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The Foreign Corrupt Practices Act Medical Devices

The Foreign Corrupt Practices Act is a United States Federal law enacted in 1974 to create transparency and prevent bribery for U.S.-based corporations conducting business overseas.

Managing Sanctions and Export Control Risks in the Health Care Industry

by Ropes & Gray LLP on

Over the past 15 years, pharmaceutical manufacturers, medical device companies, and other participants in the health care industry have been regular targets of U.S. Foreign Corrupt Practices Act (“FCPA”) enforcement actions...more

Top Ten International Anti-Corruption Developments for January 2017

by Morrison & Foerster LLP on

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

FCPA Recidivists: Orthofix (Part II of II)

by Michael Volkov 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

FCPA Recidivists: Zimmer Biomet (Part I of II)

by Michael Volkov 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

AGG Food and Drug Newsletter - January 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

The FCPA Enforcement Run Continues into 2017

by Michael Volkov 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

Despite Privilege, GC May Pursue Whistleblower Retaliation Suit under SOX and Dodd–Frank

California’s USDC–ND ruled that Bio-Rad Laboratories’ former General Counsel may use privileged communications to prove his retaliatory-discharge case prosecuted under Sarbanes–Oxley and Dodd–Frank’s whistleblower...more

E-Mail Communications: The Devil is on the Server

by Michael Volkov 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

GSK Settles SEC FCPA Case for $20 Million

by Michael Volkov 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

The Oscar Meyer Wiener Theme and Revisiting GSK in China

by Thomas Fox on

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

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

Top Ten International Anti-Corruption Developments for June 2016

by Morrison & Foerster LLP on

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

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

by Thomas Fox on

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

AGG Food and Drug Newsletter - June 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Justice Department Announces Largest Settlement Ever For Violations Of The Anti-Kickback Statute By A Medical Device Company

by Arnall Golden Gregory LLP on

On March 1, 2016, the United States Department of Justice (DOJ) announced that Olympus Corp. of the Americas (OCA), the nation’s largest distributor of endoscopes and related equipment, had agreed to pay $623.2 million to...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

Drug and Medical Device Corruption Risks in China

by Michael Volkov 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

Olympus: A Culture of Bribery and Kickbacks

by Michael Volkov 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

China Regulatory Enforcement Quarterly - Q3 2015

by DLA Piper on

On August 12, a series of explosions in the northern port-city of Tianjin killed over one hundred people and injured hundreds of others. The explosions were allegedly caused by hazardous chemical materials in shipping...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

by Michael Volkov 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

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

by Thomas Fox on

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

FAS Russia official recommendations on the commercial policies of manufacturers of pharmaceuticals and medical devices holding a...

by Dentons on

On June 30, 2015 on its official site FAS Russia published recommendations for entities holding a dominant position on pharmaceuticals markets and medical devices markets (hereinafter together “pharmaceutical companies”) to...more

SEC Enforcement Director Discusses Issues for Pharmaceutical and Medical Technology Companies

In a wide-ranging speech on Tuesday, Securities and Exchange Commission Director of Enforcement Andrew Ceresney discussed recent SEC actions and current concerns involving the pharmaceutical and medical technology industries....more

The FCPA Year in Review: Twist and Shout (Part I of II)

by Michael Volkov on

We all like annual reviews and predictions for the upcoming year – it is a New Year’s rite of passage and one that brings perspective and a sense of order to our otherwise chaotic lives....more

Red Notice Newsletter - November 2013

INTRODUCTION - Welcome to the November 2013 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. On the anticorruption front, a Swiss tech company’s former exec is charged in the US...more

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