Thyroid eye disease, or TED, is a rare, progressive, and debilitating autoimmune disorder that causes inflammation of the eye and the fatty tissue right behind it. The inflammation causes the eye to bulge or move forward, giving the appearance of a constant “staring look” on the patient’s face. In some cases, the eyelids and eyes become red and swollen.
Gradually, there’s a partial or complete loss of vision. Being the rare disorder that it is, TED patients had little hope of a cure until the Food and Drug Administration (FDA) approved an insulin-like growth receptor inhibitor called Tepezza, or Teprotumumab, back in January 2020.
At the time, this approval granted to Horizon Therapeutics (the inhibitor’s manufacturer) was the ray of hope TED patients had been looking for. Tepezza was marketed as an injection capable of halting the disease’s progress regardless of the severity or duration. However, something a lot more sinister was lurking behind the scenes. Let’s understand all about the Tepezza lawsuit and its progression in the Federal Court.
August 2022 – Present: An Active Lawsuit in the Federal Court
For nearly two-and-a-half years since its accessibility to the public, Tepezza was used to treat patients with thyroid eye disease. But the tables turned when Daniel Weibel, an Arizona resident, filed a lawsuit against Horizon on August 2022, claiming that the drug led to permanent hearing loss in his case.
He further alleged that Horizon failed to label any possible risks and side effects of using the drug, concealing raw data, analysis reports, and clinical trial results from the regulators and the public. It is important to state that Horizon did acknowledge hearing loss as a possible side effect, but the risk was grossly understated, and hence, ruled out as a meaningful warning.
Horizon filed a motion to dismiss the Tepezza hearing loss lawsuit on October 2022, but the same was not granted. The lawsuit began turning in favor of the plaintiff when the biopharmaceutical company, Amgen, stepped forward in January 2023 to disclose that they had plans to acquire Horizon. However, claims regarding the company’s attempts to hide the side effects of Tepezza led them to file a suit to block the acquisition.
According to TorHoerman Law, 10 more Tepezza lawsuits had been filed in the Federal Court of Northern District in Illinois by this time. Proposals to consolidate the cases into a single class-action multi-district litigation (MDL) were made. Horizon filed a motion to dismiss the lawsuits on the basis of Federal preemption, stating that the FDA regulated Horizon’s ability to alter Tepezza’s warning label.
Over the course of March 2023, a total of 34 Tepezza lawsuits were pending in different district courts across the country. But 13 were taken down on the basis of voluntary dismissals, indicating that Horizon did agree to settle. The lawsuit is currently active in the US Federal Court and was consolidated into a class-action MDL on June 2023 (despite Horizon’s attempts to oppose the consolidation).
New lawsuits are still being filed in various district courts across the US.
Horizon Still on the Loose
Through the Tepezza lawsuits, various cracks in Horizon’s story began to surface. For instance – the drug’s label indicates that the manufacturer had no clear idea of its mechanism in action. Horizon claimed that the drug works by binding and blocking a protein-coding gene called IGF-1R, but no studies were conducted to determine the exact mechanism of action.
Furthermore, the label also states that no definite pharmacodynamics studies were conducted, meaning the drug’s safety was hanging by a thread. The FDA requires all pharmaceutical companies to conduct post-marketing drug studies on larger population groups to test the efficacy of a drug for different demographics and gain additional information.
Horizon delayed this post-marketing study, pushing it to the last quarter of 2021. The drug was still available to the public despite no concrete post-marketing clinical trials. Finally, the post-marketing study results were released through a press release on February 2022. Horizon claimed that the drug was found to be safe, with only 10% of the patients (out of thousands used for the study) facing hearing-related issues, and even then, only a reduction in hearing (hyperacusis) and a ringing sensation in the ears (tinnitus).
But, doctors and patients started reporting serious hearing complications immediately after using Tepezza. Even today, Horizon is on the loose as it announced (in April 2023) that the FDA has passed approval for amending the label language for Tepezza. Essentially, this means the FDA is broadening the scenarios in which the drug may be used. This is based on a Phase-4 clinical trial, the results of which are to be declared in an upcoming medical conference.
Such a move by Horizon makes two things crystal clear –
- The company wishes to continue milking Tepezza even as lawsuits pile in the Federal Court.
- A couple of lawsuit settlements are like a drop in a bucket for multi-billion dollar corporations with plenty of resources.
Third-Party Studies Before and After the First Filing
Though Horizon failed to do its due diligence on Tepezza’s efficacy and safety, several third-party studies were conducted to test its claims. They were as follows –
- The National Library of Medicine released a report in 2021 that Tepezza led to hearing-related side effects in 46% of the patients after four infusions of the drug. In fact, only 3.6 infusions later, many reported a strong ringing sensation in their ears as well as muffled hearing or complete hearing loss. It was also noted that the issue of tinnitus reversed after three months of stopping Tepezza use.
- The Endocrine Society also conducted a study to test Tepezza’s efficacy on March 2021. It was found that Tepezza led to hearing impairment in at least 65% of the test subjects.
- The latest study was conducted in April 2023 by Stanford University to understand the link between Tepezza and hearing loss. The subject was a 64-year-old woman with advanced TED, who was given four infusions of the drug. She reported adverse side effects, including hearing loss in both ears. However, the side effects were reduced after getting off of the drug. A year later, the doctors tried reducing the dosage of Tepezza to continue treating progressive TED. This time, the side effects were not as adverse. This research again proved that Tepezza dosage was directly linked to hearing problems.
MDL Class-Action Driving Hope
As of today, Horizon’s story has completely fallen apart as Tepezza is directly linked to otologic side effects. In the past year, the pharmaceutical Giant has made several attempts to dismiss lawsuits, going as far as opposing an MDL consolidation.
However, the official MDL consolidation, as of June 2023, has raised plaintiffs’ hopes for fair settlements and payouts. The class-action MDL will be presided over by Judge Thomas M. Durkin of Chicago as the plaintiffs work on an organized discovery plan to develop a solid case against Horizon.
The first status conference for the newly consolidated MDL will be held on June 28th, 2023, where Judge Durkin familiarizes himself with the litigation as well as explains the selection process for lawyers on the plaintiffs’ steering.