Lawsuit Alleges Tepezza Caused Tinnitus, Permanent Hearing Loss Following Infusions of Thyroid Eye Disease Drug

A Florida man has filed a product liability lawsuit against the makers of Tepezza, claiming that information has been withheld from users and the medical community about the risk that the thyroid eye disease drug may cause permanent hearing damage.

The complaint (PDF) was filed by Syed Zafar in the U.S. District Court for the Northern District of Illinois on August 14, naming the drug manufacturer Horizon Therapeutics USA, Inc. as the sole defendant.

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 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.

According to the lawsuit, Zafar, of Miami-Dade County, was diagnosed with thyroid eye disease, or Graves’ Disease, in July 2021, and received Tepezza infusions until November 2021. As a result of those infusions, Zafar indicates he has suffered permanent hearing loss and tinnitus.

The lawsuit claims Horizon knew about the risks of Tepezza causing tinnutis and hearing loss, but failed to provide adequate warning to the medical community or those receiving the infusions.

“Defendant failed to disclose a known defect and, instead, affirmatively misrepresented that Tepezza was safe for its intended use. Defendant disseminated labeling, marketing, promotion and/or sales information to Plaintiff, Plaintiff’s healthcare providers, and the general public regarding the safety of Tepezza knowing such information was false, misleading, and/or inadequate to warn of the safety risks associated with Tepezza use,” the lawsuit states. “They did so willfully, wantonly, and with the intent to prevent the dissemination of information known to them concerning Tepezza’s safety.”

The U.S. Food and Drug Administration (FDA) released a new version of the Tepezza prescribing information guide last month, which added many of the hearing loss warnings that plaintiffs indicate should have been included when the drug was first introduced.

The new Tepezza label update now discloses that users have been left with severe and permanent hearing loss. It also indicates that doctors should assess patients’ hearing before, during, and after Tepezza infusions, to avoid users experiencing permanent ear damage.

August 2023 Tepezza Lawsuit Update

Given common questions of fact and law raised in complaints filed in federal courts nationwide, a Tepezza MDL (multidistrict litigation) was established in June, centralizing the lawsuits 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, it is expected that Judge Durkin will establish 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 these 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.