News & Analysis as of

False Claims Act (FCA) Food and Drug Administration (FDA) Settlement

Paul Hastings LLP

At the Crossroads: Illumina Settlement Reflects the Intersection of Cybersecurity and Healthcare Law

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On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

ArentFox Schiff

Investigation Newsletter: Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims

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Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

ArentFox Schiff

Investigations Newsletter: Ultragenyx to Pay $6 Million To Settle False Claims Act Case

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Ultragenyx to Pay $6 Million To Settle False Claims Act Case - Ultragenyx Pharmaceutical Inc. recently agreed to pay $6 million to settle a qui tam action filed under the False Claims Act (FCA). Ultragenyx manufactures a...more

Harris Beach Murtha PLLC

HHS Office of Inspector General October 2023 Enforcement Activity

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

ArentFox Schiff

Investigations Newsletter: DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence

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DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence - Mark Schena, the former president of Arrayit Corporation, a Silicon Valley-based medical technology company, was...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Bass, Berry & Sims PLC

11th Annual Healthcare Fraud & Abuse Review 2022

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We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Foley & Lardner LLP

Migraine Company Fails to Avoid Own Headache: Jet Medical and Others to Pay $745,000 to Resolve Allegations that Medical Device...

Foley & Lardner LLP on

On January 4, 2023, the Department of Justice issued a press release stating that Jet Medical Inc. has agreed to pay $200,000 to resolve criminal allegations relating to a migraine headache treatment. Jet Medical and two...more

ArentFox Schiff

Investigations Newsletter: Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations

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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

Gardner Law

Anti-Fraud & Sunshine Update

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Staying up-to-date with fraud enforcement trends and recent cases and settlements can sometimes be viewed as a “Glass Half Empty” perspective, focusing on negative aspects of the industry and the perceived threat of...more

Mintz - Health Care Viewpoints

Pharmaceutical Manufacturer Pays $7.9 Million to Resolve Allegations that it Caused the Submission of Over-the-Counter Drugs to...

On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of...more

ArentFox Schiff

Investigations Newsletter: Physician Partners of America Agrees To Pay $24.5 Million To Resolve False Claims Act Allegations

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Physician Partners of America Agrees To Pay $24.5 Million To Resolve False Claims Act Allegations - Physician Partners of America LLC (PPOA), its founder, and its former chief medical officer agreed to pay $24.5 million to...more

Dorsey & Whitney LLP

DOJ Announces First Settlement Under New Civil Cyber-Fraud Initiative

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In October 2021, the Department of Justice (“DOJ”) announced its new Civil Cyber-Fraud Initiative, led by the Civil Division’s Fraud Section, to enhance its ongoing efforts to address cybersecurity threats. The initiative...more

ArentFox Schiff

Investigations Newsletter: DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008

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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

Knobbe Martens

Alere Settles False Claims Act Allegations for $33 Million

Knobbe Martens on

The United States Department of Justice announced in a press release that Alere Inc. and its subsidiary, Alere San Diego, reached a settlement agreement with the United States government for $33.2 million over allegations...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

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