Hearing Loss Victims Propose Tepezza Lawsuits Be Selected For Early Bellwether Trial Process To Avoid Undue Delay in MDL

Manufacturer of the thyroid eye disease drug indicates it plans to move to dismiss any Tepezza lawsuits over hearing loss on federal preemption grounds, seeking to delay the work up of individual cases for potential bellwether trials.

Plaintiffs involved in Tepezza hearing loss lawsuits have proposed a plan that calls for the early selection of a group of cases that will be prepared for a series of test trial dates, as part of an effort to avoid lengthy delays as the coordinated pretrial proceedings get under way in the recently established federal multidistrict litigation (MDL) created for complaints filed throughout the federal court system.

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 loss side effects from Tepezza, including persistent ringing in the ears known as tinnitus, and complete hearing loss. In many cases, the problems persist 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 last month, centralizing the lawsuits before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

Tepezza Lawsuit Proposed Bellwether Trial Protocols

As part of the coordinated management of the litigation, it is expected that Judge Durkin will establish 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 disagree about how early in the MDL proceedings that bellwether process should begin.

On August 21, attorneys representing plaintiffs in Tepezza lawsuits proposed bellwether protocols (PDF), which they say should govern the selection of initial bellwether discovery and trial cases.

“Entering this protocol now sets the sage for an efficient MDL that will serve the legitimate litigation interests of the Court and parties,” the proposed protocol plan states. “Plaintiffs’ protocol is well tailored to ensure that the litigation proceeds on an efficient path.”

The plan calls for plaintiffs and defendants to each choose three bellwether discovery cases, for a total of six Tepezza lawsuits to form the initial bellwether discovery pool. Once those cases are selected, parties would have 150 days to complete fact discovery.

After the discovery period, the pool will be cut to three cases to be prepared for trial; one selected by plaintiffs, one selected by defendants, and one selected by the Court.

The proposal calls for rapid implementation of the bellwether selection protocols to ensure efficient and speedy management of the Tepezza MDL.

On the same day, Horizon Therapeutics issued its own Tepezza bellwether selection protocols (PDF), which call for the selection of five cases by each side, for a total of 10. However, Horizon indicates it plans to then file a motion to dismiss each of the cases put forward based on preemption grounds.

The company argues that the claims in Tepezza lawsuits are preempted by federal law and should not be allowed to move forward.

September 2023 Tepezza Lawsuit Update

Judge Durkin has scheduled an in-person status herine for Thursday, August 31, 2023, to discuss the proposed bellwether protocals and other preliminary issues in the litigation, including the timing for arguments on any motion to dismiss filed by the manufacturers, claiming that the failure to warn design defect claims are preempted by federal law, since regulators approved the medication and label warnings.

The U.S. Food and Drug Administration (FDA) recently 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.