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www.fdanews.com/articles/205380-judge-gives-green-light-for-claims-over-mercks-shingles-vaccine

Judge Gives Green Light for Claims Over Merck’s Shingles Vaccine

November 17, 2021

A federal judge in Pennsylvania is allowing a trial to proceed against Merck alleging the company’s Zostavax shingles vaccine induced the disease instead of preventing it.

The lawsuit by five plaintiffs charges the company with failing to submit a safer drug to the FDA for approval, specifically one not based on a live-attenuated virus. In his ruling, Justice Harvey Bartle of the U.S. District Court for the Eastern District of Pennsylvania said that Merck hadn’t met the criteria for a summary judgment in lieu of trial proceedings.

“While Merck raises the defense that the science did not exist to [submit a safer, nonlive virus design] … before the Zostavax application was approved, there exists genuine disputes of material fact on this issue that will have to be resolved at trial,” the judge said.

The case is just one of thousands of multidistrict complaints in recent years charging Merck with selling an unsafe shingles shot. The FDA approved Zostavax in 2006, making it the first agency-approved vaccine for the disease.

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