Elmiron Eye Disease Fact Sheet

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On March 26, 2020, Johnson & Becker PLLC  filed the first lawsuit against Teva Pharmaceuticals and Johnson & Johnson on behalf of an IC patient who was diagnosed with permanent retinal injury and vision loss due to Elmiron toxicity. In Pelczar v. Teva Branded Pharmaceuticals R&D et al. , the plaintiff/patient alleges that the company “failed to provide adequate warnings to patients and the medical community.. of the risks associated with using the drug.” They claim that the Defendants withheld material about key adverse events including the “serious link between Elmiron use and significant visual damage, including pigmentary maculopathy.” 

The filing cites the labelling provided for another medication, Plaquenil, that is also associated with retinal damage. The Plaquenil label provides explicit information on the risk of injury and encourages users to actively monitor their vision for signs of toxicity. They also suggest that a baseline ocular examination be performed in the first year of Plaquenil use so that changes can be monitored over time.

In contrast, Elmiron provides no education about potential vision changes nor instruction to have annual eye exams despite the fact that the label has been changed at least four times. In fact, the case says that Elmiron materials state “Warnings: None” despite about a dozen studies demonstrating an association of retinal disease with Elmiron use especially with long-term use. Elmiron is well known for its long-term use with some patients using it for more than twenty years.

The suit alleges that Teva Pharmaceuticals and Johnson & Johnson have ignored reports from patients and health care providers and failed to inform the public and physicians about the visual adverse events. (To date, we are not aware of any public statement offered by either company about this issue. ) Had they been informed of the risk of eye damage, the plaintiffs physicians would not have prescribed the medication or, at least, suggest proactive eye monitoring.

Count 1 focuses on the Connecticut Products Liability Act, suggesting that Elmiron was a defective and unreasonably dangerous product. It alleges that the company was aware of the risk of eye damage, “negligently and intentionally concealing and failing to disclose clinical data which demonstrated the risk of serious harm.” Their failure to notify physicians and patients about the risk of retinal damage is the heart of the lawsuit.

Perhaps the most serious claim is that the defendants are “continuing to manufacture and sell Elmiron with the knowledge that Elmiron was unreasonably unsafe and dangerous.” 

Johnson & Becker represent several individuals who allege that they have suffered permanent vision loss.  The lawsuit, Pelczar v. Teva Branded Pharmaceuticals R&D et al., was filed in the United States District Court for the District of Connecticut.

Timothy J Becker and Stacy K Hauer are counsel on record, with combined 40 years of litigating mass tort cases involving pharmaceuticals and medical devices.