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Medical Devices Compliance Foreign Corrupt Practices Act (FCPA)

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

King & Spalding

General Counsels Decision Tree for Investigations of Life Sciences Companies

King & Spalding on

Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more

King & Spalding

H1 2019: Latin America Enforcement Observations

King & Spalding on

The U.S. Justice Department, the U.S. Securities and Exchange Commission, and their enforcement partners throughout Latin America remain focused on actively investigating corruption activities and bringing enforcement actions...more

Thomas Fox - Compliance Evangelist

Corruption in China: Part 3 – Red Flags

I continue with the multi-part blog post series based upon the New York Times (NYT) article by Alexandra Stevenson and Sui-Lee Wee, entitled “Selling CT Scanners with Bricks of Bills in China”, which details allegations of...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

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Thomas Fox - Compliance Evangelist

Stryker FCPA Enforcement Action: Compliance Lessons For Distributors and Dealers – Part II

Over this two-part blog post series, I have been considering the Stryker Corporation 2018 Foreign Corrupt Practices Act (FCPA) enforcement action brought by the Securities and Exchange Commission (SEC)....more

Thomas Fox - Compliance Evangelist

Stryker FCPA Enforcement Action: Compliance Lessons For Distributors and Dealers – Part I

Last month, Stryker Corporation joined a rather ignominious list of recidivists under Foreign Corrupt Practices Act (FCPA) enforcement annuls....more

A&O Shearman

Medical Device Manufacturer Enters Into Second FCPA Settlement In Five Years With SEC

A&O Shearman on

On September 28, 2018, the Securities and Exchange Commission (“SEC”) announced a settlement with a Michigan-based manufacturer and distributor of medical devices, over allegations that the company had violated the books and...more

The Volkov Law Group

Stryker Suffers “Strike Two” and Settles SEC FCPA Case

The Volkov Law Group on

Stryker Corporation has suffered a second FCPA enforcement action, and will now bear the stigma of FCPA “recidivist.” In reaching a settlement with the SEC and agreeing to pay a $7.8 million civil penalty, Stryker will now...more

The Volkov Law Group

Anti-Corruption Risks and Drug and Device Companies

The Volkov Law Group on

For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more

Baker Donelson

Update on Regulatory Compliance in the Global Health Care Industry

Baker Donelson on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

Morrison & Foerster LLP

Top Ten International Anti-Corruption Developments for January 2017

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...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

The Volkov Law Group

The FCPA Enforcement Run Continues into 2017

The Volkov Law Group on

Just when we thought 2016 was over and we could all breathe a sigh of relief, DOJ and the SEC have continued to run with a string of new enforcement actions. To all of those prognosticators, paparazzi, commentators, chicken...more

The Volkov Law Group

E-Mail Communications: The Devil is on the Server

The Volkov Law Group on

It is hard to imagine how prosecutors were able to bring cases before there was email communications. When I was a prosecutor, we looked for evidence in a lot of other sources, internal memos, calendars and other places where...more

The Volkov Law Group

GSK Settles SEC FCPA Case for $20 Million

The Volkov Law Group on

The SEC finished with the last nail in GSK China’s coffin by announcing a $20 FCPA million settlement for GSK’s violations in China. The Justice Department declined to prosecute this case. In 2014, a Chinese court...more

Thomas Fox - Compliance Evangelist

The Oscar Meyer Wiener Theme and Revisiting GSK in China

Last week a true American original died when Richard Trentlage passed away. If you do not know his name you certainly know signature contribution to American culture, the Oscar Meyer Weiner Song. Rather amazingly Trentlage...more

Thomas Fox - Compliance Evangelist

Battle of the Somme Week – Part I: The Analogic FCPA Enforcement Action

I have not written much in honor of the centennial of the First World War (WWI). However this week I will to remedy this oversight by focusing on the Battle of the Somme, leading up to the first day of the long battle, which...more

The Volkov Law Group

Drug and Medical Device Corruption Risks in China

The Volkov Law Group on

Medical device and pharmaceutical companies know the risks of conducting business in China. Company after company has had to settle FCPA enforcement actions in China. Many of these enforcement actions include fact patterns...more

The Volkov Law Group

Olympus: A Culture of Bribery and Kickbacks

The Volkov Law Group on

When compliance officers read about a major Justice Department settlement action, we can all hear the collective sigh of relief – “Thank goodness, that did not happen here in my company.”...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

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

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