Qui Tam

News & Analysis as of

Proof by Proxy in FCA Suits? District Court Says It Depends

Admissibility of statistical sampling to prove liability in FCA suit is fact dependent. In a February 14, 2017 decision, the Fourth Circuit declined to rule on the question of whether statistical sampling can be used to...more

Fourth Circuit Takes a Pass on Statistical Sampling, Finds DOJ's Settlement Veto Authority Unreviewable

After granting the relators’ petition for an interlocutory review of the district court’s rejection of the use of statistical sampling to establish FCA liability, the Fourth Circuit ultimately declined to reach that issue in...more

Fourth Circuit Permits DOJ to Reject an FCA Settlement, But Punts Decision on Statistical Sampling

In a closely watched False Claims Act (“FCA”) case, the Fourth Circuit Court of Appeals decided that the Department of Justice (“DOJ”) has an unreviewable right to object to a proposed settlement agreement between a relator...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

Fifth Circuit Limits Reverse False Claims Act Liability

On December 13, 2016, in United States ex rel Simoneaux v. E.I. DuPont de Nemours & Co., No. 16-30141, 2016 WL 7228813 (5th Cir. Dec. 13, 2016), the Fifth Circuit rejected an expansive construction of “reverse” false claims...more

Statistical Sampling in FCA Cases Remains Uncertain, But the Government’s Absolute Veto Power Regarding Settlements Gets Affirmed

While all hoped the Fourth Circuit would finally provide some clarity regarding the use of statistical sampling in False Claims Act (FCA) cases, Valentine’s Day 2017 yielded some surprising events for those awaiting the...more

False Claims Act Alert: Fourth Circuit Punts on Sampling and Extrapolation

Tuesday, the Fourth Circuit Court of Appeals ruled in the interlocutory appeal in United States ex rel. Michaels v. Agape Senior Community, Inc.. In an opinion considering two significant questions arising under the qui tam...more

Federal Whistleblower Laws Collide With The Attorney-Client Privilege: The Bio-Rad Case Study

Seyfarth Synopsis: Federal whistleblower laws collide with the in-house attorney-client privilege. The trial round goes to the whistleblower. The expected appellate round has still not been fought. In a February 7,...more

2016 Saw Rise in False Claims Act Actions and Recoveries

The U.S. government and whistleblowers brought an increased number of False Claims Act (“FCA”) cases – as well recovered a larger amount in settlements and judgements – in the fiscal year 2016, as compared to 2015. In 2016,...more

15-Year-Old Whistleblower Lawsuit Survives Statute of Limitations Challenge

The Eastern District of Pennsylvania recently allowed a fifteen-year old False Claims Act (“FCA”) qui tam action to proceed when it rejected a strict application of the statute of limitations and broadly construed the...more

The Risks and Implications of Failing to Comply with U.S. Government Cyber and IT Requirements

This article summarizes some of the many risks and implications that are associated with failing to comply with U.S. government-unique cyber and information technology requirements. We are often asked by small and...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: January 2017

We have identified 30 health care–related qui tam cases that have been unsealed in whole or in part. Trends & Analysis - A substantial majority of the unsealed cases had been under seal for periods well in excess of...more

Third Circuit Holds eBay-Based Allegations Sufficient to Plead Reverse False Claim For Failure to Pay Import Duties

In October, the Third Circuit held in United States ex rel. Customs Fraud Investigations, LLC v. Victaulic Co., 839 F.3d 242 (3rd Cir. 2016), that the 2009 amendments to the False Claims Act (“FCA”) allowed a relator to...more

Fourth Circuit Holds that the False Claims Act Does Not Expand Common Law Corporate Successor Liability

In United States ex rel. Bunk v. Gov’t Logistics N.V., 2016 U.S. App. LEXIS 20481, 842 F.3d 261 (4th Cir. 2016), the Fourth Circuit addressed a successor corporation’s liability for a predecessor corporation’s liabilities...more

Tenth Circuit Affirms False Claims Act Summary Judgment on Scienter Grounds

In United States ex rel. Smith v. The Boeing Co., 825 F.3d 1138 (10th Cir. 2016), the Tenth Circuit affirmed the district court’s grant of summary judgment on scienter grounds, finding that a difference of opinion as to two...more

False Claims that Don’t Violate the False Claims Act

The False Claims Act (FCA) establishes heavy liability (treble damages and penalties that can exceed over $20,000 per claim) for any person who knowingly presents a false claim for payment to the government. It also provides...more

False Claims Act: 2016 Year in Review

We are pleased to present Bradley’s annual review of significant False Claims Act (FCA) cases, developments, and trends. From a relatively short article several years ago, the Review has grown to a significant publication...more

Healthcare Law Update: December 2016

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

First Circuit Affirms Dismissal of False Claims Act Case

Happy birthday to Stan Lee, the main man behind Marvel Comics. He wrote the stories for The Amazing Spider Man which, when we were 10 years old, we read with a good deal more enthusiasm than we presently feel when...more

Jury Verdict in Declined Civil FCA Action Need Not Bar Criminal Prosecution for Same Conduct

The qui tam provisions of the False Claims Act allow private citizens to file FCA claims on behalf of the government. The government may elect to intervene in the action—or it may not. The United States District Court for...more

The “Public Interest” Prevails: Third Circuit Vacates Order That Sealed Whistleblower’s Profit-Sharing Settlement Agreement

In a recent decision, the Third Circuit held that a New Jersey federal district court wrongly sealed a profit-sharing settlement agreement between qui tam litigants. The plaintiffs, Fair Laboratory Practices Associates...more

2016 Marks Third Highest Annual False Claims Act Recovery

Wednesday, the Department of Justice (DOJ) announced that 2016 was its third highest recovery year in False Claims Act (FCA) history. According to the press release, “DOJ obtained more than $4.7 billion in settlements and...more

U.S. Supreme Court Rules That Seal Violations Do Not Require Dismissal of Qui Tam False Claims Act Suits

On Tuesday, the Supreme Court issued an anxiously anticipated False Claims Act (“FCA”) decision in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby, holding that a violation of the statute’s seal requirement...more

Supreme Court Rejects Mandatory Dismissal for an FCA Seal Breach

The Supreme Court held that a relator’s breach of the seal in a qui tam case does not require mandatory dismissal of the complaint, but the Court declined to articulate what factors are appropriate to consider in determining...more

This Is How A False Claims Act Case Works—And Fails

It took us a long time to understand how off-label promotion of prescription drugs had anything to do with the False Claims Act, and we’re still not so sure that the two are a fit. The FCA penalizes anyone who presents, or...more

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