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Tepezza Litigation in a Nutshell

Clinical trials for Tepezza, a Thyroid Eye Disease medication, have demonstrated an increased risk of hearing-related side effects including irreversible ones such as hearing loss and tinnitus . The risk is far greater than what had been previously disclosed by Horizon Pharmaceuticals when Tepezza was initially approved by the F.D.A.

 

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MERCK

Manufacturer of VIOXX which received a
$4.85 billion settlement for victims.

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AMERICAN HOMEPRODUCTS

Makers of “Fen-Phen” diet drug which
received a $3.75 billion settlement for victims.

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3M & MCGHAN MEDICAL CORP

Makers of silicon breast implants. Plaintiffs were
awarded $4 billion for damages.

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What is Tepezza?

Tepezza is an intravenous infusion medication for Thyroid Eye Disease (TED),  marketed by Horizon Therapeutics. It has been shown to relieve eye pain from inflammation in patients who suffer with this rare but serious autoimmune condition that can cause the eyes to be pushed forward resulting into proptosis or outward bulging of one or both eyes.

History of Tepezza

Tepezza was approved by the FDA in January 2020 as a medication for Thyroid Eye Disease. The F.D.A.’s approval was based upon two clinical trials, which consisted of a total of only 170 patients with TED. During two clinical trials, 10% of those given Tepezza experienced hearing loss symptoms compared to 0% for placebo recipients. Horizon described these hearing loss symptoms as temporary to the F.D.A. Despite these findings the information about the hearing risks associated with Tepezza were not included on the warning label. Subsequent much larger studies have found not only that the incidence of hearing loss was higher than initially reported, they have also found the hearing loss and tinnitus to be irreversible and permanent.

On July 18th, the FDA revised the warning label of Horizon Pharmaceutical's TEPEZZA to incorporate risks related to hearing damage. This newly added cautionary note highlights "hearing impairment, including hearing loss" as a major recent update under the drug’s warnings and precautions section. This modification is seen as a pivotal turn in ongoing legal proceedings. The changed warning implies Horizon's prior knowledge of the inadequate label and their omission in promptly disclosing adverse effects like significant hearing loss and tinnitus.

In June 2023, the Judicial Panel on Multidistrict Litigation decreed that all existing and forthcoming Tepezza lawsuits should merge at the U.S. District Court for the Northern District of Illinois, under Judge Thomas M. Dunkin. According to a June 2, 2023 order by Judge Durkin, this consolidation aims to efficiently navigate pre-trial processes, minimize repetitive discovery, and avert contradictory judgments. Initially, the consolidation motion contained 18 cases nationwide, but as of this article's publication, there are around 35 Tepezza lawsuits. Baker Legal Team is actively involved, leading with 4 ongoing cases. Every day, more cases are under review. If Tepezza infusions have caused you or someone you know to suffer from hearing loss or tinnitus, we're available for a complimentary consultation about your legal entitlements.

In May 2023, a peer-reviewed research article, helmed by the distinguished Professor Andrea Lora Kessler, M.D. from Stanford University School of Medicine, was introduced by the Endocrine Society. Titled "Increased Risk of Hearing Impairment With New Thyroid Eye Disease Treatment," the study revealed startling findings. Contrary to Horizon's earlier claims, the study demonstrated that nearly 65% of patients undergoing multiple Tepezza infusions encountered substantial hearing loss, tinnitus, and other related symptoms. This discovery starkly contrasts with Horizon's earlier assertions to the FDA, where they reported merely 10% of patients facing such complications in their two clinical trials.

The research was conducted independently, with its authors holding no prejudice for or against Horizon, and without any compensation for the study. The Endocrine Society represents over 18,000 endocrinologists spanning 122 countries. Parallel investigations are underway, and previous similar studies consistently indicate a more elevated risk of hearing damage than what Horizon initially disclosed during the drug's marketing phase and up to the current time.

PAST MASS TORT RECOVERIES

$ BILLION
Payment to victims who took the diet drug "Fen-Phen"
$ BILLION
Settlement for victims who used VIOXX
$ BILLION
Settlement against 3M and McGhan for defective breast implants

Tepezza Litigation

In April 2022, David Weibel of Illinois filed suit against Horizon pharmaceuticals claiming that their failure to warn him or his doctors about the risks of hearing loss and tinnitus caused by Tepezza lead directly to his permanent disability. The Complaint details how he received infusions which began less than six months after its approval by FDA (June 2020-September 2021).

The lawsuit seeks punitive damages stating, Horizon Pharmaceuticals, “willfully, wantonly and intentionally conspired, and acted in concert, to ignore relevant safety concerns and to deliberately not study the safety and efficacy of Tepezza”.

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Do I Have A Case?

 

Don’t suffer this problem alone. You can trust Baker Legal Team to provide compassionate legal counsel while

You may have a case and be entitled to significant compensation if you experienced hearing-related side effects including hearing loss and/or tinnitus after receiving Tepezza infusions.  Call Baker Legal Team to further discuss the details of your potential case. All cases are reviewed completely free of charge.

 

What Damages Can I Recover?

*Past Medical Bills

*Future Medical Bills

*Lost Income

*Lost Future Earnings

*Physical Pain and Suffering (both past and future)

*Emotional Trauma

*Disability/Impairment

WHY CHOOSE BAKER LEGAL TEAM

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You’ll work directly with Robert Baker, a Board Certified Civil Trial Attorney who has recovered over 250 Million Dollars. Less than 1% of Florida Attorneys are Board Certified Civil Trial Lawyers.

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FORMER PROSECUTOR

Robert began his career as a prosecutor working as an Assistant District Attorney in Kings County, New York. With over 30 years of experience, you’ll have one of Florida’s leading experts in personal injury on your side.

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Over 500 Million Recovered

Over 30 years experience and 1000’s of Cases Handled. You can trust us to recover the highest possible amount as quickly as possible and remember we only get paid if you get paid!

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