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Formation
Active Litigation
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<45
45–55
55–70
70+
Elmiron
BorderlineFLATMDL 2973Pharma
1,200+
Total Cases
Causation
Plaintiffs allege long-term use of Elmiron (pentosan polysulfate sodium) causes pigmentary maculopathy, a unique and progressive retinal condition that damages the macula and leads to permanent vision loss. A landmark 2018 Emory University study first identified the association, and subsequent peer-reviewed research in Ophthalmology and JAMA Ophthalmology confirmed dose-dependent retinal toxicity. The FDA added a warning about retinal pigmentary changes to the Elmiron label in June 2020, years after the risk was identified in the literature. Plaintiffs contend Janssen knew or should have known of the vision risk and failed to warn patients and prescribers.
Defendants
| Entity | Role | Note |
|---|---|---|
| Janssen Pharmaceuticals | Manufacturer | J&J subsidiary — marketed and sold Elmiron in the US |
| Johnson & Johnson | Parent Company | Corporate parent of Janssen — assumed product liability |
| Teva Pharmaceutical Industries | Generic Manufacturer | Manufactured generic pentosan polysulfate sodium |
Litigation Timeline
Sep 1996
FDA approves Elmiron for interstitial cystitis
Aug 2020
First wave of Elmiron lawsuits filed
2023
Bellwether discovery and expert depositions
2025-2026
Settlement discussions ongoing — 1,200+ cases pending
Intelligence Signals
Courtcourt
IN RE: Roblox Corporation Child Sexual Exploitation and Assault Litigation
Key Facts
- Status
- active
Geographic Exposure
·D.N.J. (MDL 2973, Judge Martinotti)
·Nationwide filing — all 50 states
·Parallel state court proceedings in New Jersey and California
Eligibility Criteria
- ✓Took Elmiron (pentosan polysulfate sodium) for interstitial cystitis
- ✓Used the medication for 1+ years
- ✓Diagnosed with pigmentary maculopathy, macular degeneration, or significant vision changes
- ✓Vision problems occurred during or after Elmiron use