What Is Tepezza Used For?

Financial compensation might be available to individuals via a lawsuit or settlement if they suffered permanent hearing loss, developed tinnitus, or received multiple drug injections. Compensation is meant to account for medical bills, pain and suffering, lost wages, and decreased quality of life.

While the consequences of hearing loss cost money to treat, hearing loss has a broad and profound emotional effect on individuals. It can cause the sufferer to feel socially isolated, frustrated, and depressed. It can also impact their ability to make a living. Hearing loss can even be connected to serious health conditions such as heart disease, diabetes, dementia, and fall rates in older adults.

As of January 2023, a group of plaintiffs has petitioned to consolidate all Tepezza lawsuits into one multidistrict litigation (MDL). This is often the strategy when a dangerous or defective drug affects a large number of individuals across the nation to allow for better management of the case. One court then handles all discovery and pretrial proceedings. The intent of an MDL is to safeguard resources and promote the standardization of rulings across different lawsuits, usually with the objective of coming to a settlement. 

A small study that found that 65% of Tepezza users were reporting hearing loss was presented at ENDO in 2021, which is the Endocrine Society's annual meeting. While Tepezza is the first and only drug with FDA approval to treat thyroid eye disease, initial drug tests only reported 10% of users experiencing hearing problems. The subsequent study showed a vastly higher number. The researchers examined 26 patients that had received at least four injections of the drug. Seventeen complained of symptoms that included subjective hearing loss (26%), ringing in the ears (27%), ear-plugging sensation (12%), and autophony (29%). The evaluated individuals reported symptoms after an average of 3.6 injections.

The Stanford University researchers that performed the study recommended that physicians warn their patients of the danger of hearing loss as a side effect of Tepezza use. The Endocrine Society is the world's largest and oldest organization of scientists dedicated to performing hormone research and doctors who treat individuals with hormone-related conditions. Thyroid eye disease is related to the endocrine gland in the neck.

Another report published in The Annals of Otology, Rhinology, and Laryngology linked the use of Tepezza to significant hearing loss in a 61-year-old female who received injections to treat her symptoms caused by Grave's disease. She suffered bilateral hearing loss, sound distortion, and ringing in the ears, which did not subside even four months after she stopped using the drug.

Yet another report published by the Ophthalmic Plastic and Reconstructive Surgery medical journal concerned a study of four patients who were evaluated after suffering substantial hearing loss side effects post Tepezza injections. In the report, researchers warned the drug might be linked to irreversible hearing loss symptoms, and doctors should consider this when prescribing the treatment to patients.

Based on the recent link between hearing loss and Tepezza use, people are justifiably concerned, especially when individuals suffering from thyroid eye disease may already have vision problems. Patients that participated in the study described new hearing issues and/or experienced worsening sensorineural hearing loss. Sensorineural hearing loss is caused by damage to the hair cells located in the inner ear. Some patients developed a disorder with the patulous eustachian tube. The eustachian tubes normally remain closed and only open to balance the pressure around the ear drum. A patulous eustachian tube is a disorder that causes the tube between the ear, nose, and throat to stay open. Lastly, some patients reported permanent sensorineural hearing loss, making it challenging to pick out words against background noises and causing higher-pitched tones to sound muffled.

While some patients reported an improvement in symptoms three months after ceasing the injections, others did not. As with many new drugs on the market, the long-term effects are unknown because of the lack of clinical data. Without sufficient research, the likelihood of recovery can't be understood.  

Horizon Pharmaceuticals is the maker of Tepezza and conducted two clinical trials to gain the Orphan Drug designation by the FDA. These clinical trials involved 100 patients, with 10% reporting new hearing issues, including deafness, eustachian tube problems, hyperacusis, hypoacusis, and autophony. Still, while reporting these conditions, the drug manufacturer asserted that these side effects were temporary and would subside after months of stopping the treatment. However, subsequent studies revealed that patients still suffered from hearing side effects more than four months after stopping the drug.

Class action lawsuits typically take a lengthy amount of time to come together, and we're still in the early stages. Generally, when a dangerous drug manufacturer is facing many lawsuits for the same injury, the cases will be consolidated into an MDL so one U.S. District Court Judge is in charge. The assigned judge will then hear a chosen group of representatives and hold a bellwether court trial. The purpose of a bellwether trial is to determine the result of future litigation and gauge what sort of compensation other class members can expect based on the jury's reaction to evidence and testimonies. Generally, a bellwether trial catalyzes the defendant to resolve the pending litigation with a settlement. Don't hesitate to reach out to us about joining a class action.

The number of individuals learning about the link between new and worsening hearing loss and Tepezza is expected to cause lawsuit numbers to swell in the coming years. The first lawsuit was filed in Illinois in 2022 by Daniel Weibel. The lawsuit alleges the plaintiff developed permanent hearing loss after receiving treatments with Tepezza from June 2020 to September 2020 for his thyroid eye disease.

The plaintiff alleges the drug manufacturer misrepresented the development of hearing problems as temporary in its clinical trials. Furthermore, he asserts that Horizon Pharmaceuticals failed in its duty to perform sufficient research concerning the potential permanency of the hearing loss that trial members reported. Lastly, he alleges the manufacturer failed to warn users and regulators that the drug can cause severe and permanent problems with hearing.

In this case, the basis for the lawsuit is failure to warn, negligent failure to warn, design defect, and negligent design. He is seeking compensatory and punitive damages.

It's important to understand here that just because the FDA greenlights a new drug doesn't mean that it is absolutely safe. In fact, most pharmaceutical drugs have a slew of side effects. However, the FDA is more likely to approve a drug if its usefulness outweighs the dangers. Considering no drugs were available to treat thyroid eye disease, the FDA was willing to accept a reasonable level of risk. Still, in order for patients to accept a reasonable amount of risk, they have to be informed of the potential side effects. In this instance, Horizon Pharmaceuticals did not sufficiently warn people of the potential for permanent and irreversible hearing loss.
 
Likewise, a drug manufacturer cannot escape liability for failure to warn if they don't know the risk. They must do adequate testing, reasonable research, and investigating, which in the case of Tepezza, likely wasn't done. It could be that the manufacturer was willing to put users' well-being at risk unnecessarily to focus on profits.

Thus far, since no lawsuits have been heard, we don't know what kind of compensation claimants can expect. In lawsuits and class actions concerning dangerous drugs, settlement amounts can vary widely depending on many factors. Generally, the following will be considered:

• How long was the drug used
• The permanency of the hearing problems
• The cost of medical treatment, now and in the future, to treat the symptoms
• The amount of income lost due to missed work or changes in employment
• The effect the drug has on the individual's physical and mental health
• The level of mental anguish, pain, and suffering the individual has experienced or will likely encounter in the future
• Additional damages relevant to the effects of Tepezza

Morgan and Morgan Law Firm has extensive experience in class actions and personal injury lawsuits. We understand that when a negligent pharmaceutical company causes you harm, you need someone to hold them accountable. While many law firms shy away from difficult and lengthy cases against powerful pharmaceutical companies, we're fearless in doing the hard work for our clients. You deserve to be compensated for your losses. Let us help you. Contact us today for a free case evaluation concerning your Tepezza-induced hearing loss.