Hearing Acuity Testing Should Have Been Recommended for Tepezza Users, Lawsuit Alleges

An Ohio woman alleges in one of the latest Tepezza injury lawsuits that manufacturer Horizon Therapeutics should have advised patients to undergo hearing acuity testing before and after receiving Tepezza infusions, to establish a baseline and to monitor for signs of hearing loss or tinnitus. The lawsuit joins a growing number of complaints alleging that the thyroid eye disease medication causes irreversible hearing damage, which users could have avoided if the manufacturer had made clear the importance of hearing acuity testing. If you or someone you love has suffered hearing loss, tinnitus, or another hearing problem allegedly related to Tepezza treatment, contact Consumer Safety Watch right away. You may be entitled to damages for the injuries you have sustained, which you can pursue by filing a Tepezza hearing loss lawsuit against Horizon Therapeutics.

Tepezza Treatment Linked to Permanent Hearing Impairment

Thyroid eye disease (TED), also known as Graves’ disease, is an autoimmune disorder that causes inflammation and swelling behind the eye, resulting in an unnatural bulging of the eyes. Tepezza (teprotumumab-trbw), a new-generation treatment introduced by Horizon Therapeutics in January 2020, is the first medication approved to treat TED. However, dozens of former Tepezza users have recently come forward with complaints of irreversible hearing loss, deafness, tinnitus, muffled hearing, and other hearing symptoms after receiving one or more Tepezza infusions. As a result, Horizon faces a growing number of product liability lawsuits alleging that the drug maker failed to adequately research the potential risk of hearing-related side effects from Tepezza infusions, and failed to disclose important drug safety information to consumers and the medical community.

In this latest Tepezza lawsuit filed in late May in the U.S. District Court for the Southern District of Ohio, plaintiff Zdena McMullen states that she was left with irreversible hearing damage after receiving a series of Tepezza infusions. According to her complaint, she was diagnosed with TED and/or Graves’ disease and received a series of Tepezza infusions between April 2022 and October 2022, which she claims permanently damaged her hearing. “Plaintiff and Plaintiff’s physicians were given no warning and had no knowledge of the serious risk of permanent hearing loss and/or tinnitus Tepezza posed,” McMullen’s lawsuit states. Specifically, […] there is no warning or indication that Tepezza can, and in fact does, cause permanent hearing damage. Nor are physicians directed by Defendant to conduct baseline audiology testing before treatment with Tepezza, or monitor hearing acuity during treatment.”

Horizon Acknowledges “Hearing Impairment Events of Greater Severity” than Those Indicated in Clinical Trials

McMullen’s lawsuit cites an annual report filed with the U.S. Securities and Exchange Commission (SEC) in March, in which Horizon Therapeutics states that “While our post-marketing studies and pharmacovigilance reporting data have shown similar rates of hearing impairment as compared to the TEPEZZA pivotal clinical trials, which is reflected in the FDA-approved label, there have been third party reports that have purported to show higher rates of hearing impairment.” The drug maker goes on to say that “a recent analysis of safety data as part of our ongoing pharmacovigilance program indicated a signal of hearing impairment events of greater severity, in limited cases, than those observed in the TEPEZZA pivotal clinical trials.” Despite these findings, Horizon has yet to update the Tepezza drug label to reflect the very real risk of irreversible hearing loss from Tepezza. Rather, “hearing impairment” is merely listed in the “Warnings and Precautions” section of the drug label as a possible adverse reaction with an incidence rate of ≥5% and greater than a placebo, on the same level as nausea, fatigue, and headache. 

Find Out if You May be Eligible for Compensation

Given common questions of fact and law raised in Tepezza lawsuits filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) earlier this month consolidated all federal Tepezza claims in the Northern District of Illinois. Claims filed in other courts, McMullen’s included, will be transferred to this Tepezza multidistrict litigation (MDL) for coordinated pretrial proceedings. If you or a loved one took Tepezza for thyroid eye disease or Graves’ disease and subsequently suffered hearing impairment, tinnitus, or some other hearing-related injury, do not hesitate to speak to a Tepezza hearing loss attorney about your legal options. You may be eligible to file a Tepezza injury lawsuit against Horizon Therapeutics, in order to pursue the financial compensation you deserve for the harm you and your family have suffered.