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Lawsuit Claims Drugmakers Hid Elmiron’s Link With Retinal Damage


elmiron retina

A lawsuit filed on August 25 in North Carolina alleges that drugmakers hid Elmiron’s link with retinal damage from the public and community for years. The lawsuit names Johnson & Johnson, Janssen Pharmaceuticals, Ortho-McNeil and Teva Pharmaceuticals as defendants.

Elmiron is an interstitial cystitis medication. The plaintiff was diagnosed with interstitial cystitis in or around 2003 and was prescribed Elmiron for it, according to the lawsuit. She took Elmiron as prescribed from around 2003 until early 2020.

The lawsuit says she started experiencing trouble adapting to darkness, trouble with night vision, trouble reading, eye pain, vision distortion and blurry vision in or around 2015, then was diagnosed with pentosan polysulfate maculopathy in 2019.

Pentosan polysulfate maculopathy is a new condition discovered by the Emory Eye Center. They found a new progressive eye disease in six of their patients, looked through those patients’ histories and discovered that all of the patients took Elmiron. Their findings were published in 2018.

The lawsuit notes that Elmiron’s label was only updated to warn about the drug’s link with maculopathy on June 16, 2020.

The lawsuit seeks to recover damages based on numerous claims for relief, including:

Fraudulent Concealment: “Defendants were aware of the health risks inherent in Elmiron®, but intentionally chose not to disclose this material fact to patients,” the lawsuit states. “Defendants’ failure to disclose and omission of material facts… was capable of deceiving and, indeed, did deceive a substantial portion of patients to a serious health risk.”

Negligence – Failure to Warn: The lawsuit argues that the defendants had a duty to warn patients, doctors, the medical community and the general public about the risk of ophthalmological side effects. The lawsuit claims the defendants failed to uphold this duty even though they knew or should have known about Elmiron’s link with maculopathy.

Strict Liability – Defective Design: The lawsuit argues that Elmiron was defective by design and dangerous because of this, and that “better and safer methods of design” of the drug were available which the defendants failed to use.

Breach of Express Warranty: The lawsuit claims that the defendants expressly warranted that Elmiron was safe to use for the purpose of treating interstitial cystitis when, in fact, it was not.

The lawsuit requests that the court issue a permanent injunction requiring the defendants to recall all Elmiron still in circulation which lacks a label warning about maculopathy and to stop distributing and/or selling any Elmiron without such a warning.


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