Breaking: Federal Judge Hands Merck Win in Key Gardasil HPV Vaccine Case
By Brenda Baletti, Ph.D.
A federal judge in North Carolina ruled late this afternoon in Merck’s favor in a lawsuit alleging the drugmaker failed to adequately warn people about serious side effects of its Gardasil HPV vaccine.
A federal judge in North Carolina today ruled in Merck’s favor in a lawsuit alleging the drugmaker failed to adequately warn people about serious side effects of its Gardasil HPV vaccine.
The ruling will allow the drugmaker to avoid over 200 cases pending against it in federal court.
The plaintiffs alleged that Merck knew Gardasil carries multiple risks, including ovarian failure and postural orthostatic tachycardia syndrome (POTS), but failed to warn the public.
U.S. District Judge Kenneth Bell concluded 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.
That federal law preempts the plaintiffs’ claims that Merck violated state laws when it failed to warn them of potential side effects, Bell said.
Children’s Health Defense CEO Mary Holland, an attorney and co-author of “The HPV Vaccine on Trial: Seeking Justice for a Generation Betrayed,” said:
“I am deeply disappointed by the federal district court decision to rule that Merck owed no duty to warn under state law of the risks Gardasil posed of premature ovarian insufficiency (‘POI’) and POTS.
“The judge accepted the questionable premise that Gardasil has ‘prevented innumerable deaths from cancer’ and decided federal law trumps the plaintiffs’ state law claims.”
The case is the first “bellwether” case before Bell’s court in a multi-district litigation (MDL) that brought together over 200 similar cases pending against the pharmaceutical company in federal court for injuries related to the Gardasil vaccine.
Bell previously dismissed several claims brought by the plaintiffs, including manufacturing and design defect claims. The decision extends to all of the plaintiffs in the MDL.
The plaintiffs plan to appeal the ruling. “I am pleased that plaintiffs’ counsel will persevere and appeal,” Holland said. “This case is not over.”
