Impaired Vision Lawsuit Filed Over Elmiron Retinal Maculopathy

A West Virginia woman recently filed a lawsuit which indicates she suffers blurred and impaired vision due to retinal maculopathy caused by Elmiron, an interstitial cystitis drug.

The complaint (PDF) was filed by Mary Downey in New Jersey Superior Court for Mercer County on June 24, alleging that Janssen Pharmaceuticals, Inc. and its parent company, Johnson & Johnson, knew Elmiron carried a risk of retinal damage, but did nothing to warn patients or medical providers.

The drug makers have marketed Elmiron (pentosan polysulfate sodium or PPS) as a safe and effective treatment for interstitial cystitis for decades, without providing any warnings about the vision impairment or importance of monitoring for retina changes until last year, when updated Elmiron FDA label warnings were added about vision risks for the first time.

Although independent studies and case reports have described cases of irreversible Elmiron retinal maculopathy for years, many doctors remained unaware of the connection until recently, leading many users to continue taking the medication for years after they developed signs or symptoms of vision side effects, further worsening the permanent damage to the retina.

According to the impaired vision lawsuit, Downey was diagnosed with interstitial cystitis and was prescribed Elmiron in April 2010. She took the drug until October 2019, when she was diagnosed with maculopathy, at which time her ophthalmologist told her Elmiron was the cause of her vision problems.

As a result of the Elmiron-induced retinal maculopathy, Downey indicates she now suffers from blurred vision, difficulty distinguishing colors and reading, and is unable to go outdoors without sunglasses.

“Elmiron injured Plaintiff Mary Downey by causing harmful, but latent, retinal damage and pigmentary maculopathy, which ultimately resulted in significantly impaired vision,” the lawsuit states. “Defendants knew or should have known that Elmiron, when taken as prescribed and intended, causes harmful retinal damage and maculopathy.”

While Downey’s lawsuit has been filed at the state level, there are also hundreds of Elmiron vision lawsuits filed throughout the federal court system, which have been centralized as part of a federal multidistrict litigation (MDL), since they each involve common questions of fact and law.

Following coordinated discovery, it is expected that a series of “bellwether” trials will likely be scheduled to help gauge how juries respond to certain evidence and testimony that is likely to be repeated throughout the litigation. Through multimodal ophthalmologic imaging that provides a distinct signature for Elmiron retinal maculopathy, plaintiffs will have much stronger evidence of causal connection than is typically available in pharmaceutical litigation.

If the drug makers fail to negotiate Elmiron settlements for vision impairment, each of the individual complaint centralized in the federal MDL may later be remanded back to U.S. District Courts nationwide for individual jury trials nationwide, exposing the manufacturers to substantial liability.