Tepezza, a prescribed injection used for the treatment of thyroid eye disease (TED), is under the microscope due to recent studies indicating it may lead to irreversible hearing damage and/or tinnitus (ear ringing) in some patients. If you’ve had Tepezza treatments for TED and subsequently experienced hearing loss or tinnitus, you might qualify to file a product liability lawsuit and potentially receive financial compensation. Our team of attorneys is currently accepting cases related to hearing impairment caused by Tepezza. Get in touch with us at 1-800-YOUR-LAWYER (1-800-968-7529), or reach us online for your free consultation.
What is Tepezza?
Tepezza, or teprotumumab-trbw, is an FDA-approved medication exclusively used to treat TED – a rare autoimmune disorder causing eye tissue inflammation and swelling. Tepezza works by inhibiting the insulin-like growth factor 1 receptor (IGF-1R), implicated in TED development. This treatment, developed by Horizon Therapeutics, is administered intravenously over three to six months, providing symptom relief like reduced eye bulging, double vision, and eye pain in active TED patients.
Upon its approval by the U.S. Food and Drug Administration (FDA) in January 2020, Horizon admitted to the possibility of hearing impairment as a potential side effect of Tepezza. The company, however, estimated that this potential side effect would only affect 10% of users and characterized the hearing loss as temporary and of limited duration.
However, contrasting the official statement, patients and physicians quickly reported serious complications relating to ear and permanent hearing problems post-FDA approval. Emerging research indicated that Horizon might have underestimated the hearing damage risk and severity associated with Tepezza.
What is the Problem With Tepezza?
Research published in the March 2021 edition of the journal Endocrine Society reported that 65% of Tepezza users experienced hearing loss, hearing damage, or tinnitus. This percentage significantly exceeds the estimated risk disclosed by Horizon in its product packaging and warning labels. Subsequent reports in 2022 further validated these findings and proposed potential mechanisms for Tepezza-caused hearing damage.
Every Tepezza lawsuit alleges that Horizon’s warning was inadequate as it significantly downplayed the risk level. A product warning that does not fully communicate the risk is insufficient. There was substantial medical evidence suggesting that low IGF-I levels are associated with hearing loss. Therefore, Horizon should have known this when Tepezza was submitted for FDA approval or at least when reports and studies started linking it to hearing damage.
In 2022, lawsuits began against Horizon from individuals who experienced hearing loss or tinnitus post Tepezza injections. These suits argue that Horizon negligently failed to adequately inform patients and doctors about the genuine risks of hearing damage associated with Tepezza. The claimants argue that had they known the potential harm, they would not have opted for Tepezza treatment.
The future may see hundreds more of Tepezza-related lawsuits as more patients suffer hearing damage. While these lawsuits have not yet been consolidated into a class action MDL, this could change with an influx of cases.
May 31, 2023: An individual in Ohio diagnosed with thyroid eye disease, also known as Graves’ disease, has lodged a Tepezza lawsuit. She underwent Tepezza infusions between April and October 2021, and now alleges that neither she nor her doctors were given warnings about the potential risk of permanent hearing loss or tinnitus linked to Tepezza. The plaintiff is now dealing with permanent hearing impairment.
May 22, 2023: The pace of new Tepezza-related hearing loss cases is gaining speed as the Judicial Panel on Multidistrict Litigation (JPML) prepares to hear oral arguments about potential class action MDL. Ten new cases have been filed in federal courts in the past week. Meanwhile, the Federal Trade Commission’s injunction request could derail Amgen’s planned acquisition of Horizon Therapeutics for $27 billion.
May 11, 2023: With an increasing number of Tepezza hearing loss lawsuits, the JPML has scheduled a hearing on May 25, 2023, to decide on the consolidation of these cases into a class action MDL. However, Horizon Therapeutics, the manufacturer of Tepezza, has filed a motion opposing the consolidation, stating that the volume of pending cases does not justify an MDL and optimistically predicting a limited number of future Tepezza lawsuits.
May 8, 2023: There has been a substantial increase in the filing of new Tepezza hearing loss lawsuits over the last six weeks. When an MDL consolidation motion was filed in March, it cited just 18 Tepezza cases in 5 different federal districts. However, since that motion, seven additional Tepezza hearing loss lawsuits have been lodged in various federal courts. A decision on a potential class action MDL is expected later this month.
April 26, 2023: The U.S. Judicial Panel on Multidistrict Litigation (JPML) is a panel of federal judges responsible for deciding whether to consolidate civil cases with similar fact questions across multiple federal courts. The panel aims to streamline pretrial proceedings, avoid duplicate discovery, and prevent inconsistent rulings. On May 25, 2023, this panel will decide if there should be a Tepezza class action lawsuit to consolidate all federal court cases under one judge.
April 14, 2023: As more Tepezza lawsuits are filed and pending the decision on a potential class action lawsuit, Horizon continues to profit from Tepezza. Horizon announced a new FDA approval for an amendment to the indication language for Tepezza, expanding its use in treating Thyroid Eye Disease (TED). This change could increase access for all eligible TED patients, reducing treatment time and potentially easing the access burden for patients and doctors.
April 13, 2023: A motion was recently submitted to consolidate the hearing damage lawsuits into a single Tepezza class action lawsuit for federal court claims. The motion, filed with the JPML, cites 18 pending Tepezza product liability cases across five different federal districts. If the MDL is approved, the movers suggest the Northern District of California as the venue.
April 4, 2023: A Stanford University research team published a case study suggesting a direct link between the dosage levels of Tepezza injections and hearing loss. The study further provides evidence that there is a clear and direct link between Tepezza and hearing loss.
March 24, 2023: Four new lawsuits were filed this month in federal courts alleging that Tepezza injections caused permanent hearing damage, bringing the total number of Tepezza hearing loss lawsuits filed in the federal courts to 34. Thirteen of these cases were voluntarily dismissed, which might indicate settlements.
February 28, 2023: An example of a Tepezza hearing loss lawsuit.
February 14, 2023: Horizon Therapeutics, the maker of Tepezza, is looking to have the hearing loss claims against it dismissed under the doctrine of federal preemption. Horizon’s dismissal motion contends that the tort claims made by the Tepezza plaintiffs are preempted by federal law, which regulated Horizon’s ability to change Tepezza’s warning label.
January 20, 2023: Lawyers representing Tepezza plaintiffs have requested to consolidate 10 hearing loss cases currently pending in the Northern District of Illinois. The request aims to consolidate these 10 cases before a single judge, forming a “local MDL class action lawsuit” within the federal district and applicable only to these ten cases (and perhaps more in the future).
January 18, 2023: It was recently announced that Amgen, a significant biopharmaceutical firm, had agreed to acquire Horizon Therapeutics at $116.50 per share. However, a group of Amgen investors has since filed a lawsuit to prevent the sale, alleging that Horizon failed to disclose information about the risk of hearing damage associated with Tepezza.
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