Elmiron Lawsuit Alleges Johnson & Johnson Subsidiary Failed to Warn on Vision Risk

Published on May 18, 2020 by Sandy Liebhard

Elmiron lawsuits are mounting in courts around the United States, as more and more plaintiffs seek compensation for vision loss that allegedly resulted from long-term use of the bladder pain drug.

One the most recent cases was filed in the U.S. District Court, Eastern District of Pennsylvania, by Tina Pisco, a Nevada resident who was prescribed Elmiron in 2012 to treat interstitial cystitis. She was still using Elmiron when she began experiencing deteriorating vision in 2018. On March 29, 2019, Pisco was diagnosed with permanent retinal injury and vision loss associated with Elmiron use. (Case No. Case 2:20-cv-02147)

Elmiron and Vision Loss

Elmiron (pentosan polysulfate sodium) is manufactured by Johnson & Johnson’s Janssen Pharmaceutical subsidiary and is the only medication currently approved by the U.S. Food & Drug Administration (FDA) to treat bladder pain and discomfort associated with interstitial nephritis.  Because this condition is incurable, long-term use of Elmiron is common.

Since bringing Elmiron to market in 1996, Janssen has promoted the medication as a safe and effective remedy for bladder pain. But according to Pisco’s Elmiron lawsuit, multiple reports and studies have linked long-term use to maculopathy and other retinal disorders that can result in the permanent loss of vision.

Doctors at the Emory Eye Institute, for example, have been reporting on Elmiron-related eye disorders since November 2018, when they published a paper in the Journal of Ophthalmology detailing the cases of six women developed maculopathy. While one had a family history of maculopathy or other vision disorders, all had been using Elmiron at the time of diagnosis.

In September 2019, a study published by the same Emory team in JAMA Ophthalmology concluded that Elmiron-associated macular degeneration “is a vision-threatening condition that can manifest in the setting of long-term exposure to the drug.”

Just two months later, researchers from Emory and the University of Pennsylvania published an epidemiological study in the British Journal of Ophthalmology that concluded “PPS users had significantly increased odds of having [maculopathy].”

Elmiron Canadian Label Includes Maculopathy Warning

In 2019, Janssen did update the Canadian label with information about pigmentary maculopathy, including a recommendation that Elmiron patients – particularly long-term users – undergo regular ophthalmic exams to ensure early detection. Yet the defendants have not changed the label in the United States or taken any other action to warn doctors and patients about these possible side effects.

“As a result of Defendants’ actions, Plaintiff and her physicians were unaware, and could not have reasonably known or have learned through reasonable diligence that Plaintiff would be exposed to the risks identified in this Complaint and that those risks were the direct and proximate result of Defendants’ conduct,” Pisco’s Elmiron lawsuit states.

“As a direct result of being prescribed and consuming Elmiron, Plaintiff has been permanently and severely injured, having suffered serious consequences.”