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According to allegations raised in a recent product liability lawsuit filed against Merck, side effects of the Zostavax vaccine caused a New Jersey woman to suffer severe and recurring shingles outbreaks, rather than preventing the disease, joining a growing number of similar Zostavax lawsuits filed in courts nationwide in recent weeks.
The complaint (PDF) was filed by Patrice Colamesta in the U.S. District Court for the District of New Jersey, indicating that the live virus vaccine was not weakened enough, or “under attenuated”, creating a risk of more serious shingles outbreaks.
Colamesta received the vaccine in September 2013, for the prevention of shingles. However, rather then helping avoid the disease, the lawsuit indicates that Zostavax caused her to suffer recurring shingles outbreaks, resulting in chronic pain, rashes and lesions on various parts of her body, and leaving her with permanent nerve damage.
Despite information about a link between side effects of Zostavax and shingles, the lawsuit notes that Merck failed to provide adequate warnings for consumers or medical providers prescribing the vaccine.
“Merck failed to exercise due care in the labeling of Zostavax and failed to issue to consumers and/or their healthcare providers adequate warnings as to the risk of serious bodily injury, including viral infection, resulting from its use,” the lawsuit states. “Merck continued to manufacture and market its product despite the knowledge, whether direct or ascertained with reasonable care, that Zostavax posed a serious risk of bodily harm to consumers. There is especially true given its tenuous efficacy.”
Zostavax was introduced by Merck in May 2006, for the prevention of shingles among individuals ages 60 or older. It is a more potent version of the Merck chickenpox vaccine, Varivax, but reports of problems have surfaced involving longer and more painful shingles outbreaks from Zostavax.
Colamesta and other plaintiffs allege that Merck used an under attenuated live strain of the varicella zoster virus (VZV) in Zostavax, which was not weakened enough to prevent reactivation of the virus. Instead of the body developing the proper immune response, the live virus combined with the old virus in some users, resulting in a more virulent strain of shingles.
Shingles itself can cause scarring, bacterial infections, encephalitis, hearing loss, vision problems and other complications.
In response to a growing number of lawsuits filed throughout the federal court system, each involving similar allegations, the U.S. Judicial Panel on Multidistrict Litigation (JPML) recently decided to centralize all Zostavax shingles cases before U.S. District Judge Harvey Bartle III in the Eastern District of Pennsylvania, for coordinated discovery into common issues in the lawsuits and to avoid conflicting pretrial rulings in different courts.
Colamesta’s complaint will be consolidated with about 100 lawsuits pending in the federal court system. However, as lawyers continue to review potential lawsuits over the Zostavax vaccine, it is expected that the size of the litigation will grow rapidly in the coming months.