A federal judge has granted a request from Elmiron manufacturer Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, to stop a proposed national Elmiron class action lawsuit from proceeding.
Elmiron is the only oral medication approved by the Food and Drug Administration for the treatment of interstitial cystitis, or painful bladder syndrome. Despite being on the market since 1996, the risk of permanent eye damage and vision problems wasn’t associated with Elmiron (pentosan polysulfate sodium) until as recently as 2018.
Pigmentary maculopathy, also known as pentosan polysulfate maculopathy, is a new type of macular degeneration linked exclusively to Elmiron use, typically occurring in patients taking the drug for three years or longer.
In June 2020, Janssen updated their Elmiron package insert with a warning about the risk of pigmentary maculopathy and with instructions for patient screening and care.
About 80 individual Elmiron lawsuits have been filed so far and hundreds more are “waiting in the wings” at law firms, according to a Law.com report. By bringing together claimants to share costs and streamline court appearances, class action lawsuits enable considerably more people to take legal action than might otherwise be able to do so on their own.
The decision issued by U.S. District Judge Wendy Beetlestone of the Eastern District of Pennsylvania last month only blocks the particular class action proposed in Almond v. Janssen Pharmaceuticals.
The case at hand differs from some other lawsuits in that the claimants were unharmed, meaning they have not experienced eye damage or visual problems from taking Elmiron. Unlike plaintiffs seeking damages for actual injury, these plaintiffs sought compensation for medical monitoring to detect the signs of potential eye damage from Elmiron as early as possible.
Beetlestone disagreed with the argument that Pennsylvania’s approach to “no-injury” medical monitoring claims applied regardless of residency. Citing variations from state to state and noting that Illinois and New Jersey deny such claims entirely, Beetlestone deemed the Elmiron lawsuits “not sufficiently cohesive” to warrant a class action.
According to Beetlestone’s Nov. 6 opinion, the law of the state in which the patient was prescribed and took Elmiron is the law that applies.
By Carah Wertheimer
Carah Wertheimer is an editor and reporter based in Boulder, Colorado. Her areas of specialization include food, health, environment, social justice and community reporting. Her work has appeared in National Geographic, The Denver Post, The Daily Beast, the Boulder Daily Camera, Boulder Weekly and other publications.