Overview of Tepezza Lawsuits Against Horizon Therapeutics USA Inc.
Ireland-based pharmaceutical company Horizon Therapeutics USA Inc. is currently facing lawsuits in the United States from patients who claim that Tepezza, its thyroid eye disease drug, caused them to experience permanent hearing loss or tinnitus.
Tepezza: The First FDA-Approved Drug for Thyroid Eye Disease Tepezza, known generically as teprotumumab-trbw, received approval from the U.S. Food and Drug Administration as the first prescription drug for treating thyroid eye disease, an autoimmune condition characterized by swollen, red eyes, double vision, and eye bulging.
Allegations of Harmful Side Effects One of the earliest Tepezza lawsuits, filed by Daniel Weibel in August 2022 against Horizon Pharmaceuticals Inc., alleges that the drugmaker was aware of the potential for Tepezza to cause harmful hearing loss and tinnitus. Despite this knowledge, Horizon purportedly failed to adequately warn doctors and patients about these risks.
Absence of Specific Warnings While the drug’s label includes warnings for various side effects such as infusion reactions and exacerbation of preexisting conditions, it notably lacks specific warnings regarding hearing loss or tinnitus.
Marketing Allegations Lawsuits further claim that Horizon aggressively marketed Tepezza without properly alerting consumers and medical professionals to the associated risks.
Hearing-Related Side Effects In February 2022, Horizon addressed concerns about hearing-related side effects, stating that approximately 10% of reported cases included such events. However, subsequent studies published in journals like the American Journal of Ophthalmology and BMJ Case Reports have indicated a much higher incidence of hearing problems, with some patients experiencing ongoing issues even after treatment cessation.
Legal Response from Horizon On October 25, 2022, Horizon filed a motion to dismiss Weibel’s lawsuit, arguing that the plaintiff failed to demonstrate that the drug’s label could have been altered without FDA approval. Horizon also contends that federal law preempts the plaintiff’s failure-to-warn claims.
Ongoing Litigation Tepezza litigation is still in its early stages, with legal experts anticipating a surge in lawsuits in the coming months as more affected individuals come forward.
