Merck Seeks To Dismiss Gardasil Lawsuits, Claiming They Are Preempted by Federal Law

Motion asks the court to dismiss all 16 Gardasil IVC vaccine lawsuits selected to serve as bellwether test trials in the federal MDL.

As lawyers prepare a group of Gardasil lawsuits for early trial dates in the federal court system, Merck is asking the U.S. District Judge presiding over the litigation to dismiss the claims, arguing that plaintiffs’ failure to warn allegations are preempted by federal law, and that the lawsuits fail to properly state a claim.

Merck currently faces more than 200 product liability lawsuits brought by individuals who experienced painful and debilitating side effects from Gardasil, which has been widely promoted for use among both young girls and boys to aid in the prevention of human papilloma virus (HPV) infections that may lead to the development of cervical cancer.

Each of the lawsuits raises similar allegations, indicating that the drug maker knew or should have known about the risk that some users would experience postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure, idiopathic thrombocytopenic purpura (ITP), chronic pain, brain fog, fatigue, headaches, nerve damage and other injuries.

However, plaintiffs maintain that Merck placed a desire for profits before the health and safety of users, by concealing information about these potential risks from physicians and regulators, and failing to include information about the side effects on the vaccine label warnings.

All Gardasil lawsuits filed in federal courts nationwide are currently consolidated as part of a multidistrict litigation (MDL), under U.S. District Judge Kenneth D. Bell, Sr. in the Western District of North Carolina.

Last year, Judge Bell ordered the parties to select 16 Gardasil bellwether lawsuits to undergo case-specific discovery and preparations for a series of early trial dates, which are designed to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

However, on November 1, Merck filed a motion for summary judgment (PDF), calling for Judge Bell to dismiss all 16 potential Gardasil bellwether lawsuits, indicating that the claims are preempted by federal law, since it did not have the scientific evidence necessary to convince the U.S. Food and Drug Administration (FDA) to update the label warnings.

The company argues the FDA would not have approved label changes without that evidence, and that the FDA’s labeling requirements supersedes failure to warn lawsuits filed under state lawsuits.

Plaintiffs have not yet filed a response to the motion.

If Judge Bell does not dismiss the claims, the court is later expected to narrow the 16 selected claims down to a smaller group that will likely be prepared to go to trial near the end of 2025 or the beginning of 2026.

While the amount of any damages awarded in the bellwether cases will not have any binding impact on other Gardasil claims, the trials will be watched closely to see how juries rule, and whether they hit Merck with large financial penalties for failing to adequately warn about the potential Gardasil side effects.