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January 2020 was the time when the Food and Drug Administration (FDA) approved a drug called Tepezza or Teprotumumab. This drug, delivered intravenously, treats a rare autoimmune condition known as Thyroid Eye Disease (TED).
To date, this medication has been the only FDA-approved treatment for the said disease. Patients must receive Tepezza infusions once every three weeks, extending the same to eight dosages.
However, not all is good about this therapy as there is active litigation in the Federal court against Horizon Therapeutics, the manufacturer of Teprotumumab. This article will explore this lawsuit in detail to understand whether settlements will be made in 2024.
The Litigation’s Premise
To better understand the Tepezza lawsuit, we must first discuss Thyroid Eye Disease. This condition is rare and extremely progressive in nature, affecting around half a million people across the world.
TED is originally a disease of the thyroid gland but its impact is experienced in the eye. People with this condition showcase the following symptoms –
- Discomfort and swollen eyelids
- Vision impairment
- Proptosis or bulging of the eyes
- Difficulty in moving the eyes or eyelids
- Watery, gritty, or irritated eyes
- Double or blurred vision
- Low tolerance to bright lights
The Cleveland Clinic states that there is no cure for this disease. Healthcare treatments are directed towards managing the symptoms. Given how little TED is known and its seriousness, Tepezza appeared as the light at the end of the dark tunnel.
As per Harvard Medical School, even the advertisement for the drug was pretty dramatic. It opened with a lady wearing dark sunglasses due to proptosis. She mentions how she must wear them wherever she goes.
What’s shocking is that the lady removed her glasses only to reveal that she had two more underneath! This is the moment when the music turns upbeat and she gladly talks about her doctor’s recommendation of Tepezza. Providing some statistics for the drug’s effectiveness, the ad concludes by portraying Tepezza as the panacea for TED.
Despite such impressive marketing tactics, Tepezza’s side effects blew it all in Horizon’s face. According to TorHoerman Law, plaintiffs have alleged that Tepezza led to the following injuries –
- Tinnitus or a ringing sensation in the ear
- Subjective hearing loss
- Autophony or the perception that one’s voice is louder than it is
- Hyperacusis or reduced sensitivity to the stimuli of sound
- A sensation of having the ears plugged
So we see that the Tepezza litigation is primarily centered on side effects that affect a patient’s auditory sensations. Besides the injuries, plaintiffs have alleged that the drug manufacturer was fully aware of the complications but issued no warnings (not even to physicians).
Progress Made Since the First Filing
The ongoing litigation against Horizon Therapeutics is a novel one. The first-ever case in this lawsuit was filed sometime during January 2023. At the time, there were 10 lawsuits including similar case contents.
As a result, the court consolidated them into a class-action multi-district litigation (MDL). Nearly two years before the litigation started, a study by the Endocrine Society revealed that Tepezza carried an increased risk of hearing impairment.
A shocking 65% of the patients reported some form of otologic symptoms, from mild to severe. This meant that the litigation did lean in favor of the plaintiffs from the get-go. As the months progressed, Horizon attempted to have the lawsuit dismissed under the Federal preemption doctrine.
In other words, the drug manufacturer argued that the FDA regulated its ability to alter Tepezza’s warning labels. The court declined this motion and case filings continued. With time, more evidence against Horizon’s Tepezza came to the surface.
In the meantime, Tepezza was not recalled because it was the only effective treatment against painful TED. The FDA did issue fresh warning labels for Tepezza being associated with hearing loss and other issues. Overall, the litigation moved forward but rather slower than expected.
Average Settlements and Jury Verdicts
By the middle of 2023, over 40 Tepezza lawsuits had been filed. The plaintiff’s counsel was not anticipating hundreds of thousands of cases, given the rarity of the condition Tepezza is used for.
However, the litigation was still found to be moving at a snail’s pace. By the time we reached the end of last year, the number of Tepezza lawsuits reached close to 100. Was it because many people were still not aware of the litigation? Was it because many patients experienced no Tepezza-induced complications? This part is difficult to tell with any certainty.
One good news is that the first-ever jury trials are expected to begin in 2025. Lawyers believe that the average settlement will range between $75,000 and $250,000 depending on the severity of injuries and other factors.
As of now, both sides are busy preparing for trials. In the plaintiff attorney’s opinion, progress is still slow since only 13 new cases have been added over the previous 100. Hopefully, more affected patients and healthcare providers will come forward in the upcoming months before the Bellwether trials commence.
Note: This is a collaborative post
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