Pharmaceutical manufacturers are responsible for ensuring their products are safe and effective before making them available for public consumption. Under general product liability law, pharmaceutical companies must provide an accurate and adequate warning of any medication’s adverse effects. Failure to warn cases are a form of design defect that fall under products liability law when products are unreasonably dangerous, the product leaves the manufacturer or distributor, and causes injury to the victim.
Janssen Pharmaceuticals has manufactured and marketed the drug, Elmiron, for more than twenty years. It was approved for production in 1996 by the Food and Drug Administration to treat interstitial cystitis. Elmiron is the brand name for Pentosan Polysulfate Sodium. Interstitial cystitis is an incurable and chronically painful condition of the bladder and pelvis. As the only oral drug approved for the treatment of this syndrome, hundreds of thousands of patients have consumed Elmiron. Elmiron is also used as an anti-coagulant blood thinner and “off label” to treat osteoarthritis.
Research Has Exposed the Health Risks of Elmiron
In 2018, researchers at the Emory Eye Center in Atlanta, Georgia, studied patients who were experiencing progressive vision loss from 2015 to 2017. The study linked Elmiron to a pathological condition in the macula, causing an eye disease called retinal maculopathy. The function of the macula of the eye is visual acuity and light sensitivity. Damage to the macula causes permanent vision loss. In May 2019, the Emory researchers presented the results of an expanded study at the American Urological Associations’ Annual Meeting. This study concluded that structural changes in the retina occurred from Elmiron consumption. It was encouraged that patients discontinue the drug’s use. Studies by other researchers corroborate these findings.
A review of ophthalmology patients at Kaiser Permanente in Northern California found that about a quarter of their patients with significant exposure to Elmiron had signs of eye damage caused by toxicity. The amount of eye damage increased with a higher dosage of Elmiron. Given the alarming research being conducted, the American Academy of Ophthalmology reported in October 2019 that Elmiron appears to be a toxin that damages the retina. It affects the light-sensing tissue at the back of the eye that allows us to see. In addition to retinal maculopathy, researchers identified retinal pigmenting maculopathy, retinopathy, age-related macular degeneration, and scotoma as side effects associated with Elmiron’s usage. These irreversible, progressive ophthalmologic diseases lead to blindness.
Symptoms of Eye Damage Associated with Elmiron are:
- Macular degeneration
- Blurred vision
- Color fundus
- Halo vision
- Difficulty adapting to changes in light
- Dark spots in the center of vision
- Straight lines appearing curved
- Changes in eye color
- Less vivid colors
- Eye pain
The Michael Brady Lynch Firm is a Nationwide, Complex Litigation Law Firm
Our law firm has been committed to holding pharmaceutical companies accountable for negligent manufacturing and marketing for more than twenty years. We fight for the rights of those who suffer harm due to the negligence of others. As a nationwide pharmaceutical and medical device law firm, the Michael Brady Lynch Firm is widely regarded as one of the country’s most successful trial law firms. We have recovered millions of dollars in settlements and awards for our clients.
Janssen Pharmaceuticals were aware of the unreasonably dangerous side effects for patients prescribed Elmiron, yet marketed it to reap huge profits. After multiple clinical studies, publications, and many nationwide, complex product liability lawsuits, Janssen Pharmaceuticals acknowledged, on June 16, 2020, the significant side effects of Elmiron. They have since placed a warning label on this medication.
The current criteria for filing an Elmiron lawsuit requires:
- Elmiron patients must have used the prescription medication for at least two years.
- Vision changes and side effects need to begin while on Elmiron must take place within one year of stopping.
If you or a loved one are the victim of vision changes or blindness and have a history of taking Elmiron, you may be entitled to compensation. Damages can be awarded for medical expenses, lost wages, and pain and suffering. Contact The Michael Brady Lynch Firm in Winter Park, Florida, at 888-585-5970 for a free, initial consultation to discuss your options.