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Merck faces a product liability lawsuit over failure to warn about side effects of the Zostavax vaccine, which allegedly caused a Georgia woman to develop skin patches, bronchitis, hearing loss and other health problems after receiving what he believed would be inoculation against shingles
In a complaint (PDF) filed in the U.S. District Court for the Eastern District of Pennsylvania on November 19, Venita Smith indicates that shortly after receiving the single-dose vaccine, she experienced complications caused by the live virus contained in the injection.
Smith indicates that she was inoculated against shingles in December 2016. However, shortly after the Zostavax vaccine was administered, she indicates that side effects caused her to develop acute bronchitis, sudden idiopathic hearing loss in her left ear, and erythematous skin patches.
Zostavax was introduced by Merck in May 2006, as a single dose vaccine the prevention of shingles among older individuals. It is a more potent version of the Merck chickenpox vaccine, Varivax, but it has been linked to reports involving longer and more painful shingles outbreaks, as well as other infections, allegedly caused by an “under-attenuated” live virus contained in the vaccine.
The varicella zoster virus (VZV) in Zostavax was allegedly not weakened enough to prevent reactivation of the dormant virus in the body, according to the lawsuit. Instead of the body developing the proper immune response, the live virus may combine with the old virus in some users, resulting in a more virulent strain of shingles.
“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.”
Smith’s case joins a growing number of Zostavax vaccine lawsuits filed nationwide, each involving similar allegations that Merck failed to adequately inform patients and the medical community about the side effects of the shingles inoculation.
Given similar questions of fact and law presented in complaints filed throughout the federal court system, the Zostavax litigation has been 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 pretrial proceedings before Judge Bartle, 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 over the Zostavax vaccine side effects.
It is ultimately expected that several thousand Zostavax cases will be brought by individuals nationwide who experienced problems after receiving the shingles vaccine.