The makers of Elmiron face yet another product liability lawsuit filed on behalf of a long-term user who claims that side effects of the interstitial cystitis drug caused her to suffer severe vision problems indicative of pigmentary maculopathy or retinal maculopathy. Such vision problems have been linked to Elmiron use lasting three years or longer, although cases of pigmentary maculopathy have also been reported with a shorter duration of Elmiron use. If you or someone you love has been diagnosed with an eye disorder like pigmentary maculopathy, retinal maculopathy, macular degeneration, Stargardt disease or pattern dystrophy, the vision problems could be the result of Elmiron use. Contact us today to find out if you are eligible to file an Elmiron vision loss claim against Janssen Pharmaceuticals.
Elmiron (pentosan polysulfate) entered the market in the United States in 1996, and for more than two decades, was marketed by Janssen Pharmaceuticals and Johnson & Johnson as a safe and effective treatment for interstitial cystitis. Commonly known as “painful bladder syndrome,” interstitial cystitis (IC) is a chronic condition characterized by bladder pressure and pain ranging from mild discomfort to severe pain. There is no known cure for interstitial cystitis and because Elmiron is the only oral medication approved to treat the pain and discomfort associated with the chronic bladder condition, long-term use of the drug is common among IC sufferers. Unfortunately, patients who have taken Elmiron for years to treat IC are just now finding out that the medication may put them at risk for permanent vision loss and other serious vision problems.
Janssen Pharmaceuticals faces a growing number of lawsuits filed in courts across the country on behalf of long-term Elmiron users diagnosed with pigmentary maculopathy and other vision problems who claim that the drug maker failed to provide adequate warnings about the potential for Elmiron to cause irreversible retinal damage. This latest Elmiron lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania on August 19, by Carol Ware, who alleges that she suffered retinal damage and maculopathy side effects from Elmiron. According to Ware’s lawsuit, she used Elmiron for 17 years as a treatment for interstitial cystitis and subsequently suffered a number of vision problems, including difficulty reading, driving at night, recognizing people, watching television and engaging in other activities. Ware’s ophthalmologist ultimately diagnosed her with macular degeneration and other vision problems related to Elmiron toxicity.
Ware’s lawsuit names as defendants Elmiron maker Janssen Pharmaceuticals, its parent company, Johnson & Johnson, and Bayer Healthcare, and alleges that the drug manufacturers knew or should have known about the potential for Elmiron to cause severe vision problems among users, yet withheld warnings about this potential risk until earlier this summer, when the Elmiron label was finally updated to reflect the risk of pigmentary maculopathy. As the new Elmiron warning states, “Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron. Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use.” These so called “pigmentary changes” are reported to include blurred vision, difficulty reading and slow adjustment to low or reduced light environments, among other vision problems.
The new Elmiron warning label in June 2020 came on the heels of a growing number of reports linking the widely used bladder drug to a rare retinal disease occurring in long-term users. Similar warnings were added to the Elmiron label in Canada in October 2019, in response to several studies and case reports indicating that side effects of Elmiron may lead to pigmentary maculopathy, permanent vision loss, dark spots, blurry vision, difficulty reading and a loss of vision detail, among other problems.
The new drug label urges Elmiron users to undergo regular eye examinations that include retinal examinations for early detection of retinal/macular changes potentially linked to the medication. The label also advises patients to call their healthcare provider if they notice any vision changes that may be linked to Elmiron treatment, to determine whether the drug treatment should be continued, “since these changes may be irreversible and may progress even after stopping treatment.” Unfortunately, for Elmiron users who have already suffered vision loss and other problems linked to pigmentary maculopathy, this new Elmiron warning comes far too late.
“Defendants failed to disclose a known defect and, instead, affirmatively misrepresented that Elmiron was safe for its intended use. Defendants disseminated labeling, marketing, promotion and/or sales information to Plaintiff, her healthcare providers, and the general public regarding the safety of Elmiron knowing such information was false, misleading, and/or inadequate to warn of the safety risks associated with long-term Elmiron use,” Ware’s lawsuit states. “They did so willfully, wantonly, and with the intent to prevent the dissemination of information known to them concerning Elmiron’s safety.”