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By Susan Barfield /
October 9, 2020

Elmiron Eye Injury MDL Formation on the Horizon

Elmiron attorneys are pushing the Judicial Panel on Multidistrict Litigation to create a Multi-District Litigation (MDL) in the U.S. District Court of New Jersey to consolidate pretrial discovery and related proceedings. Due to the widespread number of patients suffering from eye injuries, experts expect the number of Elmiron lawsuits to grow significantly over the coming months. Several plaintiffs have already filed suit in the New Jersey Federal Court while other cases are pending in Alabama, Florida and Pennsylvania.

According to plaintiffs’ attorneys, since the Elmiron cases involve the same questions of law and fact, MDL consolidation will facilitate the just and efficient prosecution, enhance judicial economy and serve the convenience of the parties.

New Jersey is a likely forum because it is conveniently located near three major airports and the defendant, Janssen, has business operations in the state. The New Jersey Federal Court and Judge Brian R. Martinotti have dealt with some of the most complicated illegal corporate actions that have arisen in the past decade making it a logical fit for the Elmiron litigation according to briefs filed by Plaintiffs’ counsel. Plaintiffs argue New Jersey is the best forum because it is conveniently located near three major airports and the defendant, Janssen, has business operations in the state.

The plaintiff brief states “Judge Martinotti will be an excellent jurist to manage the litigation given his experience in mass tort litigation during his time on both the federal and state benches.” Judge Martinotti was nominated and confirmed to the state court bench in 2002.

Background on Elmiron

Elmiron is commonly prescribed for the treatment of interstitial cystitis (IC), also referred to as painful bladder syndrome (PBS). Elmiron, also known as pentosan polysulfate sodium, or PPS, is taken orally and was first approved by the U.S. Food and Drug Administration (FDA) in 1996. The drug was thought to ease bladder pain and discomfort by providing an extra coating of protection to the inner bladder walls, helping to mitigate painful irritation from urine in the patient’s bladder. Although men can develop interstitial cystitis, more than 90% of patients are female.

Painful Bladder Syndrome or Interstitial Cystitis (ICC)

Interstitial cystisis is a rare chronic bladder issue causing extreme pain and pressure in the bladder area. Along with pain are other lower urinary tract symptoms which can last for more than 6 weeks without signs of infection or other clear cause. Symptoms range from mild to severe and are sporadic for some patients. While IC is not a bladder infection, it may feel like one.

Long-term use of Elmiron has been linked to a rare but very serious eye condition called pigmentary maculopathy which is a type of macular degeneration of the eye. The condition was first discovered in early 2018 by a group of Ophthalmologists during a research study conducted by the Emory Eye Center in Atlanta. The disease was identified for the first time in 6 female patients whose only common trait was they were all taking Elmiron for interstitial cystitis.

When the scientists at Emory took a closer look at the manufacturer’s own studies during the development process, they found some disturbing evidence. The Emory scientists looked back at all the early clinical trials of Elmiron performed by Janssen, the original manufacturer. They found in Janssen’s own clinical trial of 2,500 patients who took Elmiron for up to four years, both vision and eye-related adverse events were reported. Clinical trials revealed optic neuritis and retinal hemorrhage. Not only do these risks not appear on Elmiron’s warning label, but Janssen performed no further tests or research to explore the connection.

Symptoms of Pigmentary Maculopathy

Pigmentary maculopathy is a gradual, progressive degenerative condition that first causes the loss of central vision or blind spots and can worsen into total blindness. Within the eye, Pigmentary maculopathy causes the pigmented cells underneath the retina to break down releasing pigment that winds up settling on the macula. The build-up of pigment causes vision distortion and/or blurriness, difficulty adjusting to light and darkness and loss of vision. Other common injuries include:

  • Dark spots
  • Eye pain
  • Distorted vision (metamorphopsia)
  • Sensation of flashing lights
  • Hallucinations
  • Blurred vision
  • Loss of color
  • Difficulty adjusting after exposure to bright light
  • Complete blindness

Case Development Support for Elmiron

If your firm is considering joining the fight to help victims of Elmiron, Case Works can help get your cases proven up and ready to file. The Elmiron Team at Case Works is expertly trained to evaluate medical records and work with clients to maximize the value of their claim.

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