Horizon Therapeutics’ Claims About Tepezza and Hearing Loss
Tepezza was developed by Horizon Therapeutics to treat a rare autoimmune disease called Thyroid Eye Disease (TED). This condition causes eye pain, swelling, and bulging of the eyes, and double vision. It can begin with inflammation of the eyes, leading to other symptoms, and may progress to a point where the symptoms are chronic and debilitating. TED can be experienced by patients who have Graves’ Disease, so some may associate that illness with treatment of Graves’ disease. While Tepezza serves an important purpose in treatment of TED, if the side effect of hearing loss and other hearing issues are chronic and possibly permanent, the company has a responsibility to let the public know.
Our attorneys are prepared to aggressively pursue compensation if you’ve suffered hearing loss after taking Tepezza. Depend on experienced attorneys to go to battle with the Big Pharma manufacturer Horizon Therapeutics.
Horizon does provide notice to users of the dangers of taking Tepezza. It lists hearing loss among several possible side effects but understates the dangers. In the company’s description of clinical trials of Tepezza, it lists the adverse reactions, downplaying the potential risks by claiming that those who suffer hearing loss are a very low percentage of users1.
In an announcement of the company’s presentation of research findings at an ophthalmology medical conference, Horizon makes the claim that hearing loss was experienced by close to 5% of those taking Tepezza2. Independent research shows the percentage of users suffering serious hearing issues is significantly higher. In the clinical trials of Tepezza for the FDA approval application process, Horizon documented hearing loss in 10% of the study participants. That is higher than the original 5% and is still very low compared to independent research on hearing loss and Tepezza.
When a pharmaceutical manufacturer fails to provide notice of the full range and risk of side effects, it can be held responsible for its negligent actions.
Putting Profit Over Safety May Lead to Negligence
Why would Horizon want to downplay the risks of hearing loss to users of Tepezza? To find an answer, follow the money.
Like many brand-name medications, Tepezza has a hefty price tag. While some of this cost can be justified by the lengthy process of research and development, Big Pharma companies like Horizon typically have the sole market share for their medication when it is new. Tepezza is very expensive: $14,900 per vial for a single injection, and well over $100,000, if not near $200,000, for a full course of treatment over 6 months3.
FDA Approval for Tepezza Was Fast Tracked
Sometimes, medications that treat rare diseases get special treatment in the FDA approval process. In January of 2020, the FDA granted Horizon Therapeutics “Priority Review,” “Fast Track” designation, “Breakthrough Therapy” designation, and “Orphan Drug” designation for Tepezza4. A medication labeled an “Orphan Drug” means it treats a rare disease. With this administrative measure, a company can get up to 7 years of market exclusivity after the FDA approves the drug. That means no competition to challenge its revenue stream for 7 years. On what evidence did the FDA approve Tepezza? Horizon’s clinical trial prior to FDA approval followed fewer than 70 patients. That is a very low number for testing a drug, yet the approval moved right along.
The quicker to market, the sooner Horizon made revenue on Tepezza. But the true costs of patients suffering hearing loss aren’t part of that calculation.
Why Hire Terry Bryant Accident & Injury Law for Your Tepezza Hearing Loss Lawsuit?
Learn the Many Reasons Why You Need Our Attorneys at Your Side
We know that you have many choices of law firms for your Tepezza lawsuit. So, why choose Terry Bryant? We have just the right team you need, with the exceptional skills necessary to handle a large lawsuit against Big Pharma companies like Horizon Therapeutics. When you work with our team, you’ll benefit from the depth of our experience with drug injury cases and our commitment to our clients. Our attorneys have extensive background in personal injury law and, in particular, taking on drug manufacturers that don’t provide full information to users about the dangers of their medication.
When you take on Big Pharma, you want highly experienced lawyers at your side who have fought similar battles before.
What Sets Us Apart from Other Law Firms in a Tepezza Hearing Loss Lawsuit
We have a long track record of winning, and of providing clients with exceptional legal representation. Learn how we helped our past clients in drug injury cases.
- Our winning record. We get proven results for our clients, winning millions in drug injury cases. We always seek maximum compensation for our clients.
- Our long history of helping clients in injury cases. We’ve served clients in the Houston area for over 35 years.
- Our exceptional qualifications. Terry Bryant, the firm’s founder, is a former Texas judge. He is also board certified in personal injury law by the Texas Board of Legal Specialization.
- What our clients say about how we successfully helped them win their case. See our testimonials.
- We don’t leave clients in the dark. We will explain the process of your Tepezza lawsuit at every stage. We will answer any and all questions you have.
- We are steadfast in our dedication. You are not just another client when you work with our team. You’ll be surprised at how much we value your concerns and your needs.
- Our compassion in a difficult time. When you face the possibility of permanent hearing loss, many aspects of your life could change drastically. We know clients need our legal expertise, but they also need an understanding friend.
Make the right choice to ensure you get the treatment you deserve from your attorney and the full compensation for the injuries you suffered. Call our Tepezza hearing loss lawyer today at (713) 973-8888.
How Our Tepezza Hearing Loss Lawyers Can Help You
We Can Help Prepare and File Your Tepezza Hearing Loss Lawsuit
You deserve full compensation for your hearing injuries caused by Tepezza. Hearing aids are expensive, and so is medical care, but it’s hard to put a price tag on the loss of your hearing or the suffering that comes with persistent tinnitus or sound suddenly being so loud it’s painful.
When you work with our Tepezza hearing loss lawyers at Terry Bryant, we’ll handle all the legal work so you can focus on your health needs.
Here’s what we can do for you:
- Provide a free case evaluation
- Determine whether you are eligible to take legal action against Tepezza
- Collect evidence to build your case, including gathering medical records
- Use expert witnesses to help prove your case against Tepezza for your hearing loss
- Handle all communications with Horizon Therapeutics attorneys and staff
- File a lawsuit against Horizon for your hearing loss
- Negotiate with Horizon for a fair settlement that provides you the full compensation you deserve for your hearing injuries
- Take your case to court if Horizon fails to make a reasonable settlement offer.
We Are Seasoned Negotiators and Fierce Litigators
When you work with our team at Terry Bryant Accident & Injury Law, you can rest assured we will bring our full resources and experience to your case. You’ll receive exceptional legal representation from attorneys who have won millions for our clients.
Proof of Negligence in a Tepezza Hearing Loss Lawsuit
Essential to Your Case Will Be Showing Horizon Was Negligent
While Horizon Therapeutics did make clear the range of possible side effects caused by use of Tepezza, the company did not accurately alert users to the actual degree of risk. In particular, the company did not share all potential data on the risks of experiencing hearing loss from taking Tepezza. In a drug injury case, drug manufacturers are commonly to blame. Our attorneys will investigate your case in detail to be sure we identify all those liable for the hearing loss or related hearing injuries you suffered from taking Tepezza.
Typically, in a case like your Tepezza hearing loss lawsuit, one essential question is…
Did Horizon Adequately Warn Users of the Full Dangers of Taking Tepezza?
Information Horizon made public about side effects of Tepezza claimed that a very low percentage of patients suffered hearing loss or related hearing problems after taking Tepezza. Several research studies show that is not accurate.
Rather than somewhere between 5% and 10% of Tepezza users’ suffering hearing loss, the true number may be as high as 65%.
Horizon would have been well aware of the frequency and duration of hearing problems, if the company tracked the data. When Horizon did not fully warn users about the likelihood of side effects related to hearing issues, it acted with negligence. A failure to warn about the full dangers of a medication constitutes corporate negligence.
A Tepezza hearing loss lawsuit will depend on proving negligence and will focus on four elements:
- Duty of care: Horizon owes you a duty to provide you safe medication with reasonable care and to provide full notice of any side effects, as to both their possibility and their symptoms.
- Breach of duty: Horizon did not share accurate data in its public statements about side effects related to hearing loss for those taking Tepezza. This lack of proper notice is a breach of a duty of care.
- Breach of duty caused injury: The next step is to prove your injury happened because you took Tepezza. If we can rule out other possible causes, our attorneys can prove that Tepezza caused your hearing problems.
- Show the breach of duty caused damages: The last component of building your Tepezza hearing loss case will be showing the injuries you suffered resulted in damages for you. We discuss damages in more detail next.
A failure to warn Tepezza users of the possibility of hearing loss or related injuries is a negligent act on the part of Horizon Therapeutics.
Liable parties in a Tepezza hearing loss lawsuit may include testing laboratories, sales representatives from Horizon Therapeutics, and others who are involved in the design, manufacturing, and distribution process of Tepezza. Our attorneys will dedicate themselves to holding Horizon and any other responsible parties accountable.
Types of Damages in a Tepezza Hearing Loss Lawsuit
To better understand how much you might expect in a lawsuit related to your hearing loss issues and use of Tepezza, our attorneys at Terry Bryant Accident & Injury Law explain what types of compensation you can receive. In a drug injury case, “damages” is the term that captures the various costs you suffer from taking Tepezza.
Economic damages relate to your actual financial losses or costs. Non-economic damages are also reflected in financial amounts; together with economic damages, they are considered “compensatory damages” (Texas C.P.R.C. §41.001)5. Damages in your legal case can include:
Economic Damages in a Tepezza Lawsuit
- Medical bills
- Cost of a hearing aid
- Costs for transportation to medical appointments
- Costs for therapists or other related treatment
- Loss of future wages related to hearing issues that impede your ability to work.
Non-economic Damages in a Tepezza Hearing Loss Lawsuit
- Pain and suffering
- Emotional anguish
- Impact on your quality of life.
It may also be appropriate to pursue punitive damages in your case. When a drug manufacturer like Horizon Therapeutics has a product on the market that they know causes harm, and they fail to inform users of that medication of those harms, they are, at the very least, negligent.
However, some courts may find their level negligence is more egregious and may award punitive damages, known as “exemplary damages” in Texas. These are meant to punish those responsible for the injury and stop them from the same behavior in the future (Texas C.P.R.C. §71.009)6.
Our Tepezza hearing loss lawyers are ready to aggressively fight for you. At Terry Bryant Accident & Injury Law, we’ve won millions for our clients and are unafraid to take on Big Pharma. Let us help you. Call our team today at (713) 973-8888 or toll-free 1 (800) 444-5000.
Who is Eligible to Pursue a Tepezza Hearing Loss Lawsuit?
If you have used Tepezza and suffered hearing loss or other hearing injuries, you may be eligible to pursue a Tepezza lawsuit. There are several hearing-related side effects found in research of patients who took Tepezza. If you have any of the side effects listed below, you should contact our attorneys as soon as possible to discuss your case.
- Hearing loss (hypoacusis)
- Tinnitus (ringing in the ears)
- Plugged sensation in ears
- Autophony (your voice sounds overly loud)
- Hyperacusis (sounds are painfully loud)
- Eustachian tube dysfunction.
If you have a family history of any of these hearing issues, your case may be more difficult to prove. Our attorneys will need to clearly show your hearing loss may be caused by your use of Tepezza rather than a family predisposition.
Are you unsure if you have a legal case? Talk to our Tepezza hearing loss lawyers at Terry Bryant Accident & Injury Law. We will help you understand your legal options.
Is There a Tepezza Hearing Loss Class Action Lawsuit?
Not yet. A class action lawsuit is one in which numerous people have been similarly harmed by the same parties (defendants). Some drug injury cases become class actions, but there is another way in which cases can be combined called a multidistrict litigation (MDL). In a class action case involving Tepezza hearing loss, the plaintiffs would all have very similar injuries and voluntarily join. They also would be represented by one law firm. In an MDL, the Tepezza hearing loss lawsuits would be filed separately in various courts across the country and a court order would consolidate them and move them to one federal court. In MDLs, plaintiffs would retain separate attorneys.
Tepezza has been on the market for a short time, and, already, legal cases are beginning to grow in number. As more users of the medication suffer hearing loss and related injuries after taking Tepezza, they will seek legal representation to be compensated for the injuries they suffered. If the company had told them about the true risk of hearing loss, some may never have taken Tepezza in the first place. Horizon Therapeutics should be held accountable for every patient harmed by Tepezza. There is a possibility that Tepezza will become the subject of an MDL. If it does and you have filed a legal case against Tepezza, you may be part of the MDL.
Make your best choice when it comes to who represents you in a battle against Big Pharma. Our attorneys have the experience you need and will provide you with powerful legal representation.
We have a history of winning drug injury cases and our attorneys have won over $100 million for our clients, overall. Why settle for anyone else?
What Research Shows about Tepezza and Hearing Loss
This Data Is Important for Your Tepezza Hearing Loss Lawsuit
A central element to your Tepezza hearing loss lawsuit is evidence that shows hearing loss associated with the drug. Several studies find that is exactly what happened for a substantial percentage of patients taking Tepezza. Our drug injury attorneys know how to strategically use strong scientific research to prove that a connection exists between your hearing loss and your use of Tepezza. A look at some of the most significant research can help you understand that you are not alone in experiencing your symptoms of hearing loss, whether you have tinnitus, a sensation that your ears are plugged, or a reduced ability to hear sounds.
Research about Tepezza and Hearing Loss Since Early 2021
After the FDA approved Tepezza in January of 2021, its manufacturer, Horizon Therapeutics USA, began a small study of 62 participants to examine the “efficacy, safety and tolerability” of Tepezza7. That research won’t be complete until October 2023. The company may hope to show that the drug does not cause hearing loss. However, evidence from case studies and other research seems to overwhelmingly show that Tepezza does cause hearing loss. The studies are recent, so there is no long-term data available regarding a potential return of hearing after a patient stops taking Tepezza. Research shows that most patients do not gain back their hearing.
In the spring of 2021, only a few months after the drug was approved, scientists tracked a small cohort who had at least 4 infusions of Tepezza to find whether any had hearing loss: 46% did8. The study, published in the Journal of Endocrinology, followed the patients for several months and found that none showed much improvement after they stopped taking Tepezza for 3 months.
Scientists concluded that hearing loss associated with taking teprotumumab is a concern, as is the possibility that it may not be reversible. They also express the need for hearing tests to be conducted before, during and after taking the drug.
About a year later, further research by the scientists who did the spring 2021 study was published in the American Journal of Opthalmology9. They gathered data on the same cohort. Their results showed 81% of the patients had new hearing loss symptoms. Four months after they stopped the medication, they averaged about 45% improvement in hearing loss. That’s improvement, but not a return to their level of hearing prior to taking Tepezza. One unique, and important, element of this study was that several of the participants had a baseline hearing test conducted before they started taking Tepezza. With that data, the researchers definitively showed 83% of them developed hearing loss.
Three separate case studies also documented hearing loss among patients taking Tepezza:
- A 61-year-old female had moderately severe hearing loss10.
- A woman in her 50s had chronic hearing loss which did not improve when she stopped taking Tepezza11.
- A 77-year-old woman suffered hearing loss which did not return by the end of the study12.
Several scientific studies consistently found hearing loss in research participants taking Tepezza. And in almost every case, the researchers emphasized the need to monitor patients with audiometric testing. When data from hearing tests is collected before, during and after a patient takes Tepezza, medical providers will know clearly the effects of taking Tepezza.
Scientists plead for hearing tests to be conducted before, during and after taking Tepezza. They know the risks of the medication and call for proof to unequivocally show the drug can cause hearing problems.
Why You Should Pursue a Tepezza Lawsuit Sooner Rather than Later
Don’t wait to call our Tepezza hearing loss lawyers. Other cases are pending, and you want to be sure to get outstanding attorneys on your side. In addition, the general statute of limitations in Texas for injury lawsuits is 2 years (Texas C.P.R.C. §16.003 (a))13. (*Always speak directly to an attorney for the exact deadlines that apply to your potential claim(s).) Drug injury cases can be complex and take a lot of time to prepare, so the sooner you contact us, the sooner we can begin work building your case.
Depend on Our Tepezza Hearing Loss Attorneys for Their Expertise and Experience
Terry Bryant opened Terry Bryant Accident & Injury Law in 1985 because he is passionate about helping people who have been victims of a company’s negligence or wrongful acts to get the compensation they deserve. Since starting the firm over 35 years ago, he has built a skillful legal team that is as dedicated as he is to helping people who have been harmed by large drug companies, so they get financial recovery for their losses.
Our attorneys have the expertise, experience, skills, and resources to take on Big Pharma companies like Horizon Therapeutics. We don’t shy away from a fight like this. We rise to the occasion. We dedicate ourselves to getting you justice and holding large companies accountable for harms they cause.
Make sure you work with the best available attorneys when you pursue a Tepezza hearing loss lawsuit. Don’t wait to call. Drug injury cases are complex and take a lot of time to prepare, so the sooner you contact us, the sooner we can begin.
CALL OUR TEPEZZA HEARING LOSS LAWYERS AT (713) 973-8888 OR TOLL-FREE 1 (800) 444-5000 TODAY FOR YOUR FREE CONSULTATION. IF WE TAKE YOUR CASE, YOU WILL PAY NO FEES UNLESS YOU WIN.
1 Horizon Therapeutics. Horizon Therapeutics plc Initiates Phase 3 Clinical Trial (OPTIC-J) in Japan Evaluating Teprotumumab for the Treatment of Active Thyroid Eye Disease (TED). Feb. 23, 2022. https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-therapeutics-plc-initiates-phase-3-clinical-trial-optic
2 Horizon Therapeutics. New TEPEZZA® (teprotumumab-trbw) Data to be Presented at the American Academy of Ophthalmology (AAO) 2021 Annual Meeting. Oct. 12, 2021. https://ir.horizontherapeutics.com/news-releases/news-release-details/new-tepezzar-teprotumumab-trbw-data-be-presented-american-0
3 Kyle Blankenship. Horizon notches blockbuster FDA Approval for Rare Eye disease med Tepezza. Fierce Pharma. Jan. 21, 2020. https://www.fiercepharma.com/pharma/horizon-notches-fda-approval-for-rare-eye-disease-med-tepezza
4 U.S. Food and Drug Administration. FDA approves first treatment for thyroid eye disease. Jan 21, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eye-disease
5 Texas Civil Practice and Remedies Code 41.001 (4). Economic Damages. https://statutes.capitol.texas.gov/Docs/CP/htm/CP.41.htm
6 Texas Civil Practice and Remedies Code 71.009 (4). Exemplary Damages. https://statutes.capitol.texas.gov/Docs/CP/htm/CP.71.htm
7 National Institute of Health. National Library of Medicine. A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease https://clinicaltrials.gov/ct2/show/NCT04583735
8 Andrea Kossler, Connie Martin Sears, Chrysoula Dosiou. Hearing Loss and Teprotumumab. Journal of the Endocrine Society, Volume 5, Issue Supplement_1, April-May 2021, Page A839, https://academic.oup.com/jes/article/5/Supplement_1/A839/6241215
9 Connie M. Sears, et al. Hearing Dysfunction After Treatment With Teprotumumab for Thyroid Eye Disease. American Journal of Opthalmology. 2022 Aug;240:1-13. doi: 10.1016/j.ajo.2022.02.015. Epub 2022 Feb 25. https://pubmed.ncbi.nlm.nih.gov/35227694/
10 Julie Highland, Steven Gordon, Deepika Reddy, Neil Patel. Ototoxicity and Teprotumumab. Annals of Otology, Rhinology and Laryngology. 2022 Aug;131(8):910-913. doi: 10.1177/00034894211042740. Epub 2021 Aug 27. https://pubmed.ncbi.nlm.nih.gov/34448414/
11 Audrey Chow and Rona Silkiss. Teprotumumab-associated chronic hearing loss screening and proposed treatments. BMJ Case Rep. 2022 Apr 13;15(4):e248335. doi: 10.1136/bcr-2021-248335. https://pubmed.ncbi.nlm.nih.gov/35418378/
12 Andy S. Ding, Nicholas R. Mahoney, Ashley A. Campbell, Francis X. Creighton. Sensorineural Hearing Loss After Teprotumumab Therapy for Thyroid Eye Disease: A Case Report. Otolology & Neurotology. 2022 Feb 1;43(2):e148-e152. doi: 10.1097/MAO.0000000000003428. https://pubmed.ncbi.nlm.nih.gov/34789694/
13 Texas Civil Practice and Remedies Code 16.003. Two-Year Limitations Period. https://statutes.capitol.texas.gov/Docs/CP/htm/CP.16.htm