A group of plaintiffs in Florida have filed a class action lawsuit against the makers of Elmiron, alleging that side effects of the widely used bladder medication may expose users to an increased risk of retinal maculopathy, a progressive eye disease characterized by permanent retinal damage, vision loss and blindness. If you or someone you love has been diagnosed with retinal maculopathy or another severe eye disorder and you believe alleged Elmiron side effects to be the cause, contact us today to find out if you are eligible to file an Elmiron injury claim. Former Elmiron users are pursuing product liability lawsuits against Janssen Pharmaceuticals, alleging that the drug maker knew or should have known that Elmiron can cause irreversible retinal maculopathy, even when taken as prescribed.
Janssen Pharmaceuticals faces a growing number of Elmiron lawsuits filed in courts across the country, alleging that the bladder drug caused users to suffer severe vision loss side effects. This new Elmiron lawsuit was filed earlier this month in the U.S. District Court for the Southern District of Florida by plaintiffs Jane Appelbaum, Linda Hall, Kenaope Rutang and Dawn Darrow. The plaintiffs are seeking class action status to pursue damages on behalf of themselves and former Elmiron users in Florida, who the plaintiffs indicate will require regular retinal examinations and vision monitoring to detect retinal maculopathy complications from Elmiron. The plaintiffs are asking the court to require Janssen to implement a medical monitoring program for the early detection, treatment and study of Elmiron vision loss side effects for the remainder of the plaintiffs’ and class members’ lives.
Elmiron was introduced to the U.S. market in 1996 as a treatment for a bladder condition called interstitial cystitis (IC), one of a group of bladder diseases known collectively as “painful bladder syndrome.” For decades, Elmiron was sold as a safe and effective treatment for interstitial cystitis without any warnings about the potential for Elmiron users to experience retinal damage possibly leading to vision distortion, blurred vision, dark spots in vision, difficulty reading, difficulty adjusting to dim lighting and other vision complications. It wasn’t until June 2020, after a series of scientific studies and independent case reports identified a link between Elmiron and maculopathy, that Janssen announced a warning label update for Elmiron.
“Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron,” the new Elmiron warning label reads. “Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.”
The plaintiffs in this new Elmiron class action lawsuit allege that the defendants knew or should have known that Elmiron, when taken as prescribed, causes harmful retinal damage and retinal maculopathy, also known as pigmentary maculopathy. “Numerous patient reports, scientific studies, and even alerts by governmental agencies have established that Elmiron causes retinal damage, including Pentosan Polysulfate Sodium Maculopathy (“PPS Maculopathy” or “pigmentary maculopathy”), a signature condition caused by Elmiron toxicity,” the lawsuit states. “Nevertheless, Defendants failed to warn, instruct, advise, educate, or otherwise inform Elmiron users, Elmiron prescribers, or United States governmental regulators about the risk of pigmentary maculopathy or the need for medical, ophthalmological monitoring. At all relevant times, the U.S. label for Elmiron made no mention of risk to patients’ eyes or vision.”
As the only oral medication approved to treat the chronic pain and discomfort associated with interstitial cystitis, Elmiron is widely used by IC patients across the United States, and because there is no cure for the bladder condition, long-term Elmiron use is common. In light of a growing body of evidence linking Elmiron use to permanent vision loss, however, many former Elmiron users have stopped taking the medication. Unfortunately, reports indicate that vision problems from Elmiron are irreversible and may continue to progress even after treatment is discontinued, possibly for as long as 10 years after discontinuation.
“Regular examinations, monitoring, and early detection are necessary to identify and possibly alleviate the devastating vision issues that Elmiron is causing and will continue to cause in the years to come,” the Elmiron class action lawsuit states. If you or a loved one took Elmiron to manage the symptoms of interstitial cystitis and subsequently suffered vision loss problems like blurred vision, difficulty adapting to dim light or darkness, near vision difficulty or blind spots, you may have grounds to file an Elmiron injury claim against Janssen Pharmceuticals. Contact us today to find out if you are eligible to join the ongoing Elmiron vision loss litigation.