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If you or someone you love has experienced hearing loss after undergoing TEPEZZA® infusions to treat thyroid eye disease, contact Bailey Cowan Heckaman PLLC today. Our team of experienced attorneys is now accepting cases and can help determine if you are eligible to receive financial compensation in a product liability lawsuit.
We offer free consultations with no obligation, so don't hesitate to get the help you need right away. We handle all matters on a contingency basis, meaning that you pay no fees unless we win your case. Take the first step towards justice today and call us at (888) 367-7160.
TEPEZZA® (teprotumumab-trbw) is an infused prescription medication that treats thyroid eye disease (TED), also known as Graves’ Disease, a rare autoimmune disorder that causes swelling and inflammation of tissue near the eyes. Tepezza blocks the activity of the protein insulin-like growth factor-1, believed to play a role in the development of the disorder that causes bulging eyes, double vision, and eye pain.
When undergoing Tepezza treatment, medical providers administer a series of eight intravenous infusions, each three weeks apart. The entire course takes about three to six weeks to complete, with the first and second sessions lasting about 90 minutes. The remaining sessions usually take about 60 minutes. Depending on how patients react to the drug, their infusions could take longer. The amount of Tepezza given to patients depends on how much they weigh.
The manufacturer indicates that most reactions occur within 24 hours after receiving an infusion. Patients with inflammatory bowel disease may experience worsening symptoms. Warnings also include a possible increase in blood sugar.
Other immediate reactions include:
The manufacturer published the following list of the most common side effects, noting that the list is not complete:
Hearing problems are noted, but not emphasized. Although Horizon Therapeutics, the manufacturer of Tepezza, indicated that 10% of users could experience hearing loss, the manufacturer stated that this side effect was temporary and only of limited duration. Unfortunately, this has not proven to be true. Our legal team is pursuing lawsuits against Horizon Therapeutics for not adequately disclosing the dangers involved when undergoing Tepezza treatment.
After the U.S. Food and Drug Administration (FDA) approved Tepezza as the first drug to specifically treat TED in January 2020, reports surfaced almost immediately claiming that Horizon seriously understated the risk of hearing damage associated with the drug.
The Endocrine Society’s March 2021 edition published a study outlining how 65% of patients who received Tepezza treatments experienced some form of hearing loss or damage of tinnitus. This percentage is more than six times higher than the estimate provided by the manufacturer.
Another study published by Ophthalmic Plastic Reconstructive Surgery in January 2022 outlined cases of Tepezza-associated hearing loss. The authors proposed a mechanism for how the drug produced hearing damage.
An observational study in February 2022 in the American Journal of Ophthalmology noted that three of five patients with Tepezza-related hearing loss had persistent hearing problems at their last follow-up.
October 2023: There are now more than 54 Tepezza cases. Some of the most significant conferences will begin this month regarding discovery protocols and evidence.
September 2023: One of the world's largest biopharma companies, Amgen Inc. will be acquiring Horizon Therapeutics and assuming liability for the Tepezza hearing loss claims.
August 2023: There are now 46 Tepezza cases named in the MDL.
June 5, 2023: An official Tepezza class action begins against Horizon Therapeutics USA Inc. The lawsuits have been consolidated in a Multi-District Litigation (MDL) overseen by Judge Thomas M. Durkin of Chicago.
April 14, 2023: Horizon Therapeutics announces FDA clearance to treat a wider range of TED (Thyroid Eye Disease) patients, which comes after a recent clinical trial that indicated positive results for treating TED. This new approval allows the drug to be used by patients regardless of how long they have been experiencing TED, while initially the drug was only approved for patients who had the disease for 9 months or less. Meanwhile, plaintiffs for the hearing loss lawsuit await the U.S. Judicial Panel's decision regarding the Multidistrict Consolidation.
April 13: A motion is filed seeking a multidistrict consolidation (MDL) of the 18 pending Tepezza product liability cases, which come from five different districts across the country. If the MDL is granted, the motion requests that the Northern District of California be the venue.
April 4, 2023: A Stanford University report examines a 64-year-old woman who received a complete round of Tepezza in 2021 and suffered immediate side effects, including temporary hearing loss in both ears. When taken off the drug, her hearing returned. A year later, her doctors tried another round of Tepezza at a much lower dose, and she did not experience the same side effect. The case study concluded that hearing loss is directly tied to Tepezza dosage levels.
February 14, 2023: Diaz v. Horizon Therapeutics USA, Inc. alleges that the plaintiff, Norma Perez Diaz, received Tepezza infusions from November 2021 through April 2022, but neither Diaz nor her doctors received any warning about the drug’s severe risk of permanent hearing loss or tinnitus. The lawsuit contends Horizon did not direct physicians to conduct baseline audiology testing or monitor hearing levels during treatment. Diaz contends that she now has permanent hearing loss, as Horizon did not adequately warn about the real risk of hearing loss associated with the drug.
February 6, 2023: Horizon Therapeutics file a motion to dismiss the complaint that they failed to properly warn patients in their safety label, stating that they were prohibited by the FDA to change their label.
January 20, 2023: Attorneys representing Tepezza plaintiffs filed a motion to consolidate 10 Tepezza hearing loss cases currently pending in the Northern District of Illinois before a single judge. The result would be similar to multidistrict litigation for product liability cases.
January 18, 2023: Although not an injury claim, a group of investors from Amgen, a giant pharmaceutical company with a deal in place to buy Horizon Therapeutics, filed a lawsuit to block the sale citing concerns over withheld information regarding the risk of hearing damage.
January 21, 2020: The FDA approves Tepezza for treatment of eye disease. Horizon markets the drug for early treatment of anyone diagnosed with TED.
August 27, 2021: The European Group on Graves’ Orbitopathy (EUGOGO) issued clinical practice guidelines recommending that Tepezza be used as a second-line treatment for moderate-to-severe Graves’ orbitopathy, which leads to TED in about 50% of cases. The group’s recommendation noted the drug’s lack of long-term efficacy and safety data.
Tepezza’s label indicates that the drug’s safety was not thoroughly tested before approval. The only reference to hearing loss on the label only mentions hearing loss and does not indicate duration of the symptoms or whether the problems are permanent. Neither does it mention tinnitus.
Plaintiff’s tort complaints have included:
Plaintiffs in a Tepezza lawsuit may be able to receive compensation for the following:
If you or a loved one have experienced hearing loss after Tepezza infusions, contact Bailey Cowan Heckaman today at (888) 367-7160. You might be eligible to receive compensation in a product liability lawsuit. We offer a free, no-obligation consultation and handle matters on a contingency basis, meaning you pay no fees unless we win. Get the help you need now!