MDL Judge Dismisses Gardasil Lawsuits, Finding Failure To Warn Claims Preempted by Federal Laws

Lawsuits alleged Merck failed to disclose that side effects of the Gardasil HPV vaccine may cause POTS or primary ovarian insufficiency.

The U.S. District Judge presiding over all Gardasil HPV vaccine lawsuits pending in the federal court system has issued a ruling, which will result in the dismissal of the majority of claims, after determining that the plaintiffs’ claims are preempted by federal law, and that Merck would not have been allowed to add more stringent safety warnings based on the available science.

The Gardasil vaccine has been widely used for years on young girls and boys, as a prophylactic against the development of human papilloma virus (HPV) infections, which can be sexually transmitted and can lead to the development of cancer.

However, while the vaccine is widely believed to be safe and effective, Merck has faced more than 200 lawsuits brought by individuals throughout the U.S., each raising similar allegations that the manufacturer failed to adequately disclose the risk of serious life-changing autoimmune complications, including postural orthostatic tachycardia syndrome (POTS), premature ovarian insufficiency (POI) and other devastating injuries.

Since August 2022, the federal litigation has been centralized as part of a Gardasil MDL (multidistrict litigation) in the Western District of North Carolina, where U.S. District Judge Kenneth D. Bell, Sr. has been presiding over coordinated discovery and pretrial proceedings.

In advance of a series of early bellwether trials expected to begin next year, Merck filed a motion for summary judgment, arguing that they should be immune from the state law-based failure to warn claims, since federal laws would have prevented the drug maker from strengthening the warning label. Merck indicated that there is a lack of scientific evidence establishing that the HPV vaccine may cause autoimmune side effects, which would have been necessary to convince the U.S. Food and Drug Administration (FDA) that such updated warnings were warranted.

Gardasil Lawsuits Dismissed

In a court order (PDF) issued on March 11, Judge Bell agreed and granted Merck’s motion based on implied federal preemption, noting that there was only one case of POTS linked to Gardasil before 2011, and 20 unverified reports.

“It is an understatement to conclude that such evidence does not rise to the level that qualified scientists could find a ‘causal association’ between POTS and Gardasil,” Judge Bell wrote. “With tens of millions of doses given, the Court cannot find that literally a single verified case and a few scattered reports of an illness that is most commonly found in the same young women typically vaccinated with Gardasil could be ‘reasonable evidence’ sufficient to allow a warning on the vaccine’s label. Indeed, to so find would effectively make the regulatory standard meaningless.”

As a result, Judge Bell granted Merck’s summary judgment motion, which will end the federal litigation, unless the decision is overturned on appeal.

However, there are still a number of Gardasil lawsuits filed at the state level, which are unaffected by Judge Bell’s ruling.