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Enforcement Actions Corruption Pharmaceutical Industry

Hogan Lovells

China’s first compliance guidelines to prevent corruption risks in the life sciences industry

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On January 14, 2025, China issued the final version of its compliance guidelines for health care companies to prevent commercial bribery risks (“Guidelines”), which took effect immediately. The Guidelines are applicable to...more

Morrison & Foerster LLP

China Issues First Compliance Guidelines to Combat Commercial Bribery Risks - UPDATED February 2025

On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more

The Volkov Law Group

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

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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

Avanos Medical Pays $22 Million to Settle Criminal Mislabeling Charges for Surgical Gowns

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Avanos Medical, a global medical device company, agreed to pay $22 million to resolve criminal charges relating to its fraudulent misbranding of its MicroCool surgical gowns....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

The Volkov Law Group

Merit Medical Systems Settles False Claims Act Case for $18 Million (Part I of II)

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Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to...more

The Volkov Law Group

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

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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

The Volkov Law Group

DOJ Catches Big Fish in Generic Pharmaceutical Criminal Antitrust Investigation

The Volkov Law Group on

The Justice Department’s Antitrust Division announced a major guilty plea with Sandoz, Inc., in its expanding criminal investigation of the generic pharmaceutical industry....more

The Volkov Law Group

Cardinal Health Pays SEC $8.8 Million for FCPA Violations

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Cardinal Health (“Cardinal”) agreed to pay the SEC $8.8 million for FCPA violations in China relating to its internal controls and books and records. Cardinal acknowledged facts relating to internal controls deficiencies and...more

Polsinelli

DOJ’s False Claims Act Recoveries Rise to More Than $3 Billion in FY2019, With Continued Emphasis on Health Care Fraud Cases

Polsinelli on

On January 9, 2020, the Civil Division of the U.S. Department of Justice (DOJ) announced that it recovered over $3 billion from civil False Claims Act (FCA) judgments and settlements in the fiscal year ending September 30,...more

The Volkov Law Group

2019 FCPA Enforcement Highlights (Part II of III)

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In a record year, there are bound to be numerous interesting enforcement actions and principles.  I picked out a few to highlight....more

Thomas Fox - Compliance Evangelist

Bribery Schemes from 2019 FCPA Enforcement Actions

In today’s blog post, I want to look at some of the more unusual bribery schemes from Foreign Corrupt Practices Act (FCPA) enforcement actions in 2019. Some of these schemes were not unusual but they were accomplished with...more

The Volkov Law Group

FCPA 2019: A Record Year in Enforcement and Compliance (Part I of III)

The Volkov Law Group on

Happy New Year!! In the FCPA arena, 2019 was a record year – in enforcement and compliance. Many continuing trends are becoming more than trends – meaning they are turning into established practices....more

Thomas Fox - Compliance Evangelist

Top Five Department of Justice FCPA Enforcement Actions in 2019

Welcome to the 2020’s. The past decade helped shape both Foreign Corrupt Practices Act (FCPA) enforcement and corporate compliance programs. 2019 FCPA enforcements bore out many of the developments from the preceding years of...more

The Volkov Law Group

Two Charitable Foundations Pay $6 Million for Anti-Kickback Violations

The Volkov Law Group on

Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million.  The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2...more

The Volkov Law Group

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

The Volkov Law Group on

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

Thomas Fox - Compliance Evangelist

Corruption in China: Part 2 – The Bribery Schemes

After a sidetrack into the ethical train wreck detailed by the SEC Cease and Desist Order re: KPMG yesterday, I am returning to the blog post series I am running based upon the New York Times (NYT) reporting by Alexandra...more

Hogan Lovells

U.S. and Brazilian Authorities Reportedly Cooperating in Investigation of Alleged Bribery and Price Fixing Related to Medical...

Hogan Lovells on

In a May 17, 2019 press report that has been widely distributed in Brazil and the United States, Brazilian Federal Prosecutor Marisa Ferrari confirmed that the U.S. Federal Bureau of Investigation (FBI), the U.S. Department...more

Thomas Fox - Compliance Evangelist

Fresenius FCPA Enforcement Action: Part VI – FCPA Enforcement Going Forward

We are at the end of my exploration of the long-awaited Fresenius Medical Care AG & Co. KGaA (FMC) Foreign Corrupt Practices Act (FCPA) enforcement action. ...more

Thomas Fox - Compliance Evangelist

Fresenius FCPA Enforcement Action: Part V – Lessons Learned on Investigative Steps and Remedial Actions

We continue this multipart exploration of the recent announcement of the Fresenius Medical Care AG & Co. KGaA (FMC) Foreign Corrupt Practices Act (FCPA) enforcement action....more

Thomas Fox - Compliance Evangelist

Fresenius FCPA Enforcement Action: Part IV – Lessons Learned on the Bribery Schemes

We continue this multipart exploration of the recent announcement of the Fresenius Medical Care AG & Co. KGaA (FMC) Foreign Corrupt Practices Act (FCPA) enforcement action....more

Thomas Fox - Compliance Evangelist

Fresenius FCPA Enforcement Action: Part III – The NPA, Fines and Monitor

I continue my multipart (not quite sure how long it will go) exploration of last week’s announcement of the Fresenius Medical Care AG & Co. KGaA (FMC) Foreign Corrupt Practices Act (FCPA) enforcement action. It involved...more

Thomas Fox - Compliance Evangelist

Fresenius FCPA Enforcement Action: Part II –  The Bribery Schemes

Last week, the long-awaited Fresenius Medical Care AG & Co. KGaA (FMC) Foreign Corrupt Practices Act (FCPA) enforcement action was announced. It involved massive multi-year and multi bribery schemes by the company in multiple...more

The Volkov Law Group

Lessons Learned from Fresenius Medical FCPA Settlement (Part III of III)

The Volkov Law Group on

Fresenius Medical’s FCPA settlement for $231 million demonstrates again the continuing vitality surrounding the FCPA Corporate Enforcement Policy – which provides a carefully constructed framework for encouraging voluntary...more

Thomas Fox - Compliance Evangelist

Fresenius FCPA Enforcement Action: Part I – Introduction

The long-awaited Fresenius Medical Care AG & Co. KGaA (FMC) Foreign Corrupt Practices Act (FCPA) enforcement action was recently announced. ...more

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