Tepezza Hearing Tests Should Have Been Recommended For Users of The Thyroid Eye Disease Drug: Lawsuit

According to allegations raised in a product liability lawsuit recently filed against Horizon Therapeutics, a woman from Texas indicates that she could have avoided permanent damage to her ears if her doctors had been warned about the importance of obtaining Tepezza hearing tests before and after receiving infusions of the thyroid eye disease drug.

Patrice McCracken filed the complaint (PDF) in the U.S. District Court for the Northern District of Illinois on November 17, alleging that the drug maker knew or should have known about the risk of hearing loss from Tepezza, yet failed to provide adequate instructions for users and the medical community about steps that can be taken to detect and avoid the damage.

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 permanent ringing in the ears or tinnitus, as well as irreversible hearing damage, which persists long after last use of the medication.

McCracken’s complaint indicates that she was diagnosed with thyroid eye disease in July 2021. She was prescribed Tepezza infusions, which she received from then until December 2021.

During that time period, neither McCracken nor her doctor were warned about the importance of obtaining before and after Tepezza hearing testing to obtain baseline levels and detect early symptoms of hearing loss, so that treatments can be stopped before permanent damage is suffered by the sensory cells in the inner ear.

According to the lawsuit, Horison knew based on the mechanism of action that allows the thyroid eye disease to work that side effects of Tepezza may impact hearing of users, yet false and misleading information was provided for years.

“Defendant actively concealed the true risks associated with the use of Tepezza, particularly as they relate to the risk of serious hearing-related injuries, by affirmatively representing in numerous communications that there were no hearing loss warnings required to safely prescribe and take Tepezza and no permanent hearing-related adverse side effects associated with use of Tepezza,” the lawsuit states. “Due to the absence of any warning by Defendant as to the significant permanent health and safety risks posed by Tepezza, Plaintiff was unaware that Tepezza could cause serious hearing-related injuries, as this danger was not known to Plaintiff, Plaintiff’s healthcare providers, or the general public.”

Years after McCracken suffered irreversible hearing loss, the drug maker did finally issue a new version of the Tepezza prescribing information guide in July 2023, which added many of the hearing loss warnings that plaintiffs now indicates should have been included when the drug was first introduced.

The new Tepezza hearing loss warnings now disclose that users have been left with severe and permanent damage, and recommends that doctors assess patients’ hearing before, during, and after Tepezza infusions, to avoid users experiencing permanent ear damage.

November 2023 Tepezza Hearing Loss Lawsuit Update

Given common questions of fact and law raised in complaints filed by McCracken and hundreds of other individuals pursuing lawsuits throughout the federal court system, a Tepezza MDL (multidistrict litigation) was established in July 2023, centralizing the claims before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

As part of the coordinated management of the litigation, Judge Durkin is establishing a “bellwether” program, where a small group of representative cases will be 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.

While the outcome of Tepezza bellwether early trial dates will not be binding on other claims in the litigation, the average lawsuit payouts may influence eventual Tepezza settlement negotiations that will be necessary to avoid each individual case being set for trial in the coming years.