A Zostavax lawsuit is a legal claim asserted by consumers of the drug against its manufacturer Merck & Co Inc. Pharmaceuticals. These lawsuits allege that the drug is defectively designed, and Merck failed adequately to warn about serious side effects. Plaintiffs are seeking compensation for serious Zostavax side effects and complications such as:
- development of shingles (the virus Zostavax was meant to prevent),
- hearing loss,
- blindness,
- paralysis, and
- liver failure.
Thousands of Zostavax lawsuits have been filed since the first case that appeared in 2016. A federal judicial panel recently consolidated many of the cases in federal court and created the Zostavax lawsuit multidistrict litigation (“Zostavax MDL”). This litigation is before U.S. District Judge Harvey Bartle of the Eastern District of Pennsylvania.
In short, the plaintiffs in the Zostavax MDL state that:
- Zostavax, as designed, is unreasonably dangerous,
- the vaccine can cause serious injuries, including death,
- Merck (and the company’s owner Bayer) failed to warn the public of the potential negative effects of using their drug, and
- The defendants willfully misrepresented the safety of their vaccine.
Zostavax lawsuits represent a mass tort, or a series of civil claims brought by separate plaintiffs, claiming similar injuries. A mass tort is different from a class action.
One of the main assertions in the Zostavax lawsuits is that the medicine is defectively designed. A design defect claim essentially alleges that a product’s design poses a risk to a consumer’s safety. As to design, Zostavax is a live type of vaccine, which is different from a drug that uses a recombinant design.
If successful in their claims, the Zostavax MDL plaintiffs may receive compensation in the form of:
- compensatory damages, and
- punitive damages.
Plaintiffs qualify to participate in the Zostavax litigation based on meeting three conditions. These are:
- he or she took Zostavax after 2006 (the year it was licensed by the Food and Drug Administration (“FDA”)),
- he or she experienced shingles anywhere between three weeks to a year after taking the vaccine, and
- he or she was diagnosed with shingles by a licensed doctor or physician.
Zostavax (or, zoster vaccine live) is a vaccine that was intended to reduce the risk of a person getting shingles. The medicine was meant to help patients aged 50 years or older and it was licensed by the FDA in 2006. Upon licensing, the FDA reported that the drug could result in certain adverse effects, such as:
- shingles,
- chickenpox,
- muscle pain,
- headache,
- fever,
- nausea, and
- joint pain.
Our national mass tort lawsuit attorneys will highlight 13 critical things to know about the Zostavax litigation:
- 1. What are the Zostavax lawsuits?
- 2. What are some examples of suits filed against Merck?
- 3. What is a mass tort and what is the MDL process?
- 4. What is a design defect claim?
- 5. How can plaintiffs in the Zostavax lawsuits be compensated?
- 6. What are the possible defenses that Merck may raise in the Zostavax MDL?
- 7. Who may join in the Zostavax MDL?
- 8. What is Zostavax?
- 9. What is shingles?
- 10. What injuries and complications are associated with Zostavax?
- 11. How does Zostavax work?
- 12. What is the difference between a live virus design and a recombinant design?
- 13. Do any other vaccines help prevent shingles?
1. What are the Zostavax lawsuits?
Zostavax lawsuits are legal claims asserted by consumers of the drug against its manufacturer Merck & Co Inc. Pharmaceuticals.
These suits mainly allege that the drug is defectively designed, and Merck failed to adequately warn about serious side effects. Plaintiffs are seeking compensation for injuries such as:
- development of shingles (the virus Zostavax was meant to prevent),
- hearing loss,
- blindness,
- paralysis, and
- fatal liver failure.
The first Zostavax lawsuit was filed in 2016.1 Since that time, thousands of similar suits have been filed across the nation.
A federal judicial panel recently consolidated many of the lawsuits in federal court and created the Zostavax lawsuit multidistrict litigation (“Zostavax MDL”).2 This litigation is before U.S. District Judge Harvey Bartle of the Eastern District of Pennsylvania. Judge Bartle has been overseeing the very first Zostavax case filed.3
In short, the plaintiffs in the Zostavax MDL state that:
- Zostavax, as designed, is unreasonably dangerous,
- the vaccine can cause serious injuries, including death,
- Merck (and the company’s owner) Bayer failed to warn the public of the potential negative effects of using their drug, and
- the defendants willfully misrepresented the safety of their vaccine.
The order creating the Zostavax MDL does not apply to lawsuits brought on behalf of 300 patients in California state court and 800 plaintiffs in New Jersey state court.4
The first Zostavax trials are expected to take place sometime between fall 2020 and summer 2021.
2. What are some examples of suits filed against Merck?
Three different lawsuits help exemplify the types of claims alleged in the Zostavax lawsuits and the injuries the claimants have suffered. These lawsuits contain plaintiffs in the states of:
- Wisconsin.
- South Carolina, and
- New Jersey.
2.1. Wisconsin plaintiff
A Wisconsin woman filed a suit against Merck alleging that, rather than Zostavax protecting her against Shingles, the drug caused her to develop repeated outbreaks of the virus.5
The woman was first vaccinated with the medicine in 2011. Since that time, she experienced several episodes of “post-herpetic neuralgia.” This is a complication of shingles that causes a rash and burning nerve pain.6
The plaintiff states that she lives with chronic pain from her Zostavax vaccinations.7
2.2. South Carolina plaintiff
A man in South Carolina filed a Zostavax lawsuit (in Pennsylvania) alleging that he began experiencing the loss of vision in one eye two months after receiving the drug. The man was later diagnosed with “retinal necrosis,” or tissue decay in his retina.8
Among other claims, the man states that Merck:
- failed to warn the public of the negative effects of Zostavax, and
- produced a defective medicine.9
2.3. New Jersey plaintiffs
In July of 2017, several plaintiffs filed a lawsuit against Merck in New Jersey.10 The plaintiffs themselves come from a range of states, including:
- Louisiana,
- Tennessee, and
- Michigan.
The plaintiffs assert that Zostavax caused them to develop shingles, rather than prevent them from getting the illness. They state the drug caused:
- pain,
- hospital visits, and
- post-herpetic neuralgia in two cases.11
The suit’s allegations include:
- negligence,
- defective drug design,
- failure to warn,
- misrepresentation involving risk of physical harm, and
- unjust enrichment.12
3. What is a mass tort and what is the MDL process?
The Zostavax lawsuits are an example of a mass tort. A mass tort is a series of civil claims or lawsuits brought by a series of plaintiffs, claiming similar injuries, against one or a few defendants.
A mass tort differs from a class action. In a class action, numerous plaintiffs are joined into one lawsuit. In a mass tort, each plaintiff maintains a separate lawsuit.
Most mass tort litigations in the United States involve injuries stemming from dangerous drugs, defective medical devices, or products liability. When enough lawsuits are filed, the cases are often consolidated into a “multi district litigation” or MDL. An MDL is a particular federal court that is charged with overseeing and managing the litigation as a whole.
It’s common for an MDL to “test out” the lawsuits by hearing a series of bellwether trials. These are representative cases selected by:
- the court,
- the plaintiffs’ lawyers, and
- the defendants’ lawyers.
The cases are brought to trial to get a picture of how juries respond to the claims and defenses. The bellwether trials set the stage for settlement negotiations.
4. What is a design defect claim?
Please recall that one of the allegations in the Zostavax MDL is that the drug, as designed by Merck, is unreasonably dangerous. This is a design defect claim. The claim simply states that a product’s design is harmful to a consumer’s safety.
In a design defect lawsuit, the manufacturer of a product will be held liable if:
- the plaintiff can show the product created a dangerous risk to a product user, and
- this risk took place when the consumer was using the product for its intended purpose.
A design defect claim typically includes the allegation that a manufacturer acted with negligence. A negligence claim asserts that the manufacturer knew, or should have known, that there was a risk associated with its product’s design.
Please note that a design defect claim is different from a manufacturing defect claim.
5. How can plaintiffs in the Zostavax lawsuits be compensated?
Compensatory damages compensate a plaintiff for losses in personal injury cases. Compensatory damages for an accident or injury fall into two basic categories:
- “economic” (pecuniary) damages, such as medical bills, property damage and lost wages, and
- “non-economic” damages, such as pain and suffering.
Compensation in a personal injury case may also include punitive damages. Punitive damages are also known as “exemplary” damages.
Unlike compensatory damages, punitive damages are based not on the plaintiff’s losses, but on the reprehensibility of the defendant’s conduct and the defendant’s ability to pay.
They are granted to punish a defendant who has acted with malice, oppression or fraud, typically in cases of intentional harm or extreme recklessness.
When granted, punitive damages are in addition to amounts awarded as compensatory damages.
6. What are the possible defenses that Merck may raise in the Zostavax MDL?
There are five defenses that Merck may raise in the Zostavax MDL. These defenses will be raised to counter the plaintiffs’ allegations. The defenses are:
- no design defect,
- if a defect, the defect did not cause any injury,
- the plaintiffs were negligent in taking the vaccine,
- the plaintiffs assumed the risk, and
- any applicable statute of limitations for bringing a Zostavax lawsuit, has expired.
7. Who may join in the Zostavax MDL?
A person may join in the Zos lawsuit if he meets three conditions. These are:
- he took Zostavax after 2006 (the year it was licensed by the FDA),
- he experienced shingles anywhere between three weeks to a year after taking the vaccine, and
- he was diagnosed with shingles by a licensed doctor or physician.
A person may also be able to join the Zostavax MDL if he suffered from a certain injury within two years from taking Zostavax. Some of these injuries are:
- postherpetic neuralgia (“PHN”)
- stroke,
- hearing loss,
- congestive heart failure,
- blindness,
- certain neurological disorders,
- pneumonia, and
- death.
8. What is Zostavax?
Zostavax (or, zoster vaccine live) is a vaccine whose goal is to reduce the risk of contracting shingles. Zostavax is administered as an injection into the patient’s upper arm. The cost of Zostavax is approximately $212.00 to $240.00 per shot. The drug was designed to help appropriate patients aged 50 years or older. As stated above, the drug is manufactured by Merck & Co Inc. Pharmaceuticals.13
The Zostavax vaccine was licensed by the FDA in 2006. It is given to patients in a single dose and is administered as a shot. The medicine can be given in a doctor’s office or pharmacy.14
The vaccine, though, is only successful in about 51 percent of patients that take it. According to the New England Journal of Medicine, the efficacy of Zostavax could be near 50%.15 If it does work, the vaccine is effective for approximately six years.16
9. What is shingles?
Shingles is a virus or infection that causes a painful rash. The rash most often forms on a person’s torso. Shingles is caused by the varicella-zoster virus (“zoster virus”), which is the same virus that causes chickenpox.17
A few common signs and symptoms of shingles include:
- pain, burning, or tingling in an area of the body,
- a red rash that emerges a few days after pain,
- itching, and
- the appearance of fluid-filled blisters.18
Shingles tends to be most common in people over the age of 50. A person must have had chickenpox before they can get the virus. 19
10. What are the injuries and complications associated with Zostavax?
The FDA reports that the following side effects, infections, and injuries are associated with Zostavax use:
- shingles,
- chickenpox,
- rash,
- hives,
- headache,
- fever,
- nausea,
- joint pain,
- muscle pain, and
- eye disorders.20
The plaintiffs in the Zostavax MDL allege that the vaccine can cause even more serious complications. Some of these are:
- blindness,
- hearing loss,
- paralysis,
- brain damage,
- liver failure, and
- death.
11. How does Zostavax work?
Zostavax is a live virus. This means it works by injecting a live (although weakened) form of the zoster virus into a person’s body.21
Once injected, the body fights off the virus. This “fight” increases the immune system’s opposition to the zoster virus.22
As a result, the immune system becomes heightened, and in theory, is better able to fight a real zoster virus, or a case of shingles.
Please note that there is a difficulty with the fact that Zostavax is a live virus. This is that the immune system of many people that take the vaccine is weak and cannot even fight off the live virus. This means that these people run the risk of contacting other viruses, like chickenpox and even shingles.23
12. What is the difference between a live virus design and a recombinant design?
As mentioned above, Zostavax is a live vaccine (or virus). A “live vaccine” uses a weakened form of the virus that causes the subject infection or illness.
The science behind a live virus design is that it will create a strong immune response to infection over a long period of time. This heightened response is because the immune system is made to fight off a weakened form of the infection because of the initial live vaccine injection. Most often, one or two doses of a live vaccine can protect a person from a virus (and the illness it causes) for several years.24
In addition to Zostavax, Shingrix is a vaccine that helps protect a person from shingles. Unlike Zostavax, however, Shingrix uses a recombinant design rather than a live design. (See our article on comparing and contrasting Zostavax vs Shingrix).
A recombinant designed vaccine does not use the entire germ or virus that causes an infection. Rather, it uses specific pieces of that germ, like the germ’s:
- protein,
- sugar, or
- housing component.25
The use of specific pieces gives a person a strong immune response to an illness that targets key parts of the germ in question. A vaccine using a recombinant design may require a person to receive ongoing shots to receive maximum protection against the target germ.26
13. Do any other vaccines help prevent shingles?
As mentioned above, Shingrix is another vaccine that is aimed to prevent a person from experiencing shingles. The vaccine uses a recombinant design as opposed to a live design.
The Centers for Disease Control and Prevention (“CDC”) states that Shingrix is the preferred drug over Zostavax. CDC recommends that healthy adults 50 years and older should get two doses of Shingrix, separated by 2 to 6 months, to best fight off the Shingles illness.27
According to the CDC:
- two doses of Shingrix is more than 90% effective at preventing shingles, and
- protection stays above 85% for at least the first four years after a patient gets vaccinated.28
In one trial that involved more than 15,000 patients (aged 50 or older), Shingrix’s efficacy for preventing Shingles was greater than 95%.29 In a companion trial that included almost 14,000 patients (aged 70 or older), efficacy was about 90%.30
Did you experience an injury or adverse condition after taking Zostavax? Call us for help…
If you or someone you know has experienced an injury or adverse effect upon taking the Zostavax vaccine, we invite you to contact us for a free consultation. We can be reached 24/7.
Legal References:
- The Legal Intelligencer, “MDL Panel Sends Shingles Vaccine Lawsuits to Pennsylvania,” August 2, 2018.
- See same.
- See same.
- See same.
- Kate Raines, “Merck Sued Over Zostavax-Related Injury.” The Vaccine Reaction.
- See same.
- See same.
- Tsalichis v. Merck, Inc., 2018-cv-01806, Eastern District Court of Pennsylvania.
- See same.
- Eric Sagonowsky, “Merck’s Zostavax draws new litigation from patients alleging they contracted shingles.” FiercePharma.com.
- See same.
- See same.
- Centers for Disease Control and Prevention (CDC), “What Everyone Should Know about Zostavax.” CDC website.
- See same.
- NEJM JW Gen Med July 1, 2005 and N Engl J Med 2005; 352:2271.
- See same.
- Mayo Clinic, “Shingles – Symptoms and Causes.” Mayo Clinic website.
- See same.
- See same.
- U.S. Food and Drug Administration, “Zostavax.” FDA website.
- U.S. Department of Health and Human Services, “Vaccine Types.” www.vacines.gov.
- See same.
- Centers for Disease Control and Prevention (CDC), “What Everyone Should Know about Zostavax.” CDC website.
- U.S. Department of Health and Human Services, “Vaccine Types.” www.vacines.gov.
- See same.
- See same.
- Centers for Disease Control and Prevention (CDC), “What Everyone Should Know about Shingrix.” CDC website.
- See same.
- Abigail Zuger, MD, “New Shingles Vaccine is Here!” New England Journal of Medicine.
- See same.