Tepezza Lawsuit What is, Definition, Meaning

What is the Tepezza Lawsuit? (2024)

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Rae Fitzgerald


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Tepezza, also called teprotumumab, fights a rare autoimmune disorder called thyroid eye disease. This condition causes eye inflammation and bulging, leading to discomfort and vision problems. If not treated, it can even cause blindness.

Horizon Therapeutics, PLC makes and sells Tepezza. It's a special medicine infused into the body. This drug, made from living things, targets and blocks parts of the immune system causing thyroid eye disease.

Tepezza blocks insulin-like growth factor-1 receptors (IGF-1R). In thyroid eye disease, these receptors are too active, causing too many fibroblasts. This leads to the disease's symptoms.

Patients get Tepezza through IV infusions every three weeks for about five months. A nurse usually gives the treatment in a clinic.

At present, Tepezza is the sole FDA-approved remedy for thyroid eye disease, a noteworthy achievement in medicine. Of course, that means you had no other options when seeking treatment for thyroid eye disease.

Despite its success for many, Tepezza has associated risks, notably alleged permanent hearing loss and ringing in the ears. These side effects have led to lawsuits against Horizon Therapeutics.

Does Tepezza Cause Hearing Loss?

According to the FDA, the answer is yes — Tepezza can cause hearing loss.

The FDA now warns that Tepezza (teprotumumab) could cause severe hearing problems, possibly leading to permanent loss. And it’s not just straight hearing loss; the drug may lead to other hearing-related problems, such as the following:

  • Muffled hearing
  • Feeling like ears are blocked
  • Heightened sensitivity to sound
  • Hearing your own voice and breath loudly

This isn’t a new warning from the FDA. But now, it seems that the initial warning might not have captured the full severity of the hearing loss risks. A recent study suggested that more patients might face hearing symptoms from Tepezza than initially thought.

What Is the Tepezza Hearing Loss Lawsuit?

Following growing concerns, the manufacturer of Tepezza included a warning label on the medication in 2023, stating the following:

“Hearing Impairment Including Hearing Loss: Tepezza may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with Tepezza and consider the benefit-risk of treatment with patients.”

Despite this warning, many patients like you had already taken the medication since its FDA approval in January 2020.

Patients started experiencing hearing problems shortly after the FDA approval, leading to lawsuits against Tepezza's manufacturer, Horizon Therapeutics.

Possible Legal Process for Tepezza Lawsuits

The legal process for Tepezza lawsuits falls under product liability law, where negligence doesn't need to be proven.

Instead, plaintiffs — meaning people who believe they were harmed by Tepezza — can sue the drug manufacturer and others involved in distributing the product.

Currently, Horizon Therapeutics is the primary defendant in the Tepezza lawsuits.

If plaintiffs prove the product caused harm as intended or lacked sufficient warnings, they may receive compensation for their losses.

How These Lawsuits Might Proceed

Due to the high number of Tepezza users experiencing hearing issues, they may combine their cases.

This can happen in a few ways. One way is through a class action, grouping many cases together. Alternatively, cases can be consolidated in multidistrict litigation (MDL), where several cases are overseen by one judge.

Tepezza plaintiffs have already moved for MDL consolidation, and the U.S. Judicial Panel on Multidistrict Litigation issued a transfer order in June 2023, merging pending lawsuits in the Northern District of Illinois.

Once combined, pretrial proceedings occur, where the judge addresses common issues. As the MDL is relatively new for Tepezza, not many pretrial actions have happened yet.

There are currently over 59 pending cases in the consolidated MDL as of December 2023. More plaintiffs may join in federal court filings, while some may pursue claims in state court.

During MDL, bellwether trials are scheduled with representative plaintiffs to gauge case outcomes. This informs settlement talks, where defendants may offer a settlement split among all plaintiffs involved in the mass tort case, depending on trial results.

Frequently Asked Questions

  • Tepezza is manufactured and distributed by Horizon Therapeutics, PLC, a global biopharmaceutical company.

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