False Claims Act (FCA)

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

Criminal Conviction Leaves Defendant Defenseless in FCA Civil Action

Pity Dr. Christina Clardy. In 2011 she was convicted of health care fraud, sentenced to 135 months in prison, and ordered to pay $16 million in restitution. Then in 2014 the government added Christina as a defendant in its...more

University of Massachusetts Medical School Not a “Person” Under FCA; 1st Circuit Adopts “Arm-of-the-State” Test

In an opinion issued on January 27, 2016, the United States Court of Appeals for the First Circuit affirmed the dismissal of a qui tam lawsuit against the University of Massachusetts, holding that the University was...more

Implied Certification and the FCA: Legally False or a False Legality? The Supreme Court Is Set to Decide

The United States Supreme Court recently granted certiorari in the case of Universal Health Services, Inc. v. U.S. ex rel. Escobar, No. 15-7, which places implied certification under the False Claims Act (FCA) squarely in the...more

DuPont Appeal May Clarify What Constitutes a Reverse False Claim “Obligation”

On January 20, a federal district court in Louisiana certified for appeal its 2014 ruling denying defendant DuPont’s motion for summary judgment, thereby permitting DuPont to seek appellate review of the district court’s...more

Another Day, Another Whistleblower Retaliation Suit

A False Claims Act (“FCA”) retaliation claim, 31 U.S.C. 3730(h), filed January 26, 2016 in federal district court in Oregon, provides a perfect example of the type of challenging cases confronting health care employers today....more

Double-check existing policies for whistleblower coverage

Whistleblower lawsuits under the False Claims Act, also known as qui tam actions, have become more common in recent years. This is particularly so in heavily regulated industries and those in which the government routinely...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

Was Whistleblowing a Reason for Firing or the Reason?

The outcome of a physician whistleblower’s retaliation claim against his former medical group turns on the question whether whistleblowing was a reason or the reason he was fired. If it was a reason, he loses. If it was the...more

Statistical Sampling Debate: A Growing Web Of FCA Cases

The government and qui tam plaintiffs are increasingly employing statistical sampling in False Claims Act cases, particularly in cases where addressing and analyzing large numbers of allegedly false claims poses substantial...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

The UK Modern Slavery Act and Supply Chain Responsibility

In October 2015, the UK Modern Slavery Act (MSA) became effective, which requires all companies doing business in the UK with worldwide turnover of at least £36 million (or approximately $51 million as of the date of this...more

Court Explains Rigorous 'Caremark' Pleading Requirements

A recent opinion containing the report and recommendation of the magistrate judge in the U.S. District Court for the District of Delaware, In re Chemed Shareholder Derivative Litigation, C.A. No. 13-1854-LPS-CJB (D.Del. Dec....more

M&A, Cybersecurity Identified as Top Areas for Healthcare General Counsels

A September 2015 Consero survey of general counsels (GCs) from mid-size to large U.S. hospital and health systems provides some interesting insight into the top issues facing legal departments....more

Reed Smith Clients Vindicated – Illinois Circuit Court Grants Motion to Dismiss in Qui Tam Winery Cases

On January 20, 2016, Judge Thomas Mulroy of the Cook County Circuit Court in Chicago granted the Illinois Attorney General’s Motions to Dismiss numerous qui tam cases brought against California wineries, 17 of which are...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

District Court Dismisses Government’s False Claims Act Complaint for Failure to Allege Actual False Claims with Particularity

On January 7, 2016 the United States District Court for the Middle District of Florida took the rare step of dismissing (with leave to amend) the government’s Complaint in Intervention in a False Claims Act Case. This case...more

Trade & Manufacturing - News of Note - January 2016

United States Repeals Country of Origin Labeling Legislation, Avoiding Retaliation - On December 18, President Obama signed a bill that repealed legislation requiring country of origin labeling (COOL) on beef and pork...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

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

Public disclosure bar prohibits "bounty-hunting" relators from filing duplicative FCA claims

The United States Court of Appeals for the Seventh Circuit has issued an opinion that underscores the importance of the "public disclosure bar" in False Claims Act (FCA) litigation. The court affirmed a lower court’s...more

Contractor to Pay $3 Million for Alleged Use of Noncompliant Materials

The recent case highlights the importance of complying with domestic preference requirements in government contracts. The US Department of Justice (DOJ) recently announced that Novum Structures LLC (Novum) will pay $3...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

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