Pharmaceutical MDL-3080 • D. New Jersey

Insulin Pricing Lawsuit (Antitrust Litigation)

Major antitrust litigation alleging insulin manufacturers and pharmacy benefit managers conspired to artificially inflate insulin prices, harming millions of Americans who depend on this life-sustaining medication. Plaintiffs claim the pricing scheme forced patients to pay inflated costs or ration their insulin.

Last Updated: May 1, 2026
16 min read
JPML Data Verified
8 sources cited

Key Takeaways

  • 521 cases pending in federal MDL with antitrust and RICO claims
  • 8.4 million Americans rely on insulin therapy for survival
  • Defendants include Big Three manufacturers: Eli Lilly, Novo Nordisk, Sanofi
  • Inflation Reduction Act capped Medicare insulin at $35/month (2023)
  • Manufacturers cut prices 70% in 2023 amid litigation and legislative pressure
521
Pending Actions
8.4M
Americans on Insulin
$35
Medicare Cap (IRA)
Aug 2023
MDL Created

Key Facts (May 2026)

Pending Actions 521 cases in federal MDL (May 2026)
Total Actions 608 actions filed historically
Defendants Eli Lilly, Novo Nordisk, Sanofi + Major PBMs
Presiding Judge Hon. Brian R. Martinotti (D. New Jersey)
MDL Created August 3, 2023
Case Type Antitrust / RICO / Consumer Protection
Affected Population 8.4 million Americans requiring insulin
Medicare Cost Increase 76% higher out-of-pocket costs (2007-2020)

Case Growth (2025)

The Insulin Pricing MDL saw rapid growth in early 2025 as cases consolidated, with count increasing 338% since January.

Jan 25
119
Feb 25
294
Mar 25
433
Apr 25
449
May 25
417
Jun 25
416
Jul 25
417
Aug 25
434
Sep 25
439
Oct 25
439
Nov 25
444
Dec 25
445
Jan 26
444
Feb 26
493
Mar 26
518
Apr 26
517
May 26
521

Source: JPML MDL Statistics Reports, February 2025-May 2026

Inflation Reduction Act (August 2022)

The Inflation Reduction Act capped insulin costs at $35 per month for Medicare beneficiaries, effective January 2023. This affects approximately 3.3 million Medicare insulin users, though private insurance and uninsured patients are not covered by the cap.

Source: Public Law 117-169; KFF Analysis, June 2024

1 What Is This Lawsuit About?

Insulin is a life-sustaining medication for approximately 8.4 million Americans with diabetes. For people with Type 1 diabetes, insulin is absolutely essential for survival—there is no alternative. Many people with Type 2 diabetes also require insulin therapy.

Plaintiffs allege that the three major insulin manufacturers—Eli Lilly, Novo Nordisk, and Sanofi—coordinated with pharmacy benefit managers (PBMs) to artificially inflate insulin prices. The alleged scheme involved raising list prices while increasing rebates to PBMs, benefiting both parties while patients paid costs based on inflated list prices.

According to KFF data, aggregate out-of-pocket spending by Medicare Part D enrollees for insulin quadrupled from $236 million (2007) to $1.03 billion (2020), while average annual out-of-pocket spending per insulin user increased 76%.

Life or Death Medication: Without adequate insulin, glucose accumulates in the blood and the body begins producing ketones, leading to diabetic ketoacidosis (DKA)—a life-threatening emergency that can cause coma and death. The CDC reports 240,000 emergency visits for DKA annually.

2 Who Are the Defendants?

The defendants include the "Big Three" insulin manufacturers and major pharmacy benefit managers:

Insulin Manufacturers (~90% of market)

  • Eli Lilly and Company — Humalog, Humulin, Basaglar
  • Novo Nordisk Inc. — Novolog, Levemir, Tresiba
  • Sanofi-Aventis U.S. LLC — Lantus, Apidra, Toujeo

Pharmacy Benefit Managers (~80% of claims)

  • CVS Caremark — Part of CVS Health
  • Express Scripts — Part of Cigna
  • OptumRx — Part of UnitedHealth Group
Insulin's History: Insulin was discovered in 1921 and the patent was famously sold for $1, with the discoverers believing it should be widely accessible. The current pricing situation is a stark contrast to that original intent.

3 The Alleged Pricing Scheme

Plaintiffs allege manufacturers and PBMs engaged in a pricing system that benefited both at patients' expense:

Antitrust Allegations

  • Coordinated list price increases
  • Market allocation among manufacturers
  • Lack of true price competition
  • U.S. prices far exceeding other countries

Rebate System Claims

  • Higher list prices = larger rebates to PBMs
  • Rebates not passed to patients
  • Patients pay based on inflated list price
  • Opaque, confidential rebate negotiations

Legal Claims

  • Antitrust violations (Sherman Act)
  • RICO violations (racketeering)
  • State consumer protection violations
  • Unjust enrichment

Patient Impact

  • Patients rationing insulin due to cost
  • ER visits from inadequate access
  • Deaths attributed to unaffordability
  • Financial hardship for families

4 Industry Response & Price Cuts

Mar 2023
Eli Lilly Cuts Prices 70%

Announced 70% price cuts on most commonly prescribed insulins, capped patient out-of-pocket costs at $35/month, and introduced authorized generic for Humalog.

Mar 2023
Novo Nordisk Follows

Matched competitor price reductions and introduced expanded patient assistance programs.

Mar 2023
Sanofi Matches Cuts

Matched competitor price reductions and introduced Lantus authorized generic.

Feb 2025
First Rapid-Acting Biosimilar

FDA approves Merilog (insulin-aspart-szjj), the first rapid-acting insulin biosimilar, potentially increasing competition and access.

Note: While manufacturers have reduced prices, the litigation continues. Plaintiffs seek damages for years of alleged overcharges, and the $35 Medicare cap only applies to Medicare beneficiaries—not private insurance or uninsured patients.

5 Who is Bringing Claims?

This MDL includes various types of plaintiffs who allege they were harmed by inflated insulin prices:

Types of Plaintiffs

  • Individual consumers — People with diabetes who purchased insulin at allegedly inflated prices
  • Third-party payors — Insurance companies, unions, and health funds that paid for insulin
  • State attorneys general — Separate actions on behalf of state residents
Most Affected: Uninsured patients (who pay full list price), high-deductible plan enrollees, and Medicare Part D enrollees before the IRA cap were particularly impacted by inflated insulin prices.

6 Frequently Asked Questions

What is the $35 insulin cap?
The Inflation Reduction Act (August 2022) capped insulin costs at $35 per month for Medicare beneficiaries, effective January 2023. This applies to all Part D plans and all covered insulin products. However, this cap does not apply to private insurance or uninsured patients.
How is this different from a product liability case?
This is an antitrust case about pricing practices, not a case alleging that insulin itself is defective or dangerous. Insulin is a life-saving medication. Plaintiffs allege the defendants conspired to inflate prices, not that the product caused injury.
What are pharmacy benefit managers (PBMs)?
PBMs are intermediaries between drug manufacturers, insurers, and pharmacies. They negotiate rebates with manufacturers, create formularies (lists of covered drugs), and process prescription claims. The three largest PBMs—CVS Caremark, Express Scripts, and OptumRx—manage approximately 80% of all prescription claims.
If prices dropped in 2023, why continue the lawsuit?
Plaintiffs seek damages for years of alleged overcharges before the price cuts. Additionally, the price reductions don't help uninsured patients or those on private insurance without $35 caps. The lawsuit also aims to address the alleged anticompetitive conduct itself.
What is the FTC doing about insulin pricing?
The Federal Trade Commission has launched an investigation into PBM practices and issued an Interim Staff Report on Pharmacy Benefit Managers examining competition concerns in the industry. This regulatory scrutiny is separate from the private litigation in MDL-3080.
Have there been any settlements?
No global settlement has been announced in MDL-3080 as of May 2026. The litigation is ongoing with 521 pending cases. Given the complexity of antitrust cases and the number of defendants, settlement discussions may be extended.
What do the defendants say?
The defendants deny wrongdoing. They have pointed to the complexity of the pharmaceutical distribution system, the role of insurance design in patient costs, and their own patient assistance programs. The case remains in active litigation.

Sources & References

8 official sources cited

• JPML MDL Statistics Report — Pending MDL Dockets (March 2026)

• NIDDK — "What is Diabetes?" and "Insulin, Medicines, & Other Diabetes Treatments" (2022-2023)

• CDC — National Diabetes Statistics Report (May 2024)

• KFF — "Insulin Out-of-Pocket Costs in Medicare Part D" (July 2022)

• KFF — "The Facts About the $35 Insulin Copay Cap in Medicare" (June 2024)

• U.S. Congress — Inflation Reduction Act, Public Law 117-169 (August 2022)

• FDA — Biosimilar Insulin Approvals (February 2025)

• U.S. District Court, District of New Jersey — MDL-3080 case docket (2:23-md-3080)

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