An Elmiron lawsuit is a legal claim for compensation by patients diagnosed with pigmentary maculopathy after taking the bladder medication. Plaintiffs allege that the manufacturer, Janssen Pharmaceuticals, failed to warn both doctors and patients that the drug could cause vision problems and possibly lead to blindness.
Shouse Law Group is representing Elmiron victims throughout the United States. We are demanding that the company compensate our clients for medical bills, lost earnings, and pain and suffering.
This is not a class-action lawsuit. We bring each claim separately. But most of the lawsuits are joining into a multidistrict litigation (MDL). This will expedite the negotiation and settlement process.
Plaintiffs can include anyone who developed maculopathy eye damage after taking Elmiron.
The statute of limitations to file a claim is short. In most states, it is only a year or two. Therefore, victims should consult a lawyer right away.
In this article, our attorneys will discuss 8 critical things to know about Elmiron and the current litigation:
- 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 that the company failed to warn about the dangerous side effects of the drug. The packaging and warning label did not list maculopathy as a risk prior to June 16, 2020.
Therefore, doctors were unaware of this complication of Elmiron use. Had they known, they may not have prescribed it. And many patients may have chosen not to take it.
Now, Elmiron’s label states:
Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.
The U.S. Food and Drug Administration also recommends that Elmiron users get eye exams that include auto-fluorescence imaging and optical coherence tomography.
There is substantial evidence from recent studies that at least six months of Elmiron consumption causes about 25% of users to develop pigmentary maculopathy. This is an eye injury of the macula. (The macula is the central part of the retina, so pigmentary maculopathy 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 of unknown etiology.1
The following year, AAO published an update. More Emory Eye Center patients on Elmiron developed the eye condition, presumably because of the drug’s toxicity.2
Common symptoms of the eye disorder pigmentary maculopathy include:
- Dark spots (hyper-pigmented spots) on the retina
- Retinal pigment epithelium atrophy
- Yellow, round lesions under the macula (vitelliform deposits a.k.a. adult pattern macular dystrophy)
- Abnormal capillaries and blood vessels (parafoveal pigmented deposits)
- Night blindness or blindness (loss of vision)
- Seeing dark spots in the field of vision
- No close vision
- Blurred vision and/or dimming
- Trouble reading
Patients may also present with hyperpigmented – or darkened spots – on the retina during an eye examination.
Sometimes doctors confuse retinal maculopathy for age-related macular degeneration or pattern dystrophy.
Separate lawsuits. But these lawsuits get consolidated into a multi-district litigation (MDL). The Elmiron MDL is out of the District of New Jersey. It is called:
MDLs are a way to streamline litigation, especially for defective drugs and medical devices. 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 approved it in 1996,3 and 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) logging 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 financial settlements.
No price can be placed on a person’s ability to see. Vision problems affect every aspect of a victim’s life. Ultimately, attorneys are fighting for enough financial compensation 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 was originally developed by Baker Norton Pharmaceuticals, Inc. The FDA approved Elmiron in 1996 for interstitial cystitis. Alza Corporation obtained the rights in 1997 to sell Elmiron in the U.S.
Elmiron is a brand name. Elmiron’s generic name is Pentosan polysulfate sodium (PPS). Considered an “orphan drug”, Elmiron is prescribed by doctors to treat:
- Interstitial cystitis (a bladder condition also called IC, painful bladder syndrome, or bladder pain syndrome); and
Patients take one 100 mg capsule three times a day.
IC is more common among older women with fair skin and red hair. IC causes the sensation of a urinary tract infection (UTI), and it is similar to overactive bladder syndrome. But IC actually changes the urothelium – the tissue layer around the bladder. IC can decrease the patient’s quality of life by affecting sleep, stress, and intimacy.
The FDA rejected Elmiron two times before finally approving it for IC. There is little evidence proving that Elmiron is effective. Formerly, doctors used PPS as a blood thinner / anticoagulant.5
In addition to vision problems, victims can experience such Elmiron side effects as:
- Skin rashes and/or bruising,
- Hair loss (alopecia),
- Sleeping problems,
- Gaining weight,
- Liver problems,
- Bloody stools,
- Diarrhea, and/or
The product labeling does mention some eye diseases and eye problems observed in clinical trials, such 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).
Other Elmiron victims who have recently brought lawsuits include Valerie Hull and Tina Pisco.
For the latest on the Elmiron MDL, go to the official Elmiron MDL website.
Did you or a loved one get maculopathy or other retinal damage from the use of Elmiron? Contact our dangerous drugs attorneys for a free case evaluation and case review.
Attorney advertising disclaimer: Results cannot be guaranteed.
- 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 (140 patients consumed 5,000 doses over an average of 15 years; upon examination of 91, 22 developed pigmentary maculopathy.); Robin A. Vora, Amar P. Patel, Ronald Melles, Prevalence of Maculopathy Associated with Long-Term Pentosan Polysulfate Therapy, AAO (January 16, 2020). Other types of maculopathy include age-related macular degeneration, cellophane maculopathy (“macular pucker”), and Malattia Leventinese (“Doyne Honeycomb Retinal Dystrophy” or DHRD).
- 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.