Elmiron Vision Damage Lawsuits
Elmiron (pentosan polysulfate sodium) is used to treat Interstitial Cystitis (IC). The pharmaceutical medication should in no way impact a patient’s vision, but research has shown that long-term use of Elmiron can result in vision impairment (maculopathy) including blindness. Maculopathy refers to a certain type of damage to the macula—the central part of the retina—that provides humans with central vision.
This research has led firms like Chaffin Luhana to organize filing Elmiron lawsuits against Elmiron’s manufacturer, Janssen Pharmaceuticals, for consumers who used Elmiron for extended periods because Janssen failed to warn of these serious adverse side effects in the drug’s label. The story of how Elmiron was identified as causing maculopathy eye injuries is dramatic and compelling.
From 1997 to 2019 there were over 100 reports to the FDA of eye-related adverse events for Elmiron. The signal, however, was largely missed and it was not until researchers at Emory Eye Center identified a unique and new eye disease in six patients.
Specifically, the Emory Eye Center researchers had observed unhealthy vision changes in six patients who had been using Elmiron for several years. Upon further analysis, the researchers found that exposure to Elmiron was the only factor significantly associated with this unique type of maculopathy. It was considered “unique” because it was unlike any other type of maculopathy seen before in any patients.
The researchers named it “pigmentary maculopathy” because it involved the development of excess capillaries or pigmented spots over the macula that damaged vision. This “Elmiron signature injury” led the researchers to publish an article in the journal Ophthalmology in May 2018 detailing their findings regarding these six patients.
They pointed out that all patients suffering from this new type of eye damage reported difficulty with reading and adapting to areas of dim light and had subtle hyperpigmentations (spots) on their retinas. Concerned about potential drug toxicity, they decided to investigate further.
Since May 2018, the researchers published additional research identifying more patients. In April 2019, for example, the Emory Eye Center researchers published a second case series, identifying 10 patients with a median age of 59 who had been diagnosed with interstitial cystitis and either were currently using Elmiron or had used it in the past. All of them showed symptoms of pigmentary maculopathy. The researchers encouraged the patients to stop taking the drug.
More studies followed. Scientists at Kaiser Permanente found that of the 140 of their patients who had taken Elmiron for a minimum of 5 years, an astonishing 23% of Elmiron patients (with an odds ratio of 2.95 with 95% confidence)showed signs of maculopathy (eye damage). The study suggests that there is a dose-response with the greater the quantity of Elmiron taken resulting in greater eye damage to the Elmiron patient.
Another study followed in November 2019. Using data from a large U.S. medical claims database between 2002 and 2006, researchers found that patients taking pentosan (Elmiron) for seven years or longer were at an increased risk of having maculopathy.
Canada in 2019 and April 2020 required the Elmiron label to be updated. The European Union followed suit requiring a label warning update for eye damages in April 2020. The United States required an updated label for Elmiron in June 2020.
Elmiron’s Signature Injury - Pigmentary Maculopathy Eye Injury
The Elmiron signature injury is commonly referred to in the medical literature as Elmiron-induced eye disease or pigmentary maculopathy.
The challenge is that many patients may suffer various side effects after using Elmiron for six months or longer but not be formally diagnosed by their doctors, or perhaps even be misdiagnosed with other diseases such as AMD, macular degeneration or aytpical maculopathy.
Accordingly, anyone who has taken Elmiron for six months or longer and experience any of the following symptoms is encouraged to seek medical evaluation and contact Chaffin Luhana for more information:
- Blurred vision
- Difficulty reading
- Dark spots in the center of vision
- Muted, less vivid colors
- Difficulty adapting to dim lighting
- Straight lines appearing curved or squiggly
- Degenerative maculopathy
- Macular retinopathy
- Eye damage
- Vision impairment
- Vision loss
The Elmiron Label Warning Changes
In April 2019, the International Cystitis Network (ICN) submitted a Citizen Petition to the FDA requesting that they require Elmiron manufacturer Janssen Pharmaceuticals to update its product label to include a warning about eye damage. “Patients should be notified that there is a strong association between retinal disease and pentosan use,” the petition read. “Annual eye examinations are suggested.”
The group also conducted an informal survey of IC patients. With close to 1,000 respondents, results showed that 53 percent of Elmiron users reported eye and/or macular disease.
In the summer of 2019, the European Medicines Agency (EMA) demanded changes to the Elmiron label, and Health Canada followed in October 2019, requiring similar changes. Manufacturer Janssen Pharmaceuticals followed those recommendations and made those changes, but at that time left United States users in the dark.
Finally, as a result of mounting evidence linking Elmiron to vision damage and pressure from the ICN, Janssen Pharmaceuticals recently changed the label for Elmiron products sold in the U.S. The new verbiage warns patients that pigmentary maculopathy has been identified with long-term use of Elmiron and that cases had been seen with shorter duration of use as well. On June 16, 2020, the FDA approved the changes.
The new warning also suggests a baseline retinal examination for all patients within six months of initiating treatment and periodically while continuing treatment—a recommendation first put forth by scientists and doctors researching this condition. The label further suggests that the warning largely only applies to patients who used the drug 3 years or longer, but also recognizes that the medical literature reports cases where patients used Elmiron for a significantly shorter period of time.
Chaffin Luhana is investigating cases where the patients were prescribed and used Elmiron for six months or longer.
The company had previously made similar changes in other countries.
What is Interstitial Cystitis?
Interstitial cystitis (IC) is a chronic condition that affects the bladder, causing symptoms like recurring pain and pressure in the bladder and pelvis area, urinary frequency and urgency, and dyspareunia (painful intercourse). The pain ranges from mild to severe and can be bad enough to qualify as debilitating, making it difficult for people to go about their normal daily activities and interfering with their quality of life. IC impacts millions of women, and some men.
Also called painful bladder syndrome (PBS), IC has two recognized subtypes:
- Non-ulcerative: The majority of patients with IC have this form of the condition, in which pinpoint hemorrhages occur in the bladder wall. The bladder looks irritated and inflamed.
- Ulcerative: Only about 5-10 percent of IC patients have this type, which is characterized by red and bleeding ulcers or patches on the bladder wall. This type is often more severe and can be extremely painful.
IC typically causes recurrent symptoms—many patients have pain that comes and goes, while others experience a more steady pain. Though IC is not an infection, it can feel like a bladder or urinary tract infection. It can also cause pain during intercourse and may appear alongside other conditions like irritable bowel syndrome and/or fibromyalgia.
So far, doctors don’t know what causes IC, but the following factors may be involved:
- A defect in the bladder tissue that allows irritating substances in the urine to penetrate the bladder wall.
- A defect in the immune system producing a specific type of inflammatory cell that releases histamine and other chemicals leading to IC symptoms. Or, an immune system defect that causes the immune system to attack the bladder.
- Something in the urine that damages the bladder.
- Changes in the nerves that carry bladder sensations making the bladder over-sensitive.
Currently, there is no cure for IC, so treatments are focuses on relieving symptoms largely through Elmiron, which is typically prescribed at 100 mg taken 3 times daily. Chronic, long term use of Elmiron is typical.
What is Elmiron?
Elmiron (pentosan polysulfate sodium or PPS) is a prescription drug used to treat bladder pain and discomfort associated with IC. It is the only prescription drug approved by the FDA specifically for treating IC and came onto the market in 1996. Patients typically take a 100 mg capsule three times a day. Relief from symptoms sometimes takes as long as three-to-six months to occur, and patients have to keep taking the drug for continued benefit.
Before Elmiron came onto the market, treatments for IC were limited and included diet modification, bladder distention procedures, and the use of other drugs requiring painful administration by a catheter. These treatments also provided only short-term relief, after which they’d have to be repeated.
Elmiron offered thousands of patients a welcome option for treating IC and has remained a popular choice among healthcare providers. Scientists aren’t sure why it works as it does. They think it helps restore damaged tissue in the bladder and provide a protective coating over the bladder wall, protecting it from irritating substances in the urine. It may also offer some anti-inflammatory action.
In double-blind, placebo-controlled clinical trials used to gain approval for Elmiron, 38 percent of patients taking Elmiron for three months reported improvement in their IC symptoms. In open-label trials, 61 percent of patients reported improvement.
Doctors also use other medications off-label to help ease IC symptoms, including antidepressants and antihistamines, sometimes combining these with Elmiron. The patent for Elmiron expired in 2010, but to date, there are no generic options available. Meanwhile, the manufacturer has repeatedly increased the price over the past several years.
According to the Interstitial Cystitis Network (ICN), ten years ago, Elmiron cost about $200 for a prescription. Today, that price has gone up to $1,000 or more.
Over 60 Elmiron lawsuits have been filed around the United States in state and federal courts against Janssen Pharmaceuticals, a division of Johnson & Johnson. All of these Elmiron vision damage lawsuits focus on patients who have used Elmiron for six months or longer and suffered vision damage. Plaintiffs claim that Janssen Pharmaceuticals knew or should have known that the drug could increase the risk of vision damage, and should have provided warnings to patients long before this.
Most recently, in the Fall of 2020, various plaintiffs moved the Judicial Panel on Multidistrict Litigation (JPML) to form a multi-district litigation (MDL) to centralize all federal filed Elmiron lawsuits before a single federal judge. The JPML, sitting in Washington, D.C., is not holding in-person arguments but instead heard remote arguments on December 3, 2020 on MDL No.2973, In re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation.
The federally filed Elmiron lawsuits have been filed in federal courts in Alabama, California, Florida, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania and Wisconsin. Separate from the federal litigation, Elmiron cases have also been filed in state court in Connecticut, New Jersey and Pennsylvania (in Philadelphia). We anticipate an Elmiron MTP (Mass Tort Program) in the Court of Common Pleas in Philadelphia, Pennsylvania.
We anticipate potentially tens of thousands of cases being filed, largely on behalf of women, given that Elmiron has been prescribed to hundreds of thousands of patients over the course of many years, 90% of whom are women. Also the incident rate from Elmiron studies suggests that over 23% of patients in studies who took Elmiron long-term developed eye damage.
The hallmark diagnosis or signature injury for an Elmiron lawsuit is pigmentary maculopathy. The diagnosis can only be done by imaging conducted by an eye doctor. This particular disease tends to develop over time and unfortunately is subject to significant misdiagnosis.
Accordingly, patients may need to revisit their previously diagnosed eye conditions if they used Elmiron for six months or longer, and suffered any of the vision side effects, to get appropriate testing and a proper diagnosis to include or exclude pigmentary maculopathy. Typical misdiagnosis seen include wet and dry age-related maculopathy (AMD), atypical maculopathy, and macular or pattern dystrophy, among other Elmiron misdiagnoses.
Chaffin Luhana has a team of professionals trained on the proper testing to be done and can assist people with getting an evaluation from an appropriate eye doctor to evaluate whether they suffer from pigmentary maculopathy and have an Elmiron lawsuit.
If you took Elmiron regularly and were later diagnosed with pigmentary maculopathy or other forms of vision damage or vision loss, you may be eligible to file an Elmiron lawsuit to recover damages.
Chaffin Luhana is investigating these cases and invites you to call today at 888-480-1123.
You can expect, when you call us, to be knowledgeable of the disease state, be able to obtain your necessary pharmaceutical and medical records, be able to guide you in getting a proper evaluation if you have not already been diagnosed with pigmentary maculopathy, and, if you have the disease, to file an Elmiron, lawsuit on your behalf. Our team will take care of the Elmiron lawsuit so you can focus on your health.