The Supreme Court denied cert in this case; all relevant Supreme Court filings can be found here.
Potential Impact:
Why this Matters:
The Plaintiffs argue that the Inflation Reduction Act’s Medicare drug negotiation process violates the First Amendment, Due Process Clause of the Fifth Amendment, the Nondelegation Doctrine, the Administrative Procedure Act, and exceeds statutory authority. In this appeal, the Plaintiffs argue that the district court erred in finding that the Centers for Medicare and Medicaid Services’ actions were lawful.
Potential Impact:
Successful challenges to Medicare’s negotiation authority would negate savings to Medicare beneficiaries and taxpayers, and could severely restrict federal regulatory authority in the health care arena.
Novo Nordisk Inc. et al. v. Department of Health and Human Services et al.
Goal
Issues
Case History
Litigation Content
The Supreme Court denied cert in this case; all relevant Supreme Court filings can be found here.
Potential Impact:
Why this Matters:
The Plaintiffs argue that the Inflation Reduction Act’s Medicare drug negotiation process violates the First Amendment, Due Process Clause of the Fifth Amendment, the Nondelegation Doctrine, the Administrative Procedure Act, and exceeds statutory authority. In this appeal, the Plaintiffs argue that the district court erred in finding that the Centers for Medicare and Medicaid Services’ actions were lawful.
Potential Impact:
Successful challenges to Medicare’s negotiation authority would negate savings to Medicare beneficiaries and taxpayers, and could severely restrict federal regulatory authority in the health care arena.
News And Analysis (13)
Health Affairs
IRA Litigation: Pharma’s Failed Challenges To Medicare Drug PricingHealth Affairs
A Tale Of Three Decisions: Courts Continue To Reject Challenges To Medicare NegotiationHealth Affairs
Medicare Drug Price Negotiation Program: A Litigation Status CheckHealth Affairs
What’s The Nondelegation Doctrine Got To Do With Drug Price Negotiation?Health Affairs
The Medicare Drug Price Negotiation Program: Statutory And Agency Authority ChallengesHealth Affairs
Setbacks For Pharmaceutical Industry In Challenges To Medicare Drug Price NegotiationsO'Neill Institute
Policy Dispute Masquerading As Constitutional Theory? Due Process Attacks on Medicare Drug Negotiation ProgramHealth Affairs
Current And Future Legal Attacks Against The Medicare Drug Price Negotiation ProgramO'Neill Institute
Challengers to Medicare Drug Price Negotiation Program Suffer Major DefeatVox
Big Pharma’s Legal Fight to Stop Cheaper Medicare Drugs, ExplainedMedPage
An Analysis of the Blizzard of Lawsuits to Block Drug-Price NegotiationsHealth Affairs
Amicus Briefs In Merck Lawsuit Defend Constitutionality Of Medicare Drug Price Negotiation ProgramHealth Affairs
A Deep Dive Into Takings Clause Challenges To The Medicare Drug Price Negotiation Program27 Major Filings
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SUPREME COURT NOTICE (May 18, 2026)
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SUPREME COURT NOTICE (Dec 30, 2025)
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MANDATE (Nov 28, 2025)
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JUDGMENT (Oct 6, 2025)
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OPINION (Oct 6, 2025)
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PLAINTIFFS' RESPONSE TO NOTICE OF SUPPLEMENTAL AUTHORITY (Aug 13, 2025)
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DEFENDANTS' NOTICE OF SUPPLEMENTAL AUTHORITY (Aug 8, 2025)
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PLAINTIFFS' NOTICE OF SUPPLEMENTAL AUTHORITY (Jul 3, 2025)
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PLAINTIFFS' NOTICE OF SUPPLEMENTAL AUTHORITY (Apr 9, 2025)
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SCHEDULING ORDER (Mar 26, 2025)
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SCHEDULING ORDER (Feb 25, 2025)
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PLAINTIFFS' REPLY RE: MOTION TO EXPEDITE (Feb 6, 2025)
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DEFENDANTS' RESPONSE TO MOTION TO EXPEDITE (Feb 3, 2025)
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PLAINTIFFS' MOTION TO EXPEDITE (Jan 27, 2025)
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PLAINTIFFS' RESPONSE TO BRIEF (Jan 3, 2025)
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AMICUS BRIEF [US SENATORS] (Dec 23, 2024)
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AMICUS BRIEF {ABRAMS INSTITUTE FOR FREEDOM OF EXPRESSION] (Dec 23, 2024)
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AMICUS BRIEF [MEDICARE EXPERTS] (Dec 20, 2024)
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AMICUS BRIEF [AARP ET AL] (Dec 20, 2024)
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AMICUS BRIEF [PATIENTS FOR AFFORDABLE DRUGS] (Dec 19, 2024)
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AMICUS BRIEF {AMERICAN PUBLIC HEALTH ASSOCIATION ET AL] (Dec 17, 2024)
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DEFENDANTS' BRIEF (Dec 16, 2024)
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AMICUS BRIEF [CENTER FOR AMERICAN PROGRESS ET AL) (Dec 13, 2024)
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AMICUS BRIEF [LAW SCHOLARS] (Dec 13, 2024)
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PLAINTIFFS' OPENING BRIEF (Oct 15, 2024)
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SCHEDULING ORDER (Sep 16, 2024)
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PLAINTIFFS' NOTICE OF APPEAL (Aug 19, 2024)
View MoreRelated Litigation
Litigation Information
Current Status
Decision issued
Legal Issues
Separation of Powers, Fourteenth Amendment - Due Process Clause; First Amendment - Free Speech, Administrative Procedure Act - Notice and Comment Violation, Ultra Vires
Litigation Metadata
Law Scholars; Center for American Progress et al.; American Public Health Association et al.; Public Citizen et al.; Patients for Affordable Drugs; AARP et al.; Medicare Experts; Abrams Institute for Freedom of Expression; U.S. Senators