Elmiron Manufacturers Should Have Done More to Check for Retinal Damage

A West Virginia couple recently filed a new Elmiron lawsuit in the Superior Court of New Jersey, Mercer County. The female plaintiff claims that after using Elmiron (pentosan polysulfate sodium or PPS), she suffered from vision loss. The couple seeks to hold Elmiron manufacturer Janssen Pharmaceuticals and parent company Johnson & Johnson liable for the damages.

Plaintiff Takes Elmiron for Years, Then Develops Vision Loss

According to the complaint, the plaintiff was diagnosed with interstitial cystitis (IC)—a painful bladder condition—in April 2010. Her doctor prescribed Elmiron (pentosan polysulfate sodium or PPS) to treat her condition. She took it regularly through October 2019 until her ophthalmologist told her that the drug had caused her vision loss.

Specifically, her doctor diagnosed her with “pentosane maculopathy,” a distinct type of eye damage related to Elmiron alone that can be detected through eye imaging. The plaintiff now suffers from blurred vision, difficulty distinguishing colors from one another, difficulty reading, and inability to go outdoors without sunglasses.

Elmiron May Be Toxic to the Retina of the Eye

Interstitial cystitis (IC) is a medical condition that causes bladder pressure and pain and sometimes, pelvic pain as well. IC can also cause increased frequency and urgency of urination.

The U.S. Food and Drug Administration (FDA) approved Elmiron for the treatment of IC in 1996. It was the first drug approved specifically for this condition, though doctors do have other drugs they can use “off label” to treat IC symptoms.

Scientists don’t know how Elmiron eases the painful symptoms of IC, only that it does. It is believed to be a sort of “chemical bandaid” that coats the epithelial cells in the bladder to provide pain relief. It has poor bioavailability, however, requiring users to take long-term high doses. This can result in accumulation and toxicity over time. Indeed, the drug has been found to accumulate in retinal epithelial cells in the eye.

Users must take Elmiron for at least 3-6 months to see benefits, and then must continue to take it to experience symptom relief.

Elmiron Drug Makers Failed to Warn About Possible Vision Damage

The retina of the eye is specifically susceptible to the effects of systemic drugs. Any drug that a person takes is absorbed into the bloodstream, and the retina has a unique dual blood supply. It also has limited ability to repair or regenerate itself, meaning once the cells are damaged, they are usually damaged for good.

Thus, manufacturers must watch for adverse drug effects on the retina. Elmiron manufacturers failed to do that. It wasn’t until 2018 when doctors first reported a strange eye condition they were seeing in patients taking Elmiron, that the public heard anything about this possibility.

In November of that year, Doctors from the Emory Eye Center in Georgia published a report in the scientific journal Ophthalmology describing six patients with vision damage. All of the patients had been taking Elmiron. Imaging tests showed that nearly all eyes showed strange hyperpigmentation around the retina—dark-colored spots. The most commonly reported symptom was difficulty reading.

That report opened the floodgates, as several other similar reports and studies followed. They all connected Elmiron to a unique eye disease scientists later named “pigmentary maculopathy.” But it wasn’t until June 2020 that Janssen finally updated the Elmiron product label to include a warning about potential vision damage.

Plaintiffs Filing Elmiron Lawsuits Have Access to Strong Evidence

When it comes to seeking compensation in court, plaintiffs must provide evidence to convince a judge and/or jury of their claims. Whereas proving a causal connection between a drug and an injury can sometimes be difficult, in Elmiron lawsuits, plaintiffs will have access to stronger evidence than usual.

Here’s why:

• Doctors can detect pigmentary maculopathy through imaging tests. The eye X-rays specifically show the tell-tale “dark spots” that can form on the retina after long-term use of Elmiron.
• This type of retinal damage is unique to Elmiron users. So far, it has not been detected in anyone else. Indeed, scientists had to create a new name for the injury after they discovered it in Elmiron users.

These two facts together give plaintiffs a unique advantage when filing Elmiron lawsuits. Elmiron attorneys will be able to present as evidence imaging scans clearly indicating the presence of so-called “pentosan maculopathy,” making it difficult for the defendants to dispute a causal connection.