Three Elmiron Lawsuits Selected For First Bellwether Jury Trials Over Vision Problems Caused by Bladder Drug

The U.S. District Judge presiding over all Elmiron lawsuits has identified three cases that will be prepared for a series of early “bellwether” jury trials, which are slated to begin in the first half of 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. 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 test trials, which are expected to begin in January 2023, March 2023 and May 2023.

In November 2021, each party selected 10 potential cases to serve in a Bellwether Discovery Pool, for a total of 20. From there, they were ordered to each select one case for trial, and each side submitted recommendations to the Court for the third claim.

To qualify as a bellwether trial case, it was required that the plaintiff was prescribed and ingested Elmiron on or before November 7, 2021, and developed either pigmentary maculopathy or suffered exacerbation of an underlying retinal disorder after consuming the drug.

On May 9, Judge Martinotti issued a court order (PDF) identifying the final three claims that will go before juries.

The case chosen by plaintiffs was filed by Julia and Brian Manning (PDF), of Georgia, in May 2021. According to the lawsuit, Julia Manning took Elmiron from about 2008 through 2014, suffering injury to both eyes as a result. The lawsuit indicates the couple, like other plaintiffs, were given no warning and had no knowledge that Elmiron use presented a serious risk of eye injury.

The defendants’ selection is a case filed by Opal Faye Broussard (PDF) in January 2021. Broussard, of Louisiana, claims she suffered vision loss and macular degeneration as a result of years of Elmiron use.

The third case, chosen by the court and recommended by the defendants, was filed by Maria Windham (PDF), also of Louisiana, in October 2020. Her lawsuit indicates Windham used Elmiron from 2012 to 2014, before suffering retinal pigmentary changes, including macular degeneration.

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.