Court Upholds Dismissal of Zostavax Shingles Lawsuits

Court Upholds Dismissal of Zostavax Shingles Lawsuits

Introduction

A federal appeals panel has upheld the dismissal of nearly 1,200 Zostavax lawsuits that alleged the vaccine caused the very shingles it was designed to prevent.

The panel agreed with a lower court judge that the plaintiffs failed to provide adequate evidence establishing that the vaccine caused their shingles injuries.

Zostavax was the first shingles vaccine approved in the United States, involving a single-dose injection containing a live version of the virus that causes shingles, aimed at protecting against the painful condition. Despite being promoted for years as safe and effective, thousands of former users filed lawsuits against Merck, claiming that the live virus in the vaccine was not sufficiently weakened, leading to severe autoimmune reactions and persistent shingles outbreaks.

Due to similar questions of fact and law raised in complaints across the federal court system, all Zostavax lawsuits were centralized before a U.S. District Judge in the Eastern District of Pennsylvania in 2018 as part of a federal multidistrict litigation (MDL). Several groups of “bellwether” cases were prepared for trial, involving different categories of injuries.

The judge established two separate bellwether tracks: “Group A,” involving claims that Zostavax caused shingles-related injuries, and “Group B,” involving other autoimmune reactions such as postherpetic neuralgia, acute disseminated encephalomyelitis (ADEM), paralysis, transverse myelitis, meningitis, hemorrhagic strokes, and other injuries.

Before allowing any of the “Group A” cases to proceed to trial, the judge issued a controversial order requiring each plaintiff to provide polymerase chain reaction (PCR) evidence to establish that their shingles were linked to the live strain of the virus contained in the Zostavax vaccine. Since doctors do not typically perform such testing during shingles treatment, and the results cannot be obtained after recovery, this requirement led to the dismissal of all Zostavax shingles lawsuits in December 2022.

The plaintiffs appealed the decision to the U.S. Court of Appeals for the Third Circuit, arguing that the PCR requirement set an impossible standard and that they could provide specific causation without the PCR testing. However, in an opinion issued on July 16, a panel of judges rejected the plaintiffs’ arguments. They found that the dismissal of the claims was valid and that the PCR tests were the only reliable method to distinguish between the live-attenuated and wild-type strains of the virus.

“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 produced 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. This decision emphasizes the critical role of specific and reliable evidence in vaccine-related injury claims and highlights the challenges plaintiffs face in proving causation in complex medical litigation.