Craig Rosenbaum | January 15, 2021 | Mass Torts
Have you or a family member experienced vision problems or problems with your eyes after taking Elmiron? Have you or a family member been diagnosed with Maculopathy after taking Elmiron?
Many people in New York and across the nation utilize Elmiron and have for many years, and have experienced the devastating outcomes, as well. Hundreds of thousands of people may have taken the drug and may have been exposed to the risk of potentially permanent vision damage. You are not alone, and we are here to help.
You may have the right to file a mass tort injury lawsuit and recover compensation for you or your family members medical bills, lost wages, pain and suffering.
The experienced NYC Elmiron injury lawyers at Rosenbaum & Rosenbaum, P.C. can help you fight to maximize your financial recovery. Give our New York City law office a call to discuss your legal options today. There’s absolutely no charge for your initial case evaluation.
Elmiron: What is it?
Elmiron is a drug manufactured by Janssen Pharmaceuticals, prescribed to treat Interstitial Cystitis, which is a disorder in the urinary tract system that causes abdominal and pelvic pain. The pain can be chronic or intermittent and the condition can often lead to frequent urination. Interstitial Cystitis is also sometimes referred to as Bladder Pain Syndrome. The condition afflicts millions of women in the United States and a much smaller number of men.
Elmiron works by attaching itself to the wall of the bladder and providing a buffer between irritating substances and the bladder. The drug has been on the market since the late 1990s, and it is the only drug FDA approved to treat pain associated with Interstitial Cystitis.
Elmiron: Possible Side Effects and Irreversible Injuries
Recent studies have found that patients who have been prescribed and use Elmiron have developed Maculopathy, an eye disorder that can lead to blindness. Medical experts are now recommending that patients that use the drug Elmiron have an ophthalmic examination for early detection of maculopathy.
The manufacturer of Elmiron has failed to fully test the drug prior to its release and warn patients of the dangers of using the drug.
Specifically, Elmiron is associated with pigmentary maculopathy. The macula is the portion of the eye that is highly sensitive and important for accurate vision. Maculopathy is more commonly known as macular degeneration. This condition is associated with the gradual loss of central vision, which has been found to be a result of taking Elmiron.
Early symptoms of Maculopathy include:
- Blurred vision
- Having difficulty reading
- Difficulty of eyes adjusting to darkness
- Difficulty of seeing close objects
- Vision becomes dim
- Spot of vision lost in the field of vision
- Metamorphosia (visual defect that causes linear objects to appear curved or rounded)
Patients who develop vision problems and retinal damage caused by Elmiron may experience different symptoms, depending on the dose that they were prescribed and the time that they were treated with the drug.
Injuries linked to the prolonged use of Elmiron include:
- Total vision loss
- Partial vision loss
- Blurred vision
- Reduced night vision
- Pigmentary maculopathy
- Degenerative maculopathy
- Halo vision
- Macular retinopathy
- Macular/pattern dystrophy
- Retinal pigment epithelium atrophy
- Unilateral or bilateral blindness
- Vision impairment
For many years, Janssen Pharmaceuticals made no mention in their prescribing information and warning labels about the risks of vision problems or Maculopathy, even though studies have been continuously preformed since 2018 documenting irreversible vision problems associated with the long-term use of Elmiron.
In addition, over 100 adverse event reports for eye-related injuries (including maculopathy) were filed with the FDA by the manufacturer from 1997 to 2019, with most of the safety reports being categorized as “serious.”
In June 2020, Janssen Pharmaceuticals updated their prescribing information in the United States to include “Pigment changes in the retina of the eye (also referred to as pigmentary maculopathy in medical journal articles) have been reported with long-term use of Elmiron. While the cause of the pigmentary changes is unclear, continued long-term dosing with ELMIRON® may be a risk factor…”
Despite having had over 100 reports of vision problems over a 20-year period, Janssen Pharmaceuticals did not warn doctors who prescribed the drug or the patients who took Elmiron about the possible risk of vision impairment. Responsible drug manufacturers usually add warnings to their package insert once the receive far fewer reports of serious injury.
They have a responsibility to make this information available so patients and their doctors can decide whether to use Elmiron based on the best information available. Despite complaints of these adverse events, Janssen Pharmaceuticals decided to withhold the information about the connection between Elmiron and Maculopathy. To date, Janssen Pharmaceuticals has yet to fully associate the serious side effects individuals are experiencing with the prolonged use of Elmiron.
Case Study Suggests Maculopathy Can Develop Years After Stopping Elmiron
According to doctors from the Emory University School of Medicine in Atlanta, Georgia, a 44-year-old female was evaluated three years after she had stopped taking Elmiron complaining of vision problems. Upon examination, the doctors found that she had characteristics of “pentosan polysulfate maculopathy,” or Elmiron-induced maculopathy.
The woman showed no signs of this condition for the two year before this, indicating that it developed well after she stopped taking Elmiron. The instance suggested that new-onset maculopathy may develop years after an individual stops taking the dangerous drug.
This study suggests that if your symptoms arise even years after you have stopped taking Elmiron, you may still have a case. Rosenbaum & Rosenbaum, P.C. will discuss your case and legal options with you.
Do I have an Elmiron Injury Lawsuit?
The only way to know if you have a legitimate legal claim against Janssen Pharmaceuticals is by discussing the details of your case with an experienced mass tort injury lawyer in New York City. You may want to really consider scheduling a free consultation with Rosenbaum & Rosenbaum, P.C. if:
- You or a family member used Elmiron and are experiencing vision problems; or
- You or a family member used Elmiron and are experiencing early symptoms of Maculopathy; or
- You or a family member used Elmiron and have been diagnosed with Maculopathy.
The fact that you know that you or your family member have suffered a serious injury and/or death as a result of a dangerous drug can be traumatic to the individual and the family. Using such a dangerous drug could lead to significant issues down the line as a result of your injuries, leaving you responsible for medical bills, pain and suffering, lost wages, which could severely impact you financially.
There’s no risk in discussing your case and learning about your legal options. Your first case evaluation with our NYC personal injury attorneys is 100% free.
How much is my Elmiron case worth?
Every case is different. The value of each individual case will ultimately depend on several factors, including:
- You or your family member’s present and future medical expenses
- The severity of injury/ultimate fatality
- You or your family member’s prognosis and what the road to recovery looks like
- The emotional and psychological impact your injury and/or fatality has had on you or your family
Generally speaking, plaintiffs in Elmiron injury lawsuits will be entitled to recover both economic (financial) and non-economic (intangible) damages. This can include the cost of medical care, lost income and wages, emotional distress, mental anguish, and pain and suffering.
Rosenbaum & Rosenbaum, P.C. can help you navigate this difficult time. Give our law office a call to discuss your rights today.
Pharmaceutical Companies, Dangerous Drugs, and New York Product Liability Laws
Even though drugs like Elmiron have to undergo extensive testing to get the FDA’s seal of approval, dangerous medications can still find their way into the healthcare market and into the patients’ hands. Unfortunately, the agency can’t be expected to keep tabs on everything and ensure that all products are safe – especially after they’ve been approved and released onto the market.
In order to compensate for this, states like New York have passed product liability laws to ensure that companies have an incentive to make sure that the products they sell are safe.
Under New York states’ product liability laws, pharmaceutical companies can be strictly liable if the drugs they design, manufacture, or market are dangerous and cause harm.
Strict liability means that injured Elmiron users don’t have to prove negligence. Financial and legal responsibility attaches, regardless of how much care the company used in creating or selling the drug.
Keep in mind that New York limits the amount of time a plaintiff can file a product liability lawsuit against a pharmaceutical company. Typically, the statute of limitations is three years from the date of injury (or discovering that injury).
Schedule a Free Consultation to discuss your Elmiron Injury Lawsuit
Were you or a family member prescribed Elmiron to treat interstitial cystitis or painful bladder syndrome and developed poor eyesight, vision loss, or even blindness? If so, you may have the right to file a lawsuit against Janssen Pharmaceuticals, the company that manufactures the dangerous drug.
The NYC mass tort injury lawyers at Rosenbaum & Rosenbaum, P.C. can help you navigate the process and work to maximize your financial recovery.