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Supreme Court of the United States › Prescription Drugs › Pharmaceutical Industry

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... more +
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 -
Carlton Fields

Fourth Circuit Applies Supreme Court’s Coinbase Decision Outside Context of Arbitration

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The Fourth Circuit Court of Appeals recently concluded that the U.S. Supreme Court’s decision in Coinbase Inc. v. Bielski is not limited to interlocutory appeals involving arbitration....more

Perkins Coie

First Circuit Imposes Higher “But-for” Causation Standard for False Claims Act Liability Based on Alleged Anti-Kickback Statute...

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On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Circuit Win and the End of Chevron Deference Could Shift Tides in Drug Price Negotiation Program Challenges

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As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D...more

Epstein Becker & Green

The 340B Reimbursement Battle: What Hospitals and Insurers Need to Know

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The U.S. Supreme Court’s ruling in American Hospital Association (“AHA”) v. Becerra (2022) sent shockwaves through the 340B drug pricing program when it held that CMS’ reduction of reimbursement for drugs purchased under the...more

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

Fuerst Ittleman David & Joseph on

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

McDermott+

M+ Check-Up: September 6, 2024

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Congress Returns. The House and Senate will be back in session on September 9, 2024, with a joint focus on completing consideration of a continuing resolution (CR) to maintain government funding beyond the end of fiscal year...more

McDermott Will & Schulte

Loper Bright and the 340B Statute

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In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and...more

Jenner & Block

Client Alert: Access to Mifepristone Still Standing for Now, but Questions Remain

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On Thursday morning, the Supreme Court issued its decision in FDA v. Alliance for Hippocratic Medicine. Justice Kavanaugh wrote for a unanimous Court dismissing the Alliance for Hippocratic Medicine from the case for lack of...more

Dinsmore & Shohl LLP

Supreme Court Rejects Challenge to FDA Regulation of Abortion Medication

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In a unanimous decision today, the Supreme Court rejected efforts to limit access to the abortion pill mifepristone, overturning an earlier decision by the 5th Circuit Court of Appeals. The Supreme Court ruled that the...more

Foley & Lardner LLP

Cancer Drugs: Strategies For Patenting Antibody-Drug Conjugate Inventions

Foley & Lardner LLP on

Antibody-drug conjugate (ADC) is a promising class of cancer treatments with accelerating U.S. Food and Drug Administration (FDA) approval and rapidly growing market size as discussed in previous articles in this series. This...more

Foley Hoag LLP

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

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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

Foley Hoag LLP - State AG Insights

State Attorneys General Weigh in Amidst Supreme Court Case That Could Restrict Access to Abortion Drug Mifepristone

Foley Hoag LLP - State AG Insights on

Attorneys general across the country have joined in litigation related to mifepristone, a drug used for medication abortions. A case currently before the Supreme Court, FDA v. Alliance for Hippocratic Medicine, could affect...more

Epstein Becker & Green

State Regulation of Pharmacy Benefit Managers: Tenth Circuit Holds That ERISA and Medicare Part D Preempt Key Parts of Oklahoma...

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On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit (the “Tenth Circuit”) issued its decision in Pharmaceutical Care Management Association (PCMA) v. Mulready, one of the first major opinions to further define...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

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

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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

Troutman Pepper Locke

Grappling With Increased Insurance ‎Regulatory Scrutiny of Pharmacy Benefit Managers

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Insurance regulators and examiners (“Insurance Regulators”) are increasing their efforts to scrutinize pharmacy benefit managers (“PBMs”), including conducting examinations of their business operations and initiating...more

Troutman Pepper Locke

All Is Not Lost: The Hidden Defense Benefits of the Supreme Court’s Recent Unanimous Ruling on False Claims Act Scienter

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On June 1, the U.S. Supreme Court published a unanimous decision in a False Claims Act (FCA) case, United States ex rel. Schutte v. SuperValu, Inc., No. 21-1326. The opinion, authored by Justice Clarence Thomas, was notable...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

Bradley Arant Boult Cummings LLP on

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

Sheppard Mullin Richter & Hampton LLP

Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

Sheppard Mullin Richter & Hampton LLP on

For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended...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...

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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

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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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

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