On September 22, 2020, Burg Simpson filed a products liability lawsuit against Janssen Pharmaceuticals regarding its drug Elmiron®. Elmiron, also known as pentosan polysulfate, is a drug used to treat bladder pain and discomfort from a condition known as interstitial cystitis. In the filing, Plaintiff alleges that use of this drug caused the deterioration of her vision and maculopathy. The complaint was filed in federal court in the Southern District of Ohio in Cincinnati and has been assigned to Judge Timothy S. Black.
Plaintiff’s complaint asserts several causes of action, including that Elmiron ® was defectively manufactured and designed, that Elmiron ® failed to conform to representations and warranties made by Janssen and that Janssen failed to adequately provide required safety information to the Plaintiff and her doctors. Plaintiff also alleges serious issues as to whether Elmiron actually works to relieve bladder pain, including data from Janssen’s own Phase IV study that showed Elmiron to be less effective than a placebo.
Not until June 16, 2020, did Janssen update Elmiron’s label to provide any warning of the risk of retinal damage. The new label acknowledges that “[p]igmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON[.]” The new label does not reveal that Janssen stopped its Phase IV study of Elmiron due to Elmiron’s lack of efficacy.
If you or a loved one have taken Elmiron® and are experiencing worsening vision or have been diagnosed with macular degeneration, pattern dystrophy, or other retinal conditions that impair vision, contact one of the award-winning defective drug attorneys at Burg Simpson Cincinnati today. Burg Simpson’s experienced products liability team has the knowledge and resources to hold dangerous drug manufacturers accountable for the harm they have caused, and have experience handling these cases. Call 513-852-5600 or fill out our contact form for a FREE no-obligation consultation with one of our Cincinnati dangerous drug lawyers today!