Popular, Settlement, Pharmaceutical Industry

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

The Fate of the “Last Gasp” of the Biden FTC: Will Its Legacy Survive the Trump Administration?

Axinn, Veltrop & Harkrider LLP on 1/27/2025

In the days leading up to President Trump’s inauguration, the Biden FTC rushed to initiate major lawsuits and to tie a bow on various antitrust policy efforts. In a series of dissenting statements, the minority Republican...more

Fresenius Kabi and Formycon Reach Settlement Agreement for Ustekinumab Biosimilar Candidate in Europe and Canada

Goodwin on 3/29/2024

On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the...more

Antitrust & Competition Life Sciences Quarterly Update - Q3 2023

Goodwin on 10/24/2023

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

10 Years after Actavis, the Cases that Follow Tell a Story

Haug Partners LLP on 10/11/2023

I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more

False Claims Act Settlements to Know from Q2 2023

Bass, Berry & Sims PLC on 7/18/2023

There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023. Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....more

5 Major Drug and Device Developments of 2022

Faegre Drinker Biddle & Reath LLP on 12/23/2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Novel DOJ Settlement For Sunshine Act Violations

Goodwin on 10/30/2020

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

Securities Class Action Against Swiss-Based Company Dismissed On Forum Non Conveniens Grounds

Goodwin on 8/25/2020

Securities Class Action Against Swiss-Based Company Dismissed On Forum Non Conveniens Grounds; Second Circuit Finds Strong Inference of “Conscious Recklessness” In Allegations And Reverses Dismissal of Securities Suit Against...more

CIA Imposes Requirements for Pharmaceutical Speaker Programs and Events

Arnall Golden Gregory LLP on 7/22/2020

On July 1, 2020, the United States Department of Justice (DOJ) announced two settlements with Novartis Pharmaceuticals Corporation (“Novartis”), resolving allegations that the company had paid illegal kickbacks to physicians...more

Novartis Agrees To $678 Million False Claims Act Settlement With SDNY For Sham Speaker Programs

Farrell Fritz, P.C. on 7/16/2020

Novartis Pharmaceuticals Corp. agreed earlier this month to pay $678 million to settle an SDNY False Claims Act case. The SDNY alleged that Novartis violated the False Claims Act and the Anti-Kickback Statute by giving...more

Episode 149 -- A Deep Dive into Alexion's SEC Settlement for FCPA Violations

The Volkov Law Group on 7/5/2020

Notwithstanding the pandemic and remote working arrangements, the Securities and Exchange Commission is continuing to bring FCPA enforcement actions. In its latest action, the SEC settled with Alexion Pharmaceuticals for $21...more

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

Thomas Fox - Compliance Evangelist on 7/1/2020

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

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

Pharmaceutical company pays $54 million in settlement for FCA violation

Society of Corporate Compliance and Ethics... on 3/24/2020

CEP Magazine (March 2020) - On January 6, Teva Pharmaceuticals agreed to pay $54 million to settle allegations that the company violated the False Claims Act and the Anti-Kickback Statute by providing unlawful compensation...more

Another Biosimilar Litigation Settlement: Amgen v. Tanvex (Filgrastim)

Goodwin on 12/23/2019

Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar...more

FDA Approves Pfizer’s Adalimumab Biosimilar ABRILADA

Goodwin on 11/19/2019

On November 15, the FDA approved Pfizer’s Humira® biosimilar, ABRILADA (adalimumab-afzb). The acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, Sarah...more

Financial Daily Dose 10.1.2019 | Top Story: Credit Suisse COO Resigns in Wake of Corporate Spying Scandal

Robins Kaplan LLP on 10/1/2019

Top Tidjane Thiam ally Pierre-Olivier Bouee, Credit Suisse’s COO, has resigned in the wake of an internal probe finding that he “ordered the surveillance of the bank’s former wealth-management chief, Iqbal Khan, without...more

Sanofi Coughs Up $25 Million to Settle SEC FCPA Charges

The Volkov Law Group on 9/18/2018

Well, add another pharmaceutical company to the FCPA healthcare “sweep.” Frankly, the term “sweep” makes it sound like a coordinated enforcement effort – instead, it is more accurate to think of it as multiple prosecutions...more

State Of Louisiana, As Absent Class Member, Escapes CAFA Settlement Trap

Carlton Fields on 1/11/2018

The Third Circuit Court of Appeals affirmed a Pennsylvania district court decision holding the Eleventh Amendment to the United States Constitution prevented a private party from enjoining the state of Louisiana from bringing...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

Skadden, Arps, Slate, Meagher & Flom LLP on 10/26/2016

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

The Volkov Law Group on 9/6/2016

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

Be Careful What You Say – Or Rather What You Don’t Say – AVEO Pays $4 Million to SEC to Settle Fraud Charges

Sullivan & Worcester on 4/22/2016

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

Amarin Pharma Settles First Amendment Claims Against FDA: Potential Implications

Foley & Lardner LLP on 3/14/2016

Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading”...more

"One-Two Punch: Amarin Settlement Order and Vascular Solutions Acquittal Further Erode Off-Label Promotion Enforcement Regime"

Skadden, Arps, Slate, Meagher & Flom LLP on 3/9/2016

In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more

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