Pharmaceutical Industry Dept. of Justice

News & Analysis as of

Business Litigation Report - May 2015

In This Issue: - Main Article: ..Insider Trading After United States v. Newman, the Second Circuit’s Landmark Decision Limiting Liability of Downstream Recipients of Insider Information - Noted With...more

Antitrust Enforcers Discuss Recent Highlights, Ongoing Cases, Enforcement Priorities and General Trends at the 2015 ABA Section of...

The American Bar Association (ABA) Section of Antitrust Law Spring Meeting concluded earlier this month with the traditional “Enforcers’ Roundtable,” an interview with leading competition authorities about recent highlights,...more

Update on the DOJ's Criminal Investigation into Generic Pharmaceuticals

The Department of Justice Antitrust Division's (DOJ's) investigation into the generic pharmaceutical industry may be expanding. On March 15, 2015, a third generic manufacturer disclosed that it received a subpoena from the...more

FinCrimes Update - February 2015 Summary, Volume 2, Issue 2

On February 25, New York DFS Superintendent Benjamin Lawsky delivered remarks at Columbia Law School focusing on how state bank regulators can better supervise financial institutions in a post-financial crisis era. In his...more

DOJ Settles False Claims Act Allegations Against Pharmaceutical Manufacturer

On February 11, the DOJ announced a $7.9 million settlement with a Delaware-based pharmaceutical manufacturer for allegedly violating the False Claims Act by engaging in a kickback scheme with a pharmacy benefits manager...more

Blog: Congress Eyes Pharmaceutical Company Settlement Agreements as Source for Additional FDA & NIH Funding

Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental...more

"Insights Conversations: Life Sciences"

A healthy market for M&A activity, particularly cross-border deals, and a strict regulatory environment are the big factors influencing the health and activities of life sciences companies. Skadden partners John T....more

Top Ten International Anti-Corruption Developments for November 2014

For busy in-house counsel and compliance professionals, we have tried to summarize the most important international anti-corruption developments in the past month with links to primary resources. November was definitely a...more

District Court Allows Monopolization Claims to Move Forward on Allegations of Direct Evidence of Monopoly Power

Traditionally, plaintiffs asserting claims under Sections 1 and 2 of the Sherman Act allege the existence of one or more product markets relevant to the defendants’ anticompetitive conduct and the defendants’ shares of those...more

Criminal Global Cartel Focus on Generic Pharmaceuticals

The Antitrust Division is nearing the end of its largest, record-setting criminal cartel investigation – global auto parts suppliers. It has been a sprawling investigation that has leaped from product-to-product in the auto...more

Public Outcry Over Generic Price Hikes Spurs Criminal Investigations

Drug manufacturers Impax Laboratories and Lannett Company have come under public scrutiny and, more recently, criminal investigation for their recent generic drug price increases. The companies disclosed in recent SEC filings...more

DOJ Investigation into Generic Pharmaceutical Pricing Signals Potential Criminal Exposure

The United States Department of Justice Antitrust Division (DOJ) recently served two U.S.-based generic pharmaceutical manufacturers with criminal grand jury subpoenas. It is reported that the subpoenas request all...more

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

The Houston Astros and a Compliance Defense in the FCPA

The Astros act like a corporation and like almost all corporations they look to pay the absolute cheapest that they can to get something. Those who advocate that there be a compliance defense added to the FCPA miss this...more

Red Notice Newsletter - July 2014

Welcome to the July 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, two Noble Corporation executives settle with the U.S. Securities and Exchange...more

GSK Faces a Bad Day at Black Rock

One of my favorite movies is Bad Day at Black Rock. It is one of the few movies to combine elements of film noir into something approaching a traditional Western. It also attacks directly the prejudice and hate against...more

Red Notice Newsleter

Welcome to the May 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month, on the anticorruption front, Avon Products, Inc. (“Avon”) agrees to pay USD $135 million to settle a...more

Pharmaceutical Association Calls Out FTC in Filing Seeking to Enjoin New Rule Targeting the Industry

Last November, the Federal Trade Commission (“FTC”) with the “concurrence” of the Antitrust Division of the Justice Department, and over the strenuous objection of Pharmaceutical Research and Manufacturers of America...more

"Antitrust and Competition: Nonmerger Enforcement Activity Heats Up on Both Sides of the Atlantic"

U.S. and European antitrust agencies had similar enforcement priorities last year, a trend we expect to continue in 2014. Nonmerger enforcement will continue to focus on intellectual property, financial services and...more

"Antitrust and Competition: Surveying Global M&A Enforcement Trends"

US: Agencies Continue Aggressive Enforcement - Despite changes in leadership at the U.S. Department of Justice’s (DOJ) Antitrust Division and the Federal Trade Commission (FTC) (collectively, the Agencies) in 2013, the...more

Health Services Provider’s Settlement with DOJ Includes Detailed Factual Admissions and Agreement to Cooperate Against...

On January 8, 2014, pharmaceutical provider BioScrip, Inc. (BioScrip) reached a settlement with the Department of Justice (DOJ) to resolve claims under the False Claims Act (FCA) and the Anti-Kickback Statute (AKS), stemming...more

False Claim Act: 2013 Year in Review

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

Justice Department Announces $3.8 Billion In False Claims Act Recoveries In FY 2013

On December 20, 2013, the Justice Department announced a total of $3.8 billion dollars in settlements and judgments from civil cases involving the False Claims Act for Fiscal Year (FY) 2013. Total recoveries under the False...more

Antitrust and Competition Newsletter - December 2013

Japan’s METI Submits Amicus Brief in the TFT-LCD Litigation Seeking to Limit the Extraterritorial Reach of U.S. Antitrust Laws - On Oct. 31, 2013, Japan’s Ministry of Economy, Trade and Industry submitted a brief in...more

Antitrust agencies amend premerger notification rules to clarify reporting of certain acquisitions of exclusive patent rights in...

The US Federal Trade Commission, with the concurrence of the Antitrust Division of the US Department of Justice, has amended the premerger notification rules to clarify when a transfer of exclusive rights to a patent or part...more

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