Elmiron Lawsuit
pentosan polysulfate sodium · Janssen (Johnson & Johnson) · updated June 2026
Elmiron, prescribed for interstitial cystitis (bladder pain), faces lawsuits alleging that long-term use causes pigmentary maculopathy — a form of retinal damage and vision loss.
This page is general information about ongoing litigation and FDA safety actions — not medical or legal advice, and not a statement that Elmiron caused any injury. Allegations described here are claims that have not been proven in court. Always consult a licensed professional.
What the lawsuits allege
Plaintiffs allege Janssen failed to warn that long-term use of Elmiron (pentosan polysulfate sodium) can cause pigmentary maculopathy, a form of retinal damage.
- Pigmentary maculopathy
- Vision loss
FDA action
In 2020 the FDA added a warning about retinal pigmentary changes (maculopathy) to the Elmiron label.
Verify against the current FDA-approved label: Elmiron label on DailyMed (U.S. NLM).
Where the litigation stands
As of mid-2026, roughly 600–700 cases remain in MDL 2973 (District of New Jersey) — down about two-thirds from the peak. The litigation is in a resolution phase, with Janssen settling cases since 2023.
Case counts and MDL status are published by the U.S. Judicial Panel on Multidistrict Litigation — JPML pending MDLs. Any figure not on the court record is attributed to the secondary legal-press links below.
Who may be affected
The Elmiron lawsuits are brought by people who say they used Elmiron (pentosan polysulfate sodium) and were later diagnosed with one or more of the alleged injuries above. Whether any individual situation could support a claim depends on the specific facts, the medical records, and each state's filing deadline (statute of limitations) — which can expire, so timing matters. Only a licensed attorney can evaluate a specific case. This page is general information, not legal advice.
Frequently asked
- What is the Elmiron lawsuit about?
- Plaintiffs allege Janssen failed to warn that long-term use of Elmiron (pentosan polysulfate sodium) can cause pigmentary maculopathy, a form of retinal damage. As of mid-2026, roughly 600–700 cases remain in MDL 2973 (District of New Jersey) — down about two-thirds from the peak. The litigation is in a resolution phase, with Janssen settling cases since 2023.
- What injuries are alleged in the Elmiron lawsuits?
- Lawsuits allege pigmentary maculopathy, vision loss. These are allegations; a court has not found that Elmiron causes them.
- Has the FDA acted on Elmiron?
- In 2020 the FDA added a warning about retinal pigmentary changes (maculopathy) to the Elmiron label.
- Is there a deadline to file a Elmiron lawsuit?
- Yes — every state sets a filing deadline (statute of limitations) for product-injury claims, often running from the date of injury or diagnosis, and once it passes a claim is usually barred. The exact window varies by state and circumstances, so anyone considering a claim should check with a licensed attorney promptly. This is general information, not legal advice.