Elmiron, also known by its generic name pentosan polysulfate sodium, is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Elmiron is prescribed to treat interstitial cystitis, a chronic condition characterized by bladder pain and discomfort. It is used to alleviate symptoms such as bladder inflammation and irritation.
Long-term use of Elmiron can cause severe vision problems, including vision loss and blindness. The primary concern is a condition known as pigmentary maculopathy, which is a degenerative eye disease that affects the retina. Patients have reported experiencing distorted vision, blurred vision, and difficulty seeing at night.
Plaintiffs have asserted four theories of liability against Janssen:
- Failure to Warn: Plaintiffs argue that Janssen failed to adequately warn users about the potential vision-related side effects of Elmiron.
- Design Defect: Plaintiffs claim that Elmiron was defectively designed, making it inherently dangerous for long-term use.
- Negligence: Plaintiffs allege that Janssen was negligent in researching and testing Elmiron, leading to unforeseen and severe side effects.
- Breach of Warranty: Plaintiffs assert that Janssen breached implied warranties by marketing Elmiron as safe without disclosing its potential to cause vision damage.
The science behind Elmiron’s harmful effects centers on its impact on the retina. Studies have shown that Elmiron can be toxic to the retina, leading to pigmentary maculopathy. The drug’s active ingredient, pentosan polysulfate sodium, causes damage to the retinal cells over time, resulting in vision loss and other eye-related issues.
Numerous individual settlements — ranging from $100,000 to $500,000 — have already occured, depending on the severity of the vision damage and other factors. Future settlements are expected to range from $200,000 to $1,000,000 per plaintiff.