Zostavax

Merck & Co. faces a growing stack of lawsuits after its Zostavax shingles vaccine allegedly caused blindness, paralysis, brain damage, liver failure, and even death.

Zostavax Zoster Vaccine

Manufacturer: Merck Sharp & Dohme Corp.

Labeled Indications: ZOSTAVAX® is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. Limitations of Use of ZOSTAVAX: (1) ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia (PHN); (2) ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox).

Active Ingredient(s): ZOSTAVAX is a lyophilized preparation of live, attenuated varicella-zoster virus (Oka/Merck) to be reconstituted with sterile diluent to give a single dose suspension with a minimum of 19,400 PFU (plaque forming units) when stored at room temperature for up to 30 minutes.

Contraindications: (1) Hypersensitivity: Do not administer ZOSTAVAX to individuals with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin or any other component of the vaccine. Neomycin allergy manifested as contact dermatitis is not a contraindication to receiving this vaccine. (2) Immunosuppression: ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration may result in disseminated disease in individuals who are immunosuppressed or immunodeficient. Do not administer ZOSTAVAX to immunosuppressed or immunodeficient individuals including those with a history of primary or acquired immunodeficiency states, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy. (3) Pregnancy: Do not administer ZOSTAVAX to pregnant women. It is not known whether ZOSTAVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. However, naturally occurring varicella-zoster virus (VZV) infection is known to sometimes cause fetal harm. Therefore, ZOSTAVAX should not be administered to pregnant women, and pregnancy should be avoided for 3 months following administration of ZOSTAVAX.

Description: ZOSTAVAX is a lyophilized preparation of the Oka/Merck strain of live, attenuated varicella-zoster virus (VZV). ZOSTAVAX, when reconstituted as directed, is a sterile suspension for subcutaneous administration. Each 0.65-mL dose contains a minimum of 19,400 PFU (plaque-forming units) of Oka/Merck strain of VZV when reconstituted and stored at room temperature for up to 30 minutes. Each dose contains 31.16 mg of sucrose, 15.58 mg of hydrolyzed porcine gelatin, 3.99 mg of sodium chloride, 0.62 mg of monosodium L-glutamate, 0.57 mg of sodium phosphate dibasic, 0.10 mg of potassium phosphate monobasic, 0.10 mg of potassium chloride; residual components of MRC-5 cells including DNA and protein; and trace quantities of neomycin and bovine calf serum. The product contains no preservatives.

(Updated August 13, 2018)

Drug maker Merck & Co. faces a growing stack of lawsuits in Philadelphia over its blockbuster shingles vaccine Zostavax, which plaintiffs allege can cause serious side effects ranging from blindness and paralysis to brain damage and even death. Merck, meanwhile, “stands behind the demonstrated safety and efficacy” of Zostavax.

Plaintiffs allege Zostavax can cause blindness, paralysis, and even death.

The U.S. Food and Drug Administration (FDA) approved Zostavax to reduce the risk of shingles in 2006. Since that time, Merck says it has been administered more than 36 million times.

But attorneys say there will be thousands of complaints from patients who have suffered extreme side effects not listed on Zostavax’s warning label. These plaintiffs may feel encouraged by Merck’s history of settling these cases for millions, sometimes billions of dollars.

If you or a loved one received the Zostavax vaccine and experienced severe complications—such as blindness, paralysis, brain damage, an autoimmune disorder, or death—please contact us to see if you are owed money.

Zostavax Sales Totaled Roughly $700 Million in 2016

Zostavax is a more potent version of Merck’s chickenpox vaccine, Varivax. It is purported to reduce the risk of contracting shingles by about 50 percent.

The FDA approved Zostavax in 2006; the vaccine has since become one of Merck’s bestsellers, with sales totaling between $685 and 749 million in 2016. (These numbers vary by source.) That’s because it was the only shingles vaccine on the market, and was recommended by the Centers for Disease Control and Prevention (CDC) for people 60 and older.

But Zostavax’s patent protection recently expired in the U.S., so the market will soon become much more competitive, with GSK’s Shingrix joining the field.

Merck says that the vaccination has been administered more than 36 million times in more than 50 countries—which the company considers a testament to its safety. In response to the lawsuits, Merck issued a statement:

Nothing is more important to Merck than the safety of our medicines and vaccines. Merck stands behind the demonstrated safety and efficacy of Zostavax, which has been licensed in over 50 countries.

But given Merck’s checkered history in these matters, one has reason to doubt this statement.

Merck Paid $5 Billion to Settle Vioxx Cases

Merck & Co. is an American pharmaceutical giant founded by George Merck in 1917. Its 2015 revenue was $39.5 billion, making it one of the most profitable pharmaceutical companies in the world.

Its most notable products include the arthritis medication Vioxx, the river blindness medication Mectizan, the osteoporosis medication Fosamax, and of course Propecia.

Like many Big Pharma companies, Merck has a history of questionable ethics and business practices, especially pertaining to Vioxx:

  • From 2002 to 2005, Merck’s Australian affiliate paid a Dutch publisher called Elsevier to put out a “medical journal” called the Australasian Journal of Bone and Joint Medicine. The journal presented itself as independent and peer-reviewed, and featured many articles that favored Merck medications.
  • In 2007, Merck paid nearly $5 billion to settle several lawsuits related to Vioxx, which Merck pulled from the market in 2004 after the drug was shown to increase the risk of heart attacks and strokes.
  • In 2008, Merck paid $650 million to settle U.S. Justice Department charges that it overcharged the Medicaid program for its drugs. This was one of the largest settlements of its kind in American history.
  • In 2011, Merck paid $950 million settle yet another Justice Department charge, this one over its unlawful marketing of Vioxx.
  • In 2016, Merck agreed to pay $830 million to settle a class action securities lawsuit regarding Vioxx.

Given this checkered history, it is not especially surprising that Merck now faces lawsuits over Zostavax—and may have to shell out hundreds of millions to settle these cases.

Shingles Can Have Serious Complications

Complications that can arise from shingles include blindness, hearing problems, pneumonia, brain inflammation, and death.

Shingles (herpes zoster), the virus Zostavax is meant to guard against, is a rash that resembles chickenpox and usually occurs in a stripe on one side of the face or body. People with weak immune systems and those over the age of 50 are most susceptible to shingles.

In addition to itching, irritation, pain, and scabs/blisters, the side effects of shingles can include:

  • Fever
  • Chills
  • Headache
  • Stomach pain

Shingles rashes typically scab over in 7-10 days and then clear up after 2-4 weeks. But serious complications can arise from the virus, including post-herpetic neuralgia (PHN), a pain that lingers for weeks or even months after the rash has cleared up. In rare cases, people can suffer pain from PHN for years. As with shingles, the elderly and infirm are more likely to develop PHN.

Other complications that can arise from shingles include eye disease and blindness, hearing problems, pneumonia, brain inflammation, and death.

Because shingles’ side effects can be so serious, millions of people have taken the precaution of getting vaccinated against the virus. But it seems like that precaution can backfire in a devastating way.

Alleged Zostavax Side Effects

Some of the side effects alleged in the Zostavax lawsuits are extremely serious, even fatal. They include:

  • Blindness/blurred vision
  • Hearing loss
  • Paralysis in the extremities
  • Autoimmune disorders
  • Fibromyalgia
  • Arthritis
  • Brain damage
  • Liver failure
  • Death

If attorneys can prove that the injuries experienced by plaintiffs are linked to the Zostavax vaccine, Merck could be held liable for failing to warn patients of these devastating side effects. 

Zostavax Lawsuit Allegations

Jorja Bentley’s complaint (filed in Philadelphia) includes claims for the following:

  • Negligence
  • Design defect
  • Failure to warn
  • Breaches of express and implied warranties
  • Fraudulent and negligent misrepresentation
  • Unjust enrichment

The complaint seeks compensation for medical bills, lost wages, pain and suffering, and punitive damages.

More than 50 similar lawsuits were recently combined in a multi-district litigation in the Eastern District of Pennsylvania. For more information on these complaints and whether or not you might be eligible for a lawsuit, please see our Zostavax lawsuit page. 

Get a Free Legal Consultation

If you or a loved one received the Zostavax vaccine and experienced serious complications—such as blindness, paralysis, brain damage, or death—it’s in your best interest to speak with our legal team as soon as possible.

Our attorneys have recovered more than $5 billion for our clients.

Our attorneys have recovered more than $5 billion for our clients, and we are one of the only consumer protection firms in the country with the resources to take on a large company like Merck.

There are never any costs unless we win a jury award or settlement. Contact us today for a free, no-obligation legal consultation.