News & Analysis as of

Fraud Federal Food Drug and Cosmetic Act (FFDCA) Pharmaceutical Industry

Fraud is the making of false representations or engaging in deceptive behavior in order to unlawfully secure financial or personal gain. 
Skadden, Arps, Slate, Meagher & Flom LLP

Core False Claims Act Theories Top the List of DOJ Criminal Enforcement Priorities

The May 12, 2025, memo from the head of the Department of Justice’s (DOJ’s) Criminal Division highlights 10 “high-impact” areas as the focus of DOJ’s criminal enforcement efforts. (See our May 14, 2025, client alert “In a New...more

Arnall Golden Gregory LLP

What the Dissolution of DOJ’s Consumer Protection Branch Means for Future Life Sciences and Consumer Protection Enforcement

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

Holland & Knight LLP

Healthcare Law Update: April 2021

Holland & Knight LLP on

William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

King & Spalding

Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud

King & Spalding on

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

ArentFox Schiff

Investigations Newsletter: Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and...

ArentFox Schiff on

Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and Members of the Sackler Family - On October 21, the Department of Justice (DOJ) announced that it reached a global resolution...more

Foley Hoag LLP - White Collar Law &...

First Circuit's New England Compounding Center Decisions Illustrate Reach of Federal Criminal Law

In 2012, New England Compounding Center (“NECC”) shipped contaminated anti-pain medication to hospitals and clinics around the country, with devastating consequences. Patients around the country developed fungal meningitis...more

Nutter McClennen & Fish LLP

Product Liability: 2017 Year in Review

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

Patterson Belknap Webb & Tyler LLP

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

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