Landmark Lawsuit Exposes Merck’s Knowledge of Gardasil Contamination
Internal Emails and Regulatory Oversight Raise Serious Concerns
A landmark lawsuit against Merck is underway in Los Angeles, marking the company’s first jury trial over claims it misrepresented the safety of its highly profitable Gardasil HPV vaccine. Newly declassified documents revealed during the trial show Merck’s failure to conduct proper safety tests, raising serious questions about the company’s practices and regulatory oversight.
Concerns about Gardasil’s DNA contamination have persisted for over a decade. In 2011, Dr. Sin Hang Lee discovered high levels of HPV DNA fragments in Gardasil vials from several countries, including the U.S., New Zealand and Australia. These DNA fragments, originating from the plasmid DNA used in production, were supposed to be removed but remained in the final product, binding tightly to aluminum adjuvants. This DNA is resistant to breakdown and can trigger immune responses, potentially leading to autoimmune conditions like Postural Orthostatic Tachycardia Syndrome (POTS) or, in rare cases, sudden death.
Internal emails from Merck, revealed during the trial, show the company was aware of the contamination but failed to take action. Despite knowing the risks, Merck’s Chief Medical Officer admitted the company did not specifically test for HPV DNA and downplayed the issue. Merck even attempted to bypass testing requirements by using yeast DNA as a proxy, which was rejected by regulators. Instead, the company lobbied for a waiver and only made minor adjustments to the product label to downplay the concern.
Regulatory bodies, including the FDA and Swissmedic, overlooked these flaws in Merck’s testing procedures, allowing the vaccine to be distributed globally without addressing contamination concerns. This raises questions about either regulatory capture or incompetence, which could have devastating consequences for the millions who received the vaccine.
This trial could determine Merck’s liability and lead to a broader examination of safety standards in vaccine production and regulation. Dr. Lee is set to testify on February 13, 2025, providing key evidence that may push for stricter regulations and greater accountability in the pharmaceutical industry.
Sources: Maryanne Demasi, PhD, Substack; Children’s Health Defense, The Defender
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