Drug companies have a duty to provide a comprehensive list of potential side effects associated with a drug. It is the responsibility of drug companies to practice transparency when introducing a drug to the market. With the appropriate warnings, doctors and patients can then weigh the possible benefits against the side effects. But sometimes companies fail to sufficiently test a drug or neglect to include certain hazards on a label. For instance, many people took the bladder drug Elmiron without knowing the full extent of its potential side effects. Did you suffer vision damage after taking Elmiron? Reach out today to learn more about how an Elmiron lawyer can assist you.
Our law firm is currently handling lawsuits on behalf of individuals who suffered vision damage after taking Elmiron. Lawsuits against the manufacturers claim that patients taking Elmiron to treat interstitial cystitis or “bladder pain syndrome” developed retinal maculopathy.
Elmiron, pentosan polysulfate sodium (PPS), is the only oral drug available to treat people with interstitial cystitis (IC). Interstitial cystitis is a chronic condition that causes bladder pain and pressure. People with IC have weakened bladder wall linings and are susceptible to uncomfortable inflammation. Elmiron stops irritants in urine from ever reaching the bladder. In some instances, doctors may prescribe the medication to treat bladder pain from urinary tract infections.
Since the FDA’s approval of the blood thinner in 1996, many people have taken Elmiron to treat their IC. Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, is the current manufacturer of Elmiron.
IC is a very common condition. It may affect between 3 and 8 million women and between 1 and 4 million men in the United States. Many IC sufferers relied on Elmiron to ease their bladder pain. But, over the last few years, studies have shown that the drug may damage the retinas.
In 2015, ophthalmologists at the Emory Eye Center indicated that patients taking Elmiron continuously showed signs of progressive eye disease and a new condition known as retinal maculopathy. Maculopathy is a disease that affects the back of the retina (macula). The macula controls the ability to read, see fine detail, and recognize faces and colors. Kaiser in Oakland, which studied a larger sample of 140 patients, reported that patients developed some form of retinal disease while receiving Elmiron.
Another study in 2018 by respected eye surgeon Nieraj Jain reinforced this data. Jain reported a higher risk of maculopathy for those who took the bladder drug for an average of fifteen years. Also in 2018, the Journal of Ophthalmology reported that maculopathy was associated with chronic exposure to the active drug in Elmiron. The IC Network, an advocacy group for interstitial cystitis, found that over 50 percent of the subjects taking Elmiron showed signs of eye disease.
Canada and Europe updated Elmiron labels to warn of vision damage and loss in 2019. However, it was not until 2020 that the United States finally updated the label to include vision damage and loss.
In June 2020, the U.S. Food and Drug Administration (FDA) issued a new warning for Elmiron. This update alerted the public about the risks of retinal pigmentary damage identified as “pigmentary maculopathy” associated with the drug based on previous case studies and reports. According to the new warnings, the most significant risk factor among patients is the cumulative dosing of Elmiron. The warning specifies that symptoms include trouble reading, difficulty adjusting to low-light environments, and blurred vision.
Elmiron-linked retinal maculopathy may cause:
Hundreds of individuals have filed Elmiron lawsuits nationwide. As of September 2023, 1,915 Elmiron cases were pending under multidistrict litigation (MDL). Attorneys expect more victims to file lawsuits in the future, given the suspected latency of the drug. For example, one study published in Retinal Cases & Brief Reports found that Elmiron patients may develop maculopathy years after stopping it.
In May 2022, the judge presiding over the federal MDL chose three cases to move forward as bellwether trials. The presiding judge announced the first bellwether trial will take place in January 2023, and the other two will begin in March and May 2023. However, Judge Martinotti moved the first bellwether trial to March 27, 2023. So far, no bellwether trial has taken place in 2023.
If you or a loved one has been injured by Elmiron, you may recover compensation for any or all of the following:
No one should have to endure impaired vision or vision loss. Losing your sight is an alarming and frightening experience that can completely alter your way of life. Lawsuits allege that manufacturers did not warn patients about worsening vision damage associated with Elmiron. It took decades for the company to finally update the drug’s label with accurate information to specify vision damage. For many, vision deterioration can result in a negative and profound impact on one’s life. Although an Elmiron lawsuit cannot restore your vision, it can assist you in holding reckless manufacturers accountable for your injuries. Speak with an Elmiron lawyer at The Lake Law Firm to understand how you can hold Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, accountable for the damage caused by Elmiron.
The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 525-3529 or submit an inquiry on this page.