First Elmiron Pigmentary Maculopathy Case Selected for Bellwether Trial

The federal judge presiding over the Elmiron multidistrict litigation (MDL) has selected the first case to go to trial early next year over claims that the interstitial cystitis medication put users at risk for irreversible vision loss and other debilitating vision problems. This “bellwether” claim was brought by Maria Windham, a 67-year-old Louisiana resident who alleges that she suffered pigmentary maculopathy after taking Elmiron for just two years. If you or someone you love has experienced vision loss, distorted vision, difficulty reading, or other symptoms of retinal maculopathy that you believe to be related to Elmiron use, do not hesitate to contact us. The Elmiron litigation is growing, and you may be entitled to financial compensation for your injuries.

Vision Loss Linked to Interstitial Cystitis Drug

Elmiron (pentosan polysulfate sodium, or PPS) is a prescription medication approved to treat interstitial cystitis, a chronic bladder condition characterized by bladder pain, bladder pressure, and sometimes pelvic pain. Interstitial cystitis can be difficult to treat, and Elmiron is currently the only prescription drug approved by the FDA for people with the bladder condition. Moreover, since there is no cure for interstitial cystitis, many people end up taking Elmiron for years, which emerging evidence suggests may increase their risk of experiencing a rare type of retinal damage known as pigmentary maculopathy. People who suffer retinal maculopathy after taking Elmiron may experience a wide range of irreversible vision problems, from blurred vision to difficulty reading, difficulty adjusting to dim lighting, blind spots in the visual field, difficulty reading, or even blindness.

Lawsuits Claim Elmiron Causes Permanent Vision Changes

People who took Elmiron long-term to treat interstitial cystitis are now filing claims against Johnson & Johnson and its Janssen Pharmaceuticals subsidiary, alleging that the drug makers misled patients and healthcare providers for years, and failed to warn about the importance of monitoring for vision changes during Elmiron treatment. Because Elmiron lawsuits filed throughout the federal court system all raise similar claims, the cases have been consolidated before U.S. District Judge Brian R. Martinotti in the District of New Jersey for coordinated pretrial proceedings as part of an MDL.

In an effort to gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout the Elmiron litigation, Judge Martinotti has selected a small group of representative Elmiron vision loss claims for early trial dates. These bellwether trials are expected to begin in early 2023. In a Hearing Order issued on June 1, Judge Martinotti announced that Maria Windham’s lawsuit will be the first Elmiron case to go before a jury in the MDL, followed by a claim brought by a Georgia woman who took Elmiron for six years and suffered damage to both eyes. While the outcome of these early bellwether claims will not be binding on the other Elmiron lawsuits in the MDL, verdicts in favor of plaintiffs may persuade J&J and Janssen to consider Elmiron settlements.

Maculopathy Warning Added to Elmiron Label

More than 1,000 claims against Johnson & Johnson and Janssen Pharmaceuticals allege that the manufacturers knew for years that Elmiron was associated with permanent vision loss, especially with long-term treatment, yet the first warnings about vision problems tied to Elmiron use were not added to the drug label until June 2020, more than two decades after the drug entered the market. As more and more former Elmiron users claim that the interstitial cystitis drug caused them to suffer irreversible damage to their vision, a number of new studies and case reports have shed some light on the novel retinal disease often referred to as “pentosan polysulfate sodium-associated maculopathy.” In one Elmiron study published in March 2021, researchers concluded that approximately 20% of long-term Elmiron users may suffer retinal maculopathy, and indicated that “Patients with unexplained retinal pigment epithelium changes and difficulty with dark adaptation should be questioned regarding PPS exposure, and patients with known exposure to PPS should be examined.”

Consumer Safety Watch Can Help

If you or a loved one experienced retinal damage after taking Elmiron, you are not alone. Hundreds of thousands of people have likely been exposed to the interstitial cystitis drug and many of those people are now pursuing legal claims for their vision problems, seeking to hold Janssen Pharmaceuticals accountable for the harm they have suffered. Contact Consumer Safety Watch today to find out if you are eligible to file a claim for compensation.