Elmiron Lawsuit - Vision Loss Settlement Lawyers
The Elmiron lawsuits claim 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.
We are no longer accepting Elmiron cases.
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.
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."
Elmiron Injuries and Side Effects
Numerous peer-reviewed post-marketing studies recently have linked the use of Elmiron with a very serious eye condition known as maculopathy. Maculopathy is a progressive illness which can lead to impaired vision, central vision loss, and blindness.
The form of macular degeneration that has been linked with Elmiron is identified as “pigmentary maculopathy”. Maculopathy involves damage to the macula in the back of the eye. Patients with damaged maculae can experience a range of visual symptoms from general poor vision or dimming of vision, distortion of images, blurry or black spots in the center of vision, and legal blindness.
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 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 The form of macular degeneration that has been linked with Elmiron is associated with abnormalities in the retinal pigment epithelium.
Symptoms of this maculopathy can range from distortion of vision to central vision loss and even blindness. Presentation of the condition differs slightly from one patient to another, but imaging may 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;
- hyperpigmented, or darkened spots.
How Liability Law Applies to the Elmiron Cases
Under most state laws, a patient injured through the use of a defective drug can bring a lawsuit based on the following legal theories:
- Design Defect: When a drug is manufactured per design specifications, but the design itself renders the drug ineffective or unsafe;
- Manufacturing Defect: When a drug is safely designed, but has a defect through the manufacturing process, rendering it dangerous or unsafe; and/or
- Failure to Warn: When the drug manufacturer fails to warn the public of the risks or to provide adequate instructions about the use of the drug, thereby rendering it unsafe or dangerous.
All states enforce a statute of limitations that limits the amount of time you have to file a lawsuit against a drug manufacturer. A member of our legal team can inform you of your state’s laws.
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.