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Johnson & Johnson and its Janssen Pharmaceuticals unit face a product liability lawsuit brought by an Oklahoma woman diagnosed with age-related macular degeneration, alleging that the vision loss was actually a form of eye problems caused by Elmiron, a bladder drug she had been taking for more than 15 years.
The complaint (PDF) was filed by Carole A. Tibbs in the U.S. District Court for the District of New Jersey on August 16, alleging doctors were unaware Elmiron may cause a specific type of retinal problems, since the drug makers failed to disclose the risk.
Tibbs began taking Elmiron in September 2003, for treatment of a bladder condition known as interstitial cystitis. She subsequently began suffering vision problems and was diagnosed with age-related macular degeneration in September 2019. However, the lawsuit claims the true cause of the changes to Tibbs retinal pigmentary epithelium and impaired vision were the side effects of Elmiron.
Johnson & Johnson and Janssen 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 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.
“Defendants knew or should have known the risks associated with the use of Elmiron, including the risk of changes to the retinal pigmentary epithelium (among other injuries),” Tibbs’ lawsuit states. “The development of Plaintiff’s injuries was preventable and resulted from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize safety signals, suppression of information revealing serious risks, failure to provide adequate warnings, and misrepresentations concerning the nature, efficacy and safety of Elmiron. This conduct, as well as the product defects complained of herein, was a substantial factor in bringing about and exacerbating Plaintiff’s injuries.”
Hundreds of similar Elmiron lawsuits are filed throughout the federal court system by individuals previously diagnosed with age-related macular degeneration and other retina conditions, which are now recognized as Elmiron-associated maculopathy. Given common questions of fact and law, the cases have been centralized as part of a federal multidistrict litigation (MDL) in the District of New Jersey.
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 complaints 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.