Two lawsuits have been filed over the interstitial cystitis medication Elmiron allegedly causing the progressive eye disease pigmentary maculopathy.
A Kansas woman has filed a lawsuit alleging that the defendants, Janssen Pharmaceuticals, Inc. and Johnson & Johnson failed to warn consumers about Elmiron’s associated risk of eye disease when they knew or should have known about the risk.
The lawsuit notes, “In November, 2018, Pearce, et al, reported a case series of patients known to be long term users of Elmiron that presented with an atypical maculopathy that resulted in significant vision loss.” Elmiron’s Canadian label had a warning added to it in September 2019 regarding eye problems and the drug’s U.S. label was updated with a similar warning on June 16.
“Defendants ignored reports from patients and health care providers throughout the United States of Elmiron’s failure to perform as intended, and injuries associated with long term use which led to the severe and debilitating injuries suffered by Plaintiff, and numerous other patients. Rather than doing adequate testing to determine the cause of these injuries or rule out Elmiron’s design as the cause of the injuries, Defendants continued to market Elmiron as a safe and effective prescription drug for interstitial cystitis,” the lawsuit continues.
The lawsuit alleges that the defendants were negligent because they “failed to exercise ordinary care in the manufacture, sale, labeling, and marketing Elmiron in that Defendants know or should have known that Elmiron created a high risk of unreasonable harm to Plaintiffs and other users.”
The lawsuit also claims that the drug is defective by design and its manufacturers are thus strictly liable for damages the drug causes.
“The Elmiron product, as distributed by Defendants, was dangerous in design at the time it left the Defendants’ control,” the lawsuit states. “When compared to other feasible alternatives, the Elmiron product greatly results in a much higher risk of visual injuries and side effects… at all times relevant to this action, Defendants manufactured, supplied, distributed, and/or sold Elmiron in a defective and dangerous condition, as described above, to Plaintiff.”
A California woman has also filed a lawsuit against Janssen and Johnson & Johnson, as well as Bayer Healthcare Pharmaceuticals, Inc., Ortho-McNeil Pharmaceuticals, Inc. and others. The woman allegedly suffers from vision loss, pigmentary maculopathy and retinal damage as a result of Elmiron use.
The lawsuit claims that defendants failed to warn consumers and others about the risk of eye damage associated with Elmiron. The lawsuit also claims that some clinical studies have failed to demonstrate that Elmiron is an effective interstitial cystitis treatment.