Elmiron®, the only FDA-approved oral medication for IC/BPS, was linked to the development of severe, sometimes progressive, retinal disease several years ago.(1,2) Since then, hundreds of patients have participated in lawsuits against the companies involved.
In November of 25, the special master in the Elmiron® product liability case, the Honorable Mark Falk, (United States District Court of New Jersey Docket Case No. 2:20-md-02973) authorized more than $43 million dollars in fees to be paid to 30 law firms in the USA, along with another $3 million to cover legal expenses, providing our first glimpse into just how much money has been paid out to patients and their attorneys by defendents Jannsen Pharmaceuticals, Inc. and Teva Pharmaceuticals.(3) There are, however, hundreds of cases that have yet to settle.
Patients who have contacted the ICN have reported settlements ranging from roughly $250,000 to $600,000, depending upon the amount of eye damage experienced. One complicating issue, however, is that eye damage can progress long after the medication is stopped; thus, if the settlement is based on a patient’s eye health today, it may not be sufficient to cover expenses and care should eye damage progress to the point of blindness.(4,5) One patient who received a settlement believes it should have been much larger because she now requires in-home help. She cannot read, drive, or see her face in a mirror.
Another significant health concern, inflammatory bowel disease, also appears to be associated with Elmiron® use.(6) Some patients using the medication have developed extensive and uncontrolled polyp growth that has required the removal of their bowel. If they had already settled their eye case, they may be precluded from filing any other lawsuits against the company. For patients with clauses in their settlements that allow another lawsuit, finding an attorney to represent them has been challenging.
Every month, the ICN receives calls from patients who have been newly diagnosed with retinal maculopathy and inflammatory bowel disease, some stunned to discover that this may have occurred because of their Elmiron® use. It is vital that these patients contact attorneys promptly, as the statute of limitations is approaching expiration. We’ve also been told, but cannot confirm, that no new lawsuits will be filed in 2027, which, given research showing that damage progresses over time, appears highly advantageous to the pharmaceutical companies involved. If you are currently in settlement discussions, I encourage you to seek lifetime eye care, including coverage for all testing needed, treatments (if any), and home assistance, if needed.
Sadly, some urologists continue to prescribe the medication, with patients reporting that the risk of eye damage was minimized if not disclosed at all. Should it still be on the market today??
References:
You can view the case and its filings on the PACER website, a public database of federal lawsuits. You’ll see the attorneys currently involved in the cases, various filings, reports, and much more.
- Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium. Pearce WA, Chen R, Jain N. Ophthalmology. 2018 May 22.
- Osborne J. The Tragic & Tarnished History of Elmiron®, A New Investigative Report. IC Network. June 14, 2025.
- Order on Report and Recommendation – US District Court for the District of New Jersey. Master Docket Case No. 2:20-md-02973. Filed November 24, 2025.
- Osborne J. New Elmiron Study Finds Progressive Eye Damage AFTER Stopping The Medication. IC Network. July 13, 2020
- Osborne J. Elmiron® Maculopathy Appears To Progress. IC Network. December 31, 2024
- Osborne J. Inflammatory Bowel Disease Associated with Pentosan Polysulfate (aka Elmiron®) Use. IC Network. June 19, 2023
