Group of 12 Tepezza Lawsuits Over Hearing Problems To Be Selected For Bellwether Discovery and Early Trials

The U.S. District Judge presiding over all Tepezza lawsuits has issued guidelines for selecting 12 cases for early “bellwether” test trials, while also rejecting an attempt by the drug maker to dismiss the litigation over failure to warn about the risk of hearing problems.

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 on the market 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.

Hundreds of former users are now coming forward to report that they experienced various hearing problems 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.

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.

Tepezza Bellwether Selection Guidelines

As part of the coordinated management of the litigation, Judge Durkin is establishing a “bellwether” program, where a small group of 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. However, the parties disagreed about how early in the MDL proceedings that bellwether process should begin.

Last week, Judge Durkin issued a case management order (PDF) directing the parties to start selecting claims that will be part of the bellwether discovery pool in early 2024.

Plaintiffs have been directed to select four cases within the next sixty days, and defendants will select another four cases within ninety days. The court will then randomly select another four claims, resulting in a total of 12 cases that will go through discovery.

The parties have been instructed to select cases “that they have a good-faith belief are representative of the body of then-filed cases as a whole,” Judge Durkin indicated. This will allow eventual bellwether trials to be more informative for the parties, and potentially drive Tepezza settlement negotiations that may avoid the need for hundreds of individual cases to be set for trial.

Within 30 days after fact discovery is complete, Judge Durkin ordered the parties to submit a memorandum summarizing each of the 12 cases, explaining their respective positions on which four should go before a jury first, and why. The court will then select which of the four Initial bellwether trial cases will be tried first.

Tepezza Lawsuit Preemption Argument Rejected

The bellwether selection protocol issued days before Judge Durkin rejected an attempt by the drug manufacturers to obtain a ruling that may have resulted in the dismissal of the litigation.

The defendants filed a motion in one specific claim in July 2023, arguing that the design defect claims are preempted by the federal law. The Court decided to use that case to evaluate whether similar preemption motions may be filed in other claims.

In a memorandum opinion and order (PDF) issued on November 3, Judge Durkin has rejected the motion to dismiss claims filed by plaintiff Cynthia Williams, allowing discovery and pretrial proceedings to move forward in that claim and others.

The decision notes that there has not yet been enough discovery to determine whether there is no safer alternative design that would have been approved by federal regulators, and indicated Horizon could renew the argument at a future date when the case is further along.

November 2023 Tepezza Lawsuit Update

Plaintiffs each raise similar arguments that they 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, 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 trial dates will not be binding on other claims in the litigation, the average lawsuit payouts may influence eventual Tepezza settlement negotiations that will be necessary to avoid each individual case being set for trial in the coming years.