News & Analysis as of October 19, 2024

Prescription Drugs

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The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term. The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -

Oral Arguments in FDA v. Alliance for Hippocratic Medicine: Mifepristone Case Likely to Turn on Article III Standing Requirements

Foley Hoag LLP on 4/18/2024

Nearly two years after the Court overturned Roe v. Wade in June 2022, additional challenges are being brought that may limit access to abortion in the U.S. Mifepristone was originally approved in 2000 by the U.S. Food and...more

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

Foley Hoag LLP - White Collar Law &... on 6/6/2023

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

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

Perkins Coie on 6/6/2023

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

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

Zuckerman Spaeder LLP on 6/6/2023

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

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

ArentFox Schiff on 6/5/2023

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

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

Sheppard Mullin Richter & Hampton LLP on 6/5/2023

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

Part II - April 18 Oral Argument: “Knowing” Violations of Unknowable Rules: Is the Supreme Court Poised to Alter the FCA...

Zuckerman Spaeder LLP on 5/17/2023

On April 18, 2023, the Supreme Court heard oral arguments in United States ex rel. Schutte v. Supervalu Inc., 9 F.4th 455, 459 (7th Cir. 2021) and United States ex rel. Proctor v. Safeway, Inc., 30 F.4th 649 (7th Cir. 2022)...more

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

Polsinelli on 4/25/2023

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

The Government’s Ability to Combat Fraud is on the Line in False Claims Act Supreme Court Case

Kohn, Kohn & Colapinto LLP on 4/17/2023

Oral arguments are scheduled for April 18, 2023, in the Supreme Court case combining two Seventh Circuit Court of Appeals cases U.S. ex rel. Schutte v. SuperValu, Inc. (“SuperValu”) and U.S. ex rel. Thomas Proctor v. Safeway,...more

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Supreme Court of the United States › Oral Argument › Prescription Drugs

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