In recent weeks, our team at Romanucci & Blandin filed a lawsuit against Johnson & Johnson (J&J) and its subsidiary, Janssen Pharmaceuticals, for permanent damage to our client’s vision caused by the prescription medication, Elmiron (pentosan polysulfate sodium or PPS). It is just the latest of lawsuits against one of America’s most notorious lawbreakers and its subsidiaries, like Janssen Pharmaceuticals, whose products have caused cancer (Talc), addiction (Opioids), bleeding events (Xarelto), kidney damage (Invokana), metal poisoning (hip implants), and male breast growth (Risperdal).

Elmiron was developed and has been used for treatment of a condition known as interstitial cystitis (IC), sometimes referred to as painful bladder syndrome. Our client first started taking the medication following her diagnosis with IC in 1999 at the age of 30. She then proceeded to take the medication consistent with doctor recommendations three times per day for 14 years until 2013. Now, at just 50 years old, she received the terrible news that she was diagnosed with toxic maculopathy, which is a hallmark of Elmiron use and PPS toxicity. She will likely continue to experience deterioration of her vision; she has already been strongly advised against driving; and her doctors believe she has a strong likelihood of going blind in the future.

With any lawsuit involving a pharmaceutical product, much of the case comes down to the science behind causation: (1) Can the product cause the medical condition in question (general causation); and (2) Did the product cause that particular individual’s medical condition (specific causation).  While it is still early on in the litigation, the science behind Elmiron’s devastating side effects is growing stronger as time presses on. In 2018, scientists published a study showing a relationship between Elmiron usage and maculopathy—the deterioration of the part of the eye known as the macula. More recently, Kaiser Permanente and Harvard University studies demonstrated similar findings, with the Harvard study noting further deterioration even after use of Elmiron stopped. Studies have shown that up to one-quarter (25%) of patients taking Elmiron for extended periods of time may show signs of eye damage. It was not until this past year (June 2020) that Janssen finally included a warning label on Elmiron advising patients of the life-altering consequences. 

Unfortunately, for many, it’s too late and they must now seek justice through the court system. Individuals bringing their claims allege that, among other things, Janssen and other pharmaceutical company defendants should have known—or worse, knew and concealed their knowledge—of Elmiron’s dangers; failed to take reasonable steps to discover such dangers; and failed to warn users and the medical community. As a result of those actions, those afflicted with IC now have additional suffering to endure in the form of permanent eye damage, including vision loss and blindness caused by the following conditions:

• Maculopathy (Toxic, Retinal, Pigmentary, or PPS/Elmiron-induced)
• Maculitis
• Macular Degeneration
• Retinal Toxicity

Those conditions can begin with one or more of the following symptoms:

• Blurred Central Vision
• Central Vision Loss
• Dark Spots 
• Eye Pain
• Light Sensitivity
• Poor Light to Dark Adaptation
• Reduced Vision at Night
• Difficulty Reading
  

Many of the above conditions can only be detected with certain imaging studies and tests conducted by licensed medical professionals, such as an ophthalmologist. If you or someone you know has ever taken Elmiron and has been diagnosed with one of those conditions or are experiencing one or more of those symptoms, the team at Romanucci & Blandin is a resource to discuss your legal options.

To learn more about cases involving pharmaceutical products and errors, click here.