News & Analysis as of

Pharmaceutical Industry Scienter

Mintz - Health Care Viewpoints

Petition for Certiorari Filed in Supreme Court in False Claims Act Case Seeking Review of Whether “Willful” Under the...

The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the...more

A&O Shearman

Northern District Of California Dismisses With Prejudice Putative Class Action Against Pharmaceutical Company

A&O Shearman on

On May 7, 2024, Judge Beth Labson Freeman of the United States District Court for the Northern District of California dismissed with prejudice a putative shareholders’ class action against a pharmaceutical company (“Company”)...more

A&O Shearman

Second Circuit Affirms District Court’s Summary Judgment Dismissal Of Securities Fraud Class Action Against Pharmaceutical Company

A&O Shearman on

On April 15, 2024, the United States Court of Appeals for the Second Circuit affirmed in a non-precedential summary order the summary judgment dismissal of securities fraud claims against a pharmaceutical company (the...more

A&O Shearman

Northern District Of California Court Partially Grants Motion To Dismiss Putative Securities Class Action Against Pharmaceutical...

A&O Shearman on

On March 11, 2024, Judge Haywood S. Gilliam, Jr. of the United States District Court for the Northern District of California granted in part and denied in part a motion to dismiss a putative securities class action brought...more

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

A&O Shearman

Southern District Of New York Dismisses Proposed Securities Class Action Complaint Against Drug Manufacturer For Failure To Plead...

A&O Shearman on

On September 25, 2023, Judge Lorna Schofield of the United States District Court for the Southern District of New York granted a motion to dismiss a proposed class action against a biopharmaceutical company (the “Company”)...more

Epstein Becker & Green

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

Epstein Becker & Green on

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

Cozen O'Connor

Whistleblower Watch - A quarterly update on FCA Enforcement and Qui Tam Litigation

Cozen O'Connor on

Summer 2023- Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the...more

Dickinson Wright

False Claims Act “Knowledge” Is a Subjective Standard

Dickinson Wright on

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

Burr & Forman on

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

A&O Shearman

District Of New Jersey Allows Securities Fraud Claim To Proceed Against Outside Accounting Firm, Finding Plaintiff Sufficiently...

A&O Shearman on

On June 15, 2023, Judge Michael A. Shipp of the United States District Court for the District of New Jersey, in an unpublished opinion, adopted a Special Master’s Report and Recommendation denying a motion to dismiss claims...more

Polsinelli

SCOTUS Rejects Defense-Friendly Scienter Standard In Schutte Opinion

Polsinelli on

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

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 & Emery

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

McDermott Will & Emery on

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

K&L Gates LLP on

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

Baker Donelson

Supreme Court Holds That FCA Requires Subjective Intent

Baker Donelson on

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

A&O Shearman

Supreme Court Clarifies Scienter Standard For False Claims Act Liability

A&O Shearman on

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

Husch Blackwell LLP on

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...

Venable LLP on

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

The Volkov Law Group on

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

Jones Day

The U.S. Supreme Court Clarifies the Scienter Standard for False Claims Act Cases

Jones Day on

The U.S. Supreme Court clarified the standard for a defendant's state of mind in False Claims Act ("FCA") cases, holding that a defendant acts "knowingly"—which the FCA defines also to include deliberate ignorance and...more

75 Results
 / 
View per page
Page: of 3

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide