A class action lawsuit has been brought against the makers of the widely used interstitial cystitis drug Elmiron, claiming that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary should be required to pay for vision monitoring and eye exams for long-time Elmiron users, who may be at risk for permanent vision loss from retinal maculopathy. The complaint was filed earlier this month by plaintiff Mary Lee Allen in the U.S. District Court for the Eastern District of Pennsylvania, seeking class action status to pursue damages on behalf of herself and other former Elmiron users who now require diagnostic testing due to the potential risk of maculopathy associated with the bladder pain medication. If you or someone you know took Elmiron and has since suffered vision problems like blurred vision, vision distortion, difficulty reading or blindness, contact a knowledgeable Elmiron injury lawyer today for legal help.
Elmiron (pentosan polysulfate) is the only oral medication approved by the U.S. Food and Drug Administration (FDA) to treat interstitial cystitis, a bladder condition that causes chronic bladder pain, bladder pressure and a frequent urge to urinate. Interstitial cystitis (IC) is often mistaken for a urinary tract infection, but there is no infection. IC actually belongs to a spectrum of diseases known as painful bladder syndrome and there is no cure for the condition, which can have a long-lasting impact on the affected individual’s quality of life. In order to relieve some of the symptoms of IC, many patients take Elmiron, which has been on the market in the United States since 1996 and has been marketed by Johnson & Johnson and Janssen Pharmaceuticals as a safe and effective treatment for interstitial cystitis. What the drug makers failed to notify Elmiron users of, is the potential risk of irreversible vision loss associated with the medication.
A growing number of studies and case reports have linked Elmiron to an eye disease known as retinal maculopathy or pigmentary maculopathy, which can cause them to suffer vision problems ranging from difficulty reading, seeing close objects and adjusting to dim light, to a loss of vision detail, dark spots in the vision and blindness. As more information comes to light about the potential risk of permanent vision loss from Elmiron treatment, more and more former users are pursuing legal claims against Johnson & Johnson and Janssen, alleging that the drug makers failed to provide users with proper warnings about possible Elmiron vision problems. “Throughout the time Defendants marketed Elmiron, Defendants withheld material adverse events from the public, medical community, and the FDA,” this new class action lawsuit claims. “Defendants failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy. Ultimately, tens of thousands of patients, including Plaintiff, were placed at risk and harmed as a result of this misleading conduct.”
According to Mary Lee Allen’s lawsuit, she began taking Elmiron for interstitial cystitis in 2009 and now faces an increased risk of pigmentary maculopathy and permanent vision loss as a result of her long-time use of the drug. Elmiron vision loss studies have linked long-term use of Elmiron or pentosan polysulfate to an increased risk of atypical retinal maculopathy, now known as Elmiron maculopathy or pentosan polysulfate-associated maculopathy. Last year, the makers of Elmiron revised the drug warning label in Canada to include information about the possibility of vision loss symptoms and urged users to obtain regular eye exams during treatment. Unfortunately, Elmiron users and healthcare providers in the United States have received no such warning, and as a result, many patients suffering from Elmiron-related maculopathy have been misdiagnosed with macular degeneration, pattern dystrophy, Stargardt’s disease and other eye diseases.
The majority of the Elmiron lawsuits brought against Johnson & Johnson and Janssen Pharmaceuticals have involved patients who have already suffered irreversible eye damage and vision loss and alleged that plaintiffs could have avoided these life-altering problems had the drug makers provided adequate warnings about the potential risk of pigmentary maculopathy from Elmiron treatment. However, a growing number of lawsuits, this new class action included, seek compensation for medical monitoring on behalf of Elmiron users who have not yet suffered retinal damage, but now face an increased risk of these problems due to their use of the interstitial cystitis drug. If you or someone you love has suffered retinal damage, vision loss or other problems allegedly caused by the bladder pain drug Elmiron, contact a reputable Elmiron vision loss attorney as soon as possible to discuss your options for legal recourse.