Tepezza Hearing Damage Lawsuit Filed Against Makers of Thyroid Eye Disease Drug

A California woman has filed a product liability lawsuit against Horizon Therapeutics, alleging that the drug maker failed to adequately warn about the potential hearing damage side effects from Tepezza, a blockbuster injection for treatment of thyroid eye disease, indicating users could have avoided permanent hearing loss if medical or audiological monitoring had been recommended to doctors.

Tepezza (teprotumumab-trbw) is a new-generation biologic treatment which was just introduced in January 2020, as the first medication approved to treat thyroid eye disease or bulging eyes, which is caused by hyperthyroidism and linked to Graves’ disease, resulting in inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye.

Although Tepezza was originally intended as a niche treatment, with only a limited market, during the second year the drug was on the market in the United States sales doubled to $1.66 billion, and critics have expressed concern that Tepezza was aggressively marketed without adequately disclosing all of the potential risks.

Over the past three years, hundreds of users have reported experiencing various forms of hearing damage from Tepezza, including tinnitus (ringing in the ears), hearing loss and complete deafness, with many of the problems persisting long after last use of the medication.

In a complaint (PDF) filed in the U.S. District Court for the Northern District of Illinois on February 14, Norma Perez Diaz indicates that her physician administered Tepezza infusions from November 2021 through April 2022, following a diagnosis of thyroid eye disease and Graves’ disease. However, neither she nor her doctor were ever provided any warnings about the risk of Tepezza hearing damage or the importance of conducting baseline audiological testing before treatment, or monitoring for hearing loss following infusions.

As a result of the treatments, Diaz indicates that she now suffers from hearing loss and tinnitus, which she indicates is permanent and irreversible.

Failure to Warn About Tepezza Hearing Damage

The case joins a growing number of Tepezza lawsuits filed over the past few months by individuals left with permanent hearing damage, alleging that Horizon knew or should have known about the risk before the drug was ever introduced. However, rather than disclosing the information to doctors and the medical community, the drug maker placed it’s desire for profits before the safety and wellbeing of users.

“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,” the 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 details hundreds of adverse event reports submitted to the drug maker involving users who experienced hearing damage from Tepezza, and the repeated decisions by the drug maker to provide false or misleading warnings about the potential Tepezza side effects.

“Despite adverse-event reports from healthcare professionals and consumers around the world, Defendant never adequately warned of the risk of serious and irreversible hearing loss, including, but not limited to, hearing loss and tinnitus, associated with using Tepezza,” according to the complaint.

February 2023 Tepezza Lawsuit Update

Diaz’s complaint joins nearly a dozen Tepezza lawsuits already pending in the the U.S. District Court for the Northern District of Illinois, where a group of plaintiffs filed a motion to centralize the Tepezza cases before one judge in December 2022, to avoid duplicative discovery in different cases, contradictory pretrial rulings and conflicting scheduling orders.

Although the size and scope of the litigation is expected to continue to increase rapidly, Horizon Therapeutics has objected to the proposed consolidation, claiming the cases involve substantially enough different facts and defenses that they would not benefit from coordinated pretrial proceedings. Instead, the drug maker has filed motions to dismiss Tepezza hearing loss claims, arguing that it should be insulated from liability for failing to warn under a theory of federal preemption, arguing that the FDA would have to approve a label update.

Plaintiffs maintain that ultimate responsibility for the safety and warnings provided falls on the drug maker, indicating that if they are going to sell and profit from a medication they need to conduct adequate research and disclose all known or knowable risk information.

Tepezza is an insulin-like growth factor 1 receptor (IGF-IR) inhibitor medication, and plaintiffs maintain that it is well known that IGF-I is crucial to protecting the inner ear hair cells from noise-induced hearing damage, ischemia and medication toxicity. Therefore, Tepezza lawsuits allege that the drug maker should have recognized that hearing loss would be a potential side effect, and provided warnings about the importance of monitoring during treatment and obtaining hearing tests before use.