Some medications cause devastating side effects such as heart attacks, strokes, and seizures. All drug manufacturers are required to list all potential drug side effects on the product’s label, but they rarely do it.
Horizon Therapeutics is a good example of a manufacturer that failed to warn patients of the potential side effects of its drugs.
After developing Tepezza, a prescription drug for treating thyroid eye disease, Horizon Therapeutics did not warn patients and doctors of potential side effects.
The drug is linked to hearing-related adverse effects such as tinnitus and permanent hearing loss. Horizon Therapeutics knew of this risk but understated it as a temporary side effect.
If you have suffered hearing loss after using Tepezza, you could file a Tepezza hearing loss lawsuit to seek compensation for your damages.
Read on to learn about Tepezza, associated risks, and whether you qualify for compensation.
What Is Tepezza?
Tepezza (teprotumumab) is a brand-new medication available only by prescription, used to treat Graves’ eye disease and thyroid eye disease (TED).
TED is a disorder that inflames the fatty tissue behind the eyes, eyelids, tear glands, and eye muscles. The inflammation results from an aberrant immunological response which can cause the eyes to swell and impair eyesight.
Tepezza was the first medication recognized for managing TED. The drug was produced by Horizon Therapeutics and approved by the Food and Drug Administration (FDA) in January 2020.
Tepezza obstructs a particular protein thought to be involved in the development of TED. It is administered by injection once every three weeks for about five months.
Unfortunately, the FDA approved Horizon to manufacture Tepezza without conducting much testing and determining the drug’s precise action mechanism. The clinical trials used by Horizon to get FDA approval for Tepezza included less than 100 participants.
What Is Thyroid Eye Disease?
Thyroid eye disease (TED) is a disorder that affects the eyes and the thyroid gland. The following are the most typical TED signs and symptoms:
- Bulging eyes
- Pressure or pain behind the eye
- Redness in the white part of the eye
- One eye moving slower than the other.
- Difficulty reading signs.
- Eyelid swelling
- Watery eyes
- Blurred or double vision
- Light sensitivity
- Vision loss
There is no known therapy for TED, but there are ways to lessen the symptoms. Tepezza is one such therapy that reduces double vision and eye bulging.
Tepezza may effectively cure TED but has certain adverse side effects, including headaches, nausea, and vertigo. Tepezza may occasionally also result in dry eyes and blurred vision.
Study Links Tepezza to Serious Hearing Loss
Tepezza’s manufacturer, Horizon Therapeutics, admitted during FDA evaluation and clearance that there was a slight chance that the medication might cause hearing loss as a side effect.
However, Horizon Therapeutics claimed in their FDA submission that the hearing loss was “temporary and typically of short duration” and that less than 10% of patients experienced it.
Contrary to this, patients and medical professionals reported major hearing problems shortly after Tepezza was made available on the American market.
The findings of a 2021 study on Tepezza revealed that, in addition to hideously understating the risk of hearing impairment linked to Tepezza, Horizon Therapeutics also downplayed how severe that hearing damage may be.
A study published in the Endocrine Society in March 2021 revealed that 65 percent of patients who got Tepezza experienced hearing impairment or ringing in the ears.
This was more than six times the predicted risk of hearing loss that Horizon admitted during the FDA approval process. These findings were followed by several case studies relating to Tepezza’s potential risk of hearing loss.
Horizon’s Failure to Warn About Tepezza and Hearing Loss
Hearing loss was a potential adverse effect of Tepezza infusions, which Horizon partially disclosed in their warnings.
However, the warning needed to be more adequate since it understated the risk and did not inform physicians (or patients) of the possibility of long-term hearing impairment or the need for frequent checkups.
Horizon knew about this possible risk linked with Tepezza and should have notified doctors and patients accordingly.
Tepezza Risk of Hearing Loss
Since the release of the “Endocrine Society” study, Tepezza-related hearing loss and associated problems (tinnitus) have drawn attention in the health sector for at least twenty months.
Tepezza is still promoted and sold, albeit only with a prescription. In fact, there are more Tepezza advertisements currently than ever before.
In the Tepezza study, the following primary symptoms (subjective otologic symptoms) were noted:
- Ringing in the ears (tinnitus) (38%)
- Earaches (27%)
- Subjective hearing loss (22%)
- Sensation of plugged ears (12%)
- The feeling that one’s voice is louder than it is.
Three patients reported a prolonged hearing problem known as patulous eustachian tube illness, which blocks the canals between the ears, nose, and throat. Acute hearing loss and tinnitus are also consequences of this condition.
Before this, clinical trials undertaken by Tepezza’s manufacturer, Horizon Therapeutics, suggested that 10% of patients could develop hearing issues. However, this most recent FDA-supported study indicates that the percentage is considerably more significant now.
Tepezza Hearing Loss Lawsuits
Patients who used Tepezza and later had tinnitus or hearing loss started filing product liability claims against Horizon Therapeutics in the summer of 2022.
Got a Legal Issue? Let Us Help You Find An Attorney Near You
These Tepezza hearing loss lawsuits allege that the manufacturer negligently failed to warn physicians and patients of the full extent of the hearing loss risk posed by the drug.
So far, the federal court has received two Tepezza hearing loss cases against Horizon Therapeutics. The lawsuits were filed in the Northern District of Illinois, home to Horizon Therapeutic’s corporate headquarters, in August and September.
The claimants in these lawsuits assert that they suffered hearing loss after using Tepezza infusions to manage their TED.
According to the lawsuits, the plaintiffs and their physicians were not informed of the possible risks associated with Tepezza since there was no sufficient warning regarding the possibility of hearing impairment.
The lawsuits include allegations of negligent failure to warn and design defects. More Tepezza hearing loss cases are anticipated to be filed as more patients experience hearing loss.
There has yet to be any consolidation of the Tepezza claims into a class action MDL, but if more of these cases are filed, it may occur in the future.
Since federal law preempts the plaintiffs’ state law tort claims, Horizon’s defense approach in each Tepezza litigation has been to ask for dismissal of the cases.
The argument—which is frequently made in pharmaceutical tort cases—is that warning labels are regulated by federal standards and legislation, which exclude state law tort claims.
Damages in a Tepezza Lawsuit
In a civil lawsuit, the adverse effects of Tepezza hearing loss or related complications are often treated as damages. Damages are losses caused by an injury, both economic and non-economic, for which one may file a claim for reimbursement.
Tepezza’s adverse effects might cause severe damage due to their long-term nature and potential to impact every aspect of someone’s life resulting from permanent hearing loss.
Tepezza hearing loss economic damages
Economically speaking, Tepezza has caused extensive and widespread harm. For many people, having good hearing is vital for their jobs.
People who suffer unfavorable side effects from Tepezza may not only lose a portion of their income but also their job title or possibly have their entire career become untenable.
It should go without saying that this will have severe economic consequences. A person’s finances are severely strained by therapy costs, medical equipment such as hearing aids, and treatment for hearing impairment.
Non-economic damages inflicted because of tepezza infusions
Tepezza also results in significant non-economic damages, although these don’t affect your finances immediately. Non-economic damages arise from an injury and are not directly monetary in nature.
Hearing impairment is difficult, and dealing with Tepezza’s irreversible hearing loss can be emotionally distressing.
Injuries brought on by Tepezza may result in pain and suffering, lost enjoyment of life, and even loss of consortium. These losses may be included in the compensation recovered in your Tepezza hearing loss lawsuit.
Can I File a Tepezza Lawsuit?
The use of Tepezza has associated safety risks. For Horizon Therapeutics, the risk of hearing loss is too severe to ignore.
Horizon Therapeutics failed to issue any warnings regarding Tepezza’s risk for causing hearing loss or tinnitus. Instead, they continue to disregard pertinent safety issues.
So, can you file a Tepezza hearing loss lawsuit? The simple answer is yes. You can file a product liability lawsuit to seek damages for the harm caused by Tepezza, but you must meet specific requirements.
Plaintiffs seeking to file lawsuits must, first and foremost, have sustained substantial losses due to Tepezza. You are ineligible to sue simply because you got Tepezza injections.
Plaintiffs must have received Tepezza and had at least one of the side effects listed above, such as hyperacusis, eustachian tube malfunction, inner ear injuries, hearing loss or tinnitus, etc.
In these circumstances, it’s crucial to demonstrate that you received Tepezza, that Tepezza is what harmed you, and the severity of your damages.
When considering filing a product liability claim, having a lawyer is paramount because there may be uncertainty and ambiguity around these issues.
Hire a Personal Injury Lawyer for Your Tepezza Hearing Loss Lawsuit
Have you suffered permanent or severe hearing problems after being prescribed Tepezza for your thyroid eye disease?
If so, you may consider filing a Tepezza hearing loss lawsuit to seek financial compensation for your hearing problems.
Legal Giant partners with the best product liability and personal injury attorneys who understand the legal protocols surrounding defective products and product liability lawsuits.
Our partner attorneys can help you gather the evidence to strengthen your case, represent you in court, and win you the maximum compensation.
Contact us for a free case evaluation today.