Merck settles lawsuits about serious neurological harms of Gardasil, its HPV vaccine

The European Medicines Agency committed scientific misconduct, too

My wife is a professor of clinical microbiology, and as a doctor, I have spent more time with infectious diseases than with any other specialty. We had not perceived vaccines to be an issue before we in 2008 got a letter from a colleague upon our oldest daughter’s 12^th birthday asking us to enrol her in an HPV vaccine trial conducted by GlaxoSmithKline (GSK).¹

We asked for the trial protocol, but there was no information about harms, only meaningless industry mantras that the vaccine was “generally safe and well-tolerated.”² However, the information to parents noted that it had “affected the nervous system, blood cells, the thyroid and the kidneys.”

We asked what that meant and how common these harms were. They were listed in an investigator’s brochure, but the protocol stipulated that GSK owned the data and we could not get access to the brochure, even though such material does not contain commercially confidential information.

We were denied the possibility to give informed consent and refused to enrol our daughter in this unethical trial.

My wife vaccinated her, but we were in doubt. Thousands of reports had already been submitted to the authorities of adverse effects of Gardasil, Merck’s first HPV vaccine, including nausea, paralysis and death, and many people were worried.³

Heated debate and pivotal research in Denmark

Seven years later, in 2015, there was a heated debate in Denmark after a TV documentary reported on hundreds of girls who felt the healthcare system had treated them very badly when they complained about serious HPV vaccine harms, they had experienced.⁴

The documentary was very good and it stated that no one knew with certainty if the symptoms were caused by the vaccine. The journalists had found out via the Freedom of Information Act that, in its propaganda, the Board of Health had failed to communicate warnings about the vaccine. Nonetheless, the authorities and interest organisations like the Danish Cancer Society raised a storm of protests. This had the effect that the TV station didn’t dare touch this subject again.

Everyone with shoulder stripes was determined to keep people in the dark except for Doctor Louise Brinth at the Syncope Centre in Copenhagen. The same year, she published three unique studies that earned her a PhD.^5,6 They suggested that some girls had been seriously harmed by the vaccines. These harms included postural orthostatic tachycardia syndrome (POTS), complex regional pain syndrome (CRPS) and chronic fatigue syndrome (CFS).

Serious neurological harms can be caused by an autoimmune reaction where the body produces antibodies against its nervous tissue. An example is the influenza vaccine Pandemrix that caused narcolepsy.⁶ Other examples are myocarditis, immune thrombocytopenia, and Guillain-Barré syndrome after a Covid-19 vaccine.^7,8

A study demonstrated a strong relationship between adrenergic autoantibodies and POTS,⁹ and the Syncope Centre reported that, after HPV vaccination, antibodies against autonomic nerve receptors and their related proteins were found in most girls with POTS combined with other symptoms of dysautonomia, but only in a minority of vaccinated girls who were healthy.¹⁰

When the Board of Health arranged a meeting in August 2015 to discuss the issues, a previous Head of Cabinet in the Ministry of Health urged me to attend, hoping I would become convinced that there was nothing to worry about.

There surely was. Louise said that many of the affected girls were elite sportswomen, which made sense to me because such people have a weakened immune system. Furthermore, they are not faking that they are ill, which a psychiatrist suggested at the meeting.¹

This spurred my interest, and in 2016, I asked Doctor Lars Jørgensen to do a PhD about the HPV vaccines tutored by Professor Tom Jefferson from Oxford and me.¹¹

Before 2010, it had been impossible to get access to the detailed clinical study reports of drugs the manufacturers submit to drug agencies to get their drugs approved. In 2007, the European Medicines Agency (EMA) refused to give me access to reports of slimming pills, arguing it would undermine commercial interests.

I complained to the European Ombudsman, and after three years of fruitless discussion with EMA whose only interest was to protect the drug industry, not the patients, the Ombudsman played his trump card, accusing the EMA of maladministration in a press release. After this, EMA had no choice other than opening its archives.¹²

But EMA obstructed our research again. They denied us access to the HPV vaccine reports saying it “would undermine the protection of commercial interests.”¹³ This was extremely arrogant because - during the process I had instituted against EMA earlier - the Ombudsman had inspected study reports and protocols at EMA’s headquarters and had concluded that they do not contain commercially confidential information.

We appealed, and EMA approved our request but released the study reports with extraordinary slowness. After three years, we went ahead with what we had, which was the major trials.

Against all odds, as the control groups had active comparators - vaccines or the strongly immunogenic aluminium vaccine adjuvant - we found that the HPV vaccines increased serious nervous system disorders significantly: 72 vs 46 patients, risk ratio 1.49 (P = 0.04).¹⁴ We called it an exploratory analysis, but it was the most important one because these suspected harms were what caused the EMA to assess vaccine safety in 2015 (see below).

We knew that the companies had deliberately concealed serious neurological harms,⁶ and not a single case of POTS or CRPS was mentioned in the study reports. We therefore did another exploratory analysis where we asked a blinded physician, Louise Brinth, to assess the coded terms for adverse events. The HPV vaccines increased serious harms definitely associated with POTS (P = 0.006) or CRPS (P = 0.01), and new onset diseases definitely associated with POTS were also increased (P = 0.03).

Our results were not welcomed. The media went amok, and the journal that published them committed editorial misconduct.^1,6,13 Our paper was accepted for publication in Systematic Reviews, owned by Springer, in 2019, but a year later, it had still not been published, although the journal promised publication within 20 days of acceptance.

Our email correspondence with the journal takes up 66 pages, and we received 20 apologies and a variety of odd, contradictory, and implausible reasons for why our paper had not been published.⁶

We lost our patience and warned Springer that their censorship bordered on scientific misconduct and fraud, and that we would involve our lawyers if Springer failed to publish our paper within the next two weeks.

This made Springer publish our review with record speed, two days before our deadline.¹⁴ The journal’s Editor-in-Chief, David Moher, subsequently stepped down, putting the blame on Springer: “The delay is a substantial embarrassment … We have experienced some internal issues.”^1,13

Springer committed horrific censorship also in another case. They tried to avoid publishing our rebuttal¹⁵ of a letter whose authors criticised our work with the HPV vaccines on false grounds. It took three years before our reply was published, and this was only because we had threatened Springer with litigation.^1,6,13

We had disturbed a holy cash cow: vaccines.

EMA committed scientific misconduct

Denmark contacted the European Commission with its concerns, and in July 2015, the EMA was asked to assess the research linking the HPV vaccines to the serious alleged harms.

Four months later, EMA issued a report concluding that “the evidence does not support a causal association between HPV vaccination and CRPS and/or POTS.”¹⁶

Incompetent, malicious and aggressive journalists triumphantly touted the case was settled for good and repeated EMA’s outrageously wrong and defamatory assertion that Louise had studied “a highly selected sample of patients, apparently chosen to fit a prespecified hypothesis of vaccine-induced injury.”¹³ Louise had included all consecutively referred patients, except those that did not meet the inclusion criteria, and had no prespecified hypothesis but raised one based on her observations. This is what good science is about.

A leaked confidential report used to brief EMA’s appointed scientific advisory group showed that there were important disagreements between the experts,¹⁷ which we wanted to bring to the public’s attention. We submitted our paper to the BMJ in 2016 but were exposed to absurd censorship over several years.¹³ It took 4.5 years before we got the paper out in a BMJ sister journal.¹⁸

EMA’s investigation was a sham. It was not only of appallingly poor quality; it was scientific misconduct.^1,6,13,18 We accused EMA of maladministration because they had not assessed the possible serious neurological harms of the vaccines appropriately,¹⁹ but EMA’s reply was also disappointing. Some of our concerns were not addressed and several statements were incorrect, misleading or irrelevant. We therefore complained to the European Ombudsman, but she also disappointed us.²⁰ No one, the BMJ included, wanted to touch the hot potato.

Our criticism was major. EMA had asked Merck and GSK to do the work for them even though EMA knew that these companies are engaged in organised crime and could not be trusted.^21,22 EMA’s trial inspectors had criticised Sanofi substantially (Sanofi Pasteur MSD was a joint venture with Merck), and the Danish authorities had noted that only 3 of 26 registered reports of POTS showed up in Sanofi’s searches.^6,13

EMA asked the companies to search for possible harms in their databases and did not react to the fact that the search strategies were grossly insufficient and must have overlooked many cases.^6,13 This misconduct must have been deliberate. For example, the companies did not search for headache even though all Louise’s patients had headaches, and dizziness needed to occur together with orthostatic intolerance or orthostatic heart rate response increased to count. Louise dryly noted that Merck’s approach was like saying that we will only recognise that people have seen a Granny Smith apple if they in their description include the word “fruit” AND “apple” AND “Granny Smith.”¹³

EMA knowingly contributed to Merck’s fraud. An insider provided us with a confidential copy of an EMA expert report for Gardasil 9, which showed that Merck had deliberately avoided identifying possible cases of serious neurological harms of its new vaccine.²³ For example, three patients who had been diagnosed with POTS in the clinical safety database after receipt of the vaccine were not reported as adverse events; a case of POTS was called “new medical history;” hospitalisation for severe dizziness was not reported as a serious adverse event; and the term “dysautonomia” was not included in the list of adverse events.

EMA declared that the strong aluminium adjuvants used in the vaccines to boost the immune response are safe, yet the five references provided were either non-accessible or irrelevant.^6,13 Adjuvant safety studies have never been carried out. The manufacturers and regulators say the HPV vaccines are safe because the adjuvants have similar harm profiles.²⁴ This is like saying that cigarettes and cigars are safe because they have similar harm profiles.

The adjuvants are of course not safe.^25-27 They cannot be. As they are used to boost the immune response, a banal virus infection occurring at the same time as an adjuvant is used as a control in a randomised trial could lead to an autoimmune reaction.

EMA knew this. EMA did its own literature searches but withheld the results from its scientific advisory committee.^6,13 The withheld reports, which the Ombudsman helped us get access to, revealed that HPV vaccines, other vaccines and perhaps also the adjuvant (in combination with an otherwise harmless virus infection) might cause POTS or CRPS. EMA even admitted that POTS frequently starts after a viral illness.

It looked like a cover up that EMA withheld this information from its appointed experts, and EMA’s attempts at explaining away their actions were so implausible that they were outright laughable.^6,13

EMA’s secret literature searches revealed that autoantibodies were found in 33% of 82 CRPS patients and in only 4% of 90 healthy controls. The Ombudsman found it problematic that EMA had removed what they called confidential information so that its own experts could not see it and urged EMA not to do so in future. However, EMA was so arrogant that they didn’t even reply when the Ombudsman repeated her request.^6,13

EMA allowed the companies to lump the “placebo” groups in their trials although, in almost all cases, the “placebo” was an adjuvant or a hepatitis vaccine. EMA’s Director Guido Rasi falsely explained to the Ombudsman that all the studies Merck had submitted to get Gardasil approved were placebo controlled, and EMA’s official report also gave this impression.¹⁶

EMA uncritically reproduced the incidence rates of POTS and CRPS constructed by the manufacturers, even though - in one of the reports EMA withheld from its own experts -EMA said that no data existed on the background incidence and prevalence of POTS.^6,13

EMA’s key argument, mentioned 10 times in its official report,¹⁶ was that the manufacturers had not found any difference between what was observed and the expected background incidence of POTS and CRPS. However, EMA’s confidential briefing note revealed that both the Belgian and the Swedish co-rapporteurs were critical of the observed versus expected analyses.¹⁷

Curiously, EMA’s official report admitted that the underlying research was of poor quality and that such comparisons could not confirm a causal relationship between vaccines and harms, even if it existed.¹⁶ When that is the case, the finding that there was no difference between observed and expected incidences is meaningless.

Both the Uppsala Monitoring Centre,^28,29 a WHO collaborating centre, and the Danish health authorities had found signals of harm and were dissatisfied with how their observations and reports were dismissed by EMA.

The lawsuit and Merck’s fraud

In 2019, CrossFit invited me to give a talk, which they filmed,³⁰ in their headquarters in Santa Cruz in California based on my book about the Cochrane Collaboration’s moral and scientific collapse.³¹ I updated the book³² when my filmmaker and I decided to do a documentary film about Cochrane’s demise and the lack of scientific freedom, which has world premiere in September in Norway.³³

While I was in Santa Cruz, Michael Baum, Bijan Esfandiari and another associate from his Los Angeles law firm Wisner Baum came by, as they wanted to hire me as an expert witness for their lawsuit. Michael collaborated with Robert F Kennedy Jr. on this, and he flew up from Los Angeles the next day.

I disagree with some of Kennedy’s views on vaccines but he is correct that substantial changes in the recommended US vaccine programme and more research on vaccine harms are needed. The level of mis- and disinformation in the United States related to vaccines is second to none, and I have written many articles and three books documenting the pervasive dishonesty in the media, the CDC and the FDA.^{6,13,27,34,35}

I read 112,452 pages of confidential study reports, corresponding to five hundred medium-sized books, and wrote an expert report of 350 pages with four appendices.¹³ During the ongoing trial, when my report had been declassified, Michael asked me why I didn’t write a book about it, which I did:¹³

Merck had used numerous tactics to avoid reporting serious neurological harms of Gardasil. These included biased designs, omission of essential data, and unwarranted conclusions in the animal studies; obscure and contradictory methods, even for the investigators, for collecting, analysing, and reporting adverse events in the human trials; at least 11 different procedures for reporting adverse events; highly flexible cutoffs for reporting harms (e.g. events with an incidence below 1.6%, 1%, 2% or 5% were not shown); calling adverse events new medical history, which concealed their intensity; many different intervals for reporting adverse events; only two weeks of follow-up (which resulted in a death being omitted from the serious adverse events in a summary table because it occurred outside this interval for reporting!); and unclear reporting periods because the language was unclear and inconsistent.

Merck’s study reports were consistently written in a way that downplayed the harms of its two vaccines. There were discrepancies in numbers and mathematical impossibilities, both in the reports, publications, and the package inserts. It was sometimes impossible to check if the numbers of patients randomised and analysed were correct because the data were scattered around in huge study reports and because the explanations were often unclear or contradictory.

As an example, my calculations for a large and hugely important trial that compared Gardasil with Gardasil 9 led to four different numbers of randomised people.

Even the number of deaths differed. In the Future 3 study, there were 8 vs 4 deaths in the US trial register, 7 vs 1 in the study report, and no deaths in the trial publication in The Lancet. Most of these deaths were not even listed in a table of discontinuations due to serious adverse events even though you cannot continue in a trial after you have died.

There were also extreme discrepancies between trials with the same design for adverse events.

Merck’s claim - in its study reports, consent forms, published trial reports, and package inserts - that the adjuvant is a placebo is false, also according to Merck’s own definition of what a placebo is. In its publications, Merck effectively concealed that its so-called placebo was the adjuvant.

Merck’s publications of its pivotal trials in major medical journals are so misleading that it is justified to call it scientific dishonesty.

In many cases, the harms disappeared. I have detailed knowledge about some Danish cases because I discussed them with the investigator, Tabassam Latif. At the Syncope Unit, a girl was diagnosed with POTS after having received the vaccine but when Tabassam attempted to report this to Merck, her report was rebuffed.

Tabassam saw three girls with POTS in this trial, two of whom had been hospitalised. This is by definition a serious adverse event that must be reported. The girls could not say exactly when the POTS symptoms started but it was long before the last two weeks of the obligatory recordings on the vaccination report card. Tabassam sent reports of the two serious adverse events to Merck, and Merck’s Danish monitor agreed this was appropriate.

But Merck USA became involved and they did not want to register them. As the symptoms appeared gradually, it was impossible for the girls to give an exact date for their onset, so Tabassam wrote a time interval instead of a date on the forms, which was a year or more before the patients were admitted to hospital.

Merck dismissed the reports and determined falsely that the starting date for the onset of symptoms was the date of hospitalisation, which fell outside the reporting period. I searched the study report and did not find these cases.

This was fraud. It is well known that, even though symptoms of POTS may appear early, it can take years before the diagnosis is objectively established by a tilt test.³⁶

In my book,¹³ I describe in detail how I was harassed by Merck’s lawyer, Emma C. Ross, who is also a medical doctor. It was stressful and the most absurd day in my entire life. Ross made some interesting scientific points, but she was highly arrogant, intimidating, unpleasant, condescending, and aggressive.

Ross interrupted me and my supporting lawyer, Bijan Esfandiari, on numerous occasions, particularly when she became annoyed that I didn’t fall into any of the many traps she had set up for me. She interrupted me 10 times with the question: “Are you finished?” when I explained what was wrong with her arguments.

Ross fired countless irrelevant and repetitive questions the whole day, many of which were designed to impugn my character and scientific credibility. The idea with this was that Merck would try to convince the judge in a so-called motion that I should be dismissed as an expert witness because I was untrustworthy. But Merck’s arguments were highly unprofessional¹³ and were dismissed by the judge.

What I was exposed to by Ross and subsequently by the Merck legal team was so hilarious and primitive that people who have read my book have said that this alone makes it worth reading. I have not seen such verbatim accounts of grilling an expert elsewhere.

In relation to EMA’s investigation in 2015, Merck argued that there were no background incidence rates for POTS in the scientific literature. Instead, they based their estimate on the background rate for chronic fatigue syndrome. This is like estimating bicycle accidents based on the number of car accidents.

In her expert report to the court, PhD Lucija Tomljenović provided a detailed account of these issues.¹³ She documented that Merck’s estimates of the background incidence of POTS were hugely exaggerated compared to estimates from institutions with an interest in such cases.

Conversely, Merck excluded all observed cases of POTS following Gardasil vaccination that did not meet all four diagnostic criteria for POTS, as well as those that were not reported by a healthcare professional. Several medical experts and the Danish Board of Health objected to this. As Louise Brinth observed, it is well known that an adverse event report will not include all the details of the clinical history and it is therefore rare that any spontaneous report will meet diagnostic criteria.

The former director of the WHO-affiliated Uppsala Monitoring Centre and the Danish Board of Health maintained that it is neither safe nor wise to completely disregard reports with limited information. However, EMA rejected a request from the Danish Board of Health for a sensitivity analysis that included both confirmed and unconfirmed cases of POTS, thereby violating their own Good Pharmacovigilance Practices (GVP) guidelines.

Lucija noted that Merck apparently failed to include in their analyses for EMA four medically confirmed POTS cases that were reported to Merck’s database. She also showed that the CRPS background incidence is several times lower than that reported in a study cherry-picked by Merck. Furthermore, Merck used much more stringent criteria when assessing reports in its database, which had the effect that only 7 of the 53 cases diagnosed by healthcare practitioners fulfilling the usual criteria were accepted by Merck.

When Merck included cases that partially met the narrow criteria, they found that the observed count was greater than the expected count, but disingenuously, they dismissed this finding by saying that it was not known if cases that partially meet the case definition criteria were actually CRPS. Well, sensitivity analyses do not assume that this is the case!

Doctor Rebecca Chandler, safety assessor for the initial signal assessments of CRPS and POTS for EMA, noted that the harms signals were best characterised as a potential association between HPV vaccination and dysfunction of the autonomic nervous system.²⁹ Louise

Brinth arrived at the same conclusion.³⁷

Chandler also noted that previous evaluations of the adverse events that focused on individual diagnoses likely excluded many clinically relevant case reports. Her cluster analysis of symptoms that occur together is unique and revealed that many reports of adverse events after HPV vaccination were of a serious and often incapacitating nature.²⁸

Lucija wrote in her expert report that Merck acknowledged in 2022 in its Gardasil 9 guide for proper vaccination in Japan that the various symptoms commonly reported following HPV

vaccination that comprise neurosensory, autonomic, motor and cognitive symptoms have been treated in clinical practice “under a variety of diagnostic names that may differ depending on clinical fields, pathological interpretations, and manifestation of chief symptoms.”¹³ Thus, Merck invalidated the analyses they submitted to EMA in 2015.

Lucija provided much more realistic estimates than Merck did in 2015, both for the background incidence of POTS and on the reporting rates for adverse events, based on the scientific literature.¹³ Using Merck’s methods, she found that, with most of her rather conservative assumptions, the observed number of POTS cases following Gardasil vaccination was much greater than the expected number, even though Merck had grossly underestimated the observed number.

Lucija’s work was very threatening for Merck, which tried to prevent her from testifying.

The settlement

The lawsuit, Robi v. Merck, BC628589, California Superior Court, County of Los Angeles, was filed in 2016. It was claimed that Merck failed to adequately warn patients and physicians about the risks of severe autoimmune disorders, specifically POTS.

Jennifer Robi, a former high school athlete, ended up in a wheelchair after she was vaccinated with Gardasil as a teenager 15 years ago.

She was correct about Merck’s failings. In June 2026, it was announced that Merck settled with her, and it was alleged that the settlement involved over 200 suits for over $50 million,³⁸ but the amount cannot be verified, as the conditions for the settlement are confidential.

Merck stated that the amount it would pay is “considerably less than Merck’s anticipated costs” in defending the cases.³⁸ There could be other reasons. Perhaps Merck realised that they would lose in the Supreme Court. Another advantage of settling is that the company avoids admitting any guilt and can continue touting their product’s “safety and efficacy,” which Merck did.³⁸

This is also what Eli Lilly did years ago. Antidepressants can cause violence and homicide,³⁹ and in 1989, a man shot 8 people dead, wounded another 12, and killed himself one month after starting fluoxetine.⁴⁰ Lilly claimed it was “proven in a court of law … that Prozac is safe and effective.” However, the trial judge suspected a secret deal had been struck and pursued Lilly and the plaintiffs, eventually forcing Lilly to admit that it had made a secret settlement with the plaintiffs during the trial.

Infuriated by Lilly’s actions, the judge said that “Lilly sought to buy not just the verdict but the court’s judgment as well.” Peter Breggin was an expert in support of the family, but his own attorney betrayed him and presented a weak case, as he knew about the secret

deal.⁴¹ After this deal, Breggin’s attorney sent back the revealing documents to Lilly where they disappeared against the law impeding other lawsuits.

This is how gangsters operate. Obstruction of justice and obstruction of law enforcement are two of the offences that constitute organised crime.²¹

Incriminating documents also disappeared at the FDA, and Lilly bought FDA panel members, too.²² Throughout the 1990s, while swearing publicly that fluoxetine didn’t increase the risk of suicide or violence, even though it clearly does,⁴² Lilly quietly settled lawsuits out of court and kept the incriminating evidence hidden by obtaining court orders to seal the documents.

According to Black’s Law Dictionary, fraud is any activity that relies on deception to achieve a gain, and Merck has committed fraud before. I described in my expert report that Merck’s fraud related to its arthritis drug, Vioxx, killed tens of thousands of patients because Merck concealed that it causes heart attacks.¹³ Merck’s lawyers found this information baseless and irrelevant and wanted the court to exclude it.

The information was not baseless but factual, and I find it “interesting” that Merck wanted to exclude it. If a man is suspected of sexual child abuse, it is not considered irrelevant if that person is a convicted sex offender.

Conclusions

Based on my extensive investigations, I have no doubt that HPV vaccines in rare cases can cause serious neurological harms that can be irreversible and incapacitating, and that Merck committed fraud by deliberately hiding these harms from public view, which fulfil the definition of organised crime.²¹ I also have no doubt that Merck’s aluminium adjuvant causes harm and that virtually all Merck’s so-called placebo-controlled trials were unethical because the “placebo” group was exposed to a harmful substance, Merck’s aluminium adjuvant, which the patients were not informed about.

Victims should receive economic compensation. Already in 2017, three girls in Denmark had received over one million crowns (about €135,000) each in compensation for nerve damages after the HPV vaccine from public sources, the Patient Compensation Fund.⁴³

References

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39 Gøtzsche PC. Antidepressants can cause homicide. Substack 2026;June 3.

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43 Rasmussen LI. Læger: HPV-programmet ligger i ruiner. Politiken