On Aug. 12 two women filed lawsuits against manufacturers of Elmiron, the sole oral medication approved by the U.S. Food and Drug Administration to treat interstitial cystitis, also referred to as painful bladder syndrome.
The Elmiron lawsuits were filed by Clara Johns and Shirley Ruth Levy within the U.S. District Court for the District of latest Jersey against units of Johson & Johnson, Bayer and Teva, as reported by Law360. Johns and Levy allege that the drug manufacturers knowingly withheld information about harm caused by long-term use of Elmiron like blurred and distorted vision and retinal damage, and did not alert physicians or patients of those risks.
Pigmentary maculopathy also referred to as pentosan polysulfate sodium maculopathy, maybe a unique sort of retinal damage related to long-term use of Elmiron consistent with a 2018 case study of six patients and a bigger 2019 study of 219 patients. The median duration of Elmiron use for affected patients was 15.5 and 14.5 years, respectively.
The women are seeking compensation for pain and suffering, pain, anxiety, physical impairment, and medical expenses. Johns, of Tennessee, treated her interstitial cystitis with Elmiron (pentosan polysulfate sodium) for about 10 years while Levy, of California, used Elmiron for four.
Each of the manufacturers is accused of multiple civil wrongs including failure to warn consumers of Elmiron’s risk, negligence, designing Elmiron during a way that creates the drug defective and unsafe to health, and fraudulent misrepresentation of the risks related to Elmiron.
These Elmiron lawsuit filings bear a striking similarity to a lawsuit filed in May 2020 against Johnson & Johnson and its subsidiary Janssen. therein Elmiron lawsuit, the plaintiff claimed that the manufacturers “failed to disclose the intense link between Elmiron use and significant visual damage, including pigmentary maculopathy.”
At publication, none of the cases had concluded.