Merck secured a legal victory as a federal court in North Carolina ruled in its favor regarding lawsuits tied to its HPV vaccine Gardasil. Judge Kenneth Bell concluded that Merck did not have sufficient evidence at the time to link Gardasil to the alleged side effects, rejecting claims that the company failed to warn patients. The lawsuits, which began in 2020, allege that Gardasil caused autoimmune diseases and ovarian failure. Bell stated that federal law requires more than speculative claims before adding serious warnings to vaccines. His decision will apply to over 200 cases currently pending across the U.S. Merck expressed satisfaction with the ruling, while plaintiff attorneys have not commented.
On the same day, Merck revealed plans to invest $1 billion to expand vaccine manufacturing at its Durham, North Carolina site. The company has invested over $12 billion in its U.S. operations since 2018, with an additional $8 billion planned by 2028. Gardasil, Merck’s second-highest-grossing product in 2024 with nearly $8.6 billion in sales, faces challenges, including declining demand in China and upcoming patent expirations in 2028. Merck’s vaccine portfolio also includes Capvaxive, Vaqta, and shots for diseases such as measles, rubella, and ebola. Gardasil shipments to China are suspended until at least mid-2025.
