Parker Waichman LLP is investigating potential lawsuits involving side effects from Zostavax, the shingles (herpes zoster) vaccine manufactured by Merck. Zostavax is the only live vaccine currently available in the United States; it is approved for adults aged 50 and over. Currently, the U.S. Centers for Disease Control and Prevention (CDC) recommends that adults aged 60 and older receive the shingles vaccine. Lawsuits allege that Merck was aware of the side effects, including viral infection and nervous system complications, but failed to adequately warn patients or the medical community.
The firm is investigating possible lawsuits involving Zostavax side effects, including the shingles virus itself and adverse events affecting the nervous system. If you or someone you know has questions about filing a shingles vaccine lawsuit, contact one of our experienced drug injury attorneys today.
What is the Shingles Vaccine?
The U.S. Food and Drug Administration (FDA) approved Zostavax in May 2006 to prevent herpes zoster, also known as shingles. The vaccine is approved for adults who are at least 50 years old. Zostavax is used to prevent reactivation of the varicella zoster virus; this is the same virus that causes chicken pox. Shingles may occur in anyone who has had chicken pox, according to the FDA.
Zostavax contains a “live attenuated virus.” In other words, the shingles virus is alive, but weakened in vaccine form. The idea is that the patient’s immune system attacks the virus and builds immunity upon vaccination.
The shingles vaccine is recommended for everyone aged 60 and older, according to CDC guidelines. However, getting the vaccine does not necessarily guarantee protection against shingles. The FDA states that, based on clinical studies of 38,000 people aged 60 and older, Zostavax was most effective in people between the ages of 60 and 69 (64 percent). The vaccine was less effective in older patients. For example, effectiveness was only 41 percent in patients between the ages of 70 and 79 and 18 percent in participants ages 80 and older.
What are Possible Side Effects of Zostavax?
According to the FDA, the most common side effects associated with Zostavax include headache and reaction at the injection side. Allergic reactions may also occur in some patients, as with all medications. Zostavax may also cause the shingles virus itself in some patients.
In August 2014, the FDA approved labeling changes to Zostavax to include the risk of shingles. The Postmarketing Experience section of the Package Insert was updated to include “infections and infestations: Herpes zoster (vaccine strain).” This information was also added to the Patient Package Insert. Under the section titled “What are the possible side effects of Zostavax?” the document was revised to include “Shingles.”
The shingles virus causes a painful rash. Any part of the body may be affected by shingles, but it occurs most often as a single stripe of blisters wrapping around one side of the torso. Patients with shingles may experience a great deal of pain. Symptoms of shingles may include:
- Pain followed by a red rash
- Burning, tingling, numbness, or itching sensations in a small section of the body or on one side of the body
- Fluid-filled blisters that burst and crust over
- Sensitive touch
- Light sensitivity
For most patients with shingles, the first symptom is pain. The degree of pain can vary, being very painful in some patients.
Regulators approved another label update in February 2016 to include the risk of necrotizing retinitis in patients on immunosuppressive therapy. This information was added under “Eye Disorders” in the Postmarketing Experience section.
Shingles may lead to various complications. One of the most common complications is post herpetic neuralgia (PHN), a type of nerve pain. The shingles virus is reactivated along the nerve cells, sometimes causing inflammation and pain. Even after the shingles rash has disappeared, some patients may continue to suffer from nerve pain.
Other complications from shingles include vision loss, neurological issues, and skin infections. Neurological complications may include encephalitis, or brain inflammation, paralysis in the face, and problems with hearing or balance.
Merck Faces Zostavax Shingles Vaccine Lawsuit
The first Zostavax lawsuit was filed against Merck on February 22, 2017 in the Philadelphia Court of Common Pleas. The plaintiff is a woman from Nevada who was injected with Zostavax in November 2014 to prevent shingles. According to the complaint, the plaintiff experienced a headache, dizziness, and blurred vision within 24-hours of receiving the shingles vaccine.
The lawsuit alleges that Zostavax caused injuries in her right eye, elevated blood pressure, headaches, and dizziness. She alleges that she continues to suffer injuries related to Zostavax, including mental and emotional distress. These adverse events have allegedly caused physical limitations. The plaintiff also alleges that her injuries were caused by Merck’s marketing, distribution, and sale of the shingles vaccine. She alleges that Merck’s wrongful conduct has caused her to suffer serious, progressive, permanent injuries and significant pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury.
The suit alleges negligence, design defect, failure to warn, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, negligent misrepresentation, and unjust enrichment.
Among other things, the lawsuit alleges that Merck misrepresented the safety of Zostavax to the plaintiff and others by failing to warn about the increased risk of viral infection. Allegedly, Merck knew or should have known that Zostavax may cause side effects such as viral infection that causes shingles, postherpetic neuralgia, and other nervous system diseases.
The suit alleges that Zostavax was defective when it left Merck because it failed to adequately warn the plaintiff or her healthcare providers about the risk of viral infection and nervous system adverse events.
Merck develops a chicken pox vaccine called Varivax. According to the complaint, Zostavax is the same as Varivax, only stronger. The suit points out that Merck updated the safety information on Varivax to include adverse events such as encephalitis, cerebrovascular accident, transverse myelitis, Guillain-Barré syndrome, Bell’s palsy, ataxia, non-febrile seizures, aseptic meningitis, dizziness, and paresthesia.
The lawsuit also indicates that scientific and medical journals have raised questions about the safety of Zostavax since its approval.
When a virus is “under-attenuated,” or not weakened enough, it may inadvertently cause the very disease it was designed to prevent. In 2000, a study published in the journal Nature Medicine found that under-attenuated varicella zoster virus may lead to reactivation. The lawsuit alleges that the attenuated live virus may recombine into more potent strains, causing shingles.
The plaintiff states that, in July 2012, the patient information sheet, label, and prescribing information included with the Zostavax vaccine did not disclose a risk of viral infection. The lawsuit alleges that warnings were inadequate and Merck only mentioned a risk of rash and itching at the injection site. Clinical trials documented the occurrence of shingles, the suit points out.
Aside from PHN, the lawsuit states that shingles may lead to serious complications including scarring, bacterial superinfection, allodynia, cranial and motor neuron palsies, pneumonia, encephalitis, visual impairment, hearing loss, and death.
Zostavax Shingles Vaccine Litigation Grows
As of March 2017, litigation against Merck over the Zostavax shingles vaccine is mounting. Court records indicate that plaintiffs are suing the pharmaceutical company through civil lawsuits. These complaints are subject to normal laws associated with allegedly defective drugs. Since the shingles vaccine is not a routine childhood immunization, Zostavax claims are not filed through the Vaccine Injury Compensation Program (VICP).
Zostavax side effects lawsuits are typically filed in Pennsylvania. Judge Denis Cohen is presiding over the shingles vaccine litigation in state court. Judge Harvey Bartle III is overseeing Zostavax product liability litigation against Merck in federal court.
Personal injury attorneys anticipate that the Zostavax litigation will continue to grow, potentially numbering in the thousands.
In 2016, Zostavax generated $749 million in sales. Lawsuits allege that Merck downplayed the risks of the shingles vaccine and placed profits over patient safety.
Plaintiffs suing over the Zostavax shingles vaccine similarly allege various adverse events, including the shingles virus itself, complications associated with shingles, eye injuries, eye infections, and blindness. Other complaints allege that Zostavax caused seizures, paralysis in the extremities, brain damage, and even one death.
Zostavax lawsuits also allege that Merck was aware of the risks associated with the shingles vaccine but failed to adequately warn patients or the medical community. Plaintiffs allege that they would not have agreed to receiving the shingles vaccine if the drug maker had fully informed them of the risks.