Within the last six months, the drug sold under the brand name Elmiron joined the ranks of mass tort litigation currently making its way through the U.S. federal court system. 

Doctors prescribe Elmiron to treat interstitial cystitis (IC). IC is a painful bladder disorder for which Elmiron is the only oral drug approved by the U.S. Food and Drug Administration (FDA) to treat the discomfort and pain associated with the condition.  

Read on for more information about MDL 2973, the multi-district litigation that consolidated Elmiron cases.  

History of Elmiron and Vision Problems 

Elmiron manufacturer, Janssen Pharmaceuticals, is a subsidiary of Johnson & Johnson Pharmaceuticals, Inc. Janssen introduced Elmiron to the marketplace in 1996 after the FDA approved the drug to treat IC. Problems with long-term use of Elmiron appeared in 2018 when studies began to show retinal injuries in Elmiron’s patients. 

If caught early, it’s possible that the damage to the retina might stop after the patient stops taking Elmiron. However, long-term users experience irreversible vision damage. The most egregious injuries are from retinal maculopathy, a condition that results in damage to the macula, located in the center of the retina at the back of the eye—the spot most sensitive to light and where vision is sharpest.  

The active ingredient in Elmiron is pentosan polysulfate sodium, or PPS. Studies have shown that PPS causes a unique degenerative eye condition known as pigmentary maculopathy. Unique pigmentary maculopathy is linked to PPS medication toxicity. The broad category of maculopathy is a major cause of blindness in the U.S. 

Elmiron Lawsuits Pick Up Pace 

Over the last 12 months, plaintiff lawsuits filed against the manufacturer and distributors of Elmiron have continued to accumulate. Plaintiffs’ lawyers currently anticipate that the number of Elmiron MDL cases will continue to grow because: 

  • Elmiron is a popular drug for the treatment of IC with potentially thousands of patient sufferers; 
  • The drug is still widely available in the marketplace; and 
  • The FDA so far has not issued a recall. 

MDL 2973 Timeline  

Below is a timeline of significant events related to MDL 2973. 

December 15, 2020: The Judicial Panel on Multidistrict Litigation (JPML) reviewed 63 federal Elmiron lawsuits, as well as 65 potentially related actions, initially filed in various courts. The JPML consolidated those lawsuits into the U.S. District Court in the District of New Jersey to settle all issues of discovery and other pre-trial matters. The case name is In Re: Elmiron Products Liability Litigation (Pentosan Polysulfate Sodium) MDL 2973. The JPML assigned the case to supervision by Judge Brian R. Martinotti. The MDL plaintiffs all seek monetary compensation for injuries that plaintiffs assert they suffered as a result of the ingestion of Elmiron. The defendants in MDL 2973 include Janssen, TEVA, Bayer, Alza, Centocor, Ortho-McNeil and IVAX.

June 16, 2020: The FDA announced a change to Elmiron labels. The new labels must exhibit a warning about the potential for vision damage. Before June 16, 2020, the Elmiron labels contained no warning about the risk of injuries, other than common side effects.

March 10, 2021: The District of New Jersey issued Case Management Order No. 5 stating that as of March 10, 2021, there were 196 product liability claims filed under MDL 2973. That number included 171 federal cases and 25 state cases filed in New Jersey and Pennsylvania. The order also set April 14, 2021 as the date for the next case management conference.

April 14, 2021: Case Management Order No. 7 stated that the number of cases consolidated under MDL 2973 grew to 209 (180 federal and 29 state cases filed in New Jersey and Pennsylvania). The Court ordered that the parties continue to meet and submit proposed orders to the Court regarding plaintiff and defendant fact sheets, implementation orders, deposition protocols, discovery interrogatories and requests for production. The parties also discussed the termination of several TEVA defendants and a possible Science Day to bring the judge up to speed on technical issues.

May 13, 2021: The District Court of New Jersey issued a new case management order stating that as of May 12, 2021, the cases grew to 225 (192 federal and 33 state cases in New Jersey and Pennsylvania). The court also ordered that the first Elmiron bellwether trial will be held in or about January 2023 with other bellwether trials to follow.

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