Elmiron is the brand name for the pentosan polysulfate sodium (PPS) drug. It’s used to treat interstitial cystitis (IC), a chronic bladder condition. As of today, Elmiron is the only FDA-approved drug to alleviate pain associated with interstitial cystitis. The FDA (Food and Drug Administration) approved this drug in 1996.
However, research conducted in 2018 uncovered that Elmiron adversely affects vision. Another study conducted in 2019 October showed that Elmiron use leads to retinal damage. The study substantiated claims that this drug could cause a severe eye disease known as maculopathy, which may, in turn, lead to blindness.
This discovery has led to lawsuits across the country against Elmiron manufacturers, Janssen Pharmaceuticals. Patients who have been adversely affected by this drug seek financial compensation for the damage the drug has caused to them. If you took the Elmiron drug and developed maculopathy or any other severe vision problem, you might qualify to bring an Elmiron suit as well.
Elmiron Manufacturers Allegedly Failed to Caution the Public about Elmiron Risks
Complainants in Elmiron suits accuse the drug manufacturer, Janssen Pharmaceuticals, of not properly warning consumers about the possibility of developing eye problems after using the drug. Recent studies connected this IC drug to permanent vision damage and ocular toxicity.
In 2019, doctors Ronald Melles, Amar P. Patel, and Robin A. Vora presented research at the American Academy of Ophthalmology (AAO), which disclosed that patients using the Elmiron drug exhibited clear symptoms of toxicity.
As mentioned above, Elmiron has been in use since the late 1990. It’s the only medication approved to alleviate pain interstitial cystitis pain. Interstitial cystitis is a condition affecting millions of citizens every year. It’s more common in women, and most of them use Elmiron to cure this disease. Hundreds of thousands of patients might have used this drug and might have exposed themselves to the danger of possible irreversible vision damage.
Studies have shown that continued Elmiron use for at least six months causes approximately 25% of the users to suffer from pigmentary maculopathy. Pigmentary maculopathy is an eye-related injury to the macula, the central retinal part. Therefore, it’s a disease affecting the retina. An injury to the macular can lead to total blindness and permanent loss of vision. In less severe cases, it could lead to difficulty in reading or other forms of visual impairment.
The AAO published an article in 2018 discussing six patients from Emory Eye Center who had used Elmiron from 2015-2017 for bladder issues and developed maculopathy of unknown cause. The succeeding year, it published a follow-up update. More patients from the clinic had developed this eye condition. The most common pigmentary maculopathy symptoms include:
- Trouble reading
- Dimming or blurred vision
- No close vision
- Seeing dark spots
- Blindness (vision loss) or night blindness
- Abnormal blood vessels and capillaries (parafoveal pigmented deposits)
- Round, yellow lesions underneath the macular.
- Retinal pigment epithelium atrophy
- Dark (hyper-pigmented) spots on the retina
At times doctors confuse retinal maculopathy for pattern dystrophy or age-related macular degeneration.
Recent Elmiron Lawsuits
As mentioned earlier, several people have come forward to sue Janssen pharmaceuticals for failing to warn them about the high risk of developing vision problems after taking Elmiron. The following are the most recently filed cases:
Kimberly Pelczar
On 26th March 2020, Kimberly Pelczar sued Janssen Pharmaceuticals and Teva Pharmaceuticals, USA Inc. due to vision loss she alleges to be associated with Elmiron. Kimberly started using Elimiron in 2005. In 2015, she started suffering from eye-related problems. From 2015-2019, she visited several doctors concerning her visual symptoms. In 2019, Kimberly was diagnosed with permanent vision loss and retinal injury, which she alleges are due to Elmiron toxicity.
In her lawsuit, Pelczar claims that the drug manufacturers did not properly caution the public and doctor of the vision-related problems Elmiron may cause. She further alleges that drug manufacturers actively attempted to hide the side effects from the consumers.
Valarie Hull
On June 9th, 2020, complainant Valerie Hull file a personal injury suit against Elmiron manufacturers. Hull consistently used Elmiron from 2001 to 2008. Consequently, she developed severe visual injuries, which she suffers from to date. These injuries include severe vision loss, changes in eye color pigment, pigmentary maculopathy, and loss of night vision.
Valarie and five other patients who were part of the study exhibited the same injuries to the eyes but shared only one common drug— Elmiron. Physicians and researchers have since linked Elmiron use with a high visual complication risk.
About hundreds of thousands of patients have taken Elmiron, and it continues being sold with minimal to zero warning of possible vision complications. Some studies have displayed that up to 25 percent of patients who use Elmiron have been proven to have eye damage associated with this drug.
Tina Pisco
On May 4th, 2020, Tina Pisco filed a lawsuit against Elmiron. In her case, Pisco claims that this drug made her develop maculopathy. She started taking the medication in 2012, and in six years, her vision depleted, and then in March 2019, she was diagnosed with permanent retinal damage in both eyes.
Pisco sued Jonson & Johnson Pharmaceuticals and Janssen Pharmaceuticals, one of its branches claiming that they designed, promoted, and distributed this dangerous drug when well aware of the significant risks associated with it. Yet, they never disclosed them to the healthcare providers and medical community.
Additionally, she claims that Janssen Pharmaceuticals failed to reveal the critical adverse side effects of Elmiron and the connection between its use and substantial damage, pigmentary maculopathy included.
Janssen described only optic neuritis, conjunctivitis, retinal hemorrhage, and amblyopia as possible visual side effects of Elmiron use and mentioned that the likelihood of them occurring is less than 1%. Additionally, Elimiron’s prescription guide, patient leaflet, and official website do not mention maculopathy or permanent vision loss.
Both Johnson & Johnson and Janssen Pharmaceuticals haven’t made any official statements, but they’ll likely deny these allegations.
Multi-District Litigation (MDL) for Elmiron Lawsuits
Elmiron suits are not class action lawsuits. They are filed separately. However, these suits are consolidated into multi-district litigation. The Elmiron MDL is out of the District of New Jersey. It’s called ‘In re Elmiron (pentosan polysulfate sodium) Products Liability Litigation; MDL 2973.
Multi-district litigation is the same as a class-action suit. All pending lawsuits from across the nation involving one defective product or drug are consolidated under one federal judge for pre-trial discovery.
Lawsuit basic information and details are gathered then compiled for all the complainants. After this is done, a few separate test cases are chosen for the trial. The results for these trials are then used in negotiating a universal settlement for all the other cases. The settlement usually has levels or tiers of payments to complainants, depending on how severe their injuries are. This is to say that unlike in class action suits, MDL complainants receive separate compensation.
Apart from Johnson & Johnson Pharmaceuticals, Janssen Pharmaceuticals, and Teva Pharmaceuticals, other respondents in these lawsuits include Bayer Pharmaceuticals, Alza Pharmaceuticals, Ortho-McNeil Pharmaceuticals, IVAX pharmaceuticals, and Centocor.
The Status of These Suits
The Elmiron lawsuits are still in their beginning stages. As of March 2021, there were eighty cases in state and federal courts throughout the country. Things seem to be moving quite slowly because people are just beginning to link their vision problems to Elmiron. As time passes, everyone expects thousands of individual Elmiron eye damage suits to be filed eventually.
The lawyers of complainants in Elmiron lawsuits are seeking significant financial compensation. No amount of money can be equated with an individual’s ability to see. Vision-related problems impact all aspects of a patient’s life. Therefore, lawyers are fighting for financial compensation enough to cover:
- Pain and suffering
- Lost wages (both past and future)
- Past, present, and future medical expenses (including mental health counseling)
Since hundreds of thousands of people possibly took Elmiron, lawyers expect the lawsuit to continue growing.
Possible Elimiron Suit Settlement Amount
As of now, the first cases are just being filed. Thus, there’s no sure technique of knowing what the settlement amount will be. However, an estimation of these case values can be made by comparing the lawsuits to the previous cases involving the same injuries. Please note that these are only assumptions based on the little available information. It’s still too early to predict the anticipated settlement amounts of these lawsuits accurately. But people wish to be informed what the compensation amount could be, so this is only an estimation.
The Elmiron lawsuit plaintiffs will have similar basic injuries— vision loss or vision impairment. The compensation amount of vision impairment or vision loss in other claims gauges the Elmiron suit’s settlement amount. Depending on the available data, attorneys involved in these cases expect that Elmiron suits where the complainants suffered permanent vision loss might receive compensation worth one million dollars or more.
This is only speculation. Further observations continue to be made. But since vision loss is a horrific injury, everyone would agree that it deserves a significant compensation amount.
Elmiron lawsuits that involve vision impairment are likely to be grouped into tiers depending on the extent of impairment to the victim’s vision. The most severe injuries will be those of permanent vision loss. Complainants with the most extensive vision impairment (possibly 75% to 80% impairment level) will be placed in the highest settlement tier (i.e., tier one). Victims with minor impairment (40% to 75% level) will be placed in tier two, and there are likely to be two or lower more levels after tier two.
Depending on the average compensation amounts in the other lawsuits involving vision impairment, Elmiron vision impairment suits in tier one might have a compensation value ranging from three hundred thousand dollars to six hundred thousand dollars. Tier two cases might have a compensation amount ranging somewhere between seventy-five thousand dollars and two hundred and fifty thousand dollars. Elmiron lawsuit attorneys are particularly optimistic about these settlement amounts.
Will Elmiron Be Recalled?
Elmiron hasn’t been recalled yet, and despite various researches linking its constant use to possible irreversible vision damage, urologists and rheumatologists continue to prescribe it. There’s no over-the-counter version of Elmiron.
Even though the initial report on retinal damage due to Elmiron use was made in 2018, it wasn’t until June 2020 that the drug manufacturers updated the drug’s safety label to warn people that the medication could lead to retinal damage. The FDA did publish the new label but hasn’t issued any safety communication and statement about it. Since the first report was issued, the medical literature concerning vision loss and eye damage linked to Elmiron drug continues to rise. However, the agency hasn’t mentioned any plans to demand that the manufacturer withdraw the drug from the market.
Are You Eligible for an Elimiron Suit?
Attorneys are currently accepting any case from persons who used Elmiron for two years at the minimum and developed vision-related problems, particularly if they were still taking Elmiron from 2018 to the present.
The vision-related issues must have begun while using the drug or within a year of completing or stopping the treatment. For instance, if you completed/stopped treatment in 2011 and were diagnosed with a vision-related problem in 2012, you may be eligible.
Injuries Named in Elmiron Lawsuits
The injuries alleged in Elmiron suits affect the eyes, ranging from pigmentary maculopathy to blurry vision. Symptoms begin while using the medication or within a year of using it. General vision-related problems named in Elmiron suits include:
- Retinal maculopathy
- Pigmentary maculopathy
- Blurred vision
- Macular degeneration
- Distorted vision
- Eye pain
- Halo vision
- Difficult reading
- Vision loss
- Vision disturbance
- Problem adjusting to the darkness
Things Your Elmiron Lawyer May Want to Know
When you reach out to an attorney with a case about possible vision damage due to Elmiron use, they might ask you several questions about how your experience was with the medications. Ensure you answer all of their questions with all the details. Your lawyer may want to know the following:
The types of Injuries You Experienced
The victims bringing Elmiron suits have generally been found to have macular degeneration or maculopathy. Medical records from your doctor will assist the lawyer in confirming the diagnosis.
When Your Vision-Related Problems Started
Knowing when you first began experiencing vision-related problems might help your attorney establish the link between Elmiron and vision problems accurately. People seeking to recover damages for Elmiron-related harm were generally diagnosed with these problems either within a year of discontinuing the medication or when they were still taking the drug.
Whether Your Vison-Related Problems Impact Your Daily Activities
Be honest with your lawyer about how vision-related problems have affected your daily activities. They’ll also need to know how these vision-related issues have impacted you emotionally.
The Period You Used Elmiron
Vision-related issues have been connected to continued exposure to Elmiron. Most of the people bringing Elmiron suits had used the medication for two years at the minimum before they started having vision problems.
If You or Any of Your Family Members Has a History of Eye-Related Problems
Your attorney will want to know how your medical history is like to establish whether you might be susceptible to vision-related issues. You should have all your medical record copies with you when you meet them.
The Kind of Treatment That Your Doctor Recommended for Your Eye or Vision Problems
Carry with you any medications you are presently using for your eye/vision-related problems. Your lawyer may need to know whether your symptoms have so far improved due to this treatment.
The Kind of Prognosis That Your Doctor Gave You
You should be ready to discuss whatever your doctor told you concerning the odds of restoring your eyesight and whether your symptoms would disappear eventually.
There might be a deadline to bring your lawsuit. Thus, you have to contact a lawyer immediately you discover you have suffered an injury. There’s no fee to reach out to an attorney about a possible Elmiron vision damage case.
Elmiron Side Effects
Apart from vision problems, you may also experience the following side effects after taking Elmiron:
- Bruising or skin rashes
- Sleeping problems
- Alopecia (hair loss)
- Gaining weight
- Headaches
- Dizziness
- Swelling
- Bloody stools
- Liver problems
- Reflux
- Diarrhea
The labeling on the product mentions some eye problems and eye diseases observed during clinical trials, including:
- Optic neuritis
- Conjunctivitis (pink eye)
- Retinal hemorrhage
- Nystagmus
- Amblyopia
If you are an Elmiron patient, you may also want to consult with your ophthalmologists and doctors. Maybe your doctor will suggest that you switch medications or have a vision test.
Contact an expert Elmiron Lawsuit Attorney Near Me.
At Consumers Alert Now, our job is to provide you with information on dangerous drugs and defective medical devices and help you obtain justice if any of these has caused you injuries. If you or your loved one took Elmiron drug and has been diagnosed with pigmentary maculopathy or any other vision-related problem, you may qualify to recover damages. Reach out to us at 800-511-0747 as soon as you discover or believe you have developed an injury after taking this drug. We will connect you with a lawyer who will review your case and let you know if you’re eligible to join a mass tort. We continue to fight for compensation and the rights of people like you across the nation to ensure justice is served.
