Preemption Defense Rejected for Zostavax Shingles Lawsuits Design Defect Claims

The U.S. District Judge presiding over more than 2,000 Zostavax shingles lawsuits filed in federal courts nationwide has rejected an argument by the vaccine manufacturer, which claimed the design defect claims should be preempted by federal law.

Zostavax was introduced 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 severe and persistent shingles outbreaks, as well as other auto-immune reactions.

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 a small group 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.

During the pretrial proceedings, the shingles vaccine maker Merck & Co. filed a motion for summary judgment in five bellwether claims, urging the court to find that the plaintiffs’ state law design defect claims are preempted by federal law, since the vaccine was approved by the FDA.

In a memorandum (PDF) issued on November 10, Judge Bartle rejected that argument, and denied the motion for summary judgment.

“Plaintiffs maintain that the safer design of Zostavax should not have included a live-attenuated virus,” Judge Bartle noted. “While Merck raises the defense that the science did not exist to do so in the timeframe before the Zostavax application was approved, there exists genuine disputes of material fact on this issue that will have to be resolved at trial.”

The first Zostavax trial is currently expected to begin in January 2022, which will be selected from a group of cases that have gone through case-specific discovery as part the bellwether process.

Each of the nearly 2,000 product liability lawsuits filed against Merck & Co. raise similar allegations, alleging that the drug maker withheld critical information about side effects of the Zostavax shingles vaccine, and failed to disclose evidence that users were experiencing severe and persistent outbreaks and other auto-immune problems after receiving the vaccine, such as meningitis, acute disseminated encephalopmyelitis (ADEM), paralysis and other health problems.

While the outcome of the bellwether trials will not be binding on other plaintiffs, it 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.