Merck Seeks Summary Judgment on Preemption Grounds in Gardasil Bellwether Cases

CHARLOTTE, N.C. — Merck & Company Inc. has moved for summary judgment in all bellwether Gardasil injury cases, arguing that the failure-to-warn claims are preempted because Merck could not have used the Changes Being Effected regulation to enhance the vaccine’s warning label.

In a heavily redacted brief filed on Nov. 1 in the U.S. District Court for the Western District of North Carolina, Merck says it did not have “newly acquired information” that would have allowed it to unilaterally change the warning label to reflect the risks of postural orthostatic tachycardia syndrome (POTS) or Primary Ovarian Insufficiency (POI).

The 16 …