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A recently filed product liability lawsuit indicates many instances of vision loss and maculopathy among individuals suffering from bladder pain could have been avoided if warnings had been provided about the risk of Elmiron toxicity on the retina.
The complaint (PDF) was filed by Beverly N. Zekoff late last month in the U.S. District Court for the Northern District of Alabama, indicating she developed vision problems which resulted from toxic maculopathy caused by long-term use of Elmiron for treatment of a bladder condition known as interstitial cystitis.
Elmiron (pentosan polysulfate sodium or PPS) was introduced in 1996, and is commonly used for years, if not decades, since there is no known cure of the bladder and pelvis pain associated with interstitial cystitis. Although the drug has been on the market for decades, no warnings were provided about the toxic effect Elmiron may have on the retina until earlier this year.
It was only after a series of independent case reports and studies were published about the link between Elmiron and maculopathy that the drug maker announced a warning label update in June 2020, which now advises users, urologists and opthalmologists that users have experienced a form of eye disease known as pigmentary maculopathy, which can cause a range of vision problems, including difficulty adjusting in dark light, trouble reading, centralized dark spots and other complications.
“All of the Defendants ignored reports from patients and health care providers throughout the United States of Elmiron’s failure to perform as intended, and injuries associated with long term use which led to the severe and debilitating injuries suffered by Plaintiff, and numerous other patients,” Zekoff’s lawsuit states. “Rather than doing adequate testing to determine the cause of these injuries or rule out Elmiron’s design as the cause of the injuries, the Defendants collectively and individually continued to market Elmiron as a safe and effective prescription drug for interstitial cystitis.”
Zekoff’s doctor prescribed Elmiron to her in 2001, after she was diagnosed with interstitial cystitis. After continuing to use the drug for nearly two decades, Zekoff indicates she was diagnosed with vision loss and permanent retinal injury in June 2020, which she directly relates to Elmiron toxicity.
Her lawsuit names Johnson & Johnson, its Janssen Pharmaceuticals subsidiary, and Teva Pharmaceuticals as defendants, indicating that critical safety information and warnings were withheld from users, regulators and the medical community, which could have helped many individuals nationwide avoid permanent retina damage.
Since most ophthalmologists were previously unaware of the vision risks associated with Elmiron, many users were misdiagnosed with other forms of retinal disease and continued to be exposed to the medication, further worsening the damage.
The case joins a growing number of Elmiron lawsuits now being pursued throughout the U.S. court system. However, as lawyers continue to review and file claims in the coming months and years, it is expected that hundreds, if not thousands, of similar complaints may be brought in state and federal courts nationwide.