Nearly 200 Elmiron Vision Lawsuits Pending Over Retinal Maculopathy Problems: Court

According to recent court documents, there are already about 200 Elmiron lawsuits filed in federal and state courts nationwide, each raising similar allegations suggesting long-term users of the bladder drug were left with retinal maculopathy and vision problems, and the number of claims is expected to continue to grow rapidly in the coming weeks.

Elmiron (pentosan polysulfate sodium or PPS) is a prescription medication for treatment of interstitial cystitis, which is commonly referred to as “painful bladder syndrome”. It has been on the market since 1996, and users typically continue to take the drug for years, since there is no known cure for the underlying condition.

Although lawsuits allege the drug makers knew about reports involving vision loss and deterioration among users, the first warnings about the importance of monitoring for retinal damage on Elmiron were not added to the label until June 2020. At that time, doctors and users were told for the first time by regulators about the risk of pigmentary maculopathy associated with Elmiron exposure, which has left users with difficulty adapting in dark light, spots or floaters in the vision, as well as complete blindness.

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Side effects of Elmiron have been associated with vision loss and retina damage known as pigmentary maculopathy.


Given similar questions of fact and law raised in complaints filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings for the Elmiron cases in December, centralizing claims brought in U.S. District Courts nationwide before Judge Brian R. Martinotti in the District of New Jersey, for coordinated discovery and a series of early “bellwether” trials.

In a case management order (PDF) issued on March 29, the Court reports that, as of March 10, there were 196 Elmiron claims filed; with 171 pending in federal multidistrict litigation (MDL), and another 25 filed in New Jersey and Pennsylvania state courts combined.

Those numbers are expected to continue to grow in the coming weeks and months, as thousands of individuals nationwide have retained Elmiron lawyers to investigate their vision loss claims, determining whether ophthalmological exams establish that individual users have the pattern of retinal maculopathy associated with exposure to the drug.

In February, a study published in the medical journal Clinical Opthalmology identified a distinct signature for Elmiron-related maculopathy, which can be identified using multimodal imaging, which will provide compelling evidence for individuals who have been dealing with vision problems for years.

Additional research published last month in the journal Current Opinion in Opthalmology estimated that about one out of every five long-term users of Elmiron may be left with retinal maculopathy. Researchers encouraged eye doctors to ask questions about Elmiron exposure when patients present with unexplained retinal pigment changes and difficulty adapting in dark or dim light.

As more doctors learn about the link between Elmiron and maculopathy, individuals who have been dealing with vision problems for years may finally discover that their prior user of the bladder drug was the cause of the damage.

In the order, Judge Martinotti indicates the parties have proposed a process which will allow plaintiffs to file future Elmiron vision lawsuits directly in the MDL, avoiding delays associated with transferring claims from different U.S. District Courts. The Court indicates the order will be reviewed with the clerks office, and review any necessary changes to the parties’ proposal before the next status conference on April 14.

If a direct filing procedure is adopted, which will likely allow plaintiffs to file lawsuits through an abbreviated “short form” complaint, which is also likely to drive a rapid increase in new cases filed in the coming months.

As part of the coordinated management for the growing litigation, Judge Martinotti has raised the possibility of scheduling a coordinated “Science Day” for state and federal judges, where the parties would make non-adversarial presentations about the link between Elmiron and vision problems, for purposes of educating the court before pretrial motions and discovery disputes arise.

Following the completion of discovery and any “bellwether” trials held in the MDL, if the parties fail to reach Elmiron settlements or another resolution for the litigation, each of the claims may later be remanded back to U.S. District Courts nationwide for individual trial dates.

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