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Focus on Regulation

Tag Archives: False Claims Act

Medical Device Contractor Settles FCA Allegations Based on TAA Violations

On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade Agreements Act (“TAA”) (19 U.S.C. § 2518) by selling products to the Defense Logistics Agency (“DLA”) and the Department of

DOJ announces one of largest False Claims Act recoveries concerning U.S. Government small business programs

Last week, the Department of Justice (DOJ) announced a $16 million settlement with Virginia-based government defense contractor, ADS Inc., to resolve allegations that ADS and its subsidiaries violated the False Claims Act by submitting claims for payment under fraudulently obtained small business set-aside contracts.

Understanding Escobar: The Supreme Court Endorses FCA Implied Certification, with Limits

A unanimous Supreme Court held in Universal Health Services, Inc. v. United States ex rel. Escobar (“Escobar”) that under the civil False Claims Act (FCA), an “implied certification” of compliance could serve as a basis for liability for treble damages and penalties, but only in certain circumstances, rejecting attempts to extend liability under this theory to include any violation of a statute, regulation, or contract term that could theoretically permit the government to deny payment of a claim. The boundaries of this highly anticipated FCA ruling will be the source of additional litigation in the coming months and years.

Supreme Court Strikes Down Wartime Tolling of Civil Fraud Claims, While Affirming First-to-File Reinstatement for Civil False Claims Act Cases

Offering a mixed bag for federal contractors, on May 26, 2015, the Supreme Court of the United States unanimously overturned the Fourth Circuit’s decision in United States ex rel. Carter v. Halliburton Co., 710 F.3d 171 (4th Cir. 2013) that the Wartime Suspension of Limitations Act (WSLA) could be used to toll the statute of

The Sixth Circuit in United Technologies Corp. Requires Government to Prove Actual Loss for False Claims Act Damages

The Department of Justice and qui tam relators were dealt another blow regarding how damages are calculated in False Claims Act (FCA) cases. In an FCA case involving allegations of defective pricing, the U.S. Court of Appeals for the Sixth Circuit in United States v. United Technologies Corporation overturned the lower court’s award of $657

A New Landscape of DOJ Sanctions for Pharmaceutical and Medical Device Manufacturers

The U.S. Department of Justice (DOJ) announced another significant settlement with a pharmaceutical company earlier this week.  The settlement with GlaxoSmithKline PLC (GSK) includes:  a criminal plea, through an Information charging the company with two counts of misdemeanor misbranding as well as a single count for failure to report information about the initiation or status