Elmiron Maculopathy Lawsuit – Current Status

Elmiron (pentosan polysulfate sodium) is a bladder drug tied to lawsuits over eye damage. Plaintiffs allege it caused retinal injury, notably atypical or pigmentary maculopathy. Janssen Pharmaceuticals, the maker, is a named defendant. The Elmiron product liability cases sit in MDL No. 2973 in the District of New Jersey. The Judicial Panel on Multidistrict Litigation set up the MDL on December 15, 2020. The Elmiron label warns of retinal pigmentary changes. No recall of the drug has been issued. The MDL began with 63 actions in eleven districts. The panel also noted 65 related actions.

Latest Elmiron Lawsuit Updates

August 3, 2026: Elmiron MDL No. 2973 Remains Pending in New Jersey

The Judicial Panel on Multidistrict Litigation published a pending-docket report dated August 3, 2026. It lists MDL No. 2973, In re Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation, among active transferred MDLs [1]. The Elmiron cases remain together as one MDL in the District of New Jersey, where Judge Brian R. Martinotti presides over the cases.

October 12, 2022: Court Reports 1,926 Cases and Sets Bellwether Trial

After a case management conference, MDL Case Management Order No. 31 reported 1,926 Elmiron product liability cases filed and served [2]. The order lists 1,680 federal cases and 169 in state courts. It also set the Windham bellwether trial for January 30, 2023.

June 8, 2022: Court Reports 1,041 Cases and Names First Bellwether

Following a case management conference, MDL Case Management Order No. 29 reported 1,041 Elmiron cases filed and served [3]. The order counted 915 federal cases and 126 state cases. It named the Windham case the presumptive first bellwether trial in the MDL.

December 15, 2020: JPML Centralizes Elmiron Cases in New Jersey

The JPML issued its transfer order. It centralized Elmiron actions in the District of New Jersey before Judge Brian R. Martinotti [4]. The order describes common factual issues about whether Elmiron tends to cause retinal injuries. It notes that no responding party opposes centralization. This order created MDL No. 2973.

What Is Elmiron?

Janssen makes Elmiron, also called pentosan polysulfate sodium. The NIDDK calls interstitial cystitis “a chronic, or long-lasting, condition that causes painful urinary symptoms” [5]. The Elmiron label says it is indicated for the relief of bladder pain linked to that condition [6]. The American Academy of Ophthalmology says it is the only FDA approved oral drug for it [7].

Who May Be Affected?

People who took Elmiron for interstitial cystitis may be affected. The label says most reported cases of retinal changes came after three years of use or longer. The label adds that the total dose over time appears to be a risk factor. Only an individual legal review can say whether you may qualify.

Reported Injuries or Damages

The Elmiron claims concern retinal injury. That is the court’s description of the claims. It is not a finding. The label says the visual effects are not fully characterized. The AAO says cystoid macular edema, macular neovascularization and retinal pigment epithelium atrophy may occur and can cause severe vision loss. Pearce and colleagues described a unique pigmentary maculopathy in people chronically exposed to pentosan polysulfate sodium. They published it in the November 2018 issue of Ophthalmology [8]. A 2022 Asia-Pacific Journal of Ophthalmology review calls it a potentially sight-threatening side effect [9]. EyeWiki says long-term use is strongly linked to a vision-threatening macular disease.

Recall and Regulatory Background

No recall of Elmiron has been issued. The label has a warning called “Retinal Pigmentary Changes.” The FDA updated the label in June 2020 to warn about these changes. The label, revised 07/2024, suggests a baseline retinal exam within six months of starting treatment and periodic exams after that. If pigmentary changes develop, the label says the “risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible.”

Evidence to Preserve

Records can show how long a person took Elmiron and when vision changes began. Keep original copies, add dated notes as symptoms change, and keep these items together:

• Prescription and pharmacy records showing the dates, dose and length of Elmiron use
• The bottles or pill packaging
• Eye-exam records, retinal imaging (OCT, autofluorescence) and diagnoses
• Notes of when vision symptoms began
• Medical bills
• Communications with doctors and the manufacturer
• A record of daily-life effects such as reading or driving difficulty

Filing Deadlines

Filing deadlines come from state law. They vary with where you live and when the exposure, the injury and the diagnosis happened. Some states start counting from the date of diagnosis. Missing the deadline can end a claim, however strong the facts are. Check with a lawyer promptly about the deadline that applies to your situation.

Frequently Asked Questions

Is There an Elmiron Lawsuit?

Yes, there is an Elmiron lawsuit. Elmiron product liability cases are centralized in federal court in MDL No. 2973 in New Jersey. The MDL groups individual cases rather than a class action.

What Does the Research Say About Elmiron and Maculopathy?

The research on Elmiron and maculopathy includes a 2018 study by Pearce and coworkers. They described six patients with a pigmentary maculopathy after chronic exposure to pentosan polysulfate sodium. A later review says they postulated the drug caused it.

What Vision Changes Should I Tell My Doctor About?

Tell your healthcare provider, including your eye doctor, right away about vision changes. Examples are difficulty reading, vision that takes longer to adjust to low or reduced light, and blurred vision.

Can Elmiron Maculopathy Be Reversed?

Elmiron maculopathy is not known to be reversible, says EyeWiki. It may get worse after the drug is stopped. The Medication Guide says vision changes may continue even after stopping treatment.

References

1. https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-August-3-2026.pdf
2. https://www.njd.uscourts.gov/sites/njd/files/MDL2973_CMO31.pdf
3. https://www.njd.uscourts.gov/sites/njd/files/MDL2973_CMO29.pdf
4. https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2973-Transfer%20Order-12-20.pdf
5. https://www.niddk.nih.gov/health-information/urologic-diseases/interstitial-cystitis-painful-bladder-syndrome
6. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f0ba651e-3d8a-11df-8fbe-119855d89593
7. https://eyewiki.aao.org/Pentosan_Polysulfate_Maculopathy
8. https://pubmed.ncbi.nlm.nih.gov/29801663/
9. https://pmc.ncbi.nlm.nih.gov/articles/PMC9096915