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Merck & Co. has failed to adequately warn consumers and the medical community about problems with the shingles vaccine Zostavax, which allegedly caused an Arizona man to develop a facial rash, permanent scarring and vision loss, according to a recently filed product liability lawsuit.
The complaint (PDF) was filed by Philip Reina in the U.S. District Court for the District of New Jersey on January 14, indicating that the manufacturer failed to disclose that the vaccine may reactivate the shingles virus, instead of preventing it.
Reina indicates that he was inoculated with the shingles vaccine Zostavax, and developed a painful rash on his face shortly after receiving the injection. He also indicates that he has been left with blurry vision in his left eye, pain, weakness and fatigue.
The lawsuit blames the shingles vaccine for causing the facial scarring and vision problems, indicating that the live virus used by the manufacturer was not sufficiently weakened to prevent reactivation of the dormant varicella zoster virus, which causes shingles.
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 problems where it actually causes users to experience longer and more painful shingles outbreaks, as well as other infections.
According to allegations raised the lawsuit filed by Reina and other plaintiffs nationwide, Merck failed to warn that the Zostavax vaccine may cause the shingles virus, rather than prevent it, indicating that the manufacturer knew or should have known that the live virus in the vaccine was “under-attenuated”.
“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 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.
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.