Merck Settled Hundreds of Gardasil Vaccine Lawsuits. Now the Expert Reports are Public.
Stephen Amato, Ph.D., a former FDA regulatory consultant, says Merck failed to adequately warn the public that its Gardasil HPV vaccine could be linked to postural orthostatic tachycardia syndrome (POTS) and other autoimmune-related conditions, according to a public court filing.
The expert reports, released after Merck settled hundreds of Gardasil lawsuits, allege the company had sufficient evidence to strengthen the vaccine’s safety warnings years earlier but chose not to do so.
Since Merck’s highly profitable Gardasil vaccine first came on the market in 2006, the list of side effects on the label has grown.
The collection of symptoms — along with evidence from animal studies, Merck’s own clinical trials, case reports submitted to the company and published scientific literature — all indicated that Gardasil could cause autoimmune disorders and POTS in some individuals.
Amato provided testimony and argued Merck should have specifically identified POTS, rather than listing individual symptoms associated with it—such as dizziness, fatigue, fainting and rapid heart rate—without connecting them as a syndrome. He stated that by January 2011, there was sufficient “reasonable evidence of a causal association between Gardasil and autoimmune reactions, including development of POTS.”
Amato determined that Merck knew about many factors that could cause autoimmune reactions. For example, the Gardasil vaccine uses a highly potent aluminum adjuvant, and such adjuvants have been linked to autoimmune reactions.
Merck also acknowledged it knew DNA fragments were left in the shot — and never investigated their possible side effects.
The expert reports submitted during the case are now public. See the links below.
“Merck’s pharmacovigilance plan for Gardasil states its purpose to “pre-empt and guard against erroneous associations that are made by anti-vaccine advocates” without mentioning that the true purpose of pharmacovigilance is to ensure the safety of those vaccinated with Gardasil.”
—Stephen Amato, Ph.D.
The Gardasil HPV vaccine remains on the market. Merck is funding research to make the vaccine available to younger age groups.
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Expert Report by Stephen Amato, Ph.D.: childrenshealthdefense.org/wp-content/upl
Expert Report by Jesper Mehlsen, M.D.: childrenshealthdefense.org/wp-content/upl
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