Teprotumumab, or Tepezza, is a drug designed by the pharmaceutical company Horizon Therapeutics Inc. to treat thyroid eye disease. The drug got FDA approval in January 2020 and is the first of its kind. Not long after doctors started giving Tepezza to patients, those who received treatment began complaining of hearing problems. Doctors and patients claim that Horizon Therapeutics failed to provide proper warning about potential hearing problems as a side effect of taking the drug. Additionally, Horizon Therapeutics allegedly misled the FDA about the duration of hearing loss or problems that could be a result of undergoing Tepezza treatment.
Several lawsuits have come from studies that show a link between Tepezza and hearing loss. Plaintiffs claim their hearing problems are the result of taking Tepezza and they were not properly warned of the risk before agreeing to treatment. As the number of cases grows, there is a chance that the Tepezza lawsuits are combined into one multidistrict litigation (MDL). Anyone who took Tepezza and experienced permanent or severe hearing loss may want to contact an attorney to find out if they should file a Tepezza lawsuits.
Tepezza Lawsuit Updates
Is there a Tepezza lawsuit?
Yes. There are currently several Tepezza lawsuits. The first lawsuit was filed in August 2022 against Horizon Therapeutics in the U.S. District Court for the Northern District of Illinois by Daniel Weibel, a man who suffered permanent hearing loss after undergoing Tepezza treatment for his thyroid eye disease (TED), which is also referred to as Graves’ disease.
Two weeks after Weibel filed suit, another suit was filed against the same defendant for the same reason. Plaintiffs in both cases received four-month Tepezza treatments, after which they claim they suffered hearing loss. The case alleges that the doctors for both plaintiffs had no warning about the potential for hearing loss. More cases followed, all with a similar pattern where patients experienced new or heightened hearing issues after Tepezza infusions.
The most recent Tepezza case was filed by Norma Diaz in February 2023. Diaz alleges that her hearing loss started after she underwent Tepezza treatment for her TED. She claims her doctor was not aware of the risk of permanent hearing loss or tinnitus, so she did not receive the proper warning about the drug’s true side effects. Her Tepezza treatments lasted from November 2021 through April 2022. Before her treatments were complete, Norma noticed significant hearing loss after she went through an adverse immune system reaction she believed was caused by Tepezza.
In addition to Illinois, Tepezza cases have been filed in:
- New York.
As of February 2023, nearly 20 cases have been brought against Horizon Therapeutics for hearing loss-related concerns regarding the thyroid eye disease drug Tepezza. A motion to combine these cases into one MDL is undergoing consideration. However, the MDL will only include the cases filed in the Illinois Court system and not all of the cases filed so far. Of course, this could change if more cases are brought against the drug manufacturer in the future.
Tepezza linked to hearing loss and tinnitus
Tepezza is used to treat TED, an autoimmune condition that causes inflammation of the fatty muscle and tissue around the eye. Severe cases also have symptoms like bulging eyes and blurry vision. Tepezza is said to decrease eye bulging and prevent tissue from forming behind the eye through a biological inhibitor. The drug is administered intravenously in several doses over a period of several months. Patients usually receive therapy once every three weeks for eight treatments. Each treatment lasts approximately 90 minutes. The drug is reported to treat symptoms, which get progressively better, but it does not cure the disease.
Although Tepezza is an FDA-approved drug, it only went through two clinical trials in the U.S. and Europe before it was approved. These trials only had a total of 170 participants. Horizon Therapeutics told the FDA about and added warning labels on Tepezza for these common side effects:
- Muscle spasms (25%).
- Menstrual disorders (23%).
- Nausea (17%).
- Alopecia (13%).
- Diarrhea (12%).
- Fatigue (12%).
The company reported that a lower percentage of people also experienced:
- An increase in inflammatory bowel disease flares.
- A blood glucose increase.
- An increase in blood pressure.
- Muscle pain.
- Hearing impairment.
Tepezza hearing loss
Tepezza was first approved in January 2020, so it has not been on the market long. However, many patients have reported hearing issues such as hearing impairment and tinnitus after using the product. In some cases, the hearing impairment side effects disappear over time, while others experience long-term hearing problems they allege are related to their Tepezza treatments. In a post-marketing safety analysis of hearing events associated with Tepezza for the treatment of TED, Horizon Therapeutics reported that only 10% of cases mention a hearing-related event.
In an observational study conducted by American Journal of Ophthalmology through the National Institute of Health (NIH), 27 patients were analyzed who received Tepezza infusions. Of these, 22 developed hearing-related problems after receiving 3.8 infusions. In a follow-up exam upon completing all treatments, many of the hearing issues patients experienced during treatment had subsided. Hearing loss, though, remained in 5 out of 11 patients who experienced this symptom during treatment. This observational study concluded that hearing loss is an adverse event that needs to be monitored in patients who undergo Tepezza treatment.
Another NIH study, Teprotumumab and Hearing Loss: Case Series and Proposal for Audiologic Monitoring, reported that “Teprotumumab may cause a spectrum of potentially irreversible hearing loss ranging from mild to severe, likely resulting from the inhibition of the insulin-like growth factor-1 and the insulin-like growth factor-1 receptor pathway.” This study concluded that surveillance and monitoring before, during, and after treatment is vital to understand how this drug affects hearing in those who receive treatment.
A report by the Endocrine Society says that 65% of patients reported hearing issues after Tepezza treatment. The most common were subjective hearing loss, tinnitus, ear plugging sensation, and autophony, which is when a person’s own voice sounds unusually loud. While some hearing conditions improved over time, most did not fully resolve themselves. Patients complained that their hearing loss has poorly affected their quality and overall outlook on life. Some people have had their ability to work diminished by their hearing loss.
Tinnitus, or a persistent ringing in the ears, is another common side effect people complain about after getting Tepezza infusions. In fact, as many as 27% of cases report a ringing in the ears after Tepezza treatment for their TED. It is common for hearing problems to begin about halfway through Tepezza treatment, including tinnitus. Although some patients report improvement in tinnitus within a few months of their treatment, the condition can persist in others. It is unknown whether tinnitus that continues in patients even after stopping treatment is reversible.
Another hearing condition that might occur in those undergoing Tepezza treatment is patulous Eustachian tube. This is a hearing problem that causes the Eustachian tube to stay open longer than it should, making your voice sound louder than it should. More studies need to be conducted to determine how Tepezza affects hearing to help prevent permanent hearing damage for those seeking TED treatment options.
Projected Tepezza settlement amounts
There have been no settlements for Tepezza lawsuits so far, making it difficult to determine the settlement amounts plaintiffs can expect from this litigation. Attorneys are hesitant to provide estimates, as this case is still developing. Typically, in lawsuits of this nature, an attorney uses similar cases to help them estimate how much their clients can expect in the event the case results in a payout. Because the cases for the Tepezza drug are so recent, attorneys are only able to give claimants an estimated payout amount at this time.
If the Tepezza case is favorable for plaintiffs, expected payout amounts will vary based on the patient’s age and preexisting hearing loss or damage. However, some attorneys believe plaintiffs could receive anywhere from $140,000 to $250,000. A patient who underwent Tepezza treatment at a young age and had no history of hearing problems could receive a settlement of between $350,000 and $500,000. Keep in mind that these numbers are fluid and will change as the case develops, new data is released, and more people file suits.
Often in cases against pharmaceutical companies, thousands of plaintiffs file suit, and these cases are consolidated into one MDL. Then, a few cases are selected and heard in what’s called a bellwether trial. The outcome of the bellwether trial helps attorneys better predict settlement amounts. The legal process for these types of cases can take years. However, with the Tepezza lawsuit, plaintiffs should only number in the hundreds, not thousands, which will help speed up these cases.
In addition, the lawsuit is expected to move along quickly because of a possible acquisition of Horizon by Amgen, one of the world’s largest biopharmaceutical companies. Amgen wants to acquire Horizon specifically for its patent-protected TED drug. A lengthy and public lawsuit could put Horizon at risk of losing out on the potentially $27.5 billion deal.
Do you qualify for the Tepezza lawsuit?
The main qualification for the Tepezza lawsuit is that you have to have taken the intravenous treatment at some point and suffered hearing loss possibly as a result. The infusions were only approved by the FDA in 2020, so use of the TED treatment is fairly new. Doctors and patients claim that Horizon Therapeutics used deceitful practices by not disclosing the true risk of hearing loss and damage associated with receiving Tepezza treatments. If you received Tepezza infusions and experienced severe or permanent hearing loss or other hearing problems, you could talk to a lawyer about filing a lawsuit.
There is no MDL for Tepezza yet, but the possibility is being considered. The Illinois cases may consolidate first, with more joining the MDL if the number of cases continues to rise. A motion to dismiss the case was put in by the defendant, but attorneys are hopeful this will be excused. Many cases brought against drug companies attempt to dismiss cases on similar grounds without merit. If more people suffer hearing loss after receiving Tepezza treatment, the number of people filing claims against Horizon could reach the hundreds.
Talking to a lawyer is the best way to determine whether you meet the qualification to file a suit against Horizon Therapeutics for your hearing loss that could be related to receiving doses of Tepezza. This TED treatment is linked to serious and permanent hearing loss, and several lawsuits are currently underway.
Tepezza Lawsuit Timeline
2013: The FDA granted Orphan Drug and later fast-track designation to teprotumumab, the active ingredient in Tepezza .
2016: The FDA granted Breakthrough Therapy Designation to teprotumumab.
January 2020: Tepezza was approved by the FDA to treat thyroid eye disease (TED), without including a warning about deafness and hearing-related issues on its label.
May and June 2020: Reports of tinnitus following Tepezza use began to emerge shortly after its approval.
July to December 2020: Continued reports of hearing issues, including deafness, were recorded. These incidents were reported to the FDA.
March 2021: A study found that up to 65% of people taking Tepezza experienced hearing issues.
October 2021: Horizon Pharmaceuticals initiated a post marketing study to gather more data on the drug’s safety and efficacy.
February 2022: Horizon released the results of the post marketing study, revealing that about 10% of patients treated with Tepezza experienced hearing-related events.
January to September 2022: There were ongoing reports of hearing issues, including deafness, hearing loss, and tinnitus.
July 2023: A multidistrict litigation (MDL) was established, centralizing the Tepezza lawsuits for coordinated pretrial proceedings.
Late 2023: A case management order was issued to start selecting claims for the bellwether discovery pool in early 2024, with a total of 12 cases to go through discovery.
July 2023: The FDA released a new version of the Tepezza prescribing information guide, which included warnings about severe and permanent hearing loss. This update advised doctors to assess patients’ hearing before, during, and after Tepezza infusions.