Elmiron Lawsuit | 2025 Latest Updates

If you or a loved one experienced vision problems or macular degeneration as a result of taking Elmiron, you may be entitled to pursue compensation.

At Schmidt & Clark, LLP, we are dedicated to helping individuals who have suffered due to Elmiron-related eye damage. Our experienced legal team is here to guide you through the process and fight for the compensation you deserve.

Contact Schmidt & Clark, LLP today for a free, no-obligation consultation.

Elmiron Lawsuit Overview

Elmiron lawsuits allege that Janssen Pharmaceuticals failed to adequately warn about the drug’s vision-related side effects. Before June 16, 2020, the packaging and warning labels did not include maculopathy as a potential risk, leaving doctors unaware of this complication. Multiple scientific studies have linked Elmiron to an incurable eye disease that can lead to blindness.

At least 100 complaints involving “eye disorders” in patients treated with Elmiron were filed with the FDA Adverse Event Reporting System from 1997 to 2019.

Latest Elmiron Lawsuit Updates

May 13, 2021 – Judge Brian R. Martinotti issued a Case Management Order directing lawyers to continue with general discovery and to present the Court with a plan to select cases for additional discovery before trial. The judge noted that the first bellwether trial would be held around January 2024.

June 16, 2020 – Janssen Pharmaceuticals updated Elmiron’s warning label to include pigmentary maculopathy as a potential risk from long-term use, advising regular eye exams for monitoring. This update came after increased scrutiny following Valarie Hull’s landmark lawsuit (Case No. MIDL003646-20) filed in September 2018, which was the first to link Elmiron to severe eye problems and drew significant attention to the drug’s risks [1].

FDA Reports and Statistics

At least 100 complaints involving “eye disorders” in patients treated with Elmiron were filed with the FDA Adverse Event Reporting System (FAERS) from 1997 to 2019. Eighty of the reports were classified as serious, and 22 listed maculopathy as the specific condition.

The FDA now advises Elmiron users to have regular eye exams, including auto-fluorescence imaging and optical coherence tomography, to monitor for potential retinal changes.

Elmiron Injuries & Side Effects

Elmiron has been linked to severe eye-related side effects, particularly with long-term use.

• Pigmentary Maculopathy: A unique form of retinal damage specifically associated with Elmiron use [2].
• Retinal Damage: Including permanent retinal pigment epithelium (RPE) injury.
• Vision Impairment: Blurred vision, difficulty reading, and prolonged dark adaptation.
• Visual Distortions: Objects appearing deformed or smaller than they are (metamorphopsia).
• Night Vision Loss: Difficulty seeing in low-light environments.
• Total Vision Loss: In severe cases, can progress to blindness.

Do You Qualify for an Elmiron Lawsuit?

You may qualify for an Elmiron lawsuit if:

• You experienced serious side effects including vision problems, pigmentary maculopathy, or other retinal damage after long-term use of Elmiron.
• The injuries required medical treatment or examination by an ophthalmologist.
• You can provide medical documentation linking your injuries to Elmiron use.

Evidence Required for an Elmiron Lawsuit

• Medical Records: Comprehensive eye exam reports from an ophthalmologist, including visual acuity and retinal health evaluations
• Advanced Imaging Results: Results from Optical Coherence Tomography (OCT) and autofluorescence imaging showing retinal damage
• Prescription History: Documentation of Elmiron dosage, duration, and any symptoms reported over time
• Specialist Diagnosis: Confirmation of pigmentary maculopathy or related condition from a qualified eye specialist

Damages You Can Recover

• Medical Expenses: Past and future costs for vision treatments, medications, and rehabilitation
• Lost Wages: Compensation for work missed due to vision impairment
• Pain and Suffering: For physical discomfort and emotional distress
• Diminished Quality of Life: Compensation for limited ability to perform daily activities
• Punitive Damages: In cases where manufacturer negligence is proven

Statute of Limitations for Elmiron Lawsuits

The statute of limitations to file an Elmiron Lawsuit is short. In most states, it is only one or two years from the time you discover your injury. This is why you should contact an attorney immediately if you suffer vision problems after taking Elmiron.

FAQs

1. How do I prove that Elmiron caused my vision problems?

To prove that Elmiron caused your vision problems, you will need to provide evidence of your Elmiron usage and medical records documenting your diagnosis of an eye condition linked to the drug. Expert testimony from medical professionals who can connect your condition to Elmiron may also be necessary.

2. Do I need a lawyer to file an Elmiron lawsuit?

Having an experienced attorney can significantly increase your chances of a successful outcome. A qualified Elmiron lawsuit lawyer can help navigate the complex legal process, gather necessary evidence, represent your interests in negotiations or court, and work to secure the maximum compensation for your case.

3. What evidence is needed to support an Elmiron lawsuit?

To support an Elmiron lawsuit, you need evidence of Elmiron usage, medical records showing vision problems or a diagnosis linked to the drug, and expert testimony connecting your condition to Elmiron.

4. What is interstitial cystitis?

Interstitial cystitis is a chronic bladder condition that causes bladder pressure, bladder pain, and pelvic pain. The condition is part of a spectrum of diseases known as painful bladder syndrome. In patients with IC, signals get mixed up — you feel the need to urinate more often and with smaller volumes of urine than most people.

5. Does Elmiron cure interstitial cystitis?

Elmiron is not a cure for interstitial cystitis. The drug helps to treat the symptoms by preventing irritation and swelling of the walls of the bladder. Elmiron is thought to function as a synthetic mucus layer around the bladder to guard against irritation.

6. Has Elmiron been recalled?

Janssen Pharmaceuticals has not issued a recall for Elmiron, and rheumatologists and urologists continue to prescribe it to patients across the U.S., despite the drug being linked to hundreds of reports of serious vision problems.

7. What is maculopathy, and how is it connected to Elmiron?

Maculopathy is a painless disease characterized by progressive loss of central vision that impairs eye function [3]. Studies have found that Elmiron causes maculopathy as a result of drug toxicity.

After at least 6 months of Elmiron use, about 25% of users develop pigmentary maculopathy, a unique form of macular injury that can cause blurred vision, permanent vision loss, and in severe cases, total blindness. The condition may occur without noticeable symptoms initially, as a healthy eye may compensate for vision loss in the affected eye.

8. How does vision damage from Elmiron progress over time?

Vision damage often develops gradually, with the first signs appearing after 3 years of using the medication or even earlier. Many affected individuals have used Elmiron for approximately 14.5 years, with symptoms intensifying over time. Even after discontinuation, vision issues can persist for one to nine years, suggesting permanent retinal damage in some cases.

9. Are there alternatives to Elmiron?

Although Elmiron is the only FDA-approved medication for interstitial cystitis, alternatives include dietary adjustments, nutraceuticals (calcium glycerophosphate, L-arginine, aloe vera), physical therapy, acupuncture, mind-body therapies, and, in severe cases, surgical options.

Get a Free Elmiron Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for Elmiron-related vision damage. With statutes of limitations as short as one to two years from the date of injury discovery, acting promptly is essential to preserve your legal rights.

Our services include:

• Free, confidential consultations
• No upfront costs or fees
• Payment only if we win your case