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A pharmaceutical regulatory expert 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 report, released after Merck settled hundreds of Gardasil lawsuits, alleges 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.
Over time, Merck added reports of dizziness, fatigue, fainting and other conditions. And eventually, the label noted that there had been postmarketing reports of autoimmune diseases, motor neuron disease, transverse myelitis and other conditions.
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 postural orthostatic tachycardia syndrome (POTS) in some individuals.
Yet the company never warned the public about these risks, according to regulatory affairs specialist Stephen Amato, Ph.D., a professor and department chair of Graduate Regulatory Affairs and Life Science at Northeastern University and former U.S. Food and Drug Administration consultant with decades of experience in pharmaceutical regulation.
Amato concluded that Merck should have added stronger warnings about possible autoimmune-related adverse events, including POTS, to the Gardasil label.
In his declaration to the court, Amato said that Merck listed POTS symptoms on the label as individual adverse events, when the drugmaker should have warned about the condition itself.
A warning is a higher level of precaution that would more effectively alert the public to a possible causal relationship between Gardasil and POTS and other autoimmune disorders.
“Merck continued to add other symptoms of POTS to postmarketing sections of its labels, but never a Warning of POTS; rather Merck merely added what appeared to be a random collection of symptoms without ever connecting them to one another,” he wrote.
Amato said federal regulations require manufacturers to update warnings when there is “reasonable evidence of a causal association,” even if a causal relationship has not been definitively proven.
He said that by January 2011, Merck either knew or “should have known” that there was reasonable evidence of a causal connection between Gardasil and autoimmune reactions, including POTS.
Merck has consistently maintained that Gardasil is safe and effective.
Amato’s findings are detailed in an expert report submitted as evidence in a lawsuit against Merck by Jennifer Robi, a California woman who alleged the Gardasil vaccine permanently disabled her.
Robi and hundreds of other plaintiffs recently settled with Merck on confidential terms. The expert reports submitted during the case are now public.
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Failure to warn at heart of lawsuits against Merck
Amato’s argument that Merck failed to warn consumers about the link between Gardasil and POTS was at the heart of Robi’s — and many other plaintiffs’ — vaccine injury lawsuits against the company.
When consumers purchase a product in the U.S., they typically assume that it is safe and that manufacturers have disclosed any risks. Manufacturers typically have a duty to warn consumers of risks associated with their products, and may be held liable if they don’t.
That responsibility includes the requirement that they update labels as new information becomes available. When they don’t, they can be liable for failing to warn the public about the risks.
This theory of liability has been at the heart of many high-profile lawsuits, including legal battles over Roundup weedkiller and toxic baby food.
In all of these cases, plaintiffs alleged that the companies knew the risks. However, to protect their profit margins, they deliberately chose not to disclose the risks to the public.
In the case of Gardasil, Amato determined that the company knew about many factors that could cause autoimmune reactions. For example, the vaccine uses a highly potent aluminum adjuvant, and such adjuvants have been linked to autoimmune issues.
Merck acknowledged that it knew there were DNA fragments left in the shot — which the company never investigated for possible side effects. Studies of Gardasil in mice showed evidence of autoimmune reactions.
There were also numerous postmarketing adverse event reports of POTS, POTS symptoms and other autoimmune issues.
Amato also criticized aspects of Merck’s clinical trial design, postmarketing surveillance practices and its marketing of the vaccine.
Amato contends that Merck’s marketing materials overstated the vaccine’s benefits and that the company’s pharmacovigilance efforts prioritized protecting the product’s reputation rather than fully investigating potential safety concerns.
Related articles in The Defender
- Merck Ignored Gardasil Safety Warnings From Its Own Trial Investigator, Court Documents Reveal
- Woman Confined to Wheelchair Settles With Merck Over HPV Vaccine Lawsuit
- CDC Relied on Cherry-picked Data to Claim No Link Between Merck’s Gardasil Vaccine and POTS
- Merck Used Highly Potent Aluminum in Gardasil HPV Vaccine Trials Without Informing Participants
- ‘Indefensible’: Merck Designed Gardasil Trials to Mask HPV Vaccine Harms
