Johnson & Johnson Faces Elmiron Lawsuit for Allegedly Concealing Adverse Event Data

On May 4, 2020, an Elmiron lawsuit complaint was filed. In the complaint, a woman named Tina Pisco claimed Elmiron caused her to develop maculopathy ⁠ — a degenerative disease of the retina ⁠ — in her eyes.

According to the May Elmiron lawsuit, Pisco began taking the drug in 2012 following a diagnosis of interstitial cystitis, also known as “painful bladder syndrome.” Approximately six years later, her vision rapidly deteriorated.

In March 2019, Pisco was diagnosed with permanent retinal injury in both eyes.

Fourteen months later, Pisco filed suit against the Johnson & Johnson subsidiary Janssen Pharmaceuticals. Its product, Elmiron, has been on the market since 1996. The company marketed it as a safe, effective treatment for interstitial cystitis and osteoarthritis.

Pisco’s complaint alleges the “dangerously defective prescription drug” was “designed, marketed, and distributed . . . while knowing significant risks that were never disclosed to the medical and healthcare community.”

Pisco’s complaint claims that Janssen Pharmaceuticals “withheld material adverse events” and “failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy.”

In the Elmiron lawsuit complaint, the plaintiff attorney notes that the “label and prescribing information that accompany Elmiron when prescribed to patients contains the following: ‘Warnings: None.’”

And despite the status in the U.S., Canada required Janssen to update its warnings last year.

“Post-market cases of pigmentary maculopathy have been reported with chronic use of pentosan polysulfate sodium (PPS). Visual symptoms in these cases included difficulty reading and prolonged dark adaptation. All patients should have regular ophthalmic examinations for early detection of pigmentary maculopathy, particularly those with longterm use of PPS.”

The Elmiron lawsuit claims that misinformation makes Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, liable for the plaintiff Tina Pisco’s damages.

Neither Johnson & Johnson nor Janssen have made any official statements regarding the Pisco v. Janssen et al. case, but it’s expected the company will deny wrongdoing.

On Elmiron’s official U.S. website, the common side effects are listed as:

  • Hair loss
  • Diarrhea
  • Nausea
  • Bloody stool
  • Headache
  • Rash
  • Abnormal liver function tests
  • Dizziness
  • Bruising

The only visual side effects that Janssen attributed to Elmiron were in the less than 1% category. Those side effects were:

  • Conjunctivitis
  • Optic neuritis
  • Amblyopia
  • Retinal hemorrhage

No mention of permanent vision loss or maculopathy is present on either Elmiron’s official website, prescription guide or patient leaflet.

As the case progresses, Medtruth will update its coverage of Elmiron risks and safety.

Originally published May 18, 2020

By James Parker

James Parker is a news writer and fact-checker from Coral Springs, Florida. He majored in Communication and Media Studies at Stetson University, where he spent much of his time examining the role of optics in various fields. When not covering the latest medical or legal development, James works on personal writing projects and board game design.




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