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Burg Simpson is investigating potential product liability claims against the manufacturer of Tepezza related to hearing loss.
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On July 17, 2023, Horizon updated the drug label for Tepezza to include warnings of hearing impairment, including hearing loss, caused by the drug. The Warnings and Precautions section of the label now states “Tepezza may cause severe hearing impairment including hearing loss, which in some cases may be permanent.” The label advises doctors administering the drug to “assess patients’ hearing before, during, and after treatment with Tepezza and consider the benefit-risk of treatment with patients.”
Horizon’s update to the Tepezza label comes after numerous adverse advents were reported to the FDA in the last three years since approval of the drug. The FDA adverse event data for Tepezza includes reports of deafness, hypoacusis (hearing loss or decreased sensitivity to sound stimuli), tinnitus (ringing or buzzing in ears), and autophony (perception that your voice is too loud or is echoing in your ears).
Several reports have been published by concerned medical professionals describing patients who suffered serious and potentially irreversible hearing impairment side effects after using Tepezza. Such hearing impairments include:
Hundreds of hearing impairment adverse events associated with the use of Tepezza have also been reported to the FDA. A new study published in early 2022 found that over 81% of the patients in the study taking Tepezza developed new hearing impairment symptoms. Several of these patients continued to suffer from hearing loss even after the 6-month study period.
Tepezza (teprotumumab-trbw) is a prescription drug marketed in the United States by Horizon Therapeutics USA, Inc. (“Horizon”). Tepezza was approved for marketing by the FDA in January 2020 for the treatment of Thyroid Eye Disease (TED), also known as Graves’ eye disease. Thyroid Eye Disease can cause blurry vision and double vision, making it difficult to read. Tepezza is administered through an IV infusion.
Horizon received FDA approval for Tepezza after performing two small clinical trials involving a total of only 84 patients who received the drug. Horizon reported that less than 10% of the test patients experienced any hearing impairment symptoms. It further represented that of these hearing related side effects, all were mild/moderate and temporary. However, since Tepezza’s approval, new information has come to light that indicates the risk of suffering hearing impairment after using Tepezza may be more common and severe than what Horizon previously reported. Despite such information, Horizon continues to sell Tepezza and has not added any further warnings on guidance to the drug's label concerning the risk of hearing impairments.
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Seth A. Katz, a former prosecutor in New York City, joined Burg Simpson in 2005. Since 1999, Seth has focused his practice on representing people who have been injured by defective drugs and medical devices as well as protecting consumers from deceptive corporate conduct. Seth has been appointed to leadership roles in many drug and device mass actions in federal and state courts across the country, including being appointed as Co-Lead Counsel in the Pradaxa Multidistrict Litigation. Seth has been the lead trial counsel in multiple trials on behalf of people injured as result of using dangerous medications. In his various roles, Seth has also been involved in negotiating settlements totaling in excess of a billion dollars for those who were injured by various drugs and medical devices.
Seth leads Burg Simpson’s Mass Tort and Class Action practice. Seth has represented people injured by birth control product (including Yaz and the Ortho Evra Birth Control Patch), Pradaxa, DePuy Hip Replacements, Gadolinium-Based Contrast Dye, Testosterone Replacement Therapy (including AndroGel and Testim), Viread and Truvada, Proton Pump Inhibitors (including Prilosec and Nexium), Exactech Hip and Knee Replacements, Power Morcellator devices, Propulsid, Vioxx, and many more.
In addition to representing Burg Simpson’s clients, Seth is frequently invited to speak at seminars across the country on various issues related to representing people injured by defective products.
Burg Simpson shareholder Melanie Bailey is a highly skilled and experienced attorney who is committed to protecting the best interests of those who have been harmed by the negligence of another party. A dedicated advocate for her clients, Melanie fights to maximize financial recoveries, and provide her clients with the best possible outcome to their legal matters.
Melanie Bailey is a member of the firm’s Cincinnati office and practices in the areas of complex civil litigation, pharmaceutical and general products liability, multi-district litigation, personal injury, wrongful death, and class action litigation. During her tenure at Burg Simpson, Ms. Bailey has devoted time to working on pharmaceutical cases, such as Elmiron, Depakote, Yasmin/Yaz, Ortho Evra, and contaminated Heparin. Ms. Bailey is a member of the Plaintiff’s Steering Committee in the Elmiron MDL litigation. She has also litigated several product liability cases for defective medical devices, such as hip replacements, knee replacements, elbow replacements, and abdominal aortic aneurysm grafts.
David Harman focuses his practice on personal injury, mass tort, and class action litigation. David has considerable experience representing individuals in complex products liability cases against some of the largest pharmaceutical and medical device manufacturers in the world. For example, David was significantly involved in the Yaz/Yasmin (Drospirenone) Products Liability Litigation (MDL 2100), representing women who suffered injuries as a result of their use of Bayer’s oral contraceptives. David also helped represent hundreds of children that suffered birth defects caused by the drug Depakote. David has also worked on the Testosterone Replacement Therapy (TRT) Products Liability Litigation (MDL 2545), Fosamax Products Liability Litigation (MDL 1789), and the contaminated Heparin litigation.
Outside of mass torts, David is experienced representing individuals in a variety of personal injury claims involving motor vehicle collisions, trucking accidents, and defective products.
If you or a loved one have been diagnosed with hearing loss, deafness, tinnitus, hypoacusis, autophony, or any other serious hearing impairment after using Tepezza, contact the experienced product liability attorneys at Burg Simpson today. Our award winning team of compassionate lawyers has spent years fighting drug companies and others who refuse to take responsibility for the harm they cause. Let us fight for you. Call 1-888-895-2080 - or fill out our contact form for a free, no-obligation consultation today.
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