Janssen Pharmaceuticals, a subsidiary of American giant Johnson & Johnson, is the main manufacturer of pentosyn polysulfate sodium (PPS), commonly known as Elmiron. Elmiron is commonly used to treat some type of interstitial cystitis or painful bladder symptoms. Janssen is currently being sued for allegations that Janssen did not warn patients about the risks of taking Elmiron. Lawsuits increased after Elmiron users reported significant visual impairment after years of taking the drug.
Designated an orphan drug under Title 21 of the United States Code, Elmiron was made available to people suffering from bladder pain and interstitial cystitis while further studies and tests were being conducted by Elmiron. Janssen continued to be required to provide drug interactions and warnings as part of the packaging and educational materials made available to prescribing physicians. It is disputed that Elmiron, as marketed by Janssen, is a defective and dangerous product and that Janssen has not provided adequate and reasonable warnings and instructions to make the drug reasonably safe for its use.
An unforeseen threat
While the causal link between low vision and bladder medication may seem unlikely, the allegations made in the Elmiron lawsuit are backed up by a number of studies conducted by various medical and academic experts. One 2018 study in particular involved doctors at Emory University’s Emory Eye Center who found that chronic exposure to PPS or Elmiron caused “a novel and potentially preventable maculopathy,” suggesting that Elmiron causes visual impairment. A year later, the Emory Eye Center published a study that found that patients who had interstitial cystitis but did not take PPS did not have pigmented maculopathy, confirming that PPS is the only known cause of the so far specific type of maculopathy is pigmentary maculopathy experienced by Elmiron users. The same study ended by encouraging affected patients to stop taking PPS.
What is maculopathy?
Maculopathy, also known as macular degeneration, is the progressive loss of central vision. Although maculopathy never leads to complete blindness because lateral vision is preserved, damage to a person’s central vision is so severe that many of those suffering from maculopathy have difficulty coping with everyday tasks. The pigmented maculopathy that many Elmiron users suffer from is characterized by the symptoms of normal maculopathy, in addition to difficulty adjusting to dim lighting and reading.
Subsequent studies showed that a disproportionate number of chronic PPS users suffered from maculopathy, especially when compared to other drugs involved in other mass crimes. In October 2019, a study by healthcare company Kaiser Permanente found that 22 out of 91 patients who took significant amounts of PPS for 15 years had significant retinal damage. In January 2020, another study found that 27 out of 117 PPS users had clear signs of maculopathy. So far, three independent studies have found that PPS causes maculopathy at a rate that could be almost as high as 1 in 4 users. As a result, Janssen is faced with evidence suggesting potentially preventable maculopathy associated with chronic exposure to PPS.
Bad optics
Individual lawsuits are now being filed accusing Janssen of failing to warn users of the risk of vision problems when taking Elmiron. In fact, Janssen decided to wait until June 2020 to put a warning on its label. The warning contains potential side effects with prolonged use of Elmiron, including “pigment changes in the retina … have been noted with long-term use”. As of May 2021, there have been no product recalls for Elmiron.
We see your pain, let us serve you
With Elmiron’s lawsuit still in its infancy, now is the time to act. You may be entitled to compensation if you have been using Elmiron for a long time and if you have either been diagnosed with pigmented maculopathy or if you have any of the following symptoms:
• Difficulty reading
• Blurred vision
• Difficulty adjusting to the dark
• Dark spots in the center of your field of vision
• Blurry spots in the center of your field of vision
• Impaired ability to perform routine tasks due to impaired vision
Our team at Oppenheim Law is aware of the emotional and economic burdens that these impairments can have on individuals and their lives. For this reason, our law firm provides a team of professionals who are committed to eagerly representing our clients.
Please call us at (954) 384-6114 or contact us at [email protected] or chat with us at www.oppenheimlaw.com so we can inform you of your statutory rights so that you can receive compensation, to which you are entitled.
Originally published at: https://www.oppenheimlaw.com/elmiron-lawsuit-attorneys/
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