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Pharmaceutical Industry Criminal Prosecution Today's Popular Updates

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Jones Day

DOJ Obtains First Divestitures in a Criminal Antitrust Case

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The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more

Vinson & Elkins LLP

Data Corruption: DOJ Targets Fraud In Medical Research Trial In The Era Of COVID-19

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In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more

WilmerHale

Antitrust in 2020 - The Year To Date

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The first half of 2020 was a busy time for antitrust in the United States. The Department of Justice (DOJ) and the Federal Trade Commission (FTC) implemented expedited procedures for reviewing collaborations during the...more

Health Care Compliance Association (HCCA)

US Department of Justice charges co-owners of pharmaceutical company for fraud

Compliance Today (August 2020) - The Department of Justice’s Criminal Fraud division indicted six Texas-based owners and marketers for a scheme to defraud TRICARE and the U.S. Department of Labor, resulting in more than $14...more

Cadwalader, Wickersham & Taft LLP

The Delaware Court of Chancery Rejects Termination of Merger Agreement Based on Material Adverse Effect

In Channel Medsystems, Inc. v. Boston Scientific Corporation, the Delaware Court of Chancery rejected an attempt by Boston Scientific to terminate and thus avoid consummating a merger agreement with Channel on the grounds...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

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

Butler Snow LLP

Walking the Line Between Marketing and Malfeasance

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Opioid manufacturers, distributors, pharmacies and prescribers are facing a deluge of lawsuits that involve criminal and civil claims in both federal and state courts. On May 2, 2019, a federal jury in Boston, Massachusetts,...more

Skadden, Arps, Slate, Meagher & Flom LLP

Cross-Border Investigations Update - September 2019

This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more

K&L Gates LLP

“A Prescription for Competition”: DOJ Antitrust Division Affirms Its Enforcement Focus on the Healthcare Industry

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The healthcare industry remains a “high enforcement priority” for the U.S. Department of Justice (DOJ) and the Federal Trade Commission, according to statements last week by a senior official in the DOJ’s Antitrust Division. ...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Hogan Lovells

Antitrust, Competition and Economic Regulation Quarterly Newsletter - Autumn 2017

Hogan Lovells on

First come, first served. That’s not the principle behind the clearance of Bitcoin transactions. Equally for other blockchain technology networks, the relevant factor to get a transaction on the next available block is not...more

Arnall Golden Gregory LLP

DOJ and SEC Close Out 2016 with a $520 Million FCPA Settlement

The Securities and Exchange Commission (SEC) and Department of Justice (DOJ) wrapped up 2016 on December 22 with a near record-breaking Foreign Corrupt Practices Act (FCPA) settlement involving Teva Pharmaceuticals and its...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Mintz - Health Care Viewpoints

Jury Acquits Former Pharma Exec in One of the First Post-Yates Memo Health Care Fraud Prosecutions

Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s...more

Patrick Malone & Associates P.C. | DC Injury...

For congressional overseers, red flags fly over issues at FDA

Congressional overseers of the federal agency that regulates drugs and medical devices have gotten red-flag warnings about problems at the Food and Drug Administration, including: two separate calls for improvements from...more

Foley Hoag LLP

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

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A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

The Volkov Law Group

Justice Department Charges Pharma President with Kickback Conspiracy

The Volkov Law Group on

In the public relations battle following the issuance of the Yates Memo, the Justice Department can now cite one example for the new policy – the recent arrest and charging of Carl Reichel, former President of Warner...more

Skadden, Arps, Slate, Meagher & Flom LLP

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

The Volkov Law Group

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

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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

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