News & Analysis as of

Failure To Disclose False Claims Act (FCA)

Health Care Compliance Association (HCCA)

NIH Disavows China Initiative, Offers ‘Trusted Asians’ Support But Cases, Questions Linger

In recent months, NIH signaled that it, in the words of Director Monica Bertagnolli, understands the “difficult climate for our valued Asian American, Asian immigrant and Asian research colleagues who may feel targeted and...more

Benesch

The “China Initiative” Just Won’t Die - Recent DOJ Settlement Highlights the Lasting Effect of Trump-Era Policy on Health Care...

Benesch on

In 2022, the United States Department of Justice (“DOJ”) announced its decision to shut down the “China Initiative”—the controversial program used to investigate and prosecute academics, health care workers, and...more

Health Care Compliance Association (HCCA)

DOJ: Stanford FCA Case Involved Failures to Disclose Foreign Support From Seven Countries

Report on Research Compliance 20, no. 11 (November, 2023) It wasn't just China. China is among the countries whose support for Stanford University investigators wasn’t reported to five federal research funding agencies,...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - October 2023

Morrison & Foerster LLP on

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Wiley Rein LLP

Recent False Claims Act Decision Offers Important Lessons on Risks and Perils of GSA Schedule Contracting, Calculation of Damages...

Wiley Rein LLP on

After more than 10 years of litigation and a four-week bench trial, a District Court in D.C. recently found a contractor liable under the False Claims Act (FCA) in connection with the U.S. General Services Administration’s...more

Bass, Berry & Sims PLC

Government Contractors Face False Claims Act Liability for Cybersecurity Non-Compliance

Last week, the District Court for the Eastern District of California denied the defendant’s motion for summary judgment of a False Claims Act (FCA) count against Aerojet Rocketdyne (Aerojet) for allegedly fraudulently...more

King & Spalding

DOJ Announces FCA Settlement with NIH-Funded Institute Related to Disclosure of Foreign Influence in Research

King & Spalding on

The Department of Justice (DOJ) recently announced that it reached a $5,500,000 settlement with a biomedical research institute that received NIH grant funding–the Van Andel Research Institute (VARI)–to resolve allegations...more

Health Care Compliance Association (HCCA)

After $5.5M FCA Settlement, Institutions Face Bigger Risks for Mishandling Foreign Support

Report on Research Compliance 17, no. 2 (January 23, 2020) - Acting with “deliberate ignorance” and “reckless disregard” are not words that any institution wants to hear associated with its name. But these are at the heart...more

Kramer Levin Naftalis & Frankel LLP

SEC-Mylan Settlement: The SEC Filed Suit Regarding Investigation Disclosure

On Sept. 27, 2019, the Securities and Exchange Commission (SEC) announced that Mylan N.V., a global pharma company that manufactures and sells EpiPen, which is used to treat serious allergic reactions, agreed to pay $30...more

Bass, Berry & Sims PLC

Failure to Voluntarily Self-Report is a "Non-starter" under the FCA

Bass, Berry & Sims PLC on

On July 5, 2019, the D.C. Circuit Court of Appeals affirmed dismissal of a qui tam lawsuit against several chemical manufacturers that set forth a unusual theory of liability: the relator alleged that the manufacturers...more

Bass, Berry & Sims PLC

No Consensus on Materiality: Courts Continue to Grapple with Escobar’s Key Holdings

Bass, Berry & Sims PLC on

Since the 2016 Supreme Court decision in Universal Services Inc. v. United States ex rel. Escobar, courts have wrestled with exactly how to apply the unanimous decision. This post highlights developments across the country in...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Alleged Environmental Violation/False Claims Act: U.S. District Court Considers Application of Implied False Certification Theory

A United States District Court (Eastern District-Pennsylvania) (“Court”) addressed a qui tam action filed by Gary Cressman (“Cressman”) under the federal False Claims Act (“FCA”) in connection with an alleged environmental...more

Jones Day

Judge Cites Escobar Materiality Standard, Vacates $350 Million False Claims Act Judgment

Jones Day on

The Situation: The False Claims Act imposes civil liability on any person or entity that "knowingly presents, or causes to be presented" to the U.S. government "a false or fraudulent claim for payment or approval." The...more

Jones Day

False Claims Act's "Rigorous" Materiality Standard Enforced by Second Circuit

Jones Day on

The Situation: A decision by the U.S. Court of Appeals for the Second Circuit reinforces the growing body of case law regarding the strict materiality requirements of the False Claims Act. The Result: Coyne v. Amgen is...more

Sheppard Mullin Richter & Hampton LLP

Escobar: Year One

Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989 (2016) was a landmark case in FCA jurisprudence. In Escobar, the Supreme Court held that the implied false certification theory can be a basis for...more

Bass, Berry & Sims PLC

FCA Deeper Dive: Escobar and Its Aftermath – Part II

Bass, Berry & Sims PLC on

The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we will...more

Bass, Berry & Sims PLC

FCA Deeper Dive: Escobar and Its Aftermath – Part I

Bass, Berry & Sims PLC on

The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we are...more

Williams Mullen

Risk and Uncertainty for Health Care Providers and Government Contractors in the Wake of Universal Health Services v. Escobar

Williams Mullen on

The Supreme Court’s decision in the closely watched case of Universal Health Services, Inc. v. United States ex rel. Escobar, decided on June 16, 2016, provides a long-awaited interpretation of the False Claims Act (“FCA”)...more

Parker Poe Adams & Bernstein LLP

Implied False Certification Theory as Basis for FCA Liability Endorsed by Supreme Court with Limits

In a recent and highly anticipated opinion that will significantly affect healthcare providers and other government contractors, the U.S. Supreme Court unanimously ruled that the “implied false certification theory” is a...more

Bradley Arant Boult Cummings LLP

Supreme Court Narrows Application of Implied Certification under the False Claims Act and Establishes a Demanding Materiality...

The Supreme Court’s decision in Universal Health Services v. United States ex rel. Escobar reframes when falsity may be implied under the False Claims Act (FCA) and raises the bar for materiality under the statute. Though the...more

Sheppard Mullin Richter & Hampton LLP

FCA’s “Implied Certification” Theory Survives

We previously reported on the viability of the “implied certification” theory of FCA liability based on oral argument before the Supreme Court in Universal Health Services, Inc. v. U.S. ex rel. Escobar. We concluded that the...more

Patterson Belknap Webb & Tyler LLP

Supreme Court Endorses Implied Certification Theory of Liability But Establishes “Demanding” Materiality Standard Under the False...

Yesterday, the United States Supreme Court decided Universal Health Services, Inc. v. United States ex rel. Escobar et al., holding that the so-called “implied certification” theory is viable under the False Claims Act...more

Sheppard Mullin Richter & Hampton LLP

Supreme Court Preserves But Significantly Changes “Implied Certification” Theory of False Claims Act Liability

On June 16, 2016, the Supreme Court issued its opinion (“Op.”) in Universal Health Services v. U.S. ex rel. Escobar (“Escobar”), a case testing the viability and scope of the implied certification theory of False Claims Act...more

Morgan Lewis

US Supreme Court Opines on Implied Certification Theory in Escobar

Morgan Lewis on

The Court’s rejection of the condition of payment analysis and adoption of a rigorous materiality standard represents a significant shift in how courts must analyze FCA cases premised on underlying regulatory or contractual...more

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