Data on Zostavax Vaccine Problems Sought from Merck

Plaintiffs are urging the U.S. District Judge overseeing all federal Zostavax lawsuits to force Merck to turn over documents detailing adverse event reports submitted regarding the problems with their controversial shingles vaccine.

Merck & Co. faces nearly 600 product liability claims, each raising similar allegations that the drug maker failed to warn about problems with the live virus vaccine, which plaintiffs claim was not sufficiently weakened to prevent reactivation of the dormant virus in some people. As a result, plaintiffs indicate they were left with more severe and persistent shingles outbreaks, as well as various auto-immune disorders.

In addition to injuries outlined in lawsuits, large numbers of adverse event reports have been submitted directly to the manufacturer by doctors and consumers, detailing potential side effects of the Zostavax vaccine, which plaintiffs argue should be turned over during the discovery phase of the litigation.

Given common questions of fact and law raised in complaints filed throughout the federal court system, the Zostavax litigation is centralized before U.S. District Judge Harvey Bartle III in the Eastern District of Pennsylvania, who is presiding over coordinated discovery into common issues in the claims and will schedule a series of early “bellwether” trials to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the claims.

According to a motion (PDF) filed earlier this month, Plaintiffs’ Executive Committee (PEC) indicates that Merck has refused or delayed providing adverse event reports, which detail injuries, complications and other negative experiences reported by doctors and patients after receiving the Zostavax vaccine.

The plaintiffs ask the Court to force Merck to turn over the data about the various Zostavax vaccine problems, and indicate that the company should also be required to produce their standard operating procedures related to adverse event reports.

“This is now the PEC’s third motion to compel, and it is necessitated once again by Merck’s repeated unwillingness to produce documents that: (1) are clearly relevant to the claims and defenses at issue in this MDL; and (2) are proportional to the needs of this MDL and not unduly burdensome,” the memorandum states. “The discovery at issue in the present motion (and the two before it) is discovery that is typically produced in MDLs without issue.”

In an opposition response (PDF) filed this week, Merck claims that the plaintiffs’ request is overly broad, arguing that they should only have to produce adverse event reports that involve the same injuries mentioned in lawsuits filed to date. The company claims that processing thousands of adverse event reports that are irrelevant to the case would be an undue burden, and notes they would have to redact all of them in order to comply with federal regulations.

Zostavax Litigation Status

Judge Bartle previously indicated that the first federal trial will begin in November 2020, and lawyers involved in the litigation will select a small group of representative claims that will go through the discovery process to be ready to go before a jury.

While the outcome of these Zostavax bellwether trials will not be binding on other plaintiffs, they will be closely watched by lawyers involved in the litigation and may greatly influence any eventual Zostavax settlement negotiations.

Each of the complaints present similar claims that Merck knew or should have known that the shingles vaccine was unreasonably dangerous, with an “under-attentuated” live virus that posed a serious risk for individuals receiving the injection as part of their routine health maintenance.

Zostavax was introduced in May 2006, as the first approved vaccine for prevention of shingles among older adults. It is a single-dose injection, which includes a stronger version of the chickenpox vaccine Varivax. However, it has been linked to reports of persistent shingles outbreaks, as well as auto-immune disorders like meningitis, paralysis, traverse myelitis, acute disseminated encephalomyelitis (ADEM), chronic inflammatory demyelinating polyneuropathy (CIPD) and other painful conditions.

While all cases filed throughout the federal court system are currently centralized before Judge Bartle, if Merck fails to reach settlements or another resolution for the claims following bellwether trials, each individual lawsuit may eventually be remanded back to different U.S. District courts nationwide for separate trial dates in the future.