Tepezza Hearing Injury Could Have Been Avoided With Better Warnings, Lawsuit Claims

In a product liability lawsuit filed last week, an Arizona woman indicates she has been left with a permanent hearing injury from Tepezza, alleging that side effects of the thyroid eye disease infusions could have been avoided in the drug makers had adequately warned users about the risk and the importance of monitoring for hearing loss during treatments.

Donna Baldwin filed the complaint (PDF) in the U.S. District Court for the District of Arizona on April 10, indicating that Horizon Therapeutics USA, Inc. knew or should have known that Tepezza causes harmful hearing loss when used as prescribed and intended.

Tepezza (teprotumumab-trbw) is a new-generation biologic treatment, which was introduced in January 2020 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.

A growing number of former users are now coming forward to report that they suffered a Tepezza hearing injury, including ringing in the ears or tinnitus, as well as irreversible hearing loss, which often persists long after last use of the medication.

Baldwin indicates that after she was diagnosed with thyroid eye disease and Grave’s disease, she received a series of Tepezza infusions between June 2021 through October 2022. As a result, she suffered permanent hearing loss, the lawsuit maintains.

The lawsuit accuses Horizon of failing to meet its duty to adequately warn the medical community and patients about the risk of Tepezza hearing damage.

“Numerous patient reports, including significant newly acquired reports immediately following Horizon’s launch of Tepezza, scientific studies, and even Defendant’s post-marketing studies established that Tepezza causes hearing loss,” Baldwin’s lawsuit states. “Nevertheless, Defendant failed to warn, instruct, advise, educate, or otherwise inform Tepezza users, Tepezza prescribers, or United States governmental regulators about the risk of hearing loss, or the need for medical and/or audiological monitoring.”

Baldwin indicates the foreseeable risk of irreversible hearing injury from Tepezza could have been reduced or avoided entirely, if the drug makers had provided reasonable instructions and warnings.

 April 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 injuries experienced by former users nationwide.

The motion comes as each of the plaintiff’s have raised similar claims indicating that if Horizon 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.

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), Baldwin’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.