Zostavax is vaccine manufactured by Merck & Co. used to prevent shingles, a reactivation of the chicken pox virus (varicella zoster, VZV) that tends to manifest in older individuals above the age of 50 and can turn into a very painful rash. It has also been used to treat systemic lupus erythematosus.
Zostavax contains a live, but weakened version of varicella zoster, the virus that directly causes shingles and chickenpox. However, because Zostavax is a weakened version of the actual virus that causes chickenpox, it carries with it an increased risk of actually developing the disease itself (and a number of associated side effects) because the virus, as administered, could actually be too strong for an individual immune system.
The FDA’s Approval Was Conditional
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Over 36 million Americans have likely been injected with Zostavax since it was approved by the Food and Drug Administration (FDA) in 2006, earning the company that produces it—Merck & Co.—approximately $685 million per year. However, the FDA’s approval came with a number of commitments that Merck agreed to in order to ensure the safety of the vaccine, including establishing a randomized, placebo-controlled safety study to assess the chances of patients developing serious adverse side effects, as well as an observational study relying on a health maintenance organization and 20,000 vaccinated individuals in order to address safety issues. These requirements were put in place—presumably—because, when it was released, there were still a number of issues associated with the product’s safety.
Questions over Effectiveness
Zostavax has been found to only be approximately 51 percent effective. In addition, its efficacy against postherpetic neuralgia—the pain associated with getting shingles—was found to be approximately 67 percent, and after four years, this decreased to approximately 30 percent.
Research has shown that Zostavax also loses its ability to prevent shingles after five years. According to some studies, Zostavax diminishes in effectiveness by 15 to 25 percent after the first year, and shows no significant protection at all by the ninth year. As a result, the Centers for Disease Control (CDC) strongly recommend Shingrix, a new vaccine manufactured by GlaxoSmithKline, in its place. Still, Shingrix has only been recommended since 2017, and reportedly contains even more adverse side effects than Zostavax. It remains to be seen whether additional issues will develop in association with this vaccine as well, although it does not contain live strains of the VZV virus, like Zostavax.
Allegations That Zostavax Causes Strokes, Loss of Eyesight, Hearing Loss, and Shingles
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One woman allegedly suffered from a stroke four months after receiving and due to Zostavax. In addition, more than 60 federal lawsuits have been filed against Merck to date, claiming that patients suffered from flare-ups of shingles and cardiovascular events due to the vaccine. Other lawsuits also allege that the drug has caused patients complete and permanent loss of eyesight, vertigo, and complete and permanent loss of hearing. According to patients who have been treated for these side effects, the loss of vision—known as “retinal necrosis”—is likely due to the development of VZV.
Patients who took the drug for systemic lupus erythematosus have also complained of injection site pain, skin redness, and joint disease. Other side effects associated with the drug when taken for shingles include fever, headaches, hives, muscle pain, nausea, rashes, and additional complications related to the development of shingles from the vaccine, such as bacterial superinfection. Perhaps most significantly, vaccine adverse event reports have demonstrated that a disease of the central nervous system known as acute disseminated encephalomyelitis can result from using Zostavax. Of course, in addition to all of these physical symptoms, patients who have suffered from taking Zostavax have also suffered from emotional and mental stress, loss of enjoyment of life, and pain and suffering from developing serious adverse conditions as a result.
In April 2018, Merck & Co. requested that these lawsuits be consolidated into multidistrict litigation. In August 2018, approximately 1,000 lawsuits against Merck in association with Zostavax were consolidated and assigned to the United States District Court of Pennsylvania. Claims brought against Merck in association with Zostavax have not only included negligence, but also products liability claims for designing, marketing, and selling a defective product that was unreasonably dangerous.
Questions over whether the labeling for Zostavax included all of the proper information relevant to the drug have been raised since the first lawsuit was filed against the drug. The initial labeling simply listed an increased risk of developing a rash and itching at the injection site. Yet, at the time the drug was released to the public, it was known that shingles occurred as a side effect during the vaccine’s clinical trials. In no way did the labeling, prescription information, or patient information sheet adequately address the risk of developing nervous system disease and/or viral infection as a consequence of the drug. This is especially surprising given that an earlier version of a similar vaccine manufactured by Merck—Varivax—did contain warnings concerning the risk of developing a number of adverse reactions, such as neurological diseases.
Contact Our Zostavax Attorneys Today With Questions
If you or a loved one has been harmed by Zostavax, contact one of our experienced personal injury and products liability attorneys today to find out more about your options. Keep in mind that each state has a statute of limitations, mandating that you file your lawsuit within a certain amount of years after you have been injured by the drug. Companies like Merck have a duty to create, design, and manufacture products that are reasonably safe and not unreasonably dangerous when used as intended. A reasonably prudent manufacturer would not have placed the product into the stream of commerce, especially given that safer alternative designs existed at the time.