Two Florida law firms are suing Janssen Pharmaceuticals and its parent company, Johnson & Johnson, over a plaintiff’s eye injuries that allegedly resulted from her taking a drug to treat bladder pain.
Attorneys Benjamin Widlanski of Kozyak, Tropin & Throckmorton LLP and Francisco Maderal of Colson Hicks Eidson in Coral Gables filed the lawsuit on behalf of plaintiff Tara O’Flaherty of Charlotte County earlier this month. O’Flaherty allegedly sustained retinal damage and impaired vision as a result of taking the prescription drug Elmiron to treat a bladder pain syndrome known as interstitial cystitis (IC).
The drug gained the approval of the Food and Drug Administration for the treatment of IC in September 1996.
“Numerous patient reports, scientific studies and even alerts by government agencies have established that Elmiron causes retinal damage,” the lawsuit states. “Nevertheless, to date, defendants have failed to warn, advise, educate or otherwise inform Elmiron users, prescribers or governmental regulators in the United States about the risk of pigmentary maculopathy or the need for medical, ophthalmological monitoring.”
The lawsuit, which was filed in the U.S. District Court for the Middle District of Florida, refers to a number of scientific studies and concerns expressed in researchers from the Emory Eye Center in the Journal of Ophthalmology. It points to reports of adverse Elmiron effects that range from blurred vision to blindness.
But a statement provided to the Florida Record from Janssen Pharmaceuticals defends the drug and its effectiveness in helping patients.
“Interstitial cystitis is a painful and debilitating disease,” the emailed statement says. “Elmiron (pentosan polysulfate sodium) is the only FDA-approved oral prescription medicine that has been helping patients suffering from this condition for more than two decades. We plan to defend against the claims made in this litigation.”
Despite such lawsuits involving its products, J&J continues to put its efforts behind strategies to address the coronavirus pandemic. J&J and Janssen Pharmaceuticals have chosen a COVID-19 vaccine candidate that the companies hope to advance to clinical trial by the fall, and J&J is providing health care workers with medicines and products to help them treat coronavirus patients, according to the company
The lawsuit over Elmiron seeks compensatory damages for lost earnings, medical expenses, pain and suffering, and other impairments, as well as punitive damages and attorneys’ fees and costs.