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Tepezza Lawsuit Proves That FDA Approvals Don’t Mean There Are No Side Effects!

No doubt, the Tepezza Lawsuit is a prime example of how some pharma companies don’t care how their customers will suffer from the side effects of the drugs they’re selling with that so-called FDA approval. That same thing happened here, and sure enough, dozens and dozens of people ended up with hearing loss, vision loss, and other kinds of problems. For now, this case is an ongoing one, but let’s hope the trial starts soon and the people get the justice that they’re waiting for.

Tepezza

What Is Tepezza, and What Was It Used For?

Tepezza​‍​‌‍​‍‌​‍​‌‍​‍‌ is a medication that received FDA approval in 2020. And in case you literally don’t know anything about it yet, see, it is intended for the treatment of Thyroid Eye Disease (TED), which is a disorder characterized by bulging of eyes, swelling, pain, and double vision. This medication helps by inhibiting a protein that is associated with inflammation around the eyes.

The patients receive eight intravenous infusions within a period of about five months. For the majority of patients, Tepezza treatment was able to alleviate eye symptoms. Nonetheless, shortly after the drug became available in the market, some users disclosed experiencing hearing-related ​‍​‌‍​‍‌​‍​‌‍​‍‌issues.

When Did Hearing Issues Come to Light?

News​‍​‌‍​‍‌​‍​‌‍​‍‌ reports started coming out a very short time after Tepezza was launched. Initial evidence suggested that only 10% of users experienced hearing issues. However, subsequent studies revealed that these figures were much higher – somewhere between 40% and 65%.

In 2021, a Stanford University study discovered a direct correlation between Tepezza dosage and hearing impairment. FDA agents asked the pharmaceutical company responsible for Tepezza, Horizon Therapeutics, to revise the drug label and clearly indicate the risk of permanent hearing loss around mid-2023. As a matter of fact, a lot of patients had already finished their treatment by the time this warning was issued, which is when lawsuits started ‌ ‍ ​‍​‌‍​‍‌​‍​‌‍​‍‌increasing.

Why Are Patients Suing Horizon Therapeutics?

Patients​‍​‌‍​‍‌​‍​‌‍​‍‌ claim Horizon probably knew about the hearing risks much earlier, or at least should have known, and therefore, they have a claim against Horizon for not warning users on time. Some lawsuits allege that the company brushed off the early warning signs and went on advertising the drug as safe.

How Did the Lawsuit Expand?

Cases​‍​‌‍​‍‌​‍​‌‍​‍‌ that were initially isolated incidents eventually escalated into a class action on a large scale. As of mid-2023, the lawsuits were considered as one multidistrict litigation (MDL). This is a mechanism under which the cases, which are of the same nature, are brought before a single judge, who will manage the common evidence and thus speed up the process, but each patient still retains his or her own claim.

Thomas​‍​‌‍​‍‌​‍​‌‍​‍‌ Durkin is in charge of the MDL in the Northern District of Illinois. The number of cases has increased from less than 50 to over 270 by early 2026. The initial bellwether trials, which are test cases that can help forecast the outcomes of the rest, are scheduled to start later this ​‍​‌‍​‍‌​‍​‌‍​‍‌year.

What Kind of Compensation Is Being Discussed?

The​‍​‌‍​‍‌​‍​‌‍​‍‌ estimates of the settlement vary and a lot of legal professionals consider that the settlement per person may be in the lower hundreds of thousands, maybe even over $200,000. It is the degree to which the hearing loss limits the person’s life that determines the payout.

Settlement may include medical expenses, lost wages, hearing aids, as well as compensation for pain and suffering and loss of enjoyment of life. On top of that, if there is proper evidence that the company acted irresponsibly, then it is possible to seek more damages.

As of now, no decision has been made, but a lot of people anticipate that there will be either settlement negotiations or verdicts after the first few trials, maybe around the end of 2026 or even ​‍​‌‍​‍‌​‍​‌‍​‍‌2027.

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