More Than 1,000 Elmiron Lawsuits Over Vision Problems Pending, As Parties Prepare For Trials Next Year

According to recent court documents, Merck now faces more than 1,000 Elmiron lawsuits over vision problems and retinal changes suffered by former users of the bladder drug, and the number of claims continues to mount as the parties prepare for the first bellwether trial set to begin early next year.

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. However, lawsuits filed by former users allege that long-term use of Elmiron may cause a form of retinal damage known as pigmentary maculopathy, .

Johnson & Johnson and its Janssen Pharmaceuticals subsidiary have known for years about the risk, according to the complaints, which indicate the drug makers withheld important warnings from users and the medical community about the importance of monitoring for vision changes while taking the bladder drug, which is now known to cause blurry or distorted vision, as well as blindness.

Given common questions of fact and law raised in claims brought throughout the federal court system, consolidated pretrial proceedings were established for all Elmiron lawsuits in December 2020, centralizing the litigation before U.S. District Judge Brian R. Martinotti in the District of New Jersey, for coordinated discovery and pretrial proceedings.

Lawsuits Over Elmiron Vision Loss Being Prepared for Trial

In a case management order (PDF) issued on June 30, Judge Martinotti revealed there were at least 1,041 product liability claims pending over Elmiron vision loss injuries as of June 8, including 915 cases filed at the federal level, and an additional 126 filed in various state courts nationwide.

As part of the coordinated management for the large litigation, Judge Martinotti has established a “bellwether” process, where a small group of representative claims went through a case-specific discovery process and are being prepared for a series of three early bellwether trials scheduled to begin in January 2023, March 2023 and May 2023.

While the outcome of these early trial dates will not be binding on other plaintiffs, they are designed to help gauge how juries are likely to respond to certain evidence and testimony which will be repeated throughout the litigation and may help promote potential Elmiron settlement negotiations, to avoid the need for hundreds of individual trials to be scheduled nationwide.

Elmiron Vision Loss Risks

Although lawsuits allege the drug makers knew about reports involving vision loss and deterioration among long-term users for years, the first warnings about the importance of monitoring for vision side effects of Elmiron were not added to the drug 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, which are expected to provide compelling evidence for plaintiffs at trial.

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 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.