A number of Elmiron lawsuits allege that the drug, taken to control painful bladder syndrome, causes vision loss.

Generically known as pentosan polysulfate sodium, Elmiron received U.S. Food and Drug Administration (FDA) approval in 1996. The prescription medication helps control pain caused by interstitial cystitis, which mainly affects women. The condition causes severe pain in the bladder and pelvic areas in addition to an increase in the frequency of urination, but side effects of Elmiron may include permanent vision damage.

Elmiron has been linked with an increased risk of pigmentary maculopathy, a type of macular degeneration that causes the pigmented cells under the retina to come apart, resulting in the pigment floating into the macula.

Dr. Nieraj Jain, MD was one of the first doctors to question whether there could be a link between Elmiron and pigmentary maculopathy. He saw several of his patients begin to develop a similar pattern of visual disturbances after more than a decade of taking Elmiron. His views were noted in 2018 by the American Academy of Ophthalmology.

Janssen Pharmaceuticals, Ortho-McNeil Pharmaceuticals, Johnson & Johnson and Teva Pharmaceuticals are the companies behind Elmiron.

Alleged Retinal Damage

Plaintiffs Sherry D. and James D. filed an Elmiron lawsuit in July 2020, alleging that the bladder medication caused Sherry to develop retinal damage, adversely affecting her vision. She said she started taking Elmiron in 2004 and alleges that drugmakers kept the potentially serious side effects from doctors and patients in order to not impede sales.

Sherry claims that the drug companies knew as far back as 1996 that Elmiron was causing visual disturbances and damage to the eyes, but no warnings were provided to physicians or patients. She is seeking compensation for pain and suffering, emotional distress, economic losses, past and future medical expenses, and continued mental anguish that the loss of her visual acuity has caused her.

Woman Suffers Vision Loss

Kimberly P. of Connecticut alleges in her lawsuit that she began taking Elmiron in 2005, which purportedly caused her to begin suffering vision problems around 2015. According to her complaint, she received a diagnosis in 2019 that she had incurred permanent retinal injury and vision loss, which she says was brought on by her years on Elmiron. She further noted that because Elmiron is meant to be used as a long-term medication, most patients such as herself will be expected to depend on it for years, and even decades. Sherry’s lawsuit alleges that the retina is particularly susceptible to damage caused by systemic drugs like Elmiron because the retina has almost no ability to regenerate damaged cells. The damage has resulted in Kimberly’s diagnosis of retinal macula dystrophy, which causes vision impairment when looking straight ahead to read, drive or conduct other activities that don’t depend upon peripheral (side) vision only.

Loss of Balance, Night Vision

In October, plaintiff Beverly Z. filed an Elmiron lawsuit alleging the drug has caused her numerous visual disturbances. Beverly claims she’s suffered loss of vision, problems adjusting to changes in light, loss of the ability to discern colors, loss of night vision, loss of balance, and a diagnosis of toxic maculopathy in June 2020, all of which she attributes to her use of Elmiron.

According to Beverly’s complaint, she began taking Elmiron in 2001, which means she took the medication for about 19 years.

Elmiron Lawsuits Combined as MDL

In mid-December, at least 42 Elmiron lawsuits were combined as a multi-district litigation (MDL) in New Jersey where the Elmiron MDL will be overseen by Judge Brian R. Martinotti.

The plaintiffs had asked the Judicial Panel on Multidistrict Legislation (JPMDL) to centralize the lawsuits, which the JPMDL granted, citing the probability that the individual lawsuits would probably duplicate discovery and possibly result in inconsistent pretrial rulings. The JPMDL said it expects the MDL to expand, most likely addressing hundreds of lawsuits.