Drug Maker Files Motion to Dismiss Tepezza Lawsuit Over Hearing Loss Warnings

Horizon Pharmaceuticals claims the Tepezza hearing loss lawsuit is preempted by federal law because the manufacturer would have been unlikely to change the label warnings without FDA permission.

As Horizon Pharmaceuticals faces a growing number of Tepezaa lawsuits brought by former users left with permanent hearing loss, the drug maker has filed a motion to dismiss one of the first complaints, arguing that the failure to warn claims should be preempted by federal law.

Tepezza (teprotumumab-trbw) is a biologic treatment approved by the FDA in January 2020, as the first medication approved to treat thyroid eye disease, which is caused by hyperthyroidism and linked to Graves’ disease, resulting in inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye. This can lead to blurred or double vision and can cause the eyes to appear to bulge.

The FDA approved Tepezza through a controversial fast-track Orphan Drug program, since it targets a condition that has no other treatments, which allowed Horizon to introduce the medication without extensive testing or studies. However, plaintiffs claim the drug maker knew or should have known Tepezza side effects cause hearing loss before it was ever submitted to the FDA, and that the company continued to aggressively market the drug shortly after it was approved, without warning users or the medical community about the importance of monitoring for hearing loss or ear damage during treatment.

In November, a Tepezza hearing loss lawsuit was filed by Donna Walker in the U.S. District Court for the Northern District of Illinois, indicating neither she nor her doctors were given adequate warnings about the risk of irreversible hearing loss and tinnitus associated with the medication.

Horizon filed a motion to dismiss (PDF) last week, arguing the lawsuit is preempted by federal law, because Walker failed to demonstrate that Horizon could have added the warnings to the label. Horizon claims it should not be held liable for failing to warn about the risk of hearing loss from Tepezza, suggesting it could have not unilaterally added the information on the drug label, and that no new evidence has been presented which could have resulted in the FDA approving such a warning.

The motion to dismiss also claims that under the laws of Arizona, where the case was filed, the complaint does not allege sufficient facts for strict liability, negligence or defective design claims, and that Arizona state law does not allow for punitive damages.

While the filing is specific to the Walker case, the court’s decision could have wide-ranging implications for the growing number of other Tepezza lawsuits being pursued against the manufacturer.

February 2023 Tepezza Lawsuit Update

Given similar questions of fact and law raised in at least 10 complaints filed in the U.S. District Court for the Northern District of Illinois, Walker and a group of other plaintiffs have joined together to file a motion to consolidate the Tepezza lawsuits before one federal judge for coordinated discovery and pretrial proceedings.

Although common issues will be involved in each of the claims, Horizon filed a response opposing consolidation in January 2023, arguing that each of the claims will involve unique facts and circumstances, which would not benefit for coordination.

Throughout the remainder of 2023, as more individuals realize that their permanent hearing loss was caused by Tepezza, the number of lawsuits brought against Horizon Pharmaceuticals is expected to increase, and there may eventually be over 100 claims pursued over the lack of adequate hearing loss warnings.

Tepezza is an insulin-like growth factor 1 receptor (IGF-IR) inhibitor medication, and it is well known that IGF-I is crucial to protecting the inner ear hair cells from noise-induced hearing damage, ischemia and medication toxicity. Therefore, Tepezza claimants allege that the drug maker should have recognized that hearing loss would be a potential side effect, and provided warnings about the importance of monitoring during treatment and obtaining hearing tests before use.