Why Are Tepezza Manufacturers Under Legal Scrutiny?

Controversy is rarely far behind in pharmaceutical development and approval. The latest drug attracting legal attention is Tepezza, a promising new treatment for thyroid eye disease. Since receiving FDA approval, questions about its testing and risks have emerged. This has fueled debates around product safety, patient care, and corporate responsibility. 

This article explores the growing scrutiny facing Tepezza’s manufacturers and what it might mean for those relying on this medication.

Overview of Tepezza

Tepezza is a medication approved by the U.S. Food and Drug Administration (FDA) for treating thyroid eye disease (TED), which is also known as Graves’ orbitopathy. TED is a serious autoimmune condition where the body’s immune system mistakenly attacks tissues behind the eyes. This causes symptoms such as eye pain, swelling of eyelids, bulging eyes, and double vision.

According to Drugwatch, Tepezza targets the underlying cause of TED rather than just the symptoms. Cells behind the eyes have receptors that can activate immune responses. In TED, the immune system attacks these cells in the wrong way. Tepezza binds to the receptors to block the immune signals from activating. This helps reduce swelling of eye muscles and tissues caused by the autoimmune reaction.

Tepezza has been used to reduce symptoms such as inflammation, protruding eyes, and double vision, even if it does not treat TED. A physician or nurse will give the medication to you via intravenous infusion over the course of 90 minutes.

Patients receive up to 8 doses spaced three weeks apart. Clinical studies found symptoms continued improving with each treatment session over the full treatment course. Tepezza represents an important new targeted treatment option for people suffering from vision problems and appearance changes caused by TED.

Tepezza Side Effects: What to Watch For

Tepezza can cause mild to serious side effects in some patients. According to Medical News Today, common mild side effects include muscle spasms, nausea, diarrhea, fatigue, and hair loss. These problems usually go away quickly. But if adverse effects worsen or last longer than a few weeks, you should definitely call your doctor.

Additional mild side effects reported in clinical trials of Tepezza include changes in taste, dry skin, brittle nails, hearing problems, and mild allergic reactions. Once again, most mild side effects tend to be temporary in nature. However, ongoing or severe issues still warrant discussion with your healthcare provider.

In rare cases, Tepezza can lead to serious side effects requiring immediate medical attention. Infusion-related reactions like headache, muscle pain, increased heart rate or blood pressure, and breathing difficulties are possible during treatment. 

The Rise of Tepezza Lawsuits

Hearing loss is a growing public health concern impacting hundreds of millions worldwide. By 2050, it is estimated that over 700 million people will experience disabling hearing impairment, according to Statista. This troubling rise in hearing issues has also manifested among patients treated for certain medical conditions. 

Specifically, studies have found an unexpected incidence of hearing problems in people who had been prescribed Tepezza. Early trials indicated approximately 10% experienced tinnitus, hearing loss, or ear problems. According to TorHoerman Law, more recent research suggests that the actual rate may be substantially higher, potentially affecting as many as two-thirds of patients. 

One study published in the Endocrine Society journal detailed the nature and severity of new hearing symptoms reported. Sensorineural hearing loss, caused by damage to delicate inner ear structures, affected several patients. Others suffered from a patulous eustachian tube, an abnormal passage opening connecting the middle ear and throat that disrupts pressure regulation in the ear.

For some people, symptoms like patulous eustachian tube saw improvement within months yet did not fully disappear. In other cases of sensorineural hearing loss, signs abated somewhat but persisted to a degree even half a year later. The results point to Tepezza’s potential for long-term or permanent deafness.

As a result of these findings, legal action has been taken against the maker of Tepezza in the form of a Tepezza hearing loss lawsuit. Lawsuits argue the drug’s label failed to appropriately warn of irrevocable hearing damage, depriving users of informed consent about this debilitating side effect.

Plaintiffs in the Tepezza hearing loss lawsuit alleging the company was aware of the risks but did not disclose them. Ongoing research continues to shed light on Tepezza’s auditory risks and impact on patients.

Potential Next Steps for Tepezza Lawsuits

Since many individuals who have used Tepezza have reported side effects like hearing loss or tinnitus, there are likely to be many potential plaintiffs. Consolidating these cases could make legal proceedings more efficient.

One approach would be a class action lawsuit, combining all plaintiffs’ claims into a single large case. The cases could also be consolidated through a multidistrict litigation (MDL) process. This process involves transferring similar pending cases to a single judge for coordinated pretrial proceedings.

Plaintiffs have already requested that independent Tepezza lawsuits be consolidated via MDL. The Judicial Panel on Multidistrict Litigation granted this motion in June 2023, designating the U.S. District Court for the Northern District of Illinois as the appropriate court for all linked federal litigation.

Now that the cases are combined, the presiding judge will make rulings that apply to all plaintiffs during the preliminary stage. However, as the MDL is newly established, significant pretrial motions have not occurred yet.

As of December 2023, over 59 pending cases were part of the consolidated MDL. More plaintiffs may join as new cases are filed in federal court. Some plaintiffs may also choose to pursue state court claims separately.

In an MDL, “bellwether trials” are typically scheduled to assess how representative cases may fare at trial. This can inform settlement negotiations by showing outcomes the defendant may face if other cases proceed similarly. Depending on the bellwether results, the defendant may choose to offer a settlement. If accepted, this settlement could resolve claims for all plaintiffs involved in the mass tort litigation.

FAQs

1. How much compensation can I expect for hearing loss and tinnitus?

 A: Most personal injury claims involving tinnitus stem from car accidents. There isn’t a straightforward calculator for determining settlement amounts based on specific injuries. However, typical compensation ranges for tinnitus or hearing loss claims in auto accident cases fall between $50,000 to $250,000.

2. Is it possible to reverse hearing loss?

A: Many cases of conductive hearing loss can be reversed. Sometimes, the body naturally resolves the issue, such as clearing an infection. In other cases, medical treatments like medications or surgical procedures may be necessary to restore hearing.

3. Does Tepezza cure thyroid eye disease (TED)?

A: Tepezza does not treat thyroid eye disease (TED), unfortunately. Nonetheless, Tepezza therapy helps lessen a few TED-related symptoms. According to clinical research, Tepezza has lessened symptoms like double vision and eye protrusion throughout a 24-week period.

To summarize, legal scrutiny surrounding Tepezza underscores the tension between providing new treatments and fully disclosing health risks. While it has helped many TED sufferers, the emerging concerns around permanent hearing loss raise serious questions about informed consent. 

How manufacturers and regulators respond could impact patient trust in future pharmaceuticals. It signals either prioritizing corporate interests over well-being or a willingness to rectify oversights through appropriate means.