Long-Term Side Effects of Tepezza Cause Hearing Loss, Lawsuits Allege

Although Tepezza was introduced as a breakthrough new treatment for thyroid eye disease (TED), a growing number of individuals are now pursuing Tepezza hearing loss lawsuits, alleging that the manufacturer withheld important information about long-term side effects, which could have been avoided if warnings had been provided about the importance of monitoring for hearing damage during treatment.

Given common questions raised in complaints filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will consider oral arguments next week about whether each of the lawsuits over long-term side effects of Tepezza should be consolidated before one judge, as part of an MDL or multidistrict litigation.

Leading up to the hearing, at least three new complaints have been filed this week, each raising nearly identical allegations. However, it is widely expected that this just represents the tip of an iceberg of lawsuits that will be brought in the coming years, each claiming that Tepezza side effects caused hearing loss.

Hearing Loss Side Effects From Tepezza

Tepezza (teprotumumab-trbw) was first introduced by Horizon Therapeutics in January 2020, as the first-ever FDA approved therapy for treating Thyroid Eye Disease treatment, or commonly known as Graves disease.

Thyroid eye disease is a rare and progressive autoimmune disease that affects the tissues and muscles surrounding the eyes, and can cause painful side effects including eye irritation, double vision, eyelid swelling and sensitivity to light. One of the hallmark symptoms of TED is forward displacement or protrusion of one or both eyes. This occurs due to inflammation and swelling in the tissues and muscles behind the eyes.

After Tepezza received fast-track approval under the FDA’s Orphan Drug designation, individuals suffering from symptoms of TED were eager to begin treatment in hopes that the drug would alleviate their symptoms, and restore their eyes to normal depth.

With Tepezza’s warning label only suggesting that users may face a low risk of experiencing temporary hearing problems, many consumers and medical providers believed it was worth the perceived benefit to treat their symptoms of thyroid eye disease. However, within months of the drug hitting the market, individuals receiving Tepezza infusion began to experience long-term side effects and irreversible hearing problems that neither patients nor their doctors were warned about.

Tepezza Lawsuits Describe Long-Term Hearing Impairment

Lawsuits claim that although Horizon Therapeutics acknowledged the potential risk of hearing damage as a side effect of Tepezza, the drug maker understated the level of risk and did not provide sufficient warnings or advise healthcare providers about the need to monitor hearing during treatment to avoid long-term risks.

In a series of Tepezza lawsuits filed this week, plaintiffs describe long-term hearing damage after Tepezza infusions, each indicating that they may have avoided the permanent hearing impairment if the manufacturer had fulfilled its duty to disclose known risk information.

Traci Lynn Thompson indicates in one complaint (PDF) filed on May 15 that she was left with permanent hearing loss and tinnitus after a series of Tepezza infusions from June 2021 through November 2021. Dennis Breach filed a separate complaint (PDF) the same day describing his experiences with hearing damage from Tepezza infusions received from March 2022 to August 2022, and Peter Chryssos filed a third complaint (PDF) over problems he experienced after treatments between June 2022 and September 2022.

“During the relevant time periods, Plaintiff and Plaintiff’s physicians were given no warning and had no knowledge of the serious risk of permanent hearing loss and/or tinnitus posed by Tepezza,” according to each of the complaints. “[T]here is no warning or indication that Tepezza can, and in fact does, cause permanent hearing loss. Nor are physicians directed to conduct base-line audiology testing prior to treatment with Tepezza or monitor hearing acuity during treatment.”

How does Tepezza cause hearing loss side effects?

Lawsuits claim that Tepezza causes hearing loss by blocking a protein called IGF-1R that can harm hair cells responsible for hearing and balance. Hair cells in the inner ear play a crucial role in detecting sound waves and transmitting them to the brain, and damaged hair cells can lead to hearing loss and other auditory issues.

Although Horizon Therapeutics knew or should have known that this mechanism of action may lead to hearing loss problems, the lawsuits claim that the drug maker failed to adequately test the potential Tepezza side effects.

Tepezza was submitted to FDA for approval using less than one hundred patients enrolled in clinical trials, according to the complaints, which indicate that Horizon Therapeutics failed to conduct tests to determine the mechanism of action for their drug.

Tepezza Hearing Damage Could Have Been Avoided

Plaintiffs claim that if Horizon Therapeutics had disclosed the true risks of hearing loss from Tepezza, doctors could have performed before and after Tepezza hearing testing on patients to catch the onset of hearing problems, and prevent permanent damage to hair cells in the ear canal.

Baseline audiogram tests provide a comprehensive assessment of an individual’s hearing abilities before the initiation of any medication or treatment. By establishing a baseline measurement, healthcare providers can compare subsequent audiograms to identify any potential hearing changes or abnormalities that may arise during the course of Tepezza treatment. Regular monitoring and follow-up audiograms can help detect early signs of hearing loss or other hearing-related issues and enable timely intervention or adjustments to treatment plans.

Thompson, Breach and Chryssos each point out that other medications with side effects impacting hearing, known as ototoxic drugs, have included instructions and warnings about audiometric monitoring.

The American Speech-Language-Hearing Association 2020 guidelines, which were available to the drug maker prior to the time when each of the three plaintiffs used the drug, also suggest that baseline audiological monitoring should occur when using ototoxic medications, indicating that the information can help patients and doctors “make any important decisions to stop or change the medication therapy before your hearing is affected.”

If Tepezza hearing monitoring had been recommended, doctors could have had a reference point for detecting any changes in patient hearing during treatments, allowing them to either stop Tepezza infusions, or lower the dosage before long-term hearing damage occurred.

May 2023 Tepezza MDL Hearing Update

The U.S. JPML is scheduled to hear oral arguments on May 25, 2023, in Philadelphia, to consider whether all hearing loss lawsuits brought against Horizon Therapeutics should be consolidated as part of a Tepezza MDL, to reduce duplicative discovery into common issues in the claims, and to avoid conflicting pretrial schedules and rulings.

According to an order issued in advance of the hearing, there are currently at least 18 cases filed in five different U.S. District Courts nationwide.

Horizon Therapeutics has opposed centralization of the Tepezza infusion lawsuits, maintaining that there are currently too few claims to justify the formal consolidation. However, the number of cases has been steadily increasing, and is widely expected to include several hundred hearing loss claims by the end of this year.

Given that Graves’ disease affects nearly 1 in 100 Americans, and studies are finding Tepezza may cause up to 81% of patients to suffer hearing loss symptoms, the size of the Tepezza litigation may eventually reach over 1,000 lawsuits.

Lawyers are providing free consultations and claim evaluations for individuals throughout the United States to help determine whether financial compensation or settlement benefits may be available through a Tepezza hearing loss lawsuit, and claims are being pursued on a contingency fee basis, meaning that there are no fees or expenses unless a recovery is obtained.