For decades, Elmiron was the sole FDA-approved medication for interstitial cystitis (IC), a painful bladder syndrome that strikes millions. Yet, increasing research has associated long-term use of Elmiron with severe eye damage, including a rare type of retinal disease called pigmentary maculopathy. Patients who had once relied on this drug are now experiencing irreparable vision impairments, and many are seeking justice through the legal system.
In this article, you will find out what are the Elmiron lawsuits, who can qualify to make a claim, what symptoms to look out for, and what to expect throughout the legal process.
What Is Elmiron?
Elmiron (pentosan polysulfate sodium) is a prescription drug manufactured by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary). It was approved in 1996 by the U.S. Food and Drug Administration to treat interstitial cystitis, a chronic bladder pain syndrome. The drug is believed to work by forming a protective layer on the bladder wall to reduce irritation.
For decades, Elmiron was seen as a safe and effective treatment for IC. However, emerging studies have uncovered a disturbing link between long-term Elmiron use and irreversible vision loss.
Health Risks Linked to Elmiron
In 2018, ophthalmologists began noticing a pattern of vision damage in patients who had taken Elmiron for extended periods. This damage appeared as a distinct form of pigmentary maculopathy, which affects the macula — the part of the retina responsible for central vision.
Some of the key symptoms associated with Elmiron-related eye damage include:
- Blurred or distorted vision
- Difficulty reading or seeing in low light
- Dark spots in vision (scotomas)
- Muted colors or difficulty adjusting to light
- Eye pain or pressure
- Vision loss over time
What makes these cases particularly troubling is that the retinal damage can continue even after stopping the drug. In many instances, the damage is irreversible and can lead to blindness.
Scientific Evidence and Warnings
Several peer-reviewed studies have supported the connection between Elmiron and retinal damage:
- 2018 Study by Emory Eye Center: This landmark study first identified pigmentary maculopathy in six patients taking Elmiron long-term. The condition had previously been misdiagnosed as age-related macular degeneration.
- 2019 Kaiser Permanente Study: An analysis of over 90 patients found that nearly one-quarter of long-term Elmiron users showed signs of retinal damage.
- FDA Warning: In June 2020, the FDA required Janssen to update Elmiron’s label to include warnings about the risk of retinal pigmentary changes and visual disturbances.
Despite these warnings, critics argue that Janssen should have acted sooner to alert the medical community and the public.
Basis for Elmiron Lawsuits
Thousands of patients who suffered vision problems after using Elmiron have filed product liability lawsuits against Janssen Pharmaceuticals. The core allegations include:
- Failure to Warn: Plaintiffs claim that Janssen failed to adequately warn patients and healthcare providers about the risk of vision damage.
- Negligence: The lawsuits allege that the manufacturer ignored early warning signs and failed to conduct proper safety testing.
- Defective Design: Some suits argue that the drug’s chemical makeup is inherently dangerous, especially with long-term use.
- Misrepresentation: Plaintiffs also claim that the drug was marketed as safe without disclosing serious risks.
In 2020, these individual lawsuits were consolidated into a multidistrict litigation (MDL) in the District of New Jersey. MDL 2973 allows similar claims to be grouped together to streamline the discovery process and pretrial proceedings.
Who Qualifies to File an Elmiron Lawsuit?
If you or a loved one took Elmiron for at least six months and were later diagnosed with vision problems, you may qualify for compensation. Criteria often include:
- History of Elmiron use (usually six months or longer)
- Diagnosis of pigmentary maculopathy, macular degeneration, or other retinal conditions
- Onset of symptoms while using Elmiron or shortly after stopping
- No prior history of retinal disease unrelated to Elmiron
If you are unsure whether you qualify, speaking with an attorney who specializes in defective drug litigation can help clarify your options.
What Compensation Can Victims Recover?
Elmiron lawsuits seek to hold the manufacturer accountable and secure compensation for the devastating impact of vision loss. Plaintiffs may be eligible for:
Economic Damages
- Medical expenses (past and future)
- Costs of vision aids or accommodations
- Lost wages or earning capacity
- Transportation and support services
Non-Economic Damages
- Pain and suffering
- Emotional distress and anxiety
- Loss of independence or quality of life
- Loss of enjoyment of hobbies, such as reading or driving
Punitive Damages
In cases where the defendant’s conduct was particularly reckless or intentional, punitive damages may be awarded to punish wrongdoing and deter similar behavior.
Legal Process and Timeline
Here’s a general overview of what to expect if you decide to file a claim:
1. Consultation and Case Evaluation
An attorney will review your medical history, prescription records, and symptoms to determine whether you have a valid claim.
2. Filing the Lawsuit
If eligible, your attorney will file your claim either as part of the MDL or as an individual lawsuit in state or federal court.
3. Discovery Phase
This stage involves exchanging evidence, conducting depositions, and building the legal arguments.
4. Settlement or Trial
Many mass tort cases end in settlement. However, some claims may go to trial if the parties cannot agree on compensation.
5. Compensation Distribution
If a settlement is reached or the plaintiff wins in court, funds will be distributed to cover damages, legal fees, and other costs.
While timelines can vary, mass tort cases like this typically take several months to years to resolve.
Why Legal Representation Matters
Filing a drug injury lawsuit can be complex. Pharmaceutical companies have deep pockets and aggressive legal teams, and proving causation requires medical records, scientific evidence, and expert testimony.
Hiring an experienced Elmiron lawsuit attorney gives you access to:
- Medical and scientific experts
- Knowledge of MDL procedures and court rules
- Resources to investigate and build a strong case
- Skilled negotiation with the defendant’s legal team
- Confidence that your rights are being protected
Most attorneys in these cases work on a contingency fee basis, meaning you pay nothing unless they win compensation for you.
Elmiron Lawsuit Status in 2025
As of early 2025, the Elmiron MDL is ongoing, with over 1,800 cases pending. Bellwether trials, which help gauge how juries respond to evidence, are expected to influence potential settlement negotiations. Attorneys continue to accept new clients who meet the criteria, as the litigation remains active and evolving.
If you believe Elmiron may have caused your vision loss, time is critical. Each state has a statute of limitations for filing personal injury lawsuits—often two to three years from when the injury occurred or was discovered.
About the Author
Neil Bhartia
Neil Bhartia isn’t your typical, stuffy attorney that you see on TV. While some have their sights exclusively on money and treat their clients like a number, Neil takes a personal interest in every single client he has. As an empath, Neil understands that people that seek legal help are typically in an involuntary, and stressful situation, and he goes out of his way to diffuse the stress and educate clients on each every detail of the legal process.
