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Under pressure from the Food and Drug Administration, Horizon added a stronger hearing loss warning label to one of its best-selling drugs.
The warning advises purchasers about the potential for severe hearing impairment including hearing loss associated with Horizon Therapeutics’ Tepezza (teprotumumab). The new labeling indicates that hearing loss could be permanent. It adds that patients’ hearing should be tested before, during, and after Tepezza treatment.
Tepezza Issues
People who take Tepezza have a higher risk of serious auditory issues. Additionally, and probably more importantly, Horizon knew about the risk and didn’t pass this information on to patients. This fact is the basis for the Tepezza lawsuit.
During Tepezza’s development in the late 2010s, researchers discovered that teprotumumab, a drug which treats a rare condition called thyroid eye disease (Graves’ disease) caused serious hearing impairment problems, such as:_
- Tinnitus (ringing in the ears)
- Autophony (echoing in the ears), and
- Hypoacusis (tone deafness).
Horizon told FDA officials that such side-effects were remote and sporadic. According to later analysis, the hearing loss side-effect rate was over 80 percent, a fact Horizon carefully concealed.
To summarize, Horizon knew about serious side-effects and buried that information, while the FDA didn’t ask questions. When drug manufacturers and government watchdogs don’t protect people, a skilled defective drug lawyer must intervene.
Attorneys file legal actions which not only obtain fair compensation for injury victims; these actions also force companies like Horizon to change the way they do business and prioritize public health and safety above everything else.
FDA Response
Contrary to popular myth, the FDA cannot unilaterally recall dangerous drugs or even unilaterally compel manufacturers to add warning labels. This agency can only publicly pressure the company to do these things.
Your Claim for Damages
Victims have filed a class action Tepezza lawsuit in a Chicago federal district court. At the end of 2022, fewer than two dozen victims had stepped forward. By early 2023, the number had skyrocketed to over 200, and that number is increasing every month.
If you or a loved one took Tepezza and was diagnosed with serious hearing loss, we urge you to take action. When the Tepezza lawsuit is likely settled, only victims who have filed legal actions receive maximum compensation. Victims who qualify to join the lawsuit but don’t receive much less money.
Pharmaceutical class actions are quite complex, mostly because they involve some additional procedural and logistical hurdles.
Procedurally, the long multidistrict litigation process usually includes motions to dismiss based on preemption and other obscure doctrines. Basically, preemption is the idea that once a government agency, like the FDA, declares a drug is safe, a court cannot second-guess that finding. This idea short-circuits the independence of a federal court and its right to resolve a failure to warn dispute.
For a free consultation with an experienced pharmaceutical litigation attorney, contact Napoli Shkolnik. We accept cases nationwide and do not recover a fee until we win your case.