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Johnson & Johnson and its Janssen Pharmaceuticals subsidiary have actively concealed information about the serious vision risks from Elmiron, according to allegations raised in a product liability lawsuit filed by a California woman left with permanent retinal damage and other complications caused by the controversial bladder pain drug.
Natalie Baum filed the complaint (PDF) in the U.S. District Court for the Northern District of California on February 8, indicating manufacturers, developers and distributors of the interstitial cystitis treatment withheld important warnings and safety information from users and the medical community for years.
According to the lawsuit, Baum began taking Elmiron in 2005, for treatment of interstitial cystitis, which is also known as painful bladder syndrome. Baum indicates side effects of Elmiron caused her to suffer vision loss and other problems, including difficulty adapting to dim lighting, dark spots in the center of her vision, muted and less vivid colors, distorted vision, and straight lines began appearing curvy or squiggly. She was diagnosed with retinal and mascular damage, maculopathy, as well as retinal and macular pigmentary changes, which have been reported in recent years among a growing number of former users.
Elmiron was marketed for decades as a safe and effective treatment for interstitial cystitis, without any warnings until last year about vision risks reported in a number of independent studies and published case reports.
In June 2020, the drug makers updated the warnings about Elmiron eye problems, providing information for the first time about the importance of doctors monitoring users and reporting any pigmentary changes in the retina, which may arise long after first use of the drug.
As a result of the failure to provide earlier warnings, many doctors were unaware that Elmiron was causing users to experience a variety of vision complications, and many users were kept on the medication, unaware that it was having a toxic effect on the retina.
Baum’s lawsuit alleges defendants failed to adequately warn her or her doctors about Elmiron risks, and should have warned that patients undergo regular vision testing while using the bladder pain drug.
“The injuries and damages sustained by Plaintiff were caused by Defendants’ Elmiron,” Baum’s lawsuit states. “Plaintiff may continue to suffer a progression of retinal and vision changes even though Plaintiff is no longer taking Elmiron.”
Baum now joins a growing number of former users pursuing Elmiron vision lawsuits, alleging that permanent injuries may have been avoided if earlier warnings had been provided by the drug makers.
Given common allegations raised in dozens of complaints brought throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings last month, centralized the cases before one judge in the U.S. District Court for the District of New Jersey.
As Elmiron lawyers continue to review and file claims in the coming months and years, it is expected several hundred, if not thousands, of similar complaints may be brought on behalf of former users nationwide.
Following coordinated discovery and a series of “bellwether” trials likely to be held in the federal MDL, if the drug makers fail to negotiate Elmiron settlements for users left with vision problems, the complaints filed by Baum and other plaintiffs will be remanded back to U.S. District Courts nationwide in future years, for individual jury trials.