PHARMACEUTICAL LIABILITY

Elmiron Lawsuit

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A study from the American Academy of Ophthalmology proffers more evidence that Elmiron, a drug used for decades to treat an incurable bladder condition called interstitial cystitis, is linked to significant eye damage, including partial and permanent vision loss. In January 2022, more than 600 Elmiron lawsuits had been filed and consolidated in a New Jersey federal district court, and the number of cases continues to rise.

Federal and state legal actions continue to mount against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, the makers of Elmiron. The widely prescribed drug is the only FDA-approved oral drug for interstitial cystitis in the United States.

More than a million people in the United States, predominantly women, suffer from this painful condition. Potentially hundreds of thousands of people have been exposed to Elmiron.

What is Elmiron?

Janssen Pharmaceuticals (Janssen) makes Elmiron for the treatment of interstitial cystitis (IC), a chronic bladder disease that causes bladder pressure, bladder and pelvic pain, and other urinary symptoms. Pain levels for people with IC range from mild to severe.

Janssen is a subsidiary of Johnson & Johnson (J&J), a company with a $424 billion market capitalization.

The chemical name for Elmiron is pentosan polysulfate sodium (PPS), a semi-synthetically produced derivative. There is no generic alternative available for Janssen’s Elmiron.

Studies and Data

The body of scientific research linking Elmiron to eye damage in patients using the drug for a period of time is substantial. 

Studies Raised Serious Concerns Over Elmiron Side Effects

After the American Academy of Ophthalmology’s 2018 study, which concluded that Elmiron might be toxic to retinal health, the researchers of a separate study published in the Journal of Urology in 2019 wrote, “we encourage affected patients to discontinue use [of PPS].”

The 2019 study focused on ten patients who, on average, had used Elmiron for 15 years and reported difficulty with reading and adapting to dim lighting. Retinal imaging showed abnormal pigmentary lesions, primarily in the retinal pigment epithelium. The researchers also noted that “156 patients with a history of IC/BPS but without PPS exposure have undergone ophthalmic exams at our institution during the study period. On retrospective review of these medical records, none of them were diagnosed with this unique form of pigmentary maculopathy.”

The British Medical Journal of Ophthalmology published a study in 2019 that used data from a large U.S. medical claims database. The researchers in this study determined that “PPS exposure was associated with a new diagnosis of macular disease at the 7-year follow-up in a large national cohort.”

In October 2019, a group of ophthalmologists at Kaiser Permanente identified 140 patients who had each consumed an average of 5,000 Elmiron pills over 15 years. Of the 91 patients who agreed to an eye examination by the doctors. Roughly 24% showed signs of drug toxicity.

And toxicity had developed in 42% of patients who took 1,500 grams of the drug or more. This Kaiser study was presented at the 2019 Annual Meeting of the American Academy of Ophthalmology.

Elmiron Litigation Status

On December 15, 2020, all federal Elmiron lawsuits were consolidated into a multidistrict litigation (MDL) overseen by Judge Brian Martinotti in the District Court of New Jersey.

As of February 15, 2022, there were 736 actions pending in the Elmiron MDL No. 2973.

The Lanier Law firm’s founder, Mark Lanier, was named by the court to serve on the plaintiffs’ executive committee on January 22, 2021.

Elmiron Bellwether Trials

On October 6, 2021, Judge Martinotti set out the bellwether trial schedule. Bellwether trials are cases that are selected by the parties and the court to be the first to go to trial. The Elmiron bellwether trials’ outcomes and factual findings on Elmiron eye damage and legal issues will provide insight into how other federal and state PPS trials will go.

Key Bellwether Trial Dates include:

  • March 31, 2022 – fact discovery completion for the 20 Bellwether Discovery Cases
  • April 8, 2022 – the three (3) cases to serve as Bellwether Trial Cases
  • September 9, 2022 – expert witness depositions conclude
  • January 2023 – first bellwether trial starts
  • March 2023 – second bellwether trial starts
  • May 2023 – third bellwether trial starts

Injuries Claimed in Elmiron Lawsuits

Plaintiffs in Elmiron lawsuits list various injuries that have affected their vision and eye health, many of which are related to the retina. The retina is the part of the eye that sends signals to the brain from the optic nerve and enables sight.

Pigmentary maculopathy is directly linked to the use of Elmiron. People with this condition develop blurred or reduced central vision. Symptoms include visual distortions, difficulty adapting to low lights, decreased intensity of color brightness, and a defined blurry spot or blind spot in the field of vision.

A study published in the Review of Ophthalmology noted that patients with pigmentary maculopathy were often misdiagnosed as having age-related macular degeneration. The researchers suggested that the condition was, instead, a “preventable, vision-threatening medication toxicity that could masquerade as other known maculopathies.”

They went on to say that “this characteristic maculopathy has, to date, been exclusively diagnosed in patients reporting prior PPS exposure.”

Other injuries described in the Elmiron lawsuits include:

  • Retinopathy
  • Retinal pigment epithelium atrophy
  • Macular retinopathy
  • Macular/pattern dystrophy
  • Scotoma
  • Metamorphopsia
  • Reduced night vision
  • Blurred vision
  • Vision impairment or loss
  • Unilateral or bilateral blindness
  • Halo vision

The Plaintiffs

There are now hundreds of plaintiffs suing for Elmiron side effects that damaged their vision.

Tina Pisco was diagnosed with permanent retinal injury in both eyes after taking Elmiron for six years. Her May 4, 2020, filing asserts that the drug caused her to develop maculopathy. Ms. Pisco says that Johnson & Johnson and Janssen Pharmaceuticals knew but never disclosed the link between Elmiron use and significant visual damage, such as pigmentary maculopathy. Her complaint also says the defendants withheld material adverse events related to the drug.

Plaintiff Valerie Hull has severe visual injuries, including altered pigment eye color, serious vision loss, and pigmentary maculopathy. Ms. Hull took Elmiron from 2001 to 2018. She was “patient zero” in the Emory Elmiron eye damage study.

Beverly Frizzell from New Hampshire filed a $10 million dollar lawsuit against J&J and Janssen. Frizzell’s lawsuit alleges that her injuries from Elmiron were the result of “failure and refusal to conduct proper safety studies, failure to properly assess and publicize safety signals, suppression of information revealing serious risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Elmiron.”

Do I have a case against J&J and Janssen?

If you have used the drug Elmiron and have symptoms of eye damage or have been diagnosed with maculopathy or vision impairment of any kind, you may be eligible to file a lawsuit seeking damages for your injuries caused by PPS.

Our firm has filed Elmiron lawsuits on behalf of patients who have suffered injuries to their vision. We continue to actively investigate evidence that Elmiron is toxic to the retina.

The Lanier Law Firm is recognized as a pioneer in pharmaceutical liability cases, with a track record of substantial verdicts in groundbreaking cases. Contact us today to find out if you are eligible for compensation after developing vision problems caused by Elmiron.

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