Elmiron Vision Loss Lawsuit Lawsuit Tracker

Interstitial cystitis (IC) is a chronic condition causing bladder pressure, bladder pain, and sometimes pelvic pain. It affects an estimated 3 to 8 million women and 1 to 4 million men in the United States. When the FDA approved pentosan polysulfate sodium — marketed as Elmiron — in 1996, it became the only oral medication specifically approved to treat IC symptoms. The drug works by helping to restore the glycosaminoglycan (GAG) layer that protects the bladder wall lining. Standard dosing is 100 mg taken three times daily, and because IC is a chronic condition, most patients take Elmiron for years or even decades. Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, manufactures and markets the drug. For over two decades, Elmiron was considered safe for long-term use. That changed in 2018 when Dr. Nieraj Jain and colleagues at Emory University published groundbreaking research identifying a distinctive pattern of retinal damage in long-term Elmiron users. The condition, now called pentosan polysulfate maculopathy or pigmentary maculopathy, involves toxic damage to the retinal pigment epithelium (RPE) and photoreceptor cells. This unique pattern of injury was frequently misdiagnosed as age-related macular degeneration before the Emory team identified the connection to Elmiron. Subsequent studies confirmed a clear dose-dependent relationship: patients who took more Elmiron over longer periods suffered worse eye damage. Research published in peer-reviewed journals found prevalence rates ranging from roughly 13 percent in patients with moderate cumulative exposure to over 40 percent in those with the highest exposure levels. In June 2020, the FDA required Janssen to update Elmiron's prescribing label to include warnings about retinal pigmentary changes. Janssen and J&J maintained that the drug was safe when used as directed. Lawsuits began consolidating in 2020 into MDL 2973 in the District of New Jersey under Judge Brian R. Martinotti. At its peak, nearly 2,000 cases were filed. As of February 2026, approximately 640 cases remain pending as the litigation winds toward resolution. Some cases have settled confidentially, and legal experts anticipate a broader settlement in the near future. The declining case count reflects both ongoing settlements and case consolidation rather than a lack of merit.