In January 2020, the U.S. Food and Drug Administration (FDA) approved the prescription medication Tepezza, also known as teprotumumab. The federal regulatory agency approved the Horizon Therapeutics drug to treat thyroid eye disease (TED), also known as Graves’ Orbitopathy or simply as Graves’ eye disease.
As part of the FDA approval process, patients received the thyroid eye disease treatment to assess its efficacy and to verify whether it posed any unidentified health and safety risks. In reviewing clinical data, the FDA determined that only 10% of Tepezza patients suffered hearing-related problems like hearing loss or tinnitus, the latter of which is ringing in the ears. Subsequent studies after the drug’s approval showed that this hearing damage was perhaps as high as 65%.
Patients who have joined Tepezza lawsuits claim that Tepezza manufacturer Horizon Therapeutics, formerly known as Horizon Pharmaceuticals, failed to warn doctors of the hearing-related problems associated with treating thyroid eye disease with the drug. In turn, these patients’ doctors didn’t notify their patients of the hearing loss risks they would potentially face.
These patients, who’ve now become plaintiffs in Illinois Tepezza hearing loss lawsuits, are suing Horizon Therapeutics for failing to properly warn patients of their risk for suffering potentially permanent hearing loss.
Our Chicago law firm, Thomas Law Offices, is currently seeking to speak with any individuals who believe they have suffered Tepezza-related injuries like permanent hearing loss or tinnitus. We’re looking to add those individuals to Tepezza hearing loss cases filed in accordance with state law tort claims rules.
A statute of limitations applies for filing Tepezza hearing loss lawsuits. Contact us to schedule a free consultation to discuss the onset of your permanent hearing loss so we can help you determine if pursuing a Tepezza lawsuit is right for you.
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What To Know About Thyroid Eye Disease Which Tepezza Treats
Graves’ disease is an autoimmune disorder that causes the body to overproduce thyroid hormones, a phenomenon commonly referred to as hyperthyroidism. One of the complications associated with Graves’ disease is that it can cause the emergence of thyroid eye disease (TED).
TED is an autoimmune condition that causes portions of patients’ eyes to become inflamed, leading to a bulging or swollen appearance among their:
- Eyelids
- Tear ducts
- Connective and fatty tissue
If left untreated, TED’s accompanying eye stiffness can affect patients’ ability to move their eyes in alignment with one another, which can cause blurred or double vision. In some cases, the pressure that builds up in the rear portion of a person’s eye can be so significant that it causes vision damage.
This dismal outlook has motivated many patients to take Tepezza, the only thyroid eye disease drug that has achieved FDA approval thus far. Tepezza works by blocking the IGF-1R protein that coats human cells and leads to the onset of TED.
How Is Tepezza Administered To Treat Thyroid Eye Disease?
Tepezza is an intravenous (IV) medication, which TED patients receive via needles inserted into their arms, a process also known as an infusion. Patients generally receive a single infusion once every three weeks. According to Horizon Therapeutics, the drug’s manufacturer, patients generally only receive eight total Tepezza infusions during their treatment cycle. Tepezza infusions generally take between 60 to 90 minutes to deliver.
Studies Link Tepezza to Serious Hearing Loss
Before it was approved by the FDA more than three years ago, the drug’s manufacturer, Horizon Therapeutics, performed clinical testing aimed at identifying any relevant safety concerns associated with Tepezza. Those studies were carried out in Europe and the United States and involved 170 study participants. As cited above, data compiled shows that only 10% of study participants reported experiencing hearing issues after taking the prescription drug.
A 2021 follow-up study performed after this drug’s approval shows that researchers determined that hearing problems associated with the drug were closer to 65%.
Another study post-approval involved a sample size of 26 people, each of whom had received four or more Tepezza infusions at the time of their participation in that clinical study. At least 23% reported experiencing their first onset or an exacerbation of pre-existing hearing loss. Many of those study participants continued to experience hearing difficulties for months after discontinuing taking Tepezza. Others were left with permanent hearing problems.
That same study revealed that 27% of those 26 research panelists who had at least four infusions of Tepezza suffered from tinnitus. Again, while some of those individuals’ hearing problems, and more specifically, hearing loss or tinnitus, went away within a matter of months of their onset, that didn’t happen for some—even after discontinuing the use of Tepezza.
Peer-reviewed medical journals, including the British Medical Journal (BMJ), have recently published articles chronicling how the teprotumumab medication approved by the FDA poses a chronic risk of hearing loss to patients who take the drug.
Another study published in the American Journal of Ophthalmology and shared online by the National Institutes of Health (NIH) also described the hearing dysfunction thyroid eye disease patients have experienced after receiving teprotumumab (Tepezza) infusions. In this case, this was an observational study in which doctors identified how Tepezza patients suffered damage firsthand.
Auditory Problems Attributable to Tepezza
The number of reports patients have made reporting their suffering of hearing damage after taking Tepezza infusions has steadily increased since the drug’s approval. Those individuals who have already stepped forward and filed Tepezza lawsuits allege they started experiencing temporary or permanent hearing damage or an exacerbation of their symptoms, such as the following, only after beginning to take Tepezza:
- Hyperacusis: A disorder that affects the perception of loud sounds and is often associated with tinnitus
- Sensorineural hearing loss: Inner ear damage that affects the auditory nerve of the ear or brain, thus resulting in hearing loss likened to deafness
- An inner ear injury: Such injuries can make you feel dizzy and unbalanced and cause hearing loss
- Tinnitus: This is when you experience temporary or permanent ringing in the ears or other bothersome auditory sensations either unilaterally or bilaterally
- Eustachian tube dysfunction: Involves a plugging of a person’s ears with fluid and causes fullness in the ears and muffling of sounds, potentially blocking a medication’s ability to reach the middle ear
Temporary and Permanent Hearing Loss Associated With Tepezza Treatment
What do all of the hearing-related conditions above have in common? They all have the potential to cause temporary, if not permanent, hearing damage. If you’ve suffered hearing loss, you likely don’t need any reminding about how such an impairment can affect your life.
Hearing damage, and especially sensorineural hearing loss, can make it challenging for someone to hear noises and understand words and adversely impact their speech. Hearing issues can ultimately adversely impact an individual’s quality of life. It’s not uncommon for those who’ve suffered permanent hearing loss to receive depression, anxiety, and other mental health diagnoses.
Patients are increasingly filing Tepezza lawsuits because they’re realizing that what they’re suffering from is not temporary, but instead, they’ve developed permanent hearing loss. If this is the same situation you find yourself in, you should consider filing a Tepezza hearing loss lawsuit to recover financial compensation.
Our lawyers at Thomas Law Offices regularly represent clients in product liability lawsuit cases who have been hurt by medical devices or defective drugs. We’re eager to sit down with you for a free case evaluation to assess whether your onset of hearing damage allows you to file a Tepezza lawsuit in U.S. District Court for the Northern District of Illinois.
Horizon Therapeutics Failed To Warn of the Hearing Loss Risk
Pharmaceutical companies have a responsibility to perform necessary testing on their medications to ensure they’re reasonably safe before making them available for prescribing to patients. Also, once a medication gains FDA approval, drug manufacturers and their distributors have an obligation to notify prescribers, like physicians, of:
- The conditions their medication treats
- Any known side effects
- Contraindications
- Dosage information
Patients are increasingly reporting concerns such as tinnitus (ringing in the ears) and varying degrees of hearing loss, impairments that researchers have now determined may be permanent. It’s argued that Tepezza’s manufacturers knew of the potential for hearing-related problems but failed to adequately warn prescribers of it so that patients could make informed decisions about whether to accept any potential estimated risk associated with taking any prescription drug or not.
The drug’s manufacturer, Horizon Therapeutics, formerly known as Horizon Pharmaceuticals, has denied keeping information secret about how existing Tepezza patients suffered hearing loss and that it was a real possibility for future ones receiving the infusions too.
How a Tepezza Hearing Loss Lawyer Can Help
Patients who are currently or previously took the medication are increasingly stepping forward to file Tepezza hearing damage lawsuits against this drug’s manufacturer. Tepezza users are filing hearing loss lawsuits in U.S. District Court for the Northern District of Illinois with the help of our Chicago law firm, Thomas Law Offices, for Horizon Therapeutics’ failure to adequately warn of the dangers their drug posed.
Suing for financial compensation is the only course of action our legal system allows victims to pursue when they’ve been harmed due to someone else’s negligence in situations like these. So, if you also want to file a Tepezza hearing loss lawsuit for Horizon Therapeutics improperly warning patients, the dangerous and defective drug attorneys at our Chicago law firm can help you hold the negligent pharmaceutical company liable too.
Are You Eligible To File a Tepezza Hearing Loss Lawsuit?
There are limitations placed on who can file an Illinois Tepezza hearing loss lawsuit, just like there are regarding who can take legal action in any other civil liability case.
First, it’s critically important to note that individuals don’t qualify to join Tepezza hearing loss lawsuits and thus take part in coordinated pretrial proceedings along with plaintiffs involved in more Tepezza lawsuits just because they were prescribed and received Tepezza infusions. That being said, a patient may be eligible to take action and file a product liability lawsuit, such as a Tepezza hearing lawsuit, provided they meet the following criteria:
- A doctor prescribed Tepezza to treat their thyroid eye disease and they subsequently suffered hearing damage
- They have suffered permanent hearing loss that has significantly impacted their lifestyle
What Evidence Do You Need To File a Tepezza Lawsuit?
As with any legal case, stating that you have experienced hearing damage isn’t enough to forward a Tepezza lawsuit. You must be able to produce evidence showing you’ve suffered harm and how that’s impacted your life. Some evidence that may help you strengthen your Tepezza lawsuit includes:
- Medical records or bills or any other documentation that a doctor, such as an endocrinologist or ophthalmologist, prescribed you Tepezza and how many treatments of it you received
- Any ear, nose, and throat (ENT) physician or audiologist reports documenting your onset of hearing problems, including the type of impairment you suffer from, any treatment options pursued to treat those auditory concerns, and any details regarding their prognosis
Is There a Time Limit for Filing a Tepezza Lawsuit?
Illinois law affords individuals who’ve suffered harm after using a dangerous or defective product, prescription drugs included, two years from the onset of their injury to file a lawsuit. That statute of limitations may not begin counting down in Tepezza lawsuit cases until the patient first experienced the hearing loss—not when they first started receiving the infusions.
What Damages Can You Recover by Taking Legal Action?
Illinois law allows personal injury victims to seek monetary compensation for financial damages they sustained due to another party’s negligence. You may be able to recover compensation for the following losses by filing a Tepezza lawsuit with the assistance of our Chicago product liability attorneys:
- Medical expenses
- Lost wages or future earnings
- Disfigurement or permanent disability
- Mental anguish
- Pain and suffering
- Loss of enjoyment of life
Average Tepezza Settlement Amounts per Person
The proverbial “jury is still out” on how much you may be able to recover by filing a Tepezza hearing lawsuit. As with any mass torts legal action, the average Tepezza settlement amount will depend on how many patients step up and file suit against the drug’s manufacturer and how large of a settlement a judge or jury decides on, as well as how that award is allocated out.
As you can likely tell, if a significant percentage of those patients experienced hearing loss and filed lawsuits, any potential settlement each patient receives could be greatly impacted by this. However, the way compensation is generally doled out in situations like this depends on when a plaintiff files and how serious their reported injuries are (among other factors).
Schedule a Free Legal Consultation with an Experienced Tepezza Hearing Loss Attorney
Attempting to build a product liability case is never easy because you have to get to the bottom of both how and why it caused harm. It’s often necessary for attorneys like ours to bring in medical professionals in dangerous and defective drug cases to understand causation and, thus, where liability lies. This extra step we take proves invaluable when trying a case in a court of law. It makes a difference in our ability to recover maximum compensation on behalf of our clients.
Our Chicago law firm has already been in communication with TED patients here in Chicago and across Illinois who may be eligible to join a Tepezza lawsuit instantly to seek financial compensation. We want to speak with you to help you as well.
We offer a free consultation to all prospective personal injury clients. Additionally, we don’t charge for our legal representation unless we secure a settlement for you. You have nothing to lose by speaking with us about your right to compensation, so reach out to our Chicago legal team to get scheduled for a free case evaluation today.