Retinal Pigmentary Changes, Vision Damage Caused By Bladder Pain Drug Elmiron: Lawsuit

Elmiron manufacturers failed to warn patients and doctors about the risk of retinal pigmentary changes linked to the bladder pain drug, the lawsuit alleges

An Alabama woman indicates in a recently filed lawsuit that she was left with retinal pigmentary changes from Elmiron, claiming that side effects of the bladder pain drug have permanently damaged her vision.

The complaint (PDF) was filed by Riva Zrinski in the U.S. District Court of New Jersey on June 7, pursuing claims against ohnson & Johnson, its Janssen subsidiaries, Teva Pharmaceuticals, Alza Corporation and Ivax Corporation and its subsidiaries as defendants, claiming that the drug makers withheld warnings and information about the risks from consumers and the medical community.

Elmiron has been on the market for decades, as a niche treatment for interstitial cystitis, also known as painful bladder syndrome. Since there is no underlying cure for the condition, many users remain on Elmiron long-term, which is now known to pose a risk of permanent retina damage, known as pigmentary maculopathy. However, warnings about the risk of eye problems were not added to the Elmiron FDA label until June 2020, and Zrinski indicates that earlier information should have been disclosed.

According to the lawsuit, Zrinksi was prescribed Elmiron for the treatment of interstitial cystitis in 2018, and used the bladder pain drug until June 2021. The lawsuit blames Elmiron for causing her to suffer retinal pigmentary changes which led to vision problems, pain and suffering.

As a result of the lack of warning label information when she started using the drug, Zrinski notes there is no way she or her doctor could have known about the drug’s risks.

“Plaintiff would not have used Elmiron had Defendants properly disclosed the risks associated with the drug,” Zrinksi’s lawsuit states. “Thus, had Defendants properly disclosed the risks associated with Elmiron, Plaintiff would have avoided the risk of developing the injuries complained of herein by not ingesting Elmiron.”

Zrinksi now joins hundreds of other consumers who are pursuing an Elmiron lawsuit against the drug makers, alleging that they may have avoided permanent eye damage if earlier information had been provided about the vision damage risks and the importance of monitoring for retinal pigmentary changes.

Although independent studies and case reports published over the past decade have described cases of Elmiron causing vision damage, including blurred vision, distorted vision or blindness, the first warnings about these problems and the importance of monitoring for retinal changes was not added to the FDA label warnings until 2020. As a result, many doctors remained unaware of the connection between Elmiron and eye damage until recently, leading many users to continue taking the medication even after they developed signs or symptoms of vision side effects, further worsening the permanent damage to the retina.

The complaint will be consolidated with similar claims brought by other former users throughout the federal court system, which are centralized as part of a federal multidistrict litigation (MDL) in the District of New Jersey, where the parties are engaged in coordinated discovery and preparing for a series of early “bellwether” trials scheduled to begin in January 2023.

Although the outcome of these test trials will not be binding on Zrinksi or other plaintiffs who have brought claims, they are expected to help the Court gauge how juries respond to certain evidence and testimony that is likely to be repeated throughout the litigation. However, unless the drug makers are able to negotiate Elmiron settlements or establish that they can consistently defend the safety of their drug at trial, hundreds of individual cases may later be remanded back to U.S. District Courts nationwide for individual jury trials nationwide in the coming years.