A Connecticut woman has filed a new lawsuit against the manufacturers of Elmiron, a drug for bladder pain that allegedly caused her to suffer permanent retinal injury and vision loss.
Approved by the U.S. Food & Drug Administration in 1996, Elmiron is the only medication indicated to treat bladder pain and discomfort associated with interstitial cystitis. The drug was developed by Defendants Teva Branded Pharmaceuticals R&D, Inc. and licensed to Janssen Pharmaceuticals, which now manufactures Elmiron.
Patients prescribed Elmiron are advised to take the drug for at least six months in order to determine effectiveness. Those who do experience improvement of bladder pain and discomfort will frequently continue to take Elmiron for months, if not years.
The Elmiron labeling currently states “Warnings: None.” Although the prescribing information has been updated on approximately five occasions, the label has never made mention of visual loss, including pigmentary maculopathy, in any section. Yet a growing number of studies suggest patients treated with Elmiron are more likely to develop maculopathy, a disease of the retina that affects the macula, the part of the eye associated with highly sensitive, accurate vision.
According to an Elmiron lawsuit filed in the U.S. District Court, District of Connecticut, on March 26th, Kimberly Pelczar was prescribed the medication in 2005 for a painful bladder. She began experiencing vision problems in 2015, and her symptoms were evaluated on various occasions during the subsequent four years. In 2019, Pelczar was finally diagnosed with permanent retinal injury and vision loss due to Elmiron toxicity. (Case No. 3:20-cv-00406-SRU)
“Defendants ignored reports from patients and health care providers throughout the United States of Elmiron’s failure to perform as intended, and injuries associated with long term use which led to the severe and debilitating injuries suffered by Plaintiff, and numerous other patients,” the lawsuit states. “Rather than doing adequate testing to determine the cause of these injuries or rule out Elmiron’s design as the cause of the injuries, Defendants continued to market Elmiron as a safe and effective prescription drug for interstitial cystitis.”
The complaint further contends that, a result of the defendants’ actions, Pelczar and her doctors were unaware and could not have reasonably known that Elmiron might cause permanent retinal injury and vision loss. The Elmiron lawsuit seeks compensation for Pelczar’s severe mental and physical pain and suffering, permanent injuries and emotional distress, as well as economic losses related to her medical bills and living expenses incurred as a result of a new lifestyle necessitated by her vision loss.