We have helped to secure more than $80 billion in jury verdicts and settlements since 1955.
The Tepezza lawsuits claim that patients who received the drug infusion to treat thyroid eye disease (TED) are susceptible to experiencing hearing loss and tinnitus.
Our law firm is representing individuals who suffered hearing loss or ringing of the ears after taking Tepezza.
Since 1955, we have fought large corporations on behalf of the people they injure through negligence. Our Tepezza lawyers will work to get you compensation for damages resulting from your otologic (ear-related) injuries.
If you used Tepezza to treat TED and experienced hearing loss or ringing of the ears, contact us for a free, no obligation consultation: call (800) 277-1193; or complete or Free Tepezza Case Evaluation Form.
Our Tepezza hearing impairment lawyers aim to keep our clients informed about progress in this litigation. Check back here for the latest news updates.
According to the JPML, November started off with a total of 180 pending cases in the Tepezza MDL.
In October 2024, Tepezza’s manufacturer, Horizon, faced new challenges in court. A Logan County, Oklahoma, resident filed a lawsuit in the Tepezza multidistrict litigation (MDL), claiming that the drug caused permanent hearing loss. The plaintiff argues Horizon delayed adding a warning to Tepezza’s label despite evidence of risks. Meanwhile, Horizon is trying to dismiss nine of twelve bellwether cases, arguing federal law preempts these claims since the FDA approved Tepezza’s original label, covering known hearing risks.
According to the JPML September 3, 2024, report, August saw 33 new cases added to the Tepezza MDL. As of this date, 173 cases are pending in this litigation.
This month, the next status conference in the Tepezza MDL was set for September 5, 2024. Depositions will be conducted in two phases, with one set completing before February 14, 2025, and the other finishing by April 10, 2025.
The MDL court set bellwether trial dates for the Tepezza litigation as follows: March 9, 2026; May 4, 2026; June 29, 2026; August 24, 2026
As of July 1, 2024, there are 138 cases pending in the Tepezza MDL.
As of June 3, 2024, there are 120 Tepezza lawsuits pending in MDL -3079 IN RE: Tepezza Marketing, Sales Practices, and Products Liability Litigation.
The first bellwether trial for the Tepezza MDL is scheduled for March 9, 2026. After that, three more trials are planned: the second trial will begin on May 4, 2026, the third on June 29, 2026, and the fourth on August 24, 2026.
The judge in the Tepezza hearing loss MDL has recently scheduled the first bellwether trial to begin on March 9, 2026. Judge Durkin has directed both parties to work together and submit a proposed schedule for discovery and bellwether case selection leading up to the trial.
The current total number of pending cases is now 101.
The status hearing initially set for April 22, 2024, before the magistrate judge was canceled. The joint status report, originally due on April 18, 2024, must now be submitted by April 24, 2024. An in-person status hearing before the Honorable Thomas M. Durkin is scheduled for May 1, 2024.
Defense attorneys for Horizon have asked the MDL judge to postpone the deadline for selecting four lawsuits related to Tepezza hearing loss for early bellwether discovery and potential trial preparation by two months. The company explains that they need more time due to the ongoing review of medical records to identify the most suitable cases for this process.
Attorneys working on the Tepezza hearing loss cases have asked the U.S. District Judge for a 60-day extension. They need more time to review medical records and important documents to choose the best cases for the Initial Bellwether Discovery Pool for test trials. These trials are important for deciding settlement amounts, so it’s crucial for the lawyers to get it right.
On November 1, 2023, Judge Durkin entered Case Management Order (CMO) No. 3, which establishes the protocol for selection of initial bellwether discovery cases and initial bellwether trial cases, as well as authorization of plaintiff profile forms.
This Case Management Order (CMO) sets forth the rules and steps for picking twelve cases that will follow Federal Rules of Civil Procedure 12 and, if needed, carry out individual case-specific investigations. These 12 cases are called the “Initial Bellwether Discovery Cases.” After this, a smaller group of four cases will be chosen to go to trial as the “Initial Bellwether Trial Cases” in this MDL Proceeding. This CMO also set up the format for the Plaintiff Profile Form (PPF) that each Plaintiff will need to fill out and submit.
Judge Thomas M. Durkin entered Case Management Order #2 in the Tepezza MDL. The order outlines terms for evidence and privileged materials for all parties in the multidistrict litigation.
This month, the Tepezza label was changed to add a warning about permanent hearing loss. This is a significant positive fact for the case.
On June 2, 2023, pending Tepezza hearing impairment lawsuits were transferred, along with future tag-along cases, to the Northern District of Illinois in multidistrict litigation (MDL No. 3079), as ordered by the U.S. Judicial Panel on Multidistrict Litigation (JPML).
On August 25, 2022, a product liability case was filed against Horizon Pharmaceuticals Inc. (a wholly owned subsidiary of Horizon Therapeutics PLC) on behalf of an Arizona man, Daniel Weibel. The case was filed in the United State District Court for the Northern District of Illinois (1:22-cv-04518 Weibel v. Horizon Pharmaceuticals Inc.) and was assigned to U.S. District Judge Harry D. Leinenweber.
According to the Complaint, Defendant Horizon Pharmaceuticals Inc. failed to alert regulators and the general public that Tepezza, the company’s thyroid eye disease treatment drug, could cause hearing loss and tinnitus (ringing in the ear).
The drug allegedly caused Weibel’s permanent hearing loss after he had received Tepezza infusions from June 2020 through September 2020. Neither Weibel nor his physician was warned or had knowledge of the serious health risks of permanent hearing loss and/or tinnitus presented by the drug, the complaint states.
The complaint further alleges that thousands of people developed hearing loss or ear ringing after taking Tepezza. Horizon Pharmaceuticals “willfully, wantonly and intentionally conspired, and acted in concert, to ignore relevant safety concerns and to deliberately not study the safety and efficacy of Tepezza,” the complaint alleges.
A settlement has not yet been reached in the Tepezza hearing loss or tinnitus lawsuits. However, an MDL has been established for the Tepezza cases in federal court in Illinois. Our law firm is serving on the Executive Committee for the MDL.
The creation of an MDL is the first step in the litigation process that starts the settlement negotiations. Once the MDL has been formed, discovery of the facts and trials can begin, which then leads to serious settlement discussions.
If you suffered hearing loss or tinnitus after receiving teprotumumab infusions for the treatment of your TED, our lawyers will seek the following types of damages on your behalf:
Our law firm is recognized as a national leader in lawsuits centered on defective products. We have been representing injured people since 1955. In that time, we have handled more than 100,000 personal injury claims, and our lawyers have received more than 150 verdicts for $1 million or more.
Levin Papantonio Attorney Brandon Bogle has been appointed to the Plaintiffs’ Executive Committee by the judge overseeing the federal lawsuits involving Tepezza. This means that we are directly involved in the national investigation and discovery that will hopefully result in a positive outcome for the individuals injured by this drug.
Our law firm is also the founder of Mass Torts Made Perfect, a semi-annual seminar attended by thousands of attorneys who want to learn from us how to handle these types of cases.
Our law firm operates on a contingency basis, which means we only charge our clients legal fees or cost if we recover damages by a settlement or verdict.
We offer a free, confidential, and no-obligation case review. Call us today at (800) 277-1193 for your evaluation.
Alternatively, you can request an evaluation by completing our Free & Confidential Tepezza Hearing Loss and Tinnitus Evaluation Form. Our attorneys will review your form data immediately.
July 18, 2023: The Tepezza label has been changed to add a warning about permanent hearing loss. This is a significant positive fact for the case.
June 2, 2023: Pending Tepezza hearing impairment lawsuits were transferred, along with future tag-along cases, to the Northern District of Illinois in multidistrict litigation (MDL No. 3079), as ordered by the U.S. Judicial Panel on Multidistrict Litigation (JPML).
Various otolaryngologists have written to scientific publications expressing their concerns about the otologic side effects of teprotumumab. In addition, multiple scientific papers have been written explaining how treatment with teprotumumab can cause or contribute to hearing loss.
Below are some examples of published research and case reports that have documented Tepezza hearing loss, tinnitus, and other health concerns from receiving this treatment.
This study, funded by Horizon Therapeutics, uncovered hearing loss (10%) as one of the most commonly reported adverse events resulting from two teprotumumab trials at 28 specialty centers. The Lancet. Diabetes and Endocrinology
In May 2021, a study published in the Journal of the Endocrine Society and presented at ENDO 2021 suggested the potential risk of hearing loss for patients who received Tepezza infusion treatments. Patients who reported hearing symptoms then received hearing tests and patulous eustachian tube (PET) tests. Of these patients in the study who received four teprotumumab treatments, 46% reported otologic symptoms, including:
Twenty-three percent of patients experienced sensorineural hearing loss, which did not dissipate 3 months after stopping Tepezza. Adverse events in patients developed after an average of 3.6 infusions. The researchers called this hearing loss a “concerning adverse event” that “should be further studied.” Journal of the Endocrine Society
The December 2021 issue of the American Journal of Ophthalmology Case Reports featured this article, which reported on changes in hearing function linked with teprotumumab treatment for thyroid eye disease. In one case, a 74-year-old woman with Graves’ disease and thyroid eye disease received teprotumumab treatment that resulted in a “rapidly progressive worsening” of her sensorineural hearing loss, which results from damaged hair cells in the inner ear. A 42-year-old man who suffered from Grave’s disease experienced “worsening tinnitus and low-pitch hearing loss” after receiving this treatment. American Journal of Ophthalmology Case Reports
In the January-February 2022 issue of Ophthalmic Plastic and Reconstructive Surgery, researchers explored four cases of teprotumumab-associated hearing loss reported by clinicians who had given the treatment to 28 patients. In their conclusion, the researchers endorsed implementation of a surveillance protocol of audiograms (hearing tests) and tympanometry (testing of middle-ear function) before, during, and after teprotumumab infusion treatment program. Ophthalmic Plastic and Reconstructive Surgery
This small trial followed the placebo-controlled teprotumumab Phase 3 Treatment of Graves’ Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis with Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study (OPTIC) trial. Four of the 37 patient subjects reported hearing impairment—with four events occurring during the first course of treatment and two events reoccurring after re-treatment. Ophthalmology
A 77-year-old woman sustained sensorineural hearing loss (SNHL) after receiving teprotumumab therapy for her TED. Due to the prolonged and worsening SNHL after additional infusions, medical professionals intervened with audiometric testing. The tests revealed that after the patient had discontinued treatment, she still had moderate to moderate-severe SNHL with word recognition scores of 64% in the right ear and 68% in the left ear. Otology & Neurotology
Authors wrote of a patient who was receiving teprotumumab treatment for thyroid eye disease and suffered sustained hearing loss secondary to shooting a rifle without ear protection. The authors believed that the Tepezza infusions made the patient’s inner ear hair cells more susceptible to noise-induced trauma. This outcome prompted the authors to suggest that patients on teprotumumab therapy should take ear protection protocols to prevent sustained hearing loss. Ophthalmic Plastic and Reconstructive Surgery
A woman in her 50s started on teprotumumab for her chronic thyroid eye disease developed tinnitus after three doses. After her fifth dose, she experienced “frank hearing loss.” The patient ceased her Tepezza infusion treatment, but six weeks later, the side effects had not improved. BMG Case Reports
The journal published the following charts showing hearing test results done prior to Tepezza treatment and after Tepezza treatment. American Academy of Otolaryngology
Figure 1Pretreatment hearing test demonstrating normal hearing bilaterally over all frequencies. SOURCE: OTO Open. 2022 Apr-Jun; 6(2): 2473974X221097097
Figure 2 Hearing test done after the fifth infusion and onset of hearing loss demonstrating mild sensorineural hearing loss bilaterally. SOURCE: OTO Open. 2022 Apr-Jun; 6(2): 2473974X221097097
A 61-year-old woman with Graves ophthalmopathy whose Tepezza treatment caused bilateral hearing loss, sound distortion, and tinnitus. The patient had an audiogram that showed moderately severe SNHL. Her condition remained the same four months after she stopped receiving the teprotumumab treatment and was treated with oral corticosteroids. The authors concluded that teprotumumab ototoxicity resulting in irreversible SNHL for this patient. The Annals of Otology, Rhinology, and Laryngology
If you used suffered hearing loss or ringing of the ears after using Tepezza, contact us for a free, no obligation consultation: call (800) 277-1193; or complete or Free Tepezza Case Evaluation Form.
In August 2022, the American Journal of Opthalmology published a study written, in part by a consultant for Horizon Therapeutics and an individual who has served on the corporation’s advisory boards.
The study analyzed hearing dysfunction in 27 patients who had been treated with teprotumumab for TED. Researchers found that 81.5% of the patients developed new subjective otologic symptoms, including tinnitus, ear plugging/fullness, autophony, and hearing loss/decreased word comprehension. Three out of the five patients who developed SNHL experienced persistent subjective hearing loss at their last follow-up.
The United States Food and Drug Administration (FDA) approved Ireland-based Horizon Therapeutics’ Tepezza for the treatment of thyroid eye disease in January 2020 under the Fast Track and Breakthrough Therapy Designation. The drug also received Orphan Drug designation because TED was considered a rare disease for which other treatments were not readily available.
Phase 2 and 3 studies of teprotumumab revealed 85% of patients experienced side effects on the drug, with 10% of patients reporting hearing loss symptoms, including:
Reportedly, the hearing loss and sensorineural hearing loss symptoms were reversible when patients stopped using the drug.
Tepezza (teprotumumab) is an insulin-like growth factor-1 receptor (IGF-1R) inhibitor monoclonal antibody indicated for the treatment of Thyroid Eye Disease (TED). In short, the drug blocks the protein associated with the development of TED. Patients receive the drug as an infusion—eight times over a six-month period. Horizon’s label does not mention re-treatment thereafter.
Typically, Tepezza patients receive a total of eight infusions—one every three weeks. The patients receive eye exams and otologic symptom baseline testing, then follow-up testing every six, 12, and 24 weeks.
Tepezza 2021 net sales reached $1.661 billion. The pharmaceutical company prices the drug at $14,900 per vial, which adds up to $119,200 for a six-month treatment series. Horizon’s 2021 net sales across all drugs totaled $3.226 billion.
Graves disease affects the gland in the lower neck that makes hormones that regulate body functions such as growth and development, heart rate, body temperature, weight, and menstrual cycles, according to MedlinePlus. With this condition, the thyroid becomes overactive, causing a range of signs and symptoms. Up to 50 percent of Graves disease patients suffer eye abnormalities called Graves ophthalmopathy.
The condition manifests as inflammation, dryness, redness, puffy eyelids, and a gritty feeling in the eyes. One of the most prominent symptoms of TED is a bulging of the eyes. Other symptoms can include double vision, blurred vision, eye misalignment, chronic bloody eyes that are constantly watery and in which the white is inflamed. Patients can also experience an intolerance to bright lights and might struggle to move their eyeballs.
Had you known the risks that Tepezza infusions posed to your hearing, it’s possible you might have chosen not to receive this treatment for your thyroid eye disease.
The hearing loss and/or tinnitus you are suffering is not a burden you should bear alone. Rather, the makers of Tepezza should compensate you for the losses you incurred because of the company’s negligence.
Our lawyers will work hard to get you the compensation you deserve. Call us today at (800) 277-1193 for a free consultation or simply complete our Free & Confidential Tepezza Hearing Loss and Tinnitus Evaluation Form.
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