Appeals Court Upholds Dismissal of Zostavax Lawsuits Over Shingles Injuries

A federal appeals panel has upheld the dismissal of nearly 1,200 Zostavax lawsuits alleging that the vaccine caused the very shingles injury that it was meant to prevent, agreeing with a lower court judge that those plaintiffs failed to provide adequate evidence establishing the vaccine was the cause of their shingles injuries.

Zostavax was the first shingles vaccine approved in the United States, involving a single-dose injection that contained a live version of the virus that causes shingles, which was designed to protect against development of the painful condition.

Although the Zostavax vaccine was promoted for years as safe and effective, thousands of former users have filed lawsuits against Merck, alleging that the live virus was not sufficiently weakened, resulting in severe autoimmune reactions and the development of persistent shingles outbreaks among some users.

Given similar questions of fact and law raised in complaints filed throughout the federal court system, all Zostavax lawsuits have been centralized before U.S. District Judge Harry Bartle in the U.S. District Court for the Eastern District of Pennsylvania since 2018, as part of a federal multidistrict litigation (MDL), where several groups of “bellwether” cases were prepared for trial, involving different categories of injuries.

Judge Bartle established two separate bellwether tracks, including a “Group A” involving claims alleging that Zostavax caused shingles related injuries, and a “Group B” involving other autoimmune reactions, such as postherpetic neuralgia, acute disseminated encephalopmyelitis (ADEM), paralysis, traverse myelitis, meningitis, hemorrhagic strokes and other injuries.

However, before allowing any of the “Group A” cases to proceed to trial, Judge Bartle issued a controversial order requiring each of those plaintiffs to provide polymerase chain reaction (PCR) evidence, establishing that their shingles was linked to the live strain of the virus contained in the Zostavax vaccine.

Since doctors do not typically obtain such testing during shingles treatment, and the results can not be obtained after recovery, the requirement resulted in the dismissal of all Zostavax shingles lawsuits in December 2022.

Following Judge Bartle’s decision, the plaintiffs appealed the decision to the U.S. Court of Appeals for the Third Circuit, arguing that the requirement established an impossible standard and that they could provide specific causation without the PCR testing.

In an opinion (PDF) issued on July 16, a panel of judges rejected the plaintiffs’ arguments, finding that Judge Bartle’s dismissal of the claims was valid, and that the PCR tests were the only way to “reliably discern between the live-attenuated and wild-type strains”.

“Plaintiffs knew from the start that they would have to account for and exclude the ‘obvious alternative cause’ of shingles for the Group A cases: the wild-type chickenpox strain of the VSV latent in almost every person over the age of 30,” the appeals court judges wrote. “But even after three years of litigation, plaintiffs had not drummed up a single piece of medical literature or expert medical opinion explaining how it can be determined that Zostavax and not chickenpox caused a person to contract shingles other than through PCR testing.”

As a result, the dismissal of 1,189 “Group A” cases with prejudice was upheld.