Before and After Tepezza Hearing Acuity Testing Should Have Been Recommended, Lawsuit Alleges

An Ohio woman indicates in a recently filed lawsuit that Horizon Therapeutics should have warned doctors about the importance of testing patients’ hearing before and after Tepezza infusions, to obtain baseline data and monitor for signs of hearing loss or ringing in the ears that may be caused by the thyroid eye disease drug.

In a complaint (PDF) filed last month in the U.S. District Court for the Southern District of Ohio, Zdena McMullen indicates that she has been left with permanent hearing damage from a series of Tepezza infusions, which could have been avoided if her hearing acuity had been monitored during treatments.

Tepezza (teprotumumab-trbw) is a new-generation treatment that was introduced by Horizon Pharmaceuticals in January 2020, as the first medication for bulging eyes and double vision that results from thyroid eye disease. These conditions are caused by hyperthyroidism and linked to Graves’ disease, resulting in inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye.

Many patients require multiple Tepezza infusions to treat the condition, and combined with aggressive marketing and a high cost for treatment, Horizon was able to quickly push the drug to blockbuster status, generating sales that exceed $1 billion per year. However, concerns have quickly emerged that the drug maker failed to adequately research the potential hearing side effects from Tepezza, and failed to disclose important safety information for consumers and the medical community.

McMullen now joins a growing number of former users now coming forward to file Tepezza hearing loss lawsuits, indicating that they have been left with irreversible hearing loss or ringing in the ears, known as tinnitus.

According to McMullen’s complaint, she received a series of Tepezza infusions between April and October 2022, after being diagnosed with thyroid eye disease. However, the complaint indicates her doctors were not informed by the manufacturer to conduct hearing acuity tests before and after Tepezza use, despite a known risk that the drug make cause hearing damage.

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

The lawsuit points to a recent SEC filing by Horizon Therapeutics in March, which states that a “recent analysis of safety data as part of our ongoing pharmacovigilance program indicated a signal of hearing impairment events of greater severity, in limited cases, then those observed in the TEPEZZA pivotal clinical trials.” However, McMullen points out that even with that acknowledgement, Horizon still has not strengthened the Tepezza warning label.

June 2023 Tepezza Hearing Loss Lawsuit Update

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) decided earlier this month to consolidate all Tepezza lawsuits over hearing loss, centralizing the claims before U.S. District Judge Thomas Durkin in the Northern District of Illinois, as part of an MDL or multidistrict litigation.

The complaint filed by McMullen will be transferred to this recently established Tepezza MDL, where the court will establish coordinated discovery into common issues raised in her lawsuit and similar claims brought by other former users nationwide.

An initial status conference before Judge Durkin will be held on June 28, 2023, at which time the Court will discuss the organizational structure for the litigation and it is expected that a group of Tepezza injury lawyers will be appointed to serve in various leadership roles, taking actions that benefit all plaintiffs in the litigation.

If the parties fail to reach Tepezza settlements during the MDL proceedings, Judge Durkin is expected to schedule a series of early bellwether trials to gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the claims. However, 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.