Elmiron Lawsuit

Elmiron was prescribed to treat interstitial cystitis, a urinary condition that affects up to a million people, mostly women, in the United States.

Up to 25% of people who took Elmiron long-term may suffer from a unique type of ocular damage called pigmentary maculopathy.

This condition is often mistaken for a different type of ocular damage, usually age-related macular degeneration. However, testing can link eye damage to taking Elmiron.

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  • What Is Elmiron?
  • What Does Elmiron Treat?
    • What Is Interstitial Cystitis?
    • What Are the Symptoms of Interstitial Cystitis?
    • Who Is at Risk for Developing Interstitial Cystitis?
    • What Complications Can Interstitial Cystitis Cause?
  • What Is Pigmentary Maculopathy?
    • What Are the Symptoms of Pigmentary Maculopathy?
  • What Are Elmiron’s Links to Pigmentary Maculopathy?
  • Has Elmiron Been Recalled?
  • Have There Been Any Elmiron Lawsuit Settlements?
  • What Lawsuits Are There Against Johnson & Johnson?
    • Are There Any Class Action Lawsuits?
  • Should I Consider an Elmiron Lawsuit?
    • How Do I Find an Elmiron Attorney?
    • Who Is the Right Lawyer to Handle My Lawsuit?
  • Sources

Elmiron Lawsuits

At the 2019 meeting of the American Academy of Ophthalmology, research was presented showing that Elmiron (pentosan polysulfate sodium), used for long-term treatment of a rare urinary disorder, interstitial cystitis, may cause a degenerative eye disorder. A unique type of ocular damage, pigmentary maculopathy, may develop in as many as 25% of long-term users of Elmiron.

Some of the patients who were identified in the study of the ocular disorder had originally been diagnosed with another eye condition such as macular degeneration or pattern dystrophy but additional testing had shown a link to their medication use. Some of these people may be filing Elmiron vision loss lawsuits against Janssen Pharmaceuticals, a division of Johnson & Johnson.

What Is Elmiron?

Elmiron is the brand name for pentosan polysulfate sodium and is manufactured by Janssen Pharmaceuticals, a division of the healthcare giant, Johnson & Johnson. Elmiron was approved in 1985 as a medication listed under the “orphan drug” status which is a classification given to medications that are one of a few treatments or the only treatment available for rare disorders. However, thanks to an expanded understanding of interstitial cystitis, it’s no longer considered an orphan drug, as there are more options for the treatment of IC.

Elmiron is classified as a low molecular weight heparin-like compound that has anticoagulant and fibrinolytic properties but the exact way that it works to treat interstitial cystitis is not known. Elmiron is taken as a three times daily regimen of 100mg on an empty stomach. Patients who begin the medication are reassessed at 3 months and treatment may be continued for another 3 months if no improvement is seen.

This means that patients for whom taking Elmiron was successful may be on the drug for long periods of time. Typically, those who have developed pigmentary maculopathy have taken the drug for six months or longer. This means that the more successful taking Elmiron was at treating a patient’s condition, the more at risk they were for developing an eye disorder.

What Does Elmiron Treat?

Elmiron is prescribed to treat a bladder condition called interstitial cystitis, which is also called painful bladder syndrome. Interstitial cystitis (IC) was originally thought to be a rare disorder, thus Elmiron’s classification as an orphan drug, but now is known to affect up to a million people across the United States, primarily women, although it can also affect men.

What Is Interstitial Cystitis?

Interstitial cystitis causes recurring episodes of discomfort, pressure, or pain in the bladder and pelvic region and may be accompanied by a need to urinate frequently, sometimes as many as 40-60 times per day. Symptoms of IC may emerge slowly and worsen over a period of months. They may also change from day to day and may be triggered by other conditions such as episodes of irritable bowel syndrome or endometriosis.

The specific cause is unknown but other disorders are often associated with interstitial cystitis including allergies, migraine headaches, irritable bowel syndrome, fibromyalgia, and chronic fatigue syndrome. Unfortunately, the condition is excruciatingly painful and only about half of all people with IC are able to maintain full-time employment.

What Are the Symptoms of Interstitial Cystitis?

Interstitial cystitis has symptoms that may be similar to another urinary condition, overactive bladder syndrome (OAB) which also causes urinary urgency. Unlike OAB however, interstitial cystitis may result in cellular changes in the tissue layer surrounding the bladder, the urothelium.

These symptoms include:

  • Chronic pelvic pain
  • Pain between the vagina and anus (in women)
  • Pain between the scrotum and anus (in men)
  • A persistent or frequent urge to urinate
  • Frequent urination, especially if it’s in small amounts each time, up to 60 times a day
  • Pain during sex
  • Pain as the bladder fills that is relieved by urinating

The severity of the symptoms differs depending on the person. Some people with interstitial cystitis may experience periods during which they’re free of any symptoms. The symptoms of interstitial cystitis are similar to those of a urinary tract infection, but there won’t actually be an infection present. However, if someone who has IC does develop a urinary tract infection as well, their symptoms are likely to worsen.

Who Is at Risk for Developing Interstitial Cystitis?

There are some factors that determine whether someone is more at risk for developing interstitial cystitis. These include:

  • Gender
  • Age
  • Skin and hair color
  • Pre-existing chronic pain disorder

Women are far more likely to develop IC than men are. Men who experience the symptoms of interstitial cystitis often actually have an inflamed prostate instead. In addition, most people diagnosed with interstitial cystitis are in their 30s or older. People who have fair skin and red hair are also at greater risk of developing the condition than people who have different hair and skin colors.

While the exact cause of IC isn’t known, it is associated with other chronic pain conditions, such as fibromyalgia and irritable bowel syndrome. People with a condition of this kind may be at higher risk for developing interstitial cystitis as well.

What Complications Can Interstitial Cystitis Cause?

People with interstitial cystitis were often reliant on Elmiron to treat their symptoms because of the chronic pain associated with the condition. On top of that, the condition can cause additional complications that affect patients’ quality of life. These include:

  • Smaller bladder capacity
  • Emotional difficulties
  • Trouble with intimacy
  • Lower quality of life

Both the chronic pain and the frequent urination associated with interstitial cystitis can interfere with experiencing a normal life. Social activities are impeded by having to frequently leave to urinate. Many who have interstitial cystitis are unable to hold down a job because of it. They’re unable to participate in activities that they may want to.

This, in turn, leads to IC affecting personal relationships. It’s more difficult to maintain social relationships when social activities are impacted by the condition. On top of that, painful sex makes it more difficult to experience intimacy with a partner.

These factors, along with the chronic pain and interrupted sleep that comes with having to get up throughout the night to urinate, can lead to both emotional stress and depression.

What Is Pigmentary Maculopathy?

Pigmentary maculopathy is a type of eye disorder that affects the macula of the eye, which is where the eye sees vision the most clearly. Any disease that affects the macula is a type of maculopathy and pigmentary maculopathy is a unique disorder caused by toxicity from long-term exposure to Elmiron.

Because of the typical age of the patients who developed pigmentary maculopathy as a result of taking Elmiron, they were often misdiagnosed with macular degeneration or another eye disorder such as pattern dystrophy. However, further examination showed that in these patients the ocular disorder was instead related to long-term Elmiron toxicity, which could lead to vision loss or even blindness.

What Are the Symptoms of Pigmentary Maculopathy?

This novel type of maculopathy is called pigmentary maculopathy because of changes in the pigmentation of the eye in patients who have the condition. Spots of hyperpigmentation, or darker spots on the macula, were discovered by ophthalmologists in patients with pigmentary maculopathy.

The symptoms of pigmentary maculopathy include:

  • Blurry Vision
  • Night blindness
  • Difficulty reading
  • Dark spots
  • Loss of close vision
  • Visual dimming
  • Blindness

What Are Elmiron’s Links to Pigmentary Maculopathy?

In 2018, ophthalmologists noted a trend of patients who were on Elmiron for the treatment of interstitial cystitis who developed vision problems or macular disorders. These ophthalmologists conducted a review of patients at Kaiser Permanente in Northern California and determined that up to 25% of patients using Elmiron for long-term treatment of urinary pain associated with interstitial cystitis had developed eye damage of some type.

Data presented at the 2019 meeting of the American Academy of Ophthalmology showed that researchers had identified 140 patients who had taken an average of 5,000 Elmiron doses over about 15 years. Of these patients, researchers were able to obtain further exams from 91 and found 22 or about one-quarter of these patients showed significant signs of drug toxicity as the development of pigmentary retinal maculopathy, a degenerative eye disorder which appears to be unique. The greater the exposure or longer the medication had been taken, the higher the risk for damage.

Ophthalmologists recommend that anyone taking Elmiron long-term have their vision tested annually to look for any signs of pigmentary maculopathy. If the disorder is caught early, it’s possible to stop any further damage from occurring by stopping taking Elmiron. If the damage isn’t discovered until too late, however, even stopping Elmiron may not prevent permanent vision loss.

Has Elmiron Been Recalled?

Though the vision problems have been identified since at least 2018, Elmiron prescribing information does not include any warnings for visual disturbance, vision changes, macular damage, or any other eye conditions. In addition, the FDA has not issued a recall for Elmiron nor even issued a warning to patients regarding the risk of vision loss and ocular damage.

This means that more people may suffer from vision loss due to pigmentary maculopathy because they were unaware of the risks of taking the drug long-term.

Have There Been Any Elmiron Lawsuit Settlements?

All Elmiron lawsuits are still ongoing, so there have not yet been any settlements. In a lawsuit, the settlement is the resolution that both parties come to. If the Elmiron cases are successful, this will likely involve money paid out for medical expenses, pain and suffering, lost wages, and more.

What Lawsuits Are There Against Johnson & Johnson?

A lawsuit against Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and Teva Branded Pharmaceuticals, both of which have manufactured Elmiron, was filed in Connecticut in March of 2020. The lawsuit alleges that the company failed to properly warn patients and doctors of the potential risks of vision loss due to pigmentary maculopathy. The company also failed to recommend that patients have regular eye exams to check for eye damage so that it could be caught early before vision loss was permanent.

Are There Any Class Action Lawsuits?

With up to 25% of patients taking Elmiron potentially experiencing pigmentary maculopathy due to Elmiron toxicity, the manufacturers of Elmiron may be facing more lawsuits in the future. A class action lawsuit would not only represent the people suing but also benefit those who aren’t but who took Elmiron and experienced ocular damage as a result.

Should I Consider an Elmiron Lawsuit?

People who took Elmiron for more than 6 months for pain associated with interstitial cystitis and developed vision loss, eye problems, or were diagnosed with a macular disorder like pigmentary maculopathy may be eligible for compensation and should seek legal assistance.

How Do I Find an Elmiron Attorney?

If you have taken Elmiron long-term and have suffered from vision loss as a result, make sure to be tested by your ophthalmologist for pigmentary maculopathy. If your doctor has determined that you do have pigmentary maculopathy, you may have a case against the manufacturer of Elmiron. While there are many attorneys available, you’ll want to make sure that you find the right one to take your case.

Who Is the Right Lawyer to Handle My Lawsuit?

Seeger Weiss’ lawyers are experienced in pharmaceutical litigation. We offer free consultations with all prospective clients.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.


Since its establishment in 1999, Seeger Weiss has led some of the most complex and high-profile litigations in the U.S.