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Fraud Drug Pricing

Fraud is the making of false representations or engaging in deceptive behavior in order to unlawfully secure financial or personal gain. 
BCLP

U.S. Supreme Court Explains Meaning of “knowingly” Under the False Claims Act

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In its recent unanimous and significant decision in the consolidated cases of United States ex rel. Schutte v. SuperValu, No. 21-1326 (6-1-23), and United States ex rel. Proctol v. Safeway, Inc., No. 22-111 (6-1-23), the...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

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

McDermott Will & Emery

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

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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

Patterson Belknap Webb & Tyler LLP

Supreme Court Rejects Objective Standard for Scienter for False Claims Act

On June 1, 2023, the United States Supreme Court decided two consolidated cases, United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, 589 U.S. ___ (2023), holding that a defendant’s...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

Dechert LLP

Part 2 of 2: U.S. Supreme Court Confirms False Claims Act’s Scienter Standard Accounts for Subjective Intent

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On June 1, 2023, the U.S. Supreme Court released a unanimous decision in U.S. ex rel. Schutte v. SuperValu Inc., No. 21-1326; U.S. ex rel. Proctor v. Safeway, Inc., No. 22-111, clarifying the False Claims Act’s scienter...more

Foley Hoag LLP - White Collar Law &...

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

The SuperValu case arose from separate lawsuits against two companies that operate retail drug pharmacies across the country: SuperValu Inc. and Safeway, Inc. In each case, a whistleblower – on behalf of the federal...more

Perkins Coie

US Supreme Court Clarifies Knowledge Requirement in False Claims Act Cases—Raising New Interpretive Issues

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A defendant’s knowledge of and subjective beliefs about the meaning of legal requirements—not what an objectively reasonable person may have believed—are what matters when determining whether a defendant “knowingly” submitted...more

Zuckerman Spaeder LLP

Part III | SCOTUS Ruling: “Knowing” Violations of Unknowable Rules: Is the Supreme Court Poised to Alter the FCA Enforcement...

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For background on this case, please refer to Part I. For updates from the Supreme Court oral arguments on April 18, please refer to Part II. On Thursday, June 1, the Supreme Court issued its opinion in United States et al....more

Goodwin

The Supreme Court Holds that the False Claims Act’s Scienter Element Turns on Defendant’s Subjective Beliefs, Rejecting Seventh...

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The Supreme Court recently issued a significant decision clarifying what it means to “knowingly” submit a false claim under the False Claims Act. At issue in United States ex rel. Schutte v. SuperValu Inc. were allegations...more

ArentFox Schiff

Supreme Court FCA Scienter Ruling Revives Fraud Lawsuits Against Safeway and SuperValu

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Supreme Court FCA Scienter Ruling Revives Fraud Lawsuits Against Safeway and SuperValu On Thursday, the US Supreme Court issued its highly anticipated ruling regarding the threshold of liability under the False Claims Act...more

Sheppard Mullin Richter & Hampton LLP

Supreme Court Clarifies that Subjective (Not Objective) Knowledge of Falsity of Claim Dictates False Claims Act Liability

On June 1, 2023, the Supreme Court issued a unanimous decision holding that the scienter element of the False Claims Act (“FCA”) is met if a defendant subjectively knew his or her claims were false and submitted them anyway....more

Holland & Knight LLP

U.S. Supreme Court Unanimously Rules on False Claims Act Subjective vs. Objective Standard

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The U.S. Supreme Court on June 1, 2023, unanimously settled a pivotal dispute over the subjective versus objective standard for scienter under the False Claims Act (FCA). In this case, U.S. ex rel. Schutte v. SuperValu Inc.,...more

ArentFox Schiff

Investigations Newsletter: Recent Interview With FCA Plaintiff Bar Attorneys Offers Key Insight into Trends in Anti-Kickback...

ArentFox Schiff on

Recent Interview With FCA Plaintiff Bar Attorneys Offers Key Insight into Trends in Anti-Kickback Litigation - During a recent interview commemorating the 50th anniversary of the enactment of the Anti-Kickback Statute, two...more

Polsinelli

SCOTUS Appears Poised To Reject Defense-Friendly Safeco Scienter Standard In FCA Cases

Polsinelli on

On April 18, 2023, the Supreme Court of the United States (SCOTUS) heard oral arguments in a pair of monumental False Claims Act (FCA) cases to decide whether and when a defendant’s subjective understanding of an objectively...more

King & Spalding

Supreme Court to Determine Whether False Claims Act Requires Objective Scienter Standard

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Last week, the Supreme Court granted review to clarify the scienter requirement in False Claim Act (31 U.S.C. §§ 3729 et seq.) (FCA) cases. This significant decision will affect the scope of FCA liability by addressing what...more

ArentFox Schiff

Investigation Newsletter: Eli Lilly Accused of Defrauding Government in $60 Million Qui Tam Suit

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Eli Lilly Accused of Defrauding Government in $60 Million Qui Tam Suit - In a qui tam suit alleging that Eli Lilly and Co. (“Eli Lilly”) violated the False Claims Act, a whistleblower contended that Eli Lilly defrauded...more

ArentFox Schiff

Investigations Newsletter: DOJ Continues To Prosecute PPP Fraud

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DOJ Continues To Prosecute PPP Fraud - Earlier this week, Ana Soto of Newark, Delaware pled guilty to fraudulently obtaining and spending money received through Paycheck Protection Program (“PPP”) loans. Between March...more

Bradley Arant Boult Cummings LLP

2 Recent Decisions Highlight Ambiguity As FCA Defense | Insights & Events

The past year has seen substantial activity by the federal courts in guarding against government overreach in False Claims Act cases. One of the principal areas courts have focused on is the FCA's knowledge requirement —...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Bass, Berry & Sims PLC

FCA Deeper Dive: Original Sources under the FCA’s Public Disclosure Bar

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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...more

The Volkov Law Group

Two Executives Charged in Valeant Pharmaceuticals Criminal Investigation

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Two executives were charged last week with criminal violations in the Southern District of New York relating to Valeant Pharmaceuticals activities. These charges are the first of more to come in an ongoing investigation...more

Mintz - Health Care Viewpoints

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to...more

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