Elmiron Lawsuit Alleges Latent Retinal Damage And Impaired Vision Caused By Bladder Drug

The manufacturers of Elmiron face a product liability lawsuit filed by a long-term user of the “painful bladder syndrome” treatment, which alleges that side effects caused her to experience severe vision problems.

In a complaint (PDF) filed in the U.S. District Court for the Eastern District of Pennsylvania on August 19, Carol Ware indicates she was left with retinal damage and maculopathy from Elmiron, which she used for 17 years as a treatment for interstitial cytitis.

The Elmiron lawsuit presents claims against Janssen Pharmaceuticals, its parent company, Johnson & Johnson, as well as Bayer Healthcare, alleging that the drug makers knew or should have known about the risk their treatment may leave users with impaired vision, yet withheld warnings and information about the problems until a label update was made earlier this year.

Ware indicates she suffered a variety of vision problems from Elmiron, including difficulty reading print, writing, recognizing people, seeing steps and curbs, driving at night or on bright sunny days, watching television, cooking, playing cards or engaging in other activities. Her doctors ultimately diagnosed her with vision problems as a form of Elmiron toxicity and macular degeneration, which she now indicates are permanent and continuing.

Elmiron (pentosan polysulfate sodium or PPS) has been marketed as safe and effective since 1996, without any indication that the drug may cause latent retinal damage or impaired vision until the drug makers updated the warning label in June 2020, indicating that users may be at risk of developing a form of eye disease known as pigmentary maculopathy

The new warnings were only added after a series of independent studies and case reports were published, which highlighted cases where long-term users Elmiron experienced a range of vision problems, including in difficulty adjusting in dark light, problems reading, centralized dark spots and other complications. However, Ware indicates that the drug maker knew about these problems long before the warnings were updated.

“Defendants failed to disclose a known defect and, instead, affirmatively misrepresented that Elmiron was safe for its intended use. Defendants disseminated labeling, marketing, promotion and/or sales information to Plaintiff, her healthcare providers, and the general public regarding the safety of Elmiron knowing such information was false, misleading, and/or inadequate to warn of the safety risks associated with long-term Elmiron use,” the lawsuit states. “They did so willfully, wantonly, and with the intent to prevent the dissemination of information known to them concerning Elmiron’s safety.”

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.