Elmiron Lawyers Scheduled To Meet With Court Overseeing Vision Loss Claims

With nearly 700 Elmiron lawsuits being pursued by former users of the bladder drug who developed permanent vision loss, the U.S. District Judge presiding over the litigation is scheduled to meet with lawyers involved in the federal cases for a case management conference this week.

Elmiron (pentosan polysulfate sodium) is a prescription medication that is often taken for years by individual suffering from interstitial cystitis or painful bladder syndrome, since there is no cure of the underlying condition. However, a growing number of individuals are now pursuing lawsuits against the drug makers, alleging that they failed to disclose the serious vision risks associated with long-term use of the medication, which is now known to cause a form of retinal damage known as pigmentary maculopathy.

Court records indicate Elmiron lawyers have already filed at least 597 complaints in the federal court system against Johnson & Johnson and its Janssen Pharmaceuticals subsidiary, with another 77 pending in various state courts, each involving nearly identical allegations that inadequate Elmiron warnings 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 last year, 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 December 1, Judge Martinotti indicated a case management conference will be held on Wednesday, via Zoom and a dial-in teleconference.

While the agenda has not yet been issued for that conference, in the same order, Judge Martinotti highlighted a number of issues Elmiron lawyers should continue to focus on as the litigation moves forward, including identifying new dates for an Elmiron Science Day that was postponed earlier this year, meeting and conferring regarding Janssen discovery, deposition and document production issues, and proposing case management orders on depositions and the dismissal of certain Teva entities from the litigation.

Following the meeting this week, the Court has scheduled a series of case management conferences that will be held about every month throughout 2022, leading up to the first trial date.

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.