Elmiron
Free Consultation(844) 348-9529
Maine Elmiron Lawsuit & Settlement Lawyer
Elmiron has been prescribed for nearly three decades for the treatment of interstitial cystitis or painful bladder syndrome. Since 2018, increasing reports and studies demonstrate that Elmiron causes a signature type of vision loss called retinal pigmentary maculopathy which affects the portion of the eye that is responsible for clear and straight-ahead vision. Damage to the retina from Elmiron can lead to significant and permanent vision loss and impairment. Reports also indicate that Elmiron-induced vision loss can continue to progress even after the medication has been discontinued.
Background on Elmiron
Elmiron is the brand name for pentosan polysulfate sodium. Elmiron was developed by Baker Norton Pharmaceuticals, a predecessor company to Teva Pharmaceuticals. Elmiron is currently licensed for sale in the U.S. to Janssen Pharmaceuticals, Inc., a Johnson & Johnson company.
Elmiron was first approved by FDA in September 1996. Elmiron is indicated for the treatment of interstitial cystitis or what is more commonly referred to as painful bladder syndrome. The symptoms of interstitial cystitis can include chronic pain in the bladder area, urinary frequency or urgency, and painful sexual intercourse. Interstitial cystitis predominantly affects women and typically onsets between the ages of 40-55.
The Paragard was originally designed and developed by Teva Pharmaceuticals USA, Inc. and Teva Women’s Health, LLC. In September 2017, Teva sold the rights to the Paragard to CooperSurgical who continues to sell the Paragard in the U.S.
Elmiron Vision Injuries & Elmiron Vision Loss
Elmiron has been linked to a signature type of vision loss called retinal maculopathy or retinal pigmentary maculopathy. The retina is the light sensitive tissue which lines the inside of the back of the human eye. The macula is an oval-shaped pigmented area in the center of the retina which allows us to have 20/20 and color vision. Think of the macula as a pair of sunglasses that shields the eye from too much light allowing us to see the fine details in our vision.
Retinal maculopathy is a newly described condition in patients who have used Elmiron. Retinal maculopathy causes changes to the retinal pigment epithelium cells. These changes can lead to significant vision loss and eye dysfunction. Studies also indicate that vision loss from Elmiron use is greater in patients who took higher doses of the drug.
The symptoms of Elmiron vision loss and retinal maculopathy can include:
- Dark or blurry areas in the center of vision
- Distorted, dimmed or spotty vision
- Reduced color perception
- Poor adjustment to low light or changes in lights
- Blind spots and “floaters”
- Difficulty reading
- Eye pain
Until recently, the manufacturer and sellers of Elmiron have never warned patients or physicians about the risk of retinal maculopathy. On June 16, 2020, Janssen Pharmaceuticals for the first time updated the prescribing information or label for Elmiron to warn that pigmentary changes in the retina, including pigmentary maculopathy, have been identified with long-term use of Elmiron and that cumulative dose appears to be a risk factor. This new warning about Elmiron related vision loss came nearly two years after multiple peer-reviewed studies were published in the medical literature linking Elmiron with vision loss due to retinal maculopathy.
Diagnosis of Elmiron Vision Loss
During a comprehensive eye exam, an ophthalmologist will perform a dilated fundus examination. This involves the eye doctor administering special eye drops that dilate the pupil of the eye. When the pupil is dilated, it opens wide, and allows the eye doctor to clearly see the back of the eye, where signs of disease that may lead to blindness can be identified. Next, the eye doctor performs imaging of the “fundus” of the eye, which is the interior surface opposite the lens. Fundus imaging allows the eye doctor to clearly see the retina in order to identify signs of injury to the macula including retinal pigmentary maculopathy from Elmiron use.
Elmiron Litigation
A growing number of Elmiron lawsuits have been filed against Johnson & Johnson, Janssen Pharmaceuticals, Inc., and Teva Branded Pharmaceutical Products R&D, Inc. in courts around the U.S. Plaintiffs allege that their use of Elmiron has caused vision loss and vision impairment. Plaintiffs further allege that these companies designed and manufactured a defective medication and failed to provide adequate warnings about Elmiron vision loss. The lawsuits also contend that the companies knew or should have been aware based on early clinical trials in the 1990’s that Elmiron could cause vision loss and impairment. The Elmiron lawsuits seek significant compensation for injured plaintiffs including medical expenses, lost wages or earning capacity, pain and suffering, and disability and permanent injury.
In December 2020, federal lawsuits involving Elmiron vision loss were centralized in a multi-district litigation (“MDL”) before U.S. District Court Brian Martinotti in the United States District Court for the District of New Jersey (MDL No. 2973).
Elmiron Lawsuits & Elmiron Claims
If you or someone you love has been prescribed Elmiron and suffered vision loss or impairment, you may be entitled to significant compensation for your injuries.
To speak with an experienced Elmiron lawyer, contact Fitzgerald Law Group at (844) FITZ-LAW or (207) 874-7407, or complete the Case Evaluation Form on this website for a free, confidential, case assessment.
