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With a growing number of Elmiron lawsuits being filed throughout the federal court system by former users of the bladder medication who have been left with permanent vision problems, the U.S. Judicial Panel on Multidistrict Litigation (JPML) is being asked to consolidate and centralize the cases before one judge for coordinated pretrial proceedings.
Elmiron (pentosan polysulfate sodium or PPS) is a prescription medication approved for treatment of interstitial cystitis, or “painful bladder syndrome”, which has been marketed as safe and effective since 1996.
Although concerns about a potential link between Elmiron and vision problems have been raised by independent researchers for years, lawsuits filed in recent months allege the drug makers withheld critical information and warnings from users, the medical community and regulators.
The litigation has emerged since the drug makers announced new Elmiron vision warnings would be added to the label in June 2020, confirming that users may develop a form of retina damage known as pigmentary maculopathy.
The new warnings now advise users, urologists and opthalmologists that users of Elmiron may develop a range of vision problems, including difficulty adjusting in dark light, trouble reading, centralized dark spots and other complications.
Similar warnings were placed on labels in Canada as early as November 2019, but most doctors and users in the United States did not learn about the toxic effect Elmiron may have on vision until this year.
In response to the mounting claims being filed in different U.S. District Courts, a motion to transfer (PDF) was filed by plaintiffs Sherry and James Dobbins on September 23, asking that the litigation be centralized before U.S. District Judge Brian R. Martinotti in the District of New Jersey, to avoid conflicting pretrial rulings from different courts, avoid duplicative discovery and serve the convenience of common witnesses, parties and the judicial system.
According to the motion, there are currently at least 24 Elmiron cases already filed before Judge Martinotti, with another 39 similar claims spread across 10 different federal district courts.
“[E]ach of the related Elmiron actions against Defendants allege very similar, if not virtually identical, causes of action and contain the same allegations about Elmiron and the propensity of Elmiron to cause serious injuries, including retinal pigmentary changes and/or maculopathy,” according to the motion. “These actions are based upon the same or substantially underlying facts: (1) Elmiron can cause retinal pigmentary changes and/or maculopathy as supported by, among other things, the growing medical literature; (2) Defendants negligently created, designed, researched, developed, manufactured, tested, marketed, advertised, promoted, distributed and sold Elmiron to the public, including the Plaintiffs in the respective actions and caused their alleged injuries; (3) Defendants knew or should have known of the dangers and defects associated with Elmiron; (4) Defendants failed to warn the of the dangers and defects associated with Elmiron; and (5) all Plaintiffs suffered grave ocular injuries as a result of using Defendant’s defective Elmiron.”
As Elmiron lawyers continue to review and file claims in the coming months and years, it is expected several thousand additional claims may be brought in the coming months and years.
The manufacturer has not yet responded to the motion, but the U.S. JPML is likely to consider oral argument from various parties involved during an upcoming hearing session scheduled for December 3, 2020 in San Antonio, Texas.