Tepezza was released on the market to treat thyroid eye disease. However, the manufacturer of Tepezza failed to adequately warn that it may also cause permanent hearing issues such as hearing loss and tinnitus. If you or a loved one experienced hearing loss or tinnitus after taking Tepezza, contact Jacobson Injury Lawyers today. Jacobson Injury Lawyers will evaluate and file a claim on your behalf. If you do not receive compensation for your injury, you owe nothing.
Tepezza and Hearing Impairment
Tepezza was approved by the U.S. Food and Drug Administration (FDA) in 2020. Soon after Tepezza obtained FDA approval, numerous scientific case studies were published indicating a connection between Tepezza and hearing impairment. Despite growing evidence and mounting concern provided by the scientific community, Horizon Therapeutics continued to claim that Tepezza induced hearing impairment was temporary. However, many patients that took Tepezza had lasting hearing damage. In July 2023, the FDA required Horizon Therapeutics to change the Tepezza warning label to warn of hearing loss.
The scientific mechanism that causes Tepezza users to sustain hearing damage is anticipated to be connected to the alleged beneficial mechanism in Tepezza that addresses thyroid eye disease (TED). Tepezza is a fully human monoclonal antibody that inhibits the activity of the insulin-like growth factor 1 receptor (IGF-1R). IGF-1R pathway is believed to play a key role in the development of thyroid eye disease (TED) by promoting the inflammation, fibrosis, and adipogenesis (fat cell production) that contribute to the eye symptoms experienced by patients. However, IGF-1R also has been known to protect inner ear hair cells from noise-induced damage, ischemia (restricted blood flow), and medication toxicity. Therefore, inhibition of IGF-IR is a possible mechanism for Tepezza induced hearing injuries, termed teprotumumab-induced ototoxicity.
Who is Responsible and Why
Tepezza is manufactured by Horizon Therapeutics, a company headquartered in Ireland. Horizon Therapeutics primarily produces drugs that address difficult to diagnose and treat autoimmune and inflammatory diseases. Horizon Therapeutics was purchased by Amgen in 2023 for approximately $28 billion despite objections from the Federal Trade Commission that the deal would be detrimental to consumers.
The first case against Horizon Therapeutics alleging hearing injuries was filed in 2022. Soon thereafter, dozens of cases were filed against Horizon Therapeutics, each alleging a similar injury and claims against the manufacturer. The cases were then centralized in a Multi-District Litigation (MDL). A MDL is a legal procedure designed to efficiently process large volumes of cases that involve one or more common questions of fact in the federal court system of the United States. The MDL for Tepezza was assigned to the Northern District of Illinois. Accordingly, if you have a Tepezza case, your claim will likely be filed in the Northern District of Illinois regardless of your state or territory of residence.
The Tepezza product liability cases against Horizon Therapeutics generally claim the same wrongful conduct and associated legal causes of action. Specifically, the lawsuits claim that Horizon Therapeutics failed to warn that Tepezza could cause hearing loss (teprotumumab-induced ototoxicity). The law requires a manufacturer of pharmaceutical products to warn doctors and their patients of known risks of harm. The mechanism that pharmaceutical companies use to warn doctors and their patients of risks associated with the medication is through the label on the medication. When companies fail to adequately warn of known risks on the drug label, the law usually allows those harmed to obtain compensation for their injuries. After all, physicians are unlikely to address the symptoms of TED knowing that there is a substantial risk that the patient will have hearing loss.
The allegations made against Horizon Therapeutics go beyond a simple failure to warn case. Injured Tepezza users have claimed that Horizon Therapeutics had actual knowledge that Tepezza could cause hearing loss but misrepresented information and withheld data from the FDA. Had the FDA been made aware of this information and data, the FDA would have allegedly required Horizon Therapeutics to change the label and inform users that hearing loss was a potential side effect. The intentional concealment of information and data from regulatory authorities such as the FDA subjects Horizon Therapeutics to additional legal penalties and compensation for injured Tepezza users. Trials are pending and there is no global settlement of outstanding Tepezza cases filed in Multidistrict Litigation.
Tepezza Lawsuit Qualification
Jacobson Injury Lawyers are seeking clients that have suffered hearing loss or tinnitus after taking Tepezza. If you think you may have a Tepezza claim, contact Jacobson Injury Lawyers today. A lawyer knowledgeable about Tepezza and Tepezza litigation will provide you with a free case consultation.