Elmiron Retina Damage Caused Blurred and Distorted Vision Problems, Lawsuit Alleges

Following use of the bladder drug Elmiron for more than 12 years, a North Carolina woman indicates that she was left with permanent blurred and distorted vision, alleging in a recently filed product liability lawsuit that Elmiron caused retina damage that will impact her for the rest of her life.

The complaint (PDF) was filed this month by Linda Singer, in the U.S. District Court for the District of New Jersey, pursuing damages from Johnson & Johnson, its Janssen subsidiaries, Teva Pharmaceuticals and its Ivax subsidiary, alleging that the drug makers failed to warn patients to be on the lookout for vision problems while taking Elmiron.

The prescription medication has been on the market for decades, as a niche treatment for interstitial cystitis, also known 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.

Singer indicates that after she was diagnosed with interstitial cystitis, she took Elmiron from about 2008 through 2020. However, as a result of the Elmiron exposure, she has been left with toxic maculopathy, retinal damage, blurred vision, distorted vision and other vision problems.

The complaint notes that the drug makers knew or should have known about the risk that Elmiron causes retina damage for years, but concealed information from the medical community and users, who could have permanent vision problems by monitoring for vision or retina pigment changes.

“Numerous patient reports, scientific studies, and even alerts by governmental agencies have established that Elmiron causes retinal damage, including Pentosan Polysulfate Sodium Maculopathy, a signature condition caused by Elmiron toxicity,” the lawsuit states. “Nevertheless, Defendants failed to warn, instruct, advise, educate, or otherwise inform Elmiron users, Elmiron prescribers, or United States governmental regulators about the risk of pigmentary maculopathy or retinal damage, or the need for medical, ophthalmological monitoring. At all relevant times, the U.S. label for Elmiron made no mention of risk to patients’ eyes or vision.”

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.

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.

Singer’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 Singer 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.