Dept. of Justice False Claims Act (FCA)

The United States Department of Justice is a federal executive department established in 1870 by federal statute. The Department is headed by the Attorney General and is responsible for administering and... more +
The United States Department of Justice is a federal executive department established in 1870 by federal statute. The Department is headed by the Attorney General and is responsible for administering and enforcing federal law. The Department is compromised of many different divisions which handle a wide variety of civil and criminal issues.    less -
News & Analysis as of

Fannie And Freddie Loans Could Be Next FCA Targets

By now, lenders that make loans insured by the federal government are well acquainted with the False Claims Act. Following the financial crisis, the U.S. Department of Justice has aggressively used the FCA to collect billions...more

DOJ Acknowledges in Proposed Jury Instructions That Dissemination of Truthful and Non-Misleading Off-Label Use Information Is Not...

For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more

The FCA and the USF: Reactions and Impressions from the FCBA’s False Claims Act Seminar

Last week, the Federal Communication Bar Association’s (FCBA’s) Enforcement Committee hosted a legal seminar on an issue that is somewhat new and unfamiliar to the communications bar – the federal False Claims Act (FCA), and...more

Corporate Investigations & White Collar Defense - January 2016

The FCPA in 2016: DOJ and SEC Focus on International Cooperation and Investigation of Individuals - Why it matters: As we reported in our December 2015 newsletter, both SEC Enforcement Director Andrew Ceresney and DOJ...more

First Amendment Follow-Up

The other day, we posted about, inter alia, the Department of Justice’s proposed jury instruction, in the Vascular Solutions case in Texas conceding the legality of truthful off-label promotion. In that post we asked, “Has...more

False Claims Act: 2015 Year-in-Review

In 2015, the Justice Department (DOJ) continued to give high priority to False Claims Act (FCA) investigations, bringing in nearly $3.6 billion in settlements and judgments. More than 630 qui tam suits were filed. DOJ's...more

False Claims Act Update: A Statistical Review of 2015 and Key Events for 2016

As reported by the Department of Justice (DOJ) in a December 2015 press release, the False Claims Act (FCA) remains the federal government’s primary means for combating fraud. In 2015, the DOJ recovered $3.583 billion in FCA...more

Nashville Pharmacy Services, LLC Settles FCA Allegations

Last week the Department Of Justice announced a settlement agreement with Nashville Pharmacy Services, LLC (“NPS”) and NPS majority owner Kevin Hartman. Under the agreement, NPS and Mr. Hartman will pay up to $7.8 million to...more

2015 – The Health Law Year in Review

With 2015 in the books, we are pleased to reflect on some of the major developments over the past year in the field of health law. The year was marked by changes in Medicare payment models—from government pronouncements...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

Thirty-Two Hospitals to Pay $28 Million to Resolve False Claims Act Kyphoplasty Dispute

Thirty-two hospitals have agreed to pay over $28 million to resolve outstanding False Claims Act allegations, the U.S. Department of Justice (DOJ) announced on December 18, 2015. The hospitals were accused of submitting...more

False Claims Act: 2015 Year in Review

This year continued the trend of aggressive False Claims Act (FCA) enforcement by the Department of Justice (DOJ) and high volumes of qui tam lawsuits brought by whistleblowers. In fiscal year 2015, the DOJ marked the fourth...more

DOJ Reports $1.9 Billion in Health Care False Claims Recoveries in FY 2015

The U.S. Department of Justice (DOJ) recently reported $3.5 billion in settlements and judgments from civil cases involving fraud and false claims in FY 2015 – $1.9 billion of which came from companies and individuals in the...more

Justice Department Reports Annual Results of False Claims Litigation: Numbers Remain Alarming for Health Care Related Industries

On December 3, 2015 the United States Justice Department made its annual public disclosure of the financial results of False Claim litigation around the country. The Department reported that it had collected more than $3.5...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 Reports Over $1 Billion in FCA Recoveries from Declined Cases in 2015

The Department of Justice recently released statistics about False Claims Act settlements and judgments in fiscal year 2015, announcing recoveries totaling $3.5 billion. Although down from last year’s record recoveries of...more

The Twenty-Year Ascendancy of Health Care Qui Tam Litigation in Five Simple Graphs

Experienced practitioners are anecdotally aware of the growth in recent years in the volume of health care qui tam litigation. That perceived trend is validated quite graphically in the most recent Department of Justice...more

DOJ Recovers $3.5 Billion in False Claims Act Cases in FY2015 and Pays Record Amount to Qui Tam Relators

Late last week DOJ announced that in FY2015 it obtained more than $3.5 billion in settlements and judgments from civil cases involving allegations of false claims against the government. Once again, health care fraud...more

Mortgage Company Resolves DOJ Allegations of False Claims Act Violations

On December 2, a Tennessee mortgage company agreed to pay the United States $70 million to resolve allegations that it violated the False Claims Act. According to the DOJ, the company, acting as a direct endorsement lender,...more

White Collar Enforcement Omnibus Edition—Cyber Crimes, Sanctions and Spoofing, Oh My!

Why it matters: Since our last newsletter, a lot has been going on in white collar enforcement… so much so that we decided to devote an entire newsletter to it. It was a month of superlatives. The DOJ and the SEC announced...more

Novartis Pharmaceuticals Settles $390MM FCA Allegations

Drugmaker Novartis Pharmaceuticals has agreed in principle to pay $390MM (including $20MM in civil forfeitures) to the Department of Justice. This payment, in addition to modification and an extension of Novartis’s existing...more

DOJ and OIG Launch Wave of Aggressive Prosecutions Targeting Entities and Individuals for Illegal Health Care Marketing Practices

In the last few months, the United States Department of Justice (DOJ) and the Office of Inspector General (OIG) have obtained over half a billion dollars in settlements and multiple criminal convictions arising from...more

DOJ Settles with For-Profit Education Company Over Alleged FCA Violations

On November 16, the DOJ announced a $95.5 million settlement with the country’s second-largest for-profit education company to resolve alleged federal and state violations of the False Claims Act (FCA). According to the DOJ’s...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

Final Curtain Call for Tuomey: Long-Running FCA/Stark Case Settled

After 10 years of litigation, including two trials and appeals to the 4th Circuit Court of Appeals, the U.S. Department of Justice (DOJ) and Tuomey Healthcare System (Tuomey) have entered into a settlement of DOJ's action...more

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