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Merck Ordered to Turn Over Reports on Shingles Vaccine Reactions Alleged in Lawsuits Over Zostavax

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The U.S. District Judge presiding over all federal Zostavax lawsuits has ordered Merck to turn over all adverse event reports involving reactions to the shingles vaccine that are similar to those alleged in complaints filed by hundreds of individuals nationwide.

The drug maker currently faces more than 600 product liability lawsuits involving allegations that the live virus used in the controversial shingles vaccine was not sufficiently weakened, causing plaintiffs to develop more severe and persistent shingles outbreaks, as well as various auto-immune disorders, such as meningitis, acute disseminated encephalopmyelitis (ADEM), Guillain-Barre syndrome, paralysis and other health problems.

As part of the pretrial discovery, Merck has resisted turning over large numbers of adverse event reports submitted to the manufacturer by doctors and consumers, which detail various shingles vaccine reactions.

In a pretrial order (PDF) issued on July 8, U.S. District Judge Harvey Bartle III granted a motion to compel filed by plaintiffs, indicating that Merck must “produce data from its Adverse Event Reporting and Review System for injuries which point to Zostavax and are of the type plaintiffs have alleged in any of the actions in [the Zostavax litigation].”

Production is limited to data submitted from the United States, Canada, Korea, the Netherlands and Singapore, and will exclude names and other identifying information for allegedly injured individuals.

Given similar questions of fact and law raised in complaints filed throughout the federal court system, Judge Bartle has been presiding over the coordinated discovery and pretrial proceedings involving all Zostavax claims, which are centralized in the U.S. District Court for the Eastern District of Pennsylvania, as part of a federal multidistrict litigation (MDL).

Judge Bartle has previously established a “bellwether” process, where a small group of representative cases are being prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

The first federal trial involving reactions to the Zostavax shingles vaccine is expected to begin in November 2020. While the outcome of these early trial dates will not be binding on other plaintiffs, they may greatly influence eventual settlement negotiations that will be necessary to avoid the need for hundreds of individual cases to go before juries nationwide.

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