Elmiron Lawsuits

People are filing Elmiron lawsuits claiming the interstitial cystitis (IC) drug caused them permanent vision damage. Some filings accuse the manufacturers of concealing the risks of their pentosan polysulfate sodium-based drug. Medical publications support these claims, linking Elmiron to potentially irreversible eye damage. Elmiron lawsuits are currently pending trial.

Interstitial cystitis (IC) is a chronic, painful bladder syndrome with an unclear cause. IC causes bladder pain and frequent urination. Elmiron is the only FDA approved, pill-based treatment for this rare bladder condition.

Elmiron Vision Loss Overview:
Pentosan Polysulfate-Associated Maculopathy

Active Ingredient in Elmiron: Pentosan Polysulfate Sodium
Condition Names: 

  • Pigmentary maculopathy
  • Pentosan polysulfate sodium-associated macular disease  (PPSMD)
  • PPS maculopathy
Symptoms:

  • Vision dimming
  • Difficulty reading
  • Difficulty adjusting to low light
Types of Eye Damage Involved:

  • Atrophy, or wasting, of the colored cell layer in the retina (the RPE, or retinal pigment epithelium)
  • Areas of the eye giving off too little or too much light (hypo- and hyper-autofluorescence)
  • Areas of the eye reflecting too much light (hyperreflectance)
Cause(s):

Currently under investigation. Doctors have only found this condition in long-term Elmiron users. This unique form of eye damage has not been found in individuals who used the drug for less than three years. Experts describe the relationship between Elmiron and PPSMD as "a strong drug-disease association."

Eye Anatomy Involved in Elmiron Eye Problems

cross-section of eye anatomy relevant to pentosan polysulfate sodium maculopathy

  • Retina: the layer of cells on the back of the eye responsible for sending images to the brain
  • Macula: a small region at the central part of the retina responsible for seeing details of objects directly in front of you, such as text and faces
    *Elmiron may damage certain cells within the macula.
  • Fovea: a small pit in the center of the macula responsible for the sharpest type of vision
    *In certain cases, Elmiron may damage the cells of the fovea.

Elmiron and Macular Degeneration

What Is Elmiron? Elmiron is a prescription drug. Its active ingredient is pentosan polysulfate sodium (PPS), a type of sugar molecule. PPS has anti-clotting properties, making it a weak anticoagulant. It is only FDA approved for the treatment of interstitial cystitis (IC).

Elmiron's efficacy in this painful bladder syndrome is poorly understood. However, experts suggest Elmiron may build up over time and replace or augment a layer of similar molecules in the bladder. IC symptoms caused by weak points in this layer may then improve as a result of Elmiron use.

Visit our Elmiron uses and side effects page to learn more about this drug.

Elmiron has been the only pill-based treatment for IC since 1996. The original drug label listed zero vision-related side effects and/or warnings. However, the label was updated after studies linked Elmiron to a type of macular degeneration.

Scientists have yet to confirm exactly how Elmiron may cause eye injury. Some have theorized that long-term use may allow PPS to accumulate in the eye, as it does in the bladder.

Macular Damage in Elmiron Users

In 2018, ophthalmologists reported evidence of potentially irreversible eye injury in Elmiron users. After that first report, researchers found additional Elmiron users with this unique form of maculopathy.

Until mid-2020, Elmiron's prescribing information carried no warnings. In June 2020, Janssen Pharmaceuticals added a warning about retinal pigmentary changes. For many patients, this warning may have come far too late.

How Does Elmiron Lead to Eye Disease?

Many IC patients use Elmiron for more than five years. This means their bodies endure long-term, chronic exposure to PPS. Physicians have suggested this level of exposure may allow PPS or a byproduct to accumulate in retinal cells.

If PPS or a byproduct happen to be toxic to these cells, it could lead to eye diseases such as macular degeneration and retinopathy.

How Fast Does Elmiron Damage Eyes?

Studies show some patients may develop Elmiron retinal disease after only 3 years of use. Other patients have used Elmiron for up to 22 years before experiencing vision loss.

According to several ophthalmologists, the risk of PPS maculopathy increases with longer exposure to Elmiron.

Dr. Robin Vora recommends Elmiron users have vision screening for maculopathy at least once a year. If users have retinal damage or atrophy, they should discuss stopping Elmiron therapy with their prescribing physician. 

Is Pentosan Polysulfate Sodium (Elmiron) Eye Injury Reversible?

The most recent study was published in July 2020. In it, no patient experienced reversal of vision loss after stopping Elmiron. Some patients in the study even showed progression of retinopathy after stopping the drug. Retinopathy can eventually lead to blindness.

Because the Elmiron eye condition takes so long to develop, studies with longer follow-up periods may observe a different outcome. Research on the topic is ongoing.

Why Are We Just Learning of This Side Effect After Elmiron Has Been In Use for Almost 25 Years?

A number of factors may have contributed to the seemingly late-breaking news about Elmiron eye injury.

Short Duration of Drug Approval Studies

Elmiron gained United States Food and Drug Administration (FDA) approval in 1996. The largest study supporting its approval followed less than 15% of participants for more than two years. Only 86 patients, less than 4% of the total enrolled, took the drug for more than seven years.

Takeaway: The pre-approval studies may simply have been too small and too brief to recognize the eye injury adverse event.

Long Duration of Elmiron Use Associated With Eye Injury

Currently-available data suggests patients have to take Elmiron for many years before eye injury occurs. According to one study only 12.7% of patients who took between 4.6 and 9.2 years worth of Elmiron developed vision problems. This number jumped to 41.7% for those who took more than 13.7 years worth of the drug.

Takeaway: Elmiron has only been approved for 24 years. Therefore, it is possible many patients are just now reaching the level of Elmiron use necessary for eye injury to occur. 

Elmiron Eye Injury Mistaken for Common Age-Associated Vision Loss

The specific type of vision loss associated with Elmiron may be easily mistaken for other eye conditions. It is possible that more Elmiron patients have developed this maculopathy without knowing it may have been caused by the drug.

Takeaway: Some Elmiron users may have been told their visions problems were the result of aging or other factors. However, Elmiron may have caused their vision loss.

Eye Conditions Potentially Mistaken for Elmiron Maculopathy
  • Age-related macular degeneration
  • Pattern dystrophy
  • Stargardt disease

Do You Qualify for an Elmiron Lawsuit?

Only an experienced Elmiron lawyer can determine the viability of your case. If you believe you may have a case, you should speak to an Elmiron attorney today.

Law firms will examine many eligibility factors such as:

  • Required: Confirmed Elmiron Use
    Individuals with a documented record of taking Elmiron for two years or more may have an easier time proving their case.
  • Required: Symptoms of Eye Damage or Vision Loss
    Elmiron users must have some evidence of maculopathy, eye disorder or other vision problems in order to file a lawsuit. Eligible symptoms may include:

    • Any form of blindness
    • Difficulty seeing in low light
    • Impaired nighttime vision
    • Macular degeneration
    • Macular dystrophy
    • Maculopathy
    • Retinopathy
    • Vision impairment
    • Vision loss

Elmiron Lawsuits

Elmiron users have now filed multiple lawsuits against the drug's manufacturers. Many of these legal complaints make similar claims.

Elmiron Lawsuit Claims

  • Elmiron manufacturers knew, or should have known, the drug causes retinal damage and maculopathy
  • Elmiron manufacturers failed to warn the public of the drug's risk of eye injury or vision loss
  • Elmiron manufacturers are responsible for eye injuries and vision loss in Elmiron users
  • Manufacturers named in lawsuits:
    • Alza Corporation
    • Bayer
    • Janssen Pharmaceuticals (a division of Johnson and Johnson)
    • Ortho-McNeil Pharmaceuticals
    • Teva Pharmaceuticals

Lawsuit Spotlight: Shirley Ruth Levy Sues Manufacturers for Toxic Maculopathy Condition

Shirley Ruth Levy took Elmiron for interstitial cystitis (IC) from 2013 to 2017. She filed a lawsuit against multiple companies after developing:

  • Toxic maculopathy
  • Retinal damage
  • Blurred vision
  • Distorted vision
  • Other visual symptoms

Levy is seeking damages for medical expenses, pain and suffering, legal fees, and several other costs related to Elmiron eye damage.

Lawsuit Spotlight: Kimberly Pelczar Sues for Permanent Retinal Injury

Kimberly Pelczar began taking Elmiron in 2005 for interstitial cystitis (IC). Approximately 10 years later, she sought medical care for vision problems. Pelczar was diagnosed with permanent vision loss and retinal injury. She has filed a lawsuit against Elmiron manufacturers seeking legal damages for her eye injuries.

Elmiron Class Action Lawsuits

Class action lawsuits group multiple cases together under a single plaintiff or representative. This creates a single legal case for the group instead of one case per plaintiff.

At this time, there are no Elmiron class action lawsuits.

Pentosan Polysulfate Macular Degeneration Settlements

In a similar case of drug-associated eye injury, a woman was awarded $21 million by a jury.

There have been no Elmiron settlements at this time. However, a similar case may give an idea of the size of a settlement or jury award.

Karen Bartlett took a pain medication that caused an array of side effects and rendered her nearly blind. She sued the drug manufacturer and was awarded $21 million.

Elmiron Lawsuit FAQs

Who Qualifies to File an Elmiron Eye Damage Lawsuit?

Only an experienced lawyer can determine if you have a viable Elmiron case. For information on criteria that may be helpful, please see the eligibility section above.

Does Elmiron Cause Blindness?

According to studies, Elmiron may cause a type of eye injury that could lead to blindness.

Learn more about Elmiron and blindness here >>>

Can I Join an Elmiron Class Action?

At this time, there are no class actions pending for Elmiron.

What Compensation is Available for an Elmiron Lawsuit?

Compensation for an Elmiron lawsuit may be similar to previous drug injury lawsuits, which have resulted in awards of $21 million. However, no Elmiron cases have gone to trial as of October 2020. Thus, the range of compensation has yet to be determined for these lawsuits.

Plaintiffs in other faulty drug lawsuits have claimed the following legal damages:

  • Legal damages for the cost of medical treatments related to their eye injury
  • Legal damages for the amount of income lost due to vision impairment
  • Legal damages for the physical and emotional pain of vision loss

At least one Elmiron lawsuit has already sought punitive damages to punish the manufacturers for alleged negligence.

If you or a loved one have experienced vision damage from Elmiron, you should speak with a lawyer today.

How Much Does it Cost to File an Elmiron Lawsuit?

Initially, there is no cost to filing a lawsuit. Elmiron attorneys typically take cases on contingency. This means the law firm will not get paid unless and until your case succeeds.

Has Elmiron Been Recalled?

No. Elmiron has not been recalled.