While plaintiffs’ complaints differ regarding how long Elmiron was used to treat interstitial cystitis, and a range of vision problems have been cited, all lawsuits, including the class action in British Columbia and the other in Quebec, are similar. All claim the manufacturers “failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy” and Elmiron did not properly warn patients of the risks, according to the Quebec complaint.In August 2020, two women in the U.S. filed lawsuits against Elmiron manufacturers— Johnson & Johnson and its subsidiary Janssen, Bayer and Teva—accusing them of failure to warn consumers of Elmiron’s risk, negligence, designing Elmiron in a way that makes the drug defective and hazardous to health, and fraudulent misrepresentation of the risks associated with Elmiron. One woman had taken Elmiron for about four years, the other woman ten years. These complaints (cases are Johns v. Alza Corp. et al., case number 3:20-cv-10341, and Levy v. Alza Corp., case number 3:20-cv-10342, both in the U.S. District Court for the District of New Jersey).
The British Columbia plaintiff, Arenlea Felker, filed the Elmiron side effects class action lawsuit against Janssen Inc. and Teva Branded Pharmaceutical Products R&D Inc. Felker, prescribed Elmiron to treat interstitial cystitis in 2005 and continued to take the medication daily, alleges that the drug caused “permanent vision-threatening eye disease” called pigmentary maculopathy.
Elmiron Studies Indicate Vision Problems “Possibly Avoidable”
A condition known as Pentosan Polysulfate Sodium Maculopathy, or pigmentary maculopathy, refers to damage to the retina and is highly associated with the use of Elmiron. Pentosan polysulfate sodium (PPS) is the active ingredient in Elmiron.
In a study published in Opthalmology back in November 2018, researchers concluded that maculopathy associated with chronic exposure to PPS is “possibly avoidable". Another study published in January 2019 associated the “Chronic use of pentosan polysulfate sodium with risk of vision-threatening disease, and a number of articles have been published with similar conclusions.
As well, studies have found that patients with interstitial cystitis who don't use Elmiron have no instances of pigmentary maculopathy. But many other issues are related to vision loss, from mental health issues to a higher risk of falling. One 2014 study published in JAMA Ophthalmology linked poor vision to a reduced life expectancy. Additional issues can include cognitive decline, difficulty learning, and a feeling of being discriminated against.
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- “ a significant impact on the lives of those who experience it as well as on their families, their friends, and society. The complete loss or the deterioration of existing eyesight can feel frightening and overwhelming, leaving those affected to wonder about their ability to maintain their independence, pay for needed medical care, retain employment, and provide for themselves and their families. The health consequences associated with vision loss extend well beyond the eye and visual system. Vision loss can affect one's quality of life (QOL), independence, and mobility and has been linked to falls, injury, and worsened status in domains spanning mental health, cognition, social function, employment, and educational attainment. Although confounding factors likely contribute to some of the harms that have been associated with vision impairment, testimony from visually impaired persons speaks to the significant role that vision plays in health, vocation, and social well-being…The economic impact of vision loss is also substantial.”