Key Takeaways

The Gardasil MDL opinion reinforces that preemption remains a powerful defense when plaintiffs cannot identify both the existence and timing of newly acquired information that would have permitted a label change under federal law. Courts are likely to require regulatory clarity and scientific rigor before allowing state-law warning claims to proceed.

In a significant ruling for pharmaceutical manufacturers, the Western District of North Carolina granted summary judgment in favor of Merck in the Gardasil multidistrict litigation (“MDL”). Having previously dismissed several of plaintiffs’ claims on other grounds, the MDL court found that plaintiffs’ remaining state law failure-to-warn claims were preempted by federal law. See Order, In re Gardasil Prods. Liab. Litig., No. 22-MD-03036 (W.D.N.C. Mar. 11, 2025), ECF No. 305. The court held that because Merck lacked the legal authority to unilaterally change Gardasil’s label as plaintiffs demanded, it was impossible for the company to comply with both state and federal law.

The litigation stems from allegations that Gardasil, an FDA-approved HPV vaccine, caused postural orthostatic tachycardia syndrome (a condition where the heart rate increases excessively when a person stands) and primary ovarian insufficiency. Plaintiffs argued that Merck should have used the FDA’s “Changes Being Effected” regulation, 21 C.F.R. § 601.12(f)(2)(i), to update the label with additional warnings. However, this regulation permits manufacturers to act unilaterally only when there is “newly acquired information” showing “reasonable evidence of a causal association.” 21 C.F.R. § 201.57(c)(6)(i).

The court held that plaintiffs failed to meet this standard. The evidence cited—including a handful of case reports and fewer than two dozen adverse event reports—was insufficient to establish causation. See Order 20–23, 34. As the court observed, many of these case reports were unverified and, even if verified, did not demonstrate an increased rate of incidence over that seen in the general population. Thus, the court found that these isolated incidents could not justify a label change under the federal standards.

The court also declined plaintiffs’ invitation to find that the label could have been updated at some later time than that alleged by plaintiffs based on a “totality of the record.” Id. at 24–25. That “broad, non-specific request,” was both “impractical” and “an invitation to error,” as it would require the court to assess the record “each day, month or even year between 2011 and January 2021.” Id. Instead, the court reaffirmed that plaintiffs bear the burden of identifying the specific point at which they believe newly acquired information justified a unilateral label change, and of demonstrating that such a change would have complied with federal law. Id. at 25. Absent that showing, the state law claims could not survive.

Finally, the court echoed broader regulatory concerns about overwarning. Citing FDA guidance, the court reiterated that labeling must strike a balance: providing enough detail to inform, but not so much as to confuse or alarm. “The FDA seeks to provide what may be best described as the ‘Goldilocks’ amount of information—that is, ‘just right.’” Id. at 10.

The ruling resolves the bellwether cases and, by agreement and order, will also extend to the broader pool of MDL cases involving the same alleged injuries.