Elmiron Lawsuit News: Florida Woman Alleges Janssen Failed to Warn on Maculopathy

Published on May 8, 2020 by Sandy Liebhard

A Florida woman who developed maculopathy after taking Elmiron for more than two decades has filed suit against Janssen Pharmaceuticals for failing to warn patients and doctors that the bladder drug could result in permanent vision loss and impairment.

Elmiron and Maculopathy

According to a complaint filed in the U.S. District Court, Middle District of Florida, on May 6th, Elmiron (pentosan polysulfate sodium or PPS) was approved by the U.S. Food & Drug Administration in 1996 to treat bladder pain and discomfort caused by interstitial cystitis. Since then, however, a growing body of research has suggested patients taking Elmiron are more likely to develop maculopathy, a retinal disorder that can result in the permanent loss of vision. (Case No. 2:20-cv-00330-SPC-MRM)

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 who developed maculopathy. None of the subjects had a family history of eye disorders, but all had been taking Elmiron prior to their 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, researches 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 Labeling Includes No Mention of Vision Disorders

Plaintiff Tara O’Flaherty was prescribed Elmiron in 1994 to treat interstitial cystitis, and continued using the medication through 2019. According to her Elmiron lawsuit, she was never warned and had no knowledge of the serious risk of retinal damage and vision loss posed by the drug. As a result of her exposure to Elmiron, she now suffers from maculopathy, blurriness, and distorted vision.

The complaint asserts that despite the numerous reports and studies linking Elmiron to retinal damage and vision loss, Janssen has failed to include any warnings or mention of these potential side effects in the Elmiron labeling and marketing materials provided to doctors and patients in the United States.

“Defendants had a duty to warn Plaintiff, Plaintiff’s physicians, and the public in general of Elmiron’s dangers and serious side effects,” the lawsuit states, “including serious and potentially irreversible vision issues and retinal harm, since it was reasonably foreseeable that an injury could occur because of Elmiron’s use.

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