There are currently lawsuits underway against the maker of the drug Elmiron, the brand name of pentosan polysulfate sodium (PPS), claiming that its prolonged use led to serious vision problems. These lawsuits allege that Janssen Pharmaceuticals, the makers of Elmiron, knew about the risks of eye damage but failed to adequately warn the public of these risks.
Elmiron is a prescription medication used to treat bladder pain. Doctors who diagnosed interstitial cystitis, a common cause of bladder irritation or pain, commonly prescribed Elmiron, as it is the only available treatment via oral medication. However, some patients discovered that after taking Elmiron for a prolonged period of time, they developed vision problems. Had these patients known of the risks of vision loss or severe vision impairment, they may have elected to not take the drug. Since doctors were not warned of the risks of taking Elmiron, they were unable to pass this information on to their patients.
Is there an Elmiron lawsuit?
Yes, there is currently litigation underway against Janssen Pharmaceuticals, the makers of Elmiron. These lawsuits first started to appear Â in 2020, with three of the early cases involving Jeanette Milburn, Kimberly Pelczar, and Valerie Hull. These early lawsuits alleged that using Elmiron for a long period of time caused them to develop problems such as pigmentary maculopathy, vision degradation, loss of night vision, retinal injury, and even retinal hemorrhage. In their lawsuits, they claim that Elmiron was a defective drug and that Janssen Pharmaceuticals failed to properly warn them or their doctors of the risks involved.
By the springÂ of 2021, there were hundreds of lawsuits filed related to Elmiron use. As a result, the Judicial Panel on Multidistrict Litigation (JPML) consolidated all of the Elmiron cases into a single class action MDL (multidistrict litigation). Combining all similar cases into one MDL allows plaintiffs to share information with one another, and it can expedite the litigation process.Â The Elmiron MDL was then assigned to Judge BrianÂ MartinottiÂ in the District of New Jersey.
The creation of the MDL led to a significant increase in Elmiron lawsuits. By the end of 2021, there were more than 600 Elmiron-related cases pending within federal Courts and another 80 pending within state Courts. In the following months, an average of 200 new cases were filed each month and added to the MDL. In the first six months of 2022 alone, there were around 1,200 new Elmiron lawsuits transferred into the MDL. Cases continued to enter the MDL through the remainder of the year, albeit at a slower rate.
As of May 2023, there were over 1,800 pending cases in the MDL which continue to work their way through the legal system. A bellwether case was scheduled to begin in March 2023 which will be used by both sides to better understand Â the viability of claims and identify potential settlement amounts for future claims.
Elmiron linked to maculopathy
There are several studies that link the long-term use of Elmiron with vision complications, such as pigmentary maculopathy. Maculopathy is a serious disease in which eye damage becomes progressively worse and can ultimately lead to blindness. There is also no current cure for maculopathy. Some researchers have said that this unique type of maculopathy only appears in users of Elmiron, suggesting that there is a direct link between the two.
For these studies, researchers looked at previously published literature related to Elmiron usage, along with their own patients. They took into account factors such as age or a family history of vision loss when determining whether Elmiron was the likely cause of the vision issues. After an initial study was released in 2018 linking Elmiron to vision loss, more studies were conducted with similar results and findings.
Individual report/study breakdown
Below are three prominent studies that analyzed the potential link between Elmiron (or PPS) and maculopathy:
Age-Related Macular Degeneration Masquerade: A Review of Pentosan Polysulfate Maculopathy and Implications for Clinical Practice
This study from 2022 reviewed various literature sources regarding the use of pentosan and its relation to maculopathy. The purpose of the study was to highlight the importance of correctly diagnosing PPS maculopathy and to identify avenues for further research.
According to the study, "Our review of the literature confirms the general consensus around this disease: it is caused by higher cumulative doses of pentosan and presents in a recognizable manner on multimodal imaging along with symptoms consistent with rod dysfunction, similar to AMD."Â The researchers also highlightÂ that pentosan maculopathy can appear as other diseases as well, resulting in an incorrect diagnosis. According to the study, it is conceivable that there are many more patients who are on pentosan and experiencing progressive RPE atrophy while it goes unnoticed.
Prevalence of Maculopathy Associated with Long-Term Pentosan Polysulfate Therapy
Another study, produced in 2019, provided additional evidence of a link between pentosan polysulfate sodium and maculopathy. In this study, a team of investigators from Kaiser Permanente in Northern California found that PPS use caused retinal damage in about 25% of patients. The team of clinicians began to investigate the issue after data published in 2018 showed six patients developed issues with their macula and the clinicians' patients presented the same trend.
To conduct this study, the clinicians examined 91 patients out of a pool of 140 who reported having taken an average of 5,000 pills over a period of 15 years. They then took images of the back of patients' eyes and sorted them based on evidence of abnormalities. Of the 91 patients examined, 22 showed signs of drug toxicity. The clinicians also discovered that drug toxicity was higher in patients who consumed larger doses.
Pentosan polysulfate therapy, a common treatment for interstitial cystitis, has been associated with a maculopathy
Finally, an investigation published in 2019 followed up on a previous 2018 report that first showed evidenceÂ of uniqueÂ macular pigment changes in patients receiving chronic therapy for interstitial cystitis (IC) through oral PPS. This investigationÂ found thatÂ "this unique maculopathy is strongly associated with chronic PPS exposure, not IC itself or its other therapies. In fact, this characteristic maculopathy has, to date, been exclusively diagnosed in patients reporting prior PPS exposure."
To reach this conclusion, the research team conducted a retrospective, cross-sectional study of prior patients at the Emory Eye Center who had been diagnosed with IC within a four-year period. They reviewed patient charts and pharmacy records to determine each individual's exposure to IC therapies, including PPS. Of the 219 patients studied, 80 of them had prior exposure to PPS, while no patient showed signs of this particular maculopathy without PPS exposure.
Projected Elmiron lawsuit amounts
So far, there have not been any verdicts or settlements related to Elmiron injuries. Because there have been no trials, juryÂ verdicts, orÂ global Elmiron settlement offers, it is presently difficult to determine the projected settlement amounts for Elmiron lawsuits. The settlement amount in any case depends on many factors, such as the severity of the injury and the absence of other potential causes.
Some lawyers estimate Elmiron settlement amounts could as amount to hundreds of thousands of dollars. . Verdicts from bellwether trials typically provide a benchmark for case value, and the firstÂ Elmiron bellwether was scheduled for March 2023.Â Once this bellwether case finishes, there should be a better ideaÂ of theÂ projected settlement amounts.
However, based on the results of other trials where claimants had similar injuries to those caused by Elmiron, the settlement amounts will likely be based on the amount of vision impairment. For example:
- 80% - 100%:Â $700,000 - $1,000,000.
- 40% - 80%:Â $300,000 - $699,000.
- 20% - 40%:Â $75,000 - $299,000.
- Under 20%:Â $25,000 - $74,999.
General estimates for Elmiron lawsuit settlement amounts average around $350,000, depending on the specifics of the case.
Do you qualify forÂ anÂ Elmiron lawsuit?
If you took Elmiron for an extended period ofÂ time andÂ you now have a confirmed diagnosis of eye-related issues, you may be eligible to file a lawsuit. To determine this, a lawyer will go over your specific case and see if you meet certain qualifications. You may qualify for an Elmiron lawsuit if:
- You took Elmiron for more than two years.
- You started experiencing vision problems afterÂ Jan.Â 1, 2010.
- You have recently sought medical treatment for problems with your vision.
- A doctor diagnosed you with vision problems, such as macular degeneration or pigmentary maculopathy.
- After taking Elmiron, you began to experience vision changes like blurriness,Â pain, orÂ difficulty reading.
- You were diagnosed with vision problems either while taking Elmiron or within one year of discontinuing use of the medication.
If these or similar circumstances apply to you, consult with a lawyer to learn whether you are eligible to qualify for an Elmiron lawsuit.
What factors impact an Elmiron lawsuit settlement amount?
There are a few factors that will likely impact an Elmiron lawsuit settlement amount. For starters, the settlement will take into account theÂ extentÂ of any injuries or damage. Claimants who suffered significant injuriesÂ as aÂ result ofÂ takingÂ Elmiron may receive a larger settlement amount. The next factor is theÂ extentÂ of Elmiron use, where claimants who used Elmiron for a longer period of time may receive a larger settlement amount.
Finally, the settlement will consider if there are any other potential causes for theÂ claimants'Â injuries. If there is an absence of other potential causes, such as family medical history, this will likely raise the settlement amount as well.
What questions might your Elmiron lawyer ask?
When speaking with a lawyer or their staff about an Elmiron lawsuit, you will be asked some questions related to your experience. Some of these questions might include:
What are your injuries?
A lawyer will want to know what injuries you have sustained as a result of taking Elmiron. Common injuries in Elmiron-related lawsuits include macular degeneration and maculopathy. When discussing injuries with your lawyer, it is helpful to have relevant medical documentation to confirm the diagnosis.
When did you first start experiencing problems with your vision?
Knowing theÂ time frameÂ for when you first started experiencing symptoms and when you started taking Elmiron can help your lawyer draw a connection between the two. In most cases, those experiencing issues related to the use of Elmiron first started noticing symptoms either while taking the drug or within a year of discontinuing usage.
How have these injuries impacted your day-to-day life?
The extent of your injuries and the emotional toll they have taken on you can factor into things like the settlement amount. Discuss any and all issues you have experienced as a result of taking Elmiron.
What is your family history regarding eye problems?
Your lawyer may ask about your family medical history in regard to vision problems. This is to help determine if your vision impairment is the result of Elmiron or if there are hereditary factors. If possible, identify medical records confirming injury or diagnoses for you or a loved one Â that were harmed by Elmiron.
HowÂ long did you take Elmiron?
In many cases, issues from Elmiron stem from long-term use. Therefore, your lawyer will likely want toÂ know howÂ long you took Elmiron and whether you are currently still taking it. It is common for individuals filing Elmiron lawsuits to have taken Elmiron for over two years.
Have you received a prognosis regarding your vision problems?
Identify any medical records related to prognoses related to your vision problems. For example, your doctor may have expressed your chances of regaining your vision or how likely it is that your symptoms will improve over time.
Are you taking any medications to treat your vision problems?
If you are currently taking any medications to treat your vision problems, let the Â lawyer know. Also, discuss with your lawyer whether your vision has improved as a result of taking these medications and how long you have been taking them.