Was There An Elmiron Class Action Lawsuit Over Eye Problems?
Yes. Hundreds of former users of the bladder drug pursued Elmiron class action lawsuits and individual injury claims against Johnson & Johnson and Jannsen Pharmaceuticals, over failure to warn about serious risks of losing eyesight and developing vision problems after taking the drug, including:
- Blurry Vision
- Loss of Night Vision
- Distorted Vision
- Difficulty Reading
- Trouble Driving
- Dark Spots
- Central Vision Loss
- Depth Perception Problems
- Prolonged Adaption to Dim Light
- Blindness
The Elmiron litigation emerged after a number of independent studies identified that users may be left with permanent eye damage from Elmiron, known as pigmentary maculopathy. However, the first information about a risk of retina disease was not added to the Elmiron FDA warning label until June 2020.
Reports found that 20% of long-term users of Elmiron experience pigmentary maculopathy. It is a serious and dangerous side effect, involving a degenerative eye disease that causes progressive central vision damage and blindness.
What Is the Status of Elmiron Settlement Negotiations?
Elmiron lawsuits were previously filed against Johnson & Johnson and Janssen Pharmaceuticals by individuals who alleged that long-term use of the interstitial cystitis drug caused pigmentary maculopathy, retina damage, vision loss and other serious eye problems.
The lawsuits generally sought compensation for the impact these vision injuries had on plaintiffs’ lives, including:
- Coverage for Medical Expenses and Vision Treatments
- Compensation for Pain and Suffering
- Past and Future Lost Wages or Earning Capacity
- Other Benefits for Retina Damage Caused by Elmiron
What was the average Elmiron lawsuit settlement amount?
There is no publicly established average Elmiron lawsuit settlement amount that applies to all claims. The value of any potential settlement would depend on the specific facts, medical evidence and legal issues involved. In general, settlement amounts in drug injury lawsuits may vary widely based on several factors, including:
- The extent and duration of the retinal injuries
- The severity of the vision problems linked to Elmiron use
- The effect of pigmentary maculopathy or vision loss on the individual’s daily life, physical health and emotional well-being
- The amount of past or future medical expenses related to the eye injury
- Any lost income or reduced earning capacity caused by the vision damage
- The strength of the evidence showing long-term Elmiron use and resulting eye damage.
Any settlement offer in an individual Elmiron lawsuit would typically be evaluated based on the facts of that claim and the potential risks of continuing through the court system. Plaintiffs with existing claims should speak with the attorney handling their case about any settlement discussions, case value or available legal options.
Latest Elmiron Lawsuit Update
Update – April 21, 2026: The federal Elmiron MDL has declined substantially from the height of the litigation, when nearly 2,000 lawsuits had been filed over vision injuries allegedly caused by long-term use of the drug. As of early 2026, fewer than 700 cases remained pending, indicating that many previously filed claims have likely been resolved, dismissed, withdrawn or otherwise closed.
Update – October 4, 2022: Judge Martinotti has scheduled the first Elmiron trial to begin on January 30, 2023. This is expected to be followed by additional jury trials in March 2023 and May 2023, unless Elmiron settlements are reached to resolve claims.
Update – June 6, 2022: – An Elmiron lawsuit filed by Maria Windham has been selected for the first bellwether jury trial in January 2023. Ms. Windham developed pigmentary changes and macular degeneration after taking Elmiron for two years. While the outcome of the Elmiron trial will not impact the lawsuit payout other plaintiffs may receive, it will be closely watched and may signal how juries may value the vision problems caused by Elmiron.
Update – May 13, 2021: The Judge presiding over the federal Elmiron litigation has indicated that the first bellwether trial will be held in January 2023, followed by two subsequent trials. Combined the bellwether trials are designed to help parties gauge the relative strengths and weaknesses of hundreds of other claims, and may lead to Elmiron settlement negotiations.
Update – December 15, 2021: In response to a growing number of Elmiron eye damage lawsuits brought throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to centralize pretrial proceedings before U.S. District Judge Brian R. Martinotti in New Jersey. Judge Martinotti is a well respected and fair judge, who has substantial experience presiding over complex mass tort lawsuits.
What Allegations Have Been Raised in the Elmiron Class Action Lawsuit?
Many individuals who took Elmiron and experienced eye problems may have suffered needlessly for years. According to allegations previously raised in the Elmiron litigation, drug manufacturers:
- Failed to properly research the Elmiron retina side effects before introducing the drug;
- Failed to promptly follow up and investigate reports of macular degeneration, pigmentary maculopathy and other retina damage among Elmiron users;
- Withheld critical Elmiron warnings and information from consumers and the medical community;
- Knew or should have known that monitoring for signs of Elmiron vision changes with regular examinations may help users avoid serious eye problems;
- Failed to promptly issue an Elmiron recall or updated safety warnings as it became clear that long-term users face a high risk of vision loss, blindness and other eye problems;
What are the side effects of Elmiron?
Elmiron lawsuits were filed by individuals who used the drug and were later diagnosed with:
- Blurry Vision
- Loss of Night Vision
- Distorted Vision
- Difficulty Reading
- Trouble Driving
- Dark Spots
- Central Vision Loss
- Depth Perception Problems
- Prolonged Adaption to Dim Light
- Blindness
Has Elmiron induced pigmentary maculopathy been misdiagnosed as other eye diseases?
Elmiron lawsuits claimed that some individuals who developed vision problems after long-term use of the drug were initially diagnosed with other retinal conditions before pigmentary maculopathy was identified.
Because Elmiron-related pigmentary maculopathy may share symptoms or clinical findings with other eye diseases, lawsuits alleged that some users were misdiagnosed with conditions such as:
- Age-Related Macular Degeneration (AMD)
- Pattern Dystrophy
- Stargardt disease
- other Genetic Retina Deterioration
Other Elmiron Lawyer Frequently Asked Questions
What is Elmiron?
Introduced by Janssen Pharmaceuticals in 1996, the prescription drug Elmiron (pentosan polysulfate sodium or PPS) is a medication for individuals suffering from “interstitial cystitis” (IC), which involves severe bladder pressure, bladder pain and sometimes pelvic pain. Impacting more than one million people throughout the United States, interstitial cystitis is part of a spectrum of diseases commonly referred to as “bladder pain syndrome” and is most common among women.
While it was sold as a safe and effective drug for bladder and pelvic pain caused by IC, research suggested that there is a link between side effects of Elmiron and macular degeneration, or other eye disease that results in irreversible retina damage, vision loss and blindness.
Elmiron lawsuits alleged that earlier warnings may have allowed patients and doctors to identify vision symptoms sooner, monitor for retinal changes or reconsider continued use of the drug.
How does the prescription drug Elmiron work?
Interstitial cystitis (IC) is often mistaken for a urinary tract infection (UTI), but is a chronic condition that has no known cure. As a result, most Elmiron users remain on the medication for years, if not decades.
The active pharmaceutical ingredient in Elmiron, pentosan polysulfate sodium or PPS, is a heparin-like compound that has anticoagulant and fibrinolytic effects. The exact mechanism of action for Elmiron treating interstitial cystitis is not known, even to the drug makers.
While the medication has been marketed as safe and effective, without adequate warnings that Elmiron may cause eye problems, users throughout the United States have been diagnosed with atypical retinal maculopathy and other eye disease that researchers have found is linked to long-term, chronic exposure.
Although there were more than a dozen published reports and papers involving vision problems or maculopathy from Elmiron side effects, the drug makers did not provide any information for users and doctors in the United States until June 2020, after thousands of long-term users had already been left with permanent vision loss and retina damage.
How do you confirm Elmiron caused retina damage?
After discovering the link between Elmiron and retinal pigmentary changes, researchers are continuing to examine the risk and study the mechanism of action that allows Elmiron to cause eye damage.
Pigmentary maculopathy from Elmiron is a unique form of damage to the macula in the eye, which provides central vision. This retinal injury is typically diagnosed by an ophthalmologist, following multimodal imaging eye exam.
This optical testing involves the use of multiple different types of imaging scans conducted at the same time. By correlating the different types of information those imaging scans produce, eye doctors can get a clearer picture of what is occurring.
In February 2021, researchers with Northwestern University published a study that identified a “signature” for Elmiron maculopathy, involving a “distinct clinical constellation” of retinal damage caused by Elmiron.
Subsequent findings by researchers at the Stein Eye Institute at the University of California, Los Angeles indicate that 1-in-5 long term users of Elmiron have evidence of the unique retina damage.
An ophthalmologist can easily diagnose this Elmiron eye injury through multimodal imaging scans that include fundus photography, fundus autofluorescence and ocular coherence tomography imaging all at once.
Updated Studies Linking Elmiron and Eye Damage
May 2018 Update
A retrospective case series was published in the medical journal Ophthalmology, describing six Elmiron vision loss cases involving atypical maculopathy associated with long-term use.
Users were evaluated between May 2015 and October 2017, with ages ranging from 37 to 62 years old, and the length of Elmiron exposure ranging between 12 and 20 years. Primary symptoms included difficulty reading and prolonged dark adaption, with examinations revealing retinal pigmentary maculopathy.
November 2018 Update
Letter to the editor was published in The Journal of Urology, responding to a report published in July 2018.
Researchers with the Emory University School of Medicine, Department of Ophthalmology wrote to alert readers to concerning new observations involving vision threatening retinal changes associated with Elmiron long-term exposure. Authors recommended any patient with Elmiron vision symptoms undergo comprehensive ophthalmic exams.
May 2019 Update
Findings were presented at the Annual Meeting of the American Urological Association in Chicago from a study involving 10 Elmiron patients with vision threatening retinal degradation who had been treated for interstitial cystitis.
Researchers described a “unique form of pigmentary maculopathy”, and indicated that similar problems were not seen among 156 other patients treated for the same bladder condition who were not using Elmiron.
September 2019 Update
In a study published by the medical journal JAMA Ophthalmology, Canadian researchers described an eye condition as “pentosan polysulfate sodium (PPS)-associated maculopathy” or Elmiron maculopathy.
Researchers reviewed medical records of 35 long-term Elmiron users who exhibited characteristics of maculopathy, including women between the ages of 37 and 79 years old, who had received the drug between 3 years and 22 years. Leading symptoms of Elmiron vision problems included metamorphopsia, blurred vision and prolonged adjustment to dark light.
October 2019 Update
Health Canada announced an Eliron warning update that added information about the risk of pigmentary maculopathy reported among long-term users.
Updated warnings recommended that long-term Elmiron users have regular ophthalmic eye examinations for early detection of the retinal problems, and suggested that doctors should consider stopping treatment among users diagnosed with pigmentary maculopathy.
October 12, 2019 Update
A new study was presented at the 2019 Annual Meeting of the American Academy of Ophthalmology, indicating that about 25% of patients with chronic exposure to Elmiron shows retinal damage signals.
Three California ophthalmologists reviewed records from a database involving millions of patients, and found 140 Elmiron patients who had taken an average of 4,000 Elmiron pills over a period of 15 years. 91 of the 140 patients agreed to come in for an eye exam, and about one-quarter (22) showed clear signs of drug toxicity. In the late stages, the retina toxicity can mimic age-related macular degeneration (AMD) and result in permanent vision loss.
November 6, 2019 Update
A retrospective analysis of data from a large U.S. medical claims database was published by the British Journal of Ophthalmology, indicating that at a 7 year analysis, Elmiron users had significantly increased odds of having atypical maculopathy or a new diagnosis of macular disease.
November 2019 Update
Case report published by Harvard researchers in Ophthalmic Surgery, Lasers and Imaging Retina described a case of Elmiron maculopathy that continued to worsen over six years after stopping use of the drug.
The researchers indicated that after using 200mg of Elmiron for 18 years, a 62 year old woman stopped taking the drug after developing vision problems. However, over the next six years, she continued to suffer increasing vision damage.
December 2019 Update
In the American Journal of Ophthalmology Case Reports, researchers with Kaiser Permanente described a case of eye problems from Elmiron misdiagnosed as Stargardt disease, which is a genetic form of retina deterioration.
A 41 year old woman sought a second opinion after suffering darkening vision, progressive difficulty reading and loss of night vision. Genetic testing was negative and the woman was diagnosed with PPS maculopathy from Elmiron, highlighting the importance of doctors considering medications of those with retinal damage.
July 2020 Update
Researchers with the Emory School of Medicine published findings in the medical journal JAMA Ophthalmology, finding that users diagnosed with Elmiron maculopathy continued to experience worsening vision even 10 years after they stopped taking the drug.
December 2020 Update
Strong evidence of a cause-effect relationship between the drug Elmiron and permanent vision loss problems was outlined in a study published in the medical journal Retina, finding that those with the highest rates of exposure were twice as likely to report experiencing symptoms.
February 2021 Update
Study published in the medical journal Clinical Ophthalmology identified a distinct signature of Elmiron-associated maculopathy, which can be detected through multimodal imaging by an ophthalmologist.
April 2021 Update
Researchers at University of California, Los Angeles published a study in the Canadian Journal of Ophthalmology, finding that 20% (1 out of 5) long-term users had evidence of Elmiron retina damage.
Did You or a Loved One Qualify for an Elmiron Settlement Payout?
The product liability lawyers at Saiontz & Kirk previously provided free consultations and case evaluations to help individuals review the legal options that may have been available to them. After contacting the firm or requesting a case review online, the facts and circumstances surrounding a potential claim were reviewed and evaluated by Elmiron lawsuit lawyers.
If it was determined that an individual may have been eligible for financial compensation or a settlement, it remained their decision whether to hire the firm. Elmiron lawsuits were handled under a contingency fee agreement, which meant there were no fees or expenses unless a settlement or other recovery was obtained in the case.
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