The U.S. District Judge presiding over all federal Elmiron vision loss lawsuits has issued an order which outlines the preliminary plan for discovery, procedures and bellwether trials, expected to begin in January 2023.

There are currently more than 200 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 about the importance of monitoring for symptoms of vision changes.

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 the claims before U.S. District Judge Brian R. Martinotti in the District of New Jersey, for coordinated discovery and a series of early trials designed to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the cases.

As Elmiron injury lawyers continue to investigate and file additional vision loss claims in the coming months and years, it is widely expected that several thousand lawsuits will ultimately be included in the proceedings.

To help promote potential Elmiron settlement negotiations, and avoid the need for hundreds of individual trials to be scheduled throughout the federal court system, Judge Martinotti has established a “bellwether” process, where a small group of representative claims will go through a discovery process and be prepared for early test trials in the MDL.

In a case management order (PDF) issued on May 13, the Court outlined a preliminary plan intended to help the parties conserve resources, eliminate duplicative discovery and promote the just and efficient conduct of the litigation.

The plan calls for case-specific discovery at this time to be limited to a Plaintiff Fact Sheet and a Defendant Fact sheet, which will allow an exchange of certain information about each Elmiron vision loss claim and defenses. Those fact sheets were approved in an order issued last week.

Rather than conducting further inquiry into circumstances for individual claims, Judge Martinotti instead called for parties to focus on general discovery, which includes evidence which will be relevant to all claims about the link between Elmiron and vision problems.

In addition, the Court has ordered parties to present a bellwether plan, including a plan to select which cases will be go through a case-specific discovery process and be eligible for early trial dates.

“While the details of trial selection, including the bellwether process, are premature at this stage and the parties will endeavor to work out the details of the same by agreement, the Court contemplates that the first bellwether trial in this MDL will be held in or about January 2023, with subsequent bellwether trials to follow,” Judge Martinotti wrote. “Therefore, as the parties develop the bellwether process timeline, as well as any dispositive motion practice or similar schedule, they should be guided by this time frame.”

Elmiron Vision Loss Concerns

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.

Following bellwether Elmiron trials held in the federal MDL, if the parties fail to reach a settlement or resolution for the litigation, it is expected that Judge Martinotti will begin remanding individual cases back to U.S. District Courts nationwide for separate trial schedules.