Elmiron Vision Monitoring For Users Nationwide Striken From Class Action Lawsuit in Pennsylvania

A federal judge has stricken certain claims from an Elmiron class action lawsuit pending in Pennsylvania, which called for manufacturers to establish a vision monitoring program for former users of the interstitial cystitis drug residing throughout the U.S.

Elmiron (pentosan polysulfate sodium or PPS) was introduced for treatment of interstitial cystitis in 1996, as the only oral medication approved for individuals suffering from the condition commonly referred to as “painful bladder syndrome”. Since there is no cure for the underlying condition, most users remain on the medications for years. However, it has recently been discovered that this may cause severe and permanent vision problems, known as pigmentary maculopathy.

In recent months, a growing number of personal injury claims have been filed throughout the federal court system by former users, alleging that the manufacturers failed to adequately warn about the risk of vision loss from Elmiron.

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Side effects of Elmiron have been associated with vision loss and retina damage known as pigmentary maculopathy.


In addition to claims brought by individuals diagnosed with retinal pigmentary changes, a number of class actions claims have also been brought, which seek to force the manufacturers to pay for medical monitoring of certain groups of former users, due to the continuing risk that they may develop maculopathy problems in the future.

Earlier this month, U.S. District Judge Wendy Beetlestone, issued an opinion (PDF) in one case pending in the Eastern District of Pennsylvania, which sought to establish a national medical monitoring class, as well as other proposed classes for residents of Illinois and Pennsylvania specifically.

Janssen Pharmaceuticals, Inc., which manufactures and sells Elmiron, filed a motion to strike the proposed nationwide class allegations, arguing that some states have laws which prevent such medical monitoring claims where there has been no diagnosed injury. Judge Beetlestone determined the proposed nationwide class cannot be certified, agreeing to strike only those allegations from the complaint filed in the Eastern District of Pennsylvania, but allowing the other claims to proceed.

“Here, the proposed nationwide class is not sufficiently cohesive. Rather, a fault line divides class members whom state law permits to seek relief through a no-injury medical monitoring claim, and those whom state law prohibits from asserting the very claim at issue here,” Judge Bettlestone wrote. “Because class members from various states cannot assert no-injury medical monitoring claims, common issues do not predominate across the Proposed Nationwide Class.”

Given common questions of fact and law raised in various lawsuits pending in U.S. District Courts nationwide, a hearing has been scheduled for next month to determine whether the Elmiron litigation should be centralized before one judge, which would help avoid conflicting pretrial rulings from different courts, reduce duplicative discovery into common issues in the cases and serve the convenience of common witnesses, parties and the judicial system.

As former users continue to learn about the link between Elmiron and vision problems, the number of lawsuits filed by individuals diagnosed with maculopathy is expected to continue to mount in the coming months, with hundreds, if not thousands, of individual injury lawsuits likely to be involved in the litigation.


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