News & Analysis as of

Settlement Life Sciences

Fenwick & West LLP

California AG Secures Record $1.55M CCPA Settlement Against Healthline Over Targeted Ads and Health Data Sharing

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On July 1, 2025, California Attorney General Rob Bonta announced a $1.55 million settlement, pending court approval, with Healthline Media, LLC. This settlement is the largest penalty issued to date under the CCPA, as...more

Skadden, Arps, Slate, Meagher & Flom LLP

Speaker Program Settlement Highlights Compliance Risks for Life Sciences Companies

On April 29, 2025, the U.S. Attorney’s Office for the Southern District of New York (SDNY) announced a $202 million civil False Claims Act (FCA) settlement with Gilead based on allegations that the company’s speaker program...more

Robins Kaplan LLP

ANDA Litigation Settlements

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Reported settlements in federal district court cases - This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant...more

Robins Kaplan LLP

ANDA Litigation Settlements - Winter 2024

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Epstein Becker & Green

DOJ’s False Claims Act Recoveries Top $2.9 Billion in FY 2024, but Health Care Numbers Dip—What Could FY 2025 Hold for Health Care...

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On January 15, 2025, the U.S. Department of Justice (DOJ) issued a press release announcing its fiscal year (FY) 2024 False Claims Act (FCA) recoveries and reported that settlements and judgments exceeded $2.9 billion in...more

Venable LLP

aBLA Updates: Stelara® Biosimilar Steqeyma™ (ustekinumab-stba) FDA-Approval; Lucentis® Biosimilar Xlucane™ (ranibizumab) aBLA...

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On December 17, 2024, the FDA approved Celltrion’s Steqeyma™ (CT-P43) (ustekinumab-stba) as the seventh biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab).  Celltrion previously reached a settlement agreement...more

Troutman Pepper Locke

Takeaways From Texas AG’s Novel AI Health Settlement

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On Sept. 18, Texas Attorney General Ken Paxton announced a settlement with healthcare technology company Pieces Technology pursuant to the Texas Deceptive Trade Practices-Consumer Protection Act. Originally published in...more

Knobbe Martens

Settlements Don’t Close the Door: Antitrust Claims Follow IPR Challenges in Life Sciences

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In the ongoing case of Carefirst of Maryland Inc. v. Johnson & Johnson, the plaintiffs successfully overcame a motion to dismiss. At the heart of the case is J&J’s legal strategy against biosimilar competitors, including...more

Robins Kaplan LLP

ANDA Litigation Settlements - Reported Settlements in Federal District Court Cases

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....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

Quarles & Brady LLP

Texas Attorney General Obtains Settlement of Alleged False and Misleading Statements About Healthcare Artificial Intelligence...

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On September 18, 2024, the Attorney General (AG) of Texas announced a settlement with an artificial intelligence-focused healthcare technology company to resolve allegations of false and misleading statements about the...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - May 2024

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Second Circuit Affirms “Pay for Delay” Dismissal:  On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more

Jones Day

DOJ Announces Record-Breaking Year for False Claims Act Settlements and Judgments

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Qui tam relators and the U.S. Department of Justice continue to expand usage of the False Claims Act....more

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q3 2023

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The FTC’s Amgen/Horizon Lawsuit Ends With a Whimper - We covered the FTC’s investigation into (and litigation challenging) Amgen’s $28.3 billion acquisition of rare disease specialist Horizon Therapeutics in our Q1 and...more

Goodwin

Seven Tips for Healthcare & Life Sciences Companies Engaging Independent Monitors and Compliance Experts

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For a healthcare or life sciences company settling a government enforcement action, the prospect of being subject to an independent monitor, independent review organization (IRO), or other government-mandated compliance...more

King & Spalding

DOJ Increases Scrutiny of Arrangements with EHR Vendors: What the ModMed Settlement Means for the Life Sciences Industry

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On November 1, 2022, Modernizing Medicine, Inc. (“ModMed”), an electronic health record (“EHR”) technology vendor, entered into a settlement agreement with the Department of Justice (“DOJ”), agreeing to pay $45 million to...more

Robins Kaplan LLP

ANDA Litigation Settlements - Winter 2021

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Goodwin

Novel DOJ Settlement For Sunshine Act Violations

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On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Fines, Penalties and the Cost of Recidivism

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

The Volkov Law Group

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

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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

Robins Kaplan LLP

ANDA Litigation Settlements - Spring 2020

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Please see Chart below for more information. ...more

Cooley LLP

Blog: Q4 Government Settlements Round-Up: Life Sciences

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The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in October – December 2019....more

Foley Hoag LLP - White Collar Law &...

Life Sciences Investors Beware: Private Equity Firm Settles Federal False Claims Act Suit Regarding Compounding Pharmacy It...

On September 18, 2019, the Department of Justice announced a $21.36 million settlement to resolve a False Claims Act (“FCA”) lawsuit alleging a fraudulent kickback scheme through which a pharmaceutical company (Patient Care...more

McDermott Will & Emery

Life Sciences Company Settles Regulation FD Charges with SEC

On August 20, 2019, the US Securities and Exchange Commission (SEC) charged TherapeuticsMD Inc., a Boca Raton, Florida, headquartered life sciences company, with violations of Regulation FD for sharing material, non-public...more

Fenwick & West LLP

Top SCOTUS Cases that Matter for Tech, Life Sciences and Games Industries – 2018 Term Preview

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As the U.S. Supreme Court kicks off its 2018 term this week, it prepares to take up a series of firsts, including questions about the America Invents Act, securities fraud and privacy-related class action litigation. At the...more

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