Johnson & Johnson’s subunit, Janssen Pharmaceuticals, is facing more than 600 lawsuits in multidistrict litigation (MDL). Plaintiffs claim that Elmiron, a drug for chronic bladder pain, is toxic to the retina, the part of the eye that senses light and is chiefly responsible for vision.
A $10 million lawsuit filed Jan. 10 by attorneys on behalf of a New Hampshire woman will join the MDL, according to a release by the law firm representing the plaintiff.
Beverly Frizzell’s 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 lawsuit states.
Beginning in 2018, research studies began linking Elmiron to a condition called pigmentary maculopathy. Elmiron is the only FDA-approved drug for interstitial cystitis, which is commonly referred to as painful bladder syndrome. The drug’s active ingredient is pentosan polysulfate sodium (PPS), which is the only associated cause of pigmentary maculopathy.
Pigmentary maculopathy has been linked to:
- Blurred vision and other forms of vision impairment
- Reduced night vision
- Blindness in one or both eyes
Interstitial cystitis affects more than one million people in the United States, mostly women. Plaintiffs who allege that their vision has been damaged because of the drug all used Elmiron for many years.
The first research that showed an association between Elmiron and pigmentary maculopathy was published by researchers at the Emory Eye Center in Atlanta. The researchers reported that six patients who had been taking Elmiron for about 15 years had developed unusual changes in their macula, the central part of the retina, according to ScienceDirect.com.
In 2019, three ophthalmologists with Kaiser Permanente in Northern California presented research at the Annual Meeting of the American Academy of Ophthalmology that found that about one-quarter of patients with long-term exposure to Elmiron experienced significant eye damage.
Pigmentary maculopathy can be misdiagnosed as retinal dystrophy or macular degeneration.
Frizzell’s complaint accuses Janssen of knowing about the association between Elmiron and eye damage as early as 1996. Janssen updated the product insert for Elmiron to include pigmentary maculopathy in 2020.