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Johnson & Johnson faces a growing number of vision loss claims over Elmiron, indicating its Jannsen Pharmaceuticals subsidiary failed to warn about irreversible retina damage associated with the interstitial cystitis drug.
Given common questions of fact and law raised in complaints filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has scheduled a hearing for next month over whether the Elmiron cases should all be centralized before one judge for coordinated discovery and pretrial proceedings. However, the number of new claims continues to mount, and more than a half-dozen lawyers have filed notice of their intention to present oral arguments in support of centralization over the past week.
Elmiron (pentosan polysulfate sodium or PPS) was introduced for treatment of interstitial cystitis in 1996, as the only oral medication for individuals suffering from the condition commonly referred to as “painful bladder syndrome”. Since there is no cure for the underlying condition, most users remain on the medications for years. However, it has recently been discovered that this may cause severe and permanent vision problems, known as pigmentary maculopathy.
Until earlier this year, the drug was sold without any warnings about the link between Elmiron and maculoapthy, which can leave users with centralized dark spots, difficulty adjusting in dark light, trouble reading and other vision complications.
After new Elmiron warnings were issued in June 2020, a steadily growing number of product liability lawsuits have been filed in U.S. District Courts nationwide, each raising similar claims that former users may have avoided permanent vision damage if earlier information had been provided for consumers and the medical community.
A complaint (PDF) filed late last week by Joyce and Anthony Rao, of New York, raises allegations that mirror those presented throughout the litigation. Joyce Rao began taking Elmiron in 2000 for relief from bladder pain associated with interstitial cystitis, and indicates that she was diagnosed with retinal pigmentary changes in about May 2020.
“The development of Plaintiff Joyce Rao’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize safety signals, suppression of information revealing serious risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Elmiron,” Rao’s lawsuit states. “This conduct, as well as the product defects complained of herein, was a substantial factor in bringing about and exacerbating Plantiff’s injuries.”
Rao’s attorneys are among those who have filed a notice with the U.S. JPML that they wish to present oral arguments during a hearing scheduled for December 3, 2020, which will be held through video- or tele-conference due to the ongoing COVID-19 pandemic.
The drug makers have filed a response indicating they do not oppose the creation of a multidistrict litigation (MDL) for the Elmiron vision loss claims, but it is expected various parties will advocate for the cases to be transferred to different U.S. District Courts for further proceedings.
In complex pharmaceutical litigation, where large numbers of claims have been filed throughout the federal court system by individuals who suffered similar injuries from the same medication, it is common for the courts to centralize the claims before one judge to reduce duplicative discovery into common issues, avoid contradictory pretrial rulings and serve the convenience of common witnesses, parties and the judicial system.
As former users continue to learn that vision problems may have resulted from Elmiron, the size and scope of the litigation is expected to continue to increase in the coming months and years, with over 1,000 claims likely to be filed throughout the federal court system.