Data Driven Compliance: Understanding the ECCTA and Its Impact with Jonathan Armstrong
10 For 10: Top Compliance Stories For the Week Ending, August 2, 2025
Data Driven Compliance: Understanding the ECCTA and Its Impact on Fraud Prevention with Vince Walden
Everything Compliance: Episode 158, The No to Corruption in Ukraine Edition
Daily Compliance News: July 31, 2025. The Forgotten Generation Edition
Understanding BBB Ratings: Building Trust and Mitigating Risks — Regulatory Oversight Podcast
Episode 379 -- Update on False Claims Act and Customs Evasion Liability
Data Driven Compliance: Understanding the UK’s New Failure to Prevent Fraud Offense with Sam Tate
Everything Compliance: Episode 157, The Q2 2025 Great Women in Compliance Edition
Daily Compliance News: July 22, 2025, The I-9 Hell Edition
Compliance Tip of the Day: Avoiding CCO Liability
2 Gurus Talk Compliance: Episode 55 – The From Worse to Worser Edition
Daily Compliance News: July 17, 2025, The COSO Yanked Edition
Wire Fraud Litigants Beware: Fourth Circuit Ruling Protects the Banks — The Consumer Finance Podcast
Compliance into the Weeds: Agentic Misalignment and AI Ethics: Analyzing AI Behavior Under Pressure
All Things Investigation: Due Diligence and Drama: A Deep Dive into Art World with Daniel Weiner
Daily Compliance News: July 14, 2025, The Secret Business Sauce-Reading Edition
Adventures in Compliance: The Novels – The Hound of the Baskervilles: Uncovering Compliance – Lessons from The Hound of the Baskervilles
Compliance Tip of the Day: Lessons from Internal Control Failures
Adventures in Compliance: The Novels – The Hound of the Baskervilles, Introduction and Compliance Lessons Learned
The Department of Justice’s decision to shutter the Consumer Protection Branch (“CPB”) by September 30, 2025, is sending shockwaves across multiple industries. Known for its unique dual mandate to pursue both civil and...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more
On December 16, 2024, the SEC announced settled charges against Becton, Dickinson and Company for misleading investors about risks associated with its continued sales of one of its key products and overstating its income by...more
There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more
The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing...more
A former DePuy Synthes sales representative is arrested for allegedly defrauding a hospital into submitting claims for products not actually used in surgery; A number of additional clinics enter into settlements to resolve...more
Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations - On January 4, 2023, a criminal information was filed in the Southern District of Illinois, in which Jet Medical Inc. (Jet), a medical device...more
DOJ files civil complaint alleging Fresenius performed unnecessary procedures on dialysis patients - In June, it was revealed that DOJ would partially join a whistleblower lawsuit against the dialysis provider. In a civil...more
On April 20, 2022, OIG issued an advisory opinion regarding an arrangement involving a family of physicians having an ownership interest in a medical device company that manufactures products that the physicians also order. ...more
In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more
DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008 - On January 14, 2021, the Department of Justice (DOJ) announced that it obtained more than $2.2 billion in settlements and judgments from civil cases involving...more
As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more
Earlier this week, the Office of Inspector General OIG issued a Special Fraud Alert (Alert) on speaker programs by pharmaceutical and medical device companies in connection with the Federal Anti-Kickback Statute. In the...more
Food - FDA Releases Resources on Food Traceability Proposed Rule – The FDA released a resource to allow users to explore the results of the Risk-Ranking Model for Food Tracing used in the development of the Food Traceability...more
Welcome to the August 2020 issue of our Life Sciences International Review. This issue covers new developments within Asia, Europe, and the United States in intellectual property, regulatory, pricing, and international trade,...more
Medical device manufacturers who seek to dispose of meritless claims at the initial pleading stage have long relied upon the doctrine of federal regulatory preemption. This doctrine is embodied by 21 U.S.C. § 360k(a), the...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
In Channel Medsystems, Inc. v. Boston Scientific Corporation, the Delaware Court of Chancery rejected an attempt by Boston Scientific to terminate and thus avoid consummating a merger agreement with Channel on the grounds...more
A Michigan district court judge determined last week that product liability claims against an FDA approved medical device manufacturer were preempted by federal law, but allowed the plaintiff’s claim of fraud against the...more
Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more
This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more
Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more