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An Illinois man indicates that side effects of the Zostavax vaccine not only caused him to develop a severe and persistent shingles outbreak, which the injection was supposed to prevent, but also left him with facial paralysis and other health problems.
In a complaint (PDF) filed late last month in the U.S. District Court for the Eastern District of Pennsylvania, David Brunkow claims that Merck’s widely used vaccine for prevention of shingles among adults is defective and unreasonably dangerous for consumers.
Brunkow received the Zostavax vaccine in April 2014, as part of his routine health maintenance. However shortly after the injection, the lawsuit indicates that he developed shingles in his ear, as well as medical conditions known as Bell’s palsy and Ramsay Hunt Syndrome.
Bell’s palsy involves a sudden paralysis of facial muscles, which typically causes about half of the face appear to droop. The condition is usually temporary, but involves treatment with powerful corticosteroids, which carry their own side effects.
Ramsay Hunt syndrome occurs when a shingles outbreak affects the facial nerves near one of the ears. It also results in facial paralysis, and can also cause hearing loss and other complications. If not treated quickly, the paralysis and hearing loss from Ramsay Hunt syndrome can become permanent.
Both conditions have been linked to the Zostavax shingles virus, herpes zoster.
Zostavax was introduced by Merck in May 2006, as a single dose vaccine the prevention of shingles among older individuals. It is a more potent version of the Merck chickenpox vaccine, Varivax, but it has been linked to problems where it actually causes users to experience longer and more painful shingles outbreaks, as well as other infections.
According to allegations raised in a growing number of Zostavax lawsuits, the problems are the result of Merck using an “under-attenuated” live virus in the vaccine.
The varicella zoster virus (VZV) in Zostavax was allegedly not weakened enough to prevent reactivation of the dormant virus in the body, according to the lawsuit. Instead of the body developing the proper immune response, the live virus may combine with the old virus in some users, resulting in a more virulent strain of shingles.
“Under-attenuated live virus creates an increased risk of developing the disease the vaccine was to prevent,” the lawsuit states. “Once injected, attenuated live virus has been shown to recombine into more virulent strains causing disease.”
Brunkow’s case joins a growing number of similar complaints filed nationwide, each involving allegations that Merck failed to adequately inform patients and the medical community about the side effects of the shingles inoculation.
Given similar questions of fact and law presented in complaints filed throughout the federal court system, the Zostavax litigation has been centralized before U.S. District Judge Harvey Bartle III in the Eastern District of Pennsylvania, as part of an MDL, or multidistrict litigation.
As part of the coordinated pretrial proceedings before Judge Bartle, it is expected that a small group of representative cases will be selected for early “bellwether” trials to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation over the Zostavax vaccine side effects.
It is ultimately expected that several thousand Zostavax cases will be brought by individuals nationwide who experienced problems after receiving the shingles vaccine.