Drug maker Horizon Therapeutics fails to warn taking Tepezza associated with significant risk of permanent hearing loss.
As of October 17, 2023, 54 lawsuits have been filed against pharmaceutical company Horizon Therapeutics, the manufacturer of the prescription drug Tepezza, alleging it failed to disclose to potential users that use of the drug can lead to tinnitus and permanent hearing loss.
Tepezza is an injectable prescription drug that helps reduce bulging eyes caused by Thyroid Eye Disease, also known as Graves disease. Tepezza can’t cure thyroid eye disease or bulging eyes, but it can help relieve certain symptoms for some patients.
Tepezza can lead to permanent hearing damage.
While found to be an effective therapeutic for TED, Tepezza has been also linked to permanent hearing loss and total deafness.
In fact, as soon as the medication became available on the market, numerous patients who received Tepezza infusions began reporting issues with tinnitus (ringing in the ears), reduced or muffled hearing, as well as permanent hearing loss, and total deafness.
When did Horizon learn about the side effects of Tepezza?
Horizon elected to limit Tepezza’s clinical trial size to fewer than 100 patients. It used the results from this limited trial size to obtain FDA approval for the drug. Even with the limited trial size, approximately 10% of recipients experienced some form of hearing damage.
Despite this early indication, the warning label failed to adequately address hearing loss and the permanency of this condition as an adverse reaction from Tepezza use.
Additional research into Tepezza reveals alarming risk of hearing loss.
After the medication was approved by the FDA and appeared on the market, reports began circulating that more and more patients were experiencing hearing damage and tinnitus as a result of the Tepezza infusions.
A 2021 study published by the Endocrine Society indicated that approximately 65% of patients receiving Tepezza infusions developed hearing damage after approximately three infusions. That is more than three times the percentage of what was previously reported by Horizon from their clinical trial.
Horizon notified the FDA on numerous occasions between 2020 and 2022 of patient’s adverse reactions to Tepezza. However, despite knowledge of these risks, Horizon failed to proactively upgrade the label to sufficiently warn of the risk of hearing damage from the use of its drug.
Lawsuits allege Horizon failed on a number of fronts.
The lawsuits against Horizon allege –
- Horizon failed to adequately warn of the risk of permanent hearing damage from the use of its drug Tepezza, based upon pre-market and post-market research that indicated the strong association between Tepezza and hearing impairment.
- Horizon failed to warn treating doctors of the need to closely monitor their patients’ hearing throughout the series of infusions.
- Horizon failed to perform sufficient testing on the medication prior to FDA approval.
- Horizon misrepresented the scope of individuals who would benefit from the use of the medication as widespread when, in fact, the number of individuals with TED is quite small.
Tepezza lawsuits are being consolidated for discovery.
In June of 2023, all Tepezza lawsuits were consolidated into a multi-district litigation (MDL) in the Northern District of Illinois to be overseen by the Honorable Judge Thomas M. Durkin. By consolidating all pending Tepezza lawsuits and future cases into one court, it relieves the burden on state and federal courts across the country from managing numerous cases with similar facts.
On November 3, 2023, the judge in the Tepezza hearing loss class action MDL issued a new Case Management Order laying out the rules and procedures for the bellwether case selection process and the bellwether trials. An initial pool of 12 bellwether candidate cases will be selected in 60 days. Each side will select 4 cases, and the remaining 4 will be selected at random. These 12 cases will then go through a fact-discovery process.
If you have taken Tepezza, you may be eligible for an award.
f you or a loved one has experienced adverse side effects such as permanent hearing loss or total deafness after receiving Tepezza infusions, you may be eligible for compensation.
To learn more about your rights, please fill out the form below and a Product Liability lawyer will contact you to discuss your claim. There is no cost or obligation to you.