Lawsuit: ‘Tens Of Thousands’ Of Elmiron Patients At Risk For Vision Loss
A lawsuit filed on September 8 claims that “tens of thousands” of Elmiron patients were put at risk and hurt as a result of Janssen Pharmaceuticals’ conduct.
The complaint claims that a Georgia woman suffered vision loss after being prescribed Elmiron in or about 2000. The woman was diagnosed with PPS associated pigmentary maculopathy, according to the complaint.
The lawsuit notes that a case series was reported in November 2018 describing six patients who all had the same atypical maculopathy which produced “significant vision loss.” Researchers noted that all six patients had taken Elmiron.
The complaint notes that Elmiron’s label and prescribing information, until June 2020, contained “Warnings: None.”
The complaint notes that Janssen “was aware of the risks of visual injury with Elmiron” prior to June 2020, pointing to Elmiron’s label in Canada being changed in September 2019 to warn of “post-market cases of pigmentary maculopathy.”
The complaint seeks damages based on numerous counts, including:
Strict liability: The complaint states that Janssen knew or should have known about Elmiron’s “dangerous propensities.” It claims Elmiron was a “defective and unreasonably dangerous product” as distributed by Janssen because Janssen failed to provide adequate warnings with the drug. The complaint claims there was a “feasible and suitable alternative design” for an interstitial cystitis treatment which was capable of preventing the injury to the Georgia woman.
Negligence: The complaint argues that Janssen failed to uphold its duty to exercise ordinary care in the labeling of Elmiron because they knew or should have known the product was dangerous, yet failed to warn about it on the labeling.
Loss of consortium: The complaint seeks damages for the loss of companionship, services and society that the Georgia woman’s husband has experienced as a result of Janssen’s conduct.
The lawsuit is but one of many that Janssen is facing over the interstitial cystitis medication and its link with this new, unique progressive eye disease.
Harvard Medical School once treated a patient whose progressive eye disease was still getting worse six years after she stopped taking Elmiron. The maculopathy that Elmiron appears to cause has numerous side effects, including:
• Reading problems
• Problems with eyesight in dim lighting
• Blurred vision, especially in the middle of your field of vision
• Dark spots in the middle of your field of vision
• Straight lines looking like they are actually curved
• Colors appearing not as vivid