Live Virus Used In Zostavax Vaccine Carries Shingles Risk: Lawsuit

According to allegations raised in a recently filed product liability lawsuit, side effects of the live virus Zostavax vaccine actually caused a severe shingles outbreak, which the injection was supposed to prevent.

Mary Harrell filed the complaint (PDF) in the U.S. District Court for the District of New Jersey on July 1, indicating that Merck & Co. knew the live-virus was not sufficiently weakened to avoid reactivation of the dormant virus in some individuals, but continued to market the defective shingles vaccine without adequately warning doctors and consumers.

According to the lawsuit, Harrell was inoculated with the Zostavax vaccine in 2013, and developed a shingles outbreak shortly after

Zostavax was introduced in 2006, involving a live virus that was designed to vaccinate older adults against the development of shingles. However, the vaccine injection has been linked to reports of individuals developing severe and more persistent shingles outbreaks, as well as other infections and auto-immune disorders, shortly after exposure to Zostavax.

The case joins hundreds of similar Zostavax lawsuits filed by individuals nationwide, raising claims that the manufacturer failed to adequately warn about the shingles risk associated with the live virus vaccine.

While transmission of the actual virus as a vaccine was intended to prevent the development of shingles, according to the lawsuit Merck sold the product with an “under-attenuated” version of the live virus, which was not sufficiently weakened. The varicella-zoster virus (VZV) used in the Zostavax vaccine is known to lie dormant for decades in some individuals, and may be reactivated as a more severe and persistent shingles outbreak or cause other auto-immune disorders.

“VZV can be reactivated due to factors such as disease, stress, aging, and immune modulation caused by vaccination,” Harrell’s lawsuit states. “Live-attenuated vaccines carry a serious, high risk of transmitting the live virus’s disease to individuals with weakened immune systems, long-term health problems, or who have had an organ transplant. Once injected, an attenuated live virus has been shown to recombine into more virulent strains causing disease.”

Given similar questions of fact and law raised in the complaints filed by Harrell and other plaintiffs, the federal Zostavax litigation has been centralized before U.S. District Judge Harvey Bartle III in the Eastern District of Pennsylvania, for coordinated discovery and pretrial proceedings as part of a federal MDL, or multi-district litigation.

As lawyers continue to investigate and file additional claims on behalf of people who have experienced problems from Zostavax, the size of the litigation is expected to continue to grow over the coming months and years.

If Merck fails to reach Zostavax settlements or another resolution for the claims following bellwether trials, each individual lawsuit may eventually be remanded back to different U.S. District courts nationwide for separate trial dates in the future.