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Johnson & Johnson faces a product liability lawsuit filed by a Nevada woman which alleges the side effects of Elmiron caused serious eye damage following long-term use of their bladder drug.
The complaint (PDF) filed by Tina Pisco in the U.S. District Court for the Eastern District of Pennsylvania on May 4, claims the drug maker’s failure to warn about the risk of permanent and debilitating retinal injury placed thousands of users at risk of vision loss.
Pisco indicates she began taking Elmiron in 2012, after being diagnosed with interstitial cystitis or “painful bladder syndrome”. However, in about 2018 she began experiencing vision deterioration, and was diagnosed with a permanent retinal injury in March 2019, which she claims was caused by toxic Elmiron side effects on the eyes.
Elmiron (pentosan polysulfate sodium or PPS) has been sold by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in the United States since 1996, and has been promoted as a safe and effective treatment for interstitial cystitis, which is an incurable condition that often results in users staying on the medication for years.
However, a growing number of studies and case reports now suggested users may develop a type of retinal disease known as pigmentary maculopathy. This can result in difficulty adjusting in dark light, dark spots, vision loss and other problems.
Pisco’s lawsuit claims the manufacturers knew or should have known about this problem long ago, yet withheld warnings from users and the medical community.
“Throughout the time Defendants marketed Elmiron, Defendants withheld material adverse events from the public, medical community and FDA. Defendants failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy,” Pisco’s lawsuit states. “Ultimately, tens of thousands of patients, including Plaintiff, were placed at risk and harmed as a result of this misleading conduct.”
Although users and doctors in the United States have not been warned about the risk of Elmiron eye damage, the manufacturers did update the warning label in Canada last year, warning users to seek immediate medical attention if they experience symptoms of vision loss, and urologists were urged to make sure users of Elmiron received regular eye exams with an ophthalmologist.
Pisco’s complaint joins a growing number of other Elmiron lawsuits now being pursued in courts nationwide, each raising similar allegations that users could have avoided irreversible eye damage if warnings had been provided by the drug makers.
Since most ophthalmologists were previously unaware of the effects of Elmiron on the eyes, many individuals have been misdiagnosed with other retinal diseases, such as age-related macular degeneration, pattern dystrophy and other problems.