Everything about the Elmiron Class Action Lawsuit

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Researcher: Ariana Arce​

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Journalist: Aaron Vivanco

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Editor: Daniela Polo

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Everything about the Elmiron Class Action Lawsuit

The Elmiron class action lawsuit claims that the drug can cause maculopathy and other retinal disorders that may result in blindness. This drug has been prescribed to a significant number of people and is still available for purchase.

The lawsuits also indicated that Elmiron, a medication prescribed for interstitial cystitis (IC), is a defective drug. The plaintiffs claim that Janssen failed to disclose adverse event reports to the public, the medical community, and the US Food and Drug Administration (FDA).

Evidence shows the association between Elmiron medication and retinal damage, leading to the possibility of product liability lawsuits. Janssen Pharmaceutical is facing many lawsuits over Elmiron use and vision loss.

If you developed retinal problems such as maculopathy after using Elmiron, the manufacturer could be held liable for any damages or injuries caused. The help of an Elmiron lawyer is available for free. Just fill out our form and we will contact you.

How does Elmiron work?

Elmiron is a medication used to treat interstitial cystitis, a painful bladder condition affecting mostly women in the USA. It was approved by the FDA in 1996, after being submitted by Baker Norton Pharmaceuticals (now part of Ivax Pharmaceuticals). Teva Pharmaceuticals and Janssen now own the medication.

Elmiron contains an active ingredient in Elmiron is pentosan polysulfate sodium, a component known to restore the bladder’s protective mucous layer and decrease inflammation. Elmiron exhibits anticoagulant and fibrinolytic properties, although its specific mechanism of action in the treatment of IC remains unclear. The mechanism behind its effectiveness remains uncertain.

The FDA has approved Elmiron for the treatment of interstitial cystitis for an extended period. It is considered a safe and effective choice. However, concerns about its potential to cause serious eye damage, including maculopathy, a degenerative disease that may result in vision loss, have emerged in recent years.

Elmiron’s severe adverse effects

Elmiron has been considered a safe drug with minimal risks or severe side effects since its first introduction in 1996. Significant changes have occurred in recent years.

In 2018, doctors at the Emory Eye Center in Atlanta, Georgia, observed a trend where six patients had abnormal damage to the macular region of their eyes and were diagnosed with pigmentary maculopathy, resulting in concerns regarding the potential negative effects of Elmiron.

After some time, medical professionals recognized that these individuals were consistent consumers of Elmiron. The Emory Eye Center published a preliminary report suggesting that Elmiron could potentially harm retinas in human eyes.

What are the symptoms of an Elmiron-induced eye injury?

Recent studies have shown a potential correlation between Elmiron usage and the following three conditions: pigmentary maculopathy, retinal maculopathy, and macular degeneration. Patients who have experienced an eye injury due to Elmiron may exhibit the following certain symptoms:

  • Blurred vision
  • Distorted vision
  • Eye color changes
  • Increased sensitivity to light
  • Difficulty adjusting to the darkness
  • Difficulty reading
  • Muted colors
  • Straight lines appearing curvy
  • Dark spots in vision
  • Blind spots in vision
  • Eye pain
  • Vision loss

Previous studies reported that Elmiron’s active ingredient causes pigmentary maculopathy.

Relationship between Elmiron and maculopathy

Several studies reported that Elmiron (generic name: pentosan polysulfate sodium [PPS]) has been associated with a specific type of maculopathy known as pigmentary maculopathy.

According to research by the American Academy of Ophthalmology, individuals who use Elmiron may experience a specific type of maculopathy, a progressive disease with no known cure that can potentially result in blindness.

Other studies have indicated that patients who use PPS may experience visual difficulties, such as trouble reading and adjusting to low light. Additionally, prolonged drug use can result in more severe eye damage, which may continue to worsen even after discontinuing the medication.

Recent studies have reported concerning findings regarding the use of Elmiron. A study published in April 2022 revealed that Elmiron maculopathy is frequently misdiagnosed as another eye disease, a finding that supported that of another study conducted in the same year. It reported that individuals who used Elmiron for >3 years had a significantly higher risk of maculopathy.

Are there alternatives for Elmiron use?

Certain patients diagnosed with interstitial cystitis may evaluate alternative treatment options to Elmiron due to its financial implications and potential adverse effects. The list of alternative therapies includes antidepressants, antihistamines, hydrodistention, and bladder instillation procedures.

If you have been prescribed with this drug and have experienced adverse side effects, it is advisable that you look for Elmiron alternatives that can effectively treat interstitial cystitis (IC).

Nevertheless, always consult with a healthcare professional in order to assess your individual situation and confirm the next steps in your treatment process.

When did Elmiron lawsuits begin?

The first recorded lawsuit against Elmiron was filed by Tina Pisco in May 2020. She stated that this medication caused her vision loss after 6 years of use.

Pisco filed the lawsuit against Janssen Pharmaceuticals and Johnson & Johnson alleging that they failed to disclose information about the risks associated with Elmiron.

Soon after that, Valerie Hull also filed a lawsuit against Janssen and Johnson & Johnson in June 2020 due to pigmentary maculopathy, which resulted in night vision impairment, altered eye pigmentation, and substantial vision decline.

Hull’s case was studied in the 2018 Emory Eyecare study, which found that Elmiron is toxic to the retinal tissues in the eyes. The long-term use of PPS can also lead to pigmentary maculopathy. This report has been used in Elmiron lawsuits.

Elmiron is involved in multidistrict litigation

Following a series of lawsuits, an Elmiron MDL was established as a class action in December 2020. Judge Brian Martinotti oversaw the assignment of a Master Docket and established guidelines for a series of bellwether test trials.

Before its consolidation into an MDL, Janssen Pharmaceuticals faced <100 lawsuits related to Elmiron. Since its establishment, the MDL has received >2,000 lawsuits.

What are the eligibility requirements for an Elmiron class action lawsuit?

Individuals with a verified diagnosis of eye problems following a minimum of 2 years of Elmiron usage could potentially file a lawsuit. Lawyers may consider additional criteria that could impact eligibility.

Those who meet the following specific criteria may qualify for initiating legal action regarding Elmiron:

  • Took Elmiron for at least 2 years
  • Sought medical treatment for vision issues
  • Suffered vision changes such as blurred vision, difficulty reading, distorted vision, eye pain, issues adjusting to the darkness, vision disturbances, or vision loss after taking Elmiron
  • Were diagnosed with vision problems or started having vision problems while taking the medication or within 1 year after stopping the medication
  • Started having vision problems on or after January 1, 2010

Individuals are advised to seek legal counsel to determine their eligibility for filing a lawsuit related to Elmiron. For those unsure if they meet the criteria mentioned, it is recommended to reach out to an Elmiron lawyer for clarification. By answering a few questions, it can be determined whether you meet the requirements, and the consultation is offered at no charge.

What is the expected settlement amount for a legal case related to Elmiron?

As of now, there have not been any settlements regarding Elmiron lawsuits. Certain lawyers stated that potential settlement amounts for Elmiron could reach up to hundreds of thousands. Due to the absence of trials, jury verdicts, or global Elmiron settlement offers, the amounts that may be awarded in Elmiron lawsuit settlements cannot be estimated.

The resolution process for the Elmiron litigation is expected to be lengthy. The distribution of settlement funds to numerous individuals will require a considerable amount of time, even after reaching an agreement.