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March 12, 2025

U.S. Federal Judge Rules in Merck’s Favor in Key Gardasil Lawsuit

A federal judge in North Carolina ruled in favor of Merck in a lawsuit alleging the pharmaceutical giant failed to properly warn the public about the risks associated with its Gardasil HPV vaccine.

The decision effectively shields Merck from over 200 pending federal cases.

Plaintiffs argued that Merck was aware of serious side effects, including premature ovarian insufficiency (POI) and postural orthostatic tachycardia syndrome (POTS), but failed to provide adequate warnings. However, U.S. District Judge Kenneth Bell determined that Merck could not legally alter the vaccine’s label without prior approval from the U.S. Food and Drug Administration (FDA). As a result, he ruled that federal law overrides state law claims against Merck.

Mary Holland, CEO of Children’s Health Defense expressed disappointment with the ruling, stating:

“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.”

This case was the first “bellwether” lawsuit in a multi-district litigation (MDL) consolidating over 200 similar cases. Judge Bell had previously dismissed several other claims, including those related to manufacturing and design defects. His latest decision applies to all plaintiffs in the MDL.

Despite the setback, the plaintiffs intend to appeal. Holland remains optimistic, saying,

“I am pleased that plaintiffs’ counsel will persevere and appeal. This case is not over.”

Stay tuned for further updates as the case progresses.

 

Read the original article by CHD's The Defender

 

Update: March 13

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