Johnson & Johnson subsidiary Janssen Pharmaceuticals is facing a $10 million lawsuit filed by attorneys representing a New Hampshire woman who suffered severe eye damage allegedly from years of taking the drug, Elmiron, for interstitial cystitis, the only FDA-approved drug for bladder pain.
The product defect suit adds to the more than 600 Elmiron lawsuits consolidated in a New Jersey federal court (under multidistrict litigation or MDL). Plaintiffs in the mass tort claim that Elimiron has caused them to develop damage to their retinas, causing blurred or damaged vision or even permanent blindness in some cases.
The plaintiff alleges that her injuries were “preventable and resulted directly from [Janssen’s] failure and refusal to conduct proper safety studies, failure to properly assess and publicize safety signals, suppression of information revealing serious risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Elmiron,” the complaint states.
As early as 1996, Janssen had become aware of reports of eye or vision damage as a result of the drug, the lawsuit alleges. But it wasn’t until 2018 when the Emory Eye Center clinical research study showed an association between the drug’s main active ingredient, pentosan polysulfate sodium (PPS), and a particular type of eye damage called pigmentary maculopathy, in patients who had been taking the drug for 15 years.
Other studies, such as research published in the journal Retina, have reached similar conclusions.
Despite the research studies and injury claims, Janssen did not update Elmiron’s side effect list to include eye/vision damage on the product insert until 2020.
No other drug or active ingredient besides PPS has been known to cause pigmentary maculopathy, which is sometimes misdiagnosed as macular degeneration, a common loss of vision spurred by the aging process.
Elmiron side effects also include loss of color perception, eye strain and dark spots in the field of vision, according to a press release about the lawsuit.