Strong Evidence Of Link Between Elmiron And Retinal Maculopathy Outlined in New Study

As a growing number of Elmiron lawsuits continue to be filed by former users left with serious vision problems after taking the bladder drug, the findings of a new study appear to provide strong new evidence that cases of retinal maculopathy were caused by side effects of the medication.

Elmiron (pentosan polysulfate sodium or PPS) is a prescription medication which has been on the market since 1996. It is the only approved oral treatment for interstitial cystitis, which is also commonly referred to has “painful bladder syndrome”, and is commonly used for years, since there is no known cure for the condition. However, over the past year it has been the subject of litigation and class action lawsuits over the drug makers’ failure to warn users and the medical community about a form of retinal maculopathy caused by Elmiron, known as pigmentary maculopathy.

In a new study published this month in the medical journal Clinical Ophthalmology, researchers with Northwestern University indicate Elmiron-related maculopathy has a distinct signature, which can be identified using multimodal imaging.

Although a series of case reports and independent studies have been published about the vision risks with Elmiron in recent years, the first warnings were not issued by the drug makers until June 2020, when label information was added about the importance of doctors monitoring for retinal damage or vision changes on Elmiron.

Imaging which confirms Elmiron retina damage is likely to provide compelling evidence in lawsuits filed by former users now experiencing a wide range of vision side effects, including difficulty adapting in dark light, spots or floaters, loss of vision detail or complete blindness.

In this new study, researchers looked at data on 131 patients who used Elmiron and were seen at the Northwestern Ophthalmology clinic. Of those, 40 patients had undergone imaging, five of whom had features which researchers deemed suggested Elmiron maculopathy. Another five from the remaining 91 patients also had features of macular pigmentary changes. Among the ten total patients suspected of having maculopathy, the average duration of Elmiron use was 4.2 years, with an average cumulative dose of 380g.

The researchers noted the median cumulative dose for those not suspected of having Elmiron maculopathy was only 188.1g, compared to an average of 317g among the suspect group.

“Our study adds to the growing body of work that supports the presence of a distinct pigmentary maculopathy associated with chronic usage of PPS. Future study is warranted, and guidelines are in the process of being established for the screening for PPS-associated maculopathy,” the researchers concluded. “A prospective analysis employing baseline ophthalmologic exams, regular follow-up, along with multimodal imaging is important in understanding the course of the disease while patients are on the medication as well as after discontinuation.”

Elmiron Vision Loss Lawsuits

There are currently about 200 individual injury claims and Elmiron class action lawsuits pending throughout the federal court system, which have been centralized as part of a federal multidistrict litigation (MDL) since they involve common questions of fact and law. However, as Elmiron lawyers continue to review and file claims in the coming months and years, it is ultimately expected that several thousands claims may be included in the litigation.

Following coordinated discovery, it is expected that a series of “bellwether” trials will likely be scheduled to help gauge how juries respond to certain evidence and testimony that is likely to be repeated throughout the litigation. Through multimodal ophthalmologic imaging that provides a distinct signature for Elmiron retinal maculopathy, plaintiffs will have much stronger evidence of causal connection than is typically available in pharmaceutical litigation.

If the drug makers fail to negotiate Elmiron vision loss settlements for individual users, each of the individual complaints centralized in the federal MDL may later be remanded back to U.S. District Courts nationwide for individual jury trials nationwide, exposing the manufacturers to substantial liability.