All medications come with potential side effects, but consumers have a right to know about possible risks so that they can make informed decisions about their health. When manufacturers fail to disclose side effects or mislead the medical community or public at large, they may be held responsible under theories of product liability.
A recent case filed by a Connecticut woman illustrates the dangers of prescription medications that do not contain adequate warnings or information. The lawsuit involves the drug Elmiron (pentosan polysulfate sodium), which is commonly prescribed to treat pain caused by bladder inflammation or irritation.
Vision loss after taking bladder drug
According to allegations in the complaint, the plaintiff lost her vision and was diagnosed with retinal macula dystrophy after using Elmiron as prescribed by her physician. The claimant started taking Elmiron in 2005 to treat her interstitial cystitis, a condition that causes discomfort and pressure in the bladder and pelvic region.
Elmiron is designed as a long-term therapy, and it was not until 2010 that the claimant began noticing some vision problems. Nine years later, in 2019, she sought medical evaluation for her symptoms and was diagnosed with vision loss and permanent retinal injury, ostensibly to Elmiron toxicity.
She is now suing Teva Pharmaceuticals, Janssen Pharmaceuticals, and Johnson & Johnson, seeking damages for her “permanent injuries and emotional distress, along with economic loss due to medical expenses and living-related expenses due to her new lifestyle.”
Elmiron-related macular toxicity
The FDA approved Elmiron for bladder issues in September 1996. Over the past 14 years, the product label has been updated no less than five times. According to the lawsuit, however, there was never any language or warning about the possibility of vision loss, or pigmentary maculopathy– two conditions that the plaintiff now suffers.
The product liability complaint cites a handful of studies that suggest a causal link between long-term Elmiron use and vision loss.
- In 2018, a retrospective review detailed 219 Emory patients who experienced vision loss after Elmiron use
- The same year, researchers reported a series of patients who developed atypical maculopathy and significant vision loss after long-term exposure to Elmiron
In addition, over the past few years, dozens of reports published in medical literature discuss an atypical maculopathy and vision loss associated with Elmiron use.
Misrepresenting the safety of Elmiron
Retinal toxicity has been widely researched regarding systemic drugs. Because the retina is unable to regenerate and heal itself, patients who take systemic medications like Elmiron are encouraged to be screened for retinal damage every year.
The plaintiff contends that she had no idea about the significant risks associated with Elmiron use and that the defendants continued to market the drug, knowing that it was unreasonably dangerous.
Her lawsuit is seeking damages for:
- Severe physical pain, mental suffering, inconvenience, and loss of enjoyment of life
- Past, present, and future costs for medical and rehabilitative treatment
- Past wage loss and future loss of earning capacity
- All court and litigation fees
Elmiron lawsuit case review
If you developed retinal macula dystrophy or vision loss after taking Elmiron for bladder problems, you might qualify for monetary compensation. Discuss your rights to filing an Elmiron lawsuit with Showard Law Firm. For more than 15 years, we have helped clients injured by dangerous medications recover fair reparations for their losses. The case review is free, and there are no attorney costs unless a settlement or award is obtained in your case.
- FDA, ELMIRON®-100 mg (pentosan polysulfate) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s009lbl.pdf
- RxList, Elmiron side effects https://www.rxlist.com/elmiron-side-effects-drug-center.htm