A Wisconsin woman has filed a lawsuit claiming that the interstitial cystitis medication Elmiron “caused harm” to her as well as “countless” other patients.
The woman filed the lawsuit on August 14. The lawsuit claims that Johnson & Johnson, Janssen Pharmaceuticals, Ortho-McNeil Pharmaceutical subsidiaries and Teva Pharmaceuticals behaved in a misleading manner which caused damage to her vision.
The woman took Elmiron for interstitial cystitis from 1998 to 2019, according to the lawsuit. The lawsuit claims she started experiencing double vision, blurred vision, dark spots and a loss of night vision in 2019, was diagnosed with retinal maculopathy that same year and was declared legally blind by March 2020. The lawsuit claims this occurred because drugmakers concealed and suppressed information about Elmiron’s safety.
“Defendants failed to disclose the known link between using Elmiron and the risk of harm to vision, including, but not limited to, pigmentary maculopathy,” the lawsuit states. “Defendants’ misleading conduct placed plaintiff at risk of harm, caused harm to plaintiff, and did the same for countless other patients who were prescribed Elmiron.”
The Emory Eye Center found a new progressive eye disease now known as pigmentary maculopathy in six of their patients from 2015 to 2018. They found all six of the patients had taken Elmiron when they poured through the histories of the patients, later publishing their findings in the Journal of Ophthalmology in 2018.
The lawsuit claims that Emory researchers looked at drugmakers’ early clinical trials for Elmiron and found “evidence of reported retinal eye damage that was never followed up on, never warned about or otherwise disclosed. Instead, defendants chose to ignore it.”
“Specifically, the Emory Eye Center researchers found that in defendant Janssen’s own clinical trial of patients who took Elmiron for up to four years, both vision and eye-related adverse events were reported, including optic neuritis and retinal hemorrhage. Defendant Janssen performed no further tests or research to explore the connection, and none of these risks were disclosed on the Elmiron warning label,” the lawsuit continues.
Elmiron’s Canadian label has warned about pigmentary maculopathy since September 2019, but the drug’s American label did not warn about the disease until June.
The lawsuit seeks damages based on numerous counts, including fraudulent concealment, negligence – failure to warn, strict liability – defective design, breach of express warranty and violation of the Wisconsin Deceptive Trade Practices Act.
Pigmentary maculopathy can cause dark spots in the center of the vision field, blurry vision, dimmer colors, trouble reading and eyesight problems in dim lighting.
For more information on Elmiron lawsuits, visit https://www.personalinjurylawcal.com/elmiron-lawsuit/