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An Indiana woman indicates in a recently file lawsuit that side effects of Elmiron caused her to suffer macular degeneration and serious vision problems after taking the interstitial cystitis drug for about 16 years.
The complaint (PDF) was filed by Rita Ward in the U.S. District Court for the Eastern District of Pennsylvania on October 8, indicating that the Johnson & Johnson subsidiary Janssen Pharmaceuticals, Inc. failed in its duty to adequately warn the medical community about the toxic vision risks associated with Elmiron.
Ward indicates she was diagnosed with Elmiron-related macular degeneration in August 2020, months after the drug makers first provided warnings in the U.S. about the impact the medication may retina, which is also commonly referred to as pigmentary maculopathy.
Elmiron (pentosan polysulfate sodium or PPS) was introduced in 1996, as a “niche” treatment for interstitial cystitis or “painful bladder syndrome.” For decades the drug was sold without any warnings or information that side effects may cause latent retina damage or impaired vision. It was only after a series of independent case reports and studies were published in recent years about the link between Elmiron and maculopathy that the drug maker announced a warning label update in June 2020
The new warnings now advise users, urologists and ophthalmologists that Elmiron side effects have been linked to reports of pigmentary changes in the retina, which can cause a range of vision problems, including difficulty adjusting in dark light, trouble reading, centralized dark spots and other complications.
“Throughout the time Defendant marketed Elmiron, Defendant withheld material adverse events from the public, medical community and FDA. Defendant failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy,” the lawsuit states. “Ultimately, tens of thousands of patients, including Plaintiff, were placed at risk and harmed as a result of this misleading conduct.”
Ward’s lawsuit further claims that when Janssen received reports of Elmiron vision problems from patients and healthcare professionals, it failed to properly investigate those warnings, and continued to market Elmiron as safe and effective.
The case joins a growing number of Elmiron lawsuits now being pursued throughout the U.S. court system, each involving similar allegations that former users may have avoided permanent retinal damage if earlier warnings and information had been provided.
Since most ophthalmologists were previously unaware of the vision risks associated with Elmiron, many users were misdiagnosed with other forms of retinal disease and continued to be exposed to the medication, further worsening the damage.
As Elmiron lawyers continue to review and file claims in the coming months and years, it is expected that hundreds of similar complaints may be brought in state and federal courts nationwide.