Lawsuit alleges Elmiron makers knew it could cause vision loss
A lawsuit filed in federal court in Florida on October 9 claims that Elmiron manufacturers knew the interstitial cystitis drug could cause vision loss yet failed to warn the public about the risk.
Elmiron manufacturers “knew or should have known that Elmiron, when taken as prescribed and intended, causes harmful retinal damage and pigmentary maculopathy,” the complaint states.
The complaint states that Elmiron’s link with retinal damage has been established by “numerous patient reports, scientific studies, and even alerts by governmental agencies,” yet Elmiron makers failed to warn the public about it.
Failure To Test
The complaint states that Janssen Pharma not only failed to conduct pharmacokinetic and pharmacodynamic testing on the medication, but actually advocated against this testing, claiming that pharmacokinetic testing is “inappropriate.”
“An understanding of pharmacokinetics… is crucial to understanding how the drug interacts with the human body,” the complaint states.
The complaint states that a physician’s usage study conducted from the late 80’s until the early 90’s noted adverse vision effects, including blurred vision.
A 1991 study found that Elmiron could “impair an important physiological pathway for retinal health,” according to the complaint.
Patients and doctors started reporting serious Elmiron-related complications “almost immediately after the FDA approved Elmiron,” according to the complaint, which states that the FDA received 164 cases of eye disorders related to Elmiron use from 1997 through 2020.
The complaint notes that researchers from the Emory Eye Center published findings in 2018 indicating that Elmiron was causing a new progressive eye disease which involved retinal damage and vision loss. The Emory researchers submitted another study in 2019 concluding that Elmiron was causing structural changes in the retina and that they weren’t sure if stopping use of the drug would alter the damage course.
The complaint notes that, despite all of this, Elmiron’s United States label did not warn about any risk of retinal damage or vision loss until June 2020.
“Defendants should have changed the Elmiron label to include warnings and instructions addressing the risk of injury associated with the drug as soon as they had notice of adverse reports relating to same,” the complaint states.
Failure To Uphold Duty
The complaint states that Elmiron makers “had a duty to protect U.S. consumers, but did not.”
The complaint states Elmiron makers had a duty to ensure that the warnings on Elmiron’s label were adequate, and failed in this duty.
“Despite understanding Elmiron could cause vision-related injuries,” Elmiron makers “knowingly withheld and/or misrepresented information required to be submitted under FDA NDA regulations, concerning the safety and efficacy of Elmiron,” the complaint states.