Tepezza Lawsuit | Ethen Ostroff Law
Tepezza has been hailed as an effective prescription drug for thyroid eye conditions. However, it has also been associated with severe adverse effects, including hearing loss and tinnitus. These side effects have prompted legal lawsuits against Horizon Therapeutics, the drug’s manufacturer. If you experienced hearing loss after taking Tepezza, you could be eligible for financial compensation. It is crucial to get the assistance of competent personal injury lawyers. Here, we explore the background of Tepezza lawsuit and offer insight into your legal options with Ethen Ostroff Law and its partner firms.
What is Tepezza?
Tepezza, the brand name of teprotumumab, is a targeted biologic inhibitor of insulin-like growth factor-1 receptor (IGF-1R). It is used to treat Thyroid Eye Disease (TED). It is a fully human monoclonal antibody that blocks IGF-1R activation and signaling. Its mechanism of action is not fully known.
The United States Food and Drug Administration (FDA) approved Tepezza as the first and only drug for TED. It is taken to help decrease eye bulging (proptosis) by reducing inflammation, preventing muscle and fat tissue remodeling, and preventing tissue expansion behind the eye. Tepezza is given as an intravenous infusion once every three weeks, for a total of eight infusions.
What is thyroid eye disease (TED)?
TED is an autoimmune disorder that causes inflammation of the ocular muscles and fatty tissue behind the eye. The inflammation makes the eyes bulge forward or makes the eyes and eyelids red and puffy. TED is typically associated with an overactive thyroid gland caused by Graves’ disease, although it can occur in people with an underactive or regularly functioning thyroid gland.
What are the common symptoms of TED?
- Blurred/double vision
- Difficulty moving the eyes
- Dry or watery eyes
- Eyelid and eyeball redness
- Eye pain when looking up, down, or sideways
- Gritty sensation in the eyes
- Low tolerance of bright lights
- Staring/bulging of eyes
- Swelling in one or both upper eyelids
What are the treatments available for TED?
- Artificial tear drops and selenium supplements
- High-dose steroid medications and/or radiation
- Prism glasses
- Support groups/counseling
- Surgery, including decompression surgery, eye muscle surgery, and eyelid surgery
The severity of the TED symptoms can be controlled by:
- Maintaining normal levels of thyroid hormones
- Not smoking, as TED treatments are less effective for current smokers.
- Taking selenium supplements
What is the prevalence of Tepezza-related hearing disorders?
Since its FDA approval, Tepezza has been called a breakthrough treatment for TED. However, the drug is also associated with some side effects. In two clinical trials conducted before FDA approval of the drug in January 2020, 10 percent of patients reported otologic symptoms.
But, according to a small new study presented at ENDO 2021, the Endocrine Society’s annual meeting, more patients than previously reported may experience hearing symptoms, like hearing loss or muffled hearing, from using Tepezza to cure TED. It showed that the rate could be as high as 65 percent. The most common symptoms reported were autophony (29 percent), tinnitus (27 percent), hearing loss (23 percent), and ear plugging sensation (12 percent). They developed after an average of 3.6 infusions of Tepezza.
In February 2022, a study published by the American Journal of Ophthalmology showed that 3 out of 5 patients with Tepezza-related hearing loss had persistent subjective hearing loss at their last follow-up appointments, contrary to Horizon’s claim that the hearing impairment was temporary.
What are the side effects of Tepezza?
Common side effects include:
- Dry skin
- Muscle spasm
However, some patients have reported more serious side effects, including:
- Vision loss
- Blood clots
- Heart problems
Some patients may experience a range of hearing-related side effects, including:
- Partial hearing loss
- Patulous eustachian tube dysfunction
- Permanent hearing loss
- Pulsatile Tinnitus (rhythmic thumping, whooshing, throbbing, or ringing in the ears)
- Sensorineural hearing loss
- Superior canal dehiscence syndrome (SCDS)
What are the risk factors for Tepezza users' hearing loss?
- Taking higher dosages of Tepezza
- History of hearing problems, such as tinnitus or hearing loss
- Other existing medications that might harm their ears and cause hearing loss (such as some antibiotics or chemotherapy treatments)
Are there Tepezza hearing loss lawsuits?
Yes, there are. In 2022, patients who suffered hearing loss or tinnitus after receiving Tepezza injections began filing product liability lawsuits against Horizon. Hundreds of hearing loss lawsuits are expected to be filed as more Tepezza patients suffer hearing impairments.
The first case, filed on August 25, 2022, is Weibel v. Horizon Pharmaceuticals, Inc. (1:22-cv-4518). It was followed by Nethery v. Horizon Pharmaceuticals Inc. (1:22-cv-5005) two weeks later. Both Tepezza hearing loss cases were filed in the United States District Court for the Northern District of Illinois.
The lawsuits allege that:
- Horizon negligently failed to adequately warn patients and doctors about the true risk of hearing damage from Tepezza
- Horizon engaged in deceptive marketing practices regarding their TED drug
- Horizon failed to adequately test Tepezza and investigate the risks associated with the drug
- Horizon delayed the start of an FDA-required post-marketing study to evaluate the safety of Tepezza in a larger patient population and retreatment rates relative to how long patients receive the drug
Tepezza Hearing Loss Lawsuits Update 2024
- July 1, 2023: The first Tepezza class action lawsuit status conference will be held this week.
- June 19, 2023: Judge Durkin set the initial status conference to establish protocols and rules for the litigation and appoint attorneys to the plaintiffs’ leadership committee.
- June 16, 2023: Judge Durkin issued a case management order.
- June 12, 2023: A group of Tepezza lawyers filed a motion proposing a slate of attorneys to serve in leadership positions in the Tepezza MDL.
- June 2, 2023: The Judicial Panel on Multidistrict Litigation consolidated cases against Horizon under MDL 3079, In Re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, on June 2, 2023, for coordinated pretrial proceedings. The cases will be presided over by Judge Thomas Durkin in the Northern District of Illinois.
- May 22, 2023: New Tepezza lawsuit were filed.
- May 11, 2023: A motion to consolidate Tepezza hearing loss cases into an MDL was filed. Horizon opposed consolidation.
- May 8, 2023: The volume of Tepezza lawsuit continued to increase.
- April 25, 2023: Oral arguments were heard to decide whether to create an MDL Tepezza class action lawsuit.
- March 24, 2023: Four more Tepezza hearing loss cases were filed, bringing the total to 34.
- February 16, 2023: Nine Tepezza hearing loss lawsuits were filed.
- February 14, 2023: Horizon sought to dismiss Tepezza hearing loss lawsuits based on federal preemption doctrine.
- January 19, 2023: A motion to consolidate 10 Tepezza hearing loss lawsuits in the United States District Court for the Northern District of Illinois was filed.
How much is the potential settlement payout for a Tepezza hearing damage lawsuit?
It is too early to tell how much a Tepezza lawsuit could be worth in a settlement, as the Tepezza MDL has just begun. There are too many variables at this stage to know for sure whether these cases will be viable or not. The exact value will depend on the circumstances of the case. Cases that involve major, permanent hearing loss in young plaintiffs could be worth much more. Tepezza hearing loss lawsuits with favorable facts may have a payout value at a settlement of $140,000 to $250,000.
Who can file a Tepezza hearing damage lawsuit?
- Those who received Tepezza infusion
- Those who developed/suffered permanent hearing loss and/or tinnitus as a result
How to file a Tepezza injury lawsuit?
If you decide to file a lawsuit for your hearing loss after getting a Tepezza infusion, follow these steps:
- Talk to a personal injury lawyer who knows about Tepezza hearing loss lawsuits.
- The lawyer can investigate your medical records, treatment history, and other evidence to connect Tepezza to your hearing loss.
- Your lawyer will write a complaint detailing what happened, who is involved, and what you want to happen.
- Your attorney will then file the complaint to the appropriate court, usually where the injury occurred or where the company is located.
- Horizon needs to be officially given notice of your lawsuit.
- Both sides will then exchange information, documents, and evidence related to the case.
- Your attorney can try to negotiate an out-of-court settlement. If no settlement is reached, the case can go to trial.
- If your case goes to trial, both sides will present their arguments and evidence to a judge or jury. The judgment will be based on that evidence.
What compensation can you recover in a Tepezza hearing injury lawsuit?
- Reimbursement for any medical costs you incurred because of your hearing loss
- Compensation for the income you have lost or could lose because of the injury
- Payment for the suffering brought on by the hearing loss, both physically and emotionally
- Compensation for the impact the hearing loss had on your day-to-day life
- Punitive damages
Choose Ethen Ostroff Law
If you have major side effects or issues after using Tepezza, you should consult with a personal injury lawyer to learn about your legal options. Find a lawyer who has a proven track record of success with pharmaceutical disputes and who gives a free consultation to review your case and answer your questions.
We have experienced personal injury attorneys at Ethen Ostroff Law who understand the challenges associated with Tepezza hearing loss litigation and have a track record of success in helping victims obtain the compensation they deserve. In addition to our own resources and experience, Ethen Ostroff Law offers access to a nationwide network of partner firms who share our dedication to advocating for victims of harmful drugs and medical devices. This network enables us to gather the greatest and brightest legal minds from all over the country to work on our client’s behalf.
If you have been affected by Tepezza-related hearing loss, do not put off considering legal counsel. Contact Ethen Ostroff Law at 610-510-8883 or submit form today. Schedule a free consultation on how we can help you pursue justice and hold Horizon accountable for the injury they have inflicted.