With so many Americans taking medications for one reason or another, you would think that the process for making and distributing these medicines would be foolproof. Sadly, that’s not always the case. Sometimes drugs with dangerous side effects make it to market, leaving thousands of patients to suffer the consequences.
This was the case with pentosan polysulfate sodium, a drug known by the brand name Elmiron. The drug was released in 1996. Since then, evidence has emerged that long-term exposure to the drug may cause an array of eye diseases.
If you have taken Elmiron and developed certain eye-related illnesses, you may be entitled to compensation.
The team at Ward Black Law can evaluate your case and let you know what your legal options are, including if you may have a claim against the drug’s manufacturer. To learn more, call us today or visit our contact page.
Elmiron was manufactured by a company called Janssen Pharmaceuticals to treat a condition called interstitial cystitis, also known as painful bladder syndrome. Painful bladder syndrome causes an array of distressing symptoms, including having a sudden feeling of needing to urinate, a need to urinate often, and pain during sex.
Because of these symptoms, painful bladder syndrome is often linked to depression and a lower quality of life.
Elmiron has also been used to treat knee and bone pain. It works like an anticoagulant (a blood thinner for people with high blood pressure or similar conditions).
Despite being on the market since 1996, the public remained unaware of the most dangerous side effects of Elmiron until relatively recently.
In 2018, the American Academy of Ophthalmology (the field of medicine that deals with the study and treatment of eye disorders) published an article about treating patients who had been using Elmiron for their interstitial cystitis. The article reported that six patients had developed a rare eye disease called pigmentary maculopathy.
Pigmentary maculopathy is an eye disease that affects the central part of the retina. The disease can progress slowly and can eventually lead to blindness as you lose your central vision, with deterioration of your side vision only coming in the final stages of the illness.
Following the initial 2018 article, in 2019, the American Academy of Ophthalmology published another article saying the number of patients who had taken Elmiron and later developed pigmentary maculopathy had increased to 10. That same article also noted that scientists at Kaiser Permanente reported that 25 percent of patients who had used Elmiron had shown signs of eye damage.
In the fall of 2019, the U.S. Food and Drug Administration (FDA) added eye disorders related to taking Elmiron to its list of Potential Signals of Serious Risk, working with data from the organization’s Adverse Event Reporting System. In response, the FDA is now weighing possible regulatory action.
In 2020, researchers at the Emory Eye Center reported even more cases of finding patients who had retinal injuries after long-term exposure to Elmiron. These new findings, together with the prior reports from the American Academy of Ophthalmology and others, are the basis of a series of class-action lawsuits against Janssen Pharmaceuticals.
Another point of contention in the claims against Janssen is the clinical trials Janssen conducted prior to launching Elmiron. In one trial of nearly 2,500 patients, a number of those involved in the trial reported eye or vision-related issues after taking the drug. Janssen should have known this information, but it was never on any warning labels for Elmiron. This means that the public was unaware of these potentially dangerous side effects.
The most potentially damaging side effect of long-term exposure to Elmiron is pigmentary maculopathy. Maculopathy is any injury to the macula, which is the central part of the retina. Pigmentary maculopathy is when some type of tissue deposit or lesion on the macula begins to affect your central vision. If left untreated, these deposits or lesions can gradually broaden, getting worse until total blindness occurs.
Symptoms of pigmentary maculopathy include any or all of the following:
That’s just the worst of the eye-related side effects of Elmiron. Other side effects may include:
There are also side effects when taking Elmiron that aren’t related to your eyes. These can include diarrhea, hair loss, nausea, headaches, stomach pain, dizziness, depression, and skin rashes.
Trying to win a claim against a pharmaceutical company regarding a defective drug is a complex process. The hardest part is proving that it was the drug that led to your injuries. This is often why personal injury claims regarding potentially defective drugs involve many injured people and attorneys pooling their resources to file claims in the same court, similar to a class-action suit.
We’re committed to holding these companies to account. If your claim is successful, you are potentially eligible for compensation related to many different losses you may have sustained. Potential damages from a successful defective drug claim can include:
If you want to know more about the damages for which you may be eligible, call our office. Each personal injury claim is unique, and our experienced attorneys and staff can tell you more about what compensation you could potentially receive if you wish to file a claim.
First and foremost, taking legal action is a way to personally hold Elmiron’s manufacturers accountable for what they’ve done. While regulatory action may come later, for now, your best chance at seeing justice done to Janssen Pharmaceuticals is through a personal injury claim.
Here’s how we can help if you come to us to handle your claim:
If you think your eyes have been damaged from taking Elmiron, talk to your doctor about switching medications right away. Evidence suggests that vision damage can continue even after you stop taking the drug. Your second step should be to see an ophthalmologist. They’ll be able to tell you what’s happened to your eyes, and their records will be essential to any claim you later file.
You’ll want to note all the changes to your vision and when they occurred to the best of your ability. You’ll also want to make sure you don’t have any family history of eye disease, to rule that out.
Your next step should be to speak with our experienced staff. The sooner you talk to us, the sooner you’ll know what your options are, and the earlier you can begin the process of filing your claim.
In North Carolina, you generally have three years from your date of injury to file a personal injury claim. This usually includes claims related to defective drugs. Three years may sound like a long time, but it is important to get started as soon as possible. To make sure you have a chance to recover some compensation, speak with an attorney right away.
If your loved one has died in North Carolina as a result of Elmiron or other product, you generally have two years to file a claim.
At Ward Black Law, we’re committed to helping everyday people stand up to powerful institutions like big pharmaceutical companies. These corporations have massive resources to spend on some of the best legal teams around. To prove your claim, you need a team that’s smart, dedicated, and tenacious.
That’s what you get with us, which is why one of our attorneys was recently named “Lawyer of the Year” for personal injury claims in the Triad region of North Carolina by U.S. News & World Report. If we take your case, you don’t pay us anything until we’ve collected for you. If you do not receive compensation for your injuries, you owe us no attorneys’ fees whatsoever.
To learn more, call or text our office today or go to our contact page.