Last updated on August 8th, 2023
Elmiron, also known as pentosan polysulfate sodium (PPS), is currently the only oral drug approved by the U.S. Food and Drug Administration (FDA) to treat the pain of interstitial cystitis (IC). Interestingly, Elmiron is known as an “orphan drug” because of its clinical use in the treatment of the relatively rare disease of interstitial cystitis. In the United States, rare diseases are those that affect patient populations of fewer than 200,000 per disease. There is an unmet need for therapies for patients with rare diseases, as only about 5% of rare diseases have an FDA-approved treatment.
The Orphan Drug Act, enacted in 1983, incentivizes drug development in the rare disease space by offering grants, tax credits for clinical trial costs, fee waivers, and a 7-year regulatory exclusivity period to drug developers.
Beginning in 2018, a number of studies have indicated that Elmiron causes permanent eye damage. After individual Elmiron lawsuits accumulated, a mass tort lawsuit was launched against drug manufacturer Janssen, a subsidiary of Johnson & Johnson.
Elmiron was originally designed to treat bladder pain and discomfort associated with Interstitial Cystitis (IC). IC is a chronic condition, affecting mostly women, that causes bladder pain. Although no one is quite sure exactly how Elmiron relieves the symptoms of IC, it is known to work as a mild anticoagulant. At present, Elmiron is not available in generic versions. Hundreds of thousands of people have used Elmiron, however, it is primarily women who use it long-term.
From 1996 to 2020, patients taking Elmiron filed hundreds of complaints with the FDA over vision loss and other eye problems.
Meanwhile, since 2018, study after study has linked Elmiron to retinal pigmentary maculopathy and irreversible vision damage.
The plaintiffs in the Elmiron mass tort lawsuits accuse Janssen Pharmaceuticals of failing to warn users about the risk of eye damage prior to June 2020. Until then, Janssen Pharmaceuticals listed Elmiron’s side effects but did not warn about the risk of vision damage. This means people were taking Elmiron with no way of knowing what it could do to their vision. The fact that they couldn’t possibly have assumed the risk of vision loss, and should never have been expected to, is a big reason the Elmiron plaintiffs have been so motivated to take legal action.
Although many consider it to be a defective drug, Elmiron is still on the market, but the current prescribing information includes a warning about retinal pigmentary maculopathy.
Maculopathy is a disease of the macula. The macula is the part of your retina that is responsible for your central vision, most of your color vision, and fine detail. The retina as a whole allows you to see by sensing light and sending signals to the brain, which forms 3D color images in response. Naturally, damage to the macula harms your vision. Indeed, maculopathy is the most common cause of blindness.
The most common symptoms reported in the studies linking Elmiron with vision damage were reading difficulty and difficulty adjusting to dim lighting. Other symptoms included:
These symptoms are, unfortunately, quite common among long-term Elmiron users. A recent study found that about one in four long-term users suffered vision problems and retinal damage. Vision loss is reversible if you catch it early and stop taking Elmiron. If the condition proceeds to its later stages, however, the vision loss may be permanent. Anecdotal evidence suggests that degeneration can continue even after stopping the use of Elmiron.
So far there has been no recall of Elmiron.
Scientific research appears to be substantiating the claims of plaintiffs alleging eye damage after taking Elmiron. A study by the American Academy of Ophthalmology published in October 2019 found that a quarter of patients with significant exposure to the drug showed signs of retinal damage. The study also reports that Elmiron appears to be “toxic to the retina.”
Since courts hear an excessive number of lawsuits, the legal system has devised innovative ways of conducting litigation more efficiently. “Mass tort lawsuits” are for a multitude of cases with similar facts. This term refers to either of two of these innovations: class action lawsuits and multidistrict litigation (MDL).
MDLs are usually better for claimants because damages awards can be much higher.
The lawsuits allege that the Defendants failed to warn the public about the risks of the vision conditions caused by taking Elmiron, even though they had received reports and information from doctors in the 1980s and 1990s about vision complaints.
The lawsuits also allege that the manufacturers were aware that the human body could not easily absorb pentosan polysulfate sodium, the generic name of Elmiron, a semi-synthetic made from beechwood hemicellulose. The lawsuits allege that the drug then builds up in areas other than the bladder. In this particular case, while improving chronic interstitial cystitis, it is believed that Elmiron interacts with retinal chemicals, resulting in the death of these cells.
Plaintiffs have alleged that despite having knowledge of these findings, J&J and Janssen Pharmaceuticals purposely covered up the risks of taking Elmiron, which led to a significant delay in the plaintiffs discovering the link between Elmiron and eye damage.
Many plaintiffs also suggest that at the time the drug was prescribed to them, the drug’s packaging and labels had no warning of these potential effects. As mentioned above, Janssen has since updated the warning label on the medication.
February, 2023 Update
Hundreds of additional Elmiron cases have been filed since the federal claims were consolidated into an MDL in New Jersey in late 2020. As of February 16, 2023, there are 1,872 active cases in the MDL.
The first bellwether case was originally scheduled for January of 2023, but the case was postponed. The trial in Maria Windham v. Janssen will begin on March 27, 2023. The outcome of this case and the next few will help determine the future of other Elmiron cases. If the plaintiffs are successful in the early cases, those victories will provide a greater incentive for the company to begin settling claims.
After dozens of Elmiron lawsuits were filed throughout the United States, the need for MDL became obvious. On December 15, 2020, the United States Judicial Panel on Multidistrict Litigation created an MDL for the 130 or so Elmiron cases filed in federal court so far.
All Elmiron MDL cases have been transferred to the District of New Jersey to try the issues that are common to all of the cases. Judge Wendy Beetlestone will oversee most of these cases. The attorneys involved expect the litigation to expand, perhaps to include up to a thousand claimants.
If you have taken Elmiron for at least two years, you might qualify to take part in an Elmiron lawsuit. In a best-case scenario, you could walk away with a significant sum of money. Your participation could be particularly useful if you are still taking Elmiron (or stopped using it recently). To qualify for compensation, of course, you will need to prove that you suffered symptoms such as:
If you suffer from any of these symptoms, they may be traceable to Elmiron if they emerged while you were using Elmiron or within a year afterward. You may need to visit a physician to confirm a diagnosis of pigmentary maculopathy.
If you qualify for a lawsuit or appear to be a good prospect, you will probably need to participate in a few telephone conferences with a pharmaceutical injury attorney. You will need to inform your attorney of certain background information, including the names of your doctors and which medications you take.
One of the first questions potential clients have about Elmiron is – what do the cases settle for? This is a logical question for people who are concerned about medical bills after injury from a defective drug. However, be careful with what you read on the internet. As I write this, Elmiron litigation is very much active and no cases have been settled, therefore it is impossible to know the settlement amounts. Furthermore, if Elmiron cases were to settle, the agreements would be confidential. Be very careful with any law firm that promises a certain amount of money for an Elmiron settlement.
Should you pursue a case, you will not owe your attorney any money, until and unless you receive a recovery after the lawsuit is over.
If that happens, your lawyer will take a certain pre-agreed percentage of your recovery. If you receive no recovery, you will owe nothing. Your lawyer will even pay the expenses of litigation upfront. Ultimately, you have nothing to lose. Get in touch with an experienced attorney today.
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