The Elmiron MDL, a collection of cases alleging Johnson & Johnson failed to inform patients and doctors about the harmful side effects of their interstitial cystitis drug Elmiron, has been transferred to a New Jersey federal court.
The Elmiron MDL concerns allegations that the drug causes retinal injuries, including atypical or pigmentary maculopathy. The order from the JPMDL will send 42 of these cases to the District of New Jersey to be overseen by Judge Brian R. Martinotti.
The plaintiffs asked the Judicial Panel on Multidistrict Litigation (JPMDL) to centralize the Elmiron MDL in New Jersey. Other options were federal courts in the Eastern District of Pennsylvania, the Southern District of Florida, or the Southern District of Ohio. However, the JPMDL noted that no party objected to moving the litigation to New Jersey.
“After considering the argument of counsel, we find that centralization of these actions in the District of New Jersey will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation,” state court documents ordering the Elmiron MDL be transferred to New Jersey federal court.
“This litigation likely will implicate complex scientific and regulatory issues,” noted the JPMDL in its order. “Centralization will eliminate duplicative discovery; avoid inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary.”
Court documents also note that the federal judge who will oversee the case in New Jersey is “well-versed in the nuances of complex, multidistrict litigation.” In addition, Judge Martinotti has already begun to organize the MDL, which is expected to grow by hundreds of lawsuits, says the order.
What is Elmiron?
According to court documents, Elmiron has been marketed by Johnson & Johnson and its subsidiary Janssen, the defendant drug companies, since 1996. The drug reportedly treats a bladder disorder called interstitial cystitis. It is also used to treat osteoarthritis.
Though the drug has been on the market for decades, lawsuits against the drug makers claim that patients reported suffering from severe vision problems after taking Elmiron as early as 1997. Subsequent research has reportedly linked the bladder drug to visual complications, including macular degeneration, and retinal hemorrhage.
Indeed, U.S. Pharmacist reports that at an annual meeting of the American Academy of Ophthalmology, a presentation about Elmiron indicated that it can be toxic to the retina, according to research conducted by the Emory Eye Center and Kaiser Permanente.
Researchers reportedly concluded that the risk of a toxic effect increased with the amount of the drug taken over time. In addition, researchers noted that signs of Elmiron side effects on the eyes may be disguised by age-related vision problems.
“It‘s unfortunate,” one researcher reportedly stated. “You have a patient with a chronic condition like interstitial cystitis, for which there is no cure and no effective treatment. They get put on these medications because it’s thought to have few side effects and few risks, and no one thinks about it again. And year after year, the number of pills they’re taking goes up and up.”
In June of this year, the Food and Drug Administration officially requested Janssen Pharmaceuticals change the warning label on Elmiron to include “retinal pigmentary changes” as a potential side effect.
Despite claims of Elmiron maculopathy, defendant drug maker Janssen pledged its confidence in the safety of Elmiron.
“As the MDL process moves forward, we will continue to defend against the allegations made in these lawsuits,” a representative for the drug company reportedly said in an email to legal news source Law 360. “Elmiron (pentosan polysulfate sodium) is the only FDA-approved oral prescription medicine that has been helping patients with bladder pain or discomfort associated with interstitial cystitis for more than two decades.”
The Elmiron MDL is In re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation, MDL Case No. 2973, in the U.S. Judicial Panel on Multidistrict Litigation.
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