Elmiron Lawsuit Updates

The side effects of the interstitial cystitis drug Elmiron have been linked to form of vision loss and retina damage known as pigmentary maculopathy.

ELMIRON VISION LOSS LAWSUIT STATUS: Product liability lawyers are reviewing potential Elmiron lawsuits for long-term users who have experienced eye problems or vision side effects, which may have been diagnosed as age-related macular degeneration or other retinal disease.

October 2022 Update: A series of three Elmiron lawsuits are scheduled for trial in the federal court system in early 2023, with the first bellwether trial scheduled to begin on January 30, 2023. While the outcome of this case will not have any binding impact on other claims, it will help the parties gauge how juries may respond to certain evidence about the drug makers failure to warn about the vision loss side effects and may help promote Elmiron settlement negotiations.

MANUFACTURER: Janssen Pharmaceuticals, Inc.

OVERVIEW: Elmiron (pentosan polysulfate sodium, or PPS) was approved by the FDA in 1996 for the treatment of interstitial cystitis, which affects more than 1 million people in the U.S. alone. Also known as “painful bladder syndrome”, interstitial cystitis involves to severe and chronic pain in the bladder and groin.

Although the drug has been on the market for decades, increasing evidence published in recent years has found that Elmiron may have a toxic impact on the retina, leading to irreversible vision loss.

This maculopathy from side effects Elmiron may result in:

• Vision loss
• Loss of vision detail
• Loss of night vision
• Difficulty reading
• Inability to drive

ELMIRON MACULOPATHY: A number of studies and case reports published in recent years have highlighted the potential link between Elmiron and pigmentary maculopathy, leading many experts to now describe the retinal disease as “Elmiron maculopathy” or “PPS maculopathy”, referring the active pharmaceutical ingredient in the drug.

In May 2018, researchers with the Emory Eye Center in Georgia first raised concerns about this risk in a retrospective case report published in the medical journal Ophthalmology, which suggested long-term Elmiron use could cause this atypical maculopathy that results in deterioration of areas of the retina that control highly detailed vision.

These eye problems appear to worsen the longer Elmiron is used, and vision may continue to degrade even after the medication is stopped according to a study published in February 2020. This appears to have been confirmed by another study on persisting Elmiron vision problems published in July 2020.

Following additional research, Elmiron warnings were updated in Canada to add information about the risk of pigmentary maculopathy in September 2019, but the same information was not provided to U.S. consumers or doctors.

In May 2021, researchers published a study finding that Elmiron use was linked by a strong “dose-response” relationship to retinal maculopathy.

As a result of the drug makers decision to withhold information about this risk for decades, many ophthalmologists and doctors remain unaware of the risk As a result, these Elmiron vision problems are often misdiagnosed as other conditions, such as age-related macular degeneration, pattern dystrophy or other retinal diseases.

The lawsuits are consolidated as part of a multidistrict litigation (MDL) in New Jersey federal court. The first bellwether trials are expected to begin in January 2023, March 2023 and May 2023.

LAWSUITS OVER ELMIRON VISION LOSS: Product liability lawyers are evaluating whether users may be entitled to compensation through an Elmiron lawsuit as result of the decision by the drug makers to withhold warnings for decades about the importance of carefully monitoring users for signs of vision loss or other side effects associated with pigmentary maculopathy, which may get progressively worse the longer the drug is used.

Request a free consultation and claim evaluation to determine whether you, a friend, or a family member may be entitled to financial compensation or an Elmiron vision loss settlement.