Elmiron Lawsuits

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Doctors have recently identified permanent vision damage in some long-term Elmiron users. As a result, people are now filing Elmiron lawsuits. Some filings accuse the manufacturers of concealing the risks of the interstitial cystitis (IC) drug. Elmiron users who developed maculopathy or vision loss may be eligible to file a lawsuit.

What Is Elmiron?

Elmiron is a prescription drug. Its active ingredient is pentosan polysulfate sodium (PPS), a weak anticoagulant. It is only FDA approved for the treatment of interstitial cystitis (IC), a painful bladder syndrome.

Learn more about Elmiron uses and side effects here >>>

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

  • 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)

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."

Who Can File an Elmiron Vision Loss 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:

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

Elmiron Vision Loss 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
    • Janssen Pharmaceuticals (a division of Johnson and Johnson)
    • Ortho-McNeil Pharmaceuticals
    • Bayer
    • 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.

Elmiron Lawsuit Settlements

There have been no Elmiron settlements at this time. However, a similar case of drug-associated eye problems awarded the victim $21 million. The plaintiff, Karen Bartlett, took a pain medication that caused an array of side effects and rendered her nearly blind. She sued the drug manufacturer, and the jury found in Bartlett's favor.

No Elmiron cases have gone to trial as of April 2021. 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

Maculopathy and Elmiron

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

But, PPS may have different effects in the eye and the bladder. PPS may induce toxicity in the retinal tissue at the back of the eye, called the macula.

How Does Elmiron Lead to Eye Damage?

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 to date 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.

Factor: Short Duration of Drug Approval Studies
  • Only 15% of clinical study participants were followed for more than two years.
  • Less than 4% of participants 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.
Factor: Long Duration of Elmiron Use Associated With Eye Injury
  • 12.7% of patients who took between 4.6 and 9.2 years worth of Elmiron developed vision problems.
  • 41.7% of patients who took 13.7 years worth of the drug developed vision problems.
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.
Factor: 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. 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

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. But, several Elmiron users have filed individual lawsuits.

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.

Learn more about Elmiron compensation in the settlements section above >>>

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.

When Was Elmiron Maculopathy Discovered?

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.

When Was Vision Damage Added to the Elmiron Label?

Until mid-2020, Elmiron's prescribing information carried no warnings. In June 2020, Janssen Pharmaceuticals added a warning about retinal pigmentary changes.

Elmiron Lawsuit News

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