In March 2020, a patient using Elmiron (Pentosan Polysulfate Sodium) sued its maker, Janseen Pharmaceuticals, for not warning physicians and patients about possible adverse effects to users’ eyesight. These eye disorders include macular degeneration, toxic maculopathy, double vision, blurred vision, and halo vision.
This and subsequent lawsuits followed research linking constant use of Elmiron to eye and vision problems, advisories as to the potential side effects posted with the US Food and Drug Administration in September 2019, and an October 2019 order by the Canadian government to place a warning label.
Since then, well over a thousand plaintiffs have sued or joined lawsuits in various state and federal courts. As of June 8, Elmiron-based product liability suits numbered a reported 1,041. Federal courts had 915 of those lawsuits. The United States Judicial Panel on Multidistrict Litigation (MDL) consolidated pending federal Elmiron cases before a judge in the United States District Court for the District of New Jersey. In February 2022, the New Jersey Supreme Court assigned state court suits to a Multicounty Litigation (MCL) proceeding before a Bergen County, New Jersey trial court.
Much of this Elmiron lawsuit update focuses on the progress of the federal MDL proceeding, as juries will in a matter of months begin to tackle these claims.
What Does Elmiron Treat?
Interstitial cystitis is a bladder disorder. Symptoms and effects include bladder pressure, pain in the pelvis, and bladder pain. Elmiron seeks to treat interstitial cystitis and similar bladder irritations and disorders. In 1996, the U.S Food and Drug Administration (FDA) approved this medication.
How Do the Elmiron MDLs Work?
An MDL establishes a single set of pre-trial processes for mass tort cases. A single trial judge or set of judges schedules and sets parameters for discovery – the process of gathering and exchanging information through interrogatories, document production, and depositions. You might think of the Elmiron MDL as a class action.
However, unlike a true class action, plaintiffs can and do pursue separate injury claims and have separate trials. Even with different injuries among plaintiffs, the cases share similar legal and factual issues concerning the drug’s dangers and the defendant manufacturer’s failure to warn about them.
If you believe you were injured by Elmiron and want to participate in the federal MDL, you will complete a “Case & Claim Data Form” which asks you for, among other things:
- When you first and last took Elmiron
- Whether and when you have been diagnosed with maculopathy, macular degeneration, or retinal damage
- The imaging tests such as Color Fundus Photography, Fundus Autofluorescence Imaging, *Optical Coherence Tomography, or Near Infrared Reflectance used to diagnose your eye problems
Attorneys representing Elmiron plaintiffs use these and other questions to screen eligibility for participation.
Updates on Trials
In Multidistrict Litigation cases such as Elmiron, the assigned judge selects particular plaintiffs for “bellwether” trials. The lead counsel for the plaintiffs and the defense lawyers nominate the particular plaintiffs or cases.
Three such “bellwether” cases will go to trial, with the first starting in January 2023. The plaintiff in the first one, Maria Windham, alleges that she used Elmiron from 2012 to 2014 and suffered macular degeneration as a result. From this and the other two bellwether trials, other Elmiron plaintiffs can gauge the prospects of success, the strength of their claims, and how to settle their claims.