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Elmiron Lawsuit - Vision Loss and Eye Damage

The bladder medication has been marketed as safe for decades yet new research points to risks of eye damage and blindness
Last Updated: June 1, 2024

What Is The Elmiron Lawsuit About?

New research shows that long term exposure to the bladder medication Elmiron creates toxins to form in the retina of the eye, causing serious vision problems. The research goes on to indicate that the vision damage caused by Elmiron toxicity is mostly irreversible, and vision loss is not recoverable.

Elmiron is the only drug approved in the United States to treat interstitial cystitis, which causes chronic pain in the bladder and pelvis area and mostly affects women. It is believed that hundreds of thousands of people have taken the drug and may have been exposed to the risk of potentially permanent vision damage.

Elmiron (pentosan polysulfate sodium) was introduced in 1996 and it is marketed by Janssen Pharmaceuticals. To see if you or a loved one qualify to fight against Elmiron’s negligence, start by taking a free evaluation to check eligibility for compensation.

What Is Elmiron?

Elmiron is a brand name for pentosan polysulfate sodium (PPS), which is sometimes shortened to pentosan, a drug used to treat bladder conditions, especially interstitial cystitis. Other similar pentosan polysulfate drugs are available, but Elmiron is the only one produced as sodium salt and is the only brand with FDA approval in the United States. Elmiron was first released in September 1996, and it is produced by Janssen Pharmaceuticals, which is wholly owned by the multinational pharmaceutical corporation Johnson & Johnson.

Elmiron Mass Tort

Recent research has shown that Elmiron, an intrastitial cystitis, drug used to treat bladder pain, is linked to degenerative eye disease maculopathy. Elmiron lawsuits have begun to roll in, naming Janssen Pharmaceuticals as the defendant, a subsidiary company of J & J. Janssen Pharmaceuticals is accused in Elmiron lawsuits of failing warn patients about the risks the drug poses to their retinal health. This litigation guide covers the evidence that Elmiron poses a serious risk to retinal health, the FDA's reaction, and the expert witnesses specialties attorneys should consult when pursuing Elmiron cases.

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Elmiron Risks - Updated June 2024

  • Elmiron's potential link with eye problems is one of the biggest concerns. According to some studies, long-term Elmiron use may cause a condition known as pigmentary maculopathy. This affects the retina and could lead to vision issues. This condition can cause blurred vision and difficulties adapting to low light conditions. Elmiron users should have regular eye exams to check for signs of eye problems.
  • Elmiron can be used for a long time. Some people may use it for years to treat their bladder symptoms. Elmiron is often prescribed for long periods of time, and some individuals may take it for many years to manage their bladder symptoms.
  • Elmiron may be the only treatment available for some patients who suffer from interstitial cystitis. It is difficult to compare the potential benefits of Elmiron with the limited treatment options available.
  • Warnings from regulatory agencies: As a result of the growing concern about Elmiron and its potential eye risks, regulatory bodies such as the U.S. Food and Drug Administration have updated their safety information and issued new warnings. These warnings stress the importance of regular monitoring of patients who take Elmiron.
  • Legal Implications: Since the public has become more aware of Elmiron’s potential dangers, some individuals have taken legal action claiming to have suffered vision problems after taking the drug. These legal cases have brought attention to the importance of thorough research and clear communication regarding Elmiron safety.
  • Elmiron: Balancing Benefits and Risks. Healthcare providers and patients should carefully balance the benefits and risks. Some patients may find that the relief from interstitial cystitis symptoms is worth the risk. It is important that patients have an informed discussion with their healthcare provider about whether Elmiron should be used as a treatment.
  • Elmiron has certain risks associated with it, especially in regards to eye health. Elmiron is a medication that has been associated with certain risks, particularly in regards to eye health. Patients and healthcare professionals should assess together the potential benefits and risk of Elmiron when managing interstitial cystis. Elmiron users should undergo regular eye examinations to identify any eye problems and take the appropriate measures if needed.

Elmiron Lawsuit Updates 2024

  • June 1, 2024 - Elmiron Dosage & Rx Info - Uses, Side Effects - Updated.
  • March 1, 2024 - Elmiron, a medication used to treat Interstitial Cystitis (a chronic medical condition causing bladder pain and pressure), is used by patients with the condition. Elmiron is alleged to have caused permanent retinal damage and vision-related injuries. The Supreme Court of New Jersey designated the pending and future state court litigation in New Jersey alleging injuries from Elmiron use as multicounty litigation on December 7, 2021 and assigned it to Bergen County for centralized management.
  • February 1, 2024 - Elmiron - Pentosan Polysulfate Sodium (Oral Route) 2024 Update - Mayo Clinic.
  • January 1, 2024 - Mayo Clinic Updat - Elmiron Allergies, Drug Interactions & Side Effects
  • July 1, 2023 - Log in to PACER for the latest filings on Master Docket No. 2:20-md-2973.
    The Presiding Judges:
    Judge Brian R. Martinotti, U.S.D.J.
    Judge Edward S. Kiel, U.S.M.J.
  • June 1, 2023 - National Institutes of Health (NIH) - Elmiron Management status report.
  • May 1, 2023 - Pentosan Polysulfate Sodium (Elmiron), maculopathy - a genetic perspective.
  • April 1, 2023 - Pentosan polysulfate sodium (Elmiron) maculopathy: a genetic perspective
  • February 19, 2023 - Medicaid - Arizona (AZM, AZMREF, AZMDDD) Elmiron Prior Authorization Guideline
  • February 1, 2023 - Warning about Elmiron - Retinal Pigmentary changes. Long-term use of Elmiron, which is known as Pigmentary Maculopathy in the literature, has been shown to cause Pigmentary changes in the retina. These cases were most common after three years or more of use, but some cases were seen with shorter periods of time.
  • January 15, 2023 - Serious side effects have been reported with the use of Elmiron.
  • January 1, 2023 - What Are Side Effects Associated with Using Pentosan Polysulfate Sodium?

    Common side effects of Pentosan Polysulfate Sodium include:

    • Abdominal pain
    • Depressed mood
    • Diarrhea Dizziness
    • Hair loss
    • Headache
    • Itching or skin rash
    • Nausea Stomach upset or pain

    Serious side effects of Pentosan Polysulfate Sodium include:

    • Discomfort when swallowing Heartburn
    • Mental/mood changes
    • Unusual bruising or bleeding
  • December 1, 2022 - Elmiron (Pentosan Polysulfate Sodium) common side effects update.
  • August 1, 2022 - U.S. District Court for the District of New Jersey - MDL No. 2973 - Elmiron (Pentosan Polysolfate Sodium) Products Liability Litigation Update (Judge Brian R. Martinotti & Judge Edward S. Kiel).
  • July 1, 2022 - U.S. District Court - District of New Jersey - Elmiron Case Management Orders Updates.
  • June 1, 2022 - The long term efficacy & safety of Elmiron in relieving recurring symptoms of interstitial cystitis were investigated in a long term, open label physician's usage study.
  • May 1, 2022 - Superior Court of New Jersey Law Division: Bergen County - Elmiron Products Liability Litigation: The parties shall continue to meet and confer regarding coordination and entry of proposed case management orders similar to those entered in, MDL No. 2973.
  • April 1, 2022 - U.S. District Court for the District of New Jersey - Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation MDL No. 2973
    Judge Brian R. Martinotti, Judge Edward S. Kiel - Elmiron have been filed and served (666 federal and 81 in state courts).
  • March 1, 2022 - Last month we have received over 210 inquiries on our site from people who used Elmiron and had vision problems.
  • January 2, 2022 - Elmiron & other drug removals for clients with advanced control specialty formulary - State of West Virginia Public Employees Insurance Agency.
  • November 2, 2021 - Brian R. Martinotti (U.S. District Judge, District of New Jersey) MDL-2973 - Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
  • September 7, 2021 - Hon. Glenn A. Grant - Multicounty Litigation Application New Jersey State Court Litigation Involving Elmiron®. Anyone wishing to comment on or object to this application should provide such comments or objections in writing, with relevant supporting documentation, by October 10, 2021
  • August 2, 2021 - United States District Court - Elmiron Case Management Orders
  • January 22, 2021 - A diverse group of attorneys, mostly women will lead the counsel in the Elmiron MDL Lawsuit. The judge repeatedly asked for diverse representation as a majority of the plaintiffs are expected to be women
  • Due to Covid-19 Elmiron case management conferences in New Jersey have been held via Zoom on January, 8 2021.
  • September 25, 2020 - A Tennessee Couple Requests That All Elmiron Cases Be Combined. A filing by a couple requested that all the Elmiron product liability lawsuits be combined and sent to a New Jersey federal court to “guard against inconsistent rulings”.

  • July 13, 2020 - Janssen Pharmaceuticals added a warning label about Vision and Retinal Damage on their US Packaging of the label of Elmiron.

Elmiron Withdrawal Symptoms

Interstitial cystitis has no known cure. As the only FDA-approved drug used to treat this bladder condition, many people are dependent on Elmiron for relief from interstitial cystitis’s symptoms. However, there is growing concern over Elmiron’s toxicity and side effects. Elmiron users – many of whom are understandably worried about the Elmiron eye damage evidence uncovered in recent studies – seem to have limited options for alternative treatment. There is also evidence that some Elmiron users, particularly women aged 50-59, suffer from Elmiron withdrawal symptoms when they stop taking the drug.

Elmiron Recall

There have not yet been any Elmiron recalls by the FDA or on a voluntary basis by Janssen Pharmaceuticals, but it is possible we will see Elmiron recalled in the future if more evidence comes to light about the dangers of the drug.

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Elmiron Lawsuit Settlement Amounts

It’s not fully clear what the Elmiron lawsuit payouts will be worth as a whole or to each claimant. But similar successful lawsuits against pharmaceutical companies have resulted in huge settlements, some of which have hit billions of dollars overall. As the potential injury caused to claimants by Elmiron is significant, perhaps even leading to irreversible blindness, a successful claim should lead to a substantial sum of money. This could be reached either through an out-of-court settlement by Janssen or through a judge’s ruling that would force the company to pay claimants after a trial.

Elmiron Compensation

A claimant’s compensation in the Elmiron eye-damage lawsuits will depend on several factors, including the level of injury caused by taking Elmiron. This is an active lawsuit, and anyone who has developed eye problems after taking Elmiron for interstitial cystitis is being urged to contact an Elmiron lawyer to see if they qualify for compensation.

Elmiron Lawsuit
Elmiron Vision Loss

Learn Your Rights By Speaking with Elmiron Lawyers

Millions of Americans suffer from interstitial cystitis, and many of them have opted to use Elmiron as it is the only FDA approved drug to treat the condition. As more evidence comes to light linking Elmiron to vision problems, people are being encouraged to hire Elmiron vision damage lawyers if they have suffered as a result of taking the drug. The lawsuit looks set to be significant and experienced Elmiron eye injury lawyers are preparing to represent as many injured individuals as needed to ensure they are given fair compensation for their injuries. 

Janssen Pharmaceuticals is owned by Johnson & Johnson, a company with vast resources to fight claimants in court. For that reason, potential plaintiffs should hire a specialist Elmiron eye injury law firm, i.e. those with the experience of trying – and winning – these types of lawsuits against Big Pharma. With the heart of the suit being that Elmiron can lead to the eye injury, pigmentory maculopathy,  experienced Elmiron maculopathy lawyers are ready to fight for claimants’ compensation – and justice.

If you feel you qualify to join the lawsuit or even just want to understand your options, then you should contact an Elmiron attorney to help you get the justice you deserve. 

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Elmiron Video

Elmiron Toxicity

Studies have shown that Elmiron appears to be toxic to the retina, sometimes causing significant eye damage and blindness in some cases. One of the issues facing doctors is that the Elmiron eye damage may have been misdiagnosed as age-related macular degeneration, so it’s not abundantly clear how many cases of maculopathy have been caused by taking the drug. The Elmiron lawsuits aim to prove that the drug is toxic, and that Janssen Pharmaceuticals should have done more to protect those regularly taking Elmiron.

elmiron lawsuit side effects

Elmiron Side Effects

Researchers have concluded that there are many side effects of Elmiron medication. In its research of Elmiron side effects, the Mayo Clinic has listed dozens of different problems. Some, like abdominal pain and hives, are listed as “rare”, whereas others, like nausea and hair loss (alopecia), are cited as being somewhat more common.

There are many symptoms and injuries that Elmiron causes but the most common ones are:

  • Difficulty reading
  • Difficulty adapting to dim lighting or darkness
  • Vision disturbances or distorted vision
  • Blindness
  • Dimming Vision
  • Difficulty seeing objects that are close
  • Eye pain

However, the main concern is the long-term side effects of Elmiron that are linked to eye damage, notably, pigmentary maculopathy, an eye disease that can lead to severe – and irreversible – problems like blindness. Studies have shown there is a link between the dosage and length of time patients have been taking Elmiron interstitial cystitis drugs and the likelihood of developing eye problems like maculopathy. In short, studies claim that the more Elmiron you take, the more likely it is that you can suffer Elmiron Ocular side effects. Interestingly, women may suffer from side effects and damage more than men. As more women get interstitial cystitis than men, it is logical that a greater number of women are likely to use Elmiron to treat it. Women, therefore, are considered more likely to suffer Elmiron eye damage than men.

report presented to the American Academy of Ophthalmology in 2019 cited the toxicity of Elmiron to the retina and reported that around 25% of patients taking Elmiron developed eye problems including reduced night vision and scotoma, blind spots. It’s important to note that some Elmiron long term side effects can go unnoticed for several years, so eye loss and vision issues can still develop in the future.

Elmiron Retinopathy

The lawsuits against Janssen Pharmaceuticals, as well as further scientific studies in the link between Elmiron and eye damage, may uncover more evidence about Elmiron vision loss and Elmiron retinal damage. While much of the focus of the lawsuits focus on Elmiron maculopathy, experts will be looking at broader evidence of retinal damage as a side effect of Elmiron. Any damage to the retina falls under the bracket of retinopathy, an umbrella term that takes in macular diseases.

What Is Pigmentary Maculopathy?

To understand the relationship between the drug Elmiron and the vision damage it causes, pigmentory maculopathy, it is best to first understand what Maculopathy is.

Maculopathy is an eye disorder affecting the macula (the central part of the retina associated with highly sensitive vision) that can lead to blindness. Common types of Maculapthy include:

Age-related macular degeneration

This is a type of eye toxicity that is a degenerative condition that results in gradual vision loss.

Cellophane maculopathy

This vision problem is a condition where one’s eyesight is distorted as a result of the formation of scar tissue on the macula.

Doyne Honeycomb Retinal Dystrophy (DHRD)

DHRD is a type of eye damage that is a congenital form of macular degeneration. The eye problems start with small, pale spots on the macula that eventually develop into a honeycomb pattern.

Once you find experienced Elmiron macular degeneration mass tort attorneys they will be able to help you understand your injuries better and identify if you indeed have pigmentory maculopathy, the specific type of vison problem that this eye damage lawsuit deals with.

Pigmentory Maculapothy

There are different types of Maculopathy but according to the research of Elmiron usage “pigmentary maculopathy of unknown etiology.” is the specific type of eye injury associated with users of the medication. If caught in its early stages, the vision damage may stop after taking the medication. But in late stages, the disease can lead to permanent vision loss. Symptoms of the condition differ slightly among individuals. 

Once you find experienced Elmiron macular degeneration mass tort attorneys they will be able to help you understand your injuries better and identify if you indeed have pigmentory maculopathy, the specific type of vison problem that this eye damage lawsuit deals with

Elmiron Vision Loss Lawsuit

Elmiron Uses and Approval History

Elmiron was approved by the FDA on October 1, 1996. No major safety concerns were identified when it went through approval testing and thus it was given approval.

However now what is coming to light with recent studies related to the eyes is that when Elmiron applied for approval the FDA wrote in the file that “Elmiron works by binding to exposed epithelium”. Some believe this is why it has an effect on the urinary bladder epithelium.  

However the manufactures of the drug never looked to test Elmiron on other epithelia cells and look to see if there adverse effects.  Specifically, the retail epithelial cells of the eye would have been an important place to check as it is now being shown that the drug causes vision damage.

Elmiron is prescribed in 100mg capsules and the recommended dose is one capsule 3 times a day on a daily basis. Elmiron is mostly used for chronic pelvic pain, Interstitial Cystitis and Lower urinary tract disorders in women.

Elmiron Video

Elmiron Lawsuit History

Currently, the Elmiron eye damage lawsuit is made up of separate cases against Elmiron’s manufacturer, Janssen Pharmaceuticals. However, it is possible that these Elmiron lawsuits will be consolidated, especially if more claimants continue to come forward. 

Of all the cases against Elmiron, one of the most important is the case involving Valerie Hull. She is known as patient zero because she was involved in the first study linking Elmiron to pigmentary maculopathy. She filed a lawsuit in New Jersey Superior Court on June 9, 2020.

Hull claims that all the companies involved in making Elmirom (Johson & Johnson, Janssen Pharmaceuticals, and Teva Pharmaceutical Industries Ltd.) knew about the risks linked with the medication for decades and failed to warn about the risks and potential loss of vision as a side effect. 

In addition, the suit goes on to state that product labeling includes no relevant warnings, nor does it include any language warning of pigmentary maculopathy as a risk.

How Does The Settlement Process Work?

It is too early to speculate accurate amounts that will be given as compensation from a settlement or verdict of the trial.  However what we do know is that in cases like this there are usually tiers or levels of payments awarded to plaintiffs based on the severity of their injuries.

All of the victims in the Elmiron lawsuits will have the same base of eye injury which relates to vision loss or impairment of vision. Cases with only vision damage will probably be grouped together into levels of severity of the damage to the plaintiff’s vision.

Cases with permanent loss of vision will be considered the most serious and will be in the highest awarded settlement group while those with only damage and not complete loss of vision would be in the second group.

Is Elmiron A Class Action Or a Mass-Tort Lawsuit?

Although this may sound like a class action Lawsuit it is not. The Elmiron lawsuit is a type of lawsuit called a Mass Tort Lawsuit. Most people are familiar with the definition of a class-action lawsuit. In essence, it involves a large group of people pursuing a single claim after suffering the same financial or physical harm. This means that it’s run as an individual case for a group of plaintiffs who will be treated as a single entity. 

A mass tort lawsuit is somewhat different from a class action. One of the major differences is that Mass tort lawsuits treat each individual plaintiff as a separate plaintiff as opposed to a member of a larger lawsuit.  It is still a group action taken against a company or person, but individuals in the case will often have varying circumstances and the injuries will usually have different levels of severity and because of this the settlement awarded will be different for each individual case.

Elmiron Lawsuit FAQ's

What is Elmiron used for?

Elmiron is used to treat bladder pain and discomfort caused by diseases like interstitial cystitis. Elmiron works by creating a protective layer around the bladder wall, ensuring that harmful substances in the urine don’t irritate it. Elmiron is also a “weak” blood thinner (anticoagulant).

When was Elmiron approved by the FDA?

Elmiron’s FDA approval was granted on September 26th, 1996, and the drug has been widely sold in the United States since that time.  

Who manufactures Elmiron?

Elmiron is manufactured by Janssen Pharmaceuticals, which is owned by Johnson & Johnson.

What are the side effects of Elmiron?

Common Elmiron side effects include diarrhea, nausea, vomiting, hair loss, stomach pains, headaches, and rashes. If you suffer any side effects from taking Elmiron, you should contact your doctor. However, the Elmiron lawsuits are based on the link between the drug and side effects related to eye damage, notably maculopathy and blindness.

How Many Research Studies Were Conducted?

5 separate research studies between May 2018 and November 2019 show that the drug Elmiron, most commonly prescribed for the bladder condition interstitial cystitis appears to be toxic to the retina (the light sensing tissue at the back of the eye that allows us to see). However there are no warnings at all on the product labelling describing any symptoms or side effects related to any kind of eye damage or problems.

Specifically what the research has brought to light is that long term exposure to Elmiron is causing Retinal cells in the eyes to accumulate a toxic substance. This toxicity can easily be misdiagnosed because the symptoms match very well to other well known retinal conditions, such as age-related macular degeneration or pattern dystrophy. However the most common eye disorder found among those with exposure to elmiron is called maculopathy, which can cause a number of vision problems and even has the ability to lead to blindness.

How Many People Are Affected By This?

Elmiron (pentosan polysulfate sodium) is a medication that is most commonly used to treat a bladder disorder called interstitial cystitis, which often causes urinary tract infections. However the medication has also been prescribed as a treatment for osteoarthritis.
Interstitial cystitis is a condition which causes pressure and chronic pain in the bladder. There is no cause and no cure for this condition. It affects millions of Americans each year and is more common in women. The more doses and years that a patient has taken Elmiron, the more likely that pigmentary maculopathy will develop.
Elmiron is the only medication approved by the Food and Drug Administration (FDA) to treat interstitial cystitis.

How Have Affected Individuals Fought Back?
If you or a loved have or are currently taking Elmiron it is strongly suggested that you get your eyes checked by an ophthalmologist. If you believe you have suffered vision damage or eye problems then you may be entitled to compensation and join the fight against Janssen Pharmaceuticals for failure to warn about the risks of vision loss and eye damage that are clearly associated with Elmiron usage.

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We are here to help you and loved ones advocate for justice. Feel free to send us any questions you might have, either about an injury or the process for pursuing justice so we can help you exercise your rights.

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