Elmiron Lawsuit Investigation
Results achieved in prior matters are not meant to be a guarantee of success as the facts and legal circumstances vary from matter to matter.
Were You Treated with Elmiron for Insterstitial Cystitis or Urinary Tract Infections?
Studies have linked prescription bladder drug Elmiron to partial blindness or other serious eye conditions that may be irreversible. (1) (2) (3) (4) If you have taken Elmiron to treat interstitial cystitis (also referred to as "painful bladder syndrome") and have suffered vision problems including partial blindness, you may be eligible to file a legal claim for your injuries. Discuss your legal options with an experienced Wilentz, Goldman & Spitzer, P.A. attorney by contacting us for a free case review.
What is Elmiron?
Elmiron (or its generic equivalent Pentosan Polysulfate Sodium) is the only FDA-approved prescription drug for the treatment of interstitial cystitis, a chronic bladder disorder commonly known as "painful bladder syndrome." According to the Interstitial Cystitis Association, the disorder may affect as many as 12 million people in the United States, with women making up the majority of patients. Symptoms include bladder pain, bladder discomfort, urinary urgency, pelvic pain and painful sexual intercourse.
Why Are Elmiron Lawsuits Being Filed?
Studies have linked long-term Elmiron use to medication toxicity that causes a novel type of damage to the retina, the light-sensing part of the eye that is responsible for clear vision. Despite numerous medical studies linking Elmiron to serious eye injury, the manufacturer has failed to warn patients about its risks and to recommend regular eye screenings. Because Elmiron has been widely prescribed to treat painful bladder syndrome for decades, hundreds of thousands of patients are believed to be at risk for medication toxicity.
Due to these serious side effects, scores of lawsuits were filed around the country, alleging that the manufacturer, Janssen Pharmaceuticals, failed to warn consumers that Elmiron can cause serious and permanent eye damage. In December 2020, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all pending Elmiron cases to be consolidated in the District of New Jersey. The JPML appointed U.S. District Judge Brian Martinotti to oversee the nearly 130 lawsuits.
Studies Link Elmiron to Pigmentary Maculopathy
Were you diagnosed with vision problems associated with the retina or macula?
Medical studies reveal that Elmiron may be toxic to the retina of the eye, causing a novel type of pigmentary maculopathy. Symptoms of pigmentary maculopathy include:
- Difficulty reading
- Blurry or fuzzy vision
- Delayed adjustment to low-light environments (also referred to as prolonged dark adaptation)
- Seeing dark spots
- Central vision loss or impairment
- Pattern dystrophy
- Dry macular degeneration
- Metamorphopsia, or distorted vision
Other eye damage and side effects linked to Elmiron include diagnoses of retinopathy, retinal maculopathy, retinal pigment epithelium atrophy, and macular retinopathy have also been linked in studies of patients with chronic exposure to Elmiron.
- A 2018 study led by Nieraj Jain, M.D, Assistant Professor of Ophthalmology, Emory University School of Medicine, of six patients treated for interstitial cystitis with Elmiron between 2015 and 2017 found they had developed a novel type of pigmentary maculopathy. The study concluded, “a novel and possibly avoidable maculopathy associated with chronic exposure to [Elmiron],” leading the researchers to issue a warning that long-term Elmiron use could lead to retinal damage. A follow-up study in 2019 of 10 patients demonstrated similar structural retinal damage from chronic exposure to Elmiron.
- Another 2019 study conducted by three ophthalmologists from Kaiser Permanente found that long term use of Elmiron caused retinal damage in 25% of their patients taking an average of 5,000 pills annually over a 15-year period, and that Elmiron toxicity may mimic macular degeneration, pattern dystrophy, and other well-known retinal conditions. As a result of these concerns, the physicians recommended that Elmiron users be screened, at a minimum, once a year for retina damage, and that patients demonstrating damage see their urologist or gynecologist immediately.
- Subsequently, in 2019, Dr. Rachel Huckfeldt MD PhD, of the Harvest Medical School Department of Ophthalmology published the first case study of a patient treated for interstitial cystitis with Elmiron demonstrating that maculopathy continued to progress even years after patients discontinued the use of Elmiron.
How Wilentz Can Help
Wilentz, Goldman & Spitzer, P.A. is investigating cases of serious eye damage and vision problems in adult patients who have regularly taken Elmiron (Pentosan Polysulfate Sodium). If you or a loved one have been diagnosed with pigmentary maculopathy or another serious eye condition that you believe may be related to Elmiron, you may be entitled to compensation for your injuries. Discuss your legal options with a Wilentz attorney by calling us now or by using the consultation request option on this page.
As an established personal injury law firm, our attorneys have many years of experience handling complex defective drug cases and can help you understand your legal options. There are no out-of-pocket costs if we accept your case. Over the years, we have recovered over $2 billion in damages on behalf of our injured clients. Results achieved in prior matters are not meant to be a guarantee of success as the facts and legal circumstances vary from matter to matter.
- Pearce WA, Chen R, Jain N. Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium. Ophthalmology. 2018;125(11):1793-1802. doi:10.1016/j.ophtha.2018.04.026
- Chronic Exposure to Pentosan Polysulfate Sodium is Associated with Retinal Pigmentary Changes and Vision Loss, Jenelle Foote, Adam Hanif, Nieraj Jain, Journal of Urology, Infections/Inflammation/Cystic Disease of the Genitourinary Tract: Interstitial Cystitis (MP47)
- Vora RA, Patel AP, Melles R. Prevalence of Maculopathy Associated with Long-Term Pentosan Polysulfate Therapy. Ophthalmology. 2020;127(6):835-836. doi:10.1016/j.ophtha.2020.01.017
- Huckfeldt RM, Vavvas DG. Progressive Maculopathy After Discontinuation of Pentosan Polysulfate Sodium. Ophthalmic Surg Lasers Imaging Retina. 2019;50(10):656-659. doi:10.3928/23258160-20191009-10