Any sense that is compromised might seriously harm many components of your life. Your work, relationships, mental health, and overall quality of life can all be impacted by even a mild disability.
Tepezza is supposed to promote health, but when it worsens hearing problems, one may feel especially duped, given how much we rely on medications. Damages in Tepezza lawsuits may include the adverse impacts on a person’s life brought on by hearing problems due to Tepezza. Let’s take a look at long term Tepezza side effects and Tepezza lawsuits 2023.
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What is Tepezza?
The body’s immune system attacks the muscles and tissue behind the eyes in Thyroid Eye Disease, which results in bulging eyes, discomfort, and impaired vision. Sometimes Graves’ illness results in TED.
In 2020, the FDA approved Tepezza (Teprotumumab), a relatively recent therapy for Thyroid Eye Disease. Since that time, more and more cases of Tepezza hearing adverse effects have been documented by physicians and patients.
How does tepezza work? For roughly five months, Tepezza is injected once every three weeks. Although the precise process by which Tepezza does this is not entirely known, Tepezza functions by stopping the immune system from attacking the fatty tissue behind the eyes. Tepezza was created by Horizon Therapeutics and is still covered under the first patent.
According to a news release from the FDA’s Center for Drug Evaluation and Research on January 21, 2020, the approval of Tepezza represented “significant advancements in the approval of efficient cures for uncommon disorders like thyroid eye disease.”
Furthermore, “Tepezza may change the course of the illness, sparing patients from having to undergo numerous invasive procedures.”
Unfortunately, Tepezza may carry a considerably higher risk of hearing issues than originally thought. We now understand that people receiving Tepezza as a TED treatment may be at risk for lifelong hearing problems, including unrecoverable hearing loss and tinnitus.
Tepezza Risk of Hearing Loss
In March 2021, The Endocrine Society released a small study that indicated 65% of Tepezza users might experience hearing issues due to the medication’s adverse effects.
The study’s authors specifically watched 26 individuals who received at least 4 Tepezza injections. Of these, 17 patients, or 65%, said they had trouble hearing. This proportion is exceedingly high and is six times more than the projected risk that Horizon indicated in the warning box.
Six or 23%, stated that they had Tepezza and hearing loss; seven, or 27%, experienced tinnitus or ear ringing; and three, or 12%, experienced ear plugging. Furthermore, 29% of test participants reported having autophony, in which their voices sounded abnormally loud to themselves.
According to the researchers, Tepezza’s hearing issues started after an average of 3.6 infusions. Four patients who complained of problems had sensorineural hearing loss, which happens when the inner ear’s hair cells are harmed.
In three patients, patulous eustachian tube disease was diagnosed, which causes the canal connecting the middle ear with the back of the nose and throat to remain open and results in a long-term hearing issue. The signs did not completely disappear but did become better with time.
The research authors recommended that new patients be evaluated before using Tepezza and that doctors be more aware of the possible hearing problems while giving the medication. The researchers also suggested that physicians do baseline audiogram examinations.
Tepezza Study: Long Term Side Effects of Tepezza
Numerous Tepezza lawsuits of injection-related permanent hearing loss have been documented since the product’s release. In a post-marketing study undertaken by Horizon on thousands of patients, it was discovered that 10% had hearing loss, the majority of which was mild to moderate and treatable. However, the research did not make a distinction.
Tepezza medication was only given “orphan status” by the FDA, which required further testing before Tepezza’s efficacy could be conclusively demonstrated. This is standard for drugs that treat uncommon illnesses for which there are currently no other appropriate therapy options.
For each particular drug, manufacturers must ask the FDA for orphan status. But even when an orphan medicine receives first approval, research is still done to demonstrate its efficacy and safety.
Numerous studies have connected Tepezza to severe hearing issues, including:
- Hearing loss
- Tinnitus
- Plugged ears
- Autophony
Only 10% of people who got Tepezza had hearing issues, according to the drug’s producer, Horizon Therapeutics, in pre-and post-market clinical trials. This is far less than what many other recent studies indicate.
The company also claimed that the hearing-related adverse effects in their clinical trials were generally “temporary,” even though other research has shown that Tepezza’s damaging effects can last long after stopping the drug.
People who got Tepezza injections for TED and later had hearing loss or tinnitus may be qualified to file a product liability claim and obtain financial compensation.
Does the Tepezza Label Include a Warning for Hearing Loss?
Temporary hearing loss in patients undergoing drug trials was included in Section 6 of the original Tepezza warning label. The Horizon appears to have misled the FDA about the reversibility of hearing loss.
The possibility that Tepezza side effects of hearing loss may be permanent is not included in the labeling or FDA clearance package.
One of the first hearing damage claims was made by an Arizona man diagnosed with permanent hearing loss. Tepezza lawsuits were filed against the makers of the controversial TED drug Tepezza that Horizon Therapeutics failed to warn patients and doctors about the possibility that Tepezza could harm hearing and cause tinnitus.
The Tepezza medicine label downplays the seriousness of the hearing issues purportedly connected to Tepezza, even though “many patient reports, scientific studies, and even the defendant’s post-marketing investigations have proved that Tepezza causes hearing loss,” according to the Tepezza lawsuits.
Tepezza Lawsuits for Hearing Loss
After getting Tepezza injections, patients with hearing loss or tinnitus started suing Horizon for product liability in 2022. According to the Tepezza hearing loss lawsuit, Horizon was negligent in adequately informing consumers and medical professionals about the real dangers of hearing impairment connected with Tepezza.
According to the plaintiffs in these Tepezza, neither they nor their doctors were aware of the possible risks associated with the medication since there was not a sufficient warning regarding the possibility of hearing impairment from Tepezza.
These plaintiffs contend that if Horizon had given adequate and appropriate notice about this danger, they would not have needed to take Tepezza to treat their TED.
As more and more Tepezza patients experience hearing loss, it is anticipated that hundreds of Tepezza lawsuits for hearing loss will be brought in the future. The Tepezza lawsuits have yet to be aggregated into a class action MDL, although that may happen in the future if many more similar complaints are filed.
Tepezza Lawsuit – November 2023
Over the past month, only 5 new cases have been added to the Tepezza hearing loss class action MDL. As of November 16, 2023, there were 59 Tepezza cases pending in the MDL.
Tepezza Lawsuit Update 2024
April 2024
Horizon Therapeutics requested an extension to select Tepezza bellwether lawsuits due to extensive medical records involved, but plaintiffs opposed it, arguing that enough information was already available.
The court extended the deadline until May 30 but stated that no further extensions would be allowed. Plaintiffs’ request for raw clinical data was approved by the court, despite objections from the defendants, while their request for payment records was rejected for being overly broad and burdensome.
The MDL-3079 trialed in the court of Northern district of Illinois has 101 Tepezza lawsuits waiting to resolved, as per the latest update on April 1, 2024.
May 2024
As per the latest update on May 1, 2024, there are 113 Tepezza lawsuits pending in the MDL.
Plaintiffs and defendants in Tepezza hearing loss lawsuits have proposed conflicting schedules for bellwether trials. Plaintiffs aim for early 2026, while defendant suggest a delay until mid-2027, arguing for more time for discovery. The dispute highlights differing views on trial readiness and efficiency. Horizon Therapeutics, the drug manufacturer, seeks oral arguments before Judge Durkin to resolve the issue.
Recent FDA updates to Tepezza’s label now include warnings about potential hearing loss. The outcome of bellwether trials may influence future settlement negotiations.
July 2024
Around 138 active Tepezza lawsuits are waiting to be resolved in the MDL no – 3079.
The first trial is set for March 2026, with three more trials following until August 2026. These trials will help in negotiating settlements for other cases. In 2023, the FDA updated Tepezza’s label to warn about the risk of hearing loss, advising doctors to check patients’ hearing before, during, and after treatment. If no Tepezza lawsuit payouts are reached after the bellwether trials, individual cases may go to separate trials.
A New Jersey man, Michael Wuss, has filed a lawsuit against Horizon Therapeutics, claiming he suffered permanent hearing loss from using Tepezza. He argues that the company failed to warn users and doctors about the risk of hearing damage and the importance of regular hearing tests.
Wuss received Tepezza infusions from 2021 to 2023 to treat his thyroid eye disease. He later developed hearing loss and tinnitus (ringing in the ears). His lawsuit states that there were no warnings about these risks when he started the treatment. Wuss claims that Horizon Therapeutics knew about the hearing risks since at least March 2020 but delayed updating the warning label until July 2023.
Tepezza, introduced in January 2020, is used to treat bulging eyes and double vision from thyroid eye disease. Despite being marketed as safe, many users have reported hearing problems. The lawsuit alleges that Horizon could have used a quicker process to update the warning label but chose a slower method, prioritizing profits over safety.
As of July 2024, Wuss’s lawsuit is part of a larger group of similar cases. A judge has scheduled early trial dates starting in March 2026 to help determine how juries might respond to the evidence. These initial trials could influence future settlements or outcomes for other cases.
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If you are experiencing side effects from this eye medication, contact a Tepezza lawyer as soon as possible. By analyzing medical records, lawyers can identify human errors, track the progression of treatments, evaluate the effectiveness of medications, and make informed decisions about a patient’s condition. LezDo TechMed will review accurately using information from medical records.
To conclude,
It’s essential to take action in product liability cases as soon as you can because there is a statute of limitations for bringing legal action over harmful drugs. Let’s hope that the Tepezza lawsuits help the people recover their damages through settlements.
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