Horizon Therapeutics to Face Tepezza Hearing Loss Lawsuits

In one of the first product liability lawsuits involving Tepezza, an Arizona woman alleges that Horizon Therapeutics’ thyroid eye disease (TED) drug caused her to suffer irreversible hearing loss. The claim, filed on November 15 in the U.S. District Court for the Northern District of Illinois, joins a growing number of lawsuits involving Tepezza patients who allege that they have suffered lasting hearing damage as a result of the TED treatment. If you received Tepezza infusions to treat thyroid eye disease and subsequently suffered hearing damage, hearing loss, muffled hearing, tinnitus, or an ear-plugging sensation, contact Consumer Safety Watch as soon as possible. You may have grounds to file a Tepezza lawsuit against Horizon Therapeutics, in order to pursue financial compensation for your injuries.

What is Tepezza?

Tepezza (teprotumumab-trbw) is a prescription injection used to treat thyroid eye disease (TED) or Graves’ eye disease, a rare eye disease characterized by progressive inflammation, swelling and damage to the tissues around the eyes. People with TED typically experience symptoms ranging from puffiness around the eyes to bulging of the eyes, with swelling leading to eye pain, increased pressure inside the eye socket, and decreased vision. Tepezza is designed to block the receptors in the tissues behind the eyes that are attacked by the body’s immune system in people with TED. As the first-ever treatment for TED, the U.S. Food and Drug Administration (FDA) fast-tracked Tepezza through its Orphan Drug Designation program in January 2020, without requiring Horizon to conduct extensive testing or studies. What many people taking Tepezza don’t know is that while the drug may offer some benefits in the treatment of TED, it may also cause them to suffer irreversible hearing loss.

Tepezza Lawsuits Accuse Horizon of Failure to Warn

Walker’s claim is one of the first of what is expected to be hundreds of Tepezza lawsuits linking the thyroid eye disease medication to permanent hearing loss and other hearing problems. She alleges in her lawsuit that the manufacturers of Tepezza misled users and healthcare providers by suggesting that hearing loss side effects of the drug were temporary when many users are suffering permanent hearing problems while taking Tepezza. Each Tepezza lawsuit brought against Horizon will likely involve similar allegations that the manufacturer knew or should have known that the TED drug could put users at risk for lasting hearing loss side effects and continued aggressively marketing the drug without warning users or healthcare providers about these risks or about the importance of monitoring for hearing loss. Plaintiffs allege that Tepezza users could have avoided serious side effects had Horizon provided adequate warnings about the potential risk of irreversible hearing damage with Tepezza treatment.

“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,” Walker’s 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.” Walker alleges additionally that despite post-marketing studies providing further evidence that Tepezza may cause permanent hearing loss, Horizon has failed to update the drug’s warning label to reflect this potential risk. 

Studies Linking Tepezza to Hearing Loss Side Effects

A number of studies and case reports published in the nearly three years since Tepezza entered the market have identified a connection between the TED treatment and hearing loss side effects. A study published in the American Journal of Ophthalmology in February 2022 found that, out of 27 patients who received at least four doses of Tepezza, 80% suffered some form of hearing damage within about 40 weeks of receiving the final infusion. In an analysis of the effectiveness of Tepezza presented at the 91st Annual Meeting of the American Thyroid Association in October 2022, Horizon reported that up to 15% of patients who received Tepezza infusions for TED experienced flare-ups and 5% required a second course of treatment. Researchers have not yet determined whether receiving multiple courses of Tepezza treatment increases the risk of Tepezza hearing loss problems.

Contact Consumer Safety Watch to Explore Your Options

Tepezza injury attorneys across the country are currently investigating claims by Tepezza users who have been diagnosed with hearing loss, tinnitus, and other types of hearing damage that were not present prior to receiving the TED infusion. If you or someone you love has suffered hearing loss that you believe to be linked to Tepezza treatment, do not hesitate to discuss your legal options with a knowledgeable Tepezza lawyer. Contact Consumer Safety Watch as soon as possible to find out if you may be eligible for a Tepezza hearing loss settlement.