Shingles Vaccine Zostavax Cause Health Problems. Merck’s Zostavax shingles vaccine has been at the center of a product liability action against the pharmaceutical giant. The plaintiffs include eighteen consumers from close to a dozen states who allege that they experienced medical problems after they received Merck’s shingles vaccine. The plaintiffs claim that Merck neglected to warn them about the risks linked to the medication, according to Law360.
Although Zostavax is designed to prevent shingles, the plaintiffs maintain that the vaccine caused each one of them to contract a persistent strain of the disease, leading in some instances to postherpetic neuralgia, a chronic condition of pain and nerve damage. One plaintiff alleged her symptoms included some scarring.
Zostavax Lawsuit Allegations
On July 11, the lawsuit was filed in Middlesex County Superior Court and states that Merck was aware or should have been aware that Zostavax could cause adverse side effects, including a viral infection. In addition, Merck did not sufficiently warn consumers and health care providers about such potential health risks. Merck also knew or should have known about the possibility of a safer alternative to the vaccine, the lawsuit notes.
The lawsuit also states that if the plaintiffs were equipped with the knowledge of the defective condition and potential harms of the Zostavax shingles vaccine, they would not have agreed to have the shingles vaccine injected into their body, reports Law360.
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It was also alleged that Merck minimized the serious and dangerous side effects of its vaccine to encourage sales of the product. As a result, Merck appeared to have placed its profits above the safety of its customers, according to the lawsuit.
The eighteen plaintiffs are from Louisiana, South Carolina, Tennessee, Kentucky, Mississippi, Missouri, Florida, Wisconsin, West Virginia, Michigan, and New Hampshire, according to the lawsuit. In addition to Merck and a subsidiary, the defendants include a nurse who worked for Merck and distributor McKesson Corporation. There is similar litigation against Merck concerning Zostavax that is pending in Pennsylvania federal court.
Zostavax FDA Approval and Background
Zostavax was approved by the U.S. Food and Drug Administration (FDA) in May 2007. The agency said in an approval letter that the vaccine is “indicated for the prevention of herpes zoster (shingles) in individuals 60 years of age and older when administered as a single-dose.”
Zostavax is a stronger, more potent version of the chickenpox vaccine Varivax, also manufactured by Merck. Varivax contains live latent varicella zoster virus whose capability to cause disease is reduced or “attenuated,” according to the lawsuit, reports Law360.
However, the lawsuit states that “a risk of using a live virus vaccine is that it is not weakened enough or ‘under-attenuated.’”
“Under-attenuated live virus creates an increased risk of developing the disease the vaccine was to prevent,” the lawsuit states.
Serious Adverse Event Reports
There have been a substantial number of reports involving Zostavax since it became available to the public in 2006. These reports concerning Zostavax were made to the federal Vaccine Adverse Event Reporting System. There had been 1,111 submissions received as of September 2015, of serious adverse event reports involving the vaccine, including 36 deaths, according to the lawsuit.
According to plaintiffs, GlaxoSmithKline has been developing a non-live shingles vaccine called Shingrix. It is alleged that Shingrix represents a safer alternative to Zostavax that Merck should have been aware of, reports Law360.
The lawsuit states, “In early state testing, [Shingrix] has demonstrated clinical efficacy that far surpasses Zostavax and does not pose any risks of reactivation that a live attenuated vaccine carries.”
In addition, the lawsuit maintains that the patient information sheet, label and prescribing information distributed with Zostavax did not sufficiently address the risk of viral infection as well as the risk of interactions between Zostavax and other common vaccines. Receiving any two such vaccines in too short a time together, may decrease the efficacy of Zostavax.
Law360 reports, Merck also neglected to warn consumers that the effectiveness of Zostavax allegedly wanes over time, according to the lawsuit.
“The Center for Disease Control and Prevention (CDC) published that the Zostavax vaccine wanes in efficacy within five years, having almost no remaining preventative effects after seven years. This allegation is not included on any labeling or packaging literature to alert users of decreased efficacy of the vaccine with time,” the lawsuit states. The case is in the Superior Court of New Jersey, County of Middlesex, reports Law360.