Product News and Recalls

Elmiron Eye Damage Cases Lead to Multidistrict Litigation Preparations

elmiron lawsuits leading to MDL prepWhen a 2018 study appeared to show a link between Janssen Pharmaceuticals’ bladder infection drug Elmiron and certain types of eye damage, researchers started reviewing the data they had at their own disposal. Elmiron had been in use for decades and had been prescribed to hundreds of thousands of people across the country.

One particularly exhaustive study was conducted by three Kaiser Permanente ophthalmologists in California. The doctors analyzed records of 4.3 million patients in the system. 140 patients were identified who had taken approximately 5,000 Elmiron pills over the course of 15 years. When they were contacted, 91 of those patients agreed to undergo an eye exam during which the doctors took highly detailed images of their retinas, or the photosensitive tissues at the back of the eyes.

According to information posted to, 22 of the 91 examined patients showed what they classified as “clear signs of Elmiron toxicity.” The researchers also discovered that the level of toxicity was directly corelated to the amount of Elmiron taken.

Language was added to Elmiron’s label earlier this year reflecting the findings and noting a verified link between the drug and potential retinal issues with patients depending on how much Elmiron they had been taking. At the time the language was added, at least one lawsuit had already been filed by a patient who was not only seeking compensation for her injuries but also a declaration that Elmiron is unsafe for human consumption.

That lawsuit appears to have been just the start as a federal judicial panel has moved approximately 130 Elmiron eye damage lawsuits to the New Jersey court system and is potentially expecting hundreds more. U.S. District Judge Brian Martinotti will be overseeing the cases and has an extensive record of handling multidistrict litigations. Having overseen multiple mass torts in New Jersey’s state courts, Judge Martinotti is also overseeing an MDL involving Allergan’s breast implant recall and Johnson & Johnson’s Invokana case.