Elmiron Caused “Potentially Irreversible” Vision Damage: Lawsuit

According to allegations raised in a recently filed product liability lawsuit, the toxic effects of Elmiron on the retina left a Tennessee woman with serious and potentially irreversible vision damage after years of exposure to the interstitial cystitis treatment.

Sherry Dobbins and her husband, James, filed the complaint (PDF) in the U.S. District Court for the District of New Jersey on July 28, pursuing claims against Janssen Pharmaceuticals, Inc., its parent company, Johnson & Johnson, and Teva Pharmaceuticals as defendants.

Elmiron (pentosan polysulfate sodium or PPS) is the only approved drug treatment for interstitial cystitis, also commonly referred to as “painful bladder syndrome”, and has been marketed as safe and effective since 1996. Although concerns existed for years among vision specialists about the risk of retina damage, Elmiron vision warnings were not added to the drug label in the U.S. until June 2020.

The label update came after a series of independent studies and case reports published in recent years highlighted cases involving visual injury and pigmentary changes in the retina among long-term users of Elmiron. The drug has been linked to reports in which users to experienced difficulty adjusting in dark light, problems reading, centralized dark spots and other complications, yet information about the risk of pigmentary maculpathy was withheld from the drug warning label for years.

According to the lawsuit, Dobbins began taking Elmiron in 2004 for interstitial cystitis. She was diagnosed with retinal pigmentary changes in June 2020.

“As a result of the defective nature of Elmiron, persons who were prescribed and ingested Elmiron, including Plaintiff Sherry Dobbins have suffered and may continue to suffer severe and permanent personal injuries, including but not limited to retinal pigmentary changes, vision changes, and potentially irreversible vision damage,” the lawsuit states.

Since most ophthalmologists were previously unaware of the Elmiron vision damage risks associated with the bladder drug, a growing number of long-term Elmiron users are just now learning that they may have been previously misdiagnosed with other retinal diseases, such as macular degeneration, pattern dystrophy and other problems, which were actually caused by the toxic effects of the drug on the eyes.

As Elmiron lawyers continue to review and file claims in the coming months and years, it is expected that hundreds of similar complaints may be brought in state and federal courts nationwide.