Graves Disease Patient Files Tepezza Lawsuit Over Hearing Loss Side Effects

The Tepezza lawsuit claims the manufacturer knew about the risk of hearing loss side effects, but failed to warn patients and the medical community

Horizon Therapeutics faces a new product liability lawsuit brought by a New Jersey woman who experienced Tepezza hearing loss side effects after receiving the infusion for treatment of Grave’s disease, also known as thyroid eye disease.

The complaint (PDF) was brough by Amarilis Polanco on April 20, in the U.S. District Court for the Northern District of Illinois, indicating that the biological Grave’s disease treatment carries a hidden risk of hearing loss that the drug maker failed to adequately warn users and the medical community about.

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 have been 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 Grave’s disease treatment, a growing number of former users are now coming forward to file Tepezza lawsuits over hearing loss, 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.

Polanco’s lawsuit indicates she was diagnosed with Grave’s disease in November 2021, and was prescribed Tepezza from then until May 2022. However, neither Polanco or her doctors were warned about the risk of hearing loss from Tepezza, or about the importance of conducting baseline audiology testing before treatments and monitoring hearing acuity following Tepezza infusions.

The lawsuit indicates that Horizon Therapeutics received numerous reports of Tepezza hearing loss side effects, but withheld the information from patients and the medical community about the risks.

“Despite study after study providing clear evidence of the dangers of Tepezza, Defendants failed to adequately investigate the threat that Tepezza poses to patients’ ears and hearing or warn patients of the risk that they would suffer ear injury and permanent or extended hearing impairment,” the complaint states.

May 2023 Tepezza 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) is currently considering a motion filed to consolidate all Tepezza lawsuits over hearing loss injuries experienced by former users nationwide.

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 expected to hear oral arguments on the motion at an upcoming hearing session in Philadelphia, which is scheduled for May 25, 2023.

If the cases are centralized as part of a Tepezza MDL (multidistrict litigation), Polanco’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.