Despite much recent attention to the new administration's plans to deploy the False Claim Act (FCA) to advance other policy objectives, a July 2, 2025 Department of Justice (DOJ) press release announcing a DOJ-HHS False...more
The Ninth Circuit’s recent decision in Island Industries Inc. v. Sigma Corporation, coupled with recent government pronouncements concerning trade enforcement, are likely to drive an increase in customs fraud FCA...more
On the day he was sworn in, June 11, 2025, Civil Division Assistant Attorney General (AAG) Brett Shumate took the unusual step of issuing a memorandum to all employees of the Department of Justice (DOJ) Civil Division – most...more
On May 19, 2025, Deputy Attorney General Todd Blanche issued a memorandum (Blanche Memorandum) directing the Department of Justice’s Civil Division Fraud Section and Civil Rights Division to lead a Civil Rights Fraud...more
Since his inauguration in January, President Trump has signed multiple executive orders addressing diversity, equity, and inclusion (DEI) policies across the country. These actions have significant implications, including for...more
On February 21, a federal court in Maryland preliminarily enjoined three components of Executive Order (EO) 14151 (Ending Radical and Wasteful Government DEI Programs and Preferencing) and Executive Order 14173 (Ending...more
Upon her swearing in on February 5, 2025, Attorney General Pam Bondi issued a series of memoranda to all Department of Justice employees, including a memorandum entitled “Ending Illegal DEI and DEIA Discrimination and...more
On January 21, 2025, President Trump issued an Executive Order titled “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” (EO 14173). In commentary published since then, Hogan Lovells has analyzed various...more
In the latest edition of our False Claims Act Guide: 2023 and the road ahead, we analyze the key developments from 2023 and discuss how the most important cases and issues are shaping FCA enforcement now and in the year to...more
2/14/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Fraud ,
Health Care Providers ,
Medicaid ,
Popular ,
Private Equity Firms ,
Qui Tam
The Department of Justice (DOJ) dismissal authority: Supreme Court will resolve Circuit split in standard, but DOJ seems unlikely to pick more fights with relators. For nearly two decades, when DOJ invoked its authority...more
The Eighth Circuit released an opinion Tuesday in U.S. ex rel. Cairns v. D.S. Medical LLC that creates a new circuit split on the interpretation of the causation standard for establishing that a claim “resulting from” a...more
In a split decision issued January 25, 2022, the Fourth Circuit strongly endorsed a defense to False Claims Act liability for entities that submit claims to the government in today’s complex regulatory environment, finding:...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
Government attorneys now have additional discretion in False Claims Act (FCA) civil cases to award cooperation credit to a corporation that meaningfully assists the government’s investigation without necessarily identifying...more
12/4/2018
/ Cooperation Agreement ,
Corporate Crimes ,
Corporate Investigations ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Government Investigations ,
Policy Statement ,
Qui Tam ,
White Collar Crimes ,
Willful Misconduct ,
Yates Memorandum
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum