Elmiron Lawsuit for IC Settlement

UPDATE: In December 2020, Elmiron lawsuits filed throughout the nation were consolidated into a Multidistrict Litigation (MDL 2973), in the United States District Court, District of New Jersey, before the Honorable Brian R. Martinotti, U.S.D.J.

Again, if you have taken Elmiron (pentosan polysulfate sodium) and have had a fundus autofluorescence imaging (FAF) test showing pigmentary maculopathy, you should contact our Elmiron attorneys immediately.

Elmiron is Janssen Pharmaceuticals’ brand name for the drug pentosan polysulfate sodium (or PPS). Elmiron is prescribed to treat interstitial cystitis (or IC), commonly referred to as painful bladder syndrome. Painful bladder syndrome is basically what the name entails – a condition, primarily affecting women, that causes extreme pain in the bladder and frequent urination. Elmiron essentially coats the bladder, helping to ease these symptoms. Accordingly, Elmiron has been used for decades as a long-term treatment for painful bladder syndrome.

Unfortunately, Elmiron use has given rise to numerous studies and recent well-publicized lawsuits across the country, contending that Elmiron can cause severe, possibly permanent, vision loss with long-term use.

Do you have vision loss or similar complications? Have you taken Elmiron? You may be entitled to compensation. Speak with our Elmiron IC attorneys today to be sure.

How Do I Know If I Have an Elmiron Case?

If you have been a long-term user of Elmiron and experienced vision loss, you could be entitled to compensation. Studies show that Elmiron can cause damage to the retina and a specific condition called pigmentary maculopathy, which can lead to permanent vision loss and even blindness. Note that the tell-tale signs of pigmentary maculopathy, such as difficulty reading or adjusting to the dark, can seem similar to natural vision deterioration with age. However, this can be an indication of a much more serious condition. If you have taken Elmiron over an extended period of time, suffered vision loss and been diagnosed with pigmentary maculopathy, you could be eligible to participate in ongoing national Elmiron lawsuits and settlements.

You may be entitled to compensation. Do not wait. Speak with our Elmiron attorneys today so that you can know your rights.

Contact A Stark & Stark Elmiron Lawyer To Assess Your Claim

The Stark & Stark law firm is not like many of the marketing companies you have seen on television. Established in 1933, we are a firm of over 100 attorneys in offices throughout New York, New Jersey and Pennsylvania, including experienced trial attorneys that you can meet and talk to about your case and possible Elmiron settlement. Stark & Stark is committed to holding drug and medical device manufacturers liable when their products improperly endanger the public. Our Elmiron attorneys are experienced in class action, mass tort and multidistrict litigation cases and in negotiating with medical device and pharmaceutical settlement representatives. If you or a member of your family has suffered vision loss from Elmiron use, you may be entitled to compensation via litigation and/or settlement.

Please contact Stark & Stark to speak with one of the Elmiron IC lawyers, free of charge, who can help assess any claims that you may have and to help you to understand the interstitial cystitis lawsuit and settlement process. We are experienced in PPS IC Elmiron settlements, allow us to help you today.

What Do Elmiron Scientific Studies Show?

Smaller studies going back to early 2018 appeared to give an indication of the connection between Elmiron, eye damage and vision loss. The American Academy of Ophthalmology has detailed many of these studies. [NOTE: Do not stop taking any medication without first consulting with your doctor.]

This includes an early study of six patients that had taken Elmiron for over a decade and developed damage to their retinas and corresponding vision loss. It would soon become clear that this retina damage was a unique condition known as pigmentary maculopathy. The findings were very troubling, including:

We describe a novel and possibly avoidable maculopathy associated with chronic exposure to PPS (pentosan polysulfate sodium). Patients reported symptoms of difficulty reading and prolonged dark adaptation despite generally intact visual acuity and subtle funduscopic findings. Multimodal imaging and functional studies are suggestive of a primary RPE [retinal pigment epithelium] injury. Additional investigation is warranted to explore causality further. (Source)

The striking results of these initial studies did not compel Janssen Pharmaceuticals to change its United States Elmiron labeling or otherwise warn patients of these potential risks, despite the fact that over one million patients (primarily women) in this country suffer from interstitial cystitis (or IC), commonly referred to as painful bladder syndrome, and Elmiron is the only oral medication approved by the United States Food and Drug Administration as a treatment.

Larger studies followed. Doctors at Kaiser Permanente reviewed their extensive records of several million patients and examined over ninety painful bladder syndrome patients that had taken Elmiron for more than a decade. It was found that over a quarter of those patients showed retinal abnormalities that were attributed to the toxicity of Elmiron. These results were further bolstered by a study of several thousand patients in the United States medical claims database. Part of the conclusion reached was that “[Elmiron] exposure was associated with a new diagnosis of macular disease at the 7-year follow-up in a large national cohort.” Notwithstanding, the drug manufacturer, again, made no change to its drug labels to warn of the dangers of long-term Elmiron use causing vision loss.

An additional study of ten patients similarly showed a clear connection between long-term or chronic Elmiron use and “this unique form of pigmentary maculopathy.” Part of the conclusion of that study noted:

We describe a potentially avoidable retinal degeneration phenomenon associated with chronic PPS [Elmiron] exposure. Structural changes occur at the level of the retinal pigment epithelium, manifesting as characteristic pigmentary changes. While it remains unclear whether drug cessation will alter the course of retinal disease, we encourage affected patients to discontinue use, and patients with suggestive visual symptoms to undergo a comprehensive ophthalmic examination with OCT and FAF imaging. (Source)

Perhaps even more sobering, is the recent study of at least one instance where long-term Elmiron use is linked to injuries long after treatment is stopped. Part of that conclusion was:

A pigmentary maculopathy associated with chronic use of the drug pentosan polysulfate sodium (PPS) [Elmiron] was recently described. The authors present a case of PPS-associated maculopathy that continued to progress for 6 years after discontinuation of this medication. (Source)

Presently, there seems to be little doubt in the scientific community that prolonged use of Elmiron is linked to retina damage, pigmentary maculopathy, and possibly permanent loss of vision. Some experts fear that the number of patients taking Elmiron, combined with the time that it takes for vision loss to occur, along with the misdiagnosis of the cause of that vision loss, may put patients at substantial risk.

Despite these demonstrated science-based connections between Elmiron use and pigmentary maculopathy, the drug manufacturer has still not changed its warnings or otherwise notified patients taking Elmiron of these dangers of severe injuries. This has spawned ongoing lawsuits across the nation involving allegations of permanent vision loss due to Elmiron use.

The attorneys of Stark & Stark’s Mass Tort and Class Action Team of lawyers have successfully represented thousands of clients throughout the nation in Defective Drug and Medical Device Mass Actions, Toxic Tort Mass Actions, Employment and Civil Rights Class and Mass Actions, Investor/Securities Class Actions, and Consumer Fraud Class Actions. We are not a marketing company. We are a firm of over 100 attorneys, including experienced trial attorneys that you can meet and talk to about your case.

Contact our Elmiron attorneys for an evaluation of your potential claims. There is no obligation and no cost to you. Contact us today.