Merck’s Shingles Vaccine Rather than Prevent Disease May Backfire

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Zostavax is a vaccine manufactured by Merck & Co. intended to protect consumers from shingles. However, eighteen people from close to a dozen states have launched a product liability action against Merck in a New Jersey state court claiming they suffered serious medical problems after receiving the Zostavax inoculation, reports Law360.

The plaintiffs allege that each of them contracted a persistent strain of the disease, leading in some instances to postherpetic neuralgia. Postherpetic neuralgia is a complication of shingles, which is caused by the chickenpox (herpes zoster) virus. It affects nerve fibers and skin, causing burning pain that lasts long after the rash and blisters of shingles disappear, according to the Mayo Clinic. The plaintiffs also maintained that Merck neglected to alert them about the potential risks associated with the Zostavax vaccine.

Merck Zostavax Lawsuit Background

On July 11, the lawsuit was filed in Middlesex County Superior Court, and states that the New Jersey-based company knew or should have known that Zostavax could cause side effects, including a viral infection. The lawsuit went on to allege that Merck did not adequately warn customers and health care providers about such risks. In addition, Merck knew or should have been aware of a safer alternative to the vaccine, the lawsuit states.

“If the plaintiffs were equipped with the knowledge of the defective condition and potential harms of the Zostavax vaccine, they would not have purchased it and agreed to have it injected into their body,” the lawsuit says.

Merck minimized the serious and dangerous side effects of its product to promote sales of the product, as a result, the lawsuits states, Merck placed its profits above its customers’ safety.

National law firm Parker Waichman LLP has extensive experience and success in representing clients in pharmaceutical litigation. Attorneys at the firm are available to answer questions for anyone seeking legal information for a potential lawsuit.

The eighteen plaintiffs are from Louisiana, South Carolina, Tennessee, Kentucky, Mississippi, Missouri, Florida, Wisconsin, West Virginia, Michigan, and New Hampshire, the lawsuit notes. Along with Merck and a subsidiary, the defendants include a nurse who was employed by the company, and distributor McKesson Corporation. Similar litigation against Merck over Zostavax is pending in Pennsylvania federal court.

FDA Zostavax Approval

In May 2006, the U.S. Food and Drug Administration (FDA) approved Zostavax, noting 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 Merck’s chickenpox vaccine Varivax, and contains live latent varicella zoster virus whose virulence (ability to cause disease), is reduced or “attenuated,” states the lawsuit.

Zostavax Complications

However, according to the lawsuit, 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 designed to prevent.”

There have been a substantial number of reports involving Zostavax since the drug’s debut in 2006. The reports were made to the federal Vaccine Adverse Event Reporting System, the lawsuit notes. There had been 1,111 submissions of serious adverse event reports received regarding the vaccine as of September 2015, including 36 deaths, the lawsuits states.

GlaxoSmithKline Develops Alternative Shingles Drug

Drug manufacturer GlaxoSmithKline has been developing a non-living shingles vaccine known as Shingrix. This drug would be a safer alternative to Zostavax that Merck should have had knowledge of, according to the plaintiffs.

‘In early state testing [Shingrix] has demonstrated clinical efficacy that far surpasses Zastovox, and does not pose any risks of reactivation that a live attenuated vaccine carries,” states the lawsuit.

Allegedly Inadequate Prescribing Information

The patient information sheet, label and prescribing information distributed with Zostavax, according to the lawsuit, did not sufficiently address the risk of viral infection and the risk of interactions between Zostavax and other common vaccines. Receiving any two such vaccines too closely together may decrease the efficacy of Zostavax, states the lawsuit.

Also, Merck failed to warn consumers that the effectiveness of Zostavax allegedly wanes over time, according to the suit. “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.
Legal Information and Advice for Zostavax Recipients

If you or someone you know suffered illness associated with adverse effects related to Zostavax, you may be eligible for compensation. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).