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The side effects of the singles vaccine Zostavax allegedly caused a Kentucky woman to develop painful and permanent nerve damage, known as peripheral neuropathy, according to a recently filed product liability lawsuit.
The complaint (PDF) was filed by Rita Bishop on March 21, in the U.S. District Court for the Eastern District of Pennsylvania, indicating that Merck & Co. sold a dangerous vaccine for prevention of shingles, and failed to adequately warn about the potential Zostavax risks.
Bishop indicates that she was inoculated with the shingles vaccine Zostavax in October 2012, which has been commonly given to older adults over the past decade as a preventative measure. However, shortly after the injection, she developed peripheral neuropathy and chronic inflammatory demyelinating polyneuritis.
Zostavax was introduced in May 2006, as a single dose vaccine for prevention of shingles among individuals over the age of 50. It is a more potent version of the Merck chickenpox vaccine, Varivax, which contains the live varicella zoster virus. However, an alarming number of problems have been reported, where users experienced longer and more painful shingles outbreaks and other infections, which were allegedly caused by use of an “under-attenuated” version of the virus that was not sufficiently weakened to avoid reactivating the dormant virus in some users.
The lawsuit argues that Bishop and other individuals who received the vaccine eere not adequately warned about the potential health risks. The complaint indicates that Merck knew about the risks from data obtained during clinical trials before it was approved by the FDA.
“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,” Bishop’s 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.”
Given common questions of fact and law raised in Zostavax shingles vaccine lawsuits filed throughout the federal court system, the 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.
While all cases filed throughout the federal court system are currently centralized before Judge Bartle, 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.