Elmiron Cases To Be Selected For Bellwether Trials Beginning in Jan., March and May 2023

The U.S. District Judge presiding over all federal Elmiron vision loss lawsuits has issued guidelines and procedures for selecting a group of cases that will be prepared for a series of early “bellwether” test trials, slated to begin in January, March and May 2023.

Elmiron (pentosan polysulfate sodium) is a prescription medication for treatment of interstitial cystitis or painful bladder syndrome, which is often taken by users for years, since there is no cure of the underlying condition.

While it has been marketed as safe and effective for decades, lawsuits now allege the drug makers failed to disclose serious vision risks associated with the medication, which have left users with a form of retinal damage known as pigmentary maculopathy.

More than 500 product liability lawsuits are already pending against Johnson & Johnson and its Janssen Pharmaceuticals subsidiary throughout the federal court system, each alleging that earlier Elmiron warnings should have been provided for users and the medical community.

Given similar questions of fact and law raised in complaints filed in U.S. District Courts nationwide, consolidated pretrial proceedings were established for all Elmiron cases 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.

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 case-specific discovery process and be prepared for early test trials, which are expected to begin in January 2023.

In a case management order (PDF) issued on October 6, Judge Martinotti set a number of guidelines and procedures for the selection of the cases that will be prepared for these early trial dates.

“On or before November 15, 2021, Plaintiffs Executive Committee and Lead Counsel for Defendants shall each select and exchange 10 Eligible Cases to undergo case-specific bellwether discovery for a total of 20 Bellwether Discovery Cases,” Judge Martinotti ordered.

Judge Martinotti is looking for the parties to submit potential Elmiron trial cases where the plaintiff has proof they were prescribed and ingested the drug on or before November 7, 2021, and developed either pigmentary maculopathy or suffered exacerbation of an underlying retinal disorder after consuming the drug, or both.

By November 22, the parties have been ordered to jointly notify the Court of their selections. Any cases dismissed before December 20, 2021, will be replaced by the party which originally selected the case within 10 days of the dismissal. Any case dismissed by plaintiffs after December 20 can be replaced by the defendants within 10 days of dismissal.

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.

Elmiron Vision Loss Risks

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 vision side effects of 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.

In February 2021, a study published in the medical journal Clinical Ophthalmology 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 Ophthalmology 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.

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.