What is the Elmiron Lawsuit?
Numerous Elmiron lawsuits have been filed against makers of the prescription drug Elmiron, an FDA-approved medication used to treat interstitial cystitis (IC). These lawsuits allege that Janssen Pharmaceuticals and Bayer, manufacturers of Elmiron, purposely held back information on the dangers of Elmiron use–notably, an increased risk of retinal damage known as pigmentary maculopathy.
Recent American Academy of Ophthalmology findings established a link between long-term use of Elmiron and the development of maculopathy, which can result in severe vision loss and even blindness. Anyone who has taken Elmiron for IC (also known as bladder pain syndrome) and experienced retinal damage, loss of vision, or other vision problems may be eligible to join an Elmiron lawsuit.
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What does Elmiron do?
The lawsuits revolve around Elmiron, a Food and Drug Administration(FDA)-approved oral medication designed to relieve pain and discomfort resulting from interstitial cystitis, or painful bladder syndrome. Also known as pentosan polysulfate sodium (PPS), scientists believe that Elmiron provides a protective layer within the bladder to mitigate against harm and irritation caused by substances in the patient’s urine.
Physicians have prescribed Elmiron to men and women for decades to treat the symptoms of IC. Recent studies and research show links between taking Elmiron and the conditions of pigmentary maculopathy and vision loss. This puts thousands or even hundreds of thousands of patients at potential risk of developing one or more vision-related conditions.
If you’ve taken Elmiron and experienced retinal damage or vision loss, you may qualify for an Elmiron lawsuit in 2021. Contact us today about a free case review.
Does Elmiron Cure Interstitial Cystitis?
Elmiron does not provide a cure for IC. Instead, doctors prescribe pentosan polysulfate sodium (the generic name for Elmiron) to treat symptoms associated with interstitial cystitis, including the pain and discomfort often linked to painful bladder syndrome.
Who makes Elmiron?
Janssen Pharmaceuticals, owned by Johnson & Johnson, has manufactured Elmiron since 1996.
What Are Elmiron Side Effects?
The legal case distinguishes two categories of Elmiron side effects: 1) those originally listed by Janssen Pharmaceuticals, and 2) those that were not.
Listed Side Effects
The most common side effects that the makers of Elmiron originally included were:
- hair loss (alopecia)
- trouble sleeping
- unexpected weight gain
- skin rashes
- bloody stool
- gastroesophageal reflux (GERD)
- abnormal liver function
Unlisted Elmiron Side Effects
Before June 2020, prescription drug makers like Johnson & Johnson (owner of Janssen Pharmaceuticals) failed to warn the public about many Elmiron effects related to vision impairment. The Elmiron lawsuit is expected to grow in 2021 case.
According to a 2019 report by the American Academy of Ophthalmology, patients taking Elmiron for interstitial cystitis (IC) may also suffer from:
- Varying degrees of vision loss
- Ocular toxicity
- Difficulty reading and focusing on nearby objects
- Inability to adjust eyesight in the dark or dim lighting
- Pigmentary maculopathy (retinal damage)
Are you or a loved one experiencing one or more vision-related symptoms after taking Elmiron? If so, please speak with Elmiron lawyers about a free case review.
Where Do I Report Elmiron-Related Health Issues?
Physicians and Elmiron patients are encouraged to report any health-related side effects of the drug to the Food and Drug Administration’s MedWatch Safety Information and Adverse Event Reporting Program. You have several options for reporting an issue to the FDA MedWatch Program:
- Call (800) 628-7710
What is Elmiron Maculopathy?
Elmiron pigmentary maculopathy is a form of eye damage that may result from chronic usage of pentosan polysulfate sodium (PPS), also known as Elmiron.
Often referred to as macular degeneration, Elmiron maculopathy involves damage to a part of the retina known as the macula, affecting the eye’s ability to sense light and provide a clear picture of the patient’s surroundings.
The first documentation of the relationship between maculopathy and Elmiron first appeared in a 2018 review by Kaiser Permanente in Northern California, which found nearly a quarter of patients taking pentosan polysulfate sodium “showed signs of eye damage” after long-term exposure. More is expected to know to abut the Elmiron lawsuit in 2021
Kaiser researchers discovered that vision problems resulting from extensive use of Elmiron “could masquerade as other known retinal conditions, such age-related macular degeneration or pattern dystrophy.”
A 2018 study conducted by physicians at the Emory Eye Center in Atlanta, GA, supported this research. In their report, Emory doctors reported macular abnormalities in six patients who had been taking the drug for interstitial cystitis (IC) for more than a decade, raising “a warning flag that long-term use of Elmiron may damage the retina.”
Emory physicians updated this report in 2019 to reflect that ten Emory patients had experienced similar problems.
Have you developed maculopathy after taking PPS/Elmiron? Learn more about Elmiron lawsuits and pursuing full damages for injuries.
Studies Linking Elmiron to Maculopathy
Evidence continues to emerge that links long-term use of Elmiron for interstitial cystitis (IC) to different types of eye damage, including vision distortion, gradual vision loss, ocular toxicity, and pigmentary maculopathy.
Recent studies connecting Elmiron to serious vision problems include the following.
Pearce, Chen & Jain Study in Opthalmology, November 2018
Doctors from Emory Eye Center conducting a case study of six patients taking Elmiron for bladder pain syndrome discovered a direct correlation between long-term Elmiron use and maculopathy.
Hanif, Shah, Yan, et al., Study in Opthalmology, October 2019
Emory Eye Center physicians expanded their 2018 study to include ten patients, finding more evidence of the prescription drug’s link to macular degeneration. Results were also published in The Journal of Urology.
Vora, Patel & Melles Study presented at 123rd Annual Meeting of the American Academy of Ophthalmology, October 2019
After examining more than 90 patients, Kaiser Permanente researchers Vora, Patel & Melles discovered greater levels of ocular toxicity in those taking higher doses of PPS.
Huckfeldt & Vavvas Study in Ophthalmic Surgery, Lasers and Imaging Retina: Case Report, November 2019
A report featured in the peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging Retina outlined one case of Elmiron-related maculopathy that continued to deteriorate years after use of the drug had ended.
Vora, Patel & Melles, Study in Opthalmology, January 2020
A professional review of IC patient data from Kaiser Permanente for 177 individuals found that nearly 25% of patients taking PPS showed symptoms of pigmentary maculopathy.
Yusuf, Charbel & Lotery, Study in JAMA Ophthalmology, August 2020
Three medical researchers from the United Kingdom published this study reporting on the maculopathy after PPS drug cessation in a series of 11 patients.
Mogica & De, Literature Review in Urology, October 2020
A literature review of 14 published scholarly research studies linking Pentosan Polysulfate Sodium and the development of macular disease suggests an increased risk.
Am I Suffering from Elmiron Maculopathy?
Because pigmentary maculopathy generally doesn’t cause a lot of pain, it can often be difficult to catch the condition before it worsens or causes more permanent damage.
Studies show that patients with Elmiron-related macular degeneration often have difficulty:
- Focusing on nearby objects
- Adjusting to darker settings
- Driving at night
They also report seeing spots or areas within their field of vision (also known as paracentral scotoma)
Other common symptoms of maculopathy include image distortion and gradual vision loss, which may worsen as time goes on.
If you know someone who has taken PPS and suffered from vision loss, they may qualify to join an Elmiron lawsuit MDL (multi-district litigation). Learn more today.
Has Elmiron Been Recalled?
Despite numerous studies and research tying chronic PPS exposure to unique pigmentary maculopathy, as well as other types of eye damage, there has been no recall of Elmiron. Currently, the FDA has no plans to request an Elmiron recall by the manufacturer.
Following extensive research and pressure from outside sources, Janssen Pharmaceuticals listed a warning about the drug’s potential for causing vision loss in June 2020.
Can I Go Blind from Taking Elmiron?
American Academy of Ophthalmology’s 2019 report and numerous supporting studies (see above) have shown a link between Elmiron use for interstitial cystitis (IC) and a patient’s increased risk for developing pigmentary maculopathy.
But even though maculopathy can cause major vision problems and speed up overall vision loss, it rarely results in complete blindness, particularly when diagnosed early.
If you’ve been taking Elmiron for a bladder condition and have experienced vision problems or eye damage, you may qualify to file an Elmiron lawsuit to seek compensation. Be sure to consult Elmiron lawsuit attorneys to learn more.
How Do I Qualify for an Elmiron Lawsuit?
U.S. Elmiron lawsuit lawyers are accepting cases for clients who:
- Used pentosan polysulfate sodium for two years or more
- Suffered vision damage, eye disorders, pigmentary maculopathy, or other vision-related issues while taking the PPS
You may also qualify for an Elmiron lawsuit if any vision loss, symptoms, or injuries began within one year after treatment ended.
Qualifying injuries and symptoms may include:
- Unique pigmentary maculopathy (macular degeneration)
- Paracentral scotoma
- Impaired or blurred vision
- Retinal atrophy
- Ocular toxicity
- Macular dystrophy
- Night blindness
- Bilateral or unilateral blindness
- Permanent vision loss
Suffering from an Elmiron-related vision impairment? Experienced vision loss lawyers can help you pursue damages for your injuries.
Reasons to File an Elmiron Lawsuit
Using Elmiron to treat interstitial cystitis (IC) can lead to costly vision problems that may affect your health, livelihood, and happiness for years down the road. If you took Elmiron for issues associated with interstitial cystitis and suffered vision damage as a result, you may be entitled to financial compensation for:
- Costs of past and future medical treatment
- Pain and suffering (physical and mental) resulting from your condition and related medical procedures
- Any loss of wages and earnings potential due to injury
- Other damages or loss suffered
Joining an Elmiron class action suit with the help of experienced lawyers may be the best way to achieve fair and full compensation for your Elmiron-related vision loss.
While Elmiron lawsuit settlement amounts aren’t guaranteed, a seasoned lawyer can help you file your suit, gather evidence, build your case, and pursue compensatory damages for your injuries.
Whatever your unique circumstances, it’s important to take action fast. Your state likely has a statute of limitations on how much time you have to file after discovering your injuries, making it critical to find the right law firm and file your Elmiron vision lawsuit as quickly as possible.
How to Get Started
Suffering from maculopathy or another eye disorder due to long-term use of Elmiron? If you or a loved one is coping with difficulty reading, blurred vision, maculopathy, or permanent vision loss because of exposure to PPS, contact our dedicated support team today.
At Class Action Law Center, we work with only skilled, qualified, and proven lawyers ready to take on Elmiron manufacturers and fight for full compensation for your claim.
Our trusted experts take time to evaluate your unique claim, set realistic expectations for compensation and damages, and connect you with lawyers suited to your unique Elmiron case.
We understand how terrifying and destructive this drug has been for you and your loved ones. That’s why we work hard to find the law firm and lawyers that will pursue full compensation for your Elmiron vision loss.
Seeking a free case review? Fill out this form with first and last name, email, phone number, and a brief description of your injury.
Elmiron Lawsuit Updates
Two Plaintiffs File Suit Against Makers of Bladder Drug Elmiron
09.03.20 – Two Elmiron lawsuits have been filed against Janssen Pharmaceuticals, exhibiting growing concerns about the bladder drug’s link to degenerative eye problems and permanent vision loss.
The first involves a woman in North Carolina who filed her case after taking the drug for interstitial cystitis (IC) for more than 20 years. The plaintiff took Elmiron from 1998 to 2020, though it was in 2019 when she first began experiencing issues with her vision. These problems were later diagnosed as “pentosan polysulfate maculopathy.”
The second lawsuit involves a woman from California who started experiencing such symptoms as blurred vision, retinal damage, and maculopathy after taking the drug for four years (2013-2017).
Both lawsuits allege that the manufacturer failed to provide proper warning about the drug’s link to potential vision loss, making Janssen liable for damages.
Find out more about Elmiron vision lawsuits today.
Legal Action Filed in Canadian Courts Over Elmiron Vision Loss
07.29.20 – A proposed class-action lawsuit has been filed in Canada against the makers of Elmiron, alleging a link between long-term use of the drug and a serious eye problem (maculopathy) affecting the retina.
Alleged eye damage includes difficulty reading, blurred vision, and difficulty adjusting to various lighting conditions.
Like many Elmiron vision lawsuits, this action claims the manufacturers of Elmiron failed to warn about the increased risk of vision loss associated with long-term exposure to the drug.
This suit seeks to advance claims against the drugmaker on behalf of all Canadians experiencing vision problems after taking Elmiron for interstitial cystitis, a painful bladder condition.
Suffering injuries or vision loss due to Elmiron? If so, you may be eligible for an Elmiron lawsuit.
Drugmaker Changes Elmiron Warning After Extensive Criticism
07.09.20 – After numerous studies and considerable pressure by the scientific community, Janssen Pharmaceuticals has amended the warning label for Elmiron, adding vision damage as a potential side effect of using the drug.
Designed to treat interstitial cystitis, also known as painful bladder syndrome, Elmiron has been shown to increase patient risk for a number of vision issues, including pigmentary maculopathy and vision loss.
A subsidiary of Johnson & Johnson, Janssen had already updated Elmiron drug labels in Europe and Canada, leaving U.S. patients in the dark until June 2020.
The change comes after years of studies and reports by members of the medical community, including several tying years of Elmiron use to a severe type of macular degeneration.
Prescribed to hundreds of thousands of patients over the last two decades, Elmiron, or pentosan polysulfate sodium, has been shown by researchers to increase patient risk for a variety of eye conditions.
Past studies have been featured in a number of publications, including the Journal of Urology and the American Academy of Ophthalmology.
Patients who have used the drug for two years or more and developed a serious eye condition associated with Elmiron may qualify for financial compensation. Learn more about Elmiron lawsuits today.
South Carolina Elmiron Lawsuit: Bladder Pain Drug Caused Severe Eye Injuries
06.09.20 – Plaintiff Valerie Hull of South Carolina is seeking damages from prescription drugmaker Johnson & Johnson, claiming the company failed to provide warnings of a documented link between bladder medication Elmiron and severe eye conditions.
Hull was one of six patients participating in a study conducted by Dr. Nieraj Jain, an ophthalmologist at the Atlanta-based Emory Eye Center.
In the now-famous 2018 study, Dr. Jain observed Hull and her fellow patients not only shared the same types of eye injury but were also taking Elmiron (pentosan polysulfate sodium) for interstitial cystitis.
Other studies have since confirmed a significant link between Elmiron and the development of conditions like vision loss and maculopathy, a serious and sometimes irreversible eye disorder.
A 2019 study by Kaiser Permanente Ophthalmologists Amar P. Patel and Robin A. Vora found nearly 23% of patients taking the drug Elmiron displayed alarmingly high levels of drug toxicity, particularly when compared to those taking lower doses.
If you or a loved one took Elmiron and are experiencing eye damage or loss of vision, you could be eligible for an Elmiron lawsuit in 2021.
Elmiron Use Leads to Vision Damage, New Lawsuit Claims
05.22.20 – A new lawsuit has been filed against a Johnson & Johnson subsidiary, alleging a connection between the drug Elmiron and a severe eye disorder known as maculopathy.
In her complaint, the woman argues that after nearly six years of taking Elmiron for interstitial cystitis, a
painful bladder problem, she began to experience serious problems with her vision. This was later diagnosed as maculopathy.
The complainant adds that Janssen failed to include maculopathy on the drug’s warning label, making the drugmaker liable or the plaintiff’s condition.
This marks the first time a legal injury lawsuit has been filed regarding the drug Elmiron.
As of May 2020, Janssen has yet to add warnings about potential vision-related side effects to the Elmiron label.
Studies have shown Elmiron (pentosan polysulfate sodium) to have adverse effects on vision, especially when taken over long periods of time.
Investigations presented at the 2019 meeting of the American Academy of Ophthalmology provide strong supporting evidence of the bladder drug’s link to vision loss and many other vision-threatening conditions.
Recent Elmiron Lawsuit Alleges Link Between Drug and Serious Eye Condition
05.18.20 – Long-time Elmiron patient Tina Pisco started taking the drug for interstitial cystitis (painful bladder syndrome) in 2012. Now, Pisco is taking the drug’s manufacturer, Johnson & Johnson, to court, claiming Elmiron has caused a severe eye condition and significant loss of vision over the past two years.
Pisco’s injury, known as pigmentary maculopathy, has resulted in permanent injury to both retinas. Her recent claim against the drugmaker alleges that Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, “designed, marketed, and distributed” the drug “while knowing significant risks that were never disclosed to the medical and healthcare community.”
Her complaint further adds that Janssen “withheld material adverse events” and “failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy.”
Approved by the Food and Drug Administration in 1996, Elmiron is widely used to treat a condition known as painful bladder. However, recent studies have shown that chronic use of the drug can put patients at heightened risk of eye disease, most notably a unique form of macular degeneration.
Johnson & Johnson has yet to make an official statement on this case.
Learn more about Elmiron lawsuits and if you’re eligible for damages by contacting an experienced attorney today.
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