Elmiron MDL Judge To Consider Scientific Presentations on Bladder Drug Vision Risks

Parties involved in the federal Elmiron multidistrict litigation (MDL) are preparing a series of scientific presentations on September 30, designed to educate the judge presiding over hundreds of lawsuits brought by former users of the bladder pain drug left with permanent retinal damage about issues that will come up throughout the cases.

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, the drug maker updated the Elmiron warning label last year to disclose information about vision risks linked to the medication.

Since that time, more than 500 Elmiron lawsuits have been brought in the federal court system against Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary, each raising nearly identical allegations that the drug makers knew or should have known that the drug may cause retinal damage, yet withheld information and warnings from users and the medical community.

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

Throughout the pretrial proceedings, the Court will be asked to rule on a number of matters that will require background knowledge about science related to the bladder pain drug and eye issues experienced by plaintiffs throughout the litigation. Therefore, a “Science Day” will be held next week to educate Judge Martinotti about issues and complex concepts that form the basis for the legal claims or defenses.

The non-adversarial scientific presentations will be made by expert witnesses or parties, but are not considered part of the official record in the litigation, or subject to cross examination. However, the information gleaned from the Science Day presentations may guide Judge Martinotti in any rulings or motions about evidence to be presented in the Elmiron bellwether trials, including decisions about what expert witness testimony may be presented to juries.

According to a pretrial order (PDF) issued on September 16, the presentations for the Elmiron Science Day will be conducted virtually, due to the ongoing pandemic.