News & Analysis as of

Foreign Corrupt Practices Act (FCPA) Healthcare

Mintz - Health Care Viewpoints

DOJ Announces it is Designing a Whistleblower Rewards Program

In early March 2024 at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General (DAG) Lisa Monaco’s keynote remarks previewed the development of new and significant Department of...more

Paul Hastings LLP

SuperValu and Executive Health Resources: What to Know About the FCA Following the 2023 Term

Paul Hastings LLP on

As we take stock of the Supreme Court’s 2023 term, two landmark decisions shift our understanding of scienter and government intervention as it relates to the False Claims Act (“FCA”), 31 U.S.C. § 3729. First, on June 1,...more

ArentFox Schiff

Diabetic Testing Supplier Agrees to $160 Million Penalty to Resolve False Claims Act Charges

ArentFox Schiff on

On August 2, 2021, the Department of Justice (DOJ) announced that Arriva Medical LLC (Arriva), once the nation’s largest Medicare mail-order diabetic testing supplier, and its parent company, Alere Inc., have agreed to...more

A&O Shearman

Global Healthcare Company To Enter DPA, Pay $345 Million To DOJ And SEC, To Resolve FCPA Claims

A&O Shearman on

On June 25, 2020, Novartis AG, a global healthcare company headquartered in Switzerland, and two of its subsidiaries (one current and one former) agreed to pay a total of $345 million in disgorgement and fines to the U.S....more

The Volkov Law Group

FCPA Predictions for 2020 (Part III of III)

The Volkov Law Group on

It is time to break out the crystal ball for FCPA 2020 Predictions.  In preparing for this, I always rely on my past admiration of Carnac the Magnificent....more

The Volkov Law Group

FCPA Recidivists: Orthofix (Part II of II)

The Volkov Law Group on

In its continuing quest to push the message of aggressive FCPA enforcement, the SEC resolved FCPA charges against Orthofix, a medical device company, for $6 million in penalties and disgorgement. In a related action, the SEC...more

The Volkov Law Group

FCPA Recidivists: Zimmer Biomet (Part I of II)

The Volkov Law Group on

The drug and medical device industries have been taking it on the FCPA chin for years. The risk factors in the international marketplace are significant – healthcare professionals are normally government employees; government...more

Cadwalader, Wickersham & Taft LLP

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Manatt, Phelps & Phillips, LLP

Corporate Investigations and White Collar Defense - October 2016

Supreme Court: What Constitutes an Insider Trading “Personal Benefit” - Why it matters: On October 5, 2016, the Supreme Court heard oral argument in Salman v. United States, where the central issue was what the...more

Thomas Fox - Compliance Evangelist

Monster Movie Month: Episode III – Son of Frankenstein and Evolution From Yates Memo and FCPA Pilot Program

Welcome to my third installment in this month’s classic monster movie festival. This year I am revisiting the Frankenstein series. Today I want to explore the final movie where Boris Karloff starred as Frankenstein’s Monster;...more

The Volkov Law Group

Headlines from Mid-Year FCPA Enforcement Review

The Volkov Law Group on

Just to add my voice to the cottage industry surrounding FCPA enforcement and compliance, I wanted to take a deep breath and offer some observations on FCPA enforcement in 2016. There are a few significant headlines...more

Carlton Fields

Prevailing in an Era of Regulatory Enforcement – Balancing Risk and Compliance [Expect Focus – Vol. II, July 2016]

Carlton Fields on

IN THE SPOTLIGHT - - SEC Sanctions Unregistered EB-5 Investments Broker SECURITIES - - FINRA to Assess Member Firms’ Culture - SEC Seeks Fund Responses to Distribution-In-Guise Guidance ...more

The Volkov Law Group

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The Volkov Law Group on

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Thomas Fox - Compliance Evangelist

Bristol-Myers Squibb FCPA Enforcement Action

Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more

Thomas Fox - Compliance Evangelist

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Polsinelli

DOJ Hires Compliance Counsel to Aid in Charging Decisions

Polsinelli on

In today’s robust enforcement climate, most companies have taken at least the first steps towards establishing a formal corporate compliance program. The mere existence of such a program, however, will not by itself protect a...more

Holland & Knight LLP

DOJ Appoints Compliance Counsel to Provide Advice in FCPA Investigations

Holland & Knight LLP on

The U.S. Department of Justice (DOJ) is creating a new compliance counsel position in the Criminal Division’s Fraud Section to scrutinize the compliance programs of companies under investigation for possible Foreign Corrupt...more

The Volkov Law Group

Mead Johnson: Baby Formula and Bribes

The Volkov Law Group on

Last week, the SEC announced a settlement of an FCPA enforcement action for $12 million against Mead Johnson Nutrition for payment of bribes in China to health care professionals at state-owned hospitals. Mead Johnson’s...more

Thomas Fox - Compliance Evangelist

Lessons from GSK in China – Internal Controls, Auditing and Monitoring

One of the questions that GSK will have to face during the next few years of bribery and corruption investigations is how an allegedly massive bribery and corruption scheme occurred in its Chinese operations? The numbers went...more

Dechert LLP

Legal and Ethical Risks of Healthcare Businesses in China

Dechert LLP on

Recent disputes and controversies involving Chinese subsidiaries of foreign pharmaceutical companies have sounded warning bells on legal and ethical issues regarding participation in China’s rapidly growing and evolving...more

The Volkov Law Group

The Government’s Unrelenting Reliance On Anti-Kickback Prosecutions

The Volkov Law Group on

Below the radar screen of aggressive FCPA enforcement, US Attorneys, HHS-OIG and State Attorney Generals are pushing an aggressive agenda using federal and state anti-kickback laws. It is hard to keep it all in perspective...more

Mintz - Health Care Viewpoints

How to Minimize FCPA Risk in Health Care Acquisitions

When acquiring a health care company doing business abroad, there is no such thing as being too thorough with anti-corruption due diligence. The Department of Justice and the Securities and Exchange Commission have the...more

Baker Donelson

Focus on Health Care Firms in FCPA Investigations

Baker Donelson on

I am seeing a lot of interest from health care clients regarding the Foreign Corrupt Practices Act (FCPA). I usually stay away from this topic because so many others cover it in detail. However, I want to point out that in...more

Mintz - Health Care Viewpoints

Health Care Enforcement in 2012: A Year in Review

Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more

Sheppard Mullin Richter & Hampton LLP

Pfizer FCPA Settlement Emphasizes the Importance of Robust Compliance Programs for the Healthcare Industry

The healthcare industry has been under increased SEC and DOJ scrutiny lately for potential FCPA violations. What has been described as an “industry sweep,” has focused primarily on medical device and pharmaceutical companies....more

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