Elmiron and Vision Injury Claims: What MDL 2973 Shows

Elmiron is the brand name of pentosan polysulfate sodium, a prescription capsule the FDA approved in 1996 for the relief of bladder pain or discomfort associated with interstitial cystitis. The federal lawsuits collected as MDL No. 2973, In re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation, concern retinal injuries that plaintiffs attribute to long-term use of the drug. The Judicial Panel on Multidistrict Litigation transferred the actions to the District of New Jersey and assigned them to Judge Brian R. Martinotti by an order filed December 15, 2020. The Panel’s statistics report dated October 1, 2026 lists 186 actions pending of 1,989 filed. No court has found that Elmiron caused any individual plaintiff’s retinal injury, and the documents reviewed for this article record no trial verdict and no court-approved settlement.

What is established versus what is alleged

Established by the documents reviewed here: the drug’s approved indication and dosing, the retinal warning in the FDA-approved prescribing information, the existence, court, judge, docket number and case counts of MDL No. 2973, and the procedural steps the court has published, including the setting and adjournment of a bellwether trial date.

Alleged, and not decided: that Elmiron causes retinal pigmentary changes of the kind the label describes, that the defendants’ warnings were inadequate, and that the drug caused any particular plaintiff’s vision loss. The Panel’s transfer order describes the actions as sharing “common factual issues concerning the propensity of Elmiron to cause retinal injuries, notably atypical or pigmentary maculopathy.” That sentence records the Panel’s description of the claims before it. It is not a finding that the drug has that propensity.

What the FDA label says about the retina

Elmiron is supplied as 100 mg capsules, and the label recommends 300 mg a day, taken as one capsule three times daily. The indication is narrow: relief of bladder pain or discomfort associated with interstitial cystitis.

The prescribing information contains a section headed “Retinal Pigmentary Changes” in its WARNINGS section. The June 2020 version states that pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, “have been identified with long-term use of ELMIRON.” It continues: “Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.”

The same section lists the visual symptoms reported in those cases: difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. It states that “the visual consequences of these pigmentary changes are not fully characterized.” It recommends a detailed ophthalmologic history before treatment and a comprehensive baseline retinal examination for patients with pre-existing eye conditions, and it suggests a baseline retinal examination within six months of starting treatment for all patients and periodically thereafter. If pigmentary changes develop, the label says the risks and benefits of continuing treatment should be re-evaluated “since these changes may be irreversible,” and that follow-up examinations should continue because retinal and vision changes “may progress even after cessation of treatment.”

Two limits of that document matter. The warning is not a boxed warning. And the adverse reactions section lists “pigmentary changes in the retina” among reactions identified during post-approval use, with the standard qualification that the reports came voluntarily from a population of uncertain size, so that “it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.” A label warning is a regulatory action. It is not a causation finding.

The labeling change has a date. The FDA’s supplement approval letter for NDA 020193/S-14 is dated June 16, 2020. It records that the supplement “provides revisions to the package insert WARNINGS section and Post-Marketing section, as well as an update to the Patient Labeling,” and approves it effective that date. The prescribing information issued that month carries the retinal warning quoted above.

The current prescribing information, revised July 2024, keeps the same warning in the same terms. The labels reviewed for this article do not describe a later change to the retinal section.

Where the claims stand procedurally

The Panel’s transfer order, filed December 15, 2020, transferred actions pending outside New Jersey to the District of New Jersey and assigned them to Judge Martinotti “for coordinated or consolidated proceedings.” The order records that the motion before the Panel included 63 actions pending in eleven districts, plus 65 potentially related actions, and that the parties estimated the litigation “may grow by several hundreds of cases.” The court’s page for the litigation identifies master docket 2:20-md-02973 and lists Magistrate Judge Leda Dunn Wettre alongside Judge Martinotti.

Case Management Order No. 31, dated November 2022, records the scale the docket had reached: “As of October 12, 2022, 1,926 cases alleging product liability claims relating to use of Elmiron have been filed and served.” The same order states that expert discovery had concluded in the first bellwether action and that briefing on Rule 702 motions began on September 27, 2022. It identifies that action as Windham v. Janssen Pharmaceuticals, Inc., et al., No. 20-cv-14670, and records that an earlier case management order had set the trial for January 30, 2023 while the parties continued to confer on the second and third bellwether trials.

An order signed October 24, 2022 adjourned that trial date to March 27, 2023.

On August 29, 2023, the court granted a motion to establish two accounts at Esquire Bank, designated the Elmiron Fee Fund and the Elmiron Expense Fund, to receive and disburse common benefit funds as provided in Amended Case Management Order No. 15, and appointed Archer Systems LLC as escrow agent. The order concerns the holding and disbursement of those funds. It does not describe a settlement, and it does not state terms for any claimant.

The Panel’s report of October 1, 2026 is the most recent document in this record that counts the docket. It lists 186 actions pending and 1,989 total actions filed in MDL No. 2973. A pending count measures open dockets. It does not measure merit, and it does not show how actions that are no longer pending were resolved.

Key dates

• 1996: the FDA approves Elmiron for interstitial cystitis. The Panel’s transfer order records that several defendants have marketed the drug “since its approval in 1996.”
• June 16, 2020: the FDA approves supplement NDA 020193/S-14, revising the WARNINGS and Post-Marketing sections and the patient labeling. The June 2020 prescribing information carries the retinal warning (supplement approval letter; label revised June 2020).
• December 15, 2020: the Panel files the transfer order creating MDL No. 2973 and assigns it to Judge Martinotti in the District of New Jersey (JPML transfer order).
• October 12, 2022: the court records 1,926 Elmiron cases filed and served (Case Management Order No. 31).
• October 24, 2022: the court adjourns the first bellwether trial from January 30, 2023 to March 27, 2023 (court order).
• August 29, 2023: the court authorizes the Elmiron Fee Fund and the Elmiron Expense Fund and appoints an escrow agent (court order).
• July 2024: the current prescribing information is revised. The retinal warning remains in the same terms (DailyMed).
• October 1, 2026: the Panel reports 186 actions pending of 1,989 filed in MDL No. 2973 (JPML statistics report).

What this does not establish

Nothing in the documents reviewed here shows a court finding that Elmiron caused any individual’s retinal injury, that the defendants’ warnings were inadequate, or that any plaintiff is entitled to compensation. Those remain allegations. The label itself says the etiology of the reported changes is unclear and that a causal relationship cannot be reliably established from voluntary post-marketing reports. The record reviewed here contains no trial verdict, no court-approved settlement, no class certification and no admission of liability. The October 1, 2026 pending count does not describe how the actions no longer pending were resolved, and this article does not infer a reason.

Frequently asked questions

Is there an Elmiron settlement?

No court-approved settlement appears in the documents reviewed for this article. The Panel’s October 1, 2026 report lists 186 actions still pending in MDL No. 2973. The record reviewed here contains no settlement agreement, no approval order, and no eligibility or payment terms.

What does the Elmiron label say about vision?

The WARNINGS section describes pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, identified with long-term use. It lists difficulty reading, slow adjustment to low or reduced light, and blurred vision among the reported symptoms, recommends retinal examinations, and states that the changes may be irreversible and may progress after treatment stops.

Does the label warning mean Elmiron caused a particular person’s vision loss?

No. The warning is a regulatory labeling action. It tells prescribers what has been reported and what monitoring is suggested. The label’s adverse reactions section says the reports were voluntary and that a causal relationship cannot be reliably established from them. Causation in any individual case is a question for the litigation, and no court has decided it in the documents reviewed here.

Is MDL No. 2973 a class action?

No. It is a consolidation of individual federal actions for coordinated or consolidated pretrial proceedings before one judge. Consolidation centralizes discovery and pretrial motions. It does not merge the claims into a single lawsuit or decide their merits. The difference is explained in MDLs compared with class actions.

Who are the defendants?

The first bellwether action is captioned Windham v. Janssen Pharmaceuticals, Inc., et al., and the labeling identifies Janssen Pharmaceuticals, Inc. as the entity that markets Elmiron. The Panel’s order refers to “several defendants” without naming them all.

Background appears in the pharmaceutical lawsuits hub, alongside the GLP-1 litigation, the Tepezza hearing loss litigation and the Depo-Provera meningioma litigation.

Sources

1. U.S. Judicial Panel on Multidistrict Litigation: “Transfer Order, In re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation, MDL No. 2973 (December 15, 2020)” (link, accessed 2026-10-17)
2. U.S. Judicial Panel on Multidistrict Litigation: “MDL Statistics Report: Distribution of Pending MDL Dockets by District, Report Date 10/1/2026” (link, accessed 2026-10-17)
3. U.S. District Court for the District of New Jersey: “Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation, MDL 2973” (link, accessed 2026-10-17)
4. U.S. District Court for the District of New Jersey: “Case Management Order No. 31, In re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation, No. 2:20-md-02973 (D.N.J. November 2022)” (link, accessed 2026-10-17)
5. U.S. District Court for the District of New Jersey: “Order adjourning the bellwether trial date, In re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation, No. 2:20-md-02973 (D.N.J. October 24, 2022)” (link, accessed 2026-10-17)
6. U.S. District Court for the District of New Jersey: “Order on Plaintiffs’ Motion to Establish the Elmiron Fee Fund and Elmiron Expense Fund, In re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation, No. 2:20-md-02973 (D.N.J. August 29, 2023)” (link, accessed 2026-10-17)
7. U.S. Food and Drug Administration: “NDA 020193/S-14 Supplement Approval Letter, Elmiron (pentosan polysulfate sodium) 100 mg capsules (June 16, 2020)” (link, accessed 2026-10-17)
8. U.S. Food and Drug Administration: “Elmiron (pentosan polysulfate sodium) 100 mg capsules, Prescribing Information (label revised June 2020)” (link, accessed 2026-10-17)
9. National Library of Medicine, DailyMed: “Elmiron (pentosan polysulfate sodium) capsules, Prescribing Information (label revised 07/2024)” (link, accessed 2026-10-17)

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