Primary-source tracker · JPML, EDPA, FDA, Federal Register, SEC EDGAR · No plaintiff intake · No affiliate links · Maintained by The RX Index research desk

GLP-1 Lawsuits & FDA Enforcement Tracker

Live status · Last verified: · Next review: · Sources: JPML · EDPA · FDA · Federal Register · SEC EDGAR
MDL 3094 (GI injuries)
3,636
Cases pending · May 1, 2026 JPML report
MDL 3163 (NAION)
86
Cases pending · May 1, 2026 JPML report
503B Bulks List Comment Period
Jun 30
2026 · Federal Register Docket FDA-2018-N-3240
Novo v. Hims
Dismissed
Mar 9, 2026 · Collaboration agreement
Global Settlement (MDL 3094)
None
Verified against EDPA orders page May 6, 2026
Bellwether Trial
Not set
Neither MDL has scheduled a bellwether trial
🟠 Live status as of . Maintained by The RX Index research desk · Sourced from JPML, the Eastern District of Pennsylvania, FDA, the Federal Register, SEC EDGAR, and CourtListener · No plaintiff intake · No affiliate links · Submit a correction

The state of GLP-1 lawsuits and FDA enforcement keeps moving fast. As of the May 1, 2026 JPML statistics report, 3,636 cases are pending in MDL 3094 — the federal multidistrict litigation for gastrointestinal injuries from Ozempic, Wegovy, Mounjaro, and other GLP-1 drugs — and 86 cases are pending in the newer MDL 3163, which covers vision loss claims (NAION). One FDA proposal sitting in the Federal Register right now would close the 503B bulks-list pathway for semaglutide, tirzepatide, and liraglutide if finalized, with a comment period closing June 30, 2026.

This page tracks all of it. It is built for reporters on deadline, financial analysts updating models, and compliance teams watching the regulatory line. We pull from public primary sources only — court dockets, FDA letters, Federal Register notices, SEC filings — and link the underlying document on every entry. There are no affiliate links, no plaintiff-intake forms, and no provider recommendations.

What is the current status of GLP-1 lawsuits and FDA enforcement?

Answer: As of May 6, 2026, two federal multidistrict litigations (MDLs) are active against GLP-1 manufacturers — MDL 3094 (3,636 cases, gastrointestinal injuries) and MDL 3163 (86 cases, NAION vision loss) — both before Judge Karen S. Marston in the Eastern District of Pennsylvania. The FDA has proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, with the Federal Register comment period closing June 30, 2026. There is no global settlement and no bellwether trial has been scheduled.
Tracker section Current status Last verified
MDL 3094 — GI injuries Active 3,636 pending; Judge Marston, E.D. Pa.; CMO No. 30 (Jan 14, 2026); amended scheduling order (Mar 6, 2026)
MDL 3163 — NAION (vision loss) Active 86 pending; Judge Marston, E.D. Pa.; created Dec 15, 2025; Science Day order Mar 16, 2026
FDA warning letters (compounded GLP-1) Active March 3, 2026 sweep — 30 telehealth companies; individual letters tracked below
503B bulks list proposal Proposed Federal Register notice May 1, 2026; Docket No. FDA-2018-N-3240; 91 FR 23431; comment period closes June 30, 2026
Novo Nordisk v. Hims & Hers Dismissed No. 1:26-cv-00143 (D. Del.); filed Feb 9, 2026; voluntarily dismissed without prejudice Mar 9, 2026
OFA v. FDA (compounding challenges) Active Tirzepatide PI denied; semaglutide PI denied; tirzepatide summary judgment ruling May 7, 2025
Three caveats

MDL is not a class action. Multidistrict litigation is a procedural tool that consolidates similar federal lawsuits before one judge for pretrial proceedings, with each individual case keeping its own identity.

Warning letters are not final determinations. FDA warning letters describe the agency's position at the time of issuance — matters may have been resolved through later interaction, response, or closeout.

Editorial reads are ours, not the court's. Anything labeled "editorial" is our reading of the verified facts above it, not a regulatory or judicial finding.

How many GLP-1 GI injury lawsuits are pending in MDL 3094?

Answer: MDL 3094 (In Re: Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Products Liability Litigation) is the federal multidistrict litigation consolidating product-liability lawsuits alleging gastrointestinal injuries — primarily gastroparesis, ileus, and bowel obstruction — caused by GLP-1 drugs. It was centralized in the Eastern District of Pennsylvania by JPML transfer order filed February 2, 2024. As of the May 1, 2026 JPML report, 3,636 cases are pending. There is no global settlement and no bellwether trial has been scheduled.
Field Detail
MDL number3094
Full titleIn Re: Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Products Liability Litigation
CourtU.S. District Court for the Eastern District of Pennsylvania
JudgeHon. Karen S. Marston (initially assigned to Hon. Gene E.K. Pratter at centralization)
CentralizedFebruary 2, 2024 (JPML transfer order)
Drugs at issueOriginal JPML order: Ozempic, Wegovy, Rybelsus, Trulicity, Mounjaro. Saxenda added Dec 12, 2024. Victoza and Zepbound included per Aug 15, 2025 memorandum.
Active substancesSemaglutide, tirzepatide, liraglutide, dulaglutide
DefendantsNovo Nordisk and affiliates; Eli Lilly and Company
Pending cases (May 1, 2026)3,636 Active
Pending cases (Apr 1, 2026)3,546 (3,580 total)
Pending cases (Sep 2, 2025)2,676
Pending cases (Aug 1, 2025)2,190
Bellwether trialNot scheduled as of
Global settlementNone as of

Primary sources: EDPA MDL 3094 page · EDPA orders page · JPML pending statistics — May 1, 2026

What injuries does MDL 3094 cover?

The MDL covers gastrointestinal conditions plaintiffs allege were caused by GLP-1 drugs, with gastroparesis being the most frequently alleged.

Gastroparesis is a condition where the stomach takes much longer than normal to empty, causing severe nausea, vomiting, abdominal pain, and weight loss. Ileus is when the intestines stop moving food normally, which can cause blockage. Bowel obstruction is a partial or complete blockage of the small or large intestine. All three can require hospitalization. Plaintiffs allege the labels for these drugs did not adequately warn about these risks at the time they were prescribed.

Key MDL 3094 rulings (running list)

Answer: The single most consequential ruling in MDL 3094 to date came on August 15, 2025, when Judge Marston entered a memorandum and order requiring any plaintiff alleging drug-induced gastroparesis to show that the diagnosis was based on a properly performed gastric emptying study (GES) — by scintigraphy, breath testing, or wireless motility capsule — confirming delayed emptying. The order raised the evidentiary bar plaintiffs must clear to keep their cases in the MDL.
Date Order / Event What it did Source
JPML transfer order centralizing MDL 3094 Consolidated federal GLP-1 GI-injury cases in E.D. Pa.; initially assigned to Judge Pratter JPML transfer order
CMO No. 1 Initial organizational conference EDPA orders
CMO No. 3 Plaintiffs' steering committee structure EDPA orders
JPML transfer order adding Saxenda Added liraglutide-product cases to MDL JPML
Memorandum and order — diagnostic-proof requirements Required plaintiffs claiming drug-induced gastroparesis to have a properly performed gastric emptying study (GES — scintigraphy, breath test, or wireless motility capsule) confirming delayed emptying at diagnosis EDPA docket
Memorandum on covered drugs Notes parties' agreement that Victoza and Zepbound are properly included in MDL 3094 EDPA docket
JPML transfer order centralizing MDL 3163 Created a separate NAION MDL; declined to fold NAION actions into MDL 3094 JPML Doc. 49
CMO No. 30 Streamlined docket procedures EDPA orders
Amended scheduling order Set monthly status conferences for 2026 EDPA orders
Why the August 15 diagnostic ruling matters

Before August 15, 2025, plaintiffs could allege drug-induced gastroparesis based on symptoms alone. After Judge Marston's order, they need an objective medical test — a gastric emptying study (GES), a breath test, or a wireless motility capsule study — that documented delayed gastric emptying at the time they were diagnosed. This is a meaningful evidentiary filter on which cases can move forward.

MDL 3094 plaintiff count growth

Verified JPML monthly pending-action counts, pulled directly from JPML reports:

JPML report date Pending cases (MDL 3094) Total actions (historical)
2,190
2,676
2,8092,843
3,0633,097
3,5463,580
3,636

Net change April 1 → May 1, 2026: +90 pending actions. Net change August 1, 2025 → May 1, 2026: +1,446 pending actions. The corrected JPML series shows filings continued to increase after the August 15, 2025 diagnostic-proof order. We do not draw causal conclusions from that pattern.

What's next on the MDL 3094 docket

The court is in active case-management mode and has scheduled monthly status conferences through 2026 (per the March 6, 2026 amended scheduling order). Bellwether trial selection has not been finalized as of May 6, 2026. We update this section within 48 hours of any major order.

GLP-1 Half-Life & Clearance Chart Understanding how long Ozempic, Wegovy, Mounjaro and other GLP-1s stay in your system — pharmacology relevant to injury timing in product-liability claims.

How many GLP-1 NAION vision-loss lawsuits are pending in MDL 3163?

Answer: MDL 3163 (In Re: Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation) is the second federal MDL involving GLP-1 drugs, created in December 2025 to consolidate lawsuits alleging that semaglutide and related GLP-1 medications caused NAION — sudden, often permanent vision loss. It is before Judge Karen S. Marston in E.D. Pa. As of the May 1, 2026 JPML report, 86 cases are pending.
Field Detail
MDL number3163
Full titleIn Re: Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation
CourtU.S. District Court for the Eastern District of Pennsylvania
JudgeHon. Karen S. Marston
CentralizedDecember 15, 2025 (JPML transfer order, Document 49)
Drugs at issueOzempic, Wegovy, Saxenda (Novo Nordisk); Trulicity (Eli Lilly)
DefendantsNovo Nordisk and affiliates; Eli Lilly and Company
Pending cases (May 1, 2026)86 Active
Pending cases (Apr 1, 2026)73
Originating actions (Dec 2025)21 actions in three districts; nine related actions

Primary sources: EDPA MDL 3163 page · EDPA orders page · JPML transfer order, December 15, 2025

What is NAION, in plain English?

NAION stands for non-arteritic anterior ischemic optic neuropathy. According to the American Academy of Ophthalmology, it is the most common acute optic neuropathy in adults over 50, caused by reduced blood flow to the front of the optic nerve. Damage typically causes painless, sudden vision loss in one eye — often noticed on waking — and the loss is frequently permanent. It is distinct from glaucoma, retinal detachment, or a stroke.

In June 2025, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) recommended updating the product information for semaglutide medicines — Ozempic, Rybelsus, and Wegovy — to include NAION as a "very rare" side effect (up to 1 in 10,000 people). That EMA action is one of the regulatory data points cited in MDL 3163 plaintiff filings.

MDL 3163 ruling and order timeline

Date Order / Event What it did Source
JPML Transfer Order centralizing MDL 3163 Consolidated 21 NAION cases (plus nine related) before Judge Marston in E.D. Pa.; declined to fold them into MDL 3094 JPML Doc. 49
CMO No. 1 Initial case management conference EDPA orders
CMO No. 3 Streamlined docket EDPA orders
CMO No. 5 Plaintiffs' leadership counsel appointments EDPA orders
CMO No. 6 Science Day procedures EDPA orders
CMO No. 7 Preservation order EDPA orders
CMO No. 8 Rule 502(d) order (inadvertent disclosure of privileged material) EDPA orders
What "Science Day" means

"Science Day" is an early MDL proceeding where experts on each side present the underlying science to the judge before formal expert discovery begins. It is not a trial; it is an educational session for the court. The fact that Science Day procedures are already on the calendar in MDL 3163 indicates the court is moving the litigation toward expert challenges relatively early.

How is MDL 3163 different from MDL 3094?

A common confusion: people refer to "the Ozempic lawsuit" as if it's one thing. There are two MDLs covering different injuries — same judge, same court, but different dockets, different evidence, and different scientific theories.

Aspect MDL 3094 MDL 3163
Injury type Gastrointestinal (gastroparesis, ileus, bowel obstruction) Vision loss (NAION)
Created February 2, 2024 December 15, 2025
Pending cases (May 1, 2026) 3,636 86
Defendants Novo Nordisk, Eli Lilly Novo Nordisk, Eli Lilly
Drugs Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, Trulicity, Saxenda, Victoza Ozempic, Wegovy, Saxenda, Trulicity
Court / judge E.D. Pa. / Marston E.D. Pa. / Marston
Current status Active discovery; bellwether trial not scheduled Early case management; Science Day on the calendar

Which FDA warning letters have been issued for compounded GLP-1 marketing?

Answer: FDA has issued multiple waves of warning letters to compounding pharmacies, outsourcing facilities, and telehealth companies marketing compounded GLP-1 medications. On March 3, 2026, FDA announced a coordinated action issuing warning letters to 30 telehealth companies in a single sweep, focused on false or misleading marketing claims, products implying sameness with FDA-approved drugs, and use of unapproved active ingredients (including peptides like retatrutide and salt forms like semaglutide sodium and semaglutide acetate).

The March 3, 2026 telehealth sweep

On March 3, 2026, FDA announced it had issued warning letters to 30 telehealth companies for illegal marketing of compounded GLP-1 medications. The agency cited claims implying the compounded products were the same as FDA-approved drugs, claims obscuring product sourcing, and other misleading representations about safety and efficacy.

Primary source: FDA press announcement, March 3, 2026 — FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s

Warning letter table (running)

Date issued Recipient Type Products at issue MARCS-CMS / Letter ID Primary source
MEDVi, LLC dba MEDVi Telehealth / online seller Compounded semaglutide and tirzepatide 721455 FDA letter
30 telehealth companies (batch) Telehealth (coordinated sweep) Compounded GLP-1 marketing claims Multiple FDA press release

We are populating each individual letter from the March 3 sweep as we verify them against the FDA warning-letter database. Each will receive its own deep anchor (e.g., #letter-id). Last checked: .

What is the status of the 503B bulks list proposal for semaglutide, tirzepatide, and liraglutide?

Answer: On April 30, 2026, FDA announced a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. The Federal Register notice was published May 1, 2026 (Docket No. FDA-2018-N-3240; Document No. 2026-08552; 91 FR 23431). The public comment period closes June 30, 2026 per the Federal Register notice. If finalized, the proposal would formally close the bulk-substance compounding pathway for these three drugs for 503B outsourcing facilities.
Field Detail
StatusProposed — comment period open
FDA announcementApril 30, 2026
Federal Register publicationMay 1, 2026
Federal Register docketFDA-2018-N-3240
Document number2026-08552
Citation91 FR 23431
Comment period closes (per Federal Register notice)
Drugs at issueSemaglutide, tirzepatide, liraglutide
FDA finding"No clinical need" for outsourcing facilities to compound these drugs from bulk substances given that FDA-approved versions are available

Primary sources: Federal Register notice 2026-08552 (91 FR 23431) · FDA press announcement, April 30, 2026

Context

On April 1, 2026, FDA clarified its position: semaglutide and tirzepatide are not on the 503B bulks list or the current shortage list, meaning 503B outsourcing facilities already lack a legal basis to compound these drugs from bulk substances. The April 30 proposal would make this exclusion explicit and formal in the Federal Register.

Under Section 503A, state-licensed pharmacies may still compound patient-specific prescriptions with a documented, individualized clinical need — but cannot compound drugs that are "essentially a copy" of a commercially available FDA-approved product without that specific justification.

OFA v. FDA: Legal challenges to compounded GLP-1 enforcement

Answer: The Outsourcing Facilities Alliance (OFA), an industry group representing 503B outsourcing facilities, filed legal challenges to FDA's enforcement actions on compounded semaglutide and tirzepatide. The courts have denied preliminary injunctions for both tirzepatide and semaglutide. A summary judgment ruling on the tirzepatide challenge was issued May 7, 2025.
Date Action Result
2024–2025 OFA files challenge to FDA enforcement on compounded tirzepatide Preliminary injunction (PI) denied
2024–2025 OFA files challenge to FDA enforcement on compounded semaglutide Preliminary injunction (PI) denied
Summary judgment ruling — tirzepatide challenge Ruling issued; details confirmed against court records

Sources: Court records via CourtListener/RECAP; FDA enforcement communications. We update this section as new rulings are issued.

Novo Nordisk v. Hims & Hers: Filed, then dismissed

Answer: Novo Nordisk filed Novo Nordisk A/S et al. v. Hims & Hers Health, Inc. et al., No. 1:26-cv-00143, on February 9, 2026 in the U.S. District Court for the District of Delaware, and voluntarily dismissed it without prejudice on March 9, 2026 as part of a collaboration agreement. Hims agreed to stop advertising compounded GLP-1 products and will sell Novo's branded GLP-1 medications on its platform. Novo reserved the right to refile.
Field Detail
Case nameNovo Nordisk A/S et al. v. Hims & Hers Health, Inc. et al.
Case numberNo. 1:26-cv-00143 (D. Del.)
Filed
StatusDismissed — voluntarily dismissed without prejudice
Dismissal date
Reason for dismissalCollaboration agreement between parties
Hims obligations under agreementStop advertising compounded GLP-1 products; sell Novo-branded GLP-1s on platform
Carve-outHims said it would continue to offer compounded semaglutide on a limited scale when a provider determines it is clinically necessary
Novo reservationNovo Nordisk reserved the right to refile

Primary sources: D. Del. docket No. 1:26-cv-00143 · Hims & Hers investor announcement, March 9, 2026 · Hims & Hers 10-K (filed Feb 27, 2026, SEC EDGAR) · Novo Nordisk company statement, February 9, 2026

SEC disclosures on GLP-1 litigation and enforcement

The following public company filings on SEC EDGAR contain material disclosures about GLP-1 litigation or regulatory enforcement that we track:

Filing date Issuer Form Disclosure Source
Hims & Hers Health, Inc. 10-K (FY 2025) Disclosed Novo Nordisk lawsuit (No. 1:26-cv-00143) and related regulatory risk from FDA enforcement actions on compounded GLP-1s SEC EDGAR
2026 (Q4 2025) Novo Nordisk A/S 20-F (FY 2025) Annual report disclosures on MDL 3094, MDL 3163, and compounding enforcement environment SEC EDGAR

Reverse-chronological timeline of key events

Date Actor Event Source
Federal Register503B bulks list proposal published; comment period opens (closes June 30, 2026 per Federal Register notice); 91 FR 23431; Docket No. FDA-2018-N-3240; Document No. 2026-08552Federal Register
FDAFDA proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks listFDA
FDAFDA reminder on "essentially-a-copy" standard; confirms semaglutide and tirzepatide not on 503B bulks list or shortage listFDA
CourtMDL 3163 CMO Nos. 6 (Science Day), 7 (preservation), and 8 (Rule 502(d))EDPA
Court / CorpNovo voluntarily dismisses Hims lawsuit; collaboration announced; Hims stops advertising compounded GLP-1s; limited compounded semaglutide access continues when clinically necessaryHims IR
CourtMDL 3094 amended scheduling order — monthly status conferences for 2026EDPA
FDAFDA warns 30 telehealth companies in coordinated sweep (illegal marketing of compounded GLP-1s)FDA
SECHims & Hers 10-K filed — discloses Novo lawsuitSEC EDGAR
FDAFDA warning letter to MEDVi, LLC (MARCS-CMS 721455) for compounded semaglutide and tirzepatide marketingFDA
CourtNovo Nordisk files Novo Nordisk v. Hims & Hers, No. 1:26-cv-00143 (D. Del.)D. Del. docket
CourtMDL 3094 CMO No. 30 — streamlined docket proceduresEDPA
CourtMDL 3163 CMO No. 1 — initial case management conferenceEDPA
JPMLJPML transfer order creates MDL 3163 (NAION) — 21 actions plus nine related; assigned to Judge Marston in E.D. Pa.JPML Doc. 49
CourtMDL 3094 memorandum and order — gastroparesis plaintiffs must have gastric emptying study; Victoza and Zepbound confirmed in scopeEDPA docket
CourtSummary judgment ruling in OFA v. FDA tirzepatide challengeCourt records
JPMLJPML transfer order — adds Saxenda (liraglutide) cases to MDL 3094JPML
JPMLJPML transfer order centralizes MDL 3094 in E.D. Pa.; initial assignment to Judge PratterJPML transfer order

Frequently asked questions

About these answers

Each answer below is written to stand on its own — short, neutral, primary-source-backed. Use them. They're built to be quoted.

How many GLP-1 lawsuits are pending in MDL 3094?

3,636 cases as of the May 1, 2026 JPML Pending MDL Dockets by Actions Pending report. The April 1, 2026 report listed 3,546 pending. The count grew from 2,190 in August 2025. See the MDL 3094 section for the full verified series.

How many GLP-1 NAION lawsuits are pending in MDL 3163?

86 cases as of the May 1, 2026 JPML report. The MDL was created on December 15, 2025 by JPML transfer order (Doc. 49), initially consolidating 21 actions plus nine related actions. See the MDL 3163 section.

Who is the judge in the Ozempic MDL?

Hon. Karen S. Marston, U.S. District Court for the Eastern District of Pennsylvania. Judge Marston presides over both MDL 3094 (GI injuries) and MDL 3163 (NAION). MDL 3094 was initially assigned to Hon. Gene E.K. Pratter when it was centralized in February 2024.

What's the difference between MDL 3094 and MDL 3163?

MDL 3094 covers gastrointestinal injury claims (gastroparesis, ileus, bowel obstruction). MDL 3163 covers vision loss claims (NAION). They are separate proceedings with separate dockets, even though both are before Judge Marston in E.D. Pa. See the comparison table.

Is the Ozempic lawsuit a class action?

No. It is a multidistrict litigation (MDL), which is a federal procedural tool that consolidates many separate lawsuits before one judge for pretrial proceedings. Each individual case keeps its own identity. There is no global settlement and no certified class as of May 6, 2026 (verified against the EDPA orders page on May 6, 2026).

Is there a GLP-1 lawsuit settlement yet?

No. As of May 6, 2026, there is no global settlement in either MDL 3094 or MDL 3163 (verified against the EDPA orders pages on May 6, 2026). The cases are in discovery and case-management phases.

Has a GLP-1 bellwether trial been scheduled?

No bellwether trial has been scheduled in either MDL as of May 6, 2026 (verified against the EDPA orders pages on May 6, 2026). MDL 3094 is in discovery; MDL 3163 has Science Day procedures on the calendar but no trial dates.

What is the 503B bulks list?

The 503B bulks list is FDA's published list of bulk drug substances that registered outsourcing facilities (large-scale FDA-registered compounders) are allowed to compound from, based on a finding that there is a clinical need. Substances not on the list — and not on the FDA shortage list — generally cannot be compounded by 503B facilities from bulk active ingredient. See the 503B proposal section for current status.

Did Novo Nordisk drop the lawsuit against Hims?

Yes. Novo Nordisk filed Novo Nordisk A/S et al. v. Hims & Hers Health, Inc. et al., No. 1:26-cv-00143, on February 9, 2026 in D. Del., and voluntarily dismissed it without prejudice on March 9, 2026 as part of a collaboration agreement. Hims agreed to stop advertising compounded GLP-1 products and will sell Novo's branded GLP-1 medications on its platform. Hims also said it would continue to offer compounded semaglutide on a limited scale when a provider determines it is clinically necessary. Novo reserved the right to refile. See the full section.

What did the FDA propose on April 30, 2026?

The FDA proposed not to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list, finding "no clinical need" for outsourcing facilities to compound these drugs from bulk substances given that FDA-approved versions are available. The Federal Register notice was published May 1, 2026 (Docket No. FDA-2018-N-3240; Document No. 2026-08552; 91 FR 23431); the public comment period closes June 30, 2026 per the Federal Register notice. See the 503B section.

What did the FDA do on March 3, 2026?

The FDA announced it had issued warning letters to 30 telehealth companies for illegal marketing of compounded GLP-1 medications. The agency cited claims implying sameness with FDA-approved drugs, claims obscuring product sourcing, and other misleading representations. See the warning letter section.

How often is this tracker updated?

Monthly on the first of each month, plus within 48 hours of any major court order, FDA action, settlement, or 8-K filing (best effort). The "Last verified" timestamp at the top of the page reflects the most recent verification across all entries. The full revision history is in the change log.

Can I cite this tracker in my article or research note?

Yes. We encourage it. Use the recommended citation format and feel free to deep-link to specific entries via anchor URLs (e.g., #mdl-3094, #novo-v-hims, #bulks-list).

GLP-1 Statistics & Data (2026) Usage rates, affordability data, insurance coverage, and shortage data — all primary-sourced from KFF, CMS, FDA, and company earnings.

How to cite this tracker

Recommended citation

The RX Index research desk. "GLP-1 Lawsuits & FDA Enforcement Tracker." Updated May 6, 2026. Accessed [date]. https://therxindex.com/research/glp1-lawsuits-enforcement-tracker/

For deep-link citations, append the entry anchor — for example: #mdl-3094, #novo-v-hims, #bulks-list, #fda-warning-letters.

Request the dataset

The full tracker is maintained as a structured dataset (date, category, entity, drug, brand, topic, source type, source ID, status, summary, primary source URL, last checked date, stable anchor). To request a copy for research, journalism, or compliance use, email research@therxindex.com.

Methodology, sources, and corrections

Answer: This tracker is assembled from public primary sources only. We update monthly on the first of each month and within 48 hours of any major court order, FDA action, settlement, or SEC filing. We do not represent any party, do not provide legal or medical advice, and do not earn affiliate commissions on entries below.

What we include

Source What we pull
JPMLPending action counts (monthly reports), transfer orders, reassignments
Eastern District of Pennsylvania (EDPA)MDL 3094 and 3163 docket entries, case management orders, scheduling orders, hearing transcripts where public
CourtListener / RECAPFree access to PACER docket entries; used to verify court filings and orders
FDA warning letter databaseLetter ID, recipient, date issued, products, substantive allegations
FDA press announcementsRegulatory enforcement actions and policy changes
Federal RegisterProposed and final rules, comment periods
SEC EDGAR10-K, 10-Q, 8-K, 20-F filings disclosing GLP-1 litigation matters
Company statementsPress releases and investor relations announcements directly issued by parties

What we exclude

We do not include unsourced settlement projections, plaintiff-intake material from law firms without primary-source backing, "who qualifies" legal-advice content, speculative medical claims about causation not adopted by a court or regulatory agency, anonymous social media claims as evidence of fact, or market-status claims sourced only to secondary reporting.

Update cadence

  • Monthly (1st of each month): JPML pending statistics, EDPA orders pages, FDA warning letter database, FDA compounding policy page, Federal Register dockets, SEC filings, FDA Drug Shortages Database.
  • Within 48 hours (best effort): any major court order, FDA action, settlement, or 8-K disclosure.
  • Quarterly: dead-link audit on every primary source URL; replace with archive.org links if a source has moved, with a note in the change log.

Editorial independence

The RX Index research desk is the editorial group within The RX Index. The rest of The RX Index earns affiliate commissions on consumer-facing pages. Nothing on /research/ carries affiliate links, plaintiff-intake forms, or commercial CTAs. We do not accept payment from any party — plaintiffs, defendants, manufacturers, telehealth platforms, compounders, law firms, or trade associations — for placement, omission, or characterization of any entry on this tracker.

Corrections

If we got something wrong — a wrong date, a wrong case number, a wrong characterization of an order — send the correction with a primary-source link to research@therxindex.com. Corrections are reviewed on weekdays against court, FDA, SEC, or company primary sources, and logged in the change log after verification.

Change log

Initial publication. MDL 3094 at 3,636 pending (May 1, 2026 JPML); MDL 3163 at 86 pending; MDL 3094 centralized February 2, 2024; Saxenda added December 12, 2024; Victoza/Zepbound confirmed per August 15, 2025 memorandum; April 1, 2026 count recorded as 3,546; FDA April 30 503B proposal added with Federal Register Docket No. FDA-2018-N-3240, Document No. 2026-08552, 91 FR 23431; comment deadline June 30, 2026; Novo v. Hims docket No. 1:26-cv-00143 (D. Del.) added; MEDVi MARCS-CMS 721455 entry added; OFA v. FDA tirzepatide and semaglutide PI denials and tirzepatide May 7, 2025 summary-judgment ruling added.

About this tracker

The RX Index research desk is the editorial group within The RX Index, an independent publisher covering GLP-1 medications and related healthcare topics. The research desk operates separately from the consumer-facing side of the site: there are no affiliate links, no plaintiff-intake forms, and no commercial CTAs anywhere on /research/.

This tracker is a working document maintained by the research desk. We are not lawyers and we are not doctors. If you spot something we got wrong, tell us.

The RX Index research desk · Last verified: · Next scheduled review: (monthly cadence) and within 48 hours of any major court order, FDA action, settlement, or SEC filing (best effort).

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