Data Driven Compliance: The Failure to Prevent Fraud Offense: Insights for US General Counsels with Mike DeBernardis
The State of Healthcare Enforcement
Daily Compliance News: August 21, 2025, The Fabricated Evidence Edition
Data Driven Compliance – James Tillen on the Importance of Cross-Functional Collaboration in Complying with the FTPF Offense
2 Gurus Talk Compliance: Episode 57 — The Tom on His Highhorse Edition
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
Connecticut AG William Tong announced a settlement with Triggered Brand following allegations that the company unlawfully advertised and sold counterfeit GLP-1 weight loss drugs in violation of state consumer protection laws....more
The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more
Connecticut Attorney General (AG) William Tong has taken legal action against two online distributors, Triggered Brand and Made In China, for allegedly selling research-grade GLP-1 weight loss drugs directly to Connecticut...more
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
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
HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...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
The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more
Human health is a fundamental need of the society. The pharmaceutical industry has played a pivotal role in providing mankind with drugs for preventive and curative care. COVID-19 has further underscored the immense...more
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the...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
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
The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week. The first authorization was issued to Roche Molecular...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
A year after Akorn v. Fresenius (Akorn case), the first Delaware case holding that a party was entitled to terminate a merger agreement based on a material adverse effect (MAE), the Delaware Court of Chancery, in Channel...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
On October 1, 2018, Vice Chancellor J. Travis Laster of the Delaware Court of Chancery issued a 246-page post-trial opinion in Akorn, Inc. v. Fresenius Kabi AG, C.A. No. 2018-0300-JTL, that denied the seller’s (Akorn) request...more
Massachusetts state and federal courts issued a number of important product liability decisions in 2017. The Product Liability and Toxic Tort Litigation Group at Nutter recently reviewed these cases. Highlighted below are...more
A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....more
Searcy Denney Mass Tort Unit attorneys Brenda Fulmer and Cal Warriner have filed three more lawsuits on behalf of Florida and North Carolina residents who suffered bleeding in their brains and GI tracts following use of...more
In March 2016, the Securities and Exchange Commission announced that AVEO Pharmaceuticals, Inc., a Massachusetts-based biopharmaceutical company, agreed, without admitting or denying the allegations, to pay $4 million to...more