Direct Filing of Elmiron Retinal Injury Cases Permitted in Federal MDL

The U.S. District Judge presiding over all federal Elmiron lawsuits has approved a process for the direct filing of future cases directly in the federal multidistrict litigation (MDL), which was established to help manage the growing litigation brought by individuals who experienced vision loss and retinal injuries.

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 injury 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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Elmiron Lawsuits

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 April 9, Judge Martinotti outlined procedures for the direct filing of future pleadings, which otherwise would have been brought in U.S. District Courts nationwide. The order applies both to cases alleging Elmiron retinal injuries and cases calling for medical screening and monitoring.

In complex product liability lawsuits, where large numbers of individuals are pursing similar claims and allegations, it is common for the Court to approve a Master and Short Form Complaint, where plaintiffs can then file future lawsuits through an abbreviated form, where they adopt relevant allegations.

Direct filing is intended to streamline the process for managing the litigation, and address motions which may be common to many different claims. Although all current and future claims can be brought in the District of New Jersey, the order notes it will be the venue for pretrial purposes only, and the parties preserve their right to have each case remanded to the forum where it would have originally been filed for trial, if settlements are not reached during the MDL proceedings.

Elmiron Vision Loss

The makers of Elmiron currently face about 200 product liability lawsuits in courts filed nationwide. However, 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 retinal injuries, 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.


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