Bless those who persist.
From today’s posting “PLAINTIFFS WILL APPEAL . . . a North Carolina federal judge’s ruling, “
“Gardasil is one of Merck’s highest-grossing products. Global sales . . . totaled $8.6 billion for the year (2024)”.
“(Judge) Bell’s decision was made public the same day that Merck announced a new $1 billion facility — a 225,000-square-foot manufacturing plant in Durham, North Carolina — slated to produce the blockbuster Gardasil vaccine.”
The 4th posting below, “Outrage of the father of a Gardasil- vaccinated boy . . .”. WHY on Earth would a young boy get Gardasil shots? . . . As simple as revenue? totaled $8.6 billion for the year (2024).
The coverage I remember about Mothers organizing against the Gardasil vaccine were about injured GIRLS from other countries, in large numbers. Heart-breaking cases. I listened to many of them.
Please share information. It WORKS. Canadians need to help out.
I am re-motivated because I reviewed what is known about Gardasil. It almost makes me sick what these people do for making money. HOWEVER! there is GOOD NEWS.
Third link from the bottom of the list, EXCERPT:
A bill introduced late last week in the U.S. House of Representatives would end the liability protections Congress gave vaccine makers under the 1986 Childhood Vaccine Injury Act.
Thirty Republican lawmakers signed on as co-sponsors to House Bill 9828, End the Vaccine Carveout Act. The proposed legislation would end the broad protection from liability for injuries resulting from vaccines listed on the Centers for Disease Control and Prevention’s (CDC) Childhood Immunization Schedule.
“The … vaccine makers are criminal enterprises that have paid tens of billions in criminal penalties over the past decade,” Children’s Health Defense (CHD) founder and chairman on leave Robert F. Kennedy Jr. said in a statement on the bill.
Kennedy, who has long advocated for eliminating liability protection for vaccine manufacturers, added, “By freeing them from liability for negligence, the 1986 statute removed any incentive for these companies to make safe products. If we want safe and effective vaccines we need to end the liability shield.”
Today’s posting about THOSE WHO PERSIST is below.
POSTINGS RELATED TO GARDASIL (HPV Vaccine).
2025-03-12 Plaintiffs Will Appeal Ruling in Merck Gardasil Vaccine Injury Case. Brenda Baletti, CHD (below)
2019-05-15 RFK, Jr.: Gardasil “The Science” Video and Other Facts
2018-09-02 Vaccinations, Gardasil (HPV Vaccine), Update
2017-2018 Vaccines: outrage of the father of a boy vaccinated for HPV (Merck’s Gardasil) without parental consent. Wetaskwin, Alberta, Canada . Edmonton Journal “Opinion” is propaganda for Merck. (Merck may have spent some of the $8.6 billion on advertising??)
2018-02-21 Vaccines, more on Gardasil (HPV): Letter to Alberta School Division. Using schools to cut parents out of Vaccination Decisions?
While it is not clear exactly what is causing so many adverse reactions, it is known that Gardasil contains genetically engineered virus-like protein particles as well as aluminum, which can affect immune function. Further, . . . (go to the article if you’d like to read further)
That’s 26 reported deaths of young, previously healthy, girls after Gardasil vaccination in just one year (INSERT, S: in just one country, the U.S.)
While it is not clear exactly what is causing so many adverse reactions, it is known that Gardasil contains genetically engineered virus-like protein particles as well as aluminum, which can affect immune function. Further, . . . (go to the article if you’d like to read further)
UPDATE: It would have been nice if I had I received the
2024-10-29 NIH (U.S.) EHR (Electronic Health Records). Spending $2.2 Million to ‘Nudge’ to Get More Vaccines. University “Nudge Units”. The “Nudge Ladder”. Baletti, CHD.
2024-09-30 Covid: 30 Lawmakers Sponsor Bill to End Liability Protection for Vaccine Makers
2022-01-20 Bill Gates, Indian Government Targeted in Lawsuit Alleging AstraZeneca Vaccine Killed 23-Year-Old
2017-11-28 High Aluminum Found in Autism Brain Tissue, Children’s Health Defense (Vaccinations)
= = = = = = = = =
TODAY’S NEWS: APPEAL OF THE COURT DECISION
Plaintiffs in a bellwether lawsuit against Merck alleging the company concealed the risks of its Gardasil HPV vaccine today said they will appeal a North Carolina federal judge’s ruling, handed down Tuesday, in favor of the pharmaceutical giant.
Plaintiffs in a bellwether lawsuit against Merck alleging the company concealed the risks of its Gardasil HPV vaccine today said they will appeal a North Carolina federal judge’s ruling, handed down Tuesday, in favor of the pharmaceutical giant.
Michael Baum, lead attorney for the plaintiffs, told The Defender:
“We will be appealing the court’s order concluding that all of the Gardasil cases filed in federal court are preempted. In our view, none should have been.
“We believe the court failed to recognize that vaccine adverse event databases (VAERS and VigiBase), numerous case studies and Merck’s internal data clearly showed reasonable evidence of a causal association between Gardasil and autoimmune conditions like POTS [postural orthostatic tachycardia syndrome] and POI [primary ovarian insufficiency].”
The lawsuit against Merck was the first of the “bellwether cases,” 16 cases selected as exemplar cases from a larger pool of more than 200 lawsuits pending in federal court against Merck for injuries related to its Gardasil vaccine.
In August 2022, the cases were consolidated into multidistrict litigation in a single court. The consolidation allowed Gardasil lawsuits filed throughout the country to move into coordinated discovery and pretrial proceedings. It also means that the judge’s decision in this case can apply to all of the pending cases.
The plaintiffs in the first bellwether case alleged that Merck knew Gardasil carries multiple risks, including POTS and POI, more commonly known as ovarian failure, but violated the law by failing to warn the public.
However, U.S. District Judge Kenneth Bell ruled that Merck did not have authority under federal law to add warnings to the vaccine’s label without prior approval from the U.S. Food and Drug Administration (FDA).
Federal law preempts the plaintiffs’ claims that Merck violated state laws when it failed to warn the plaintiffs of potential side effects, Bell said.
Bell said his decision extends to all of the 200-plus cases pending against Merck in federal court.
Plaintiffs reject judge’s claim of insufficient evidence to justify label change
In his decision, Bell said Merck didn’t have enough evidence to justify a label change showing that Gardasil could cause POTS or POI by 2011 and 2013, respectively, when the plaintiffs’ expert witness said warnings should have first been given.
Bell said only a few cases of those conditions had been reported by then and that broader studies had not, at that time, established causal associations.
The plaintiffs, however, said that not only was there evidence of a link at that time — which the judge failed to consider — but also that considerable evidence has since accumulated demonstrating the link and that evidence should be considered.
The plaintiffs in the 16 bellwether cases all received multiple doses of the Gardasil vaccine between 2012 and 2021 — after the 2011 date cited by the court. They all developed either POTS or POI after vaccination and allege that Merck failed to add those conditions as possible vaccine side effects to the label.
Bell’s decision was made public the same day that Merck announced a new $1 billion facility — a 225,000-square-foot manufacturing plant in Durham, North Carolina — slated to produce the blockbuster Gardasil vaccine.
A Merck spokesperson told Fierce Pharma that the company is “extremely pleased” with the court’s decision.
‘The fight goes on’ for those injured by Gardasil
In his ruling, Bell said that, as per the regulation, a label change by Merck would be required if there was “reasonable evidence” of a causal association based on newly acquired information and “during the relevant timeframe.”
He cited testimony by plaintiffs’ expert, Stephen Amato, Ph.D., who argued warnings should have been added by 2011 for POTS and 2013 for POI.
That means, Bell said, his decision focused on whether Merck had convincing evidence that Gardasil could cause POTS and POI between 2006, when the drug was approved, and 2011, which he said was a relevant timeframe.
On that basis, Bell excluded all evidence that arose both before and after the 2005-2011 timeframe. That includes new analyses of pre-approval and post-marketing data and revelations of misreporting — including Merck’s failure to include data on the presence of DNA fragments in Gardasil vials.
In his expert testimony, Amato argued early warnings should have been added based on existing post-marketing data and also that over time — after 2011 and 2013 — substantially more evidence appeared through statistical analysis of adverse event reporting systems and case series published in the scientific literature.
Bell treated those dates as a date to limit his analysis instead of how Amato presented them, which was as a starting point for when sufficient evidence was first available.
“Limiting its analysis to pre-2011 data is, we believe, in error, especially in light of the significantly elevated reporting of POTS and POI since 2011,” Baum said.
“For example, in a Danish Health Authority analysis, POTS was reported in post-HPV vaccination over 100 times more than all other vaccines,” he said. “Our experts found similar significant elevated reporting of POTS.”
Baum added:
“The bottom line is that there was a large volume of evidence that we think was misapprehended by the court. We are optimistic that the Court of Appeals will recognize that this preemption decision should be reversed.”
Kim Mack Rosenberg, an attorney for the plaintiffs and general counsel for Children’s Health Defense, said, “While we are disappointed in the decision, we believe there is substantial evidence that shows that the court’s decision was an error and we’re hopeful that the U.S. Court of Appeals will reverse the decision.”
“The fight goes on for those who have been injured by the Gardasil vaccines,” said Mack Rosenberg, who is also co-author of “The HPV Vaccine on Trial: Seeking Justice for a Generation Betrayed.”
‘The fight goes on’ for those injured by Gardasil
In his ruling, Bell said that, as per the regulation, a label change by Merck would be required if there was “reasonable evidence” of a causal association based on newly acquired information and “during the relevant timeframe.”
He cited testimony by plaintiffs’ expert, Stephen Amato, Ph.D., who argued warnings should have been added by 2011 for POTS and 2013 for POI.
That means, Bell said, his decision focused on whether Merck had convincing evidence that Gardasil could cause POTS and POI between 2006, when the drug was approved, and 2011, which he said was a relevant timeframe.
On that basis, Bell excluded all evidence that arose both before and after the 2005-2011 timeframe. That includes new analyses of pre-approval and post-marketing data and revelations of misreporting — including Merck’s failure to include data on the presence of DNA fragments in Gardasil vials.
In his expert testimony, Amato argued early warnings should have been added based on existing post-marketing data and also that over time — after 2011 and 2013 — substantially more evidence appeared through statistical analysis of adverse event reporting systems and case series published in the scientific literature.
Bell treated those dates as a date to limit his analysis instead of how Amato presented them, which was as a starting point for when sufficient evidence was first available.
“Limiting its analysis to pre-2011 data is, we believe, in error, especially in light of the significantly elevated reporting of POTS and POI since 2011,” Baum said.
“For example, in a Danish Health Authority analysis, POTS was reported in post-HPV vaccination over 100 times more than all other vaccines,” he said. “Our experts found similar significant elevated reporting of POTS.”
Baum added:
“The bottom line is that there was a large volume of evidence that we think was misapprehended by the court. We are optimistic that the Court of Appeals will recognize that this preemption decision should be reversed.”
Kim Mack Rosenberg, an attorney for the plaintiffs and general counsel for Children’s Health Defense, said, “While we are disappointed in the decision, we believe there is substantial evidence that shows that the court’s decision was an error and we’re hopeful that the U.S. Court of Appeals will reverse the decision.”
“The fight goes on for those who have been injured by the Gardasil vaccines,” said Mack Rosenberg, who is also co-author of “The HPV Vaccine on Trial: Seeking Justice for a Generation Betrayed.”
2024 sales of Gardasil hit $8.6 billion
Gardasil is one of Merck’s highest-grossing products. Global sales for the drug dropped 3% in 2024 overall but still totaled $8.6 billion for the entire year.
Merck markets the vaccine as “safe and effective,” but the lawsuits allege the drugmaker fast-tracked Gardasil through the FDA approval process and deceptively conducted clinical trials to mask serious side effects and exaggerate the vaccine’s effectiveness.
Some of the signature reactions observed following HPV vaccination — which afflict a number of the plaintiffs — include permanently disabling autoimmune and neurological conditions, fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome.
There have been thousands of reports of adverse events worldwide, peer-reviewed scientific literature from the U.S., Australia, Denmark, Sweden, France and Japan, and statistics published by public health agencies in each of these countries demonstrating associations between HPV vaccination and autoimmune conditions.
Recent documents made public in a similar case against Merck in California state court showed that Merck knew its Gardasil vaccine was contaminated with DNA, but covered it up.
Evidence from that trial also showed that Merck cherry-picked data to claim there was no link between its Gardasil vaccine and POTS.
Related articles in The Defender
Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.
