What Is It and What Does It Mean for Me?
Case: In Re: Tepezza Marketing, Sales Practices, and Products Liability Litigation
Court: United States District Court, Northern District of Illinois
Wallace Miller is investigating reports of serious and potentially permanent hearing damage related to the thyroid eye disease drug Tepezza. If you or a loved one have taken the drug and experienced adverse effects to your hearing, you may be eligible to participate in a Tepezza hearing loss lawsuit.
Get in touch with the Tepezza lawyers at Wallace Miller today by calling 312-261-6193 or fill out our online questionnaire for a free and confidential consultation.
July 2023 update
The FDA has added a notice on the Tepezza label warning consumers of hearing impairment and loss. The new warning, which is one of four on the drug packaging, states, “TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.”
June 2023 update
The Brazilian Health Regulatory Agency (ANVISA) has approved Tepezza for use, making Brazil the only country outside of the U.S. where Tepezza may be sold. The agency based their decision on the same studies that the FDA referenced in their 2020 authorization. Tepezza is the first and only medication in Brazil approved for use in treating thyroid eye disease (TED).
What is Tepezza?
First approved by the FDA for medical use in January 2020, Tepezza (teprotumumab-trbw) is an intravenous medicine used to treat thyroid eye disease (TED). It is the first and only medication approved for the treatment of TED in the U.S.
The medication works by binding to the receptor switches behind the eyes that cause TED, preventing the swelling of muscle and fat tissue characteristic of the disease. It is generally administered to patients every three weeks, for a total of eight injections.
Since its approval, Tepezza has been linked to potentially permanent hearing problems, including deafness, hearing loss and tinnitus (ringing in the ears).
What is thyroid eye disease?
TED is an autoimmune condition that causes swelling and damage to the tissues surrounding the eyes. In those with this condition, the protective immune system activates receptors in the cells behind the eyes. This causes muscle and fat tissue to swell, pressing on the eye and leading to symptoms like eye pain, redness, and swollen eyelids. The condition can also push the eye outwards, causing a bulging appearance and double vision.
People with Graves’ disease, another autoimmune disease, are more likely to develop thyroid eye disease. Graves’ disease is linked to a number of health conditions including hyperthyroidism and hypothyroidism, both of which can result in TED.
TED is more common in women than in men. You may also have a higher risk of thyroid eye disease if you have low blood levels of the mineral selenium or if you have family members with the disease.
Studies link Tepezza to serious hearing loss
In March 2021, the Endocrine Society published a study that found 65% of patients on Tepezza reported hearing problems. The hearing problems from Tepezza appeared to develop after an average of 3.6 infusions, according to the findings.
Stanford University researchers studied 26 patients who had been treated with four or more Tepezza infusions. Seventeen (65%) of the patients reported suffering hearing loss. The most common symptoms reported were hearing loss (23%), ringing in the ears (27%), ear plugging sensation (12%) and autophony, an unusually loud hearing of a person’s own voice (29%). Three patients developed a long-term hearing problem called patulous eustachian tube, a disorder in which the channel that runs between the middle ear and back of the nose and throat stays open. Some of the Tepezza users who reported worsening sensorineural hearing loss found that their symptoms improved with time, but they did not go away entirely.
The following is a list of potential hearing related side effects of Tepezza:
- Hearing loss (hypoacusis)
- Ringing in the ears (tinnitus)
- Autophony (loud hearing of a person’s own voice)
- Muffled hearing
- Ear plugging sensation
- Eustachian tube dysfunction
How common is hearing loss with Tepezza?
In the initial clinical trials conducted before the medication’s FDA approval, only about 10 percent of patients reported persistent subjective hearing loss. However, the 2021 study found that up to 65 percent of patients subsequently suffered hearing damage.
The findings of a 2022 study published in the American Journal of Ophthalmology were even more significant. The researchers found that of the 27 patients analyzed, more than 80 percent reported the development of symptoms including hearing loss and tinnitus after receiving Tepezza infusions.
Does Tepezza cause permanent hearing loss?
The 2022 study found that the symptoms of Tepezza-related hearing loss generally improved over time. However, in patients experiencing hearing loss specifically (rather than other symptoms like tinnitus or autophony) a majority reported continuing symptoms at the last research follow-up.
Research on permanent hearing loss caused by Tepezza is still ongoing. The 2021 study found that patients diagnosed with patulous eustachian tube were more likely to report long-term hearing loss symptoms but indicated that further follow-up is needed.
What is the lawsuit against Tepezza about?
One of the first lawsuits against Tepezza was filed in August 2022 by Wallace Miller and Johnson Becker in the United States District Court for the Northern District of Illinois. The plaintiff, Daniel Weibel, alleges that Tepezza caused him to suffer irreversible hearing loss.
According to the Tepezza lawsuit filed, Weibel was first diagnosed with thyroid eye disease and/or Graves’ Disease in 2020. He received Tepezza infusions from June to September of that year, with no knowledge of the potential risk of hearing damage. The plaintiff now suffers from permanent hearing loss.
In the Tepezza lawsuit, Weibel claims that Tepezza did not adequately warn patients about the risks of the medication. More than 30 lawsuits have been filed since August 2022, and in June of 2023, the individual cases were consolidated into a multidistrict litigation in the Northern District of Illinois.
In a multidistrict litigation, multiple mass tort lawsuits are brought together so that pretrial proceedings against the same defendant or group of defendants can be conducted more effectively. Read more about multidistrict litigation here.
Who is the defendant in the Tepezza hearing loss lawsuit?
Horizon Therapeutics is a pharmaceutical company with its US offices in Deerfield, Illinois. Founded in 2008 by CEO Tim Walbert, the company focuses on medicines for “rare, autoimmune and severe inflammatory diseases.” The Tepezza lawsuits claim that they should have known that the product causes hearing loss and failed to disclose the risk to patients and providers.
In a statement to the Ophthalmology Times, Horizon Therapeutics said, “We do not believe the lawsuits have merit and vigorously defend them. Hearing impairment was identified as a potential adverse event in the Tepezza pivotal clinical trials, was thoroughly discussed at the FDA advisory committee meeting prior to the approval of Tepezza and is referenced in the Tepezza product label.”
Who is eligible for a Tepezza hearing loss lawsuit?
If you have taken Tepezza and believe you may be suffering from hearing loss or tinnitus, you may be eligible to participate in the Tepezza hearing loss lawsuits. Wallace Miller is currently representing individuals who fit the following criteria:
- Have had at least three Tepezza treatments, prescribed for either TED or Graves’ Disease;
- Have suffered from hearing loss, deafness, or tinnitus for more than 6 months; and
- Had no hearing issues prior to taking Tepezza.
If you believe that you or a loved one may be eligible for a Tepezza lawsuit, reach out to Wallace Miller at 312-261-6193 or via our online questionnaire for a free and confidential evaluation of your case.
What compensation can I receive for hearing loss caused by Tepezza?
In cases like the Tepezza hearing loss lawsuits, your attorneys work to prove that the defendants’ negligence led to your injury in order to help you receive financial compensation. While it is difficult to predict exactly how long the Tepezza hearing damage lawsuits will take at this early point, many multidistrict litigations take several years to resolve.
In similar cases, defendants often opt to negotiate a global settlement. If a Tepezza lawsuit settlement is reached, the plaintiffs who have brought a hearing loss lawsuit against the manufacturer will be divided into tiers and then awarded settlement amounts based on their level of injury.
How much time do I have to file a Tepezza lawsuit?
The Tepezza lawsuit is still in its early stages. Plaintiffs are actively filing lawsuits, so the sooner you are able to file a Tepezza litigation, the better.
Different states will often have different statutes of limitations, which affect how long after an injury someone is able to file a lawsuit. The best way to determine if your case is eligible is to contact our firm today at 312-261-6193 or via our online questionnaire.
June 2, 2023: The Judicial Panel on Multidistrict Litigation has ruled to consolidate the existing Tepezza hearing damage lawsuit in a multidistrict litigation in the Northern District of Illinois. This marks an important step forward for the Tepezza lawsuits.
May 2023: More than 30 Tepezza lawsuits have now been filed.
October 2022: Horizon Therapeutics filed a motion in Illinois to dismiss Weibel’s claims, stating that it had warned of possible side effects, including hearing loss, on its label.
August 2022: Daniel Weibel, represented by firms including Wallace Miller, has filed one of the first Tepezza lawsuits in the Northern District of Illinois. His litigation claims that he developed permanent hearing loss as a result of his use of Tepezza.
February 2022: A study published by the American Journal of Ophthalmology found that a majority of patients taking Tepezza experienced hearing loss, tinnitus, or other hearing-related symptoms.
March 2021: A small study presented virtually at ENDO 2021, the annual meeting of the Endocrine Society, found that up to 65% of patients experienced hearing loss or tinnitus when taking the TED drug Tepezza.
January 2020: Tepezza was approved for use by the FDA.
Contact our firm
The legal team at Wallace Miller is proud to represent plaintiffs in mass tort litigations across the U.S. Our law firm is focused on protecting the victims of negligence and fraud through consumer protection, product liability, employment, environmental and toxic harm, and personal injury litigation.
We know that there are many choices available to you when looking for a lawyer to represent you in cases like the Tepezza lawsuit. What sets us apart from other firms is our commitment to our clients, our ability to handle complex high-stakes litigation, and our outstanding track record of success. We only take on cases that our firm has faith in—those that can make a difference in our clients’ lives.
Wallace Miller has unique insight into the Tepezza case thanks to the appointment of Partner, Molly Condon Wells, as Liaison Counsel for the MDL. She will serve alongside attorneys from other firms to represent the best interest of each and every client that is part of the case in the Northern District of Illinois under Judge Thomas M. Durkin.
Questions about your potential Tepezza case? Call our office at 312-261-6193 or fill out our online questionnaire for a confidential and free consultation.