Pharmaceutical Industry Criminal Prosecution

News & Analysis as of

The Government Seeks to Intervene in its Third Generic Drug Price-fixing Lawsuit

Since we last reported on the state and federal government’s generic drug pricing investigations and litigations (click here to read more), the U.S. Department of Justice (“DOJ”) has obtained its first guilty pleas. On...more

Health Care Fraud and Abuse in the Middle District of Florida in 2016 - a Year in Review

The United States Attorney’s Office (USAO) for the Middle District of Florida (USAO-MDFL) prosecuted several civil health care fraud matters in 2016 and issued related press releases. A review of the USAO-MDFL’s criminal and...more

Dentons' pick of global regulatory trends to watch in 2017 - Competition/antitrust law

Focus on the US - In the wake of the 2016 elections, we now await the decision as to who will be the "antitrust guard" at the top of the US Department of Justice (DOJ) and the Federal Trade Commission (FTC). At the...more

French Legal and Regulatory Update – December 2016

The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e-newsletter, which offers a legal and regulatory update covering France and Europe for December 2016. Please see full...more

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

Alert: Antitrust 2017: Trends and Developments to Watch

1. Transition to a Trump Administration is top of the agenda - President-elect Donald Trump's DOJ and FTC transition team appointments and public short list of candidates to run the agencies indicate that antitrust...more

Teva FCPA Enforcement Action – Part II

Yesterday, I began an exploration of the Foreign Corrupt Practices Act (FCPA) enforcement action involving Teva Pharmaceuticals Industries Ltd. (Teva). It was brought jointly by the Department of Justice (DOJ) and Securities...more

Two Executives Charged in Valeant Pharmaceuticals Criminal Investigation

Two executives were charged last week with criminal violations in the Southern District of New York relating to Valeant Pharmaceuticals activities. These charges are the first of more to come in an ongoing investigation...more

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

New Anti-Corruption Laws on the Health Care Sector in Germany: Is There Any Impact on the Food Industry?

Germany recently adopted new anti-corruption laws that now criminalize “taking bribes in the health care sector” and “giving bribes in the health care sector.” These new laws have implications for certain segments of the food...more

Leading a Briber On Isn't the Same as Accepting a Bribe: How Gov. McDonnell Beat His Corruption Rap

The Supreme Court has reversed Gov. Bob McDonnell's conviction for bribery under the Hobbs Act. In ruling his conviction must be set aside, the High Court conceded the case was "distasteful," but unanimously concluded that...more

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

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

DOJ Folds Criminal Case Against Federal Express

In another set back last week, after a contentious criminal prosecution, the government dismissed its criminal charges against Federal Express. DOJ indicted Federal Express for drug trafficking relating to shipping of illegal...more

DOJ Suffers Criminal Trial Setbacks: Warner Chillcott President Acquitted

Last week was a tough week for the Justice Department’s criminal prosecutors. Before everyone gets out their Yates Memorandum trending claims, it is important to recognize that DOJ’s loss in several high profile cases does...more

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

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

Competition/antitrust law

Focus on the US - Cartel enforcement activity and stiffer criminal penalties against price fixing - The Department of Justice (DOJ) continues to investigate and seek criminal charges against worldwide cartels. This...more

Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. In January 2015, Andrew Weissmann...more

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

Justice Department Charges Pharma President with Kickback Conspiracy

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

"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

Antitrust Matters - September 2015

Antitrust investigations are no longer limited to a nation’s borders, or even to a region. Enforcers are more and more sharing information and coordinating their investigative efforts as they strive to uniformly enforce the...more

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

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

Significant Number of Dawn Raids Shows Increased Antitrust and Criminal Law Enforcement in Italian Pharmaceutical Sector

On 27 November, the Italian Competition Authority dawn raided a major South African company for alleged excessive pricing of its oncology products in Italy. According to a complaint by one of the most active consumer...more

SEC – USAO Charge Trader In Analyst Insider Trading Case

Earlier this month the SEC brought an insider trading case against Zachary Zwerko, a financial analyst at a pharmaceutical company identified only as Pharma Co. SEC v. Zwerko, Civil Action No. CV 8181 (S.D.N.Y. Filed Oct. 10,...more

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