First Elmiron Bellwether Trial in MDL May Begin in January 2023

The U.S. District Judge presiding over all federal Elmiron lawsuits is considering a proposal submitted by the parties, which calls for the first bellwether trial to begin by about January 2023.

There are currently at least 209 product liability claims filed against the manufacturers of Elmiron, including 180 in federal courts and another 29 pending in New Jersey or Pennsylvania state courts.

Each of the claims involve 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.

Several thousand additional cases are also under investigation by Elmiron injury lawyers, and it is widely expected that the size and scope of the litigation will continue to grow in the coming months.

To help promote potential settlement negotiations or another resolution for the litigation, a “bellwether” process has been established in the federal courts, where a small group of representative cases will go through a discovery process and be prepared for early test jury trials.

Elmiron Litigation

Elmiron (pentosan polysulfate sodium or PPS) has been on the market since 1996, and most users 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 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.

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 30, Judge Martinotti indicated that the Court is considering a joint preposed scheduling order, which would culminate with cases starting to go before juries in January 2023.

While the outcome of these early trial dates would not be binding on other plaintiffs, they may help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

Link Between Elmiron and Eye Damage

As pretrial discovery get underway, the parties have also proposed a process for developing plaintiff and defense fact sheets, protocols for conducting depositions remotely, as well as a “Science Day” to help get the Court acquainted with the scientific principles involved in the litigation.

In complex product liability litigation, it is common for courts to schedule such scientific presentations early in the case, to educate the judge about issues and concepts that will come up during the proceedings. The presentations are designed to be educational, not adversarial, and typically are not part of the official record or subject to cross examination.

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.

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 that 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.

As more doctors diagnose Elmiron retinal injuries among individuals who have been dealing with vision problems for years, it is widely expected that before the first cases go to trial in early 2023, the litigation will likely include several thousand complaints filed nationwide.