Bladder discomfort and pain associated with interstitial cystitis (IC) can lead to debilitating conditions.
Many IC patients have found relief through Elmiron, but reports of vision loss have surfaced in recent years. The number of people who report serious eye damage after taking this medication grows by the day.
At Rosenfeld Injury Lawyers, LLC, our personal injury attorneys are handling Elmiron lawsuits involving patients who took the drug and experienced a devastating injury. Many of our lawsuits claim that long-term exposure to Elmiron causes maculopathy.
Contact our dangerous drug lawyers at (888) 424-5757 (toll-free phone call) or use the contact form to schedule a free case review. We can help you receive compensation for your injuries!
Bladder Pain Syndrome and Interstitial Cystitis
Many people are diagnosed with bladder discomfort and pain associated with interstitial cystitis (IC), but the treatment options for this condition can be limited.
The standard of care for IC is a combination of Elmiron and other medications, such as steroids or anti-inflammatories. However, many patients claim that these drugs do not work well enough to relieve their symptoms. In addition, they say they experience side effects from the therapy and want an alternative treatment option.
The treatment for this condition has been controversial because of its side effects. However, Elmiron is a Food and Drug Administration (FDA) approved medication used to treat symptoms of IC and other conditions related to bladder problems, such as overactive bladder syndrome (OAB).
About two million people in the United States experience interstitial cystitis and/or painful bladder syndrome. Many of these patients have found relief with Elmiron.
Still, there is a growing concern that long-term use of this drug could cause maculopathy, an eye disorder affecting the macula (central part of the retina), and a major cause of blindness.
File an Elmiron Lawsuit for Your Vision Loss Problems
Many people have arthritis and interstitial cystitis, also referred to as 'painful bladder syndrome.' These are severe conditions that cause lots of pain and suffering.
To alleviate these vision impairment problems for adult patients, doctors have prescribed an IC drug called Elmiron, a prescription medication used to treat interstitial cystitis and chronic bladder pain.
Alleged Eye Injury from Elmiron
However, patients have experienced several adverse reactions from the dangerous Johnson & Johnson drug and developed serious visual symptoms that could be permanent due to exposure to pentosan polysulfate used to treat bladder pain.
It is the active ingredient of the drug and the supposed link between Elmiron and serious eye injury.
Complications from Elmiron Use
Because of chronic exposure to pentosan, some patients lose their field of vision not associated with age-related macular degeneration or retinal disease. It is what causes vision impairment problems and difficulty reading.
Other Elmiron victims experienced significant hair loss in one single area, where the condition sometimes reversed after stopping medication use, allowing the hair to grow back.
The vision damage associated with the drug led the FDA to recall the drug.
Patients reported the need to adapt to dim lighting when reading or looking at objects. The dimming of natural or artificial light could restrict seeing anything except up close.
Some Elmiron users who experienced permanent eye damage or impaired vision problems (paracentral scotoma) after taking prescribed Elmiron have filed a lawsuit against the drug manufacturer Janssen (a subsidiary of Johnson Johnson).
Attorneys Committed to Protecting People with Vision Problems After Elmiron Use
The good news is that you or a loved one may be eligible for compensation via a civil lawsuit against J & J.
Rosenfeld Injury Lawyers LLC works with victims of prescription malpractice, including prescription drug Elmiron patients with eye problems like retinal maculopathy and pigmentary maculopathy.
Our legal team helps them file Elmiron lawsuits for financial compensation if they have been harmed due to negligent medication advice.
The following sections review recent developments regarding an Elmiron lawsuit, including the harm it has caused and the help some patients have obtained.
Call our law firm today if you have been harmed by this drug. Our phone number is (888) 424-5757. You could also go online and fill out a contact form. Our Elmiron attorneys offer a free case review to a potential client before forming an attorney-client relationship.
Hear about how Elmiron lawyers can assist you with getting compensation with an Elmiron lawsuit for your vision problems, retinal damage, pattern dystrophy, retinal pigmentary maculopathy, retinopathy, or other permanent vision damage. For example, in some Elmiron cases, part of the retina was destroyed, leading to permanent loss of vision.
What is Elmiron, and How is It Used?
Elmiron is a semi-synthetic polysulfated xylan medication. The specific medicinal name for the drug pentosan polysulfate sodium (PPS) identifies its chemical makeup.
For a time, doctors prescribed this prescription for blood-thinning purposes. However, recent studies show that the medication was not remarkably successful as an anticoagulant but did cause excessive bruising in some users.
What it was more commonly used for was addressing arthritis and interstitial cystitis.
Arthritis happens when the cartilage around bones breaks down over a period. Interstitial cystitis is a chronic problem causing bladder pain. When IC occurs, the bladder undergoes increased pain and pressure.
It also triggers pain in the surrounding area of the body-- sometimes referred to as bladder pain syndrome.
What Damage Does Elmiron Cause and What Symptoms Does it Show?
The prescription and use of Elmiron have led to several troubling complications for people across the country. As mentioned above, numerous patients have experienced pain in their head, stomach, and other parts of their body while on the drug.
Elmiron Linked to Maculopathy
However, the most severe effect reportedly linked to taking Elmiron has been pigmentary maculopathy resulting in an eye condition and blindness. Maculopathy is a term that refers to general pathological issues with the macula.
The macula is the area in the middle of the retina. It controls acuity and sensitivity. An ophthalmologist can determine any macular degeneration that has occurred.
Macular degeneration (like retinal maculopathy) caused by Elmiron has been labeled "pigmentary" but does not have known etiological sources. The diseases can manifest in many different forms for patients taking the medication. You can have vision difficulty reading at work or for leisure.
Yet, there are some frequent symptoms that evidence maculopathy due to Elmiron. Each day, innocent people are injured and killed by dangerous medications and medical devices.
Eye Symptoms from Prescription Drug Elmiron
Here are some of those symptoms:
- Vessel and capillary swelling, damage, and abnormality around the retina and eye generally
- Yellow lesions beneath the macula. Note, some doctors refer to this condition as adult pattern macular dystrophy
- Atrophy within the retina and around the macula
- Dark pigmentation within the retina
- Blurred vision and reading problems
- Permanent vision loss
If you have taken Elmiron and experienced side effects, you are likely concerned about other side effects and damage the medicine could cause.
Below, an Elmiron lawyer has answered some of the common questions involving Elmiron that include:
Can Elmiron (Pentosan Polysulfate Sodium) Cause Blindness?
The National Center for biotechnology information, published by the National Library of Medicine, released information in November 2018 on the visual disturbance associated with cumulative exposure to the active ingredient in Elmiron, pentosan polysulfate sodium.
The case study involved six adult patients exposed to PPS. In one case, 'For Isaac to patients showed paracentral RPE atrophy, which is the death of retinal pigment epithelial cells.
The atrophy typically occurs in a geographic area that affects vision where a patch of the retina and its functions are lost.
What Are the Side Effects of Elmiron?
Physicians typically prescribe Elmiron (pentosan polysulfate sodium) as a bladder protectant to control bladder discomfort and pain due to irritation or inflammation (cystitis).
However, the medication is also a week anticoagulant with serious side effects that include:
- Abdominal pain
- Hair loss
- Skin rash
- Stomach pain
- Upset stomach
- Mood/mental changes
- Unusual bleeding (blood in the stool)
- Unusual bruising
- Swallowing discomfort
Many doctors prescribe Elmiron to restore leaky, thin, or damaged bladder surfaces (GAG - glycosaminoglycans). The bladder surface is a mucous coating that protects the bladder wall and guards against irritation and bacteria.
Doctors often prescribe a typical dose of 100 mg of the medication taken orally three times a day, with symptoms diminishing in approximately a month.
Usually, the dosage is taken for approximately six months before the treatment is discontinued.
Sometimes, the doctor will prescribe other medications concomitantly with Elmiron, including antihistamines and antidepressants in low doses.
However, the liver must metabolize the drug's active ingredient, pentosan polysulfate sodium. Because of that, doctors often perform a periodic liver function test to ensure no damage has occurred to the organ.
Can the Bladder Lining Heal Itself?
The bladder can regenerate and self-repair damaged areas harmed through injury or infection.
The body's progenitor cells that developed in the early stages of development are highly effective at repairing injuries to the bladder lining.
Can Elmiron Cause Liver Damage?
Because the medication must be metabolized in the liver and spleen, there is a potential that pentosan polysulfate sodium, the active ingredient in Elmiron, can lead to liver damage.
The potential of saturation of the drug with continued dosing could cause health problems.
It is essential to tell your doctor that you are taking any blood thinners that might have a drug-to-drug interaction due to commonly experienced anticoagulant effects.
History of Elmiron Problems and Government Response
In recent years, problems surrounding Elmiron prescription and macular degeneration have surfaced in the medical community. They have mostly emanated out of academia, but some studies have emerged out of the private sector.
A simple review will offer great insight into the breaking timeline and rapid development of this medical issue of great concern.
Physicians working at the Emory Eye Center at the Emory School of Medicine published a study demonstrating that six patients developed special pigmentary retinal maculopathy after chronic exposure to Elmiron. They note particular harm to the retinal pigment epithelium.
The same doctors at the Emory Eye Center released another study with the American Academy of Ophthalmology demonstrating that patients with a medical history of cystitis but no exposure to Elmiron did not have the same vision problems, pigmentary maculopathy, macular degeneration, or eye condition as those who did take the drug.
The Emory Eye Center report also encourages patients to discontinue the prescription if they have symptoms of maculopathy or eye disease.
Kaiser Permanente discloses the findings of its study regarding Elmiron. It finds high levels of drug toxicity, especially in those Elmiron patients with higher dosage levels.
A study in the British Journal of Ophthalmology determines that users that took Elmiron had a higher rate of vision problems such as macular disease and retinal maculopathy seven years into their prescription use.
The National Institute of Health published an article that followed the Canadian Urological Association Journal and published information on the FDA-approved oral medication Elmiron.
The medical literature reveals alarming findings and asks doctors to disclose that regular use of Elmiron results in 'the emergence of this potential toxicity to expose patients" taking the medication.
Researchers also suggest that 'ophthalmic screening in any PPS [pentosan polysulfate sodium]-exposed patient with any visual complaints about evidence of this maculopathy.' PPS is marketed as Elmiron, a 'synthetic polysaccharide that binds to the urothelium, providing a protective layer that may help prevent painful irritation from components of the urine.'
The American Academy of Ophthalmology reported on 13 patients with PPS maculopathy at the October 2009 Annual Meeting of the American Academy of Ophthalmology in Chicago, Illinois. There were no known cases in which patients who had taken Elmiron developed bilateral disease, but this has to be further studied.
In recent years, scientists have followed the use of Elmiron and conducted randomized, placebo-controlled clinical trials of Elmiron in 45 patients with PPS, which compared the effect of oral pentosan polysulfate with that of oral hydroxyzine.
After three months had elapsed during these clinical trials, it was found that 37 percent showed no improvement while 21 percent of patients showed an improvement.
Will Elmiron Be Recalled By the FDA?
Despite these findings, the United States government (FDA) and the medical community have failed to take action to prevent the long-term use of Elmiron.
It could issue a recall to halt the use of this drug, but it has not yet done so. Some people have filed Elmiron lawsuits against the drug's manufacturer in the wake of these findings. The substantive merits of those claims and possible benefits are examined next.
Experts expect thousands of people to file Elmiron lawsuits throughout the United States.
There are about 130 Elmiron eye damage lawsuits from patients who took the prescription drug. These Elmiron lawsuits were just granted Multi-District status in Federal Court in New Jersey before Judge Brian Martinotti. In addition, Johnson & Johnson is the defendant in numerous class actions and product liability lawsuits.
Elmiron MDL (multi-district litigation) will likely take years to resolve in Federal court. As a result, many plaintiffs' Elmiron lawsuits have been consolidated in an Elmiron class action MDL before Judge Brian Martinotti of the District Court for New Jersey.
The first bellwether class-action lawsuit trial began on January 7, 2020, under re: Elmiron MDL Injury Litigation. About 130 Elmiron lawsuits are pending against Johnson & Johnson and its subsidiary Scios Inc., where the drug is made.
Elmiron was created by Scios Inc for the treatment of PPS. Scios, which was later acquired by Johnson & Johnson in 1999. It owns the rights to Elmiron and has patents on it until 2021.
Johnson & Johnson admitted that if they make any changes to their product managers' iron, they will not patent it for another ten years.
Elmiron was first approved by the FDA in 1997. It is unclear why Johnson & Johnson did not inform the FDA of these injuries while testing this drug. In addition, the FDA should have known about Elmiron's side effects but did not disclose them until 2002.
Failed to Release Information Linking to Blindness
In 2002, the FDA issued a drug safety communication on Elmiron's potential link to serious eye problems in patients with interstitial cystitis (IC) but did not release warnings about its links to blindness. Even though this information was released 13 years ago, Elmiron is still on the market today.
There was no warning to patients about this potential side effect of blindness until recently. There are also warnings for bladder cancer, but not blindness, which might be caused by its maculopathy.
It was only in September 2018 that the FDA warned that Elmiron 'may cause serious side effects, including vision loss and other side effects.'
Elmiron Macular Degeneration and Personal Injury Claims Against Janssen
In recent years, patients have begun filing claims for financial compensation against the manufacturers of Elmiron (i.e., Janssen Pharmaceuticals) related to severe eye disease.
Their claims suggest that long-term use and exposure have caused severe medical problems, including retinal maculopathy, pigmentary maculopathy, general eye disorder, and other issues.
The complaints suggest that the pharmaceutical companies had a duty to warn the consumers of such risks or make and distribute products that did present such problems.
Yet, these suits against the drugmaker have been brought individually in the United States District Federal Court by plaintiffs taking Elmiron for IC or other bladder conditions.
They have not been filed in a class-action capacity, but that option has not been ruled out. An Elmiron class action lawsuit allows plaintiffs to bring claims on behalf of groups of similarly affected victims.
Elmiron Vision Complication Claim Compensation
Claims for prescription malpractice, including Elmiron eye damage lawsuits, implicate several plaintiffs' compensation forms. Accordingly, they may pursue relief for their increased costs, including medical bills, lost wages, and similar losses.
You also seek to recover for pain, disability, vision impairment, suffering, reduced quality of life, and other intangible harms by filing an Elmiron lawsuit.
Generally, prescription oral medication lawsuits action enables plaintiffs to make up for the damage done by the defendants.
Victims of adverse reactions may estimate how their injuries stack up when analyzing the value of their Elmiron eye damage lawsuits. Of course, an experienced Elmiron vision loss law firm could assist you in that process.
Contact our Elmiron lawsuit lawyers anytime at (888) 424-5757 to discuss your legal options for filing an Elmiron lawsuit during your free case evaluation.
Elmiron Eye Damage Litigation
Our personal injury attorneys review Elmiron litigation throughout the United States in cases involving an adverse reaction from the medication's use. For example, some plaintiffs allege that the manufacturers of these drugs failed to provide sufficient warning of their dangers and operated on an 'unreasonably dangerous' standard.
They further claim that the corporations knew about the risks and yet made no attempts to remedy them until they faced lawsuits and pressure from critics making drug safety claims.
Nevertheless, many lawsuits have already been filed against the manufacturers of these drugs on behalf of people who suffered side effects, including cystitis, bladder infections, bleeding, blood clots, and other serious complications.
According to one news source:
'Tens of thousands of patients have filed lawsuits against the makers of Elmiron, a bladder medication prescribed to treat interstitial cystitis (IC). These drugs were originally developed by Janssen. Patients allege that they did not receive proper warnings regarding the potentially serious side effects associated with long-term use.'
Elmiron Lawsuit Settlements
Teva Pharmaceuticals USA Inc., a subsidiary of Teva Pharmaceutical Industries Ltd. ('Teva'), has agreed to settle 1,500 lawsuits over its drug Elmiron (pentofiloxone disodium). The first mass tort settlement involving these Teva Branded Pharmaceutical Products was reached in Elmiron litigation.
The Elmiron settlement did not include Canadian plaintiffs who filed a class-action suit against Teva in Ontario on December 13, 2011.
That case was adjourned pending the US settlement. However, Teva Pharmaceuticals USA Inc's parent company stated it 'intends to defend its interests in this litigation vigorously.'
The US plaintiffs filed their lawsuits alleging Elmiron caused or were related to the development of bladder cancer. The cases are currently in various stages of litigation throughout the United States.
Most Elmiron lawsuits were filed in Philadelphia County, Pennsylvania state court. The first trial commenced on March 19, 2013, resulting in a defense verdict. The second trial commenced on April 29, 2013; it also ended with a defense verdict.
Elmiron Settlement Amounts
The US Elmiron class-action suit was filed by Canadian plaintiffs Patric Guillet and Lynne Osmonda. The company has agreed to establish a settlement fund of $11 million to resolve claims in the 1,500 Elmiron lawsuits. The settlement also includes a one-time payment of $2,000 for each claimant.
Hire a Vision Loss Attorney Today for a Product Liability Lawsuit
Every medical malpractice case requires a substantial amount of factual investigation (review of medical records), legal analysis, and communications work. The process of building a successful Elmiron eye damage lawsuit against Janssen Pharmaceuticals for vision problems takes not only time but also money and skill.
Even under the best of circumstances, it isn't easy. It becomes incredibly harder when you factor in that Illinois puts tight deadlines on Elmiron cases (through statutes of limitations).
Hiring an experienced product liability and Elmiron lawyer could help make sure you or a loved one can get back on track to improve their health and heal from severe side effects.
The Rosenfeld Injury Lawyers law firm handles each Elmiron lawsuit on contingency so you can focus on your health, and our Elmiron attorneys can successfully resolve your case.
It will not cost you anything upfront, and you can contact our law office today to learn about what help awaits you. Get a free consultation today to see if the personal injury lawyers at our law firm agree your case meets the Elmiron lawsuit criteria.
Our Elmiron lawyers look forward to working with you in an attorney-client relationship! All confidential or sensitive information you share with our legal team remains private.