Horizon Therapeutics Opposes Centralization of Tepezza Infusion Lawsuits in MDL

Despite facing a growing number of Tepezza infusion lawsuits, each involving similar allegations that the drug manufacturer failed to warn about the risk of permanent hearing loss, Horizon Therapeutics is opposing a request to centralize the litigation before one judge as part of an MDL, or multidistrict litigation.

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 forms of hearing loss side effects from Tepezza infusions, 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 similar questions of fact and law raised in complaints filed in U.S. Distsrict Courts nationwide, a plaintiff filed a motion to establish a Tepezza MDL for all hearing loss lawsuits on March 22, asking that claims brought throughout the federal court system be transferred to the U.S. District Court for the Northern District of California for coordinated discovery and pretrial proceedings.

On April 14, the U.S. Judicial Panel on Multidistrict Litigation (JPML) announced it will hear oral arguments on the centralization of the Tepezza infusion lawsuits for May 25 in Philadelphia.

Horizon Opposes Tepezza Infusion Lawsuit Consolidation

On the same day, Horizon filed a motion in opposition (PDF) to the creation of the MDL, arguing there are too few cases currently filed to justify establishing coordinated pretrial proceedings at this time. are only 19 plaintiffs, 15 of which are represented by the same firm, and only one defendant.

“Transfer and coordination or consolidation is unwarranted here because Movant has failed to make a particularized showing that centralization – which the panel has described as the ‘last solution’ – is needed,” the motion states.

Horizon points out that there are currently only 19 plaintiffs, 15 of which are represented by the same law firm. In addition, the drug maker indicate that a limited number of lawsuits over Tepezza may be filed in the future, since the drug was approved through the U.S. Food and Drug Administration (FDA) Orphan Drug program for the treatment of rare diseases only three years ago.

If the JPML does decides to consolidate the Tepezza lawsuits, the manufacturer argues that the litigation should be centralized in the U.S. District Court for the Northern District of Illinois, where the company is headquartered and where 15 of the 19 cases have been filed to date.

Although a limited number of complaints have been filed to date, the number of claims is expected to increase dramatically over the coming months, as Tepezza infusion lawyers continue to investigate hearing loss claims. In addition, a number of different plaintiffs have filed responses supporting the request to establish coordinated pretrial proceedings.

“Due to the almost identical core facts and injuries, the Actions, as well as those that will follow, raise (or will raise) the same legal arguments and invoke substantially similar damages,” according to a brief (PDF) filed by plaintiff Amarilis Polanco on May 8. “The legal claims and defenses applicable to Horizon’s conduct are grounded in product liability. The defenses available to Horizon in each of the current and future Actions are similar if not identical regardless of where the claims are geographically located.”

In complex pharmaceutical litigation, where large numbers of claims are brought by users of the same medication or medical product, each experiencing the same or similar injuries, it is common for the U.S. JPML to centralize the litigation to reduce duplicative discovery into common issues that will arise in all claims, avoid conflicting pretrial rulings and to serve the convenience of certain witnesses and parties who will be required to testify in each of the lawsuits.

If an MDL is established, each individual claim may later be remanded back to the U.S. District Court where it was originally filed for trial, if the parties fail to negotiate Tepezza infusion settlements or another resolution for the claims.