Lawsuit Claims Elmiron Caused Eye Injury, Doesn’t Even Work
A lawsuit filed by an Ohio woman on September 21 claims that her vision deteriorated after using Elmiron for over a decade. The lawsuit also essentially claims that Elmiron doesn’t even work for the treatment of interstitial cystitis. The lawsuit names Janssen Pharmaceuticals as the defendant.
The complaint states that the plaintiff started using Elmiron around 15 to 20 years ago and started to suffer vision deterioration after over a decade of using the drug. The plaintiff was diagnosed with bilateral neovascular acute macular degeneration with active choroidal neovascularization, stable pattern dystrophy, stable lattice degeneration and dry eye syndrome in March 2020, according to the complaint.
The lawsuit notes that Janssen’s own Phase IV study into the efficacy of Elmiron was stopped about halfway through because “an interim analysis indicated that Elmiron provided no more symptom relief than placebo. In fact, it provided less relief than placebo for the subgroup of patients identified as suffering from [interstitial cystitis].”
The lawsuit argues that this Phase IV study “establishes that Elmiron does not work.”
The Phase IV study was mandated by the FDA when the FDA approved Elmiron in 1996, according to the lawsuit, but the study’s results weren’t published until March 2015.
The lawsuit notes that the only evidence that Elmiron worked, prior to Elmiron’s FDA approval, was data from a doctor who is the inventor of the patent for Elmiron, Dr. C. Lowell Parsons.
The lawsuit adds that prior to Elmiron’s FDA approval, “published medical literature indicated that Elmiron did not provide relief” for interstitial cystitis symptoms. “Thus, Janssen has been aware for decades that Elmiron was not proven effective in the treatment of [interstitial cystitis].”
“The policy against administrating drugs with no proven benefit is that it exposes patients to potentially harmful drug effects for no reason,” the lawsuit states.
The lawsuit notes that researchers published a study in 2018 linking Elmiron to retinal damage and vision deterioration, yet Elmiron’s label never warned about these risks until June 2020. The lawsuit states that even Elmiron’s updated label is still inadequate “as it fails to dispel the belief that Elmiron provides a clinical benefit which must be balanced against the actual risk of significant harm.”
The lawsuit argues that Janssen knew or should have known about Elmiron’s link to retinal damage but failed to warn the plaintiff about this risk, and that the plaintiff suffered from vision deterioration as a result of this failure to warn.
The lawsuit seeks to recover damages based on numerous causes of action, including strict products liability – design defect, strict products liability – defect due to inadequate warning, strict products liability – nonconformance with representations, negligent misrepresentation and fraud, breach of express warranty, and unjust enrichment.