Zostavax Shingles Vaccine Litigation – Outcome & History

Zostavax, the live shingles vaccine from Merck & Co., Inc. for adults 50 and older, is the subject of MDL No. 2848 in the Eastern District of Pennsylvania, where plaintiffs alleged it caused shingles, hearing loss and other injuries.

In December 2022 the court dismissed 1,189 shingles cases with prejudice, and the Third Circuit affirmed that dismissal on July 16, 2024. No verdict or settlement amount is public. The claims remain allegations.

Zostavax was licensed in 2006 and has been unavailable in the United States since November 18, 2020. It was discontinued, not recalled.

Latest Zostavax Lawsuit Updates

July 16, 2024: Third Circuit Affirms Dismissal of 1,189 Cases

The Third Circuit affirmed the dismissal of 1,189 Group A shingles cases against Merck in a non-precedential opinion, No. 23-1032 [1]. The court found no abuse of discretion in that dismissal.

The appeal came from MDL No. 2848 in the Eastern District of Pennsylvania. It concerned only the Group A cases, which allege shingles or shingles-related injuries.

November 8, 2023: Kaiser Permanente Study Shows Zostavax Protection Wanes

Kaiser Permanente researchers reported in the journal BMJ that Zostavax effectiveness against shingles waned over the 10 years after vaccination [2].

The Kaiser Permanente Vaccine Study Center published the findings, and Kaiser announced them on November 8, 2023. Merck Sharp and Dohme LLC funded the study.

December 6, 2022: MDL Court Dismisses Group A Cases

The MDL court dismissed the 1,189 Group A shingles cases with prejudice. The appeals court later reviewed this order and affirmed it.

November 18, 2020: Zostavax Becomes Unavailable in the United States

Zostavax became unavailable for use in the United States. The CDC archived its Zostavax page upon the discontinuation of the sale and use of the vaccine, effective November 18, 2020 [3].

June 2, 2020: JPML Remands the Gentile Class Action

The Judicial Panel on Multidistrict Litigation remanded the Gentile economic-loss class action to its original Ohio federal court. The panel ruled the action did not belong in the personal-injury MDL [4].

The panel noted that the Gentile complaint alleged no illness or injury. It described the case as not a products liability case.

What Is Zostavax?

According to the FDA product page, Zostavax (Zoster Vaccine, Live, STN 125123) is a Merck vaccine. It is indicated “for prevention of herpes zoster (shingles) in individuals 50 years of age and older” [5].

The Third Circuit describes its active ingredient as a “live-attenuated” strain of the varicella-zoster virus. Plaintiffs alleged that Zostavax caused shingles or other injuries from the live virus in the vaccine.

Who May Be Affected?

Plaintiffs vaccinated with Zostavax, a live vaccine for adults 50 and older, allege shingles, other injuries or hearing loss. The MDL court sorted its 2,000+ cases by alleged injury.

One in three adults will experience shingles, the Third Circuit notes. Virtually everyone over 30 in the United States has had chickenpox and carries the wild-type virus.

The court held that only PCR testing can show whether the vaccine strain or the wild-type virus caused shingles. The test works only on a rash that is still there.

Whether you qualify depends on your own records and facts, so an individual legal review is needed before anyone can say.

Reported Injuries or Damages

Complaints in MDL No. 2848 alleged shingles or shingles-related injuries (Group A), various other injuries (Group B) and hearing loss (Group C). These are allegations, not findings. No court found that Zostavax caused any plaintiff’s injury.

In March 2022 the court entered PTO 426, a Lone Pine order giving Group A plaintiffs 90 days to produce PCR test reports. Plaintiffs produced nothing, and Merck moved to dismiss under Rule 41(b).

The Third Circuit said PTO 426 rested on uncontradicted PCR evidence. Plaintiffs were twice given notice and a chance to respond. It agreed plaintiffs did not act “willfully or in bad faith,” because nonexistent PCR tests could not be produced.

The Kaiser Permanente study followed 1.5 million Northern California members aged 50 and older from 2007 to 2018. Zostavax effectiveness against shingles was 67% in year one, 50% in year two, 27% in year eight and 15% after 10 years.

For postherpetic neuralgia (nerve pain after shingles), effectiveness was 83% in the first year and 41% at 10 years. For herpes zoster ophthalmicus (eye involvement), it was 71% and 12%.

Recall and Regulatory Background

No recall of Zostavax has been announced. Zostavax was discontinued in 2020 instead, and a discontinuation does not prove liability.

Shingrix, licensed by the FDA in 2017, is the preferred shingles vaccine in the CDC recommendations [6]. The CDC recommends healthy adults 50 and older get two doses of Shingrix, 2 to 6 months apart.

Evidence to Preserve

Keep these records. A Zostavax claim may depend on proof of the vaccine, the diagnosis and the cause:

• Vaccination records showing the date and place Zostavax was given
• The lot number or package insert, if you kept it
• Medical records of the shingles diagnosis
• Any laboratory report, especially a PCR strain-identification test on a rash sample
• Photographs of the rash
• Records of other conditions or treatment
• Pharmacy receipts and insurance statements
• Communications with your providers

A PCR report is the item the courts focused on most, so ask your provider whether one exists for your rash or diagnosis.

Filing Deadlines

Deadlines to file a claim do exist, and they come from state law. That means the rules that apply to you depend on the state where you live.

The deadline also varies with when the injury happened and was diagnosed. Some states start the clock at diagnosis, so the dates in your medical records matter.

Missing the deadline can end a claim even when the facts favor the claimant. Talk to a lawyer promptly to learn which deadline may apply to you.

Frequently Asked Questions

Did the Third Circuit Decide Whether Zostavax Caused Shingles?

The Third Circuit did not decide whether Zostavax caused shingles. The MDL court had earlier excluded plaintiffs’ specific-causation expert and entered summary judgment for Merck in all five Group A bellwether cases, worked up from 2018 to 2021.

What Is the Difference Between Zostavax and Shingrix?

Zostavax and Shingrix differ in type and schedule. Zostavax was a one-dose live vaccine. Shingrix is a recombinant vaccine given in two doses. The CDC archive said Zostavax reduced shingles risk by 51% and protection lasted about 5 years.

What Does the Research Say About Zostavax?

Research on Zostavax shows its protection waned over time. The Kaiser Permanente study tallied 75,135 herpes zoster cases and found that protection declined over the ten years after vaccination.

Has a Zostavax Lawsuit Been Filed as a Class Action?

A Zostavax lawsuit was filed as a class action: Gentile v. Merck, a putative Ohio economic-loss class action alleging deceptive marketing that the vaccine was effective for long-term prevention. The JPML noted over 1,300 product liability cases in the MDL at that time.

Is Zostavax Still Used Outside the United States?

Zostavax is still used in some countries outside the United States, according to Kaiser Permanente. The vaccine has been given to more than 50 million people worldwide.

References

1. https://www2.ca3.uscourts.gov/opinarch/231032np.pdf
2. https://divisionofresearch.kaiserpermanente.org/waning-original-shingles-vaccine/
3. https://archive.cdc.gov/www_cdc_gov/vaccines/vpd/shingles/public/zostavax/index.html
4. https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2848-Remand-Order-05-20.pdf
5. https://www.fda.gov/vaccines-blood-biologics/vaccines/zostavax
6. https://archive.cdc.gov/www_cdc_gov/vaccines/vpd/shingles/hcp/zostavax/recommendations.html