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A New York woman indicates she developed a severe and persistent outbreak of shingles on her face due to side effects of the Zostavax vaccine, which was specifically given to prevent such an occurrence.
In a complaint (PDF) filed in the U.S. District Court for the District of New Jersey on October 11, Susan Flynn indicates that Merck’s Zostavax injection actually increases the risk of shingles and other viral infections, due to an “under-attenuated” live virus contained in the vaccine.
Flynn indicates that she received the Zostavax vaccine in late 2016, shortly after it was introduced by Merck as a single-dose injection for long-term protection against shingles and other zoster infections.
As a result of the vaccine, Flynn says she soon developed blisters on her chin, a rash on her left ear and scalp, as well as pain, weakness and fatigue. Following treatment with her primary care physician, she was diagnosed as suffering from herpes zoster, also known as shingles.
The lawsuit alleges that Merck was aware that the Zostavax vaccine side effects may cause shingles within a relatively short period of time after the injection, yet failed to provide adequate warnings for consumers and the medical community.
“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 or possible diseases of the nervous system. This is despite the fact that Varivax, a less potent vaccine, has added several neurological diseases and symptoms as adverse reactions to the Varivax vaccine,” the lawsuit notes. “Since Zostavax’s introduction in 2006, vaccine adverse event reports (VAERs) appeared in significant numbers addressing various adverse effects, including, but not limited to, viral infection resulting in disease of the central nervous system, including acute disseminated encephalomyelitis and acute transverse myelitis.”
The case will join a growing number of similar lawsuits over the Zostavax vaccine that are currently pending in the federal court system. Given similar questions of fact and law, claims filed nationwide are centralized before U.S. District Judge Harvey Bartle III in the Eastern District of Pennsylvania as part of an MDL, or multidistrict litigation.
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.