In what’s shaping up to be a red-letter week for Gardasil, Merck & Co. has simultaneously opened a massive new manufacturing facility for the human papillomavirus (HPV) shot in the U.S. and put hundreds of lawsuits to bed alleging that the company downplayed the safety risks of its blockbuster vaccine.
In a decision signed Monday, North Carolina federal judge Kenneth Bell granted Merck’s motion to dismiss the claims of plaintiffs who argued that Merck failed to warn that Gardasil—first approved in 2006 to prevent cervical and other cancers linked to HPV—could cause recipients to develop certain health conditions.
In particular, the plaintiffs contended that Merck should have added safety warnings to its Gardasil label in 2011 and 2013 detailing the risks of recipients developing postural orthostatic tachycardia syndrome (POTS) or primary ovarian insufficiency (POI), respectively.
POTS is a condition that leads to multiple symptoms, such as dizziness and fast heart rate when a person moves from lying down to standing up. POI, otherwise known as premature ovarian failure, occurs when the ovaries stop working before age 40, often leading to infertility.
Judge Bell specifically ruled that Merck lacked the power to add safety warnings to its Gardasil label under federal law, which pre-empts the plaintiffs’ state-based claims.
In winning its motion for summary judgment, Merck has knocked out more than 200 lawsuits in the nationwide safety communication litigation, according to court documents filed this week.
Given the lack of solid evidence on a causal relationship between Gardasil and the two conditions, Merck didn’t possess the authority to simply change the vaccine’s label of its own accord, the judge ruled.
“As of 2013, when plaintiffs contend that the latest of the warnings should have been given, more than a hundred million doses of Gardasil had been administered worldwide,” the judge said in his decision. “However, by that time, there had been only one published, verified case of POTS and four published case reports of POI.”
In turn, Judge Bell argued that “no scientist could reasonably conclude there is a causal association between POTS and POI and Gardasil based on this paucity of evidence, even putting aside the fact that the FDA was made aware of all these cases and studies.”
Further, it would have ultimately been up to the U.S. FDA, rather than Merck itself, to approve any label updates for the vaccine.
Bell also warned about the inherent risks that come with adding “unwarranted warnings” to potentially life-saving vaccines, arguing that they could sway people to forgo immunizations or “crowd out” legitimate safety risks that should be monitored.
In summarizing his position, the judge stressed that “[f]ederal law requires more than speculative inferences prior to adding dire warnings to lifesaving vaccines that discourage their use.”
In an emailed statement, a Merck spokesperson said that the company is “extremely pleased” with the court’s decision and stands by the safety of its vaccine.
“The evidence that Gardasil does not cause POTS and its associated symptoms or POI is consistent and overwhelming,” the spokesperson said, citing data from clinical trials, real-world epidemiological studies and global regulatory decisions.
Gardasil, which is now approaching two decades on the market, remains one of Merck’s top selling products. The shot’s global sales in 2024 dropped 3% overall but still landed at $8.6 billion for the entire year.
Meanwhile, despite ongoing struggles in the key Chinese market, Gardasil has notched a number of recent wins in the U.S.
Late last month, a California jury trial over Gardasil side effects was put on hold until September, in a move Merck chalked up to its strong body of safety data on the vaccine.
One of the lawyers for the plaintiff in that case told Reuters that it was difficult to run the trial alongside Robert F. Kennedy Jr.’s confirmation hearing for HHS secretary. Kennedy—a noted vaccine skeptic who has since been confirmed for the HHS post—previously disclosed in an ethics agreement that he stood to receive a payout for referring successful cases to one of the law firms representing Gardasil plaintiffs.
Separately, Merck on Tuesday announced the opening of a new $1 billion, 225,000-square-foot manufacturing facility in Durham, North Carolina, that is slated to crank out bulk drug substance for Gardasil.