Drugs or any medication serve to alleviate symptoms of a disease. Its use dosage recommendations govern its usage. Product labels also inform users of potential side effects. What if your long-standing prescription results in a severe condition that threatens to impair your vision and leave you blinded for the rest of your life?
Who do you sue when your medicine is certified by the FDA to manage your illness? Is the pharmaceutical company who manufactured the drug liable for failing to include such harmful effects in drug information?
What if you aren't the only one affected, and there are potentially thousands who may be endangered by the drug?
These questions define the context of a hallmark case-in-the-making known as The Elmiron Lawsuit.
Facts of the Case
Elmiron as Treatment for Interstitial Cystitis
In the late 1990's Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, produced pentosan polysulfate sodium, more popularly known as Elmiron, to treat symptoms associated with Interstitial Cystitis (IC). IC is a chronic condition that involves frequent urination with little release accompanied by pain in the gall bladder or the pelvis. Elmiron protects the walls of the gallbladder from irritation and swelling.
2. Studies Show links Between Elmiron and Maculopathy
Although alternative remedies can relieve chronic pain associated with painful bladder syndrome and IC, Elmiron is the only FDA-approved medication for managing symptoms of IC. Numerous patients used it over the years. In 2018, studies revealed that it causes retinal pigmentary maculopathy, a degenerative disease that affects the macula. The macula is the back part of the retina and is responsible for helping us focus on things.
Continous research from 2018 up to the present from Doctors Robin A. Vora, Amar P. Patel, and Ronald Melles shows that prolonged use of Elmiron causes the development of retinal pigmentary maculopathy. Simultaneously, some claim that damage may stop from discontinued use; using Elmiron for extensive periods could result in maculopathy. This condition could eventually lead to loss of vision in both eyes. It is an irreversible illness that could lead to visual disability.
3. Symptoms associated with the use of Elmiron
Besides maculopathy, other reported side effects of Elmiron include blurred vision, eye pain, difficulty reading, trouble adjusting to dim light, and having problems seeing objects up close. According to a recent study, an estimated one-quarter of patients taking the medication for prolonged periods sustained eye damage and vision problems.
Suppose you have been taking Elmiron for at least two years and feel the symptoms mentioned above or diagnosed with pigmentary maculopathy. In that case, you should contact a personal injury lawyer or go to https://1800injured.care/lawsuits/elmiron to gain an assessment of your potential claim.
4. Drug-Related Product Liability Claim
Those who experience Elmiron-related symptoms are eligible for damages under drug-related product liability claims involving pharmaceutical drugs. The Elmiron lawsuit qualifies for two of the categories set forth by the statute, namely:
Pharmaceutical drugs with dangerous side effects
Improperly marketed pharmaceutical drugs
Janssen Pharmaceuticals allegedly concealed Elmiron's dangerous side effects from consumers since it did not give sufficient warning regarding the damaging side effects of the drug. Elmiron was produced in the late 1990s and did not contain any alerts in its drug information regarding maculopathy as a side effect. It was only in June 2020 that the pharmaceutical company included a warning for the said degenerative disease.
5. Current Status of the Elmiron Case
There are currently 80 cases filed in federal and state courts in the United States, and half of these are under the jurisdiction of the Eastern District of Pennsylvania. It is currently pending under Judge Wendy Beetlestone. She is amenable to hearing all cases filed. She allows plaintiffs to gather evidence in the next 12 months to further their injury claim for pigmentary maculopathy and retinopathy, and other vision problems. Given the expanse of Elmiron users since its production, an estimated 1,000 cases could sue for personal injury claims.
While the case is still under trial, experts speculate that claimants are eligible for economic losses to compensate for their medical bills, cost of disability, and loss of wages or profits. They may also file claims for non-economic losses for the physical and emotional anguish from sustaining irreversible health outcomes.
The Future of Elmiron
Continued research regarding the link between Elmiron and maculopathy has increased over the years and serves to inform potential users of its potentially dangerous effect on eye health. While the drug manufacturer has included the said disease as a harmful side effect in its packages in June 2020, its status as an IC drug continues as there as no indications that the FDA will issue a recall.
