News & Analysis as of

Medical Devices Compliance

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

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

by Thomas Fox on

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...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

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

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

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

[Event] Do Not Enter: Privacy & Security for Life Sciences Companies - Regulatory Roundtable Immersion Series - Session #7 - Jan....

by Cooley LLP on

Cooley's Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant...more

Health Care E-Note - November 2015

by Burr & Forman on

With medical device related acquisitions at all-time highs, and regulatory interest intense from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of...more

OIG Hospital Compliance Audits: Is Your Number Up? Are You Ready?

by Baker Donelson on

In its Work Plan for Fiscal Year 2012, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced it would begin reviews of Medicare payments to hospitals to determine compliance...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

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

by Carlton Fields on

The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...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

New Requirements Regarding Emergency Alert Access Imposed On Device Manufacturers And MVPDs

by Kelley Drye & Warren LLP on

On May 28, 2015, the FCC released a Second Report and Order and Second Further Notice of Proposed Rulemaking pursuant to authority granted by the Twenty-First Century Communications and Video Accessibility Act of 2010 (CVAA)...more

Dechert Survey of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

by Dechert LLP on

Publicly Traded Life Sciences Companies in the United States Are an Increasingly Popular Target of Securities Fraud Class Action Lawsuits - The past year was particularly noteworthy with respect to the relative number...more

Recent False Claims Act Decision Provides Important Guidance To Manufacturers And Resellers About Trade Agreements Act Compliance

by King & Spalding on

The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court's dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

FDA Releases Final eMDR Rule and Deadline for Compliance

The Food and Drug Administration (FDA) announced and is promulgating today the Final Rule on Electronic Medical Device Reporting (eMDR). Originally proposed in 2009, the rule is now final and a deadline for compliance has...more

The Healthcare Industry And Chief Compliance Officers

by Michael Volkov on

The healthcare industry has been an innovative leader in developing compliance tools and strategies. They have come by it honestly – prosecutors and HHS-OIG have been pounding on pharmaceutical companies, medical device...more

China Solicits Comments on Good Supply Practices for Medical Devices

by Ropes & Gray LLP on

The China Food and Drug Administration (the “CFDA”) recently published a draft regulation, Good Supply Practices for Medical Devices (the “Draft GSP”), for public comment through January 20, 2014. The first-ever regulation...more

What Hath GSK Wrought? More Compliance Lessons From China

by Thomas Fox on

In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more

Letter From China-Interview With Amy Sommers

by Thomas Fox on

Ed. Note-this article is one of a continuing series of interviews of thought leaders in FCPA, Bribery Act and anti-corruption/anti-bribery. In this blog post, I interview Amy Sommers, partner in the Shanghai office of K&L...more

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