The Yost Legal Group Is Accepting Lawsuits Against Defective Drug Tepezza Do You Have a Case?
Teprotumumab (brand name Tepezza) is a United States Food and Drug Administration-approved medication used to treat the effects of thyroid eye disease (TED, also known as Graves’ disease). Historically, FDA approval is a long, winding, and costly process for pharmaceutical companies. New-drug development costs have skyrocketed in recent years to an average of more than $2 billion. After approval, drug companies must sell as many pills as possible to recoup these costs and make a healthy profit.
At the same time, Congress recently reduced the drug exclusivity period, to as little as three years in some cases. Once the exclusivity period ends, cheaper generic versions become available, and demand for the name-brand product often drops dramatically. In simple terms, since drug companies have less time to make more money, they often take dangerous shortcuts.
In this case, these shortcuts have led to a Tepezza lawsuit. According to court documents, Tepezza’s manufacturer, Horizon Therapeutics, failed to warn customers about potential hearing loss and other dangerous side effects.
If you or a loved one has been diagnosed with permanent hearing loss or deafness after taking Tepezza, you may have a case. If you have a case, you may be entitled to significant compensation. Our team is available by e-mail, phone (1-800-YOST-LAW), and text (410-973-6686). Contact us today for a free consultation.
Failure to warn claims are extremely common defective drug claims. In their rush to make as much money as quickly as possible, companies often bury information about dangerous side effects, so this negative data does not affect sales.
Horizon had several chances to change Tepezza or at least warn customers about the risk. As usual, the large pharmaceutical company did not do the right thing. And as a result, an experienced defective drug lawyer must get involved and obtain compensation for victims.
Initial Development
In the early 2000s, scientists at Genmab and Roche, a Danish pharmaceutical company that was only a few years old at the time, developed an artificial human monoclonal antibody that, they believed, would shrink cancer tumors. Early development showed some promise, but progress fizzled during clinical trials in 2009.
At this point in the development process, even though it is still early, a company has usually invested tens of millions of dollars into a drug. Hoping to recoup at least part of these costs, Genmab and Roche licensed teprotumumab to Horizon. When the baton was passed, it is unclear how much Horizon knew about the drug’s potential side effects. That is the main reason a Tepezza lawsuit is now pending. Legal actions usually bring the truth to light and hold parties responsible for the mistakes they make.
However, Horizon knew enough about the side effects to change course and continue developing the drug as a thyroid eye disease treatment instead of a cancer treatment. After successful initial clinical trials in 2017, the FDA quickly approved the drug, mostly because bureaucrats waived some safety rules to get Tepezza on store shelves as quickly as possible. More on that below…
Thyroid Eye Disease Treatment
This haste was not entirely a bad idea. Physically, thyroid eye disease (an autoimmune disorder) usually is not a serious condition. Psychologically, TED is almost always devastating.
Graves’ Disease, or TED, is inflammation in the eye muscles and the fatty tissue behind these muscles. Physically, this inflammation sometimes knocks the eyes out of alignment, causing double vision. Severe TED can cause blindness in some cases.
The psychological effects are almost as bad and affect everyone. This inflammation creates a “bug-eye” appearance that is very unsightly and, unless the person wears dark sunglasses all the time, impossible to conceal.
Risk factors include smoking and an overactive thyroid gland. Sometimes, quitting smoking and regulating thyroid activity basically cure TED. If these things do not work, the patient’s only options are eye drops, which usually do not work, or radical and risky eye surgery. That is, these were the only available options until Tepezza hit the scene.
A failed cancer drug that effectively treats an autoimmune disease is obviously a very powerful drug. Horizon performed three layers of clinical trials on teprotumumab before the FDA approved it, yet it said nothing about the hearing loss side effect.
Most likely, the company’s clinical trials were hopelessly flawed, or the company intentionally buried the hearing-loss side effect.
Either way, the Tepezza and defective drug lawyers at The Yost Legal Group have decided to wade into these muddied waters to help protect people from using it in the future and also to ensure compensation for people already injured by the defective medication.
FDA Approval
A century ago, the FDA was a taxpayer-funded organization and an effective safety watchdog. Today, industry-paid user fees account for about half the agency’s budget, so it has basically become a lapdog. As if the overall environment is not bad enough, FDA bureaucrats often hand out free passes that lead to easy drug approval.
In the 1990s, some lawmakers were concerned that the drug approval timeline in the United States was much longer than the timeline in other parts of the world. The 1997 FDA Modernization Act, along with some subsequent laws, streamlined the process and added approval shortcuts such as:
- Fast Track Approval: This status, which a drug company can request at any time, expedites the review of drugs that show promise in treating a serious or life-threatening disease and address an unmet medical need. This broad definition means almost all drugs are eligible for fast-track approval.
- Breakthrough Therapy: This track is available if a drug treats a serious condition and is a substantial improvement over existing remedies. That is also a broad definition. Breakthrough drug manufacturers might be able to skip a level of clinical trials.
- Orphan Drug: If a drug treats certain rare medical conditions and would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions, financial incentives, such as subsidies and tax incentives, are available.
Horizon hit the jackpot and received all three of these free passes. The company reaped the benefits, and customers who lost their hearing paid the price.
Fortunately, there is an old saying in the law that “Where there is a wrong, there is a remedy.” Since Horizon has almost unlimited financial resources, thanks to powerful, big-selling drugs like Tepezza, massive compensation is possible for victims.
Accepting Nationwide Tepezza Victims for New MDL
If you or a loved one has experienced adverse side effects such as permanent hearing loss or total deafness after receiving Tepezza infusions, contact the experienced Tepezza lawyers at The Yost Legal Group today. There is no time to delay. Our team is available by e-mail, phone (1-800-YOST-LAW), and text (410-973-6686).