Florida Lawsuits Over Elmiron Caused Injuries
Risk of Maculopathy with use of Elmiron
In 2018 a case report was done on the drug Elmiron by the American Academy of Ophthalmology. Elmiron is prescribed to those that suffer from severe bladder pain, otherwise known as interstitial cystitis, or IC. In the United States, this condition affects between 3 to 8 million women and 1 to 4 million men. Because Elmiron has been around for decades, it is believed several hundreds of thousands of patients have used it. While neither damaged vision nor eye disease are mentioned on the list of side effects, they were found to be a common factor among the group of people in this case study.
Again in 2019 it was found through another published case report in Ophthalmic Surgery that Elmiron “appears to be toxic to the retina”. Even those that stopped taking the medication for years still suffered from worsening eye conditions. These people suffered from side effects ranging from vision impairment to maculopathy. Although studies have pointed to Elmiron causing damage, the FDA has still failed to recall the product.
What is Elmiron (pentosan polysulfate sodium)?
Approved by the FDA in 1996, Elmiron at one point was prescribed as a weakened anticoagulant but is now used by people to treat a very painful condition, interstitial cystitis. While you can find many prescriptions over the counter, Elmiron is not one of those available.
Though researchers know Elmiron does not work in the same way as anti-inflammatory drugs, they are unsure exactly what causes it to work. Elmiron is believed to create a protective barrier around the lining of the bladder and while it cannot cure interstitial cystitis, it does protect the lining from irritants that come from urine.
What is Maculopathy?
The macula is the very center of the retina which is responsible for the fine detailing we are able to see, as well as a majority of our central vision. There are many different types of maculopathy that range from Cellophane Maculopathy, Malattia Leventinese, as well as age-related maculopathy. However, the specific form of maculopathy that Elmiron is causing is known as “pigmentary maculopathy of unknown etiology”. Even though it is a macular injury, the cause for its development is unknown.
Pigmentary maculopathy can present itself in a multitude of ways:
- Vitelliform deposits: yellowish, round lesions that form under the macula, resulting in loss of vision
- Retinal pigment epithelium atrophy: black, flat lesions that form as you age
- Parafoveal pigmented deposits: blood vessels that become abnormal which results in loss of vision
Additional Side Effects of Elmiron
During clinical trials of 2,627 participants, Elmiron patients suffered from numerous other side effects that can include but are not limited to:
- Headaches (4%)
- Hair loss (4%)
- Diarrhea (3%)
- Rash (3%)
- Abdominal pain (2%)
In an additional study of 128 patients, 6.3% of those taking the recommended dose of 300mg suffered from rectal hemorrhaging.
Elmiron in the News
As of May 4, 2020, there was a lawsuit filed against Janssen Pharmaceuticals and Johnson & Johnson by a woman named Tina Pisco. In this lawsuit Pisco states that she began taking Elmiron in 2012. It was later in 2018 that she noticed her vision had begun deteriorating at an alarming rate. She was then diagnosed in March of 2019 with injury to the retina in both of her eyes. While Janssen has multiple side effects listed on their website including conjunctivitis, retinal hemorrhage, and optic neuritis, there is no mention at all of permanent damage to vision.
There was another instance of a woman filing a lawsuit against Teva Pharmaceuticals USA and Janssen in March 2020. A Connecticut resident, Kimberly Pelzczar, stated in her lawsuit that ten years after she began taking Elmiron in 2005 her vision had also deteriorated in a rapid manner. After seeing medical professionals from 2015-2019 she was eventually diagnosed with permanent vision loss and retinal injury.
Product Liability in Regard to Defective Drugs
When a drug such as Elmiron proves to be defective and causes injuries to consumers, there will usually be a recall to avoid any further injuries for occurring. While Canada has required Janssen to update their list of side effects, the US has failed to do so. Those that have already suffered from a provable injury because of this dangerous drug are able to seek compensation for their physical and emotional damage through what is called a product liability claim.
Experienced Elmiron Lawsuit Attorney
At Dolman Law Group we are committed to giving our clients the small law firm attention they want, with the big firm results they deserve. If you or someone you love has taken the prescription drug Elmiron, we would be more than happy to schedule a free consultation to assess the details of your situation. When it comes to a product liability lawsuit, seeing a lawyer makes all the difference in obtaining a claim that you can be satisfied with. Dolman Law Group also handles defective medication cases involving Zantac, Opioids, Risperdal, Mirena, Invega, and many more. Ensuring our clients will receive the compensation needed to cover any lost wages and medical bills, and with the years of experience Dolman Law Group possesses, you can be confident that you will be in good hands. You can reach our office by either calling (727) 451-6900 or contacting us online.