Lawsuit Indicates Tepezza Hearing Impairment Warnings Were Delayed By Horizon Therapeutics, Disregarding Safety of Users

Horizon failed to instruct doctors to conduct routine hearing tests on patients to monitor for signs of hearing impairment from Tepezza, lawsuit states.

A New Jersey man indicates that he has been left with permanent hearing impairment from Tepezza, alleging in a recently filed lawsuit that he may have avoided the damage if the manufacturer of the thyroid eye disease drug had provided adequate warnings for users and the medical community.

The complaint (PDF) was brought by Michael Wuss in the U.S. District Court for the Northern District of Illinois on June 24, claiming that Horizon Therapeutics disregarded the safety of users by failing to instruct doctors about the importance of conducting routine hearing tests on patients to monitor for signs of Tepezza hearing impairment.

Wuss indicates he received a series of Tepezza infusions from 2021 to 2023, after he was diagnosed with thyroid eye disease, also often known as Grave’s disease. However, he subsequently developed hearing loss and tinnitus, which involves persistent ringing in the ears.

The lawsuit points out that at the time he initiated the drug, there were no warnings or indications that Tepezza may cause permanent hearing damage. In fact, the complaint outlines information that suggests Horizon Therapeutics knew or should have known about the hearing impairment risks during the drug’s development, and failed numerous times to take advantage of federal laws that would have allowed them to immediately update the warning label.

Tepezza Hearing Impairment Risks

Tepezza (teprotumumab-trbw) was introduced in January 2020, as the first treatment for bulging eyes and double vision that results from thyroid eye disease, which is caused by hyperthyroidism and linked to Graves’ disease. The underlying condition causes inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye, and multiple Tepezza infusions are often prescribed by many doctors.

Although Tepezza was marketed as a safe and effective treatment, a growing number of former users are now coming forward to file Tepezza lawsuits, indicating that they have been left with hearing impairments that typically persist long after last use of the medication.

Wuss’ lawsuit notes that when drug manufacturers discover there are side effects linked to their medications, which were missed or misinterpreted during clinical trials, they can submit a “Changes Being Effected” (CBE) supplement to the U.S. Food and Drug Administration (FDA). The agency will then immediately make the labeling revisions available to the public.

Although Horizon Therapeutics could have done that shortly after it learned of incidents of Tepezza hearing impairment, the lawsuit filed by Wuss failed to take those steps, despite being aware of the risk since at least March 2020.

Instead of warning users and the medical community immediately, Horizon Therapeutics waited until January 2023 to file for label changes indicating, which would have added more detail on the risks of permanent hearing damage. However, even then opted for a months’ long FDA review, during which it argued with the FDA over the language, which added to the delay. As a result, information was not added to the drug’s label until July 2023, long after Wuss had already experienced problems.

The new Tepezza hearing impairment label warnings included language about the importance of conducting audiological testing before and during treatments, and included information about post-marketing reports of hearing problems users were experiencing.

“Horizon could have changed the label immediately and unilaterally (i.e. without FDA approval) through the CBE process,” Wuss’s lawsuit notes. “Horizon instead chose to further delay providing critical safety information to the unsuspecting public, Plaintiff, Plaintiff’s healthcare providers, and the medical community by submitting a Prior Approval Supplement (PAS), which is a lengthier process. Meanwhile, the evidence of Tepezza causing severe and permanent hearing loss continued to mount.”

Tepezza Label Update Based on Three-Year Old Data

The complaint alleges that Horizon knew, or should have known, about Tepezza hearing impairment risks shortly after the drug hit the market in 2020, yet placed a desire for profits before the health and safety of users.

Although Horizon Therapeutics claimed that its January 2023 PAS label warning request was based on a reanalysis of data from its Expanded Access Protocol (EAP) clinical trial, the lawsuit points out that the data has not been updated since March 2020, meaning either Horizon sat on the data for three years before analyzing it, or analyzed it, saw the problems, and waited three years to update the label.

“By failing to use the FDA’s CBE supplement to warn Plaintiff, consumers, and physicians of the risk of permanent hearing loss associated with using Tepezza as soon as it had notice of adverse-event reports relating to those types of injuries, Defendant acted in a gross and flagrant character, evincing reckless disregard of the safety and welfare of persons exposed to its dangerous drug,” the lawsuit states. “Additionally, by failing to use the FDA’s CBE supplement to warn Plaintiff, consumers, and physicians of the risk of permanent hearing loss and/or tinnitus associated with using Tepezza, Defendant showed wantonness, recklessness, or a grossly careless disregard for the public’s safety and welfare.”

July 2024 Tepezza Hearing Impairment Lawsuit Update

Wuss’s complaint joins hundreds of Tepezza hearing impairment lawsuits, which have been centralized before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and pretrial proceedings, as part of a Tepezza MDL (multidistrict litigation).

As part of the coordinated management of the litigation, Judge Durkin has established a “bellwether” program, where a group of 12 representative cases have been selected to go through case-specific discovery in preparation for early trial dates, which will help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout various cases in the litigation.

In early June, Judge Durkin held oral arguments on the Tepezza bellwether trial schedule, determining that the first bellwether trial will begin on March 9, 2026, with the second beginning on May 4, 2026, a third trial scheduled for June 29 of that year, and the fourth and final to begin on August 24, 2026.

While the outcome of these early bellwether trials will not have any binding impact on other claims presented in the litigation, the average Tepezza lawsuit payouts awarded by juries are likely to have a large impact on settlement negotiations between the parties.

Following the bellwether trials, if the parties fail to reach Tepezza hearing loss settlements or another resolution for the litigation, Judge Durkin may begin remanding individual cases to U.S. District Courts nationwide for separate trial dates in the coming years.