Elmiron Vision Loss Lawsuit in California
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You may be eligible for compensation if you or a loved one took Elmiron for urinary pain due to interstitial cystitis and developed maculopathy or serious vision problems. Contact our Elmiron Lawyers if you have 6 months or more of regular brand name Elmiron use.
Elmiron Has Been Linked to a Severe Eye Condition Called Maculopathy
Researchers have determined that long-term use of the urinary drug Elmiron (sodium pentosan polysulfate) may cause degenerative eye disorder, pigment maculopathy, which may lead to vision loss or blindness.
What Is Elmiron Used For?
Elmiron is a prescription medication used for the treatment of bladder pain syndrome, also known as interstitial cystitis. Patients frequently take Elmiron continuously for years or decades. The active ingredient in Elmiron is sodium pentosan polysulfate or PPS.
What Is Wrong With Elmiron?
Recent medical research has connected Elmiron to an eye disease known as maculopathy, which means that the retina is being damaged. This damage to the eye worsens with time, often before symptoms begin.
The Studies
The line of studies identifying Elmiron’s toxicity started between 2015 and 2017 when doctors at the Emory Eye Center in Atlanta found a pattern among six patients with abnormal eye damage in the macula area. They were all diagnosed with pigment maculopathy, a disease that caused significant vision impairment, including blurred vision, extreme sensitivity to light and dark, and difficulty in shifting from natural light to indoors. Blindness may also occur as the disease progresses. Similarly, all six patients were found to be long-term users of Elmiron. As a result, the Emory Eye Center released a preliminary study in 2018 indicating that Elmiron was toxic to the retinal tissue of the human eye, specifically causing damage to the retinal pigment epithelium, a layer of cells that supports the retina.
In April 2019, physicians at the Emory Eye Center released an extended case study of 10 patients who developed pigmentary maculopathy after taking Elmiron for IC. The case report, published in The Journal of Urology, presented details of the Elmiron dose and period for 10 patients. The authors noted that there were 156 other patients treated by Emory who had IC but did not use Elmiron, and none of those patients had any evidence of pigmentary maculopathy. The physicians advised that patients with signs of blurred vision should stop taking Elmiron and those without symptoms should undergo a retinal imaging eye exam.
Similar findings were found in additional studies conducted in October and November 2019. Researchers at Kaiser Permanente observed greater toxicity in patients taking the medication for longer periods of time. A cohort research in the British Journal of Ophthalmology found that users taking the drug for seven years significantly increased their odds for macular disease compared with those taking it for five years.
In addition, a case study by Dr. Rachel M. Huckfeldt and Dr. Demetrios G. Vavvas found that pentosan-associated maculopathy continued to worsen six years after the end of the drug.
These warnings led to a more comprehensive review of the dangers of Elmiron and its eye toxicity by the American Academy of Ophthalmology (AAO). The study, presented in 2019 by Dr. Robin A. Vora, Dr. Amar P. Patel and Dr. Ronald Melles, revealed that Elmiron patients displayed strong signs of toxicity. Approximately 25 percent of patients who used Elmiron for a long time had signs of maculopathy or serious eye damage. The study showed that the toxicity rate was compounded by the volume of the drug ingested:
“It’s unfortunate,” Dr. Vora said in an American Academy of Ophthalmology news release. “You have a patient with a chronic condition like interstitial cystitis, for which there is no cure and no effective treatment. They get put on these medications because it’s thought to have few side effects and few risks, and no one thinks about it again. And year after year, the number of pills they’re taking goes up and up.”
The AAO research team indicated that the toxicity rate increased with the volume of the drug taken, from 11 percent of those taking 500 to 1000 grams to 42 percent of those taking 1500 grams or more. The study also found that the damage could mask other macular degeneration-related diseases. The same doctors published a follow-up study of 117 patients in January 2020 which solidified the findings that there is “strong support to the growing body of evidence that links long-term PPS [or, Elmiron,] use to the potential development of a toxic maculopathy.” AAO studies suggest that, if caught in its early stages, retinal damage can cease after taking medication. Later, after prolonged use of the medication, the disease can lead to permanent vision loss.
Patients who have taken Elmiron for a long period of time may experience pigmentary retinal maculopathy, a type of degenerative visual disorder with symptoms including:
- Trouble reading
- Dark spots in visions
- Muted, less vivid colors
- Straight lines turned curved or squiggly
- A change in the color of the retina itself
- A hard time adjusting to dimmer lighting
- Blurred vision, including in the center of the field of view
What Are Medical Experts Recommending?
Current medical experts recommend that all patients undergo ophthalmic examinations for early detection of pigmentary maculopathy, especially those with long-term use of Elmiron.
Can I Bring an Elmiron Lawsuit for My Eye Damage?
Yes.
Please contact our Elmiron Lawyers for a free review of your case. We’d like to hear from you and understand your experience. Regardless of whether you are experiencing vision issues, you might have a case because you have never been warned about the severe risks of Elmiron.
The Litigation
Beginning in May 2020, product liability lawsuits claiming failure to alert have been filed against Janssen. So far the plaintiffs are mostly women between the ages of 37 to 79. The complaints allege that Elmiron was “developed, promoted and sold […] while recognizing substantial risks that have never been reported to the medical and healthcare community.”
The claims state that Janssen “withheld material adverse events” and “failed to identify a serious connection between the use of Elmiron and serious visual damage, including pigment maculopathy.”
According to the claims, Janssen did not fully understand the detrimental effects that the medication would have on patients. When introduced to market, they did not have a good understanding of why Elmiron relieves the symptoms of IC, assuming that it coats the bladder, thereby offering protection against irritants.
Janssen admits that only a fraction of the substance is dissolved in the bladder, with the remainder absorbed elsewhere, including epithelial cells that cover the retina.
Injuries in lawsuits include:
- Scotoma
- Vision Loss
- Halo Vision
- Retinopathy
- Blurred Vision
- Metamorphopsia
- Vision Impairment
- Macular Retinopathy
- Reduced Night Vision
- Pigmentary Maculopathy
- Degenerative Maculopathy
- Macular/Pattern Dystrophy
- Unilateral or Bilateral Blindness
- Retinal Pigment Epithelium Atrophy
Do I Have to Pay to Bring a Case?
No.
The law firm of Potter Handy, LLP has been representing individuals in products liability lawsuits for over 20 years. We don’t charge our clients anything for a case evaluation and if we can’t recover anything for our clients, we never charge them a fee.
Pursue Legal Action for Your Suffering
People that have taken Elmiron for at least 6 months for urinary or pelvic pain associated with interstitial cystitis might be eligible for compensation for potential visual disorders, vision loss or blindness and should seek legal advice.
Our qualified and experienced Elmiron Lawyers are ready to offer a free case evaluation to determine if you are entitled to benefits.
- No Fees Charged, Until We Win Your Case
- We Investigate Your Case for Free
Call (415) 534-1911 or email us to schedule a free, confidential consultation.