An Elmiron lawsuit is a claim for compensation by patients with pigmentary maculopathy. Plaintiffs accuse Janssen, the manufacturer, of failure to warn. Doctors and patients were not told the drug could cause vision problems and possibly blindness.
Shouse Law Group is representing Elmiron victims throughout the United States. We are demanding Janssen pay for all our clients’ expenses: Doctor’s bills, lost earnings, and pain and suffering.
These lawsuits are not a class action. We fight each lawsuit separately, but the lawsuits may join into a multidistrict litigation (MDL). This should expedite the negotiation and settlement process.
Plaintiffs can be anyone who developed maculopathy after taking Elmiron.
The statute of limitations to file suit is short. In most states, it is only a year or two. Therefore, victims should consult a lawyer right away.
In this article, our Elmiron attorneys discuss:
- 1. What are the grounds for an Elmiron lawsuit?
- 2. Does Elmiron cause maculopathy?
- 3. Are the lawsuits class action or separate?
- 4. Is Elmiron recalled?
- 5. Have there been settlements yet?
- 6. Who makes Elmiron?
- 7. What are Elmiron’s side effects?
- 8. What are recent Elmiron cases?
The primary claim in Elmiron lawsuits is failure to warn. The packaging and instructions do not list maculopathy as a risk.
Therefore, doctors were unaware of this complication of Elmiron use. Had they known, they may not have prescribed it. And patients may have chosen not to take it.
There is substantial evidence from recent studies that long-term Elmiron consumption leads to pigmentary maculopathy. This is an injury of the macula. (This is the central part of the retina, so it is a retinal disease.) Macular injury can cause permanent vision loss. And total blindness. In more mild cases, it can cause difficulty reading and other vision impairment.
In 2018, the American Academy of Ophthalmology (AAO) published an article. It discussed six Emory Eye Center patients from 2015 to 2017. They had taken Elmiron for bladder problems and developed pigmentary maculopathy.1
The following year, AAO published an update. More Emory Eye Center patients on Elmiron developed the eye condition.2
Three common symptoms of pigmentary maculopathy include:
- Dark spots on the retina.
- Yellow, round lesions under the macula.
- Abnormal capillaries and blood vessels.
Sometimes doctors confuse retinal maculopathy for age-related macular degeneration or pattern dystrophy.
Separate lawsuits. Eventually these lawsuits may consolidate, but not into a class action lawsuit. Instead, it would be a multi-district litigation (MDL).
MDLs are a way to streamline litigation. One judge makes all the pretrial rulings, and then about four or five cases go to trial. How these bellwether trials turn out is critical. It serves as the starting point for negotiations.
Unlike in class actions, MDL plaintiffs get separate settlements. The final number depends on their injuries and circumstances.
No. The FDA (Food and Drug Administration) approved it in 1996.3 Rheumatologists and urologists continue to prescribe it. (There is no over-the-counter version.)
So Elmiron remains available. Despite the FDA Adverse Event Reporting System (FAERS). It logged 100 vision problem cases between 1997 and 2019. Eighty percent were serious. And 22 patients (at least) had maculopathy.4
Not yet. But plaintiffs’ attorneys are seeking large settlements.
No price can be put on vision. And seeing problems affect every aspect of victims’ lives. Ultimately, attorneys are fighting for enough money to pay for:
- All past and future medical bills (including mental health counseling),
- Lost wages, past and future, and
- Pain and suffering
Janssen Pharmaceuticals, a division of Johnson & Johnson. Elmiron’s generic name is Pentosan polysulfate sodium (PPS). Doctors prescribe it to treat:
- Interstitial cystitis (a bladder condition also called painful bladder syndrome or bladder pain syndrome); and
Formerly, doctors used PPS as a blood thinner.5
In addition to vision problems, victims can experience such Elmiron side effects as:
- Skin rashes and/or bruising,
- Hair loss (alopecia),
- Sleeping problems,
- Diarrhea, and/or
The product labeling does mention some eye diseases. None of these eye disorders is maculopathy. Instead, the label mentions such eye problems observed in clinical trials as:
- Retinal hemorrhage,
- Pink eye (conjunctivitis)
- Optic neuritis,
- Amblyopia, and
Elmiron patients may wish to consult with their doctors and ophthalmologists. Perhaps doctors will suggest they get a vision test. Or possibly switch medications.
Litigation is very new. Check back for updates on current litigation and settlements. One recent case includes:
- Pelczar vs. Teva Branded Pharmaceutical Products R&D et al. United States District Court District Of Connecticut. Case 3:20-cv-00406. (March 26, 2020).
Call a lawyer…
Did you or a loved one get maculopathy from the use of Elmiron? Contact our dangerous drugs attorneys for a free case evaluation.
- Joseph T Nezgoda, MD MBA, Nieraj Jain, MD, Pigmentary Maculopathy From Chronic Exposure, AAO (December 7, 2018); Elmiron use may also lead to atypical retinopathy.
- More Evidence Linking Common Bladder Medication to a Vision-threatening Eye Condition, AAO (October 12, 2019), Kaiser Permanente; Robin A. Vora, Amar P. Patel, Ronald Melles, Prevalence of Maculopathy Associated with Long-Term Pentosan Polysulfate Therapy, AAO (January 16, 2020).
- Elmiron, FDA.
- See July – September 2019 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS), FDA.
- Elmiron 100 mg, FDA.
- See same.