It’s unlikely that Merck will ever be able to revive sales for Zostavax. Once the dominant shingles vaccine on the market, Zostavax was eclipsed by Shingrix shortly after its launch by GlaxoSmithKline in 2017.
But Merck scored a significant win for the vaccine this week in U.S. District Court. In a multidistrict litigation (MDL) bellwether case, Judge Harvey Bartle III of the Eastern District of Pennsylvania ruled in Merck's favor, tossing a plaintiff's claim that the Zostavax shot he received in 2008 caused him to develop shingles eight years later.
Bartle accepted Merck’s request for the summary judgement because plaintiff John Destefano of Florida never designated an expert to testify on his behalf, a court filing shows. Destefano was required to provide an expert report to Merck by March 19 of this year.
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The case is one of more than 1,950 lawsuits against the New Jersey pharmaceutical giant over its shingles shot Zostavax. But the bellwether ruling, coming from the judge overseeing the MDL docket, has the potential for far-reaching implications.
In multidistrict litigation, cases involving product liability and large numbers of plaintiffs with common issues are funneled to a single district court in order to conserve resources and encourage consistency and quick settlements.
According to court documents, when Destefano received the vaccine in 2008, he was 64 and Zostavax was the shot recommended by the CDC. At the time, a package insert with the vaccine notified recipients that clinical trials showed a 64% efficacy rate for those aged 60 to 69. It also specified that protection from shingles four years after receiving the shot was “unknown” and the need for revaccination was “not defined.”
In 2016, when Destefano was diagnosed with shingles at a walk-in clinic, he had a raised, reddened rash which a physician’s assistant described as “mild,” according to court documents.
And nearly 2 years after his visit to the clinic, Destefano filed suit in Florida state court. He accused Merck of defective design, failure to warn, negligence and breach of implied and express warranties. He sought compensatory and punitive damages.
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“Expert testimony as to whether a plaintiff developed shingles because of Zostavax is critical in determining whether there was a breach of contract,” Bartle wrote in the order.
Merck avoided a trial in this case but still has plenty of work ahead in the Eastern Pennsylvania District Court. Destefano’s was one of six Group A bellwether trial pool cases Merck faces involving Zostavax. Trials are set to begin in next January.