Elmiron (Pentosan Polysulfate Sodium) is a popular prescription drug used to treat interstitial cystitis since the mid-90s. The use of Elmiron has been associated with an eye condition known as maculopathy. Anyone affected by this drug is entitled to financial compensation from the drug manufacturer.
What You Need to Know About Elmiron Drug
Elmiron, also known as pentosan polysulfate sodium, is an FDA-approved prescription drug used to treat discomfort and pain resulting from Interstitial cystitis. The drug also works as a weak blood thinner, although it's not indicated as a blood thinner similar to common blood thinners like warfarin. The U.S FDA ( Food and Drug Administration) approved Elmiron in 1966 to Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, are the drug manufacturers.
There is no generic version of this drug currently, and it is the only oral FDA-drug approved to ease bladder discomfort and pain associated with interstitial cystitis. Interstitial cystitis is a chronic bladder condition estimated to be affecting between 3 and 8 million women and 1 to 4 million men, according to the National Institute of Diabetes and Digestive and Kidney Diseases.
How the Drug Work
Janssen doesn't know how Elmiron works to treat interstitial cystitis. However, scientists think that Elmiron works by sticking to the bladder's wall membrane, acting as a shield, making it difficult for irritants from the urine to reach the bladder wall cells.
The recommended dosage of Elmiron is one 100mg capsule to be taken orally three times daily, making it a total of 300mg daily. It's recommendable to take the drug with water on an empty stomach at least an hour before meals or two hours after a meal.
Patients taking the drug should visit their medical provider after three months to evaluate their improvement. When there is no improvement, the provider will recommend the patient take the medication for another three months. There is no assessment made about the safety and effectiveness of the drug for the treatment.
Side Effects of Elmiron
Apart from the eye-related effect of Elmiron, there are other common side effects associated with this drug. This includes:
- Nausea
- Hair loss or alopecia
- Rash
- Headache
- Abdominal pain
- Liver function abnormalities
- Indigestion
- Rash
- Dizziness
- Diarrhea
Other side effects occurring to one percent or less of most patients include constipation, flatulence, vomiting, photosensitivity, allergic reactions, and cold-like symptoms.
Precautions and Effects on Pregnant and Breastfeeding Women
Since Elmiron is a frail anticoagulant, it can make it harder for blood to clot. Reports of bruising, gum bleedings and rectal bleedings have been made, besides the strength of this drug being one-fifteenth of heparin.
Patients about to have surgery and are taking this drug should inform their healthcare providers about avoiding any complications related to its blood-thinning ability.
Pregnant women should take the drug only if it's needed. There is no human-related research made on its effect on pregnancy and breastfeeding, but studies on rats and mice have revealed evidence of impaired fertility and harm to the fetus. However, animal studies are not always predictive of human response, but this does not entirely mean that it's safe for pregnant and breastfeeding women.
Drug Interaction
Janssen pharmaceuticals have not provided any warning about the drug's interaction. However, patients should tell their healthcare provider about their use of any herbal supplements, vitamins, and medicines to avoid increased bleeding risk.
Vision Problem Associated with Elmiron Drug
SinceElmiron'ss release in 1996, it has been viewed as a relatively safe drug with few significant risks and serious side effects. All this changed in 2018 when its toxicity was discovered. Doctors from the Emory Eye Center in Atlanta, GA, started noticing a strange trend involving six patients with abnormal damage to their eyes' macula region. These patients were discovered with pigmentary maculopathy along with their Elmiron long-term usage.
The Emory Eye Center published a preliminary report suggesting that Elmiron can be toxic to the human eye's retinal tissue. This report prompted a more detailed study into the safety of Elmiron and its potential harm to the eyes. The research was conducted by a team of ophthalmologists in Northern California based on numerous patient records.
The study revealed that Elmiron was toxic to the sensitive retina tissue in the back of the year. About 25% of the patients in the study who used Elmiron showed significant eye damage or maculopathy. Most of these patients were already showing signs of partial or complete vision loss. When these patients were tested and examined, doctors could show clear signs of drug toxicity related to the prolonged use of Elmiron.
According to Dr. Nieraj Jain, the condition went unnoticed for long since the fundus would only appear subtle unless viewed through advanced retinal imaging. Some of these cases were associated with pattern dystrophy, and their adverse effects would take more than a decade to develop. He recommended multimodal imaging of patients taking Elmiron, and if maculopathy was identified, the patient should be immediately taken off from the drug.
Timeline of Studies of Maculopathy and Its Association with Elmiron
Specifically, the kind of maculopathy associated with Elmiron is referred to as pigmentary maculopathy. Typical visual symptoms related to Elmiron include difficulty adapting to low light and reading. Other common symptoms include:
- Reading problems
- Vision dimming
- Problem seeing objects at a close range
1. May 2018 Study
After the Emory Eye Center discovery of a repetitive eye problem among six patients, Dr. William A. Pearce and colleagues of this eye center published the results associating Elmiron to the condition. Under their findings, the drug would cause a unique maculopathy, injuring the retinal pigment epithelium, responsible for nourishing the retina.
2. April 2019 Study
Doctors at the Emory Eye Center Atlanta continued their study to link maculopathy with Elmiron drug use with ten patients. Their publication stated that patients with interstitial cystitis history who didn't take Elmiron didn't show pigmentary maculopathy. Under their recommendations, they suggested that patients showing signs of damage should stop taking the drug, and those should take a retinal imaging examination.
3. October 2019 Study
Kaiser Permanente researchers undertook a study involving 140 patients who had taken a total of 5,000 Elmiron drugs over 15 years. Ninety-one patients agreed to take the examination. 22 of these 91 patients showed toxicity signs. The toxicity levels were high in patients who took high doses, 11% of the patients were taking doses of 500 to 1,000 grams, and 42% of those patients were taking doses of 1,500 grams or more.
4. November 2019 Study
Dr. Neiraj Jain et al. published a study from a larger U.S medical database that claimed to cover patients between 2002 to 2016. They showed two separate groups of Elmiron drug users. One group had 3,012 patients who have been using the drug for five years, while the other had 1,604 patients who had used the drug for seven years. Patients who had been using the medicine for seven years showed a significantly high chance of macular disease.
In the same month, Drs. Demetrios G. and Rachael M. Huckfeldt published a case report on Imaging Retina and Laser. Their report presented a case of a patient who had Elmiron-associated maculopathy, which continued to worsen even after six years of stopping taking the drug.
5. January 2020 Study
Three scientists; Drs. Amar P. Patel, Robin A. Vora, and Ronald Melles looked at the data for 117 patients with Interstitial Cystitis who took Elmiron drugs and found out that 27 of the patients had maculopathy signs. Patients who took doses of 1,500 g had the highest toxicity risk.
Lawsuits Associated with Elmiron Drug Use
Thousands of people across the United States have taken Elmiron as a treatment for interstitial cystitis. Out of these people, it's estimated that 25% could be suffering from pigmentary maculopathy. However, pigmentary maculopathy is usually misdiagnosed as an eye disorder. Most Elmiron long-term users are older, so pigmentary maculopathy is often thought to be age-related macular degeneration or dystrophy patterns.
However, after further testing, patients experiencing pigmentary maculopathy symptoms can realize the connection between Elmiron drug use and maculopathy.
The most recent lawsuit related to Elmiron drug was filed in March 2020. A plaintiff brought the case against Janssen and Teva Branded Pharmaceuticals in Connecticut. Both companies have been manufacturing and marketing Elmiron since the 1990s. The plaintiff claimed that she had suffered from pigmentary maculopathy after taking Elmiron to treat interstitial cystitis discomfort.
This lawsuit's basis was the failure of these companies to warn patients of the risk of eye damage. The case also grounded its argument on the absence of information about regular eye exams to screen pigmentary maculopathy while under Elmiron drug use.
No settlement has been made through the lawsuit filed against Teva Branded Pharmaceuticals and Janssen, although the case is still ongoing. If the lawsuit against these Elmiron manufacturers is successful, the plaintiffs will likely receive compensation for their medical expenses, pain and suffering, lost wages, and more.
Reasons Why FDA Has Not Recalled Elmiron Drug From the Market
Contrary to popular expectations, FDA has not recalled Elmiron drug. Instead, it released information regarding the medication update of their warning label on 16th June 2020. According to the FDA, doctors identified cases of eye damage related to Elmiron on long-term users.
Therefore, Elmiron has a label that includes the list of adverse reactions related to its long-term use, including retinal pigmentary changes. Specifically, the warning label states: "Pigment changes in the retina of the eye, also referred to as pigmentary maculopathy in medical journal articles have been reported with the long-term use of Elmiron. Although these cases can occur after three years of use or longer, shorter duration cases have been seen. While the etiology seems unclear, cumulative dose appears to be a risk factor."
Further, FDA has recommended that any patient considering taking Elmiron should receive retinal imaging after six months of medication. Since Elmiron is the only FDA-approved drug used in IC treatment, there are chances that more people will end up experiencing maculopathy after long-term use of this drug.
Multidistrict Litigation Against Elmiron Drug Case
On 15th December 2020, the U.S Judicial Panel on Multidistrict Litigation (JPLM) ordered all Elmiron lawsuits filed federally to consolidate in the District of New Jersey. Honorable Brian R. Martinotti was appointed to handle the proceeding.
An MDL is a legal procedure that puts together several federal cases against one defendant into one lawsuit to be tried under one court and speeds up the process of handling the complex case. Under the Elmiron-ordered JPLM, nearly 130 existing Elmiron lawsuits were transferred to the District of New Jersey.
The plaintiffs had filed a motion to consolidate their lawsuits against Elmiron back in September 2020. Their decision to consolidate was grounded on the belief that multidistrict litigation would:
- Ensure that the conduct of the actions are efficient and just
- Avoid inconsistent duplicative discovery results and pretrial rulings
- Maintaining the researches made by all involved parties
Reiteration for the New Jersey MDL
On 3rd December 2020, some of the plaintiffs, among those intending to consolidate their Elmiron drug lawsuits, reiterated against the decision to hold the multidistrict litigation in New Jersey. They argued that Judge Martinotti had been involved in pending Elmiron cases treated as mass tort, suggesting the implementation of court proceedings as a wholesome suit.
The plaintiffs also argued that the judge had already advanced into coordinating Elmiron cases with other jurisdictions. Their suggestion was to hold the MDL in the Eastern District of Pennsylvania, arguing that the litigation had made progress.
The defendants (Janssen Pharmaceuticals) were against the decision of consolidating in Pennsylvania, arguing that New Jersey is their preference since the litigation was already headquartered there and everything relevant to the case was there.
Further, Janssen pharmaceuticals are located in Titusville, NJ, and most of their potential trial witnesses were found there. This prompted a transfer order by the JPLM to consolidate the litigation in the District of New Jersey since it serves as a convenient place for both parties and would promote the efficient and just conduct of the MDL.
Although JPLM is still to decide on the litigation, anyone who has taken Elmiron for several years and has been diagnosed with retina problems can file a lawsuit against Elmiron to recover damages.
Difference Between a Multi-District Litigation and Class Action
You might be wondering why filing multi-district litigation is better than class action when it comes to the Elmiron drug case, right? Well, multidistrict litigation is a better option since it involves several lawsuits filed by different parties. All these lawsuits are joined together before a federal judge provides ease of discovery and essential legal rulings. The judge overseeing the MDL selects a group of attorneys to discover and pursue the discovery on behalf of the individual injured.
Most law firms handling the MLD work on a potential mass tort settlement for all individuals damaged or injured by a company. This happens after several bellwether jury trials from both sides decide on a reasonable value of the case.
Settlement in an MDL is decided based on individuals' merit, including causation, injuries, exposure, and damages. Every individual can decide after the court decides on the terms of the proposed settlement. MDLs also allow individuals to use the evidence gathered throughout the process to seek compensation through a different approach if the settlement is unsuccessful.
On the other hand, a class action is a lawsuit where several individuals, referred to as class representatives, represent several people's interests, even those without lawyers, and are not named in the litigation.
Clients must consent before their identification as class representatives since they will have special litigation duties. The jury ruling made in a class action impacts and binds everyone considered a member of the class action, even those who don't know whether they are part of the class-action lawsuit. Therefore, if the court approves the class-action case, the defendant might receive less compensation, which is probably not what they deserve.
Filing multi-district litigation is a better option than class action litigation. It brings efficiency in handling the lawsuit and guarantees plaintiffs the capacity to settle their cases depending on the specific facts and circumstances.
Filing a class action isn’t entirely a bad option since it can be useful when a few plaintiffs who best represent the type of harm and damages experienced by others are selected. It’s also a suitable option when the law firm representing the plaintiffs files the right legal papers and conducts an extensive discovery to prove the case before a judge or jury.
Join an Elmiron Lawsuit Near Me
Trying to win a claim against big pharmaceutical companies like Janssen and Teva pharmaceuticals is a complex process. The hardest part is holding responsible companies liable for your injuries. At Consumer Alert Now, we are committed to holding these companies accountable for the damages caused by their drug. We will help you meet court deadlines, file relevant paperwork, and negotiate a settlement as you let you go on with your daily life. Contact us today at 800-511-0747 and learn how we can help you.
