Elmiron Injury Lawyer
Millions of people, primarily women, have taken Elmiron to treat a chronic bladder condition called Interstitial Cystitis. A pharmaceutical drug named Elmiron was prescribed to millions to relieve this condition.
Unfortunately, Elmiron users have experienced unexpected complications, including maculopathy, which can result in permanent vision loss. Several studies show that the maculopathy caused by Elmiron is unique.
Our law firm is actively pursuing lawsuits against the producer of Elmiron for these injuries because Elmiron’s manufacturers failed to warn doctors and the public of these severe risks.
When You Should Contact Us: You may have a legal claim if you developed vision complications after taking Elmiron for an extended period to treat bladder pain and inflammation or interstitial cystitis. Our lawyers can hear your story and advise you of your legal options. Please call (903) 597-6000 to discuss your case. Please remember there are strict legal deadlines to file a claim.
Important Update: Elmiron’s warning label now warns of the potential for permanent vision/retina conditions. In June 2020, Janssen Pharmaceuticals updated Elmiron’s label to warn of potential damage to the retina and irreversible vision loss. According to the revised label, most damage and vision loss has occurred in patients who have taken Elmiron for at least three years. However, cases involving patients who took Elmiron for a shorter time were also reported.
What is Elmiron?
Elmiron (pentosan polysulfate sodium) is a prescription drug that has been at the forefront of treating the pain and discomfort of Interstitial Cystitis. Elmiron is manufactured by Janssen, a subsidiary of Teva Pharmaceuticals and Johnson & Johnson.
According to the Centers for Disease Control and Prevention, nterstitial Cystitis, also known as painful bladder syndrome, affects 1 to 5.1 people out of every 100,000.
In recent years, Elmiron has been the subject of several studies showing it can cause a specific form of maculopathy. Maculopathy affects the macula, which is on the backside of the retina, meaning this condition can cause significant vision loss. Unfortunately, there is evidence that Elmiron’s manufacturers failed to inform the public and doctors of these risks.
Symptoms of Maculopathy
Some of the common symptoms of the form of maculopathy caused by Elmiron include:
- Changes in the color of the retina
- Straight lines appear curved or squiggly
- Dark spots in vision
- Trouble reading
- Colors become less vivid
- Difficulty adjusting to a dimmer light
- Blurred vision
- Problem seeing nearby objects
Other secondary side effects of using Elmiron include:
- Hair loss
- Blood in the stool
- Upset stomach
- Weight gain
- Abnormal liver functions
Several studies show that the maculopathy that results from Elmiron use is unique. Halting the use of Elmiron can stop the damage if you detect the condition in its early stages.
If the condition is allowed to progress, it can result in severe vision impairment, including blindness. Please do not stop the use of any medications without consulting your physician.
Research Studies Confirm Elmiron’s Risk
Numerous studies have confirmed the risk of severe vision loss from using Elmiron. Of interest are some of the following notable studies:
Emory Center Research (2018)
In 2018, researchers from Emory Eye Center at Emory University sent a letter to the editor of the Journal of Urology voicing concern regarding a specific eye disease in some patients. All of the patients had Interstitial Cystitis and were taking Elmiron.
A key finding in their research is that the specific form of pigmented maculopathy that shows up in Elmiron users did not present among patients who had not taken the drug.
Dr. Huckfeldt’s Case Study (2019)
Dr. Rachel Huckfeldt, MD Ph.D., a physician at Harvard Medical School’s Department of Ophthalmology, published a significant case study showing that damage from Elmiron can continue to occur years after the patient stops using the drug.
The patient had used a low dosage of Elmiron for 18 years. At age 62, she presented to the clinic with blurry vision in her left eye and difficulty with nighttime sight. Six years later, the patient returned with deteriorating vision in both eyes. The same happened again two years later. At the time, the clinic could not determine the condition’s cause.
After research became public about the risks of Elmiron, the patient confirmed that she had stopped using Elmiron at the age of 63. This prompted a warning from Dr. Huckfeldt to other researchers about how the progression of the disease can continue even years after the patient stops using Elmiron.
Kaiser Permanente Research (2020)
In 2020, researchers reviewed the electronic health records of more than 4 million Kaiser Permanente patients in Northern California. The study identified 140 patients who took over 5,000 Elmiron pills on average over at least 15 years. Of these patients, 91 agreed to be a part of the study.
In the study, published in the journal Ophthalmology, the researchers found that about 25% of those taking Elmiron for five years or longer had developed significant damage to the retina.
Specifically, of the 91 patients, signs of toxicity were present in 22. The degree of toxicity varied based on the amount of Elmiron each patient had taken. For patients who were taking 500 to 1,000 grams, the toxicity levels were at 11 percent. This number rose to 42 percent among users who consumed 1,500 grams and above.
Elmiron’s Warning Label Now Includes Warning
Despite ongoing scrutiny, Elmiron is still available to prescribe to patients. The U.S. Food and Drug Administration has not declared it unfit for use.
Instead, the FDA required Janssen to update Elmiron’s warning label in the summer of 2020. The warning label now advises physicians and patients that the use of the drug may cause severe vision and retinal issues.
Should Elmiron’s Manufacturers Have Warned Patients Sooner?
Americans often understand that taking a pharmaceutical drug comes with risks and side effects. Where we draw a line, however, is when drug manufacturers obscure a known or suspected risk.
That is, unfortunately, too often the case. Our law firm has seen first-hand how drug manufacturers cave to market and regulatory pressures, causing them to hide or minimize serious risks.
This often happens when a drug company wants to be the first to the market for a particular treatment, so the company fails to investigate, let alone disclose a suspected issue.
Among the side effects that Janssen Pharmaceuticals listed for Elmiron, maculopathy was not present for over two decades. It took years of concerns for Janssen to finally add a warning to the drug’s label in June 2020.
The Lawsuits Against Janssen Pharmaceuticals
Lawsuits have been filed across the country by patients who developed vision complications after long-term use of Elmiron.
A federal panel has consolidated most of the Elmiron injury lawsuits into one court (known as a Multidistrict Litigation, or “MDL”). Two judges in The District of New Jersey oversee these cases.
As of May 11, 2022, 933 cases alleging claims relating to using Elmiron have been filed (823 cases in federal court and 110 in state courts).
The court has designated three of these cases as “bellwether” cases, meaning attorneys will try these cases in front of juries to see how real juries feel about the case.
Can I File an Elmiron Lawsuit?
If you were prescribed Elmiron, took it for at least two years, and developed maculopathy symptoms, you are likely eligible for an Elimron lawsuit. Even if you stopped taking the drug, your symptoms might not have shown up for years.
What Damages Would I Recover?
An injury caused by Elmiron comes with several damages for which you should be compensated. The primary consideration is the actual cost of past and future medical care associated with your vision complications. Impaired vision also creates many other costs and difficulties in a person’s life.
Overall, your damages might include:
- Past and future treatment costs and other medical expenses
- Lost wages and earning potential
- Pain and suffering
- Past and future physical and mental pain and suffering
- Additional tangible costs associated with your injury
- Punitive damages
Should I Consult with a Doctor?
If you experience vision complications, you should consult with your doctor immediately. Please do not discontinue the use of any medications without consulting with your doctor.
Consult with Our Lawyers Today
At Roberts & Roberts, we pride ourselves on an unparalleled commitment to our clients. For over four decades, we have fought for our clients, earning recognition in publications and media outlets such as CNN, Newsweek, and other national magazines and news programs. The corporations we have taken on include Walmart, Firestone, and Toyota.
For us, it’s not just about the work but seeing our clients prosper. So along with legal counsel and support, our team will help you get the medical support you need. Contact us today for a free consultation with an Elmiron injury lawyer.