Since the late 1990s, millions of patients have been prescribed Elmiron to treat interstitial cystitis. There is evidence that the manufacturer of this medication failed to warn the public about the risks of developing an eye injury that could result in blindness. In 2019, a study found that the drug has the potential to cause retinal damage to the eyes in approximately one-fourth of all prescribed patients.
As a result of the risk of taking medication and the related injuries, lawsuits on behalf of the victims have started. If you or a loved one took Elmiron and has since been diagnosed with maculopathy, you may be eligible for compensation. Thomas Law Offices can help you file an Elmiron lawsuit.
Table of Contents
What Is Elmiron?
Elmiron, also known as pentosan polysulfate sodium, is a drug that has been prescribed for over 25 years to treat painful bladder syndrome or interstitial cystitis—a condition that as many as 12 million people suffer from. It is classified as a urinary analgesic and a weak anticoagulant. Patients with chronic bladder disease often experience significant bladder or pelvic pain, incontinence, and dyspareunia. In the United States, the majority of the afflicted are women; however, a smaller number of men suffer from similar conditions as well.
Manufactured by Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, Elmiron has been described as the “only oral medication FDA approved to treat bladder pain or discomfort of interstitial cystitis.” It was initially approved by the FDA in 1986 for compassionate use and was given regulatory approval by the governmental safety oversight agency in 1996.
Elmiron works by attaching itself to the wall of the bladder, thereby providing a buffer between irritating substances and the bladder. Common side effects highlighted by Janssen include hair loss, diarrhea, nausea, blood in the stool, headache, rash, upset stomach, abnormal liver functions, dizziness, bruising, weight gain, and swelling. Recent studies, however, have shown users of the drug are at an increased risk of eye problems.
It’s also important to note that some studies suggest Elmiron is not an efficacious treatment for interstitial cystitis. In fact, the medication may be no more effective than the placebo. If this is confirmed, it supports the fact that the risks are not worth the benefits for patients. Regardless, lawsuits will come down to whether there should have been warnings regarding the risk of a vision-related injury.
Elmiron and Eye Problems
Eye problems in patients taking Elmiron seem to be limited in patients taking the medication for three to 22 years, with the average duration of use being 16 to 17 years. According to the American Academy of Ophthalmology, patients are at risk of experiencing drug toxicity, vision loss, problems with vision focus and reading, retinal damage, and difficulty adjusting to dim light.
The most common condition patients are suffering from is called maculopathy. Maculopathy is a progressive eye disease that can lead to vision loss—usually in both eyes. The disease affects a part of the eye in the back of the retina called the macula. Patients who develop this disease often suffer from the following:
- Difficulty reading
- Difficulty adjusting eyes to darkness
- Difficulty seeing objects up close
- Dimming vision
- Spots of vision loss
The first reports of maculopathy related to pentosan polysulfate sodium appeared in medical literature a few years ago, but it’s currently believed that the drug’s manufacturer may have known about this risk much earlier than that.
Reporting Elmiron Side Effects
If you’ve experienced any side effects from taking Elmiron, it’s essential to understand what actions to take to protect your health and wellbeing. Do not stop taking the medication without consulting your doctor. Make an appointment with the prescribing physician as soon as possible to find out how to best handle the situation.
The Food and Health Administration (FDA) is tracking Elmiron’s safety issues. The agency is encouraging both health professionals and patients to report any adverse reactions and side effects to the FDA’s MedWatch Safety Information and Adverse Reporting Program.
The Issue With Elmiron’s Warning Label
From 1997 to 2019, over 100 adverse events for eye-related injuries were filed with the FDA by the manufacturer. Most of the safety reports were categorized as serious. At the same time, the drug did not include an adequate warning label to patients and their doctors regarding the potential for vision loss and eye damage associated with long-term and high-dose use of Elmiron.
As a result of those reports over almost two decades, the drug’s warning label was updated in Canada in April 2020 to include the following information:
- Pigmentary maculopathy has been reported with chronic Elmiron usage.
- Patients should have regular ophthalmic examinations for early detection of pigmentary maculopathy.
- If pigmentary maculopathy is confirmed, the patient should consult with their doctor to determine if Elmiron treatment should be discontinued.
That warning, however, was not immediately added to the warning label for the drug in the United States. It wasn’t until June 2020 that changes were made to enhance warnings in the United States on the Elmiron package insert and warning label. Now, patients will see the following information in the drug manufacturer’s notes:
Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON®. Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. The studies published so far have found that sufferers include white women with an average age of 60. Upon examination, eye specialists have noted multiple signs of drug-induced eye disease, including parafoveal pigmented deposits, vitelliform deposits, hyperpigmented or dark spots near the retina, and atrophy of the retinal pigment epithelium.
Filing a Vision Loss and Blindness Claim
When you get in touch with a dangerous drug lawyer from Thomas Law Offices, they will schedule a consultation to go over some information and determine if you’re eligible to file an Elmiron lawsuit. Some of the questions you could expect at the case evaluation include the following:
- How long have you taken Elmiron?
- When did your vision problems begin?
- What sort of vision problems have you experienced?
- Do those problems affect your day-to-day activities?
- What diagnosis and prognosis did you receive from your medical provider?
- What treatment did your doctor recommend for your vision problems?
Once we have that information, we can begin determining the likelihood of pursuing a successful lawsuit. Current complaints are saying the drug makers failed to adequately warn physicians and the public that Elmiron could cause vision problems and claims drug makers actively hid the side effects from the public.
Elmiron Lawsuits and Multi-District Litigation
Plaintiff’s lawyers are in the early stage of the Elmiron eye damage litigation. In December 2020, the Judicial MDL Panel instituted a multi-district litigation class action, consolidating all federal court Elmiron lawsuits in U.S. District Court. Janssen is not the only defendant. Others include Teva, Bayer, Alza, Centocor, Ortho-McNeil, and IVAX.
As of January 2021, 80 lawsuits have been filed against Janssen Pharmaceutical. As many patients are just starting to connect the usage of Elmiron to their vision-related injuries, the process is slow. However, it’s likely that several thousand individuals will come forward with eye damage lawsuits.
An MDL is similar to a class-action lawsuit, and all cases involving Elmiron will be reviewed under a single federal judge for pretrial discovery. Claim details and basic information for all plaintiffs are gathered, and a few cases will be selected for trial. The results of those lawsuits are typically used to negotiate a global settlement of any remaining claims.
Potential Settlement Amounts
With an MDL, settlement typically has tiers or levels of payments that are based on the severity of injury. With the first lawsuits just getting filed, there’s no way to know for sure what the settlement value of these cases could be. Your attorney, however, may be able to estimate the value of your case by comparing it to settlement values of prior cases involving similar injuries.
In regard to the possible tiers, the levels will likely be based on the degree of impairment to a plaintiff’s vision. The most severe injuries will involve total, permanent vision loss. From there, the tiers will likely go by the percentage of vision loss.
Connect With the Lawyers From Thomas Law Offices
At Thomas Law Offices, we believe negligent drug manufacturers should be held accountable for patients’ injuries. If you think you’ve suffered an eye injury due to your use of Elmiron, contact our law firm today. We’ll review your situation, explain your legal rights and options to you, and help you decide how best to proceed to protect your health and future.