The Tepezza (teprotumumab) hearing loss and tinnitus lawsuits claim that patients who received the drug infusion to treat thyroid eye disease (TED) sustained hearing injuries as a result of this treatment.
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.
What You Should Know About the Tepezza Hearing Loss Lawsuits?
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.
What Settlements Have Been Reached in Tepezza Lawsuits
A settlement has not yet been reached in a Tepezza hearing loss or tinnitus lawsuit. However, 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:
- Medical expenses (past and future)
- Pain and suffering, both mental and physical, from your injury (past and future)
- Loss of wages
- Other economic losses resulting from your injury
- Possible punitive damages
Our Law Firm Has Won $30 Billion in Jury Verdicts and Settlements
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.
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.
How Much Does it Cost to Hire a Tepezza Lawsuit Lawyer?
Our law firm operates on a contingency basis, which means we only charge our clients legal fees or costs 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.
Scientific Studies and Published Case Reports Link Tepezza to Hearing Loss and Tinnitus
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.
“Teprotumumab For Patients With Active Thyroid Eye Disease: A Pooled Data Analysis, Subgroup Analyses, and Off-Treatment Follow-Up Results From Two Randomised, Double-Masked, Placebo-Controlled, Multicentre Trials”
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
“Hearing Loss and Teprotumumab”
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:
- Hearing loss
- New tinnitus (ringing of the ears)
- Ear plugging or muffled hearing
- Autophony (the unusually loud hearing of an individual’s own voice)
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
“Audiology Findings in Patients With Teprotumumab Associated Otologic Symptoms”
The December 2021 issue of the American Journal of Opthalmology 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 Opthalmology Case Reports
“Teprotumumab and Hearing Loss: Case Series and Proposal for Audiologic Monitoring”
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
“Teprotumumab Efficacy, Safety, and Durability in Longer-Duration Thyroid Eye Disease and Re-treatment: OPTIC-X Study”
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. Opthalmology
Case Report: February 2022
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
Case Report: March-April 2022
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
Case Report: April 2022
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
Case Report: April-June 2022
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
Case Report: August 2022
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
Horizon Pharmaceutical’s Own Study Established Tepezza-Caused Hearing Loss
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.
FDA Approval and Labeling
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:
- Eustachian tube dysfunction
- Hyperacusis (decreased sound tolerance)
Reportedly, the hearing loss and sensorineural hearing loss symptoms were reversible when patients stopped using the drug.
What Is Teprotumumab Used For?
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.
What Is Thyroid Eye Disease (TED) or Graves Eye Disease?
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.
Let Our Tepezza Lawsuit Attorneys Work to Recover Your Damages
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.