Judge Approves Fact Sheets For Exchange of Information About Elmiron Injury Claims

The U.S. District Judge presiding over all Elmiron injury lawsuits filed throughout the federal court system has approved standardized “fact sheets” for both plaintiffs and defendants, which will help streamline the exchange of information between the parties as the litigation moves toward trial.

There are currently at least 209 product liability claims filed against the manufacturers of Elmiron, each involving similar allegations that users of the bladder drug were left with a form of maculopathy or retinal damage, which may have been avoided if earlier warnings had been provided.

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

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Elmiron Lawsuits

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


As Elmiron injury lawyers continue to investigate and file additional cases in the coming months and years, it is widely expected that several thousand claims will be included in the proceedings. Therefore, the Court is establishing processes to standardize the exchange of information about the injuries and allegations raised in each lawsuit.

On May 5, Judge Martinotti issued a case management order (PDF) which approved a Plaintiff Fact Sheet and Defendant Fact Sheet that will be completed in each case.

In mass tort litigation, it is common for fact sheets to be used to gather and coordinate initial information about the potential claims and defenses. The information is then used by parties to select a group of “bellwether” cases that are representative of the circumstances involved in other claims being presented, so that early trials can help gauge how juries are likely to respond to certain evidence and testimony.

The order sets the standard format of the fact sheets, and calls for all plaintiffs with currently filed and served claims to complete a fact sheet by June 23, and for defendants to complete their fact sheets by August 23.

Cases filed after the date of this new order will have 45 days following their Notice of Appearance to file a fact sheet for the litigation.

Elmiron Retinal Damage

Elmiron (pentosan polysulfate sodium or PPS) has been on the market since 1996, and is often used for years by individuals suffering from interstitial cystitis, more commonly referred to as “painful bladder syndrome.”

Although lawsuits allege the drug makers knew about reports involving vision loss and deterioration among long-term 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.

As researchers learn more about the causes of Elmiron eye problems, a number of new studies have been published over the past few months, which are expected to provide compelling evidence for plaintiffs who are now pursuing lawsuits against the drug makers.

In February 2021, a study published in the medical journal Clinical Opthalmology identified a distinct signature for Elmiron-related maculopathy, which can be identified using multimodal imaging. A month later, a study published in the journal Current Opinion in Opthalmology estimated about one out of every five long-term users of Elmiron may be left with retinal maculopathy, leading to recommendations that eye doctors should now ask questions about Elmiron exposure when patients present with unexplained retinal pigment changes and difficulty adapting in dark or dim light.

According to a case management order issued last month, Judge Martinotti is considering a proposal by the parties that would culminate with the first Elmiron bellwether trials going before juries in January 2023.


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