Horizon Therapeutics (Horizon) makes a drug called Tepezza (teprotumumab-trbw). It is a relatively new drug approved by the FDA to treat the symptoms of Thyroid Eye Disease (TED). These symptoms include bulging of the eyes, swelling, eye pain, double vision and redness of the eyes. TED is a rare medical condition involving inflammation of the tissue around the eyes.
When made available in early 2020, Tepezza was the first FDA-approved drug to treat TED. Despite being approved by the FDA, many patients who have received this medicine have reported various side effects. One of the more notable is that many patients have started complaining about hearing problems.
Does Tepezza Cause Hearing Problems?
According to Tepezza’s own website, 10% of Tepezza patients report hearing problems. But not everyone who takes Tepezza will suffer from hearing issues. Of those that do, there may be a wide range of complaints reported. Some of the reported hearing issues include:
- Partial and/or permanent hearing loss
- Fluid plugging one or both ears
- Reduced ability to hear certain sounds
- Trouble perceiving the loudness of sounds
- Ringing of the hears (tinnitus)
The most prominent hearing issues seem to be tinnitus and partial and/or permanent hearing loss.
Tepezza works as an insulin-like growth factor-1 receptor inhibitor and it’s believed that insulin-like growth factor-1 plays a major part in causing TED. However, there have been studies that establish a likely connection between insulin-like growth factor-1 and hearing problems.
Has the FDA Taken Action Concerning Tepezza?
As of the time of this writing, it doesn’t appear the FDA has taken any actions concerning this medication, including recalls or safety alerts.
Are There Any Lawsuits Alleging Tepezza Caused Hearing Problems?
Yes. Some of the claims allege Horizon:
- Knowingly withheld or misrepresented information concerning the hearing-related risks of using the medication;
- Did not properly test Tepezza;
- Failed to properly warn doctors and patients about the hearing-related risks of taking the drug; and
- Continued to market Tepezza to patients despite being aware of its potential problems.
In early 2023, Tepezza lawsuits started getting filed around the country, such as this one filed in Georgia. As of June 2, 2023, there were 37 cases in federal court, spread out over eight districts. All of these cases were recently consolidated into multi-district litigation (MDL).
The MDL will be known as “In re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3079.” The cases subject to the MDL are being transferred to the Northern District of Illinois, likely to be presided over by Judge Thomas M. Durkin.
What’s Next for the Tepezza MDL?
This MDL was just created, so it’s not likely anything significant will occur for the next few months. What’s most likely is that cases will continue to be added to the MDL and the litigants will figure out how to conduct discovery.
In a few years, a handful of bellwether trials may begin. Once these trials conclude, there’s a greater chance for a global settlement, as the outcome of the bellwether cases will give each side a better idea of how strong (or weak) their cases are.
If you have any questions about Tepezza or think you might want to take part in this MDL, feel free to call me at 919.334.6277 (direct line). Good luck.