False Claims Act (FCA) Pharmaceutical Industry

News & Analysis as of

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...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

FDA Regulatory and Compliance Monthly Recap — December 2015

Pacira secures expanded marketing for painkiller medication as FDA agrees to settle lawsuit, revoke warning letter - The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses,...more

First Circuit Applies Kellogg Brown & Root to Allow Relator to File Motion to Supplement Previously Dismissed Complaint

In United States ex rel. Gadbois v. PharMerica Corp., — F.3d —- (1st Cir. 2015), the First Circuit, in a matter of first impression, held that a relator’s complaint was not subject to dismissal under the first-to-file bar...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

DOJ’s Increased Scrutiny of Pharmaceutical Manufacturer and Specialty Pharmacy Ties

Over the past two years, the relationship between pharmaceutical manufacturers and specialty pharmacies has been under increased scrutiny by the U.S. Department of Justice (DOJ). Specifically, the DOJ has targeted industry’s...more

Principal Deputy Assistant Attorney General Mizer on Yates Memo: “No Partial Credit for Cooperation that Doesn’t Include...

Principal Deputy Assistant Attorney General Benjamin C. Mizer’s remarks at the 16th Pharmaceutical Compliance Congress and Best Practices Forum highlighted the Department of Justice’s “renewed commitment to ensuring that...more

Principal Deputy Assistant Attorney General Mizer Sheds Additional Light on Individual Accountability and the Yates Memo

On October 22, 2015, the U.S. Department of Justice Principal Deputy Assistant Attorney General Benjamin C. Mizer, who oversees DOJ’s Civil Division, spoke at the 16th Pharmaceutical Compliance Congress and Best Practices...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Expect Focus – International, Summer 2015

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

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

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

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

Kmart Settlement Shows Breadth of Healthcare Practices Government Says Violate False Claims Act

A recent settlement by retailer Kmart Corp. illustrates the breadth of practices in the healthcare space that the government considers to be illegal kickbacks that violate the False Claims Act (FCA). The U.S. Department of...more

Pharma and Medical Device Industry Victory in Off-Label Marketing Decision

The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

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

Newest FDA Newsletter from AGG

Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and...more

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

District Court Holds That FDCA Does Not Prohibit and Criminalize Truthful Off-Label Promotion of FDA-Approved Prescription Drugs

On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more

Court Concludes that Violation of a Corporate Integrity Agreement May Form the Basis for Reverse False Claim Liability

In late July, a federal district court in Pennsylvania denied a motion to dismiss brought by pharmaceutical company Cephalon, Inc., concluding that violations of a corporate integrity agreement (“CIA”) entered into by...more

Whistleblower Lawsuit Rests on Allegedly Withheld Documents

On June 19, the whistleblower in a False Claims Act suit argued that the court should take action to secure documents that demonstrate Abbott Laboratories encouraged off-label marketing and doctor kickbacks. The whistleblower...more

The Sixth Circuit Reins in the Government's Measure of False Claims Act Damages

Pharmaceutical and device companies, financial institutions, government contractors, oil and gas conglomerates, and other public and private entities continue to be in the crosshairs of aggressive federal government...more

Successful Rule 9(b) Defense of False Claims Act Whistleblower Litigation

The lure of significant monetary awards continues to stimulate high-risk whistleblower actions under the False Claims Act (FCA), and these claims are increasingly common in the pharmaceutical and medical device industry. The...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

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

NEW YORK BANK REGULATORY CONSIDERING CYBERSECURITY REGULATIONS, RANDOM AUDITS OF BANKS - On February 25, New York DFS Superintendent Benjamin Lawsky delivered remarks at Columbia Law School focusing on how state bank...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

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