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retinal diagnostics in ophthalmology

On December 15, 2020, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all federally filed Elmiron (pentosan polysulfate sodium or PPS) be consolidated in the District of New Jersey, under the guidance of District Judge Brian R. Martinotti. Since then, both parties have been working to prepare a small number of cases for an early trial.

According to a recent case management order, those early trials may begin in January 2023.

Both Parties Moving Forward on Elmiron Litigation

As of April 14, 2021, there are 209 cases alleging product liability claims relating to the use of Elmiron pending in the Elmiron MDL (180) and in New Jersey and Pennsylvania state courts (29). In recent studies, Elmiron has been linked with a unique type of eye damage that can lead to long-term vision loss. Yet it wasn’t until June 2020 that the manufacturer, Janssen Pharmaceuticals, added any type of warning about vision loss to the product label.

On April 7, 2021, the parties submitted to the New Jersey court a proposed preliminary scheduling order, which if followed, would result in the first bellwether trial being held in or about January 2023.

The parties have already begun discovery production, and are working to coordinate processes and procedures between the New Jersey MDL and the state courts, including the scheduling of a Science Day. This is a day set aside to review the product and how it works, as well as to go over any research that is relevant to the litigation.

The court will review the proposed schedule and other materials as the litigation moves forward. The next case management conference is scheduled for Wednesday, May 12, 2021.

Studies Link Exposure to Elmiron with Unique Type of Eye Damage

The FDA approved the use of Elmiron for the treatment of interstitial cystitis (IC) in 1996. It was and remains the only drug approved to treat this painful bladder disease. Patients typically take a 100 mg capsule three times a day and must continue taking it indefinitely to experience relief.

For years, doctors and patients believed that Elmiron’s side effects were limited to minor gastrointestinal disturbances, headaches, dizziness, and itching or skin rash. Starting in 2018, however, doctors and researchers began reporting a strange new condition affecting the macula of the eye in patients taking Elmiron. All patients reporting this condition suffered from symptoms like difficulty reading and adapting to areas of dim light. Most also showed spots on the macula in imaging tests.

The macula is a small area in the center of the retina at the back of the eye that is responsible for clear and close vision. Damage to the macula is called “maculopathy,” and has now been found to occur in patients taking Elmiron, particularly those taking it for years.

Manufacturer Drags Its Feet on Warning Patients of Vision Risk

Among the many studies that eventually showed a link between the intake of Elmiron and maculopathy was one published in 2019. Using data from a large U.S. medical claims database between 2002 and 2006, researchers found that patients taking pentosan for seven years or longer were at an increased risk of having maculopathy.

In April 2019, the Interstitial Cystitis Network (ICN) submitted a citizen’s petition to the FDA requesting that they require Elmiron manufacturer Janssen Pharmaceuticals to update its product label to include a warning about eye damage. It wasn’t until June 16, 2020, that such a warning finally appeared on the product labels.

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