The thought of filing a lawsuit against a powerful pharmaceutical company can be daunting. These types of legal matters are challenging and complex. However, if you have suffered harm due to taking prescribed medication, it is your right to seek monetary damages. It is also necessary to hold accountable the drug makers who are profiting from dangerous medicines. An experienced legal expert can assist you with an Elmiron lawsuit if you have been diagnosed with a retinal condition after taking the medication.
In this article:
- What is Elmiron?
- FDA Response
- Elmiron Side Effects Spark Lawsuits
- Reasons to File an Elmiron Lawsuit if You Were Diagnosed with a Retinal Condition After Using the Drug
- Monetary Damages in an Elmiron Lawsuit
- What is the Eye Damage Associated with Elmiron?
- Symptoms of the Retinal Disease Associated with Elmiron
- Elmiron Usage
- What To Do If You Are an Elmiron User
- When Did Drug Makers Know of the Danger?
- When Did the Drug Maker Warn Consumers?
- Injured by Elmiron? Talk With an Experienced Lawyer
Elmiron is the only drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of interstitial cystitis (IC). It was approved as a primary treatment for the painful bladder condition in 1996. It has also been approved for use as an osteoarthritis medication, but far more Elmiron prescriptions are written for IC. There is no generic alternative to Elmiron, but there may be other medication types that can provide similar benefits, so consult with your physician to ask about Elmiron alternatives. The sole manufacturer of Elmiron is Janssen Pharmaceuticals, a company that records over $150 million in sales per year.FDA Response
Despite evidence of significant Elmiron side effects, to date, no recalls of the medication have been issued.Elmiron Side Effects Spark Lawsuits
There are no generic formulations of Elmiron. The sole manufacturing defendant in an Elmiron Lawsuit will be Janssen Pharmaceuticals. Plaintiffs (the injured patients) allege that Janssen failed to properly warn of the potential for dangerous Elmiron side effects - specifically ocular toxicity that can lead to vision problems, retinopathy, and permanent vision loss.
There are time limits to file a claim against Elmiron, and the time limit partially depends on when it was discovered that your eye condition was related to Elmiron usage. Many instances of Elmiron-associated eye disease surfaced relatively soon after the use of the drug, but some were diagnosed years after the patient stopped taking Elmiron. That is why medical history, an ophthalmological examination, and a corrected diagnosis are important in such situations.Reasons to File an Elmiron Lawsuit if You Were Diagnosed with a Retinal Condition After Using the Drug
- Monetary compensation for damages due to the physical condition or disease caused by the use of Elmiron.
- Monetary recovery for pain and suffering that the eye condition caused. If applicable, this could include compensation for your spouse for the damage caused to your marital relationship.
- Manufacturers of dangerous drugs need to be responsible for the damage caused by their products.
- Protect future patients: lawsuits against hazardous drug makers result in more comprehensive testing procedures. This helps ensure that future patients are not harmed by their products. In addition to holding profitable pharmaceutical corporations accountable, these lawsuits have resulted in new laws being passed to protect consumers.
Monetary compensation from an Elmiron lawsuit will depend on many factors, one of which is the severity of the disease linked to the medication’s use.
Some relevant questions to ask concerning an Elmiron lawsuit:
- What is the severity of the eye disease or condition(s) that resulted from the use of Elmiron?
- How do the eye disease and its symptoms affect the patient’s quality of life?
- Did the patient suffer any job loss or loss of earning capacity in the future due to the symptoms from the eye disease caused by Elmiron use?
The main type of maculopathy linked to Elmiron is called pigmentary maculopathy. According to studies, this particular type of pigmentary maculopathy is unique to Elmiron users.
The eye damage may not progress if the condition is caught at an early stage, and the patient stops taking Elmiron. Late stages of the disease can lead to vision loss. There has been at least one patient identified by researchers whose eye damage progressed for years after stopping the medication.Symptoms of the Retinal Disease Associated with Elmiron
A couple of the most common complaints associated with the retinal condition caused by Elmiron are difficulty adapting to dim lighting and difficulty reading. Other symptoms include:
- Dull or Less Vivid Colors
- Blurred vision
- Curving of Straight Lines
- Black or Dark Areas in the Center of Visual Field
Interstitial cystitis is a chronic condition that causes bladder pain and pressure. It is in a spectrum of conditions called painful bladder syndrome. The condition is much more prevalent in women. Accordingly, approximately 75% of Elmiron users are women.
The drug’s mechanism of action for the treatment of IC is unknown. It works by creating an extra coating of protection in bladder walls, which has the effect of mitigating the pain associated with IC.
IC patients that use Elmiron take the drug multiple times per day. The eye damage appears to be dose-dependent and cumulative, and many Elmiron users take very frequent high doses of the medication.What To Do If You Are an Elmiron User
If you are an Elmiron user and are concerned about the risk of eye damage, speak with your prescribing physician. Symptoms of the eye conditions caused by Elmiron usually appear after 3-4 years of usage but have appeared earlier. If you have noticed any eye symptoms, you should be examined by an ophthalmologist. Even if you have no symptoms, an ophthalmologic exam can provide a baseline image of your retinal health to use for comparison in the future.
If you have been diagnosed with age-related macular degeneration and have a history of taking Elmiron, you must speak with your ophthalmologist as the condition may actually be related to the medication. If that is the case, your diagnosis needs to be updated and documented as being associated with the use of Elmiron.When Did Drug Makers Know of the Danger?
During clinical trials of the drug more than 20 years ago, users reported adverse eye-related symptoms. More recently, studies beginning in 2018 revealed a link between Elmiron and an eye condition known as pigmentary maculopathy.
- May 2018: a study of six patients at Emory Eye Center found chronic exposure to Elmiron for IC caused a unique form of pigmentary maculopathy.
- April 2019: An expanded study of 10 patients at Emory Eye Center revealed that IC patients who did not take Elmiron did not have the pigmentary maculopathy that was present in patients who did use the drug. The Emory Eye Center recommended patients with signs of the condition stop taking the medication and that all users of the drug have retinal imaging done by an ophthalmologist.
- October 2019: Kaiser Permanente examined 91 patients who had taken Elmiron for 15 years. Out of the 91 patients, 22 patients exhibited signs of toxicity, which was progressive - meaning the toxicity was more significant in patients who had taken more of the drug.
- November 2019: A Cohort study was published of 2002-2016 data from a medical claims database. It found that after 7 years, users of Elmiron had a significantly increased risk of macular disease.
- November 2019: A case report was published of a patient with Elmiron associated maculopathy. The condition worsened even after the patient had discontinued the medication six prior.
In June 2020 Johnson & Johnson finally issued its first warning label for Elmiron to inform all users of the risk of retinal pigmentary changes. This decision by the company to warn consumers came months after the October 2019 requirement of a similar warning by Canadian authorities and approximately one year after the European Medicine Agency demand a warning label.Injured by Elmiron? Talk With An Experienced Lawyer
To successfully pursue a personal injury claim against a pharmaceutical manufacturer, there must be evidence to establish negligence. Plaintiffs in lawsuits against Elmiron allege that Jenssen failed to warn consumers of the risks associated with the use of the drug.
Please call our office for a no-cost case evaluation for an Elmiron lawsuit if you have used the drug for at least one year and have been diagnosed with any of the following conditions:
- Pigmentation Macular Degeneration
- Pigmentation Maculopathy
- Pigmentation Maculitis
- Dry Macular Degeneration
- Retinal Maculopathy
Pharmaceutical corporations enjoy huge profits, and to protect their money, they will pay a lot of money to defend claims made against their products. If you or someone you love has developed an eye disease after use of Elmiron, it is essential that you hire an attorney with experience in litigation against drug manufacturers.
In the following video, Dr. Sophie Bakri, an ophthalmologist with the Mayo Clinic discusses macular degeneration and explains how early diagnosis and treatments can help those with macular disease.Sacramento Drug Products Liability Lawyer
I'm Ed Smith, a Drug Products Liability Attorney in Sacramento. If you or family member has received a diagnosis of retinal eye disease after using the prescription drug Elmiron, reach out to my firm for free and friendly advice. My local phone number is 916.921.6400, and I can also be reached toll-free at 800.404.5400.
I am honored to be a member of the Million Dollar Advocates Forum and the National Association of Distinguished Counsel.
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Editor’s Note: This page has been updated for accuracy and relevancy [cha 1.25.21]
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