News & Analysis as of

Materiality

Sixth Circuit: Technical Physician Signature Deficiencies not "Material" to Reimbursement Claims

by Jones Day on

The District Court for the Middle District of Tennessee held on June 22, 2017, that the timing requirements related to a physician's certification of need for home health services were not "material" to the Centers for...more

Federal Circuit Finds Regeneron Transgenic Mouse Patent Invalid For Inequitable Conduct With Intent Inferred From Litigation...

by Foley & Lardner LLP on

In a 38 page decision with a 19 page dissent by Judge Newman, the Federal Circuit determined that Regeneron’s transgenic mouse patent is unenforceable due to inequitable conduct. The decision was rendered in Regeneron...more

Materiality – “Shoulda, Coulda, Woulda?”

by Allen Matkins on

John Jenkins recently took note of this letter from the SEC’s Office of Investor Advocate commenting on a proposal by the Financial Accounting Standards Board to amend the definition of “materiality” in Concepts Statement No....more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Regeneron v. Merus, a divided panel affirms a determination of unenforceability for violation of the duty of disclosure. What is interesting about the case is that neither the district court nor the majority reviewed...more

Ninth Circuit Ruling Weakens Materiality Standard under the FCA

by McGuireWoods LLP on

Last year in Universal Health Services, Inc. v. United States ex rel. Escobar et al. the Supreme Court reminded litigants that the False Claims Act “is not an all-purpose antifraud statute.” In that case, the Court expanded...more

Court Dispenses With Fraud Defense Based on Gumball Victims’ Disclaimers

The Chicklets and Runts vending machine at your local car repair shop last decade may have been one piece of a fraudulent enterprise that ensnarled roughly 7,000 victims. As CEO of Vendstar, Defendant Edward (“Ned”) Weaver...more

Anti-Corruption Compliance: The Need to Look Under the Cloak of Materiality

by Michael Volkov on

Sarbanes-Oxley revolutionized the auditing profession. Section 404 imposed stringent requirements for disclosure of the state of a company’s internal controls and financial reporting. The company’s independent auditor is...more

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more

Escobar case limits False Claims Act liability for providers

by Thompson Coburn LLP on

Health care providers, as government contractors, must make certain representations of fact when submitting claims for government program reimbursement, such as Medicare. Sometimes through no fault of the contractor, such...more

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more

PCAOB Adopts New Auditor Reporting Standard

by Ropes & Gray LLP on

After more than six years of outreach and public comment, on June 1, 2017, the Public Company Accounting Oversight Board (“PCAOB”) adopted a new auditor reporting standard1 that, if approved by the SEC, would significantly...more

Second Circuit Rejects First Circuit’s “Extreme Departure” Test for Assessing Materiality of an Alleged Omission of Interim...

In Stadnick v. Vivint Solar, Inc., 2017 WL 2661597 (2d Cir. June 21, 2017), the United States Court of Appeals for the Second Circuit affirmed the dismissal of claims for violations of Section 11 of the Securities Act of...more

What Is Actual Knowledge? Third Circuit to Weigh in on Post-Escobar Materiality Question

by Pepper Hamilton LLP on

One year after the Supreme Court changed the False Claims Act landscape, FCA litigants continue to grapple with the “demanding” materiality standard set forth in Universal Health Services v. United States ex rel Escobar. Now...more

Third Circuit Recognizes Escobar “Heightened Materiality Standard” in Dismissal of False Claims Act Case Tied to Avastin

In May 2017, the U.S. Court of Appeals for the Third Circuit relied on the “heightened materiality standard” endorsed by the U.S. Supreme Court in its 2016 Escobar decision in dismissing a False Claims Act (FCA) whistleblower...more

After Escobar, Lower Courts Build On The “Materiality” Analysis for False Claims Act Lawsuits

by Saul Ewing LLP on

It’s been just over a year since the Supreme Court’s seminal False Claims Act (“FCA”) decision Universal Health Servs., Inc. v. United States ex rel. Escobar. In the wake of Escobar, the lower courts are confronted with...more

Second Circuit Sets Standard for Disclosure of Interim Financial Results in Offering Documents

On June 21, 2017, the U.S. Court of Appeals for the Second Circuit issued a decision of first impression that sets the standard for determining whether to disclose interim financial documents in a prospectus. In addition, the...more

FCA Deeper Dive: Express Certification

by 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

Seven Takeaways from the ABA National Institute On Health Care Fraud

On May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud. I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with...more

FCA Deeper Dive: Escobar and Its Aftermath – Part II

by 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

Fourth Circuit Re-Affirms Sufficiency of Triple Canopy Complaint

by Bass, Berry & Sims PLC on

U.S. ex rel. Badr v. Triple Canopy, Inc., an intervened case arising out of the Fourth Circuit, has been one of the more closely-watched recent FCA cases. Previously, the Fourth Circuit held that the government’s complaint...more

Escobar in Action – Materiality is a Tall Hurdle to Clear

by Butler Snow LLP on

In the recent Third Circuit decision United States of America, ex rel. Gerasimos Petratos, et al. v. Genentech Inc; et al., No. 15-3805, 2017 WL 1541919 (3d Cir. May 1, 2017), the Third Circuit addressed a “false...more

Third Circuit joins other circuits in enforcing Escobar's strict materiality requirement

by DLA Piper on

The Third Circuit has affirmed the district court's dismissal of a relator's claims in United States ex rel. Petratos, et al. v. Genentech Inc, et al, a False Claims Act (FCA) case alleging that the defendants-appellees...more

Third Circuit Weighs in on Materiality for First Time Since Escobar

by Pepper Hamilton LLP on

A recent circuit court decision will be a welcome development for False Claims Act defendants because it reinforces a significant pleading hurdle for claims to proceed, with the court citing lack of government intervention as...more

Supreme Court to Consider Whether Non-Compliance with SEC Regulation Can Give Rise to Securities Fraud Liability

by Dechert LLP on

In Leidos, Inc. v. Indiana Public Retirement System, No. 16-581, the U.S. Supreme Court will resolve an important circuit split regarding securities fraud liability. Specifically, the Court will determine whether Item 303 of...more

Call for Comments on Proposed SEC Amendment to Rule 15c2-12

Recently, the SEC proposed amendments to Rule 15c2-12 (the "Rule"), which was published in the Federal Register on or about March 16. Since 1995 governmental issuers and other obligors (like nonprofit health care...more

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