Zostavax Shingles Vaccine Lawsuit
The Centers for Disease Control and Prevention (CDC) recommends that people 60 years and older should receive the shingles vaccine. Yet according to several recent adverse event reports, this vaccine has been linked to serious side effects, including infections and eye disorders.
Manufacturer Merck & Co. is currently defending a number of Zostavax lawsuits filed by patients who received the vaccine and then suffered serious injuries. The Pittsburgh lawyers at Chaffin Luhana are currently investigating cases in which this vaccine causes dangerous side effects.
What is Zostavax?
The FDA approved Zostavax for sale in May 2006 for the prevention of shingles in people 60 years and older. It 2011, Merck received approval for use of the vaccine in those 50-59, as well. Currently, Merck’s drug is the only shingles vaccine available in the U.S.
The vaccine contains a small amount of the live virus herpes zoster, the same virus that causes chickenpox. People who develop chickenpox at a younger age usually get better, but when they do, the virus isn’t completely eradicated. It can hide away, lying dormant for decades. Under certain circumstances, it can awaken to cause shingles.
The Advisory Committee on Immunization Practices (ACIP) recommends that people wait until they’re 60 years old to ask their doctors about the vaccine because after receiving the vaccine, the patient’s immunity fades over time. It is strongest right after immunization but then decreases each year after, until little to no benefit remains around 10 years later. And the risk of shingles increases with age as the immune system naturally weakens.
The FDA reports that in people 60 and older, Zostavax reduces the risk of shingles by about 50 percent. In those who ultimately developed the disease, the vaccine may lessen the symptoms and duration of the flare-ups a little.
What are Shingles?
Shingles are painful, blistering rashes that start in the nerves and erupt onto the skin. They are caused by the reawakened herpes zoster virus, which infects the nerve fibers in the central nervous system and causes rashes that appear in a band or strip, usually on one side the body. Common areas affected include the face, neck, head, abdomen, and back.
Doctors do not definitively know what causes the virus to become active again, but it may have something to do with the decline of the immune system as the body ages. Other illnesses and diseases, surgery, and certain medications can tax the immune system, allowing the virus to awaken. The disease may also show up as a complication of cancer or AIDS.
There are a number of symptoms that accompany a shingles outbreak. It frequently starts with a tingling or burning sensation and an increased sensitivity to touch. Some people also experience a fever, headache, or fatigue during this stage. Then the area begins to itch and eventually hurt, and finally, the rash breaks out over the skin. Pain can be moderate to intense. Fluid-filled blisters may form and then gradually burst and crust over.
Though shingles are extremely unpleasant, they don’t usually cause permanent damage. In some cases, however, complications may be more serious. For example, people who are 70 years or older have a higher risk of developing permanent eye damage and vision loss, if the rashes show up around the eyes. Some people also experience pain long after the blisters are gone. This condition is called “postherpetic neuralgia” and occurs because of nerve damage. Facial paralysis, balance problems, and inflammation in the brain may also result from damaged nerves.
Zostavax Serious Side Effects: Infections
Since its approval, Zostavax has been linked to various health problems in medical reports. These reports prompted the FDA to require the manufacturer to add additional warnings to the product prescribing information to address these potential risks.
In August 2014, the FDA required Merck to add “infections and infestations” to the possible side effects of the drug. According to the Children’s Medical Safety Research Institute (CMSRI), the FDA required this warning because the vaccine was found to actually cause shingles in some people.
In a 2011 study published in The Journal of Infectious Diseases, researchers tested 36 people over the age of 60 who were immunized with Zostavax. They took swabs of the skin at the inoculation site on the day of the vaccination and took saliva samples over a period 28 days. Results showed that 21 of the participants still had the virus in their saliva for a week after receiving the vaccination, while 6 percent still had it after 28 days. The researchers did not find any cases in which the virus was transmitted to another person, but also noted that immunized individuals remain a potential source of transmission of the virus.
Zostavax Serious Side Effects: Eye Disorders
In February 2016, the FDA required that Merck add another potential side effect to the product labeling: eye disorders. The FDA received reports of the vaccine being linked to necrotizing retinitis and keratitis. Patients taking immunosuppressive therapy were found to be at an increased risk of developing this side effect.
Necrotizing retinitis is an inflammatory condition caused by the herpes virus that causes redness, floaters, and vision disturbances. Without treatment, it can lead to detachment of the retina and blindness. In a 2011 study published in JAMA Ophthalmology, researchers reported the results of two case studies that evaluated the Zostavax vaccine leading to retinal necrosis. In one, a 77-year-old woman suffered rapid vision loss in her left eye just six days after she received the vaccine. In the second, an 80-year-old man suffered vision loss two months after receipt of the vaccine.
Keratitis is an inflammation of the cornea, the part of the eye that covers the pupil and iris. It can become infected with the herpes zoster virus, which can cause inflammation. A 2013 study described a case in which a 63-year-old man experienced a reactivation of his keratitis after receiving Zostavax. An earlier 2010 study also reported the case of a 50-year-old woman who experienced a worsening of her keratitis after vaccination with Zostavax.
Those with Compromised Immune Systems More at Risk
People with autoimmune diseases may be at a higher risk for developing serious Zostavax side effects. In March 2017, the Australian Government Department of Health warned that it had received a report of one death in a person who had compromised immune function prior receiving the vaccine.
The Australian agency reminded healthcare practitioners: “Zostavax should not be used in people who are immunocompromised, as this is associated with a risk of mild to serious complications (including death) from infection with the vaccine virus.”
Types of Side Effects Associated with Zostavax
The National Vaccine Information Center (NVIC) states that as of September 1, 2015, there were 1,141 serious adverse events reported to the Vaccine Adverse Events Reporting System in connection with shingles vaccines dating back to 1990. Over 33 percent of these events occurred in seniors ranging in age from 65 to 75 years old. In 90 of these cases, the patient died.
Zostavax has been associated with the following side effects:
- Necrotizing retinitis
- Vision loss and blindness
- Brain inflammation
- Facial paralysis
- Permanent nerve damage
Pittsburgh Zostavax Lawsuits
The attorneys at Chaffin Luhana are actively investigating potential Zostavax lawsuits. Patients in the Pittsburgh and Ohio Valley areas who have taken this medication and then experienced shingles, chickenpox, eye disorders, or other serious side effects may be able to recover damages in a Zostavax lawsuit.
Individuals across the country are already filing claims against Merck for Zostavax complications. In February 2017, for example, a Nevada woman filed a Zostavax lawsuit stating that after she received the vaccine, she suffered headaches, dizziness, injuries to her right eye, increased blood pressure, and vision loss. She claims that Merck failed to provide adequate warnings about the vaccine’s risks.
To see if you are eligible to file a similar lawsuit, call today at 1-888-316-2311.