Most medications come with their share of side effects and benefits. While they might serve to alleviate a medical problem, manufacturers of these drugs are expected to disclose all the side effects that they are aware of and warn physicians of these side effects. When they neglect this responsibility, those who suffer damages from taking the medication can sue the manufacturer for compensation. Tepezza is one of the drugs recently approved for treating the rare disorder thyroid eye disease (TED). While it has been effective at reducing symptoms of TED, it has also resulted in hearing loss and other related problems that doctors and patients were unaware of. If you or a loved one suffered damages from taking Tepezza, consult with Consumer Alert Now to establish whether you have a case to file a Tepezza lawsuit.
Overview of Thyroid Eye Disease
Thyroid eye disease (TED), also known as Graves' eye disease or Graves' ophthalmopathy, is a rare autoimmune condition that causes excessive growth in the fatty and muscle tissue behind the eye. The exact cause of TED is not yet established, but the growth factor IGF-1R is thought to play a major role in the overgrowth of fatty, muscle, and connective tissues of the eye.
The incidence of thyroid eye disease is higher in patients with an existing thyroid disorder (hyperthyroidism or hypothyroidism). The condition can arise as a symptom of a thyroid disorder or as one of the early symptoms of Graves' disease, an autoimmune thyroid disorder.
In addition to existing thyroid disorders, factors such as age, being female, a family history of TED, smoking, and low levels of selenium can increase the risks of developing thyroid eye disease.
Thyroid eye disease is a progressive disease with symptoms worsening with time for most patients. The disease begins with an active phase during which you may notice increased inflammation around the eyes. Your eyes may become swollen and pushed forward as tissue growth accumulates behind the eye.
Some of the symptoms you are likely to experience at this stage include:
- Eye pain
- Swelling of the eyelids
- Abnormal positioning of the eyelids (eyelid retraction, especially in the upper eyelid)
- Double vision
- Sensitivity to bright lights
- Problems when moving the eyeballs
- Bulging eyes
- Watery eyes
- Gritty feeling in the eye
- Difficulty closing your eyelids. If not managed, this could result in a corneal ulcer, which could cause scarring and permanent vision loss
The active stage of the disease usually lasts between six months to two years. As the severity of the condition increases, you will likely develop symptoms like vision loss, fibrosis, and corneal erosion.
Following the active stage of the disease, the inflammation of the eyes may reduce by itself, but leaving your eyes to swell and increase in size could result in more severe problems such as damage to the optic nerve (which could result in blindness).
During this stage, your doctor might also recommend additional measures to manage the conditions, such as:
- Lying down with the head elevated to reduce swelling and pressure on the eyes
- Using lubricating eye drops to relieve dryness
- Stop smoking
- Using steroids to manage the swelling in your eyes
- Wearing sunglasses to protect your eyes from the sun and wind
- Applying a cold compress to provide relief for any pain you might experience
- Taking selenium supplements, especially if you have mild active TED
- Taping your eyes when sleeping (talk to your doctor about this) to prevent damage to the cornea if your eyelids won’t close completely
- Using prisms to help with double vision. In some cases, the doctor may recommend taping one eye to help
Treatment in the early stages of the disease aims at reducing inflammation and managing the symptoms of TED and any underlying thyroid conditions. Surgery isn’t usually a viable option in the early stages of the disease as the eye tissue is progressively swelling, and results achieved from any surgical procedure would change.
Your doctor may recommend different surgeries to alleviate the symptoms as the condition progresses. Surgeries that are used in managing TED include:
- Eyelid surgery to help you close your eyes better, thus reducing the chances of a corneal ulcer occurring
- Eye muscle surgery to help correct double vision by moving the position of the affected muscle
- Orbital decompression surgery relieves pressure from the optic nerve. The optic nerve is responsible for transmitting stimuli from the eye to the brain for interpretation. When affected, vision sharpness decreases, lights seem dimmer, and it becomes harder to distinguish colors. Decompression surgery removes extra tissue or enlarges the eye socket
Until 2020, there wasn't a specific treatment for active thyroid disease. Therefore, all patients had access to were medication and treatments to reduce inflammation and improve the patients’ quality of life. The approval of Tepezza made it the first medication for active TED.
What is Tepezza
The FDA approved teprotumumab-trbw (Tepezza) as the first treatment for thyroid eye disease, a rare disease that previously had fewer treatment options. Tepezza is a product of Horizon Therapeutics developed in collaboration with researchers from The Lundquist Institute.
Before its approval, the drug underwent several clinical studies to test its effectiveness. During its clinical studies, Horizon Therapeutics reported an improvement in the symptoms of participants of the clinical study. Here are some of the improvements:
- Reduced proptosis (reduction in eye-bulging) without damaging the eye tissues by week 24 (on average)
- Reduction in the muscle and fat volume behind the eye
- Improvement of the patient’s quality of life when measured on the Graves’ Ophthalmopathy Quality of Life Scale
During the clinical trials (2020), some of the side effects noted in the patients included:
- Mild hyperglycemia
- Hearing loss
- Allergic reactions
- Muscle spasms
Tepezza is an insulin-like growth factor that works by binding IGF-1R. IGF-1R, or insulin-like growth factor one, is a protein in human cells. The growth factor plays a key role in human growth and remains active throughout a person's life.
This growth factor is responsible for hypertrophy or excessive growth of different tissues in the body, resulting in complications such as thyroid eye disease. This growth factor has also been implicated in breast, lung, and prostate cancers.
Tepezza comes in powder form. Each vial of the powdered drug contains 500 mg of active drug, which a doctor mixes with a liquid solution before administering it to the patient as an IV infusion. Patients get a dosage of Tepezza once every three weeks for eight doses. The recommended dosage is 10 mg/kg (2.2 pounds) for the first and 20 mg/kg for the second to eighth doses.
While the exact mechanism of Tepezza is not yet understood, it is believed to inhibit IGF-1R, thus reducing the abnormal tissue, muscle, and fat growth behind the eyes. Usually, patients report an improvement in their symptoms after six weeks of starting Tepezza.
Side Effects of Tepezza
As with most pharmaceutical drugs, the side effects of taking certain medications are inevitable. When taking Tepezza, the side effects may start showing within 24 hours of the first infusion, and for some patients, these side effects might show up later. The common side effects associated with Tepezza include:
- Muscle spasms
- Dysgeusia (altered taste)
- Dry skin
- Hair loss
- Changes in menstruation
- Muscle cramps
In addition, some worrying symptoms may also arise during or after treatment with Tepezza. They include fast heartbeat, feeling hot, redness of the face, problems breathing, headache, muscle pain, and high blood pressure.
Feeling hot, reddening of the face, and difficulty breathing may be signs of an allergic reaction to the Tepezza infusion. Other symptoms of an allergic reaction include swelling in the eyelids, lips, hands, feet, mouth, and throat.
Tepezza has also worsened symptoms of existing diseases such as Crohn's, inflammatory bowel, and ulcerative colitis. Those with these conditions might notice an increase in loose stools, blood in stool, and stomach pain or cramps.
If you have diabetes, Tepezza may increase your blood sugar. Therefore, you must notify your doctor if you've been diagnosed or are on diabetes treatment.
Other contraindications for Tepezza include:
- Pregnant women or those planning to become pregnant should not take Tepezza as it could harm the unborn child. Women should use a reliable form of birth control for at least six months after the last dose of Tepezza
- Breastfeeding women are also warned against taking Tepezza as it is unknown whether the drug passes into breast milk
- If you are currently on other medications and supplements, you should notify your doctor to assess the suitability of treatment with Tepezza
When first released into the market, Horizon Therapeutics failed to include the risk of developing temporary and permanent hearing problems in its drug safety information, despite clinical studies pointing to the possibility of these side effects.
Some of the hearing-related side effects of using Tepezza include:
- Autophony or hearing your voice and other bodily sounds (such as breathing) being louder.
- Muffled hearing
- Tinnitus is a ringing sensation in the ears that happens despite the absence of external sound. Pharmaceutical drugs continue to demonstrate ototoxicity (damage to the inner ear and the auditory nerve), which could result in tinnitus and permanent hearing loss
- Hearing loss. Ototoxic medication is a common cause of hearing loss in patients. In most cases, hearing problems can be resolved by stopping the medication. In other cases, hearing loss is permanent, and the patient would need additional steps to restore hearing, such as hearing aids or cochlear implants
- Hyperacusis is an increased sensitivity to sound. When this happens, you will likely become disturbed by noises that would not bother you previously – regardless of their pitch
As mentioned in the previous section, Horizon Therapeutics failed to warn physicians and patients of the risk of hearing problems resulting from Tepezza. One study by researchers from Stanford University evaluated the link between hearing loss and teprotumumab.
The researchers followed patients who received a minimum of four Tepezza infusions during the study. The researchers then evaluated the baseline hearing symptoms of the participants during and after the treatment with Tepezza.
Following this study, 46% of the participants reported hearing symptoms, the most common being autophony, muffled hearing, and hearing loss.
The study evaluated the side effects of Tepezza in 26 patients who got at least four infusions of Tepezza. Most of these problems began developing after an average of 3.6 infusions. Some patients' symptoms disappeared after several months, while others continued to experience these problems.
Tepezza lawsuits are a type of product liability suit against the manufacturer alleging that patients suffered certain damages (in this case, hearing-related issues) after using Tepezza.
These lawsuits began as the manufacturer failed to include the potential risk of hearing impairment in the drug’s warning label, despite having found the potential of hearing impairment during the clinical trial.
The company does include information about hearing loss in its clinical trial but failed to warn physicians or patients about the potential of hearing loss.
Due to this failure to notify, those whose hearing loss does not improve after stopping treatment may be entitled to compensation for their injuries.
Do you have a Case?
For most people, medication is meant to alleviate the symptoms they have. In the case of thyroid eye disease, these symptoms range from dry eyes to swollen eyelids and difficulty closing your eyes. Tepezza is one of the first drugs designed to alleviate the symptoms related to thyroid eye disease by inhibiting the growth factor that causes tissue and muscle growth.
Since each medication often comes with side effects ranging from mild to severe, manufacturers are expected to disclose these side effects in the drug warning information as soon as they are discovered.
According to lawsuits against Tepezza manufacturers, the manufacturer knew (based on clinical trial information) that Tepezza carried the risk of hearing loss. By failing to warn physicians and patients of the potential risks of hearing loss, patients could not make an informed decision when consenting to treatment with Tepezza.
Therefore, those who suffered chronic hearing problems have a legal claim against the manufacturer for failing to disclose this vital information about the risk of hearing loss from Tepezza.
If you are still in doubt about whether you have a case, work with a dangerous drugs attorney to help you evaluate your case.
Preparing for a Tepezza Lawsuit
A lawsuit, especially against a manufacturer, requires you to prepare yourself thoroughly beforehand. Some of the steps you can take in preparation include:
1. Contact an Attorney
When you file a lawsuit against a manufacturer, you can be certain that the manufacturer will work with an attorney. While you can choose to fight out the case independently, it’s wise to work with an attorney.
Lawsuits involving medications often have multiple litigants, which means the case can be dealt with as a class action suit or a mass tort. Courts deal with these lawsuits differently, meaning the laws applied also differ.
Therefore, it makes sense to work with a dangerous drug attorney who already understands the process of gathering evidence and handling such cases in court.
2. Report to the FDA
Tepezza is still a relatively new drug. It was allowed into the market sooner than most drugs are after demonstrating its effectiveness against thyroid eye disease, which had, until then, no known treatment.
Regardless of its status, the FDA encourages patients to report adverse symptoms to the FDA for further follow-up.
The FDA has a dedicated program, MedWatch, responsible for reporting serious reactions to drugs, medical devices, biological products, cosmetics, and dietary formulas, among others.
In this case, if you or a loved one developed hearing loss that has not resolved after ceasing treatment, you should fill in the reporting form.
You can report through your healthcare provider. However, if your healthcare provider is unwilling to file the report on your behalf, you can complete the online form (Form FDA 3500B) to submit your report. The FDA will respond by acknowledging your report and contact you in case they need additional information.
3. Gather any Relevant Evidence
It is not enough that you took Tepezza for thyroid eye disease. You must prove that you suffered irreversible damage from the drug. You must also prove that the manufacturer:
- Knew or should have reasonably known about the drug's risks causing the damage you suffered (developing hearing loss)
- The manufacturer failed to provide sufficient warning, which resulted in you taking the medication without all the safety information
Some of the evidence you will need include:
- Your medical records show that you took Tepezza
- Diagnostic confirmation that you developed significant hearing impairment without a pre-existing condition (Your attorney could provide evidence that taking Tepezza accelerated the rate of your hearing loss at a level that could not have occurred if you did not take Tepezza)
Various independent studies have established a link between mild to severe hearing problems after using Tepezza, including clinical trials and post-marketing data from Horizon Therapeutics.
However, this does not mean that the defendant's attorney will not question the origin of your hearing problems in court. This is why you should document your medical history, including reporting any mild or severe side effects that you experience when you start using Tepezza.
4. Contact your Healthcare Provider
As soon as you start noticing symptoms related to hearing loss, you should contact your healthcare provider. Some cases of hearing loss with Tepezza have been recorded to resolve themselves without additional intervention.
However, if your symptoms do not resolve, it is a good idea to have the treatment and progress of your hearing deterioration recorded for easier proof. Your doctor can also decide to stop your medication if the symptoms are severe.
Note: do not discontinue your medication without consulting your doctor.
Damages from a Tepezza Lawsuit
Horizon Therapeutics, the manufacturers of Tepezza, failed to provide sufficient warning of the risk of developing mild hearing problems to permanent hearing loss. Without this information, doctors and patients could not have made an informed decision on whether to take Tepezza for their thyroid eye disease or not.
Suppose you or a loved one experienced a hearing-related problem that did not resolve after stopping Tepezza. In that case, you should file a lawsuit to be compensated for the damages you suffered. Some of the damages recoverable from a Tepezza lawsuit include:
1. Economic Damages
Economic damages refer to the monetary losses you suffer directly from using Tepezza. These might include:
- Medical bills to treat the hearing problems that you developed after using Tepezza. For instance, if you develop reduced hearing, you might need treatment or hearing aids to help you communicate.
- Lost income due to missed work or as a result of the disability. For example, if your work relies heavily on your hearing ability, losing this ability means that you lose your income. Therefore, you should be adequately compensated for your lost income and earning potential.
- Costs arising from the disability
You must accompany your request to recover economic damages with proof that your injuries accrued these economic losses. Some of the evidence includes your pay stubs, your medical reports, and related billing information showing how much you spent directly from the hearing impairment resulting from Tepezza.
2. Non-economic Damages
Non-economic are those that compensate you for the non-tangible damages you suffer due to taking Tepezza. These damages cover:
- Pain and suffering
- Loss of consortium. If your injuries from Tepezza have significantly negative consequences on your relationship with your spouse, damages for the same can be awarded by the court.
Join a Tepezza Lawsuit Near Me
Many people suffer serious injuries and side effects from using dangerous drugs yearly. Tepezza is one of the drugs linked to temporary and lasting damage to your hearing after a few doses. If you or a loved one was injured from taking Tepezza, you might be entitled to compensation for the damages you suffered. Consumer Alert Now is dedicated to helping victims of dangerous drugs prepare and present their cases if a dangerous drug injures them. You can contact our attorneys at 800-511-0747 to discuss your case and the options you may have.