Lawsuit Claims Long-Term Elmiron Use Led To Cloudy, Blurred Vision
A lawsuit filed in federal court in New York on Thursday alleges that use of Elmiron from 2011 through 2019 led to a New York woman developing blurred, cloudy vision. The lawsuit names multiple defendants, including Janssen Pharmaceuticals.
Elmiron is a prescription medication which treats interstitial cystitis. The lawsuit claims that Janssen knew or should have known that Elmiron causes retinal damage, thanks to “numerous patient reports, scientific studies, and even alerts by governmental agencies,” but failed to warn the public about the risk of retinal damage associated with the drug “despite study after study providing clear evidence of the dangers of” Elmiron.
The complaint claims that a “physician’s usage study” of Elmiron from the late 80’s and early 90’s noted adverse vision events such as retinal hemorrhage, optic neuritis, blurred vision and a “filmy” sensation over the left eye.
Research from 1991, according to the complaint, found that Elmiron might impair an important retinal health physiological pathway by inhibiting regrowth and proliferation of retinal pigment epithelial cells.
Almost 150 cases of eye disorders have been reported to the FDA regarding Elmiron, according to the complaint, which states that the complaints started coming in “almost immediately after the FDA approved Elmiron.”
Emory Eye Center researchers, in 2018, published their concerns about a new eye disease they were seeing in Elmiron patients, according to the complaint.
“Examination findings in patients with this condition are suggestive of injury to the retina and the underlying retinal pigment epithelium,” the researchers found.
The Emory team later submitted another study of ten interstitial cystitis patients who had taken Elmiron, and found that the patients commonly reported difficulty reading and difficulty with adaptation to dim lighting, according to the complaint, which states the team noted their clinic had seen 156 interstitial cystitis patients without Elmiron exposure, and none of them had the new eye disease.
The Emory team “concluded that structural changes of the retina are occurring in patients taking Elmiron,” according to the complaint.
Perhaps the most frightening finding noted in the complaint was that Harvard Medical School physicians treated a patient whose Elmiron-induced retinal damage was still getting worse at least six years after she stopped taking the medication.
The label for Elmiron in the United States wasn’t updated until June 16, 2020 to warn about retinal pigmentary changes, despite all of the above evidence, but the drug’s European and Canadian labels were updated in 2019 to warn about pigmentary maculopathy, demonstrating that Elmiron continued to be sold in the United States without a warning despite clear knowledge of the dangers associated with the drug.
The lawsuit seeks to recover damages based on many counts, including strict liability – design defect and failure to warn, breach of express and implied warranties, negligence, negligence per se, and negligent misrepresentation.