by Brenda Baletti, Ph.D., Childrens Health Defense:
Plaintiffs in a bellwether lawsuit against Merck alleging the company concealed the risks of its Gardasil HPV vaccine today said they will appeal a North Carolina federal judge’s ruling, handed down Tuesday, in favor of the pharmaceutical giant.
Plaintiffs in a bellwether lawsuit against Merck alleging the company concealed the risks of its Gardasil HPV vaccine today said they will appeal a North Carolina federal judge’s ruling, handed down Tuesday, in favor of the pharmaceutical giant.
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Michael Baum, lead attorney for the plaintiffs, told The Defender:
“We will be appealing the court’s order concluding that all of the Gardasil cases filed in federal court are preempted. In our view, none should have been.
“We believe the court failed to recognize that vaccine adverse event databases (VAERS and VigiBase), numerous case studies and Merck’s internal data clearly showed reasonable evidence of a causal association between Gardasil and autoimmune conditions like POTS [postural orthostatic tachycardia syndrome] and POI [primary ovarian insufficiency].”
The lawsuit against Merck was the first of the “bellwether cases,” 16 cases selected as exemplar cases from a larger pool of more than 200 lawsuits pending in federal court against Merck for injuries related to its Gardasil vaccine.
In August 2022, the cases were consolidated into multidistrict litigation in a single court. The consolidation allowed Gardasil lawsuits filed throughout the country to move into coordinated discovery and pretrial proceedings. It also means that the judge’s decision in this case can apply to all of the pending cases.
The plaintiffs in the first bellwether case alleged that Merck knew Gardasil carries multiple risks, including POTS and POI, more commonly known as ovarian failure, but violated the law by failing to warn the public.
However, U.S. District Judge Kenneth Bell ruled that Merck did not have authority under federal law to add warnings to the vaccine’s label without prior approval from the U.S. Food and Drug Administration (FDA).
Federal law preempts the plaintiffs’ claims that Merck violated state laws when it failed to warn the plaintiffs of potential side effects, Bell said.
Bell said his decision extends to all of the 200-plus cases pending against Merck in federal court.
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