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White Collar Crimes Pharmaceutical Industry

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: Product Liability and Mass Torts

Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fourth episode of When Your Life Sciences Are on the Line, where leading...more

K&L Gates LLP

The False Claims Act and Health Care: 2023 Recoveries and 2024 Outlook

K&L Gates LLP on

On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...more

Oberheiden P.C.

A 4-Point Guide for Pharmaceutical Whistleblowers

Oberheiden P.C. on

There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more

Foley Hoag LLP - White Collar Law &...

Congressional Investigations: A Review of Investigations Likely to Continue in 2024 and into the 119th Congress

This is the sixth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

The Volkov Law Group

Justice Department Declines FCPA Prosecution Against Lifecore Biomedical Under Corporate Enforcement Policy

The Volkov Law Group on

The Justice Department has brought three corporate FCPA enforcement actions in 2023 (if you include the Ericsson DPA breach settlement).  With its recent announcement of a declination under the Corporate Enforcement Policy,...more

The Volkov Law Group

Bribery in the Pharmaceutical Industry — Avanir Pharma

The Volkov Law Group on

We always focus on foreign bribery — the FCPA and corporate bribery of foreign officials.  It is certainly a problem that undermines economic development and human rights. ...more

Robins Kaplan LLP

Financial Daily Dose 2.16.2021 | Top Story: WTO Names First Woman, First African as Org President

Robins Kaplan LLP on

After more than half a year without a leader, the WTO is poised to welcome its “first woman and first African” to the role in the form of Nigerian economist and former finance minister Dr. Ngozi Okonjo-Iweala. ...more

The Volkov Law Group

Too Big to be Accountable: The Big Case Dilemma

The Volkov Law Group on

Over the last twenty year (yes, 20 years), the Justice Department’s civil and criminal enforcement record has come under greater scrutiny.  Whether you call it “Too Big To Jail” or “Too Big to Fail,” questions continue to...more

Stinson LLP

Is Your Prior Authorization Program Demonstrably Compliant?

Stinson LLP on

A recent settlement announced by DOJ serves as a good reminder of the need for device and pharmaceutical manufacturers to periodically revisit their prior authorization assistance programs, to assure that the programs are...more

Troutman Pepper

Did Congress Intend to Criminalize Off-Label Promotion? One District Judge Suggests the Issue Is Ripe for Review

Troutman Pepper on

A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more

The Volkov Law Group

Valeant Pharmaceuticals (Now Bausch Health) and Three Former Executives Settle SEC Cases

The Volkov Law Group on

Bausch Health agreed to pay the SEC $45 million to settle Valeant Pharmaceuticals (former name) accounting fraud schemes.  Three former executives, former CEO Michael Pearson, CFO Howard Schiller and Controller Tanya Carro...more

The Volkov Law Group

DOJ Criminal Generic Pharma Price-Fixing Investigation Gathers Steam: Taro Pharmaceuticals Agrees to Pay DOJ Total of $419 Million

The Volkov Law Group on

The DOJ Antitrust Division’s multi-year criminal cartel investigation of the generic pharmaceutical industry is gaining steam.  The latest company to settle is Taro Pharmaceuticals which agreed to enter a deferred prosecution...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 5 – The Whistleblower

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Akerman LLP - Health Law Rx

Novartis’ Simultaneous Settlements Break Records

Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 3 – Compliance Failures

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 1 – Introduction

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Thomas Fox - Compliance Evangelist

Alexion Pharmaceuticals FCPA Enforcement Action: Part 2 – Data Analytics

The same day that the 2020 Resource Guide was released, the Securities and Exchange Commission (SEC) announced it had settled a Foreign Corrupt Practices Act (FCPA) enforcement action involving Alexion Pharmaceuticals Inc....more

Thomas Fox - Compliance Evangelist

Alexion Pharmaceuticals FCPA Enforcement Action: Part 1 – The Bribery Schemes

The same day that the 2020 Resource Guide was released the Securities and Exchange Commission (SEC) announced it had settled a Foreign Corrupt Practices Act (FCPA) enforcement action involving Alexion Pharmaceuticals Inc....more

Patrick Malone & Associates P.C. | DC Injury...

For Big Pharma, a $648M bribery settlement and heat over anti-viral’s price

Big Pharma focuses relentlessly on always making a buck, no matter the cost to the rest of us, and even a viral pandemic that infects 2.8 million Americans and kills roughly 130,000 of us won’t interrupt the corporate...more

The Volkov Law Group

Alexion FCPA Violations: Lessons Learned (Part II of II)

The Volkov Law Group on

The Alexion Pharmaceutical SEC FCPA enforcement action represents another in the long line of enforcement actions against drug and device companies.  The drug and device industries have been – and will continue to be — easy...more

The Volkov Law Group

Alexion Pays SEC $21 Million for FCPA Violations (Part I of II)

The Volkov Law Group on

Notwithstanding the pandemic and remote working arrangements, the Securities and Exchange Commission is continuing to bring FCPA enforcement actions....more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Data Analytics and Lessons Learned

This blog post will close my review of 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...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)

The Volkov Law Group on

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

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