A group of Elmiron lawsuits from around the country have been consolidated and transferred to federal court in the District of New Jersey, where they will be heard by U.S. District Judge Brian Martinotti.
The transfer order applies to 63 Elmiron lawsuits from 11 federal districts. Sixty-five additional Elmiron lawsuits, as well as future lawsuits — which the panel estimated could grow into the hundreds — may be included at a later date, pending review.
The decision was issued last month by the seven federal judges who sit on the U.S. Judicial Panel on Multidistrict Litigation, also known as the MDL Panel.
Multidistrict litigation, which is only possible in federal civil court, groups related lawsuits together under one judge. By reducing redundancy and increasing efficiency in the lawsuit process, multidistrict litigation streamlines things. It eases the burden on the federal court system and makes legal action more convenient for the claimants and witnesses.
“The actions (lawsuits) involve common factual issues concerning the propensity of Elmiron to cause retinal injuries, notably atypical or pigmentary maculopathy. … This litigation likely will implicate complex scientific and regulatory issues. Centralization will eliminate duplicative discovery; avoid inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary,” according to the transfer order.
Manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals, Elmiron (sodium pentosan polysulfate sodium) is the only oral medication approved by the U.S. Food and Drug Administration for the treatment of interstitial cystitis, a painful bladder condition.
First approved in 1996, long-term use of Elmiron became associated with a unique form of macular degeneration known as pigmentary maculopathy when a small case study was published in 2018. Subsequent studies have only strengthened this link. Vision loss from pigmentary maculopathy, which damages the retina, is permanent and can lead to blindness.
In June 2020 Janssen added a warning about pigmentary maculopathy to the Elmiron package insert.
Both Janssen and Johnson & Johnson are headquartered in New Jersey, which was cited as advantageous for sourcing witnesses and documents, and was a factor in the decision to consolidate the Elmiron lawsuits in New Jersey.
Other drugmakers, including Bayer and Teva, are also named as defendants. Teva holds the licensing rights to Elmiron, which it has sold to Janssen and Bayer to manufacture the drug.
In December, a federal judge in Pennsylvania blocked a proposed Elmiron class action lawsuit involving compensation for preventive medical monitoring for unharmed Elmiron users. The judge asserted that state laws regarding “no-injury” medical monitoring claims varied too widely to allow the cases to be consolidated.
By Carah Wertheimer
Carah Wertheimer is an editor and reporter based in Boulder, Colorado. Her areas of specialization include food, health, environment, social justice and community reporting. Her work has appeared in National Geographic, The Denver Post, The Daily Beast, the Boulder Daily Camera, Boulder Weekly and other publications.