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Janssen Pharmaceuticals Forced To Change Health Warning Labels Following Elmiron Lawsuits

On May 4th, 2020, a major lawsuit was filed against Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The case, brought by Tina Pisco, represented a rising number of lawsuits against the company regarding Elmiron, a drug commonly prescribed for interstitial cystitis. Drugs are often the subject of court cases, but rarely is it the big pharmaceutical companies under the spotlight. Janssen Pharmaceuticals, however, has been brought to court a number of times regarding allegations that Elmiron can cause severe vision-related side effects that its packaging does not warn against.

The Pisco case

Pisco claimed that her use of Elmiron led to the development of maculopathy, a degenerative affecting the retina. She was prescribed the drug to treat interstitial cystitis in 2012, and developed problems with her vision around six years later. By 2019, her vision in both eyes was affected enough to warrant the diagnosis of permanent retinal injury.

Elmiron was approved in 1995, and has been sold as a safe and effective treatment for both interstitial cystitis and osteoarthritis ever since. Pisco, however, accused Janssen Pharmaceuticals of knowing the risks associated with the drug despite not communicating them to the medical community. Her complaint claimed that the company ‘withheld material adverse events’ and failed to be transparent about the link between Elmiron and maculopathy.

Pisco’s attorney pointed out that the label on the drug simply said, ‘Warnings: None,’ despite there already being a requirement in Canada for the company to update its warning to include visual symptoms following a number of similar lawsuits. At the time of the case, the labeling update had not been required in the US, and the company had not updated its American packaging, despite being aware of the risks. Elmiron class action suits have been filed in both federal and state courts regarding serious visual side effects caused by the drug, and many patients continue to seek compensation for Elmiron eye damage. In the Tina Pisco case, the prosecution argued that misinformation made Janssen Pharmaceuticals liable for the patient’s damages.

FDA approves label changes

Maculopathy has been common in those experiencing severe side effects from using Elmiron. Its symptoms include loss of clear color vision, difficulty adjusting to dim light, image distortion and difficulty focusing the vision. Following pressure from the lawsuits brought against them regarding this condition and its link with Elmiron use, on June 16th, 2020, Janssen Pharmaceuticals admitted that long-term use of Elmiron may be a risk factor for ‘retinal pigmentary changes.’ With approval from the FDA, it has now updated its product labeling to include this warning, but it still does not mention maculopathy explicitly. The company now warns that retinal changes are also associated with short-term use of the medication.

Despite the label change, lawsuits continue to be brought against the company for the costs associated with its lack of transparency regarding patient risk. However, with the label change, it is hoped that doctors and patients will be better equipped to make an informed decision when treatment using Elmiron is considered.

Photo by Tingey Injury Law Firm on Unsplash

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