Selection of Tepezza Bellwether Lawsuits in Federal MDL Pushed Back to May 30

Judge agreed to delay bellwether trial picks for 60 days, but ordered Horizon Therapeutics to turn over all raw clinical trial data to plaintiffs, who indicate the drug manufacturer's science was flawed.

The U.S. District Judge presiding over all Tepezza hearing loss lawsuits is giving defendants until the end of next month to turn over their list of bellwether cases, delaying the original deadline for selecting potential trial claims by 60 days.

Plaintiffs identified their four Tepezza bellwether lawsuit picks on March 1, and the drug manufacturer was expected to select another four cases by April 1, after which the court will randomly select the final four cases that will go through cases-specific discovery in preparation for early trial dates. However, Horizon Therapeutics requested an extension, so that it could review additional medical records before selecting what they believe are the most representative claims for trial.

The selections will come from over 100 product liability lawsuits currently pending in the federal court system, each involving similar allegations that plaintiffs experienced various forms of hearing damage from Tepezza, including persistent ringing in the ears known as tinnitus, and complete hearing loss. In many cases, the hearing loss persists long after the thyroid eye disease treatments, leaving users with irreversible hearing damage.

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Tepezza (teprotumumab-trbw) is a new-generation biologic treatment introduced by Horizon Therapeutics in January 2020, as the first medication approved to treat thyroid eye disease or bulging eyes, 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.

Although Tepezza infusions were originally intended as a niche treatment, with only a limited market, during the second year the drug was available in the United States sales doubled to $1.66 billion, and critics have expressed concern that Tepezza was aggressively marketed without adequately disclosing all of the potential risks.

Given common questions of fact and law raised in complaints filed in federal courts nationwide, a Tepezza MDL (multidistrict litigation) was established in July 2023, centralizing the lawsuits before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

As part of the coordinated management of the litigation, Judge Durkin has established a “bellwether” program, where a group of 12 representative cases will be selected to go through case-specific discovery in preparation for early trial dates, which will help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout various cases in the litigation.

Tepezza Bellwether Selection Deadline Extended

Horizon Therapeutics indicated the extension for selecting Tepezza bellwether lawsuits was necessary due to the number of medical records involved, and an on-going effort to find the most representative claims to be included in the bellwether discovery process. However, plaintiffs opposed the extension (PDF) in a March 12 brief to the court.

“Horizon lacks good cause for its request,” plaintiffs wrote. “Horizon has obtained more than enough information in the past 90+ days to meet the stipulated (and already extended) deadline to select cases for discovery.”

After a hearing held on March 20, Judge Durkin agreed to extend the deadline until May 30. However, in a Docket Entry (PDF) the Court noted that no further extensions of the deadline will be allowed.

Plaintiffs’ Request for Raw Clinical Data Approved

On March 19, a day before the hearing, the Judge issued a separate order (PDF) granting a request by plaintiffs for the raw clinical data for Tepezza, as well as seeking all records of payments Horizon made to healthcare professionals to promote and market Tepezza.

Judge Durkin approved plaintiffs’ request for the data, despite opposition from the defendants, who attempted to argue the request was too broad.

“The Court is not persuaded by defendant’s objections,” he wrote. “Defendant concedes the relevance of the raw data, which plaintiffs need to test their belief that defendant’s analysis was flawed. Moreover, the cost of anonymization, though undoubtedly considerable, should not be unduly burdensome for a litigant of the defendant’s means. Accordingly, the Court orders defendant to produce the raw clinical trial data.”

However, Judge Durkin rejected the plaintiffs’ request for payment records, saying such payments are only marginally relevant to the litigation, and thus is overly broad and unduly burdensome.

April 2024 Tepezza Lawsuit Update

The bellwether selections are intended to prepare a group of representative cases for early trials, which the parties can use to gauge how juries are likely to respond to certain evidence that will be presented throughout the litigation, including allegations that users may have avoided Tepezza hearing problems if the drug maker had disclosed information about the risk, and instructed doctors to obtain hearing tests before and during treatments.

In July 2023, the U.S. Food and Drug Administration (FDA) released a new version of the Tepezza prescribing information guide, which now adds many of the same hearing loss warnings plaintiffs indicate should have been included when the drug was first introduced.

The new Tepezza label update now discloses that users have been left with severe and permanent hearing loss. It also indicates doctors should assess patients’ hearing before, during, and after Tepezza infusions, to avoid users experiencing permanent ear damage.

While the outcome of Tepezza bellwether early trials will not be binding on other claims in the litigation, the average lawsuit payouts may influence eventual Tepezza settlement negotiations, which will be necessary to avoid each individual case being set for trial in the coming years.

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