Zostavax

  • Zostavax

Zostavax is a live attenuated virus vaccine used to protect from herpes zoster, more commonly known as the shingles virus. Zostavax was developed and produced by the New Jersey pharmaceutical company Merck & Co, one of the world’s largest vaccine manufacturers. It is used in individuals 60 years of age and older. However, Merck discontinued the sale of Zostavax in the U.S. market as of June 30, 2020.

Zostavax was approved and licensed by the U.S. Food and Drug Administration (FDA) in May 2006. Later, in 2011 FDA approved the live vaccine for use in individuals aged between 50 to 59 years of age. The Advisory Committee on Immunization Practices (ACIP) in June 2011, the vaccine for adults aged 50, through 59 years was refused and reaffirmed the recommendation for adults aged 60 years and older. Later, the FDA approved the expanded indication for Zostavax in March 2011 for adults aged 50 through 59 years.

FDA had approved two important changes to the warning label of Merck Pharmaceuticals shingles vaccine, Zostavax, following the shingles controversy.

August 2014: The vaccine, in addition to potentially causing chickenpox, also causes shingles were added to the warning label. A vaccine that was marketed to prevent seniors from contracting the condition was found to cause shingles in some individuals. Another potential side effect to be mentioned on the warning label was Eye Disorders: necrotizing retinitis.

UCLA researchers found that only one in 175 people who get the vaccine will be able to evade a shingles flare-up. Whereas Merck claimed Zostavax is 50% effective, in the placebo group, 3.3 percent of the study participants developed shingles, compared to 1.6 percent in the vaccine group. Thus, while there is a 50% difference, the real risk reduction is just 1.7 percentage points.

 

As per CDC (Center for Disease Prevention and Control), shingles vaccination is recommended for people 60 years and older. This is irrespective of whether or not they recall having had chickenpox, as chickenpox is caused by the same virus as shingles.

However, post this vaccination, protection lasts about 5 years, so people vaccinated before they are 60 years old might not be protected later in life when the risk for shingles and its complications are greatest. Hence, people in the 50 through 59 years age group who have questions about the shingles vaccine should discuss the risks and benefits with a healthcare provider.

Serious Alleged Injuries may include:

  • Develop a more severe, more painful and less treatable form of shingles
  • Auto-Immune disorders
  • Herpes zoster-related conditions such as Ramsay Hunt syndrome and herpes zoster encephalitis
  • Bell’s palsy
  • Guillain-Barre syndrome
  • Hemorrhagic stroke
  • Aseptic meningitis
  • Injection site reactions (redness, itching, swelling, warmth, bruising, and pain)
  • Headache
  • Diarrhea
  • Muscle or joint pain
  • Skin rash
  • Hypersensitivity

FDA Safety Warnings:

Since the approval of Zostavax in May 2006, no safety warnings have been issued.

Legal Updates:

Defendants: Merck & Co Inc. Pharmaceuticals

Defendant Law Firm: Eileen Oakes Muskett of Fox Rothschild LLP is representing Merck.

Allegations: Allegations include that Merck & Co manufacturer and distributor of Zostavax failed to warn about its side effects.

Plaintiff Steering Committee:

  • Max Kennerly, Esq. Kennerly Loutey, LLC

  • Caryn Papantonakis, Esq. Johnson Law Group

  • Elizabeth Wilkins, Esq. M.P.H. Schlichter Bogard & Denton, LLP

  • Nicholas Rockforte, Esq. Pendley, Baudin & Coffin

  • Brian Beckcom, Esq. VB Attorneys

Lawsuit Status:

Important Verdicts & Settlements: 

As of November 2020, more than 1800 product liability lawsuits were pending against Merck & Co Inc., each alleging that the defendant knew or should have known about the risks and reactions associated with Zostavax. U.S. District Judge Harvey Bartle of the Eastern District of Pennsylvania is presiding over all bellwether cases in the Zostavax MDL. No. 2848. The cases will be grouped into two categories and prepared for five proposed trial dates that will take place between fall 2020 and summer 2021.

MDL Status: Active and on appeal.

  • On July 2, 2019,  the children of a woman filed a lawsuit against Merck & Co. for the death of their mother allegedly caused due to the side effects of the shingles vaccine Zostavax. According to the court documents, the mother was injected with the shingles vaccine on April 28, 2015, at Walgreens Pharmacy. She started suffering from a severe outbreak of disseminated shingles following the vaccination by June 1. This resulted in hospitalization, where she died on July 3, 2015. The outbreak had affected her organs and other bodily systems.

 

  •  A woman and her husband filed a lawsuit in the U.S. District Court for the Eastern District of Pennsylvania on June 21, 2019, against Merck & co., indicating that she developed a number of serious health problems due to the side effects of shingles vaccine including the shingles injury, the vaccine was designed to prevent. According to the plaintiff, the defendant sold a dangerous vaccine injection for the prevention of shingles, which contained a version of the live virus that was not sufficiently weakened to prevent reactivation of the dormant virus in older adults. The lawsuit indicated that the plaintiff received a Zostavax injection for the prevention of shingles in December 2016. After receiving the vaccine, she developed sharp tingling, burning pain on her left shoulder and was diagnosed with shingles, vertigo, and postherpetic polyneuropathy. 
  • A California woman filed a lawsuit in the U.S. District Court for the Eastern District of Pennsylvania on June 14, 2021, against Merck & Co., alleging that it sold an unreasonably dangerous and ineffective shingles vaccine. According to the complaint filed, the Zostavax shingles vaccine caused the woman to develop a painful, itchy, and blistering rash, as well as other dermatological issues, leading to the very condition it was designed to prevent. The lawsuit also claims the symptoms have resulted in physical limitations not present prior to using the vaccine. Zostavax introduced in 2006 is used for the prevention of shingles among older adults. It has been now replaced by the newer Shingrix vaccine. According to a study published in November 2018 in the BMJ, Shingrix is 85% more effective at preventing shingles than Zostavax.

  • According to a motion filed In June 2019, Plaintiff  Executive Committee (PEC) indicated that Merck has refused or delayed to provide adverse reports which include details of injuries, complications, and other negative experiences reported by doctors and patients after receiving the Zostavax vaccine. The plaintiffs requested the court to force the defendant to turn over the data regarding various Zostavax vaccine problems and to produce their standard operating procedures related to adverse event reports. The opposition response filed by the defendant this week claimed that the plaintiffs’ request was overly broad, arguing that they only had to produce adverse event reports involving the same injuries mentioned in the lawsuits filed till date.
  • June 2019- In the centralized Zostavax litigation MDL No. 2848., presiding Judge Harvey Bartle III established a bellwether process following which Merck & Co. and a Plaintiffs’ Executive Committee (PEC) selected a group of 16 Zostavax vaccine cases, which will go through case-specific discovery and will be prepared for the first trial dates. 

Evidence:

  • Indication of Zostavax vaccination in Medical Records.
  • Follow-up complications and their treatment after Zostavax vaccination in medical records.

Medical Record Review and claim validation of Zostavax case should take approximately 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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