According to Judge Kenneth Bell, there is a lack of evidence to conclude that Merck willingly misrepresented the safety of its HPV vaccine Gardasil to patients and prescribers.
A federal court ruled in favor of Merck on Tuesday, finding that the pharma had not been remiss in its duty to inform patients about alleged safety risks associated with its HPV vaccine Gardasil.
According to reporting from Reuters, Judge Kenneth Bell of the District Court of North Carolina agreed with Merck’s argument that at the time these safety signals were occurring, the company did not have enough data to conclusively link Gardasil to the side effects.
“Federal law requires more than speculative inferences prior to adding dire warnings to lifesaving vaccines that discourage their use,” Bell argued. “That evidence is lacking here.” Merck in a statement to Reuters said it is “extremely pleased” with the ruling, while counsel for the plaintiffs—patients who claimed to have suffered from side effects after receiving Gardasil—had no immediate comment.
The Gardasil lawsuits stretch back to 2020, when dozens of claimants sued Merck, alleging that the pharma had downplayed the side effects of the vaccine, including an increased risk of ovarian failure and the development of autoimmune diseases such as systemic lupus erythematosus, multiple sclerosis and Guillain–Barré syndrome.
As per the Reuters report on Tuesday, there are currently more than 200 such cases nationwide to which Bell’s decision will apply.
Also on Tuesday, Merck announced a $1 billion bump to its vaccine manufacturing capacity in the U.S., earmarked for the construction of a new production facility at its campus in Durham, North Carolina. The pharma has pumped more than $12 billion into its U.S. footprint since 2018 and plans to add another $8 billion by 2028.
Aside from Gardasil, Merck’s vaccine portfolio includes the 21-valent pneumococcal shot Capvaxive and the hepatitis A vaccine Vaqta. The company also produces shots for measles, mumps, rubella, ebola and other infectious diseases. In 2024, the Gardasil line was Merck’s second-best-selling product franchise, bringing in nearly $8.6 billion.
The vaccine has suffered from strong geopolitical headwinds, however. In August 2024, Merck flagged what it called a “significant step down” in Chinese shipments for Gardasil, which analysts pinned on weak demand. China is an important market for Gardasil, Guggenheim Partners’ Vamil Divan told BioSpace at the time, noting that the Asian giant makes up around 67% of the vaccine’s total international sales.
The situation only worsened last month, when Merck announced that Gardasil shipments to China would be suspended at least until the middle of 2025.
Gardasil is also set to lose key patent protections in 2028.
