Elmiron lawsuits are claims against Janssen Pharmaceuticals. They involve people who developed eye or vision issues after using Elmiron. The lawsuits allege the Elmiron prescribed for interstitial cystitis caused the damage.
Janssen Pharmaceuticals failed to warn the medical community, the FDA, and consumers about the vision issues.
Thousands of people are filing Elmiron lawsuits, seeking financial compensation from Janssen Pharmaceuticals. If you or someone you care about developed permanent vision injuries after using Elmiron for some time, you may have a valid case.
History of Elmiron
Elmiron is a popular prescription drug in the medical community by Janssen Pharmaceuticals. Millions of people use Elmiron daily to treat chronic conditions like interstitial cystitis (IC).
Interstitial cystitis (IC) is a chronic bladder condition that causes symptoms such as:
- Pressure in the pelvis area and bladder
- Dyspareunia or painful intercourse
- Urinary urgency and frequency
- Recurring pain
IC mainly affects older women and interferes with the bladder or urothelium tissue layer.
IC patients often experience continuous mild to severe pain. This pain can be debilitating, affecting the ability to perform routine daily activities. For most people, Elmiron is the most effective, if not the only, solution for interstitial cystitis (IC).
Typically, Elmiron should not affect vision or eyes in any way. However, the research discovered that pro-longed Elmiron use could impair vision and eventual blindness.
Maculopathy refers to diseases that affect the central part of the retina called the macula. Maculopathy is progressive, incurable, and could cause total vision loss.
After the research became public, Janssen faced thousands of lawsuits from long-term Elmiron users. The lawsuits claimed Janssen did not warn them of the severe side effects and irreversible eye injuries.
All Names It Goes by
Elmiron has an active ingredient, pentosan polysulfate sodium, which is highly effective against Interstitial Cystitis (IC).
Most doctors prescribe Elmiron at a dosage of one 100 mg capsule thrice a day to treat IC or osteoarthritis. Patients sometimes take Elmiron continuously for about three to six months to relieve the symptoms.
The generic name of this drug is Pentosan polysulfate sodium (PPS). Elmiron is the brand name for the drug manufactured by Janssen Pharmaceuticals.
The original Elmiron manufacturer was Baker Norton Pharmaceuticals, Inc. The FDA approved Elmiron for IC treatment in 1996 after rejecting two previous approval requests.
Alza Corporation then acquired the rights to market Elmiron in the US in 1997.
Before Elmiron, there were few IC treatments, such as bladder distention procedures and diet modification. The available drugs were painful to use because the application required a catheter. The relief was temporary, so patients underwent the painful procedures several times.
Elmiron was a lifesaver for most IC patients, gaining popularity in the medical community early on. It works by forming a protective layer on the bladder wall, preventing irritation from urine. It also helps to rebuild damaged bladder tissue and has some anti-inflammatory properties.
Pigmentary Maculopathy Study at Emory
According to the report by Niraj Jain, MD, of Emory Eye Center, six patients who used Elmiron experienced unusual macula changes.
The youngest patient received an IC diagnosis when 23 years old and took Elmiron daily to treat the condition. By age 30, the patient had significant visual problems.
Nothing in the diagnostic tests or patients’ medical history explained the unique abnormalities pattern.
In May 2018, the researchers issued a public warning, linking Elmiron to a new type of maculopathy. They named the condition pigmentary maculopathy or Elmiron’s signature injury. It caused pigmented spots on the macula and encouraged excess capillaries to develop, damaging the vision.
The researchers reported that the patients with the new condition experienced the following:
- Difficulty adapting to dim light
- Difficulty reading
- Small hyperpigmentations or spots on the retinas
Concerned about the possible Elmiron toxicity, they continued with further investigations.
Kaiser Pigmentary Maculopathy Research
In April 2019, researchers from the Emory Eye Center published a second case study. The study involved ten patients with IC who were using or had previously used Elmiron.
The researchers discovered that all ten patients had signs of pigmentary maculopathy.
The same year, ophthalmologists at Kaiser Permanente evaluated 140 patients who had used Elmiron for at least five years.
Shockingly, 23% of the patients had symptoms of extensive eye damage. The study suggested that the dosage also affected the extent of the damage. Patients who took a higher dosage, more than 1,500 grams, had a higher risk of toxicity.
Recalls
Despite the concerning medical reports and studies highlighting the risks of Elmiron, there is no official recall so far. Elmiron is still in the market, but Janssen Pharmaceuticals updated the label warning.
In April 2019, the ICN (International Cystitis Network) presented the FDA with a Citizen Petition about Elmiron. The petition requested the FDA to demand that Janssen Pharmaceuticals should update the label to include the risk of eye damage.
In 2019, the European Medicines Agency (EMA) and Health Canada demanded that Janssen update Elmiron’s warning label. The company complied and updated the changes.
In April 2020, the European Union also requested a label warning update highlighting the risks of eye damage, but nothing happened in the US.
Janssen finally updated the label in the US after more evidence surfaced and ICN applied more pressure.
General Physician Sentiment
Pigmentary maculopathy, Elmiron’s signature injury, develops over an extended period. The symptoms are mild initially and may go unnoticed, especially for people with previous vision issues.
According to an article by Professor J Quentin Clemens from the University of Michigan Medical Center, Elmiron relieves IC symptoms but takes time. Most people must take the drug for three to six months before observing notable differences.
Unfortunately, most people experiencing Elmiron side effects have no formal diagnosis. Others get the wrong diagnosis because pigmentary maculopathy is similar to atypical maculopathy.
Elmiron Eye Damage Lawsuit
If you took Elmiron for six months or more, you should seek medical attention if you experience these symptoms:
- Difficulty seeing distant objects or reading
- Blurred vision
- Lack of light sensitivity or dim vision
- Metamorphopsia which is straight lines appearing squiggly or curved
- Challenges seeing close objects
- Dark spots in the center of your field of vision
- Difficulty adjusting to dim light
- Unusual blood vessels near the macula
- Less vivid or muted colors
- Dark areas around the retina or hyperpigmentation
- Yellowish lesions under the macula called vitelliform deposits
- Vision impairment
- Total vision loss
- Macular retinopathy
If your doctor prescribed Elmiron for IC and you developed such symptoms, you should consider filing an Elmiron lawsuit. Talk to experts from Join the Many about your case and discover your legal options.
Brief Elmiron Vision Lawsuit History
The first lawsuit against Janssen Pharmaceuticals for Elmiron was by Teva Branded Pharmaceuticals R&D.
In the lawsuit filed on 26th March 2020, Teva, the pharmaceutical company, claims that Janssen Pharmaceuticals, the manufacturer of Elmiron, failed to adequately warn the medical community or consumers about the risks of eye damage associated with the prescription drug Elmiron. Teva alleges that despite knowledge of potential dangers, Janssen did not withdraw the drug from the market or share data from clinical trials highlighting these risks.
Individual patients also took legal action by filing Elmiron lawsuits against Janssen Pharmaceuticals in 2020. Many of these cases involve patients who experienced vision damage after using Elmiron for six months or more. These individuals claim that Janssen Pharmaceuticals either knew or should have known about the potential for Elmiron to cause vision damage and that the company should have issued sufficient warnings to consumers before more people suffered.
As Elmiron is a widely prescribed drug, the number of lawsuits naturally increased by the end of 2020. The crux of most Elmiron cases revolves around the allegation that Janssen Pharmaceuticals failed to adequately warn about the adverse effects of Elmiron. Notably, the warning label and packaging did not include maculopathy as a potential risk until the update on 16th June 2020. Had this information been available earlier, many patients might have chosen alternative treatments.
It is crucial to note that since doctors were unaware of the potential complications associated with Elmiron, they continued issuing prescriptions. If healthcare professionals had known about the risks, they might have refrained from recommending the drug to their patients.
If you believe you have been adversely affected by Elmiron and are considering legal action, filing an Elmiron lawsuit may be necessary. Consulting with an experienced Elmiron lawyer is essential to navigate the complexities of Elmiron vision loss lawsuits.
Additionally, exploring the potential for Elmiron lawsuit settlements can provide you with options for compensation. If you have been prescribed Elmiron to treat interstitial cystitis, it’s crucial to seek the guidance of a knowledgeable attorney familiar with Elmiron multidistrict litigation.
The New Jersey Elmiron MDL
The US Judicial Panel on Multidistrict Litigation (JPML) consolidated these lawsuits into a multi-district litigation (MDL) in December. Cases from various courts moved to one federal court in New Jersey. The Elmiron MDL (MDL 2973) is under Judge Brian Martinotti.
Unlike class action lawsuits, the cases in MDLs remain independent. The settlement amounts vary depending on the particular case. There are no Elmiron lawsuit trials yet, but the first bellwether trial in the MDL class action will likely begin in January 2023.
Bellwether trials are test trials that guide how settlement valuation will happen in other cases. The second bellwether trial starts in March, and the last in May 2023.
The most probable outcome of the Elmiron MDL is a structured payout. The attorneys categorize individual cases into various tiers depending on the extent of damages.
The lawsuits in a particular tier receive a certain equal settlement amount.
There’s also a pending Elmiron class-action lawsuit filed in May 2020. The lawsuit claims Janssen did not warn the consumers of the risk of vision loss and permanent eye damage.
The Elmiron Class Action Lawsuit also includes other pharmaceutical companies, including:
- Johnson & Johnson, Janssen’s parent company
- Centocor
- Teva
- Ortho-McNeil
- IVAX
- Alza
- Bayer
By June 2022, the federal court had 1,360 lawsuits, and the MDL had 1,740 claims by September.
What are the Damages in the Elmiron Eye Damage Lawsuit?
Like most personal injury claims, Elmiron Lawsuits are seeking Compensation for damages such as:
- Past, current, and future medical expenses related to vision damage or loss
- Pain and suffering
- Emotional distress
- Loss of enjoyment of life caused by the illness, injuries, and loss of vision
- Lost wages and future earning capabilities
- Punitive damages if Janssen is grossly negligent or acted maliciously
You, Too, Deserve Compensation.
Elmiron Lawsuit Settlement Amounts
Did you or your loved one develop vision damage after using Elmiron for an extended period? If so, filing an Elmiron lawsuit can help you get compensation for your pain and suffering, medical expenses, lost wages, or disability.