More than 1,100 Zostavax Lawsuits Over Shingles-Related Injuries Dismissed by Federal Judge

The U.S. District Judge presiding over all Zostavax lawsuits has dismissed more than 1,100 claims that allege the shingles vaccine actually caused users to develop the condition it was intended to prevent. However, the ruling does not impact hundreds of additional claims alleging that users developed severe auto-immune disorders and other injuries from Zostavax.

Merck introduced Zostavax in 2006, as the first shingles vaccine approved in the United States, involving a single-dose injection that contained a live virus designed to protect against development of the painful condition. However, lawsuits allege the vaccine was defectively designed and poses an unreasonable risk, since the live virus was not sufficiently weakened, causing some users to experience neurological problems, autoimmune diseases, vision and hearing losses.

Given similar questions of fact and law raised in complaints filed throughout the federal court system, all claims are currently centralized before U.S. District Judge Harry Bartle in the U.S. District Court for the Eastern District of Pennsylvania, as part of a federal multidistrict litigation (MDL), where several groups of “bellwether” cases are being prepared for early trial dates to help gauge how juries will respond to certain evidence and testimony that will be repeated throughout the claims.

The Zostavax bellwether process has divided claims into three groups, including Group A cases involving plaintiffs who allege they developed shingles or shingles related injuries after receiving the injection. Group B cases include other autoimmune disorders, such as postherpetic neuralgia, acute disseminated encephalopmyelitis (ADEM), paralysis, traverse myelitis, meningitis, hemorrhagic strokes and other injuries. Finally, Group C cases include individuals who developed hearing loss from Zostavax.

On December 6, Judge Bartle issued a memorandum (PDF) announcing that all Group A cases involving shingles injures will be dismissed, after the Court excluded expert witness testimony linking the live virus vaccine to the reactivation of the shingles virus that lay dormant in recipients.

“From the beginning, Merck made it clear that Zostavax’s effective rate was around 50% and waned over time. The effectiveness also declined with the age of the patient,” Judge Bartle noted. “While Merck concedes that an immunocompetent adult who receives Zostavax can develop shingles from the live-attenuated virus, Merck points to various studies that show that only one such case is known ever to have occurred. There is no evidence in the record of any other such case.”

The decision will result in the dismissal of 1,189 Zostavax shingles lawsuits, which impacts about half of the federal litigation pending against Merck. However, plaintiffs indicate they intend to appeal the ruling, and Merck continues to face hundreds of other Zostavax claims, which typically involve the the most severe injuries and side effects linked to Zostavax.

To help the parties gauge how juries are likely to respond to evidence linking Zostavax and auto-immune injuries raised in the Group B cases, a bellwether trial is expected to be held next year, with a hearing loss claim likely to be scheduled for trial in 2024.

While the outcome of the bellwether trials will not be binding on other plaintiffs, they will be closely watched by parties involved in the litigation and are expected to greatly influence any eventual shingles vaccine settlements that the manufacturer may offer to individuals who experienced problems with Zostavax, which may be necessary to avoid the eventual need for hundreds of individual trial dates to be scheduled in U.S. District Courts nationwide in the coming years.