Lawsuit Claims Woman May Get Permanent Vision Damage From Elmiron
A lawsuit filed in November claims that a woman may suffer permanent vision damage because she took Elmiron for interstitial cystitis. The lawsuit claims that multiple defendants knew or should have known about the vision damage risk associated with Elmiron yet failed to warn the public about the risk.
Elmiron’s Eye Damage May Worsen Over Time
The complaint states that the woman suffered from retinal pigmentary changes after taking Elmiron. The complaint notes that a Harvard researcher and the Emory Eye Center both found that eye symptoms can continue to get worse after cessation of Elmiron treatment.
The Harvard researcher detailed a case study of a woman who took 200 mg of Elmiron per day for 18 years. This woman’s Elmiron-associated maculopathy continued to worsen six years after she stopped taking Elmiron.
The Emory Eye Center case series found that nine of eleven patients in the study who had Elmiron-associated maculopathy reported that their visual symptoms got worse after they stopped taking Elmiron.
The complaint states this case series suggests that the eye damage Elmiron can cause “continues to evolve after drug cessation for at least 10 years” and “may pose a long-term threat to central vision.”
Condition Known About Since 2018, Label Only Updated In June 2020
The complaint states the Emory Eye Center published a case series online in April 2018 which investigated six patients who all had a new form of maculopathy. The center looked through their patient histories and found all six had taken Elmiron.
The same Emory team found that “structural changes occur at the level of the retinal pigment epithelium, manifesting as characteristic pigmentary changes” in patients with Elmiron-associated maculopathy, according to the complaint, then found 14 cases of this new form of maculopathy in 80 interstitial cystitis patients exposed to Elmiron and zero cases in 139 interstitial cystitis patients not exposed to Elmiron.
However, the complaint notes, Elmiron’s United States label was only updated to warn about retinal pigmentary changes in June 2020.
The complaint notes that the drug’s Canadian and European labels were updated in 2019 with a pigmentary maculopathy warning, accusing the defendants of willfully deceiving the public about the eye damage risks associated with Elmiron.
Causes Of Action
The complaint seeks to recover damages based on multiple causes of action, including:
- Strict products liability
- Breach of express warranty
- Breach of implied warranties
- Fraudulent misrepresentation
- Fraudulent concealment
- Negligent misrepresentation
- Fraud and deceit
- Punitive damages