Zostavax MDL 2848 Puts Merck Back on the MDL Hotseat
By Mark A. York (August 14, 2018)
The JPML has created the Zostavax MDL 2848 and assigned the lawsuits filed related to Merck’s shingles vaccine to the United States District Court of Pennsylvania and Judge Harvey Bartle III. See Mass Tort Nexus Zostavax brief case: ZOSTAVAX-(Zoster-Vaccine-Live)-MDL-2848-USDC-Eastern-District-of-Pennsylvania.
Shingles is a rash on the side of the face or body, usually affecting persons over 50. The U.S. Food and Drug Administration approved Zostavax as a shingles vaccine in 2006.
The August 2, 2018 order by the U.S. Judicial Panel on Multidistrict Litigation consolidates Zostavax MDL 2848 in the US District Court of Pennsylvania (Eastern District) in front of U.S. District Judge Harvey Bartle, who has been hearing one of the initial Zostavax cases filed in 016. The lawsuits, filed in courts across the country including, Pennsylvania, New Jersey, New York, Wisconsin and Massachusetts, allege that Merck failed to warn that the virus in the vaccine caused shingles, brain damage and death, among other things.
In a move not often seen, defense counsel for Merck had moved for an MDL assigned to Judge Bartle in Pennsylvania or U.S. District Judge James Moody of the Middle District of Florida.
“Issues concerning the design, testing, manufacture, regulatory approval, labeling, and marketing of Zostavax are common to all actions,” wrote the JPML chairwoman, Sarah Vance. “Seven actions are pending in this district, and they are the earliest filed and most advanced actions in this litigation.”
Lead Counsel Comments
“My cases pending before Judge Bartle are the most advanced in the Zostavax litigation,” said Mark Sadaka of The Law Offices of Sadaka Associates in Englewood, New Jersey, a plaintiffs lawyer who supported sending the cases to Bartle. “Merck has already produced millions of pages of documents in my cases in the Easter District of Pennsylvania. Judge Bartle has already decided two summary judgment motions. I look forward to working together with other plaintiffs counsel to finally move our cases to trial.”
Other plaintiffs lawyers had formally opposed creation of an MDL.
Marc J. Bern & Partners in New York, a firm with by far the most individual plaintiffs in the country—over 5,000 Zostavax clients stated “we will be looking to be leaders in this MDL” and “certainly, Judge Bartle is a judge with long experience, has handled successfully other MDL’s” said name partner Marc Bern.
Merck Previously Admits Shingles Vaccine Can Cause Eye Damage and Shingles
Two important FDA approved changes to the warning label of Merck Pharmaceutical’s shingles vaccine, Zostavax, have been made since the controversial drug was introduced in 2006. The first was in August 2014, when, in addition to potentially causing chickenpox, another side effect was added: shingles! That’s right. The vaccine that had been – and continues to be — aggressively marketed to prevent seniors from contracting this excruciating condition was found to actually cause shingles in some individuals.
The FDA approved a label change to warn those who prescribe the Zostavax vaccine of another potential side effect: “Eye Disorders: necrotizing retinitis.”
According to the authors of a Health Sciences Institute (HSI) article in January, 2016, “UCLA researchers found that only one in 175 people who get the vaccine will be able to dodge a shingles flare-up.” While Merck claims 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. So, while that is a 50% difference, the real, absolute risk reduction is just 1.7 percentage points.
The case criteria generally include the following injurie:
- Autoimmune disorders, including Guillain-Barre Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy, Meniere’s Disease
- Bell’s Palsy (facial paralysis)
- Cardiovascular event
- Congestive heart failure
- Hearing loss
- Herpetic Neuralgia (disorder in the nerves)
- Myelitis (spinal cord inflammation)
- Postherpetic neuralgia, or PHN (pain continuing after shingles blister subside)
- Serious neurological diseases or disorders, including brain inflammation (encephalitis)
- Vision problems, including blindness, eye infections, retinal damage, acute retinal necrosis
The JPML was aware of certain issues related to creation of MDL 2858, may delay cases for some plaintiffs, many of whom are older, but coordination of the litigation would help resolve all the cases, “even if some parties might experience inconvenience or delay.”
The JPML order does not apply to lawsuits brought on behalf of 300 plaintiffs in California state court and 800 plaintiffs in New Jersey state court.
One of the lawsuits filed by female plaintiff Joria Bentley from Nevada, claims she suffered high blood pressure, an eye injury and other side effects from Merck & Co.’s Zostavax shingles vaccine in Zostavax litigation filed in the Philadelphia’s Court of Common Pleas. Ms. Bentley claims in her complaint that the patient information sheet, label and prescribing information that accompanied the vaccine did not provide any warning of the risk of viral infection and cites to the many instances of adverse events and other reports on medical issues caused by Zostavax.
Patients who received the injections are filing product liability lawsuits against Merck, alleging the company produced and sold an “unreasonably dangerous vaccine” that caused serious injuries after vaccination. Hailing from a range of states including Louisiana, South Carolina, Tennessee, Michigan and Wisconsin, the plaintiffs filed their suit in Merck’s home state of New Jersey. Instead of preventing shingles, Zostavax caused the plaintiffs to “contract a persistent strain of herpes zoster,” according to the suit, resulting in painful outbreaks, hospital visits and post-herpetic neuralgia in two cases.
The common allegations in all complaints are negligence, defective design, failure to warn, breach of express and implied warranties, misrepresentation involving risk of physical harm and unjust enrichment.
“Merck knew, or should have known, that its product caused viral infection, and was therefore not safe for administration to consumers,” the suits claim. There are “thousands of complaints” yet to be filed according to one of the lead plaintiff attorneys, adding “I think Merck has failed terribly to warn about the very serious side effects and the failure of the vaccine to do what they claim it does” as Merck continues to profit from
National Vaccine Information Center
NVIC provides links and resources such as the manufacturer product information inserts for Zostavax and shingles.
- » Is Shingles contagious?
- » History of Shingles in America
- » Can Shingles cause injury and death?
- » Who is at highest risk for getting Shingles?
- » Who is at highest risk for suffering complications of Shingles?
- » Shingles prevention and treatment options
- » What is Shingles vaccine?
- » History of Shingles vaccine in America
- » How effective is Shingles vaccine?
- » Can Shingles vaccine cause injury & death?
- » Who is at highest risk for complications from Shingles vaccine?
- » Who should not get Shingles vaccine?
- » Questions to ask doctors about Shingles vaccine
- » NVIC statements and commentaries related to Shingles
- » Medical Literature & Resource Links
- » Shingles quick facts
- This information is for educational purposes only and is not intended as medical advice.
What is Zostavax?
Zostavax is a vaccine made by pharmaceutical giant Merck, and approved by the U.S. Food and Drug Administration in 2006. It was the only approved shingles vaccine in the United States until late 2017, which allowed the company to earn as much as $749 million in sales from the vaccine in 2016, according to reports.
This vaccine is designed to reduce the risk of getting herpes zoster — a painful and debilitating condition commonly known as “shingles” — in individuals ages 50 years and older, who are at increased risk of developing the virus. Zostavax is typically recommended for people aged 60 years and older by the U.S. Centers for Disease Control and Prevention, and doctors commonly give the vaccine in a one-dose shot.
Zostavax differs from some vaccines in that it contains a live, but weakened form of the herpes zoster virus (this is officially referred to as a “live, attenuated virus”). People with weakened immune systems cannot receive these types of vaccines.