Popular, Prescription Drugs, Department of Justice (DOJ)

DOJ Announces Largest-Ever National Healthcare Fraud Takedown and Launches New Data Fusion Center

Husch Blackwell LLP on 8/8/2025

In June 2025, the Department of Justice (DOJ) announced its 2025 National Health Care Fraud Takedown, marking the largest coordinated healthcare fraud enforcement action in DOJ history. The sweep included charges against a...more

DOJ Charges 324 Defendants in Unprecedented Health Care Fraud Takedown

Vedder Price on 7/23/2025

On June 30, 2025, the Department of Justice (DOJ) filed criminal charges against 324 defendants across the country alleging participation in various health care fraud schemes. The DOJ identified the operation as the 2025...more

Investigations Newsletter: Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS

ArentFox Schiff on 7/14/2025

Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS - On July 7, Southern District of New York District Judge Colleen McMahon increased a False Claims Act (FCA) judgment from $136...more

DOJ & HHS Announce Reinvigoration of False Claims Act Working Group and Healthcare Fraud Enforcement Priorities

Dorsey & Whitney LLP on 7/10/2025

The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...more

FTC Sues Nation’s Largest PBMs, Continuing Biden Administration’s Antitrust Scrutiny of the Life Sciences Sector

Wilson Sonsini Goodrich & Rosati on 9/27/2024

The Biden administration’s antitrust scrutiny of the life sciences industry continued this week as the Federal Trade Commission (FTC) filed an administrative complaint against the nation’s largest pharmacy benefit managers...more

FinCEN Issues Supplemental Advisory on Fentanyl Distribution and Growing Role of Transnational Criminal Organizations

Ballard Spahr LLP on 7/3/2024

On June 20, 2024, the Financial Crimes Enforcement Network (“FinCEN”) issued a supplemental advisory to alert U.S. financial institutions about emerging trends in the illicit fentanyl supply chain. The supplemental advisory...more

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on 4/2/2024

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Regeneron v Novartis and Vetter: Walker Process Client Update

Polsinelli on 3/26/2024

In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...more

The Nucleus: Life Sciences Enforcement and Regulatory Updates

Skadden, Arps, Slate, Meagher & Flom LLP on 11/3/2023

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

American Conference Institute (ACI) on 6/21/2022

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

American Conference Institute (ACI) on 9/14/2021

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

The Courts and Healthcare Policy - August 2021

McGuireWoods Consulting on 8/10/2021

The courts continue to play an important role in health policy. 2020 saw several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more

FTC Publishes Annual MMA Report—Continues to Scrutinize Pharma Patent Settlements

White & Case LLP on 12/8/2020

On December 3, 2020, the Federal Trade Commission (FTC) published its annual report on pharmaceutical patent settlements filed with the FTC under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003...more

Teva Pharma Charged with Antitrust Conspiracy in Generic Pharmaceuticals Industry

The Volkov Law Group on 9/1/2020

Teva, the global pharmaceutical giant, was indicted last week as part of DOJ’s expanding criminal conspiracy investigation focused on illegal price-fixing and customer allocations....more

US Department of Justice charges co-owners of pharmaceutical company for fraud

Health Care Compliance Association (HCCA) on 8/1/2020

Compliance Today (August 2020) - The Department of Justice’s Criminal Fraud division indicted six Texas-based owners and marketers for a scheme to defraud TRICARE and the U.S. Department of Labor, resulting in more than $14...more

Novartis and Alcon FCPA Enforcement Action: Lessons Learned (Part III of III)

The Volkov Law Group on 7/1/2020

At the outset, Novartis is “lucky” – the settlement is relatively positive, despite its 2016 SEC enforcement action in China. Given Novartis weak culture of compliance (if anything, a better description may be a culture of...more

DOJ Goes After The Dark Side of Artificial Intelligence (AI)

ArentFox Schiff on 2/5/2020

A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more

Walking the Line Between Marketing and Malfeasance

Butler Snow LLP on 10/7/2019

Opioid manufacturers, distributors, pharmacies and prescribers are facing a deluge of lawsuits that involve criminal and civil claims in both federal and state courts. On May 2, 2019, a federal jury in Boston, Massachusetts,...more

Window On Washington - Vol. 3, Issue 26

Clark Hill PLC on 6/25/2019

Outlook for This Week in the Nation's Capital - Congress. The House and Senate have one week of legislative work remaining before they break for the Fourth of July recess period, and it looks to be quite busy. ...more

Window On Washington - Vol. 3, Issue 20

Clark Hill PLC on 5/13/2019

Outlook for This Week in the Nation's Capital - Congress. The House this week will likely take up HR 5, the Equality Act legislation, as well as HR 987, which is actually seven separate bills that have been combined into...more

DOJ Announces Settlements with Three Pharma Companies Related to Allegations of Co-Pay Assistance Kickbacks Through Conduit...

Arnall Golden Gregory LLP on 4/24/2019

On April 4, 2019, the Department of Justice (DOJ) announced settlements with three pharmaceutical companies, Jazz Pharmaceuticals plc (Jazz), Lundbeck LLC (Lundbeck), and Alexion Pharmaceuticals (Alexion), related to...more

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