In the latest legal blow to Johnson & Johnson, the company has been sued for eye damage caused by Elmiron, its medication to treat bladder pain and discomfort. The medication is alleged to cause retinal injuries and vision loss. The initial lawsuits were filed earlier this year, but observers are now expecting a large number of claims to be filed against Johnson & Johnson. The company is already facing lawsuits for its other product such as talc powder, Risperidone and its opioid painkillers.
“The drug Elmiron, which treats interstitial cystitis, bladder pain and osteoarthritis, is being linked to permanent eyesight damage, including macular degeneration and pigmentary and retinal maculopathy. A number of studies dating to 2018 have revealed risks associated with long-term use of Elmiron. Mass tort law firms are looking for claimants now. Elmiron was developed by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary).” Versus
Elmiron Blindness lawsuit
Vision Loss, Eye Damage & Blindness Claims
If you have taken Elmiron and have experienced any problems with your eyes and vision, you may be entitled to significant financial compensation. You should contact a lawyer immediately to learn more about how you can file your own lawsuit.
What Is Elmiron?
Elmiron is used to treat interstitial cystitis and painful bladder syndrome. There are numerous side effects of this condition. Those who suffer from this suffer from frequent urination, the urge to constantly urinate and pain during sex. There is no cure for this condition, but it may be managed with medication. In addition, Elmiron is also prescribed to treat osteoporosis.
Elmiron is the name brand for a class of drugs called Pentosan polysulfate. The medication is intended to strengthen the bladder wall by providing a coating. This is supposed to reduce the urge to urinate. The medication is similar to a blood thinner. In fact, it is billed as a heparin-like substance, However, the exact way that the drug works is not known.
Patients do not take Elmiron for a short period of time. In fact, it takes months for the drug to begin working at all. The drug is intended to be a long-term medication that patients take for years. Patients will be on the drug for a minimum of six months. The drug was developed by Teva Pharmaceuticals. Teva then licensed the product to Janssen Pharmaceuticals, which is a subsidiary of Johnson & Johnson. This is why all three of these parties appear on the Elmiron lawsuits.
Elmiron has been on the market since it was approved by the FDA in 1996. European regulators only recently approved it. There have been concerns raised about the benefits of the drug versus the steep cost. In Europe, cost matters when it comes to approving the drug for use. The U.K. distributor was forced to make price concessions before it was approved for use in the U.K.In the U.S., the drug does between $150-$250 million in sales annually. Given the expensive cost of the drug, this means that roughly one million people in the U.S. take the medication.
Are There Any Warnings on the Drug’s Label?
Elmiron was originally sold to the public with no warnings on its label. A drug company is under the obligation to update its warning label when it learns of any type of side effects that can cause a danger to patients. Johnson & Johnson updated the warning label on the drug several times. However, at no time did the company warn patients specifically about any danger to their eyesight.
Issues Begin to Be Discovered By Researchers in 2018
The first issues with Elmiron began to be noted by researchers at the end of 2018. A research paper noted that long-term users of the drug experienced atypical maculopathy at a higher rate than usual. This makes sense because the retina may be one of the first areas of the body to suffer when a patient is exposed to medicine toxicity. This occurs in other drugs that are known to be possibly toxic such as malaria drugs.
The researchers did a follow-up study the next year. They looked at 219 patients who took Elmiron for the long term. Their results supported their initial conclusion that there may be a connection with Elmiron and vision loss.
Researchers studied 140 people who have been known to have taken over 5,000 pills of Elmiron. They were able to examine 91 people. Of this group, 22 exhibited symptoms of vision loss. This is an alarming ratio that shows that nearly one-quarter of the sample group who were long-term users suffered damage to their eye.
After the initial studies, multiple researchers launched their own studies and reached the same conclusions. However, even after the study results were released to the public, Johnson & Johnson made no changes to the warning label. One lawsuit notes that the company made changes to warning labels in foreign countries to warn patients of the exact same side effects of which they failed to warn U.S. patients.
Plaintiffs File Elmiron Lawsuits
After the initial research findings were published, plaintiffs began to step forward with their claims of vision loss and damage to their eyes. One particular plaintiff filed a lawsuit in Connecticut in March 2020. She claimed that she took Elmiron for nearly 15 years. Believing the drug to be without major side effects, her doctors progressively prescribed more to her and increased her dosage. However, in 2019, she was examined and found to have suffered significant vision loss.
This plaintiff is one of many that are now filing lawsuits. Many are alleging the following grounds of product liability in their lawsuits:
- Johnson & Johnson should be strictly liable for the damage caused by Elmiron because there was a design defect and a manufacturing defect.
- The defendants were negligent in their design and manufacture of the product since they failed to exercise the due care that a drugmaker owes the patients who take the medication.
- The company knew of the fact that Elmiron can cause vision loss yet took no steps to either make the product safer or warn the public.
- The defendants marketed Elmiron as safe when they knew that there were dangerous side effects.
Each Elmiron lawsuit that has been filed has variations of the same allegations.
Where the Elmiron Lawsuits Stand Today
The lawsuits have just recently been filed in different federal courts. Since the lawsuits are just in their infancy, discovery and motions have not yet happened. In many cases, the defendants have just filed their answers to the allegations.
Plaintiffs are just beginning to come forward as the initial lawsuits have been filed. It is possible that the Elmiron lawsuits will be rolled into a multi-district lawsuit so all cases can proceed with common discovery. Right now, cases are still being filed across the country.
What Should I Do if I Have Taken Elmiron?
The first thing that you should do is to see a doctor to have your vision checked. You may be taking risks with the statute of limitations if you wait to have your vision examined. Make sure that you get extensive documentation from the eye doctor of any condition that you have along with their medical opinion of what caused it. You should continue to get annual checkups so you can track your vision.
Even before you go see an eye doctor, you should consult with a product liability lawyer. The attorney will tell you what documentation you need and will help you assemble what you need in order to file your lawsuit. Then, the attorney will draft your complaint and represent you as you seek to hold Johnson & Johnson and Teva responsible for any damage to your eyes.
You may be entitled to substantial financial compensation for your Elmiron-induced vision loss if you act now.