A Maryland man who has misplaced his imaginative and prescient as a result of non-arteritic anterior ischaemic optic neuropathy (NAION) is suing Novo Nordisk, alleging that Ozempic, which he was taking for diabetes, is the reason for his situation.
Attorneys for Todd Engel, 62, filed go well with yesterday in New Jersey superior courtroom. In line with the grievance, Engel is now legally blind. Consequently he was pressured to resign from his job and has misplaced the flexibility to drive. He was prescribed Ozempic round August 2023 and identified with NAION in December of 2023.
“We see this as an important case,” Ashley Hornstein, a lawyer for Engel, instructed pharmaphorum. “An damage like this we view as extremely extreme, completely debilitating, and really life-changing. We’re proud to signify Todd Engel and his household.”
NAION is a comparatively uncommon eye situation that’s nonetheless second-leading reason behind optic nerve blindness after glaucoma. The precise trigger is just not properly understood, however docs imagine it’s associated to inadequate blood provide to the optic nerve head, usually resulting in everlasting imaginative and prescient loss in a single eye. It has no authorized remedy.
The lawsuit factors to a handful of research, together with one printed in JAMA Opthalmology, that counsel a hyperlink between NAION and GLP-1s as proof that Novo Nordisk should have recognized in regards to the threat and included it in labelling and promoting. That threat is just not presently listed in any public labelling for the drug.
“It is a state of affairs the place, had Novo Nordisk completed the suitable work upfront there may have been an applicable warning,” Dan Lipinski, one other lawyer representing Engel, instructed pharmaphorum. “However along with that, after the drug went onto the market there have been markers, whether or not they be antagonistic occasion studies or in any other case, that might have and will have led them to make some change to the label to make individuals conscious of the truth that this damage was actual and was one thing that individuals wanted to pay attention to when making that risk-benefit willpower.”
Regardless of a number of research, the proof of the hyperlink is skinny — the lawsuit itself references a research that concluded there was no statistically vital correlation. However that is difficult by the truth that NAION is a uncommon situation, making it tough to acquire statistical significance with no very giant pattern measurement.
Engel is represented by Motley Rice, a agency that specialises in representing customers and staff in fits towards giant corporations, together with pharma corporations. Plaintiffs are searching for reduction primarily based on 9 counts of legal responsibility, negligence, and breach of guarantee.
Novo Nordisk was beforehand sued in 2023, together with competitor Eli Lilly, by a affected person with extreme gastrointestinal uncomfortable side effects after taking Ozempic and Lily’s Mounjaro. That lawsuit is being coordinated with different related fits, together with one filed by Motley Rice. Proceedings are nonetheless ongoing.
Lipinski stated this case would possibly properly go the identical means.
“Whereas that is the primary grievance that was filed, I feel we’re comfy in saying that there can be extra complaints filed, not solely by our agency however by different corporations, and we could finally find yourself with a state of affairs the place there’s some kind of a coordinated continuing and these circumstances are all being managed by a single choose,” he stated.
This lawsuit is the newest growth in what’s turning into a rising concern for Novo Nordisk round NAION. Final yr, the Danish Medicines Company (DMA) requested the European Medicines Company’s Pharmacovigilance Danger Evaluation Committee to research NAION threat from Ozempic.
As of press time, Novo Nordisk didn’t reply to a request for remark.
