Tepezza Lawsuits Filed Against Horizon Therapeutics
A lawsuit, Perez Diaz v. Horizon Therapeutics USA, Inc., has been filed against Horizon Therapeutics, aiming to secure compensation for damages and hold Horizon accountable for their marketing practices and failure to sufficiently test, investigate, and disclose the health risks associated with Tepezza.
So far, the number of Tepezza lawsuits filed nationwide has been relatively small, but many more are anticipated to emerge. Currently, there is no motion to consolidate the Tepezza lawsuits into a class action MDL (Multidistrict Litigation), and the number of pending cases does not yet warrant such consolidation.
The claims against Horizon Therapeutics include:
- Misleading Actions. In every Tepezza lawsuit brought to light, Horizon Therapeutics is accused of engaging in deceptive tactics regarding their thyroid eye disease drug. Allegedly, Horizon marketed Tepezza as a treatment for all diagnosed cases of TED, including patients with mild forms of the condition who wouldn't typically experience vision impairment. However, Tepezza lawsuits argue that only a small percentage of TED patients, around 3-5%, experience vision impairment due to the condition. Despite being aware of this, Horizon allegedly promoted Tepezza as a remedy for early intervention in TED.
- Testing and Warnings Negligence. The lawsuit further claims that Horizon failed to conduct adequate testing and investigate the potential risks associated with Tepezza. While the Tepezza label does contain warnings about infusion reactions, exacerbation of preexisting inflammatory bowel disease, and hyperglycemia, it reportedly lacks any mention of the possibility of extended duration or permanent injury, particularly regarding hearing impairment. According to the lawsuit, Horizon did not adequately warn patients about the risks of ear injury and the potential for permanent or extended hearing impairment.
- Post-Marketing Study Delay. The lawsuit also alleges that Horizon purposely delayed the commencement of an FDA-required post-marketing study to assess Tepezza's safety in a larger patient population and the frequency of retreatment rates. According to the post-marketing analysis, approximately 10% of all cases reported to the safety database included hearing-related events, with hyperacusis (hearing reduction) and tinnitus (ringing in the ears) being the most commonly reported hearing issues.
Studies Show a Link Between Tepezza and Hearing Loss
Immediately after Tepezza was released on the U.S. market, reports of significant hearing damage from patients and doctors began. A new post-market study on Tepezza was published in 2021, and it showed that Horizon grossly understated the risk of hearing damage associated with Tepezza during the FDA approval process.
According to the study published in the Endocrine Society Journal, approximately 65 percent of Tepezza patients reported experiencing otologic (or hearing) symptoms, including hearing loss or muffled hearing. This is over six times higher than the estimated risk of hearing loss disclosed by Horizon during the FDA approval process.
The researchers evaluated 26 patients treated with Tepezza, and 17 (65 percent) reported otologic symptoms. The most common symptoms included subjective hearing loss, ear ringing (tinnitus), a sensation of ear plugging, and autophony (unusually loud hearing of one's own voice). The onset of these symptoms occurred after an average of 3.6 infusions of the drug.
Four patients with new hearing symptoms experienced new or worsening sensorineural hearing loss, a type of hearing loss caused by damage to the hair cells in the inner ear. Additionally, three patients had patulous eustachian tube. In this condition, the channel between the middle ear and the back of the nose and throat remains open, affecting air pressure regulation around the ear drum. While some symptoms of patulous eustachian tube improved after three months, they did not completely disappear.
The authors, including Dr. Andrea Lora Kossler from Stanford University School of Medicine, acknowledge that Tepezza is effective for thyroid eye disease but emphasize the importance of understanding its potential risks, including hearing impairment. They recommend implementing screening precautions, such as baseline audiogram testing, to monitor and reduce the risk of hearing loss in patients undergoing Tepezza treatment.
To gain a deeper understanding of this potential side effect, further research will focus on evaluating risk factors for hearing loss and the reversibility of symptoms. It should be noted that the follow-up period of three months after stopping the drug might be too short to assess the reported reversibility of otologic symptoms fully. As the medical community becomes more aware of otologic symptoms associated with Tepezza, measures can be taken to mitigate potential risks and ensure patient safety during treatment for thyroid eye disease.
How Do You Treat Thyroid Eye Disease?
Symptoms of TED may progress over the first six to twelve months, underscoring the importance of early diagnosis and treatment to prevent deterioration. Artificial tear drops can alleviate dry eyes in mild TED, and selenium supplements may also offer benefits. In severe cases, steroids or orbital radiotherapy may be considered. In some instances, TED patients may experience permanent double vision or changes in eye appearance, warranting surgical intervention as part of rehabilitative therapy after the inflammation subsides.
Surgical options may include decompression surgery to create more space behind the eye, eye muscle surgery to address severe double vision, and eyelid surgery to improve eyelid function and appearance.
Additional recommendations for TED patients involve prism glasses for double vision, high-dose steroid medications and/or radiation to reduce inflammation and double vision, and participation in support groups or counseling to address the social and psychological impact of altered eye appearance. Patients can manage the severity of TED symptoms by quitting smoking, as treatments are less effective for current smokers, and by maintaining normal thyroid hormone levels through regular blood tests and adherence to prescribed medications as directed by their doctor.
What is Tepezza and How Does It Work?
Tepezza (teprotumumab) is an injection that directly blocks IGF-1R, a key driver of Thyroid Eye Disease (TED) pathophysiology, at the source. By inhibiting IGF-1R, TEPEZZA produces quantifiable changes to the tissues behind the eye throughout the course of the disease.
Thyroid eye disease is an autoimmune condition characterized by inflammation in the eye muscles and fatty tissue behind the eye. The inflammation in the eye tissue is caused by an abnormal autoimmune response in which the body’s immune system targets the eye tissue. Tepezza has shown significant improvement in the symptoms of this disease, such as abnormal protrusion of the eyes (proptosis), double vision, soft tissue inflammation, and overall quality of life. The condition is usually associated with hyperthyroidism and is most commonly caused by Graves’ disease, an autoimmune disorder that affects the thyroid gland.
Tepezza Side Effects
Side effects of Tepezza include:
- Muscle spasms
- Hair loss
- High blood sugar
- Hearing problems
- Taste changes
- Dry skin
Infusion reactions may occur during or after Tepezza treatment, such as:
- High blood pressure
- Fast heartbeat
- Redness of the face/feeling hot
- Difficulty breathing
- Muscle pain
How Long Does Tepezza Stay in Your System?
Tepezza remains in your system for approximately 100 days after the final dose. This duration is determined based on Tepezza's average half-life, which is 20 days. The half-life refers to the time it takes for half of the medication to be eliminated from the body. Research indicates that it typically takes 4 to 5 half-lives for a drug to completely clear from the body, translating to 80 to 100 days or 11 to 14 weeks for Tepezza.
How to File a Claim for Tepezza Hearing Loss
Filing a claim for a dangerous product typically involves taking legal action against the product's manufacturer, distributor, or seller that caused harm or injury. If you believe you have been injured or suffered damages due to a dangerous product, here are the general steps to follow:
- Ensure your safety. If you have suffered adverse effects from a product or drug, contact your doctor right away.
- Preserve evidence. Try to preserve the product in its current state, along with any packaging, manuals, or receipts. Additionally, document any injuries or damages with photographs and notes.
- Review product liability laws. Understand the product liability laws in your country or state. These laws determine who may be responsible for the defective product and the types of claims you can make. If you have questions about the laws in your state, our product liability attorneys are here to help. Contact Grimes Teich Anderson today.
- Contact the company or manufacturer. If you believe the product is dangerous or defective, contact the manufacturer or company that sold the product. They might have a claims process or customer service department to handle such incidents.
- Consult an attorney. Consider consulting a product liability attorney who specializes in dangerous product claims. They can provide legal advice, assess your case, and guide you through the process.
- Gather information. Provide your attorney with all the relevant information, including product details, purchase information, medical records (if applicable), and any other evidence related to the incident.
- Notification and demand. Your attorney may draft notification and demand letters to the manufacturer or responsible parties. These letters outline your injuries, damages, and intent to pursue a claim for compensation.
- Negotiation and settlement. The manufacturer or insurer may often attempt to negotiate a settlement with your attorney. This process may involve back-and-forth negotiations to reach an agreement on compensation.
- Filing a lawsuit. If a settlement cannot be reached, your attorney may file a lawsuit on your behalf. The case will then proceed through the legal system, potentially leading to a trial.
- Discovery and trial. Both parties exchange information and evidence during the discovery phase. If the case proceeds to trial, your attorney will present your case before a judge and jury.
- Verdict and compensation. If successful, the court will determine liability and award compensation for your injuries and damages.
Remember that product liability laws can be complex and vary by jurisdiction, so seeking professional legal advice is essential to understand your rights and options in your specific situation. A well-versed attorney will thoroughly investigate your case and guide you through the claims process to ensure your peace of mind and the best chance at the compensation you deserve.
Speak with an experienced defective drug attorney to learn more about the Tepezza lawsuits and review your options. If you or a loved one has suffered hearing loss or complications such as tinnitus after taking Tepezza, the North and South Carolina dangerous product attorneys at Grimes Teich Anderson are actively monitoring the lawsuits against Horizon Therapeutics and are ready to speak with you for free.
Protecting Thyroid Eye Disease Patients Across The Carolinas
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Contact us by filling out and submitting the form below or calling our office toll-free at 800-533-6845 for a free legal consultation today.