Lawsuit Alleges Elmiron Causes Blurred Vision, Distorted Vision and Other Symptoms from Retinal Damage

The manufacturers never adequately tested Elmiron for retinal damage nor adequately warned patients of the risks, the lawsuit claims.

A Michigan woman indicates in a product liability lawsuit that she developed blurred and distorted vision as well as other eye problems after Elmiron caused retinal damage within two years of starting to use the medication for treatment of bladder pain.

The complaint (PDF) was filed by Obella George in the U.S. District Court for the District of New Jersey on December 21, indicating that Johnson & Johnson and other drug makers failed to warn users and the medical community that Elmiron causes vision problems, which are often permanent.

Elmiron (pentosan polysulfate sodium) is a prescription medication approved for treatment of interstitial cystitis, also known painful bladder syndrome. Since there is no underlying cure for the condition, many users remain on the medication for years. However, a number are now discovering that they have been left with a form of retinal damage known as pigmentary maculopathy.

Although independent studies and case reports published over the past decade have described cases of Elmiron causing 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.

George indicates she was prescribed Elmiron in 2016, and continued to take the bladder pain drug until 2018.

“During the relevant time periods, Plaintiff and Plaintiff’s physicians were given no warning and had no knowledge of the serious risk of retinal damage and vision loss posed by Elmiron,” the lawsuit states. “Subsequently, and as a result of Plaintiff’s ingestion of Elmiron, Plaintiff now suffers from toxic maculopathy, retinal damage, blurred vision, distorted vision, and other visual symptoms.”

The lawsuit indicates misconduct by the defendants, including a lack of adequate testing and a lack of sufficient warning labels, has endangered patients by exposing them to “serious vision-related injuries” as a result of taking the interstitial cystitis drug.

Hundreds of similar Elmiron lawsuits are being pursued throughout the federal court system by individuals previously diagnosed with maculopathy and other retina conditions, which are now increasingly referred to as Elmiron-associated maculopathy, given the unique form of damage only seen among users of the medication.

George’s lawsuit will be consolidated with other similar claims pending in 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 George and 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.