The Elmiron lawsuit claims that long-term exposure to Elmiron causes maculopathy, an eye disorder affecting the macula (central part of the retina) and a major cause of blindness.
Our law firm is representing individuals who took Elmiron and have suffered maculopathy or other serious eye damage. We have been handling lawsuits against drug companies since 1955. We are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
What Do We Know About the Elmiron Lawsuits?
Elmiron is the brand name for pentosane polysulfate sodium. It is utilized to treat a condition known as interstitial cystitis ("IC"), better known as “bladder pain syndrome.” IC is a very poorly understood condition, the symptoms of which include chronic bladder pain, urinary frequency, urinary urgency, and painful sexual intercourse.
In 2018, an article was published by the American Academy of Ophthalmology in which the authors wrote about six patients treated at Emory Eye Center between 2015 and 2017 who experienced pigmentary maculopathy of unclear cause following chronic exposure to Elmiron (pentosan polysulfate sodium) for interstitial cystitis.
In 2019, one of the authors issued an update writing that ten patients at Emory Eye Center had been diagnosed with this same issue. The primary complaints by individuals in the study were a loss of low light vision, generalized dimming of vision, difficulty reading, and general near-vision difficulty.
What are the Main Legal Issues Involving Elmiron?
The primary legal issue is whether the manufacturer of Elmiron failed to adequately warn doctors and patients about the potential vision-related side effects caused by Elmiron.
In addition to the fact that Elmiron can cause severe eye damage, the drug has not even been shown to be effective in treating interstitial cystitis. The earliest clinical trials for Elmiron in the 1990s revealed doubtful efficacy for the drug. In fact, one of the FDA reviewers stated: "The evidence of efficacy of Elmiron for the treatment of interstitial cystitis is very weak."
What Injuries and Side Effects Result from Elmiron?
In addition to maculopathy and other forms of vision loss, patients who have been prescribed Elmiron have reported one or more of the following side effects:
- alopecia (hair loss)
- gastroesophageal reflux
- skin rash
- sleep disorders
The U.S. Food & Drug Administration (FDA) encourages individuals to report drugs and medical devices that result in unexpected side effects or adverse events. This can be done online by completing a MedWatch Voluntary Reporting Form.
What Compensation is Recoverable in an Elmiron Lawsuit?
If you have taken Elmiron and suffer from maculopathy or other serious eye damage, we will be seeking the following compensation for you:
- Past and future medical expenses to treat your injuries.
- Past and future pain and suffering that results from your injuries, both from a physical and mental standpoint.
- Wage loss, if any.
- Other economic losses experienced because of your injuries.
- Punitive damages, if appropriate.
Have there been Financial Settlements Involving Elmiron?
As of this time, there have been no large groups of mass tort settlements involving Elmiron and the link to maculopathy or other serious eye damage. However, litigation likes this generally takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented.
Large groups of settlements do not generally occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk. The first step in this process is usually having large groups of cases combined in federal court for discovery purposes. This process is known as Multi-District Litigation (known as an MDL).
Attorneys Mike Papantonio & Tim O'Brien Discuss the Elmiron Lawsuits
What is Elmiron Maculopathy?
Maculopathy is a general term referring to any pathological condition that affects the macula, the central portion of the retina upon which visual acuity and sensitivity depends. Types of maculopathy include:
- Age-Related Macular Degeneration: a degenerative condition that develops over time, resulting in gradual sight loss, starting in the central field of vision.
- Cellophane Maculopathy: also known as “macular pucker.” This results from the formation of a thin, transparent layer of scar tissue that pulls on the light-receptive nerve cells of the macula, causing visual distortion.
- Malattia Leventinese: also known as “Doyne Honeycomb Retinal Dystrophy" or DHRD. This condition is a congenital (inherited) form of macular degeneration which begins with small, pale spots in the macula that eventually grows into a honeycomb pattern.
The form of macular degeneration that has been linked with Elmiron is identified as “pigmentary maculopathy of unknown etiology”. It is a macular injury with no known cause. Presentation of the condition differs slightly from one patient to another, but symptoms include any or all of the following:
- parafoveal pigmented deposits: capillaries and small blood vessels around the macula become abnormal, resulting in vision loss.
- vitelliform deposits: round, yellowish lesions that form underneath the macula (also known as adult pattern macular dystrophy).
- retinal pigment epithelium atrophy: a common symptom of age-related macular degeneration.
Patients may also present with hyperpigmented, or darkened spots, on the retina during an eye examination.
Have there been any Elmiron Recalls or Warnings?
Between 1997 and 2019, 100 cases identified as “eye disorders” among Elmiron patients were filed with the FDA Adverse Event Reporting System (FAERS). Eighty of these were classified as serious. At least 22 of these reports mentioned some form of maculopathy.
Prior to June 2020, Elmiron product labeling did not include any language describing pigmentary maculopathy or any other form of maculopathy. The only references to any form of ocular or vision-related disorders were located within the Adverse Reactions section, referring to nystagmus, conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage observed in premarket clinical trials. The labeling included no relevant warnings and identified no relevant adverse events.
On June 16, 2020, the FDA approved a change to the Elmiron label to state: "Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). 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." Additionally, the FDA recommends that patients receiving Elmiron should undergo periodic retinal examinations, including optical coherence tomography and auto-fluorescence imaging.
FDA and Scientific Studies Regarding Elmiron
From the beginning, Elmiron has failed to prove effective in the treatment of interstitial cystitis. On January 27, 1993, the FDA issued its first non-approval letter for Elmiron citing problems not only with the clinical trial results for Elmiron, but also with the investigators who conducted the trials.
In its November 8, 1991, Statistical Review and Evaluation relating to the clinical trials for Elmiron, the FDA reviewer stated: “The evidence of the efficacy of Elmiron for the treatment of interstitial cystitis is very weak.”
Because of the lack of efficacy evidence, the FDA requested the manufacturer to conduct an additional clinical trial without the investigators who had conducted the previous clinical trials. The manufacturer declined to conduct the additional clinical trial and, instead, re-analyzed the data from the two pivotal clinical trials.
After reviewing the re-analysis, the FDA issued a second non-approval letter for Elmiron, as the information was “inadequate and the application is not approvable” and again requested the manufacturer to conduct another clinical trial. The manufacturer again declined to conduct the additional clinical trial.
After a meeting with the FDA, the manufacturer agreed to conduct a review of the uncontrolled compassionate use database (not a clinical trial) in its attempt to corroborate its claims of the drug’s efficacy. The FDA reviewer again observed: “[T]here are no statistical procedures which can be used to unequivocally assess whether the outcomes seen in this data are a result of the placebo effect or of the use of Elmiron.”
The FDA Reviewer determined that it could not be said that the evidence was sufficient to establish that the drug should be approved. Nonetheless, because there was some evidence of efficacy for a small subset of the studied patients, the FDA reviewer issued a tepid recommendation for approval in February 1996.
More than a decade later, a much larger, multi-center clinical trial has found no statistically significant difference between the use of a placebo and Elmiron with regard to the reduction of interstitial cystitis symptoms.
Last Modified: January 3, 2021 @ 1:32 pm