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According to allegations raised in a product liability lawsuit filed this month against Merck, side effects of the shingles vaccine Zostavax caused a Kentucky woman to suffer vision loss, a stroke and other serious side effects.
In a complaint (PDF) filed last week in the U.S. District Court for the Eastern District of Pennsylvania, Delores Carter indicates that the shingles vaccine is defective and unreasonably dangerous for consumers.
Zostavax was introduced by Merck in May 2016, as a single dose vaccine for the long-term protection against zoster infections like shingles. It is a more potent version of the Merck chickenpox vaccine, Varivax. However, soon after it was introduced, reports emerged involving problems with users developing more severe shingles outbreaks and other infections, due to the “under-attenuated” live virus contained in the vaccine.
Carter that she was injected with the shingles vaccine in April 2017, and began to suffer problems with vision loss in one eye shortly afterwards, also suffering strokes.
The lawsuit alleges that Merck failed to adequately warn Carter and other consumers about problems with the Zostavax shingles vaccine reported nationwide, where users experience more severe and persistent viral infection outbreaks.
Research published last year in the Journal of The American College of Cardiology found that the onset of shingles was linked with a sudden increased risk of stroke and heart attack, particularly in the first year following an outbreak. Strokes are known to sometimes cause vision loss.
“The patient information sheet, as well as the label and prescribing information for Zostavax at all times relevant hereto, did not adequately, if at all, address the risk of viral infection,” the lawsuit states. “All that was addressed is the concern that a rash and itching might develop at the injection site. This is despite the fact that shingles was a noted occurrence during clinical trials of the vaccine.”
The case will join a growing number of similar Zostavax shingles vaccine lawsuits currently pending in the federal court system, which have been centralized before U.S. District Judge Harvey Bartle III in the Eastern District of Pennsylvania as part of an MDL, or multidistrict litigation.
Given similar questions of fact and law brought in U.S. District Courts nationwide, all Zostavax shingles cases are consolidated for pretrial proceedings, to reduce duplicative discovery into common issues, avoid conflicting pretrial schedules and to serve the convenience of the parties, witnesses and courts.
As part of the coordinated MDL proceedings, it is expected that a small group of representative cases will be selected for early “bellwether” trials to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. However, if Merck fails to negotiate Zostavax vaccine settlements for individuals who have been left with problems, or otherwise resolve the litigation, each individual case may eventually be remanded back to the federal district court where it originated for a separate trial date in the future.