Elmiron Lawsuit Involving Pigmentary Changes, Macular Degeneration Selected For First Bellwether Trial

The U.S. District Judge presiding over all Elmiron lawsuits filed throughout the federal court system has selected a case brought by Maria Windham, to serve as the first “bellwether” claim to go before a jury 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, hundreds of lawsuits now allege that the drug left users with permanent vision problems, including a form of retinal damage known as pigmentary maculopathy.

According to allegations raised in the complaints, Johnson & Johnson and its Janssen Pharmaceuticals subsidiary provided false and misleading information for decades, and failed to warn users and their doctors 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.

To help promote potential Elmiron settlement negotiations, and gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation, Judge Martinotti has established a “bellwether” process, where a small group of representative claims went through a case-specific discovery process and were prepared for a series of three early bellwether trials, which are expected to begin in January 2023, March 2023 and May 2023.

In a Hearing Order (PDF) issued on June 1, Judge Martinotti indicated that a lawsuit filed by Maria Windham in October 2020 will be the first case to go before a jury. The claim was originally selected by the drug manufacturers, and will be followed by a lawsuit filed by Julia Manning, which was selected by plaintiffs, or a third claim that the defendants will identify by June 10.

While the outcome of these early trial dates will 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 and are designed to help facilitate settlement negotiations between the parties.

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.