Elmiron Patients and Medical Monitoring Massachusetts Class Action

The defendants in this class action are a number of pharmaceutical companies (such as Teva Pharmaceuticals USA, Inc., Janssen Pharmaceuticals, Inc., and Johnson & Johnson) who have made, promoted or sold a drug called Elmiron. Elmiron is intended to treat interstitial cystitis, which is known as IC or bladder pain syndrome. However, the complaint for this class action claims that it causes damage to the retina, including the macula. It asks for medical monitoring for those who have taken this drug.

The class for this action is all Massachusetts citizens who have been prescribed and have taken Elmiron in Massachusetts and have suffered subcellular changes but have not been diagnosed with Elmiron Maculopathy.

Elmiron is also known as pentosan polysulfate sodium (PPS). Taking it causes a kind of maculopathy now called PPS maculopathy or Elmiron maculopathy, the complaint alleges, “a condition that is not seen in patients who have not ingested Elmiron and is caused only by the toxicity of Elmiron.” The complaint says this has been established by “[n]umerous patient reports, scientific studies and even alerts by governmental agencies…”

The plaintiff in this case, William Weber, began taking Elmiron after a diagnosis of IC. He took it between 2004 and 2019. Neither he nor his prescribing doctors had any warning about the damage the drug might do to his eyes. The complaint alleges, “As a result of his exposure to Elmiron, [Weber] demonstrates subcellular damage and is now at a significantly increased risk of contracting Elmiron Maulopathy and requires medical and ophthalmological monitoring for the early detection of this disease.” He has not yet been diagnosed with the actual disease.

The complaint takes issue with the drug companies because they did not warn patients, prescribers, or regulators about the effects of Elmiron: “Baseline, annual or continuing examinations, monitoring and early detection are necessary to identify and possibly alleviate the devastating vision issue that Elmiron is causing and will continue to cause in the years to come.”

However, it also says, “Recent scientific publications have also suggested that Elmiron Maculopathy can continue to evolve years after drug cessation, and may not even begin to manifest itself until months and even years after a person stops taking Elmiron.”

Concerningly, the complaint alleges that the drug companies that are the defendants in this case “knew, or should have known, that studies demonstrate there is no statistically significant difference between the treatment effect of Elmiron and a placebo.”

Drugs makers do not know exactly how Elmiron works, the complaint says, although it “is thought that it coats the epithelial cells of the bladder to provide pain relief. The drug has poor oral bioavailability and absorption, requiring users to take long-term high doses of the drug, resulting in accumulation and ultimate toxicity over time.” Unfortunately, this is coupled with a different effect elsewhere in the body: “Elmiron is also absorbed into retinal epithelial cells, which can result in retinal toxicity.”

Still, up until June 2020, the Elmiron label, under “Warnings,” said, “None.”

Article Type: Lawsuit
Topic: medical
Tags: Defective Drugs, Injury, Medical Monitoring, Pharmaceuticals