Merck Awarded Summary Judgment on Warning Claims in Gardasil MDL

CHARLOTTE, N.C. — A federal judge has awarded Merck summary judgment on state law failure-to-warn claims in the Gardasil human papillomavirus (HPV) vaccine MDL, ruling that the claims are preempted because there is a lack of “newly acquired information” that would have allowed a label change under the FDA’s Changes Being Effected regulation.

In a March 11 order, Judge Kenneth Bell of the U.S. District Court for the Western District of North Carolina agreed with Merck that it did not have “newly acquired information” that would have allowed it to unilaterally change the warning label to reflect the risks of …