Lawsuit Alleges Elmiron Caused ‘Potentially Irreversible Vision Damage’
A lawsuit filed on October 5 in federal court in New Jersey claims that an Ohio woman suffered “potentially irreversible vision damage” after taking Elmiron. The lawsuit names Janssen, Johnson & Johnson, Ortho-McNeil and Teva Pharmaceuticals as defendants.
The complaint states that it is “an action for damages suffered by Plaintiff as a direct and proximate result of Defendants’ negligent and wrongful conduct in connection with” Elmiron.
The complaint claims that people, including the plaintiff, have suffered vision damage “as a result of the defective nature of” Elmiron, stating that the plaintiff’s vision damage was “a direct and proximate result” of the defendants’ actions and inaction.
The complaint states that the defendants “have received multiple Adverse Event Reports… detailing injuries including serious visual symptoms and/or damage” following Elmiron’s approval in 1996.
“Upon information and belief, from approximately 2005 through 2017 vision injury from use of the drug continued to be an issue that was discussed by employees responsible for the drug and the drug’s safety at one or more of the Defendants,” the complaint claims.
The complaint notes that a case series detailing six patients who all had the same new retinal disease after taking Elmiron was published in April 2018. An update to that study was presented in May 2019, according to the complaint.
“We describe a potentially avoidable retinal degeneration phenomenon associated with chronic PPS exposure. Structural changes occur at the level of the retinal pigment epithelium, manifesting as characteristic pigmentary changes,” the update concluded.
The complaint also notes that a Harvard researcher published a case study in November 2019 involving a woman whose retinal disease was still getting worse six years after discontinuing use of Elmiron.
“Despite this overwhelming body of research and literature… it was not until June 16, 2020 that the ELMIRON label was updated to include a warning regarding retinal pigmentary changes,” the complaint states, alleging that the defendants knew of the risks of retinal injury associated with Elmiron yet chose not to warn the public about these risks.
The complaint seeks to recover damages based on numerous causes of action, including negligence, strict products liability, breach of express warranty, breach of implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, violation of the New Jersey Consumer Fraud Act, product liability – design defect, products liability – failure to warn, product liability – manufacturing defect, and punitive damages.