Hearing Loss Lawsuit Filed Against Tepezza Manufacturer Over Failure to Warn

Neither the plaintiff nor her doctors were warned that Tepezza could cause irreversible hearing loss, lawsuit claims

A North Carolina woman has filed a product liability lawsuit over hearing loss from Tepezza, claiming that the manufacturers of the thyroid eye disease drug failed to adequately warn about the problems and the importance of monitoring hearing during treatment.

The complaint (PDF) was filed by Wendy Johnson in the U.S. District Court for the Northern District of Illinois on May 19, indicating that Horizon Therapeutics, Inc. knew or should have known that Tepezza causes hearing loss and other symptoms, including persistent ringing in the ears known as tinnitus, yet critical warnings about the potential risk were withheld from consumers and the medical community.

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, causing the drug to quickly reach annual sales that exceed $1 billion per year.

Although Tepezza was marketed as a safe and effective treatment, a growing number of former users are now coming forward to file Tepezza hearing loss 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.

Many of the lawsuits being filed against Horizon claim that if the manufacturer had warned doctors and patients about the risk of permanent hearing loss, healthcare professionals could have performed before and after Tepezza hearing testing on patients for early signs of hearing loss and stopped treatment before permanent damage to the sensory cells in the inner ear occurred.

Johnson’s lawsuit indicates she was diagnosed with thyroid eye disease and received infusions of Tepezza from October 2022 through November 2022.

“During the relevant time periods, Plaintiff and Plaintiff’s physicians were given no warning and had no knowledge of the serious risk of permanent hearing loss and/or tinnitus posed by Tepezza,” the lawsuit states. “Specifically…there is no warning or indication that Tepezza can, and in fact does, cause permanent hearing loss. Nor are physicians directed to conduct base-line audiology testing prior to treatment with Tepezza, or monitor hearing acuity during treatment.”

The lawsuit claims that Johnson has been left with permanent hearing loss from Tepezza use.

JPML Considering Centralization of Hearing Loss Lawsuits Over Tepezza

Given similar questions of fact and law raised in complaints filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) is currently considering a motion filed to consolidate all hearing loss lawsuits over Tepezza brought throughout the federal court system.

A group of plaintiffs filed a request last month to centralize claims filed in U.S. District Courts nationwide before one judge to reduce duplicative discovery into common issues about the link between Tepezza infusions and hearing loss, and to avoid conflicting pretrial schedules and rulings.

The U.S. JPML is considering oral arguments today on the motion, at a hearing session in Philadelphia.

If the cases are centralized as part of a Tepezza MDL (multidistrict litigation), Johnson’s lawsuit will be consolidated with the other claims. However, if the parties fail to reach Tepezza hearing loss settlements following discovery and any early bellwether trials, each lawsuit may later be remanded back to the U.S. District Court where it was originally filed for a separate trial date in the future.