Tepezza Lawsuit
Tepezza has been linked to permanent hearing loss, tinnitus, and total deafness in those who receive this drug to treat thyroid eye disease. If you have experienced these effects after receiving Tepezza infusions, you may be eligible to recover substantial compensation in a Tepezza lawsuit. Call The Lanier Law Firm today at 1-800-723-3216 for a free case evaluation.
Legally Reviewed By: Rebecca Phillips
Mass Torts Director
- Page Last Updated:
- April 15, 2024
The infusion drug Tepezza has been linked to permanent hearing impairment and tinnitus, but the product’s labeling did not adequately warn patients or physicians of these effects. If you have suffered hearing problems after receiving Tepezza treatment, our Tepezza lawyers at the Lanier Law Firm may be able to help you recover significant damages.
David Kuttles:
Tepezza is a medication that’s used to treat thyroid eye disease, which is a condition involving inflammation in the back of the eye, which can lead to blurred vision or double vision, or it gives the impression or appearance of bulging eyes.
It’s a very expensive treatment. It involves eight infusions over the course of approximately six months. The medication, however, is only administered by medical providers and, or nurse practitioners.
Tepezza Lawsuit Updates
February 2, 2024 – Discovery is open, and the parties have agreed to a protocol regarding the production of electronically stored information. A status conference is set for later today where the parties are expected to discuss the progress of discovery to date.
September 29, 2023 – Lanier Law Firm filed its first Tepezza lawsuit in the Western District of Texas. The complaint was filed on behalf of an individual who suffered permanent hearing loss as a result of taking Tepezza.
Why should I choose the Lanier Law Firm to handle my Tepezza claim?
When you need representation in a case against a drug company, you need an experienced law firm with a reputation for getting results.
The Lanier Law firm has been standing up to drug companies on behalf of injured individuals for 43 years. We have recovered more than $20 billion for our deserving clients.
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We earned these recognitions with our attorneys’ consistency in winning historic verdicts and settlements, including the following pharmaceutical case results:
- $9 billion verdict against Takeda & Eli Lilly for the increased cancer risk from the diabetes drug Actos
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Our law firm is one of the most feared in the nation by large drug companies. We know what it takes to successfully try a case over harmful drugs. We have defeated large companies like Johnson & Johnson in multiple cases and are currently serving leading roles in litigation against the makers of Tylenol and Gardasil.
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Why should I choose the Lanier Law Firm to handle my Tepezza claim?
Has Tepezza been over-marketed?
Who is liable for Tepezza injuries?
Is there a Tepezza hearing loss class action lawsuit?
How can the Lanier Law Firm help with my Tepezza lawsuit?
What types of compensation can I recover for hearing loss caused by Tepezza?
How much time do I have to file a Tepezza lawsuit?
What is Tepezza used for?
Horizon Therapeutics, PLC manufactures and distributes Tepezza. Tepezza is the brand name for the drug Teprotumumab-trbw, an infusion biologic used to treat Graves’ Orbitopathy, a rare autoimmune disorder commonly known as thyroid eye disease, which causes inflammation and bulging of the eyes. It is the only drug that is FDA-approved to treat this condition.
What are the symptoms of thyroid eye disease?
According to the National Organization for Rare Disorders, thyroid eye disease may cause the following symptoms:
- Irritation of the eyes
- A sensation that something is in the eyes
- Redness of the eyes
- Dry eyes or excessive tearing
- Bulging of the eyes
- Double vision
- Swollen eyelids
- Sensitivity to light
- Inability to completely close the eyes
- Inability to move the eyes
- Vision loss
How does Tepezza work?
In Thyroid eye disease, antibodies attack the eye tissue by activating insulin growth-like factor-1 (IGF-1R). This stimulates the over-production of a type of connective tissue known as fibroblasts, causing the symptoms of thyroid eye disease. Tepezza works by binding to IGF-1R and blocking its signals.
Tepezza is administered as a series of eight infusions once every three weeks for approximately five months. According to the company’s literature, the infusions are administered intravenously, most often by a registered nurse.
The manufacturer, Horizon Therapeutics, has done very limited testing on the drug, and has done no independent studies whatsoever. Yet there is a growing body of information, of evidence showing an association between Tepezza and hearing related problems such as tinnitus and hearing loss.
Tepezza Injuries
As many as 65 percent of patients receiving the infusions experienced hearing side effects, according to a study reported by the Endocrine Society. Tepezza’s hearing -related side effects were felt after an average of 3.6 infusions. Hearing side effects included the following:
- Subjective hearing loss
- Tinnitus – ringing in the ears
- An ear-plugging sensation
- Autophony – the perception that a person’s own voice is unusually loud
Some patients experience a combination of these symptoms. The underlying damage to the inner ear labyrinth leading to these symptoms includes the following:
- Sensorineural hearing loss – hearing loss caused by damaged hair cells in the inner ear
- Patulous Eustachian tube – the Eustachian tube stays open, resulting in autophony
According to Therapeutics and Clinical Risk Management, Tepezza is also associated with sensitivity to sound and deafness.
As of December 31, 2022, the FDA had received reports of the following hearing-related adverse effects:
- 117 cases of hearing loss
- 84 cases of tinnitus
- 68 cases of deafness
David Kuttles:
There was a recently released study showing that 65% of the patients as part of that study, were experiencing hearing related problems such as hearing loss and tinnitus. Unfortunately, as of today, the label for the drug has not changed, and does not indicate any association between Tepezza and hearing loss. Nor does the label actually indicate to either patients or doctors that anyone taking Tepezza should be monitoring for hearing related problem.
How long does Tepezza hearing loss last?
Some patients have experienced improvements in a matter of months or after cessation of treatment. However, other patients have suffered permanent hearing loss, tinnitus, and deafness.
How was Tepezza approved?
Horizon received approval for Tepezza under the FDA’s orphan drug program. With that program, the FDA aims to help drug companies develop treatments for rare conditions that impact less than 200,000 people or that probably will not be profitable for at least seven years.
This ensures that patients with rare conditions also reap the benefits of drug innovation. Drug companies that develop orphan drugs receive the following incentives:
- Exclusivity for seven years
- A tax credit equal to 50 percent of the cost of performing the required clinical studies
- An application fee waiver
- Assistance in developing the drug
- Grants
Tepezza’s Pre-Approval Clinical Trials
Tepezza received FDA approval with limited data. Their Phase 2 and Phase 3 clinical trials included just 171 test patients, with 87 receiving the placebo and only 84 receiving the drug, according to The Journal of the Missouri State Medical Association. This seems like insufficient data for a drug marketed to millions of people.
Horizon Therapeutics, PLC reported that 10 percent of test subjects receiving the medication experienced hearing effects, a result that is inconsistent with the results reported by the Endocrine Society.
Has Tepezza been over-marketed?
Tepezza ia a rare disorder drug. Furthermore, it is not clinically indicated for all patients with thyroid eye disease this condition is not to be used as a first-line treatment.
The European Group on Graves Orbitopathy, a leading authority on thyroid eye disease, only recommends Tepezza as a second-line treatment and only in cases that are moderate to severe or active. Thyroid eye disease is generally active for six months to two years, accounting for only a small percentage of all patients with this disorder.
As a result, Horizon should have only marketed the product to a small number of patients and physicians. However, according to FiercePharma, Horizon launched a direct-to-consumer marketing campaign that included two websites that generated a million visits, with approximately 120,000 visitors accessing the local doctor search feature.
As a result, Horizon Therapeutics, PLC generated more than $1.66 billion in sales in fiscal year 2021 and nearly $2 billion in sales in fiscal year 2022, according to its own 2022 Fourth Quarter and Full Year Report.
How rare is thyroid eye disease?
Thyroid eye disease impacts approximately 16 per 100,000 females and 2.9 per 100,000 males, according to a study published by Eye and Vision. The population of the United States as of July 1, 2021, included 164.38 million males and 167.51 million females, according to Statista.
Thus, an estimated 4,767 men and 26,801.6 women suffer from thyroid eye disease—a total of 31,568.6 people.
According to Statistics Times, there were approximately 3.97 billion men and 3.095 billion women globally as of August 2021. This would mean an estimated 115,130 men and 495,200 women suffer from the disease—a total of 610,330 people.
Approximately five percent of patients with thyroid eye disease have moderate to severe disease, according to the Journal of Clinical Endocrinology & Metabolism. This calculates to 30,516.5 people worldwide, including 1,578.43 people in the United States, a significantly lower number of patients than the millions to whom Horizon Therapeutics, PLC marketed the product.
Who is liable for Tepezza injuries?
Horizon Therapeutics, PLC is an Irish company based in Dublin. It is the manufacturer and distributor of Tepezza. However, another Irish company, Amgen, Inc., acquired Horizon Therapeutics, PLC in December of 2022, according to Healio News. However, this merger is not yet approved for business in the United States.
If the merger receives approval in the U.S., Amgen may also be liable. Even if Amgen chose to end sales of Tepezza, it could still face liability under the doctrine of successor liability.
However, Amgen has expressed intentions to continue marketing and selling Tepezza, which is sufficient to incur liability under the doctrine of strict liability. Strict liability makes manufacturers, distributors, and retailers liable if a consumer is hamed and can prove at least one of the following:
- The product was inherently unsafe
- The product suffered a defect during manufacture
- The company failed to provide adequate warnings and instructions
It is also possible to sue manufacturers for negligence if you can show that the company breached a duty of care. For example, if you can prove that the makers of Tepezza knew or should have known that the product could cause permanent hearing loss but failed to warn the public, that could constitute negligence.
However, strict liability can apply even if the manufacturer was not negligent.
Is there a Tepezza hearing loss class action lawsuit?
Numerous individuals have sued over Tepzza’s side effects throughout the country, but no class action lawsuit has been filed. However, a motion to transfer the case to multidistrict litigation (MDL) was filed on March 22, 2023, requesting that all Tepezza cases be transferred to the Northern District of California.
If granted, the pending lawsuits and any future cases will be transferred to a single judge in the Northern District of California, regardless of where they originated. The judge will institute a selection process to hold trials in a few bellwether cases.
The outcome of these cases, known as bellwether cases, can play a significant role in determining how the remaining cases resolve. If the verdicts generally favor the plaintiffs, this could encourage the defendants to settle. Unlike class action lawsuits, MDL cases remain separate.
The purpose is to relieve the state and federal courts of the burden of heating an excessive number of cases individually, even though the basic case facts are similar. If the judge denies the motion to transfer the case to MDL, the cases will remain in the individual courts.
Rebecca Phillips:
So the Tepezza litigation is in the very early stages. Right now, there have been something close to 30 lawsuits filed across the country, and we anticipate that those lawsuits will be coordinated in what is called a multi-district litigation or an MDL for short. But that hasn’t happened yet. We’re still waiting to see, and from that point, the litigation will really take off and begin moving forward.
What are the allegations against Horizon Therapeutics, PLC?
At least 18 Tepezza lawsuits have been filed in five separate jurisdictions, and more are expected, according to the Motion for Transfer filed on March 22, 2023. The allegations against Horizon Therapeutics, PLC are summarized below.
Insufficient Testing
Plaintiffs allege that Horizon Therapeutics, PLC failed to conduct sufficient safety testing before FDA approval.
Failure to Warn and Instruct
Plaintiffs allege that although Horizon Therapeutics, PLC mentioned hearing problems in the list of potential adverse events on the product packaging, it did not warn patients or physicians that these effects could be permanent. These failures prevented patients from making informed decisions about their treatment.
According to the motion, hearing problems persisted at the end of the study for at least one patient. The company was required to include this information in the product packaging, but it did not.
Plaintiffs allege that Horizon Therapeutics failed to instruct physicians to perform hearing tests throughout treatment, which could have allowed physicians to detect hearing damage early enough to minimize the damage.
Failure to Update the Product Label
Plaintiffs allege that Horizon Therapeutics, PLC failed to update the product label despite reputable studies, medical clinics, and injured patients reporting safety data that strongly supported the association between Tepezza use and permanent hearing conditions.
Aggressive Marketing
Plaintiffs allege that Horizon Therapeutics, PLC engaged in aggressive product marketing directly to consumers and physicians as a first-line treatment even though the European Group on Graves Orbitopathy recommended it as a second-line treatment.
Plaintiffs allege that Horizon Therapeutics, PLC marketed Tepezza to millions of patients when only a small number are candidates for treatment with this drug when following the European Group on Graves Orbitopathy’s recommendations.
Timeline of Tepezza Events
May 6, 2013 – The FDA granted Orphan Drug designation to teprotumumab.
March 9, 2013 – The FDA granted fast-track designation to teprotumumab.
July 29, 2016 – The FDA granted Breakthrough Therapy Designation.
July 8, 2019 – The FDA received the Biologics License Application, a request for FDA approval to market the drug nationwide.
January 21, 2020 – The FDA approved the application.
May 13, 2020 – The FDA received an adverse effects report that a consumer developed tinnitus after using Tepezza.
June 2020 – The FDA received four reports from Horizon that patients had experienced tinnitus and hearing loss.
July 2020 – Horizon reported to the FDA that three patients experienced hearing-related adverse events after using Tepezza, including tinnitus, hearing loss, and deafness.
August 2020 – Horizon notified the FDA that a patient became deaf in both ears after using Tepezza. One patient developed tinnitus and another experienced hearing loss.
September 2020 – Horizon reported to the FDA that 10 patients had reported hearing-related adverse events from using Tepezza, including hearing loss, tinnitus, and three cases of deafness.
October to December 2020 – Horizon reported 12 hearing-related adverse events to the FDA, including hearing loss, tinnitus, and five cases of deafness.
January to March 2021 – Horizon reported five more adverse events to the FDA, including hearing loss, tinnitus, and deafness.
April to June 2021 – Horizon notified the FDA that 17 patients experienced adverse effects using Tepezza, including hearing loss, tinnitus, and seven cases of deafness.
July to September 2021 – Horizon reported 26 adverse events to the FDA, with patients developing hearing loss, tinnitus, and 10 cases of deafness.
October to December 2021 – Horizon reported 32 adverse events to the FDA, including hearing loss, tinnitus, and 11 cases of deafness.
October to December 2021 – Horizon’s required post-marketing study, which was overdue, was initiated.
February 22, 2022 – Horizon issued a press report revealing the results of its post-marketing studying, asserting that 10 percent of patients experienced hearing loss side effects.
January to March 2022 – Horizon reported 21 adverse events to the FDA, including 2 cases of deafness in both ears, five cases of deafness in one ear, and numerous cases of hearing loss and tinnitus.
April to June 2022 – Horizon reported 31 adverse events to the FDA, including 12 cases of deafness and multiple cases of tinnitus and hearing loss.
July to September 2022 – Horizon reported 20 adverse events to the FDA, including tinnitus and hearing loss, with 10 cases of deafness.
August 25, 2022 – The first lawsuit against Horizon Therapeutics, LLC was filed.
December 2022 – Amgen acquired Horizon Therapeutics, PLC.
March 23, 2023 – A motion to transfer Tepezza litigation to MDL was filed.
How can the Lanier Law Firm help with my Tepezza lawsuit?
If you have experienced hearing impairment or tinnitus after receiving Tepezza infusions, our legal team can help you pursue significant damages. Our talented team of attorneys can help you do the following:
- Determine your eligibility for compensation
- Calculate your case value
- Negotiate a significant settlement
- Present a compelling case to a jury
- File your claim on time
We will keep you informed about the status of your case throughout the litigation and remain accessible to you to answer your questions. When you retain a Tepezza lawyer at the Lanier Law Firm, you can count on us to fight for you until the end.
What types of compensation can I recover for hearing loss caused by Tepezza?
The compensation available in a Tepezza case will depend on the severity of your hearing impairment and how it impacts your quality of life and finances. Compensation may include the following economic and non-economic damages:
- Medical expenses
- The cost of hearing aids
- The cost of hearing tests
- Lost wages
- Lost earning capacity
- Pain and suffering
- Loss of society
- Loss of a bodily function
You may be able to receive punitive damages if a jury determines that Horizon Therapeutics, PLC demonstrated the following:
- Gross negligence
- A deliberate disregard for safety
- Fraudulent concealment of study results or its own misconduct
Punitive damages are not always available, and some states limit the punitive and non-economic damages a plaintiff can recover.
How much time do I have to file a Tepezza lawsuit?
Each state imposes a deadline on the filing of civil lawsuit, known as statutes of limitations. These deadlines vary from state to state but can be as little as one year. Contacting a product liability attorney as soon as possible is important to ensure you file your case on time.
Who can file a Tepezza lawsuit?
If you have received infusions of Tepezza and experienced one or more of the following hearin changes, impacting one or both ears, you may be eligible to file a claim for substantial compensation:
- Muffled hearing
- Reduced hearing
- Tinnitus
- Deafness
The best way to determine whether you have a case is to meet with a Tepezza lawyer. At the Lanier Law Firm, we offer free, no-obligation case reviews. We work on a contingency fee agreement, meaning you pay nothing for our services until we win a successful settlement or verdict.
Contact a Tepezza Lawyer at the Lanier Law Firm Today
If you have experienced hearing loss after receiving Tepezza, you deserve justice. Contact the Lanier Law Firm today to schedule a free consultation with a Tepezza attorney.
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