Elmiron (Pentosan Polysulfate Sodium) Lawsuit
Vision Damage & Maculopathy Litigation
Plaintiffs allege that long-term use of Elmiron, the only FDA-approved oral medication for interstitial cystitis, causes a unique and potentially irreversible form of retinal damage known as pigmentary maculopathy. With 634 pending actions against Janssen Pharmaceuticals (a Johnson & Johnson subsidiary), this MDL continues as confidential settlement negotiations and case resolutions reduce the active docket.
Key Takeaways
- 634 cases pending in federal MDL out of 1,988 total filed against Janssen Pharmaceuticals (J&J)
- Elmiron linked to pigmentary maculopathy — a potentially irreversible retinal condition causing vision loss
- Scientific link first identified in 2018 by Emory Eye Center researchers; Kaiser Permanente study found up to 42% toxicity rate at high cumulative doses
- FDA added retinal pigmentary changes warning to Elmiron label in June 2020 — 24 years after approval
- Confidential settlement negotiations ongoing since 2023 — no public settlement amounts disclosed
May 2026 Updates Latest
MDL has 568 pending actions out of 869 total per the May 2026 JPML statistics report — a drop of roughly 66 cases from March's 634 figure reflecting an accelerating pace of confidential resolutions. Janssen has now settled well over 100 MDL cases alongside the bulk of Pennsylvania state-court claims through individual and group agreements, with the case count down more than 56% from the litigation's 1,988-case peak.
The May 13 settlement conference was cancelled by Judge Martinotti and has not been rescheduled, signaling that the parties are progressing through private negotiations rather than court-supervised mediation. Bellwether trials remain suspended indefinitely while the qualified settlement funds (Fee Fund and Expense Fund) established in August 2023 continue facilitating tier-based payouts. Practitioners report individual recoveries in the $20,000 to $1,000,000 range depending on severity of pigmentary maculopathy and documented vision loss, with the litigation widely viewed as winding down toward a global resolution.
Key Facts (May 2026)
| Pending Actions | 568+ cases in federal MDL |
| Total Actions Filed | 1,988+ cases |
| Key Defendants | Janssen Pharmaceuticals, Inc. (Johnson & Johnson subsidiary) |
| Presiding Judge | Judge Brian R. Martinotti (D.N.J.) |
| MDL Created | December 2020 (transferred by JPML) |
| Alleged Injuries | Pigmentary maculopathy, vision loss, retinal damage |
| Drug at Issue | Elmiron (pentosan polysulfate sodium / PPS) |
| Can You Still File? | Open — limited (consult attorney for eligibility) |
Case Trajectory
Elmiron MDL filings peaked near 1,911 pending cases in early 2024 before declining as confidential settlements resolved a significant portion of claims. Pending actions have dropped 66% from peak to current levels.
Source: JPML MDL Statistics Reports, December 2020–May 2026
1 What Is This Lawsuit About?
MDL-2973 consolidates lawsuits from patients who took Elmiron (pentosan polysulfate sodium) for interstitial cystitis and subsequently developed pigmentary maculopathy — a unique form of retinal damage that can cause vision loss, difficulty reading, and problems adapting to low light. Plaintiffs allege that Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, knew or should have known about the risk of eye damage and failed to adequately warn patients and prescribing physicians.
Elmiron has been on the market since its September 26, 1996 FDA approval and remains the only oral medication FDA-approved for interstitial cystitis. The connection between Elmiron and maculopathy was not identified in published medical literature until 2018, when researchers at Emory Eye Center published a landmark case series. Janssen did not add a warning about retinal pigmentary changes to the drug label until June 16, 2020 — nearly 24 years after approval.
2 What Is Elmiron (Pentosan Polysulfate Sodium)?
Elmiron is the brand name for pentosan polysulfate sodium (PPS), a semi-synthetic heparin-like macromolecular carbohydrate derivative prescribed to treat interstitial cystitis (IC), also known as painful bladder syndrome. IC is a chronic condition causing bladder pain, pressure, and urinary frequency that affects an estimated 4 to 12 million people in the United States according to the NIDDK, predominantly women.
Elmiron is believed to work by coating the bladder lining, restoring the protective glycosaminoglycan (GAG) layer that may be deficient in IC patients. Only approximately 6% of an oral dose is absorbed into systemic circulation. It is the only oral medication FDA-approved specifically for interstitial cystitis (receiving Orphan Drug designation), making it a cornerstone treatment for patients who have no comparable oral alternative. Because IC is chronic and incurable, patients are commonly prescribed Elmiron for years or even decades of continuous use.
Drug Profile
- • Generic name: Pentosan polysulfate sodium (PPS)
- • Manufacturer: Janssen Pharmaceuticals (J&J)
- • FDA approved: September 1996
- • Standard dose: 100mg three times daily
- • Route: Oral capsule
Interstitial Cystitis
- • Chronic bladder pain and pressure
- • Urinary frequency and urgency
- • Affects 1–4 million Americans
- • Predominantly affects women (~90%)
- • No cure — treatment manages symptoms
3 Pigmentary Maculopathy: The Alleged Injury
Pigmentary maculopathy is a condition affecting the macula — the central part of the retina responsible for sharp, detailed vision. In Elmiron-associated cases, pentosan polysulfate sodium appears to be toxic to the retinal pigment epithelium (RPE), causing characteristic changes that can lead to progressive vision loss.
The condition is particularly insidious because it may not be reversible and can continue to progress even after discontinuing the medication. A 2020 study by Shah et al. found that 82% of patients reported worsening symptoms after stopping Elmiron, and 77% of eyes showed expansion of retinal damage. For years, affected patients were frequently misdiagnosed — a Macula Society study found that 54% of patients were initially referred with a diagnosis of age-related macular degeneration (AMD) rather than PPS maculopathy.
Symptoms of Elmiron Maculopathy
Diagnosis requires specialized imaging including optical coherence tomography (OCT), fundus autofluorescence (FAF), and near-infrared reflectance (NIR). Standard eye exams may not detect early changes.
4 Scientific Evidence & Key Studies
The connection between Elmiron and retinal damage was first identified in published literature in 2018, followed by increasingly large studies confirming a dose-dependent relationship between pentosan polysulfate sodium exposure and maculopathy.
Pearce, Chen, and Jain of Emory Eye Center published a landmark case series in Ophthalmology identifying a novel pigmentary maculopathy in six patients with chronic PPS exposure (median 2,263g over ~15.5 years). Genetic testing for known macular dystrophy genotypes was negative, confirming a drug-related cause.
Hanif, Armenti, Shah, Jain et al. published a multicenter study in JAMA Ophthalmology confirming PPS maculopathy across 35 patients at multiple institutions. Kaiser Permanente Northern California screened 4.3 million patients, identifying ~25% prevalence among long-term users, rising to 42% above 1,500g cumulative exposure.
Wang, Au, and Sarraf et al. (UCLA) found 20% prevalence in a prospective study. Shah et al. documented that maculopathy worsens after drug cessation in 82% of patients. On June 16, 2020, the FDA approved label supplement SUPPL-14, adding "retinal pigmentary changes" warnings — nearly 24 years after approval.
A systematic review and meta-analysis of 141,785 patients found that cumulative PPS doses above 2,000 grams carried a relative risk of 7.39 for maculopathy compared to unexposed individuals, providing strong evidence of a dose-dependent relationship.
Evidence Supporting Causation
- • Unique retinal pattern distinct from AMD/pattern dystrophy
- • Dose-dependent relationship (higher dose = higher risk)
- • Consistent findings across multiple independent studies
- • Biological plausibility (PPS accumulation in RPE cells)
- • FDA acknowledged risk by mandating label change
Dose-Response Data
- • 500–1,000g cumulative: ~11% toxicity rate
- • 1,500g+ cumulative: ~42% toxicity rate
- • 2,000g+ cumulative: 7.4x relative risk
- • Standard dose (300mg/day) reaches 500g in ~4.6 years
- • Many IC patients take Elmiron for 10+ years
5 FDA Response & Label Changes
Elmiron was FDA-approved on September 26, 1996 (NDA 020193) without any warnings about potential retinal toxicity. For 24 years, the prescribing information listed only conjunctivitis, tinnitus, optic neuritis, amblyopia, and retinal hemorrhage under "Special Senses" adverse reactions — pigmentary maculopathy was not among them.
On June 16, 2020 (SUPPL-14), the FDA required Janssen to add a new Warnings section specifically addressing "retinal pigmentary changes." On March 12, 2021 (SUPPL-15), the FDA further required a Medication Guide to be dispensed to patients, listing maculopathy as the first serious side effect. FDA authors later acknowledged in a 2021 peer-reviewed article that the evidence supported a potential association between PPS and retinal damage.
The updated label warns that visual consequences are not fully characterized, changes may be irreversible, and damage can progress even after stopping the drug. It recommends: comprehensive baseline retinal examination (including OCT and fundus autofluorescence) within six months of starting treatment, periodic follow-up exams, genetic testing if family history of hereditary pattern dystrophy, and continued monitoring even after discontinuation.
6 MDL History & Current Status
The Judicial Panel on Multidistrict Litigation (JPML) created MDL-2973 on December 15, 2020, consolidating 63 federal lawsuits plus 65 potentially related actions in the District of New Jersey under Judge Brian R. Martinotti. The MDL grew rapidly, peaking at over 1,900 total cases by mid-2023. A parallel New Jersey state MCL was created in Bergen County Superior Court in February 2022, and a Philadelphia mass tort program also ran concurrently.
As of the March 2026 JPML statistics report, the MDL has 634 pending actions out of 1,988 total filed. The significant decline from peak case counts reflects ongoing confidential settlement activity that began in 2023. Judge Martinotti facilitated settlement conferences with Special Master Mark Falk, and the court established an Elmiron Fee Fund and Expense Fund (qualified settlement funds) in August 2023 to support systematic resolution.
Key Litigation Timeline
7 Who May Qualify for a Claim?
- Took Elmiron (pentosan polysulfate sodium) for interstitial cystitis or bladder pain
- Diagnosed with pigmentary maculopathy, vision loss, or retinal damage
- Have medical records and pharmacy records documenting Elmiron use and eye diagnosis
Statute of Limitations: Time limits vary by state, typically 2-4 years from diagnosis or discovery of the connection to Elmiron. Because many patients were misdiagnosed with AMD before the PPS link was identified, the discovery rule may extend filing deadlines in some cases. Consult an attorney promptly.
8 Settlement Status
Confidential settlements have been ongoing since 2023, though no public settlement amounts have been disclosed. The substantial decline in pending cases — from over 1,900 at peak to 634 currently — indicates significant resolution activity.
In early 2023, bellwether trial preparation was underway, with the first bellwether scheduled for March 2023. However, the parties jointly agreed to withdraw all motions in April 2023, which is widely interpreted as a signal that settlement negotiations began in earnest. Since then, Janssen has been resolving cases through individual and group settlement processes.
Current Litigation Posture
The declining case count (from ~1,900 to 634) suggests Janssen is actively resolving claims. However, individual settlement amounts and terms remain confidential. Remaining cases may involve more complex claims or plaintiffs seeking higher compensation.
9 Key Defendants
The Elmiron litigation primarily targets the manufacturer and its parent company, along with an authorized generic distributor. The defendant structure is simpler than many pharmaceutical MDLs because Elmiron is a single-source drug without multiple generic manufacturers.
Primary Defendants
- Janssen Pharmaceuticals, Inc.
A wholly-owned subsidiary of Johnson & Johnson. Manufacturer and marketer of Elmiron since its 1996 FDA approval. Plaintiffs allege Janssen knew of vision-related adverse events and failed to warn patients and physicians.
- Johnson & Johnson
Parent company of Janssen Pharmaceuticals. Named as a defendant under theories of corporate liability and control over subsidiary operations and labeling decisions.
- Teva Branded Pharmaceutical Products R&D, Inc.
Named in some complaints as a distributor of Elmiron under an authorized distribution arrangement with Janssen.
Frequently Asked Questions
What is Elmiron and what does it treat?
Elmiron (pentosan polysulfate sodium) is a prescription medication used to treat interstitial cystitis (IC), also known as painful bladder syndrome. It is the only oral medication FDA-approved for this condition. Elmiron works by coating the bladder lining to protect it from irritating substances in urine. It was approved by the FDA in 1996 and is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
What is pigmentary maculopathy?
Pigmentary maculopathy is a condition affecting the macula, the central part of the retina responsible for sharp, detailed vision. In Elmiron-related cases, pentosan polysulfate sodium causes damage to the retinal pigment epithelium (RPE), resulting in characteristic pigmentary changes visible on specialized imaging. Symptoms include difficulty reading, blurred central vision, problems adapting to dim light, and progressive vision loss. The condition may not be reversible and can continue to worsen even after stopping the medication.
Should I stop taking Elmiron?
Do not stop taking any prescribed medication without consulting your doctor. If you are currently taking Elmiron, discuss the potential risks with your physician and ophthalmologist. The current FDA recommendation is that patients receive a baseline retinal examination and periodic follow-up exams. Your doctor can help weigh the benefits of IC symptom management against the risk of retinal changes and discuss alternative treatment options if appropriate.
How long do you have to take Elmiron to be at risk?
Risk increases with cumulative dose. Studies show toxicity rates of approximately 11% at cumulative exposures of 500–1,000 grams and up to 42% above 1,500 grams. At the standard dose of 300mg per day, patients reach 500 grams in approximately 4.6 years. Ophthalmology experts recommend screening as patients approach this threshold, though some cases have been identified at lower cumulative doses.
Is there a settlement?
Confidential settlements have been ongoing since 2023. No public settlement amounts or global settlement program has been announced, but the significant decline in pending cases (from over 1,900 to 634) indicates that Janssen has been resolving cases. Individual settlement amounts and terms remain confidential. There have been no jury verdicts in the MDL.
Can I still file an Elmiron lawsuit?
The MDL remains open with limited recruitment. You may qualify if you took Elmiron and were diagnosed with pigmentary maculopathy, vision loss, or retinal damage. Statute of limitations varies by state, typically 2–4 years from diagnosis or discovery. Because many patients were initially misdiagnosed with age-related macular degeneration, the discovery rule may apply. Consult an attorney promptly to evaluate your eligibility.
How is Elmiron maculopathy diagnosed?
Diagnosis requires specialized retinal imaging beyond a standard eye exam. Key diagnostic tools include optical coherence tomography (OCT), fundus autofluorescence (FAF), and near-infrared reflectance (NIR). These imaging modalities can reveal characteristic changes in the retinal pigment epithelium that distinguish Elmiron maculopathy from age-related macular degeneration and other conditions. If you take or have taken Elmiron, ask your ophthalmologist specifically about PPS maculopathy screening.
Sources & References
15 official sources cited• JPML MDL Statistics Report, March 2026 (MDL-2973 pending/total actions)
• NIDDK (NIH), “Interstitial Cystitis (Bladder Pain Syndrome) — Definition & Facts,” July 2024
• DailyMed (NLM), ELMIRON prescribing information, NDA 020193, Janssen Pharmaceuticals
• Pearce WA, Chen R, Jain N. “Pigmentary Maculopathy Associated with Chronic Exposure to PPS,” Ophthalmology (2018)
• Hanif AM, Armenti ST, Shah RA, Jain N, et al. “Phenotypic Spectrum of PPS-Associated Maculopathy: A Multicenter Study,” JAMA Ophthalmology (2019)
• Wang D, Au A, Sarraf D, et al. “Pentosan-associated maculopathy: prevalence and screening,” Canadian Journal of Ophthalmology (2020)
• Shah R, Simonett JM, Lyons RJ, Pennesi ME, Jain N. “Disease Course After Drug Cessation,” JAMA Ophthalmology (2020)
• Jain N, et al. “Expanded Clinical Spectrum of PPS Maculopathy: A Macula Society Collaborative Study,” Ophthalmology Retina (2022)
• McGwin G, MacLennan P, Owsley C. “Association Between PPS and Retinal Disorders,” JAMA Ophthalmology (2022)
• Santina A, Sarraf D, et al. “PPS maculopathy: Final analysis of prospective cohort,” Survey of Ophthalmology (2025)
• Lardieri A, et al. “FDA’s perspective on PPS-associated retinal pigmentary changes,” Int. Urogynecol. J. (2021)
• FDA Drugs@FDA: NDA 020193 (ELMIRON) Approval History, SUPPL-14 (June 2020) and SUPPL-15 (March 2021)
• Systematic Review and Meta-Analysis: Risk and Dose-Response Relationship for PPS Maculopathy, Ophthalmology Retina (2025)
• U.S. District Court, District of New Jersey — MDL-2973 Official Docket
• JPML Transfer Order, MDL-2973, December 2020
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