According to the Elmiron lawsuits recently filed in the US, this interstitial cystitis drug pentosan polysulfate sodium (PPS) is linked with serious eye damage. Plaintiffs claim the substance manufactured by Janssen Pharmaceuticals is linked with a certain type of retina damage known as pigmentary maculopathy that could lead to permanent vision loss and blindness.
If you or a loved one developed any vision symptom associated with an eye disorder after taking Elmiron for interstitial cystitis or osteoarthritis, please call us now. First, we will do our best to ascertain whether your case qualifies to be brought to court, and if you may be entitled to compensation. Then, we will contact the best lawyer available to maximize your chances of winning.
What is Elmiron?
Elmiron is a drug known as pentosan polysulfate sodium, a semi-synthetic medication manufactured by Johnson & Johnson and its subsidiary Janssen Pharmaceuticals from beech-wood hemicellulose. Since its release in 1996, Elmiron is prescribed for interstitial cystitis, a painful bladder condition associated with symptoms such as abdominal cramps and discomfort that are often very hard to treat. Pentosan polysulfate sodium provide relief from bladder pain syndrome by forming a protective coating to the organ’s wall. If the patient suffers from chronic interstitial cystitis, Elmiron must be taken for extended periods of time to provide relief from symptoms.
Pentosan polysulfate sodium has also been tested a disease modifying osteoarthritis drug (DMOAD) to improve pain and function in patients with this disorder. According to some recent studies, the drug ameliorated the symptoms and enhanced the mobility of patients in terms of pain while walking, climbing stairs, flexing knees, etc.
Why is Elmiron dangerous?
In 2019, three ophthalmologists from Kaiser Permanente in Northern California found convincing evidence of a link between the use of Elmiron in cystitis patients and maculopathy. The researchers presented their finding at the 123nd Annual Meeting of the American Academy of Ophthalmology, and they were not the only doctors who found a link between Elmiron and vision loss. PPS can very well be toxic to the retina according to Dr. Nieraj Jain, MD, from Emory Eye Center in Atlanta, GA, who found that another six patients being treated with Elmiron eventually developed a macular degeneration that could not be explained otherwise.
Since PPS is taken to treat a bladder syndrome, very few doctors initially believed it could cause eye problems and vision loss. However, the apparently safe Elmiron can subtly cause blindness over time. In fact, many patients are often forced to take increasing doses of this drug to keep up with their symptoms.
What are the symptoms of Elmiron vision loss?
If you or a loved one are under treatment with Elmiron for interstitial cystitis or osteoarthritis, you might develop a dangerous maculopathy. Although this means that you may be entitled to financial compensation if your lawsuit is successful, we care about your safety above all else. It is important that you speak with your doctor immediately if you experience any of these symptoms. They might be suggestive of ongoing vision damage or retinal maculopathy:
- Reduced, distorted or blurred vision
- Reading becomes hard
- Difficulties at watching objects that are close
- Eye strain or fatigue after watching TV or your PC screen
- Increased time to adjust to darkness or dim lighting
- Difficult time adjusting to dim lighting or the dark
- Eye pain
- Visual disturbances such as flashes, moving lights, or shadows
However, once again, before you make any decision about your treatment, you should seek your physician’s advice first and foremost. If you stop taking this bladder drug, in fact, its positive effects will gradually wear off and the pain for which you originally took Elmiron will slowly reappear.
Who filed the first Elmiron lawsuit?
On May 4, 2020, plaintiff Tina Pisco filed the first Elmiron lawsuit claiming she developed maculopathy after being prescribed the drug for her interstitial cystitis. The woman received her diagnosis of cystitis in 2012, and started taking Elmiron to treat it for several years. In March 2019, Pisco started suffering from vision problems, which were apparently unrelated with the original disease. Eventually she was diagnosed with a pigmentary maculopathy in both eyes, a much more serious eye disease that leads to permanent retinal injury.
According to her claim, the long term use of Elmiron was the reason of her vision loss, but the manufacturer never warned her or the other Elmiron patients of side effects which could lead to eye disease. In fact, Janssen Pharmaceuticals kept claiming that PPS was completely safe. If the woman’s lawsuit will be successful, she may be entitled to a large monetary compensation, and many other litigations will likely follow.
Did Janssen warn the public about Elmiron dangers?
According to Elmiron’s original label, the cystitis drug is associated with just a handful of minor side effects. In particular, those listed by the manufacturer’s official website are:
- Hair loss
- Bloody stool
- Abnormal liver function tests
Note that maculopathy is not included among them. Some vision problems are included among the uncommon side effects, but the this particularly serious eye disease is not listed among them. In particular, Elmiron may cause:
- Retinal hemorrhage
- Optic neuritis
In Canada, the national regulatory agency required the pharmaceutical company to update its warnings last year. They requested the inclusion of a specific indication about reported cases of pigmentary maculopathy associated with the use of pentosan polysulfate. Patients with long term use of Elmiron are required to have regular ophthalmic examinations for early detection of maculopathy.
In the United States, the prescribing information that accompanies Elmiron does not include these details. On the contrary it laconically states “Warnings: None.” Therefore, no one of the Elmiron patients has ever been adequately warned of the risk for these potentially permanent vision problems. Because of this, the recently filed lawsuit claim that the pharmaceutical company released a dangerously defective prescription drug without ensuring its safety with proper tests. The company has been accused of negligence and, more importantly, of voluntarily withholding critical material about side effects and adverse events associated with taking Elmiron which could lead to pigmentary maculopathy and other serious or permanent vision problems.
Common questions about filing an Elmiron Lawsuit
A common question that we are often asked is whether it is really worth to invest your time and money to file a civil action against those who allegedly harmed you. Being scared by the idea of facing a court is completely understandable, especially if you’re not sure of your winning chances. However, that’s why we’re here to answer all your questions and dispel any doubt.
How can I be sure of winning?
During our initial consultation we will properly evaluate your case to determine if your chances of winning are high enough to file a case. We understand how hard and challenging it could be to fight with a disease or injury, and having to face the stress of a trial. That’s why we will do our best to take all necessary steps to maximize your chances of winning and minimize the pressure you’re going to face. Needless to say, the initial consultation is completely free and without any obligation.
How much filing an Elmiron lawsuit will cost me?
To put it shortly: Nothing unless you win. We will put you in contact with lawyers that are only paid on a contingency basis. This means that unless you successfully reach a settlement and your case is victorious, you do not owe anything to the law firm that will handle your litigation – not even trial expenses. The fee you will be charged in case of victory is standardized as well, and is set by the corresponding national bar.
Why should I file an Elmiron lawsuit?
Nobody wants to face a disease or be harmed. We all want to live healthy and serene lives, but no matter how careful we are, bad things happen sometimes. In the United States, dealing with a physical issue requires money, even more so if it’s a long term or impairing disability as a retinopathy or maculopathy. If your case is successful, however, you may be entitled to sufficient money to pay your medical debts. In some instances, filing an Elmiron lawsuit can very well be the only way to ensure you have the necessary money to deal with the medical bills and mounting expenses.
But that’s not all. Filing an Elmiron suit means seeking justice against those who harmed you or a loved one by causing maculopathy. From a broader perspective, is every American citizen’s responsibility to do all they can to stop those who willfully harm others for their own profits. Many pharmaceutical companies such as Janssen Pharmaceuticals are negligent and unscrupulous in releasing to the market unsafe or poorly tested drugs and medical devices. Pinning them to a wall with the instruments provided us by law is a civil responsibility that we all share to prevent them from causing more damage to other patients in the future.