Bellwether Trials for Tepezza Hearing Damage Lawsuits Set To Begin in April, June, July and September 2026
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FDA Adds Tepezza Hearing Loss Warnings to Thryoid Eye Disease Drug’s Label Plaintiffs in a growing number of Tepezza lawsuits allege that hearing loss warnings should have been added before the drug was ever sold in the U.S. July 21, 2023 Irvin Jackson Add Your Comments As Horizon Pharmaceuticals faces a growing number of lawsuits over Tepezza hearing loss, alleging that the drug maker failed to adequately warn users or the medical community about risks associated with their new-generation thyroid eye disease treatment, federal regulators have announced a warning label update which now discloses side effects of Tepezza may cause severe and permanent hearing damage. Tepezza (teprotumumab-trbw) was introduced in January 2020, as the first medication for bulging eyes and double vision that results from thyroid eye disease. These conditions are caused by hyperthyroidism and linked to Graves’ disease, resulting in inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye. Although Tepezza was considered a niche treatment, Horizon Therapeutics quickly pushed the drug to blockbuster status shortly after it was approved, resulting in sales that exceed $1 billion per year. However, concerns quickly emerged about the potential Tepezza hearing side effects and whether the drug maker sufficiently researched their treatment or disclosed the risks that consumers may face following treatment. The U.S. Food and Drug Administration (FDA) released a new version of the Tepezza prescribing information guide (PDF) on Thursday, adding a new section to the warnings and precautions section about the risk of severe hearing loss that may be permanent in some cases. The new Tepezza hearing loss warnings also now indicate doctors should assess patients’ hearing before, during, and after Tepezza infusions. Tepezza Lawsuits Over Hearing Loss The warnings update comes after dozens of former users filed product liability lawsuits against Horizon, alleging they have been left with irreversible hearing problems from Tepezza side effects, which was not adequately disclosed on the initial warning labels. Plaintiffs maintain they could have avoided permanent damage to their ears if Horizon Therapeutics had provided earlier warnings about the importance of monitoring hearing before and during treatments. Tepezza Lawsuits Did You or a Loved One Receive a Tepezza Injection? Side effects of Tepezza may cause permanent hearing problems. Lawsuits are being pursued over the drug maker’s failure to warn about the risk. Find out if qualify for a settlement. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Tepezza Lawsuits Did You or a Loved One Receive a Tepezza Injection? Side effects of Tepezza may cause permanent hearing problems. Lawsuits are being pursued over the drug maker’s failure to warn about the risk. Find out if qualify for a settlement. Learn More SEE IF YOU QUALIFY FOR COMPENSATION The FDA-approved Tepezza label now includes a new section, which contains nearly identical warnings to those plaintiffs claim Horizon Therapeutics should have provided when the drug was first introduced. “Tepezza may cause severe hearing impairment including hearing loss, which in some cases may be permanent,” the new Tepezza label warning indicates. “Assess patients’ hearing before, during, and after treatment with Tepezza and consider the benefit-risk of treatment with patients.” While permanent hearing damage has been linked to Tepezza since its clinical trials, according to various lawsuits filed against the manufacturer, Horizon Therapeutics, the company has resisted calls to add a hearing loss warning to the label. The warning update comes after a recent study published in the medical journal Endocrine Practice, which found that more than 16% of those who took the thyroid eye disease drug suffered hearing problems, including hearing loss, tinnitus, autophony and eustachian tube dysfunction. Lawsuits Allege Tepezza Hearing Loss Side Effects Were Ignored Lawsuits filed against Horizon Therapeutics allege the drug maker knew or should have known that Tepezza causes hearing loss before it was ever introduced, since the drug works by blocking a protein called IGF-1R, which can harm hair cells responsible for hearing and balance. Hair cells in the inner ear play a crucial role in detecting sound waves and transmitting them to the brain, and damaged hair cells can lead to hearing loss and other auditory issues. Although Horizon Therapeutics was aware this mechanism of action may lead to hearing loss problems among users of the thyroid eye disease drug, the lawsuits claim the drug maker failed to conduct proper follow up or disclose the potential side effects. Tepezza was submitted to FDA for approval using less than one hundred patients enrolled in clinical trials, according to the complaints, which indicate that Horizon Therapeutics attempted to ignore the problems and placed its desire for profits before the safety of consumers. Amid aggressive marketing that pushed use of Tepezza infusions that carried inadequate warning labels, lawsuits point out that sales doubled to $1.66 billion during the second year the drug was on the market in the U.S., making early users uninformed test subjects. July 2023 Tepezza Lawsuits Update Hundreds of former users are now coming forward to report that they experienced various forms of hearing loss from Tepezza, including persistent ringing in the ears known as tinnitus, and complete hearing loss. In many cases, the problems persist long after the thyroid eye disease treatments, leaving users with irreversible hearing damage. Given common questions of fact and law raised in complaints filed in federal courts nationwide, a Tepezza MDL (multidistrict litigation) was established last month, centralizing the lawsuits before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and pretrial proceedings. As part of the litigation, it is expected that a “bellwether” program will be established, where a small group of representative cases will be selected to go through case-specific discovery in preparation for early trial dates, which will help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout various cases in the litigation. Following coordinated discovery and trials in the MDL, if the parties fail to reach a Tepezza settlement agreement or other resolution for the litigation, each individual claim may later be remanded back to the U.S. District Court where it was originally filed for trial. Tags: Hearing Loss, Horizon Therapeutics, Tepezza, Thyroid Eye Disease, Tinnitus More Tepezza Lawsuit Stories Tepezza Tinnitus and Hearing Loss Lawsuits Move Into Expert Discovery Phase June 11, 2025 Tepezza Lawyers Meet With MDL Judge To Review Status of Hearing Loss Lawsuits Today March 31, 2025 Bellwether Trials for Tepezza Hearing Damage Lawsuits Set To Begin in April, June, July and September 2026 March 25, 2025 0 Comments Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. Want your comments reviewed by a lawyer?To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.Contact Phone #Alt Phone #Private CommentsNOTE: Providing information for review by an attorney does not form an attorney-client relationship.CAPTCHAGA SourceGA CampaignGA MediumGA ContentGA TermNameThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Link Between Hair Relaxers and Cancer To Be Examined by Court During “Science Day” (Posted: yesterday) A federal judge has called for Science Day presentations to explain to the court the theories and evidence linking hair relaxer to increased cancer risks. 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Bellwether Trials for Tepezza Hearing Damage Lawsuits Set To Begin in April, June, July and September 2026 March 25, 2025
Link Between Hair Relaxers and Cancer To Be Examined by Court During “Science Day” (Posted: yesterday) A federal judge has called for Science Day presentations to explain to the court the theories and evidence linking hair relaxer to increased cancer risks. MORE ABOUT: HAIR RELAXER LAWSUITHair Relaxer Cancer Lawsuits Continue To Be Filed as Lawyers Prepare First Cases for Trial (06/24/2025)Replacement Hair Relaxer Lawsuit To Be Selected for MDL Bellwether Pool (06/12/2025)Hair Relaxer Lawsuits and Talcum Powder Lawsuits Designated as New Mass Torts in Philadelphia (05/30/2025)
Lawyers Ordered To Engage in Talcum Powder Settlement Talks in MDL (Posted: yesterday) A special mediator has been appointed to oversee negotiations between Johnson & Johnson and tens of thousands of women who say its talcum powder products caused them to develop reproductive system cancers. MORE ABOUT: TALCUM POWDER LAWSUITSTalcum Powder Ovarian Cancer Lawsuit Selected for First Federal Bellwether Trial (07/01/2025)Retired Talcum Powder Judge May Be Appointed To Address Renewed Expert Motions (06/20/2025)Talc Safety To Be Subject of New Independent Scientific Expert Panel Led by FDA (05/22/2025)
Depo-Provera Wrongful Death Lawsuit Blames Injections for Fatal Brain Tumor (Posted: 2 days ago) A wrongful death lawsuit claims a woman’s sister died of a Depo-Provera brain tumor which was not discovered until after her death. MORE ABOUT: DEPO-PROVERA LAWSUITLawsuit Alleges Depo-Provera DMPA Injection Increases Brain Tumor Risks (06/20/2025)Ortho-Cept, Similar Birth Control Pills Linked to Intracranial Meningioma Risks, Study Warns (06/17/2025)Status of Depo-Provera Shot Lawsuits Outlined by MDL Judge (06/13/2025)