Side Effects of Tepezza Caused Irreversible Hearing Loss, Lawsuit Alleges

A product liability lawsuit filed this week indicates an Arizona woman was left with permanent and irreversible hearing loss caused by side effects of Tepezza, alleging the manufacturers of the thyroid eye disease injection failed to adequately warn users or the medical community about the potential risks associated with their treatment.

The complaint (PDF) was filed by Donna Walker in the U.S. District Court for the Northern District of Illinois on November 15, naming the drug maker Horizon Therapeutics USA, Inc., as the defendant.

Tepezza (teprotumumab-trbw) is a biologic treatment approved by the FDA in January 2020, as the first medication approved to treat thyroid eye disease, 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. This can lead to blurred or double vision and can cause the eyes to appear to bulge.

The FDA allowed Tepezza’s approval through a fast-track Orphan Drug designation, since it targets a condition that has no other treatments, which allowed Horizon to introduce the medication without extensive testing or studies. However, Weibel claims that the drug maker knew or should have known that Tepezza side effects cause hearing loss before it was ever submitted to the FDA, and that the company continued to aggressively marketed the drug shortly after it was approved, without warning users or the medical community about the importance of monitoring for hearing loss or ear damage during treatment.

Horizon Pharmaceuticals now faces a growing number of Tepezza lawsuits brought by former users, each alleging that irreversible hearing loss could have been avoided if warnings and information had been disclosed to users and the medical community.

Walker states in her hearing loss lawsuit that she was prescribed Tepezza infusions from June 2020 through November 2020, after being diagnosed with thyroid eye disease and Grave’s disease. The complaint indicates neither she nor her doctors were given any warning that side effects of Tepezza could cause irreversible hearing loss or tinnitus, yet that is exactly what she experienced.

While the Tepezza warning label does mention hearing loss as a reported side effects, Walker indicates those warnings suggested that problems experienced by users where temporary, and failed to disclose the irreversible hearing loss caused by Tepezza or the importance of monitoring hearing during treatment to avoid long-term damage.

“Defendant 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 hearing impairment,” the lawsuit states. “Defendant continues to represent the majority of hearing-related adverse events in the pivotal trials and post-approval have been mild to moderate and reversible. In contrast to the public statements, almost immediately after the FDA approved Tepezza, patients and doctors began reporting serious complications relating to ear and permanent hearing problems in patients taking Tepezza.”

The lawsuit notes that even post-marketing studies provided more evidence Tepezza hearing problems were long-lasting and permanent, at which time the manufacturer should have added additional label warnings, if not before.

November 2022 Tepezza Lawsuit Update

Walker’s lawsuit is one of the first of what is expected to be dozens of Tepezza lawsuits filed in the coming weeks and months, as more individuals learn there may be a link between hearing damage symptoms experienced and the thyroid eye disease infusion treatment.

Tepezza is an insulin-like growth factor 1 receptor (IGF-IR) inhibitor medication, and 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 will involve claims the drug maker knew or should have known about the hearing loss risks, and withheld accurate information from the FDA, consumers and the medical community.

Walker and other potential plaintiffs maintain that if warnings and instructions about the importance of monitoring for hearing loss on Tepezza had been provided, permanent ear damage may have been avoided.

Product liability lawyers are currently investigating whether individuals may be eligible for a Tepezza hearing loss lawsuit payout if they were diagnosed with tinnitus or any degree of hearing loss that was not experienced before receiving the infusion.