into a June 6th Consent Agreement and Final Order (“CAFO”) addressing an alleged violation of the Comprehensive Environmental...more
On June 10, 2024, the U.S. Justice Department announced that together with the Federal Trade Commission, it filed an amended complaint against telehealth company Cerebral Inc., Cerebral’s founder and former Chief Executive...more
The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more
Effective February 13, 2024, the U.S. Department of Justice (DOJ) increased civil monetary penalties, for violations occurring after November 2, 2015, including those related to immigration....more
The Department of Justice’s blockbuster FCPA settlement with Gunvor restores the credibility of DOJ’s pronouncements of DOJ’s commitment to aggressive FCPA enforcement. While I have questioned DOJ’s commitment to its...more
Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more
On January 22, 2024, the Federal Trade Commission (the“FTC”) announced revised thresholds for pre-merger notifications under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”). The revised thresholds and...more
Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more
The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more
On January 22, 2024, the Federal Trade Commission (FTC) announced revised notification thresholds under the Hart-Scott-Rodino Act (HSR Act). If a proposed merger, acquisition of stock, assets or unincorporated interests, or...more