News & Analysis as of

False Claims Act (FCA) Scienter Prescription Drugs

ArentFox Schiff

Investigations Newsletter: Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict

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Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict - Following a record $1.6 billion jury verdict for off-label promotion of HIV drugs Prezista and Intelence, Johnson & Johnson (J&J) subsidiary...more

Paul Hastings LLP

SuperValu and Executive Health Resources: What to Know About the FCA Following the 2023 Term

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As we take stock of the Supreme Court’s 2023 term, two landmark decisions shift our understanding of scienter and government intervention as it relates to the False Claims Act (“FCA”), 31 U.S.C. § 3729. First, on June 1,...more

Epstein Becker & Green

SuperValu’s Effect on the FCA Scienter Standard and Impact to Future Litigation

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n June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief is...more

Epstein Becker & Green

Supreme Court Holds the FCA Scienter Standard Is Subjective, but How Will This Impact Future FCA Litigation?

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On June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief...more

Dorsey & Whitney LLP

Supreme Court’s Recent Decision on FCA’s Scienter Standard Potentially Raises Threshold for Government to Establish “Reckless...

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On June 1, 2023, a unanimous Supreme Court decision sought to clarify the meaning of “scienter” in the FCA context, which deals with the defendant’s knowledge (or lack thereof) that a claim for payment was false and intent to...more

Dickinson Wright

False Claims Act “Knowledge” Is a Subjective Standard

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The Federal False Claims Act (“FCA”) allows private parties to bring lawsuits in the name of the federal government against defendants who allegedly “knowingly” present a false claim to the government for payment. The...more

Burr & Forman

Do I Believe You? Scienter Standard in a FCA Case

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Two False Claims Act (“FCA”) cases have recently been decided by the United State Supreme Court, further clarifying one aspect of the FCA. In the recent decisions in U.S. ex rel Proctor v. Safeway, Inc. and U.S. ex rel....more

Jackson Lewis P.C.

U.S. Supreme Court: False Claims Act Liability Depends on Defendant’s Subjective Beliefs

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Liability in False Claims Act (FCA) suits depends on whether a defendant subjectively believed its claims were false, not on whether it can offer an objectively reasonable basis for its claims, the U.S. Supreme Court has held...more

Polsinelli

SCOTUS Rejects Defense-Friendly Scienter Standard In Schutte Opinion

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On June 1, 2023, the Supreme Court of the United States (SCOTUS) issued its much-anticipated opinion in United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc. (Schutte), holding...more

Fox Rothschild LLP

Supreme Court Rejects “Objectively Reasonable” Defense to False Claims Act

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The Supreme Court’s recent decision in United States ex rel. Schutte v. SuperValu, Inc. clarified that the claimant’s knowledge and subjective beliefs, and not what an objectively reasonable person may have known or believed...more

Bradley Arant Boult Cummings LLP

SuperValu: Supreme Court Clarifies FCA’s State-of-Mind Requirement

On June 1, 2023, in U.S. ex rel. Schutte v. SuperValu Inc., the Supreme Court clarified the state-of-mind (or “scienter”) standard under the False Claims Act (FCA), holding that a defendant’s subjective belief that a claim...more

Mintz - Health Care Viewpoints

The Supreme Court’s SuperValu Decision on the “Knowingly” Element in the False Claims Act: Protecting Against Liability When There...

In a resounding unanimous 9-0 decision, the Supreme Court rejected the argument that a defendant’s subjective belief is irrelevant under the False Claims Act (FCA) when evaluating whether a defendant “knowingly” submitted a...more

McDermott Will & Schulte

SuperValu: It’s Not Super Bad! A Practical Look at the Supreme Court’s Recent FCA Scienter Ruling

Two separate lawsuits alleging False Claims Act (FCA) violations by retail drug pharmacies made their way to the Supreme Court of the United States this term. The lawsuits decided whether the pharmacies could defeat these...more

Skadden, Arps, Slate, Meagher & Flom LLP

Supreme Court Clarifies False Claims Act Scienter Element in Schutte

On June 1, 2023, the U.S. Supreme Court issued its highly anticipated decision in the consolidated cases United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc., Nos. 21-1326 &...more

K&L Gates LLP

Supreme Court Issues Decision Regarding False Claims Act's Scienter Element

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The United States Supreme Court recently held that a defendant’s subjective belief is always relevant to the False Claims Act’s scienter element, regardless of what an objectively reasonable person may have believed. This...more

Wilson Sonsini Goodrich & Rosati

U.S. Supreme Court Closes Door on Objective Reasonableness Defense in Healthcare False Claims Act Cases

Leaves Window Open for Defense Based on Subjective Belief - On June 1, 2023, the U.S. Supreme Court issued a decision in a consolidated appeal of two healthcare qui tam cases that removes a very powerful defense from...more

Brownstein Hyatt Farber Schreck

U.S. Supreme Court Clarifies False Claims Act Scienter Requirement

On June 1, 2023, in United States ex rel. Schutte v. SuperValu, Inc., the U.S. Supreme Court unanimously held that the scienter requirement of a claim brought under the False Claims Act (FCA) is evaluated based on the...more

McCarter & English Blog: Government Contracts...

The False Claims Act’s Fuzzy Scienter Element Brought into Sharp Focus

Parties litigating False Claims Act (FCA) cases have long struggled with a thorny question around the essential element of scienter (the defendant’s intent, or state of mind): What/how much does a contractor need to know when...more

Warner Norcross + Judd

Supreme Court Removes Some Defenses to False Claims Act Liability for Government Contractors and Health Care Providers

Government contractors, health care providers and many other parties who submit claims for payment to the federal government are subject to liability under the False Claims Act (FCA). This month, the U.S. Supreme Court issued...more

Baker Donelson

Supreme Court Holds That FCA Requires Subjective Intent

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Is subjective intent relevant to FCA claims? The Court answered yes, holding that FCA liability turns on what the defendant actually believed, not on what an objectively reasonable person may have believed. On June 1, 2023,...more

Littler

Supreme Court: False Claims Act Liability Depends on Defendant’s Subjective Belief

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On June 1, 2023, in United States ex rel. Schutte, the United States Supreme Court held that, to impose liability on an employer for “knowingly” submitting a false claim to the government for payment, it is sufficient for the...more

A&O Shearman

Supreme Court Clarifies Scienter Standard For False Claims Act Liability

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On June 1, 2023, the Supreme Court issued a unanimous decision in the consolidated cases United States v. SuperValu Inc. and United States v. Safeway, Inc. holding that the False Claims Act’s (“FCA”) scienter element refers...more

Husch Blackwell LLP

Supreme Court Rejects an Objective Standard for False Claims Act Inquiries

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The False Claims Act imposes liability for false and fraudulent claims a defendant submitted with the requisite state of mind, or scienter. Before the Supreme Court handed down its June 1, 2023, decision in the combined...more

Venable LLP

Yes, Contractors and Providers, What You Think Matters - U.S. Supreme Court Unanimously Holds That Defendants' Subjective Beliefs...

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On June 1, 2023, the U.S. Supreme Court issued a unanimous opinion in United States ex rel. Schutte v. SuperValu Inc. reversing a pair of False Claims Act (FCA) cases on review from the Seventh Circuit Court of Appeals. In...more

The Volkov Law Group

The Supreme Court Rejects Challenge to False Claims Act Intent Standard

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The Supreme Court , in a unanimous decision, rejected a challenge by corporate pharmacy defendants, to the intent requirement in a Medicaid and Medicare over-billing False Claims Act case.  Justice Clarence Thomas, who has...more

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