Case: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 1 of 91

IN THE UNITED STATES DISTRICT COURTFOR THE WESTERN DISTRICT OF WISCONSIN
Case No.

SAHARA WALKER,
Plaintiffs,

COMPLAINT FOR

vs.

JURY DEMANDMERCK & CO., INC., a New Jersey Corporation;and MERCK SHARP & DOHME CORP., a New
Jersey Corporation,
Defendants.

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TABLE OF CONTENTSINTRODUCTION .................................................................................................................................... 5
PARTIES AND VENUE .......................................................................................................................... 5
GENERAL ALLEGATIONS ................................................................................................................... 7
I. “History Doesn’t Repeat Itself, But It Often Rhymes” – Mark Twain ........................................ 7
II. In Bringing Its Holy Grail, Gardasil, to Market, Merck Engaged in the Same Fraudulent
Research and Marketing It Had Engaged in Vis-à-vis Vioxx Resulting In Patients Being
Exposed to a Vaccine That is Of Questionable Efficacy and Which Can Cause Serious andDebilitating Adverse Events ....................................................................................................... 10
A.

Overview of the Human Papillomavirus ........................................................................ 11

B.

Overview of the Gardasil Vaccine and Its Fast-Tracked Approval ............................... 13

C.

Merck Engaged in Disease Mongering and False Advertising to Enhance Gardasil Sales........................................................................................................................................ 17

D.

Merck Used Scare Tactics and Provided Financial Incentives to Legislatures to Attempt
to make the Gardasil Vaccine Mandatory for All School Children ............................... 20

E.

Merck Pushed Gardasil Using Trusted Doctors and Third-Party Front Groups ............ 22

F.

Merck Has Systematically Misrepresented the Efficacy of Gardasil By Advertising that
Gardasil Prevents Cervical Cancer When There Are No Clinical Studies to Support This
False Claim ..................................................................................................................... 22G.

The Gardasil Vaccines Contain Numerous Hazardous Ingredients, Including At Least
One Ingredient Merck Failed to Disclose to Regulators and the Public ........................ 26
i. Gardasil Contains A Toxic Aluminum Adjuvant ........................................................... 26
ii.

Merck Lied About a Secret DNA Adjuvant Contained in The Gardasil Vaccines .. 27iii.

Gardasil Contains Borax........................................................................................... 28

iv.

Gardasil Contains Polysorbate 80 ............................................................................ 29v.

Gardasil Contains Genetically Modified Yeast ........................................................ 29

H.

As it Did in Vioxx, In Designing and Conducting Its Clinical Trials for Gardasil, Merck
Concealed Risks to Falsely Enhance the Safety Profile of Gardasil .............................. 30
i. Small Clinical Trials ....................................................................................................... 32
ii.

Merck Used a Highly Toxic “Placebo” to Mask Gardasil Injuries .......................... 32
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iii.

Merck Used Exclusionary Criteria to Further Conceal Gardasil Risks .................... 34

iv.

Merck Deceived Regulators and The Public by Classifying Many Serious Adverse
Events, Which Afflicted Nearly Half of All Study Participants, As Coincidences . 35v.

Merck Manipulated the Study Protocols to Block Participants and Researchers from
Reporting Injuries and Designed the Studies to Mask Any Long-Term Adverse
Events ....................................................................................................................... 36vi.

Merck Deceived Regulators and the Public About Its Pivotal Gardasil Clinical Trial(Protocol 018) ........................................................................................................... 38

I.

Contrary to Merck’s Representations, Gardasil May Actually Cause and Increase theRisk of Cervical and Other Cancers ............................................................................... 40

J.

Merck has Concealed the Fact that Gardasil Induces and Increases the Risk ofAutoimmune Diseases, Including But Not Limited to, POTS, OI and Other AssociatedInjuries Such as Dysautonomia and Fibromyalgia ......................................................... 43

K.

Merck has Concealed the Fact that Gardasil Increases the Risk of Fertility Problems .. 49

L.

There were an Increase Number of Deaths in the Gardasil Studies ............................... 50

M.

Post-Marketing Injuries -- The Raft of Injuries Seen in Merck’s Clinical Trials Has
Now Become A Population-Wide Chronic Disease Epidemic ...................................... 51

N.

The Gardasil Vaccines’ Harms Are Not Limited to the United States, Rather the
Vaccines Have Injured Patients All Over the World...................................................... 53
i. In Light of Gardasil’s Serious and Debilitating Adverse Events, the Japanese
Government Rescinded Its Recommendation that Girls Receive Gardasil .............. 54

O.

ii.

Denmark Has Opened Specialized Clinics Specifically Focused on Treating
Gardasil-Induced Injuries, Including Gardasil-Induced Autoimmune Diseases ...... 55

iii.

Gardasil-Induced Adverse Events Caused the Government in Colombia to Conclude
that Gardasil Would No Longer Be Mandatory ....................................................... 56

iv.

India Halts Gardasil Trials and Accuses Merck of Corruption After the Death of
Several Young Girls Who were Participants in the Trial ......................................... 56
Merck’s Fraud Has Paid Off Handsomely Resulting in Over $3 Billion in Gardasil Sales
Annually ......................................................................................................................... 57

III. Sahara Walker Sustained Autoimmune Disease, Including Postural Orthostatic Tachycardia
Syndrome (“POTS”), Orthostatic Hypotension (“OH”), Neurocardiogenic Syncope (“NCS”),
Dysautonomia and Other Serious Injuries, Including but Not Limited to, Autonomic
Neuropathy, as A Result of Her Gardasil Injection .................................................................... 58

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A.

Gardasil and Its Ingredients Caused Walker’s Autoimmune Disease and Other Related
Injuries and Has Resulted in Her Suffering From Severe, Debilitating and Painful
Chronic Ailments............................................................................................................ 58

B.

“It is Not Revolutions and Upheavals That Clear the Road to New and Better Days, But
Revelations, Lavishness and Torments of Someone’s Soul, Inspired and Ablaze.” –Boris Pasternak, After the Storm .................................................................................... 62

CAUSES OF ACTION........................................................................................................................... 64
COUNT ONE NEGLIGENCE ............................................................................................... 64
COUNT TWO STRICT LIABILITY (FAILURE TO WARN)............................................. 71
COUNT THREE STRICT LIABILITY (MANUFACTURING DEFECT) .......................... 76
COUNT FOUR BREACH OF EXPRESS WARRANTY ..................................................... 79
COUNT FIVE COMMON LAW FRAUD ............................................................................ 83
PRAYER FOR RELIEF ......................................................................................................................... 90
DEMAND FOR JURY TRIAL .............................................................................................................. 91

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COMES NOW plaintiff, SAHARA WALKER, who by and through counsel Baum Hedlund
Aristei & Goldman, PC and Robert F. Kennedy, Jr., and alleges against defendants MERCK & CO.,INC., and MERCK, SHARP AND DOHME CORPORATION, and each of them, as follows:
INTRODUCTION
1.

This common-law products liability, negligence, strict liability, breach of warranty andfraud action arises out of serious and debilitating injuries, including but not limited to autonomic,
neurological and heterogenous autoimmune injuries and resulting sequalae that plaintiff, Sahara
Walker (“Walker”), sustained as a result of receiving the Gardasil vaccine, which was designed,
manufactured, labeled, and promoted by defendants Merck & Co., Inc., and Merck, Sharp and Dohme
Corporation (collectively “Merck”).
PARTIES AND VENUE
2.

Plaintiff, Sahara Walker, is an adult and a resident and citizen of Wisconsin.

3.

Defendant Merck & Co., Inc., is a New Jersey corporation with its principal place ofbusiness at One Merck Drive, Whitehouse Station, New Jersey.
4.

Defendant Merck, Sharp and Dohme Corporation, is a New Jersey corporation with its

principal place of business at One Merck Drive, Whitehouse Station, New Jersey.
5.

Defendants Merck & Co., Inc., and Merck, Sharp and Dohme Corporation shallhereinafter collectively be referred to as “Merck.”6.

At all times herein mentioned, each defendant was the agent, servant, partner, aider andabettor, co-conspirator and/or joint venturer of the other defendants named herein and was at all times
operating and acting within the purpose and scope of said agency, service, employment, partnership,conspiracy and/or joint venture and rendered substantial assistance and encouragement to the otherdefendants, knowing that their collective conduct constituted a breach of duty owed to Walker.
7.

At all times herein mentioned, defendants were fully informed of the actions of their

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agents and employees, and thereafter no officer, director or managing agent of defendants repudiatedthose actions, which failure to repudiate constituted adoption and approval of said actions and all
defendants and each of them, thereby ratified those actions.
8.

There exists and, at all times herein mentioned there existed, a unity of interest inownership between the named defendants, such that any individuality and separateness between the
defendants has ceased and these defendants are the alter-ego of each other and exerted control overeach other. Adherence to the fiction of the separate existence of these two named defendants asentities distinct from each other will permit an abuse of the corporate privilege and would sanction afraud and/or would promote injustice.
9.

At all times herein mentioned, the two Merck defendants were engaged in the businessof, or were successors in interest to, entities engaged in the business of researching, designing,
formulating, compounding, testing, manufacturing, producing, processing, assembling, inspecting,
distributing, marketing, labeling, promoting, packaging, prescribing and/or advertising for sale, andselling products for use by patients such as Walker, her parents and her medical providers. As such,the two Merck defendants are each individually, as well as jointly and severally, liable to Walker forher damages.
10.

The harm caused to Walker resulted from the conduct of one or various combinations of

the two Merck defendants, and through no fault of Walker. There may be uncertainty as to which one
or which combination of the two Merck defendants caused the harm. The two Merck defendants havesuperior knowledge and information on the subject of which one or which combination of the two
defendants caused Walker’s injuries. Thus, the burden of proof should be upon each of the two
Merck defendants to prove that the defendant has not caused the harms Walker has suffered. As
previously stated, the two named Merck defendants shall hereinafter and throughout this Complaint
be collectively referred to as “Merck.”

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11.

Merck is the designer, manufacturer, labeler and promoter of the Gardasil and Gardasil-

9 vaccines, which are purported to be “cervical cancer vaccines” by preventing a handful of thehundreds of strains of the Human Papillomavirus (“HPV”). Merck regularly conducts and transacts
business in Wisconsin and has promoted Gardasil to consumers, patients, hospitals, physicians, nurses
and medical professionals, including but not limited to Walker, her parents and the medical facility
and medical professionals who prescribed and/or injected Walker with Gardasil. This Court has
personal jurisdiction over Merck because defendants have sufficient minimum contacts with
Wisconsin to render the exercise of jurisdiction by this Court proper.
12.

This Court has subject matter jurisdiction over the parties pursuant to 28 U.S.C.

§1332(a) because Walker and the defendants are citizens of different states and the amount ofcontroversy exceeds $75,000.00, exclusive of interest and costs.
13.

Venue is proper in this Court pursuant to 28 U.S.C. §1391 because a substantial portionof the events and omissions giving rise to the claims asserted herein occurred in this District.
GENERAL ALLEGATIONSI.

“History Doesn’t Repeat Itself, But It Often Rhymes” – Mark Twain

14.

Merck traces its history back to 1668, when the original founder of the company,

Friedrich Jacob Merck, bought an apothecary in Darmstadt, Germany. The company operated as apharmacy for the next 150+ years when, in 1827, Friedrich’s descendant, Heinrich Emmanuel Merck,
converted the company into a drug manufacturing facility. Merck’s first products included morphineand cocaine.
15.

Merck later manufactured a number of controversial products including Fosamax (apurported bone density drug that caused bone fractures), Nuvaring (a birth control device associatedwith life-threatening blood clots and death), and probably its most infamous drug, Vioxx (a pain

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medication Merck was forced to pull from the market due to its cardiovascular risks), all of which
landed Merck in litigation hot water.
16.

With regard to Vioxx, Merck was sued by tens of thousands of patients who alleged

they suffered heart attacks and other cardiovascular injuries as a result of ingesting the blockbuster
pain medication.
17.

Documents unsealed during the Vioxx litigation during the early 2000s revealed aculture wherein Merck knew early on Vioxx was linked to fatal cardiovascular adverse events but
intentionally chose to conceal these risks from the public and medical community and, instead,orchestrated a scheme to downplay the severity of the risks. Merck misrepresented the results of its
clinical trials, failed to undertake the clinical trials that would reveal risks, and blacklisted medical
professionals who dared to publicly criticize the safety of Vioxx. See e.g., Eric J. Topol, Failing the
Public Health – Rofecoxib, Merck, and the FDA, 351 NEW ENGLAND JOURNAL OF MEDICINE 1707
(2004); Gregory D. Curfman et al., Expression of Concern Reaffirmed, 354 NEW ENGLAND JOURNAL
OF MEDICINE 1193 (2006); Aaron S. Kesselheim et al., Role of Litigation in Defining Drug Risks, 17

JAMA 308 (2007); Harlan M. Krumholz et al., What We Have Learnt From Vioxx, 334 BRITISH MED.
J. 120 (2007).
18.

The British Medical Journal reported that internal documents and communications

obtained from Merck during litigation revealed that Merck scientists internally acknowledged theexistence of Vioxx’s risks very early on: “Since the early development of [Vioxx], some scientists at
Merck were concerned that the drug might adversely affect the cardiovascular system … In internal
emails made public through litigation, Merck officials sought to soften the academic authors’interpretation [of the data]. The academic authors changed the manuscript at Merck’s request [to makeless of the apparent risk] …” Harlan M. Krumholz et al., What We Have Learnt From Vioxx, 334

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BRITISH MED. J. 120 (2007). And, despite Merck’s knowledge of the risk, Merck never conducted thenecessary studies designed to evaluate cardiovascular risk. Id.
19.

In an article published in the Journal of the American Medical Association, it wasreported that Merck worked to “diminish the impact of reported cardiovascular adverse effects by not
publishing adverse events and failing to include complete data on myocardial infarctions that occurred
during a key clinical trial. The information came to the public attention through a subpoena 5 years
after the article’s publication, when [Vioxx] was already off the market.” Aaron S. Kesselheim et al.,Role of Litigation in Defining Drug Risks, 17 JAMA 308 (2007). The article concludes: “These casestudies indicate that clinical trials and routine regulatory oversight as currently practiced often fail to
uncover important adverse effects for widely marketed products. In each instance, the litigation
process revealed new data on the incidence of adverse events, enabled reassessment of drug risks
through better evaluation of data, and influenced corporate and regulatory behavior.” Id.
20.

It was also revealed and reported that, in order to control the public narrative that Vioxx

was safe and risk free, “Merck issued a relentless series of publications…complemented by numerous
papers in peer-reviewed medical literature by Merck employees and their consultants. The company
sponsored countless continuing medical ‘education’ symposiums at national meetings in an effort todebunk the concern about adverse cardiovascular effects.” Eric J. Topol, Failing the Public Health –Rofecoxib, Merck, and the FDA, 351 NEW ENGLAND JOURNAL OF MEDICINE 1707 (2004). In addition,
Merck “selectively targeted doctors who raised questions about [Vioxx], going so far as pressuringsome of them through department chairs.” Harlan M. Krumholz et al., What We Have Learnt From
Vioxx, 334 BRITISH MED. J. 120 (2007). Dr. Topol, Chairman of the Department of Cardiovascular
Medicine at the Cleveland Clinic, commented: “Sadly, it is clear to me that Merck’s commercial
interest in [Vioxx] sales exceeded its concern about the drug’s potential cardiovascular toxicity.” Eric

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J. Topol, Failing the Public Health – Rofecoxib, Merck, and the FDA, 351 NEW ENGLAND JOURNAL OF
MEDICINE 1707 (2004).
21.

Once Merck’s misdeeds vis-à-vis Vioxx were revealed in various jury trials, Merck paid

nearly $5 billion to settle the tens of thousands of personal injury actions that had been brought against
it as a result of its concealment of Vioxx’s cardiovascular risks. Merck paid an additional $1 billion tosettle a securities class action brought by investors who had lost money when Merck’s stock tanked
following revelations of the drug’s risks and subsequent lost sales. Merck was also forced to pay $950
million in civil and criminal fines to the Department of Justice and other governmental entities as aresult of various criminal activities Merck had engaged in with respect to Vioxx.
22.

In 2005, Merck pulled Vioxx from the market and was desperate to find a replacement

for its previous multi-billion-dollar blockbuster.
23.

Merck viewed Gardasil as the answer to the financial woes it had suffered from Vioxx.

Within Merck, executives joked that HPV stood for “Help Pay for Vioxx.”
24.

In the aftermath of the Vioxx scandal, and seeking a replacement product, Merck’s

senior director of clinical research, Eliav Barr, M.D., proclaimed of Gardasil: “This is it. This is theHoly Grail!”II.

In Bringing Its Holy Grail, Gardasil, to Market, Merck Engaged in the Same
Fraudulent Research and Marketing It Had Engaged in Vis-à-vis Vioxx Resulting
In Patients Being Exposed to a Vaccine That is Of Questionable Efficacy andWhich Can Cause Serious and Debilitating Adverse Events

25.

As outlined herein, in researching, developing, and marketing its new Holy Grail,

Gardasil, Merck engaged in the same unscrupulous tactics it had so infamously engaged in with Vioxx.
26.

Certain Merck employees, scientists and executives involved in the Vioxx scandal werealso involved with Gardasil, and it appears they employed the very same methods of manipulating
science and obscuring risks as they did with Vioxx.

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27.

According to Merck’s marketing claims, Gardasil (and, later, next-generation Gardasil

9) provided lifetime immunity to cervical and other HPV-associated cancers.
28.

As discussed more fully below, whether Gardasil prevents cancer (not to mention

lifetime immunity), is unproven. In fact, it may be more likely to cause cancer in those previously
exposed to HPV than to prevent it.
29.

Moreover, Merck knows and actively conceals the fact that Gardasil can cause aconstellation of serious adverse reactions and gruesome diseases, including autoimmune diseases, anddeaths in some recipients.
30.

As a result of Merck’s fraud, Gardasil today is wreaking havoc on a substantial swath ofan entire generation of children and young adults on a worldwide scale.
A. Overview of the Human Papillomavirus
31.

Human Papillomavirus (“HPV”) is a viral infection that is passed between people

through skin-to-skin contact. There are more than 200 strains of HPV, and of those, more than 40
strains can be passed through sexual contact.
32.

HPV is the most common sexually transmitted disease. It is so common that the

majority of sexually active people will get it at some point in their lives, even if they have few sexual
partners.
33.

HPV, for the most part, is benign. More than 90% of HPV infections cause no clinicalsymptoms, are self-limited, are removed from the human body by its own immunological mechanisms

and disappear naturally from the body following an infection. See, e.g., Antonio C. de Freitas et al.,Susceptibility to cervical cancer: An Overview, 126 GYNOCOLOGIC ONCOLOGY 306 (August 2012).
34.

Approximately 12 to 18 of the over 200 strains of HPV are believed to be associatedwith cervical cancer.
35.

Not every HPV infection puts one at risk for cervical cancer. Only persistent HPV

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infections – not short-term or transient infections or sequential infections with different HPV types – ina limited number of cases with certain strains of the virus may cause the development of precancerous
lesions. These precancerous lesions are typically diagnosed through Pap smears and then removed
through medical procedures. However, when undiagnosed, they may in some cases progress tocervical cancer in some women. Other risk factors, such as smoking, are also associated with cervicalcancer. See Antonio C. de Freitas et al., Susceptibility to cervical cancer: An Overview, 126
GYNOCOLOGIC ONCOLOGY 305 (August 2012). Infection with certain types of HPV are also associatedwith other diseases, such as genital warts.
36.

Public health officials have long recommended the Pap test (also known as Pap Smear),which detects abnormalities in cervical tissue, as the most effective frontline public health response to
the disease.
37.

Since its introduction, cervical cancer screening through the Pap test has reduced therates of cervical cancer in developed countries by up to 80%. Id.
38.

Incidences of cervical cancer have been declining dramatically worldwide as countries

have implemented Pap screening programs.
39.

New cases of cervical cancer in the U.S. affect approximately 0.8% of women in their

lifetime. https://seer.cancer.gov/statfacts/html/cervix.html. For those who are diagnosed, cervicalcancer is largely treatable, with a five-year survival rate of over 90% when the cancer is caught early.
See Antonio C. de Freitas et al., Susceptibility to cervical cancer: An Overview, 126 GYNOCOLOGICONCOLOGY 305 (August 2012)40.

Although the incidence of cervical cancer was in rapid decline as a result of theimplementation of routine testing and screening, including the Pap test and various DNA testing,Merck sought to fast-track a vaccine onto the market to prevent infection from four types of HPV (only
two of which are associated with cancer).

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B. Overview of the Gardasil Vaccine and Its Fast-Tracked Approval
41.

While there are over 200 types of the HPV virus, only 12-18 currently are consideredpotentially associated with cervical cancer. Merck’s original Gardasil vaccine claimed to prevent
infections from four strains (HPV Strain Types 6, 11, 16 and 18) and only two of those (Types 16 and18) were associated with cervical cancer.
42.

Under Food and Drug Administration (“FDA”) requirements, to obtain approval formarketing a vaccine, the manufacturer must conduct studies to test the effectiveness and safety of thevaccine. Once FDA approval is obtained, the manufacturer has a duty to perform further scientific andmedical investigation as those of a reasonably prudent manufacturer and to engage in any necessary
post-marketing pharmacovigilance related to the product.
43.

The FDA approved Gardasil on June 08, 2006, after granting Merck fast-track status

and speeding the approval process to a six-month period, leaving unanswered material questions
relating to its effectiveness and safety as well as when and to whom the Gardasil vaccine ought to beadministered.
44.

Merck failed, during the preapproval processing period and thereafter, to disclose to the

FDA and/or the public, material facts and information relating to the effectiveness and safety of
Gardasil, as well as to whom the vaccine should or should not be administered.
45.

Merck failed to perform in the preapproval processing period and thereafter scientificand medical investigations and studies relating to the safety, effectiveness and need for the Gardasil
vaccine as either required by and under FDA directives and regulations and/or those to which a prudent
manufacturer should have conducted unilaterally.
46.

In June 2006, after the FDA’s fast-tracked review, Gardasil was approved for use infemales ages 9 through 26 for the purported prevention of cervical cancer and, almost immediately
thereafter, the Advisory Committee on Immunization Practices (“ACIP”), a committee within the

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Centers for Disease Control (“CDC”), recommended Gardasil for routine vaccination of adolescent
girls ages 11 and 12 years old, but also allowing it to be administered to girls as young as 9 years old.
47.

Subsequently, Merck sought approval for Gardasil 9 (containing the same ingredients as

Gardasil, but in higher quantities) which purportedly guarded against five additional HPV strains
currently associated with cervical cancer (HPV Types 31, 33, 45, 52 and 58) than the original Gardasil,
for a total of nine strains.
48.

The FDA approved Gardasil 9 in December 2014 for use in girls ages 9 through 26 andboys ages 9 through 15 for the purported prevention of cervical, vaginal, and anal cancers. Presently,
Gardasil 9 has been approved for and is being promoted by Merck to males and females who are
between 9 and 45 years of age, with an emphasis by Merck on marketing to pre-teen children and theirparents. With little evidence of efficacy, FDA also recently approved, on an accelerated basis,
Gardasil 9 for prevention of oropharyngeal and other head and neck cancers.
49.

After the approval of the Gardasil 9 vaccine, the original Gardasil vaccine was phasedout of the US Market and the original Gardasil vaccine is no longer available for sale in the UnitedStates.
50.

According to data from the National Cancer Institute’s (“NCI”) Surveillance,

Epidemiology and End Results Program (“SEER”), the incidence of deaths from cervical cancer prior
to Gardasil’s introduction in the United States had been steadily declining for years and, in 2006, was
2.4 per 100,000 women or approximately 1 in every 42,000 women. The currently available rate is

essentially unchanged, 2.2 per 100,000 women, based on data through 2017.
51.

The median age of death from cervical cancer is 58, and teenage girls essentially havezero risk of dying from cervical cancer.
52.

Merck purchased fast-track review for Gardasil and Gardasil 9 under the Prescription

Drug User Fee Act (PDUFA). Fast-track is a process designed to facilitate the development, and

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expedite the review of, drugs to treat serious conditions and fill an unmet medical need.
53.

Anxious to get Gardasil onto the market as soon as possible following the Vioxx

debacle, Merck sought fast-track approval even though there already existed a highly effective andside-effect free intervention, Pap smears, with no evidence that Gardasil was potentially superior to
Pap smears in preventing cervical cancer.
54.

In fact, the clinical trials Merck undertook did not even examine Gardasil’s potential toprevent cancer, rather, the trials only analyzed whether Gardasil could prevent potential precursor
conditions, i.e., HPV infections and cervical interepithelial neoplasia (CIN) lesions graded from CIN1
(least serious) to CIN3 (most serious), the vast majority of which resolve on their own without
intervention. CIN2 and CIN3 were the primary surrogate endpoints studied.
55.

According to the FDA, whether a condition is “serious” depends on such factors as“survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progressfrom a less severe condition to a more serious one.”56.

As previously discussed, over 90% of HPV infections and the majority of cervical

dysplasia resolve without intervention.
57.

However, Merck presented misleading data to the FDA suggesting that CIN2 and CIN3

inexorably result in cancer.
58.

Federal law allows fast-track approval when there is no existing intervention to treat thetargeted disease or where the proposed treatment is potentially superior to an existing treatment.
59.

Merck knows (and knew) that Gardasil and Gardasil 9 are far less effective than Pap

tests in preventing cervical cancer.
60.

In order to obtain FDA approval, Merck designed and conducted a series of fraudulent

Gardasil studies and then influenced the votes of the FDA’s Vaccines and Related Biological Products
Advisory Committee (“VRBPAC”) and the CDC’s Advisory Committee on Immunization Practices

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61.

That ACIP “recommendation” was, effectively, a mandate to doctors to sell Merck’s

very expensive vaccine and compelling parents of American children as young as nine years old to buy
this expensive product. With ACIP’s recommendation, Merck was emboldened to build demandthrough direct-to-consumer advertising and door-to-door marketing to doctors, and, with the ACIP’s
blessing of the vaccine, circumvented the need to create a traditional market for the product.
62.

Julie Gerberding, then the Director of CDC, obligingly ushered the Gardasil vaccine

through CDC’s regulatory process manifestly ignoring clear evidence that Gardasil’s efficacy was
unproven and that the vaccine was potentially dangerous.
63.

Merck, shortly thereafter, rewarded Gerberding by naming her President of Merck

Vaccines in 2010.
64.

In addition to the revolving regulatory/industry door, wherein the Director of CDC who

approved the vaccine is subsequently employed by the manufacturer as a high-level executive tooversee the commercial success of the vaccine she previously approved, it is also worth noting some ofthe other conflicts of interest that exist within governmental agencies and with respect to theiremployees. Scientists from the National Institute of Health (NIH), which is a division of the UnitedStates Department of Health and Human Services (HHS), discovered a method of producing “viruslike-particles” (VLPs) that made creation of the Gardasil vaccine possible. The NIH scientists’ methodof producing VLPs was patented by the Office of Technology Transfer (OTT), which is part of theNIH, and the licensing rights were sold to Merck (for manufacture of Gardasil). Not only does the
NIH (and, in effect, the HHS) receive royalties from sales of Gardasil, but the scientists whose names
appear on the vaccine patents can receive up to $150,000 per year (in perpetuity). Accordingly, theGardasil patents have earned HHS, NIH and the scientists who invented the technology millions of

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dollars in revenue.
65.

Moreover, members of the CDC’s Advisory Committee on Immunization Practices(ACIP) have been allowed to vote on vaccine recommendations even if they have financial ties to drug
companies developing similar vaccines. According to a 2000 U.S. House of Representatives
investigation report, the majority of the CDC’s eight ACIP committee members had conflicts ofinterest. The Chairman of ACIP served on Merck’s Immunization Advisory Board and a number ofthe other ACIP members had received grants, salaries, or other forms of remuneration from Merck.
C. Merck Engaged in Disease Mongering and False Advertising to Enhance
Gardasil Sales
66.

Both prior to and after the approval of Gardasil, Merck engaged in unscrupulous

marketing tactics designed to overemphasize both the risks associated with HPV and the purported
efficacy of Gardasil to scare the public into agreeing to mass vaccinations of the Gardasil vaccine.
67.

Prior to Merck’s aggressive marketing campaign, there was no HPV public healthemergency in high-resource countries, such as the United States.
68.

Most women had never heard of HPV. The NCI’s 2005 Health Information National

Trends Survey (HINTS) found that, among U.S. women 18 to 75 years old, only forty percent had
heard of HPV. Among those who had heard of HPV, less than half knew of an association between
HPV and cervical cancer. Furthermore, only four percent knew that the vast majority of HPV
infections resolve without treatment.
69.

The stage was set for Merck to “educate” the public about HPV, cervical cancer, andGardasil, all to Merck’s advantage.
70.

Merck preceded its rollout of Gardasil with years of expensive disease awarenessmarketing. Merck ran “Tell Someone” commercials, designed to strike fear in people about HPV andcervical cancer – even ominously warning that you could have HPV and not know it. The
commercials could not mention Gardasil, which had not yet been approved by FDA, but did include
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Merck’s logo and name. Critics of Merck’s pre-approval advertising and promotion called it“deceptive and dishonest.” While Merck claims the promotion was part of public health education,
critics complained that this “education” was designed to sell Gardasil and build the market for thevaccine. See Angela Zimm and Justin Blum, Merck Promotes Cervical Cancer Shot by Publicizing
Viral Cause, BLOOMBERG NEWS, May 26, 2006.
71.

A year before obtaining licensing for its vaccine, Merck engaged in a major offensive in“disease branding” to create a market for its vaccine out of thin air. See Beth Herskovits, Brand of theYear, PHARMEXEC.COM, February 1, 2007. http://www.pharmexec.com/brand-year-0
72.

Merck also engaged in a relentless propaganda campaign aimed at frightening andguilting parents who failed to inoculate their children with Gardasil.
73.

In addition to paid advertising, Merck worked with third parties to “seed” an obliging

media with terrifying stories about cervical cancer in preparation for Merck’s Gardasil launch.
74.

Prior to the FDA’s 2006 approval of Gardasil, the mainstream media – under directionof Merck and its agents – dutifully reported alarming cervical cancer stories, accompanied by thepromotion of an auspicious vaccine.
75.

Merck intended its campaign to create fear and panic and a public consensus that “goodmothers vaccinate” their daughters with Gardasil. According to Merck propagandists, the only choice
was to “get the vaccine immediately” or “risk cervical cancer.”76.

Merck aggressively and fraudulently concealed the risks of the vaccine in broadcast

materials and in propaganda that it disseminated in the United States.
77.

Merck sold and falsely promoted Gardasil knowing that, if consumers were fully

informed about Gardasil’s risks and dubious benefits, almost no one would have chosen to vaccinate.
78.

Merck negligently and fraudulently deprived parents and children of their right toinformed consent.

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79.

One of Merck’s television campaigns, conducted in 2016, shamelessly used child actors

and actresses, implicitly dying of cancer, looking straight into the camera and asking their parents
whether or not they knew that the HPV vaccine could have protected them against the HPV virus thatcaused them to develop their cancers. Each actor asked the following question: “Did you know?
Mom? Dad?” See “Mom, Dad, did you know?” commercial: https://www.ispot.tv/ad/Ap1V/know-hpvhpv-vaccination. Merck spent $41 million over two months on the campaign. The ads said nothing
about potential side effects. Merck also distributed pamphlets via U.S. mail to doctors ahead of thead’s release to encourage them to share it with their patients:

80.

Merck’s fraudulent message was that cervical cancer was a real-life killer of young

women, notwithstanding the fact that the average age for development of cervical cancer is 50 years

old and, for cervical cancer, it is virtually nonexistent in women under age 20.
81.

Other television marketing campaigns Merck launched (including advertising that

Walker’s mother saw and relied upon in advance of consenting to her daughter’s Gardasil injection)falsely proclaimed that Gardasil was a “cervical cancer vaccine” and that any young girl vaccinatedwith Gardasil would become “one less” woman with cervical cancer. The “One Less” marketing
campaign portrayed Gardasil as if there was no question as to the vaccine’s efficacy in preventing
cervical cancer, and it disclosed none of Gardasil’s side effects.
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82.

Merck marketed Gardasil with the most aggressive campaign ever mounted to promote

any vaccine, spending more on Gardasil advertising than for any vaccine in history.
D. Merck Used Scare Tactics and Provided Financial Incentives to Legislatures toAttempt to make the Gardasil Vaccine Mandatory for All School Children
83.

An ACIP recommendation of a vaccine, adopted by individual states, opens the door to

mandates affecting as many as four million children annually.
84.

With Gardasil costing $360 for the original three-dose series (exclusive of the necessary

doctor’s visits) and Gardasil 9 now priced at $450 for two doses (again, not including the cost of
doctors’ visits), Merck stood to earn billions of dollars per year, in the US alone, with little marketingcosts.
85.

Prior to Gardasil’s approval in 2006, Merck was already targeting political figures to aid

in the passage of mandatory vaccination laws.
86.

As early as 2004, a group called Women in Government (“WIG”) started receiving

funding from Merck and other drug manufacturers who had a financial interest in the vaccine.
87.

With the help of WIG, Merck aggressively lobbied legislators to mandate Gardasil to all

sixth-grade girls. See Michelle Mello et al., Pharmaceutical Companies’ Role in State Vaccination
Policymaking: The Case of Human Papillomavirus Vaccination, 102 AMERICAN J PUBLIC HEALTH 893(May 2012).
88.

In 2006, Democratic Assembly leader Sally Lieber of California introduced a bill thatwould require all girls entering sixth grade to receive the Gardasil vaccination. Lieber later dropped
the bill after it was revealed there was a possible financial conflict of interest.
89.

Prior to the introduction of the bill, Lieber met with WIG representatives. In aninterview, the President of WIG, Susan Crosby, confirmed that WIG funders have direct access to statelegislators, in part through the organization’s Legislative Business Roundtable, of which WIG funders

20
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are a part. See Judith Siers-Poisson, The Gardasil Sell Job, in CENSORED 2009: THE TOP 25 CENSOREDSTORIES OF 2007-08, 246 (Peter Philips ed. 2011).
90.

Dr. Diane Harper, a medical doctor and scientist who was hired as a principal

investigator on clinical trials for Gardasil gave an interview for an article on the HPV vaccines and
WIG in 2007. Harper, who had been a major presenter at a WIG meeting in 2005, stated that “theMerck representative to WIG was strongly supporting the concept of mandates later in the WIG
meetings and providing verbiage on which the legislators could base their proposals.”
91.

WIG was one of dozens of “pay to play” lobby groups that Merck mobilized to push

HPV vaccine mandates.
92.

Another group, the National Association of County and City Health Officials(NACCHO), was also pushing HPV vaccine mandates in all 50 states.
93.

To that end, Merck made large contributions to political campaigns and legislative

organizations. By February 2007, 24 states and the District of Colombia had introduced mandate
legislation.
94.

Several states passed laws allowing preteen children as young as age 12 to “consent” tovaccination with an HPV vaccine without parental consent or knowledge.
95.

One New York state county offered children free headphones and speakers to encouragethem to consent to the Gardasil vaccine. See Mary Holland et al., THE HPV VACCINE ON TRIAL:
SEEKING JUSTICE FOR A GENERATION BETRAYED 131 (2018).
96.

Merck funneled almost $92 million to Maryland’s Department of Health between 2012

and 2018 to promote Gardasil in Maryland schools, in a fraudulent campaign that paid school officials
to deliberately deceive children and parents into believing Gardasil was mandatary for school
attendance. Josh Mazer, Maryland should be upfront about HPV vaccinations for children, CAPITAL

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GAZETTE, August 14, 2018, at https://www.capitalgazette.com/opinion/columns/ac-ce-column-mazer20180814-story.html.
E. Merck Pushed Gardasil Using Trusted Doctors and Third-Party Front Groups
97.

In order to mobilize “third-party credibility” to push Gardasil, Merck gave massive

donations to dozens of nonprofit groups to “educate” the public via “education grants.” For example, adisclaimer on American College of Obstetricians and Gynecologists’ Immunization for Women
website stated that “[t]his website is supported by an independent educational grant from Merck andSanofi Pasteur US.”98.

Merck offered influential doctors (also known as “key opinion leaders”) $4,500 for

every Gardasil lecture they gave.
99.

Among the allegedly independent organizations Merck recruited to push Gardasil were

the Immunization Coalition, the Allegheny County Board of Health, the Eye and Ear Foundation, theJewish Healthcare Foundation, the American Dental Association, the American College ofObstetricians and Gynecologists, and the American Cancer Society.
F. Merck Has Systematically Misrepresented the Efficacy of Gardasil By
Advertising that Gardasil Prevents Cervical Cancer When There Are No
Clinical Studies to Support This False Claim
100.

Merck faced a daunting problem in convincing regulators, doctors, and the public toaccept the Gardasil vaccine.
101.

Merck recommends the vaccine for girls aged 11-12 years old, to provide protection

against a disease that, in the United States, is not generally diagnosed until a median age of 50, and, in
those rare instances of death, the median age is 58.
102.

There are no studies proving that Gardasil prevents cancer.

103.

Because it can take decades for a persistent HPV infection to proceed to development ofcervical cancer, and because cervical cancer is so rare, a true efficacy study would require decades and
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likely hundreds of thousand – if not millions – of trial participants to demonstrate that eliminating
certain HPV infections would actually prevent the development of cervical cancer.
104.

Merck did not want to invest the time or money necessary to perform testing that would

prove that its vaccine actually worked to prevent cervical cancer.
105.

Instead, Merck persuaded regulators to allow it to use “surrogate endpoints” to support

its theory that the HPV vaccines would be effective in preventing cervical cancer.
106.

The clinical trials therefore did not test whether HPV vaccines prevent cervical or othercancers. Instead, Merck tested the vaccines against development of certain cervical lesions, whichsome researchers suspect are precursors to cancer, although the majority of these lesions – even themost serious – regress on their own. See, e.g., Jin Yingji et al., Use of Autoantibodies Against TumorAssociated Antigens as Serum Biomarkers for Primary Screening of Cervical Cancer, 8 ONCOTARGET
105425 (Dec. 1, 2017); Philip Castle et al., Impact of Improved Classification on the Association of
Human Papillomavirus With Cervical Precancer, 171 AMERICAN JOURNAL OF EPIDEMIOLOGY 161(Dec. 10, 2009); Karoliina Tainio et al., Clinical Course of Untreated Cervical Intraepithelial
Neoplasia Grade 2 Under Active Surveillance: Systematic Review and Meta-Analysis, 360 BRIT. MED.
J. k499 (Jan. 16, 2018).
107.

The Department of Health and Human Services (HHS), which oversees the FDA andwhich also stood to make millions of dollars on the vaccine from patent royalties, allowed the use of
Merck’s proposed surrogate endpoints.
108.

The surrogate endpoints chosen by Merck to test the efficacy of its HPV vaccine werecervical intraepithelial neoplasia (CIN) grades 2 and 3 and adenocarcinoma in situ.
109.

Merck used these surrogate endpoints even though it knew that these precursor lesions

are common in young women under 25 and rarely progress to cancer.
110.

At the time FDA approved the vaccine, Merck’s research showed only that Gardasil

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prevented certain lesions (the vast majority of which would have resolved on their own without
intervention) and genital warts – not cancer itself, and only for a few years.
111.

The use of these surrogate endpoints allowed Merck to shorten the clinical trials to afew years and gain regulatory approvals of the vaccines without any evidence the vaccines would
prevent cancer in the long run.
112.

Merck’s own lawyers told its marketing department that it was illegal for the company

to market the vaccine as preventing cervical cancer, and that the company could only claim that
Gardasil suppressed colonization by certain HPV types.
113.

Merck’s marketers ignored this advice.

114.

Merck’s advertisements assert that the HPV vaccine prevents cervical cancer. For

example, in a presentation to medical doctors, Merck proclaimed: “Every year that increases incoverage [of the vaccine] are delayed, another 4,400 women will go on to develop cervical cancer.”
The presentation goes on to tell doctors that women who do not get the vaccine will go on to develop
cancer.
115.

Merck’s foundational theory that HPV alone causes cervical cancer, while dogmaticallyasserted, is not proven.
116.

Research indicates that cervical cancer is a multi-factor disease with persistent HPV

infections seeming to play a role, along with many other environmental and genetic factors, including
smoking cigarettes or exposure to other toxic smoke sources, long-term use of oral contraceptives,
nutritional deficiencies, multiple births (especially beginning at an early age), obesity, inflammation,and other factors. Not all cervical cancer is associated with HPV types in the vaccines and not all
cervical cancer is associated with HPV at all.
117.

Despite the lack of proof, Merck claimed that Gardasil could eliminate cervical cancer

and other HPV-associated cancers.

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118.

However, Merck knows that the Gardasil vaccines cannot eliminate all cervical cancer

or any other cancer that may be associated with HPV.
119.

Even assuming the Gardasil vaccine is effective in preventing infection from the four tonine vaccine-targeted HPV types, the results may be short term, not guaranteed, and ignore the 200 or
more other types of HPV not targeted by the vaccine, and some of which already have been associatedwith cancer.
120.

Even assuming these vaccine-targets are the types solely responsible for 100% ofcervical cancer – which they are not – the vaccines have not been followed long enough to prove that
Gardasil protects girls from cancers that would strike them forty years later.
121.

Under Merck’s hypothetical theory, the reduction of pre-cancerous lesions should

translate to fewer cases of cervical cancer in thirty to forty years.
122.

Cervical cancer takes decades to develop and there are no studies that prove the

Gardasil vaccines prevent cancer.
123.

In January 2020, a study from the UK raised doubts about the validity of the clinical

trials in determining the vaccine’s potential to prevent cervical cancer. The analysis, carried out by
researchers at Newcastle University and Queen Mary University of London, revealed manymethodological problems in the design of the Phase 2 and 3 trials, leading to uncertainty regarding
understanding the effectiveness of HPV vaccination. See Claire Rees et al., Will HPV Vaccine Prevent
Cancer? J. OF THE ROYAL SOC. OF MED. 1-15 (2020).
124.

As Dr. Tom Jefferson of the Centre for Evidence-Based Medicine pointed out: “Thereason for choosing vaccination against HPV was to prevent cancer but there’s no clinical evidence toprove it will do that.”125.

Gardasil has never been proven to prevent cervical or any other kind of cancer.

126.

Yet Merck has marketed the Gardasil vaccines as if there is no question they are

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preventative against cervical cancer. In reality, they are at best protective against only four to nine ofthe over 200 strains of the human papillomavirus.
G. The Gardasil Vaccines Contain Numerous Hazardous Ingredients, Including
At Least One Ingredient Merck Failed to Disclose to Regulators and the Publici.
127.

Gardasil Contains A Toxic Aluminum Adjuvant

To stimulate an enhanced immune response that allegedly might possibly last for 50

years, Merck added to the Gardasil vaccine a particularly toxic aluminum-containing adjuvant –Amorphous Aluminum Hydroxyphosphate Sulfate (“AAHS”).
128.

Aluminum is a potent neurotoxin that can result in very serious harm.

129.

The original Gardasil vaccine contains 225 micrograms of AAHS and Gardasil 9

contains 500 micrograms of AAHS.
130.

Federal law requires that manufacturers cannot add adjuvants to vaccines that have notbeen proven safe. 21 C.F.R. § 610.15(a).
131.

AAHS has never been proven safe. AAHS is a recent proprietary blend of aluminumand other unknown ingredients developed by Merck and used in Merck vaccines, including Gardasil.
Prior vaccines have used a different aluminum formulation.
132.

Peer-reviewed studies show that aluminum binds to non-vaccine proteins, including thehost’s own proteins, or to latent viruses, triggering autoimmune and other serious conditions. See Darja
Kanduc, Peptide Cross-reactivity: The Original Sin of Vaccines, 4 FRONTIERS IN BIOSCIENCE 1393
(June 2012).
133.

Aluminum, including AAHS, has been linked to scores of systemic side effects

including, but not limited to: impairing cognitive and motor function; inducing autoimmune
interactions; increasing blood brain barrier permeability; inducing macrophagic myofascitis in muscle;
blocking neuronal signaling; interrupting cell-to-cell communications; corrupting neuronal-glial
interactions; interfering with synaptic transmissions; altering enzyme function; impairing protein
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function; and it is associated with development of abnormal tau proteins and it alters DNA.
ii.
134.

Merck Lied About a Secret DNA Adjuvant Contained in The
Gardasil Vaccines

Merck has repeatedly concealed or incorrectly identified Gardasil ingredients to the

FDA and the public.
135.

Merck lied both to the FDA and the public about including a secret and potentiallyhazardous ingredient, HPV LI-DNA fragments, in Gardasil. These DNA fragments could act as a
Toll-Like Receptor 9 (TLR9) agonist – further adjuvanting the vaccine and making it more potent.
Merck used this hidden adjuvant to prolong the immunological effects of the vaccine, but illegallyomitted it from its list of substances and ingredients in the vaccine.
136.

Dr. Sin Hang Lee has opined that, without adding the TLR9 agonist, Gardasil would not

be immunogenic. The DNA fragments bound to the AAHS nanoparticles act as the TLR9 agonist in
both Gardasil and Gardasil 9 vaccines, creating the strongest immune-boosting adjuvant in use in any
vaccine.
137.

On multiple occasions, Merck falsely represented to the FDA and others, including

regulators in other countries, that the Gardasil vaccine did not contain viral DNA, ignoring the DNA
fragments.
138.

This DNA adjuvant is not approved by the FDA and Merck does not list it among theingredients as federal law requires. See 21 C.F.R. § 610.61(o) (requiring that adjuvants be listed on
biologics’ labeling). Even if not an adjuvant, the DNA fragments should have been listed because they
represent a safety issue. 21 C.F.R. §610.61(n).
139.

It is unlawful for vaccine manufacturers to use an experimental and undisclosed

adjuvant.
140.

When independent scientists found DNA fragments in every Gardasil vial tested, from

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all over the world, Merck at first denied, and then finally admitted, the vaccine does indeed include
HPV L1-DNA fragments.
141.

Tellingly, Merck entered into a business arrangement with Idera Pharmaceuticals in2006 to explore DNA adjuvants to further develop and commercialize Idera’s toll-like receptors in
Merck’s vaccine program.
142.

To this day, the Gardasil package inserts do not disclose that DNA fragments remain in

the vaccine.
143.

Dr. Lee also found HPV DNA fragments from the Gardasil vaccine in post-mortem

spleen and blood samples taken from a young girl who died following the vaccine. See Sin Hang Lee,
Detection of Human Papillomavirus L1 Gene DNA Fragments in Postmortem Blood and Spleen After
Gardasil Vaccination—A Case Report, 3 ADVANCES IN BIOSCIENCE AND BIOTECHNOLOGY 1214
(December 2018)
144.

Those fragments appear to have played a role in the teenager’s death.

145.

The scientific literature suggests there are grave and little-understood risks attendant toinjecting DNA into the human body.
iii.
146.

Gardasil Contains Borax

Gardasil contains sodium borate (borax). Borax is a toxic chemical and may have long-term toxic effects.
147.

Merck has performed no studies to determine the impact of injecting borax into millionsof young children or adults.
148.

Sodium borate is known to have adverse effects on male reproductive systems in rats,

mice, and dogs. Furthermore, borax causes increased fetal deaths, decreased fetal weight, andincreased fetal malformations in rats, mice, and rabbits.
149.

The European Chemical Agency requires a “DANGER!” warning on borax and states

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that borax “may damage fertility or the unborn child.”150.

The Material Safety Data Sheet (MSDS) for sodium borate states that sodium borate“[m]ay cause adverse reproductive effects” in humans.
151.

The FDA has banned borax as a food additive in the United States, and yet allows

Merck to use it in the Gardasil vaccine without any proof of safety.
iv.

Gardasil Contains Polysorbate 80

152.

Gardasil contains Polysorbate 80.

153.

Polysorbate 80 crosses the blood-brain barrier.

154.

Polysorbate 80 is used in drugs to open up the blood brain barrier in order to allow theactive ingredients in a drug to reach the brain and to elicit the intended response. It acts as anemulsifier for molecules like AAHS and aluminum enabling those molecules to pass through resistive
cell membranes.
155.

Polysorbate 80 is associated with many health injuries, including, anaphylaxis,

infertility and cardiac arrest.
156.

Polysorbate 80 was implicated as a cause, possibly with other components, ofanaphylaxis in Gardasil recipients in a study in Australia. See Julia Brotherton et al., Anaphylaxis
Following Quadrivalent Human Papillomavirus Vaccination, 179 CANADIAN MEDICAL ASSOC. J. 525(September 9, 2008). Merck never tested polysorbate 80 for safety in vaccines.
v.

Gardasil Contains Genetically Modified Yeast

157.

Gardasil contains genetically modified yeast.

158.

Studies have linked yeast with autoimmune conditions. See, e.g., Maurizo Rinaldi etal., Anti-Saccharomyces Cerevisiae Autoantibodies in Autoimmune Diseases: from Bread Baking toAutoimmunity, 45 CLINICAL REVIEWS IN ALLERGY AND IMMUNOLOGY 152 (October 2013).
159.

Study participants with yeast allergies were excluded from Gardasil clinical trials.

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160.

Merck has performed no studies to determine the safety of injecting yeast into millionsof children and young adults.
H. As it Did in Vioxx, In Designing and Conducting Its Clinical Trials for
Gardasil, Merck Concealed Risks to Falsely Enhance the Safety Profile of
Gardasil161.

Merck engaged in wholesale fraud during its safety and efficacy clinical studies.

162.

In order to obtain its Gardasil license, Merck designed its studies purposefully toconceal adverse events and exaggerate efficacy.
163.

Merck sold Gardasil to the public falsely claiming that pre-licensing safety tests proved

it to be effective and safe.
164.

In fact, Merck’s own pre-licensing studies showed Gardasil to be of doubtful efficacy

and dangerous.
165.

The dishonesty in the clinical tests has led many physicians to recommend thevaccination, under false assumptions.
166.

The clinical trials clearly demonstrated that the risks of both Gardasil and Gardasil 9

vastly outweigh any proven or theoretical benefits.
167.

Merck deliberately designed the Gardasil protocols to conceal evidence of chronic

conditions such as autoimmune diseases, menstrual cycle problems and death associated with thevaccine during the clinical studies.
168.

Merck employed deceptive means to cover up injuries study group participants suffered.

169.

In early 2018, Lars Jørgensen, M.D., Ph.D. and Professor Peter Gøtzsche, M.D. (thenwith the Nordic Cochrane Centre), and Professor Tom Jefferson, M.D. of the Centre for EvidenceBased Medicine published a study indexing all known industry and non-industry HPV vaccine clinical
trials and were disturbed to find that regulators such as the FDA and EMA (European Medicines
Agency) assessed as little as half of all available clinical trial results when approving the HPV30
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vaccines. Lars Jørgensen et al., Index of the Human Papillomavirus (HPV) Vaccine Industry ClinicalStudy Programmers and Non-Industry Funded Studies: a Necessary Basis to Address Reporting Biasin a Systematic Review, 7 SYSTEMATIC REVIEWS (January 18, 2018).
170.

Per the indexing study discussed above, Merck appears to have kept a number of its

clinical trial results secret. Moreover, it appears that Merck reported only those findings that support
its own agenda.
171.

Three separate reviews of the Gardasil vaccine by the Cochrane Collaboration foundthat the trial data were “largely inadequate.”
172.

According to Dr. Tom Jefferson, “HPV [vaccine] harms have not been properly

studied.”173.

In 2019, numerous medical professionals published an article in the British Medical

Journal outlining the flaws and incomplete nature of the publications discussing Merck’s Gardasil
clinical trials. The authors issued a “call to action” for independent researchers to reanalyze or “restore
the reporting of multiple trials in Merck’s clinical development program for quadrivalent humanpapillomavirus (HPV) vaccine (Gardasil) vaccine.” Peter Doshi et al., Call to Action: RIAT
Restoration of Previously Unpublished Methodology in Gardasil Vaccine Trials, 346 BRIT. MED. J.
2865 (2019). The authors explained that the highly influential publications of these studies, which
formed the basis of Gardasil’s FDA approval, “incompletely reported important methodological details
and inaccurately describe the formulation that the control arm received, necessitating correction of therecord.” Id. The authors explained that, while the publications claimed the clinical trials of Gardasil
were “placebo-controlled,” “participants in the control arm of these trials did not receive an inert
substance, such as saline injection. Instead, they received an injection containing[AAHS], a proprietary adjuvant system that is used in Gardasil to boost immune response.” Id.
174.

The researchers further opined that “the choice of AAHS-containing controls

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complicates the interpretation of efficacy and safety results in trials … We consider the omission injournal articles, of any rationale for the selection of AAHS-containing control, to be a form ofincomplete reporting (of important methodological details), and believe the rationale must be reported.
We also consider that use of the term ‘placebo’ to describe an active comparator like AAHS
inaccurately describes the formulation that the control arm received, and constitutes an important errorthat requires correction.” Id.
175.

The authors pointed out that Merck’s conduct “raises ethical questions about trial

conduct as well” and that they and other scientists would need to review the Gardasil clinical trial raw
data, in order to be able to analyze the safety and adverse event profile of Gardasil meaningfully andindependently. Id.
i.
176.

Small Clinical Trials

Although 9 to 12-year-olds are the primary target population for HPV vaccines, Merck

used only a small percentage of this age group in the clinical trials. Protocol 018 was the only protocolcomparing children receiving a vaccine to those who did not. In that study, Merck looked at results offewer than 1,000 children 12 and younger for a vaccine targeting billions of boys and girls in that age
group over time. In Protocol 018, 364 girls and 332 boys (696 children) were in the vaccine cohort
while 199 girls and 173 boys (372 children) received a non-aluminum control.
177.

The small size of this trial means that it was incapable of ascertaining all injuries that

could occur as a result of the vaccine.
ii.
178.

Merck Used a Highly Toxic “Placebo” to Mask Gardasil Injuries

Instead of comparing health outcomes among volunteers in the Gardasil study group to

health outcomes among volunteers receiving an inert placebo, Merck purposefully used a highly toxic
placebo as a control in order to conceal Gardasil’s risks in all trials using comparators with the
exception of Protocol 018, where only 372 children received a non-saline placebo containing

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everything in the vaccine except the adjuvant and antigen.
179.

Comparing a new product against an inactive placebo provides an accurate picture of

the product’s effects, both good and bad. The World Health Organization (WHO) recognizes thatusing a toxic comparator as a control (as Merck did here) creates a “methodological disadvantage.”
WHO states that “it may be difficult or impossible to assess the safety” of a vaccine when there is notrue placebo.
180.

Merck deliberately used toxic “placebos” in the control group, in order to mask harms

caused by Gardasil to the study group.
181.

Instead of testing Gardasil against a control with a true inert placebo, Merck tested its

vaccine in almost all clinical trials against its highly neurotoxic aluminum adjuvant, AAHS.
182.

Merck gave neurotoxic aluminum injections to approximately 10,000 girls and young

women participating in Gardasil trials, to conceal the dangers of Gardasil vaccines.
183.

Merck never safety tested AAHS before injecting it into thousands of girls and young

women in the control groups and the girls and young women were not told they could receive an
aluminum “placebo.” Merck told the girls that they would receive either the vaccine or a safe inert
placebo.
184.

Merck violated rules and procedures governing clinical trials when it lied to the clinicalstudy volunteers, telling them that the placebo was an inert saline solution – when in reality theplacebo contained the highly neurotoxic aluminum adjuvant AAHS.
185.

AAHS provoked terrible injuries and deaths in a number of the study participants when

Merck illegally dosed the control group volunteers with AAHS.
186.

Since the injuries in the Gardasil group were replicated in the AAHS control group, thisscheme allowed Merck to falsely conclude that Gardasil’s safety profile was comparable to the“placebo.”

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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 34 of 91

187.

The scheme worked and enabled Merck to secure FDA licensing.

188.

Merck lied to FDA when it told public health officials that it had used a saline placebo

in Protocol 018.
189.

There was no legitimate public health rationale for Merck’s failure to use a true saline

placebo control in the original Gardasil clinical trials. At that time, no other vaccine was yet licensed
for the four HPV strains Gardasil was intended to prevent.
190.

A small handful of girls in a subsequent Gardasil 9 trial group, may have received thesaline placebo, but only after they had already received three doses of Gardasil for the Gardasil 9 trial.
iii.
191.

Merck Used Exclusionary Criteria to Further Conceal Gardasil
Risks

Merck also manipulated the Gardasil studies by excluding nearly half of the original

recruits to avoid revealing the effects of the vaccine on vulnerable populations.
192.

After recruiting thousands of volunteers to its study, Merck excluded all women who

had admitted to vulnerabilities that might be aggravated by the vaccine such as abnormal Pap tests or
women with a history of immunological or nervous system disorders.
193.

Women could also be excluded for “[a]ny condition which in the opinion of theinvestigator might interfere with the evaluation of the study objectives.”
194.

Merck’s protocol had exclusion criteria for subjects with allergies to vaccine ingredients

including aluminum (AAHS), yeast, and the select enzymes. For most of these ingredients, there arelimited resources for the public to test for such allergies in advance of being vaccinated.
195.

Merck excluded anyone with serious medical conditions from the Gardasil clinical

trials, even though CDC recommends the Gardasil vaccine for everyone, regardless of whether or notthey suffer from a serious medical condition.
196.

Merck sought to exclude from the study all subjects who might be part of any subgroupthat would suffer injuries or adverse reactions to any of Gardasil’s ingredients.
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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 35 of 91

197.

The study exclusion criteria are not listed as warnings on the package inserts and the

package insert for Gardasil only mentions an allergy to yeast or to a previous dose of Gardasil as acontraindication, rather than an allergy to any other component. Nonetheless, for most of theingredients, it is almost impossible to determine if such an allergy exists prior to being vaccinated andMerck does not recommend allergy testing before administering the vaccine.
198.

Instead of testing the vaccine on a population representative of the cross-section ofhumans who would receive the approved vaccine, Merck selected robust, super-healthy trial
participants, who did not reflect the general population, in order to mask injurious effects on all thevulnerable subgroups that now receive the vaccine. Therefore, the population tested in the clinical
trials was a much less vulnerable population than the population now receiving Gardasil.
iv.

199.

Merck Deceived Regulators and The Public by Classifying Many
Serious Adverse Events, Which Afflicted Nearly Half of All Study
Participants, As Coincidences

Because Merck did not use a true placebo, determining which injuries were attributable

to the vaccine and which were attributable to unfortunate coincidence was entirely within thediscretion of Merck’s paid researchers.
200.

In order to cover up and conceal injuries from its experimental vaccine, Merck, during

the Gardasil trials, employed a metric, “new medical conditions,” that allowed the company to dismissand fraudulently conceal infections, reproductive disorders, neurological symptoms, and autoimmune
conditions, which affected a troubling 50% of all clinical trial participants.
201.

Merck’s researchers systematically dismissed reports of serious adverse events from

49% of trial participants in order to mask the dangers of the vaccine.
202.

Instead of reporting these injuries as “adverse events,” Merck dismissed practically allof these illnesses and injuries as unrelated to the vaccine by classifying them under its trashcan metric“new medical conditions” – a scheme Merck could get away with only because it used a “spiked”

35
COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 36 of 91(poisonous) placebo, that was yielding injuries at comparable rates.
203.

Merck’s use of a toxic placebo allowed the company to conceal from the public an

epidemic of autoimmune diseases and other injuries and deaths associated with its multi-billion-dollar
HPV vaccine.
204.

Because Merck conducted its studies without a true placebo, Merck investigators had

wide discretion to decide what constituted an adverse event and used that power to dismiss a wave ofgrave vaccine injuries, that sickened half of the trial volunteers, as coincidental.
205.

Almost half (49%) of all trial participants, regardless of whether they received thevaccine or Merck’s toxic placebo, reported adverse events, including serious illnesses such as blood,
lymphatic, cardiac, gastrointestinal, immune, musculoskeletal, reproductive, neurological andpsychological conditions, chronic illnesses such as thyroiditis, arthritis and multiple sclerosis, andconditions requiring surgeries. See, e.g., Nancy B. Miller, Clinical Review of Biologics License
Application for Human Papillomavirus 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae)(STN 125126 GARDASIL), manufactured by Merck, Inc. at 393-94 (Table 302) (June 8, 2006).
v.

Merck Manipulated the Study Protocols to Block Participants andResearchers from Reporting Injuries and Designed the Studies to
Mask Any Long-Term Adverse Events

206.

Merck adopted multiple strategies to discourage test subjects from reporting injuries.

207.

Merck provided Vaccination Report Cards to a limited number of trial participants. For

example, in Protocol 015, only approximately 10% of participants – all in the United States, despite

trial sites worldwide – received Vaccination Report Cards to memorialize reactions in the first few
days following injections.
208.

Furthermore, the report cards only included categories of “Approved Injuries” mainly

jab site reactions (burning, itching, redness, bruising) leaving no room to report more serious
unexplained injuries such as autoimmune diseases. In fact, they were designed for the purposes of

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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 37 of 91

reporting non-serious reactions only.
209.

Furthermore, Merck instructed those participants to record information for only 14 days

following the injection.
210.

In this way, Merck foreclosed reporting injuries with longer incubation periods ordelayed diagnostic horizons.
211.

Abbreviated reporting periods were part of Merck’s deliberate scheme to conceal

chronic conditions such as autoimmune or menstrual cycle problems, and premature ovarian failure, allof which have been widely associated with the vaccine, but would be unlikely to show up in the first
14 days following injection.
212.

Merck researchers did not systematically collect adverse event data, from the trials,

which were spread out over hundreds of test sites all over the world.
213.

To conceal the dangerous side effects of its vaccine, Merck purposely did not follow up

with girls who experienced serious adverse events during the Gardasil clinical trials.
214.

Merck failed to provide the trial subjects a standardized questionnaire checklist of

symptoms, to document a comparison of pre- and post-inoculation symptoms.
215.

To discourage its clinicians from reporting adverse events, Merck made the paperwork

reporting requirements for supervising clinicians, onerous and time-consuming, and refused to pay
investigators additional compensation for filling out the paperwork.
216.

Thus, Merck disincentivized researchers from reviewing participants’ medical records

even when the participant developed a “serious medical condition that meets the criteria for serious
adverse experiences” as described in the protocol.
217.

Merck granted extraordinary discretion to its researchers to determine what constituted

a reportable adverse event, while incentivizing them to report nothing and to dismiss all injuries as
unrelated to the vaccine.

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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 38 of 91

218.

Merck used subpar, subjective data collection methods, relying on participants’recollections and the biased viewpoints of its trial investigators.
219.

Merck downplayed the incidence of serious injuries and used statistical gimmickry tounder-report entries.
vi.
220.

Merck Deceived Regulators and the Public About Its Pivotal
Gardasil Clinical Trial (Protocol 018)

Merck tested Gardasil and Gardasil 9 in some 50 clinical trials, each one called a“Protocol.” However, results for many of these studies are not available to the public or even to theregulators licensing Gardasil. See Lars Jørgensen, et al., Index of the Human Papillomavirus (HPV)
Vaccine Industry Clinical Study Programmers and Non-Industry Funded Studies: a Necessary Basis to
Address Reporting Bias in a Systematic Review, 7 SYSTEMATIC REVIEWS 8 (January 18, 2018).
221.

Gardasil’s most important clinical trial was Protocol 018. The FDA considered

Protocol 018 the pivotal trial upon which Gardasil licensing approvals hinged, because FDA believed1) it was the only trial where Merck used a “true saline placebo,” and 2) it was the only trial with acomparator group that included girls aged 11-12 – the target age for the Gardasil vaccine. See
Transcript of FDA Center For Biologics Evaluation And Research VRBPAC Meeting, May 18, 2006,
at 93 (Dr. Nancy Miller).
222.

Merck lied to regulators, to the public and to subjects in its clinical trials by claimingthat the Protocol 018 “placebo” group received an actual saline or inert placebo.
223.

When the FDA approved Gardasil, it described the Protocol 018 control as a “truesaline placebo.”
224.

The FDA declared that the Protocol 018 trial was “of particular interest” because Merck

used a true saline placebo instead of the adjuvant as a control.
225.

Merck told regulators that it gave a “saline placebo” to only one small group of

approximately 600 nine to fifteen-year-old children.
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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 39 of 91

226.

In fact, Merck did not give even this modest control group a true saline placebo, butrather, they were given a shot containing “the carrier solution” – a witch’s brew of toxic substances
including polysorbate 80, sodium borate (borax), genetically modified yeast, L-histidine, and possiblya fragmented DNA adjuvant.
227.

The only components of Gardasil the control group did not receive were the HPV

antigens and the aluminum adjuvant.
228.

Despite the witches’ brew of toxic chemicals in the carrier solution, those children faredmuch better than any other study or control group participants, all of whom received the AAHS
aluminum adjuvant.
229.

Only 29% of the vaccinated children and 31% of control recipients in Protocol 018

reported new illnesses from Day 1 through Month 12, compared to an alarming 49.6% of thosevaccinated and 49% of AAHS controls in the “pooled group” (composed of some 10,000 young
women and with the other participants combined) from Day 1 only through Month 7 (not 12). Because
the pooled group also included Protocol 018, even those numbers may not be accurate with respect tothose who received either a vaccine with a full dose of AAHS or who received an AAHS control.
230.

Few of the girls in the Protocol 018 control group got systemic autoimmune diseases,

compared to 2.3% (1 in every 43) in the pooled group. In a follow-up clinical review in 2008, the
FDA identified three girls in the carrier-solution group with autoimmune disease. Based on thenumber of girls in the placebo group as stated in the original 2006 clinical review, fewer than 1% ofgirls in the carrier solution group reported autoimmune disease.
231.

In order to further deceive the public and regulators, upon information and belief,

Merck cut the dose of aluminum adjuvant in half when it administered the vaccine to the nine tofifteen-year-old children in its Protocol 018 study group.
232.

As a result, this group showed significantly lower “new medical conditions” compared

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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 40 of 91

to other protocols.
233.

Upon information and belief, Merck pretended that the vaccinated children in the

Protocol 018 study group received the full dose adjuvant by obfuscating the change in formulation in
the description.
234.

Upon information and belief, Merck had cut the adjuvant in half, knowing that thiswould artificially and fraudulently lower the number of adverse events and create the illusion that thevaccine was safe.
235.

Upon information and belief, Merck lied about this fact to the FDA.

236.

The data from that study therefore do not support the safety of the Gardasil formulation

since Merck was not testing Gardasil but a far less toxic formulation.
237.

Upon information and belief, Merck was testing a product with only half the dose of

Gardasil’s most toxic component.
238.

Upon information and belief, this is blatant scientific fraud, which continues to this day

because this is the study upon which current vaccine safety and long-term efficacy assurances are
based.
239.

As set forth above, upon information and belief, Merck’s deception served its purpose:

Only 29% of the vaccinated children in Protocol 018 reported new illness, compared to an alarming
49.6% in the pooled group to receive the full dose adjuvant in the vaccine.
I. Contrary to Merck’s Representations, Gardasil May Actually Cause andIncrease the Risk of Cervical and Other Cancers
240.

Gardasil’s label states, “Gardasil has not been evaluated for potential to cause

carcinogenicity or genotoxicity.” The Gardasil 9 label states: “GARDASIL9 has not been evaluatedfor the potential to cause carcinogenicity, genotoxicity or impairment of male fertility.
241.

Peer-reviewed studies, including CDC’s own studies, have suggested that the

suppression of the HPV strains targeted by the Gardasil vaccine may actually open the ecological niche
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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 41 of 91

for replacement by more virulent strains. See Fangjian Guo et al., Comparison of HPV prevalence
between HPV-vaccinated and non-vaccinated young adult women (20–26 years), 11 HUMANVACCINES & IMMUNOTHERAPEUTICS 2337 (October 2015); Sonja Fischer et al., Shift in prevalence of
HPV types in cervical cytology specimens in the era of HPV vaccinations, 12 ONCOLOGY LETTERS 601(2016); J. Lyons-Weiler, Biased Cochrane Report Ignores Flaws in HPV Vaccine Studies, and Studies
of HPV Type Replacement, (May 18, 2018). In other words, Gardasil may increase the chances ofgetting cancer.
242.

In short, the Gardasil vaccines, which Merck markets as anti-cancer products, maythemselves cause cancer or mutagenetic changes that can lead to cancer.
243.

Merck concealed from the public data from its clinical trials indicating that the vaccines

enhance the risk of cervical cancers in many women.
244.

Merck’s study showed that women exposed to HPV before being vaccinated were

44.6% more likely to develop cancerous lesions compared to unvaccinated women, even within a few
years of receiving the vaccine.
245.

In other words, Merck’s studies suggest that its HPV vaccines may cause cancer inwomen who have previously been exposed to HPV, particularly if they also have a current infection.
246.

In some studies, more than 30% of girls show evidence of exposure to HPV before ageten, from casual exposures, unwashed hands or in the birth canal. Flora Bacopoulou et al., Genital
HPV in Children and Adolescents: Does Sexual Activity Make a Difference?, 29 JOURNAL OF
PEDIATRIC & ADOLESCENT GYNECOLOGY 228 (June 2016).
247.

Even in light of the data demonstrating that Gardasil can increase the risk of cancer ingirls who previously have been exposed to HPV, in order to increase profits, Merck’s Gardasil labelsand promotional material do not inform patients and medical doctors of this important risk factor.
248.

Some clinical trial participants have developed cancer, including cervical cancer.

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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 42 of 91

249.

Numerous women have reported a sudden appearance of exceptionally aggressive

cervical cancers following vaccination.
250.

Cervical cancer rates are climbing rapidly in all the countries where Gardasil has a high251.

An Alabama study shows that the counties with the highest Gardasil uptakes also had

uptake.

the highest cervical cancer rates.
252.

After the introduction of HPV Vaccine in Britain, cervical cancer rates among young

women aged 25 to 29 has risen 54%.
253.

In Australia, government data reveals there has been a sharp increase in cervical cancer

rates in young women following the implementation of the Gardasil vaccine. The most recent data
reveal that, 13 years after Gardasil was released and pushed upon teenagers and young adults, there has
been a 16% increase in 25-29 year-olds and a 30% increase in 30-34 year-old girls contracting cervicalcancer – corroborating the clinical trial data that Gardasil may increase the risk of cervical cancer,
particularly in patients who had previous HPV infections. Meanwhile, rates are decreasing for older
women (who have not been vaccinated).
254.

In addition to the belief that Gardasil may create and open an ecological niche forreplacement by more virulent strains of HPV, resulting in the increase of cervical cancers as outlined
above, in light of Merck’s false advertising that Gardasil prevents cervical cancer, young women who
have received Gardasil are foregoing regular screening and Pap tests in the mistaken belief that HPV
vaccines have eliminated all their risks.
255.

Cervical screening is proven to reduce the cases of cervical cancer, and girls who havetaken the vaccine are less likely to undergo cervical screenings.
256.

Data show that girls who received HPV vaccines before turning 21 are far less likely to

get cervical cancer screening than those who receive the vaccines after turning 21.

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257.

The cervical screening is more cost effective than vaccination alone or vaccination withscreening.
258.

Therefore, Pap tests, which detect cervical tissue abnormalities, and HPV DNA testing

are the most effective frontline public health response to cervical health.
J. Merck has Concealed the Fact that Gardasil Induces and Increases the Risk ofAutoimmune Diseases, Including But Not Limited to, POTS, OI and Other
Associated Injuries Such as Dysautonomia and Fibromyalgia
259.

Gardasil induces and increases the risk of autoimmune disease.

260.

Gardasil has been linked to a myriad of autoimmune disorders, including but notlimited, to: Guillain–Barré syndrome (GBS), postural orthostatic tachycardia syndrome (POTS),
Orthostatic Intolerance (OI), Orthostatic Hypotension (OH), chronic inflammatory demyelinating
polyneuropathy (CDIP), small fiber neuropathy (SNF), systemic lupus erythematosus (SLE), immune
thrombocytopenic purpura (ITP), multiple sclerosis (MS), acute disseminated encephalomyelitis(ADEM), antiphospholipid syndrome (APS), transverse myelitis, rheumatoid arthritis, interconnective
tissue disorder, autoimmune pancreatitis (AIP) and autoimmune hepatitis.
261.

Gardasil has also been linked to a myriad of diseases and symptoms that are associatedwith induced-autoimmune disease, including for example, fibromyalgia, dysautonomia, premature
ovarian failure, chronic fatigue syndrome, chronic regional pain syndrome, cognitive dysfunction,
migraines, severe headaches, persistent gastrointestinal discomfort, widespread pain of a neuropathic
character, encephalitis syndrome, autonomic dysfunction, joint pain, brain fog and fibromyalgia.
262.

In a 2015 textbook, VACCINES AND AUTOIMMUNITY, edited by Dr. Yehuda Shoenfeld,

the father of autoimmunology research, and many of the world’s leading autoimmunity experts, thescientists concluded that Gardasil can cause autoimmune disorders because of the vaccines’ strong
immune stimulating ingredients. See Lucija Tomljenovic & Christopher A. Shaw, Adverse Reactions
to Human Papillomavirus Vaccines, VACCINES & AUTOIMMUNITY 163 (Yehuda Shoenfeld et al. eds.,

43
COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 44 of 912015).
263.

Medical experts have opined that the mixture of adjuvants contained in vaccines, inparticular in the Gardasil vaccines, is responsible for post-vaccination induced autoimmune diseases inselect patients. The risks have become so prolific that medical experts have coined a new umbrella
syndrome – Autoimmune/Inflammatory Syndrome Induced by Adjuvants (“ASIA”) to refer to thespectrum of immune-mediated diseases triggered by an adjuvant stimulus contained in vaccines, suchas aluminum. See e.g., YEHUDA SHOENFELD ET AL, EDS., VACCINES & AUTOIMMUNITY 2 (2015)
264.

Indeed, even in animal studies, it has been revealed that aluminum adjuvants can induce

autoimmune disease in tested animals. As way of example, in a series of studies conducted by Lluís
Luján, DVM, Ph.D., and his colleagues, it was revealed that sheep injected with aluminum-containing
adjuvants commonly come down with severe autoimmune diseases and other adverse reactions.
265.

Specific to the Gardasil vaccines, which contain adjuvants, including, amorphousaluminum hydroxyphosphate sulfate (AAHS) and the previously undisclosed HPV L1 gene DNA
fragments, a number of mechanisms of action have been outlined (as discussed infra) as to how
Gardasil induces autoimmune disease in select patients.
266.

Given the number of HPV strains that exist, a great part of the human population has

HPV, however, HPV by itself is not immunogenic, and does not evoke immune responses. Indeed,
HPV shares a high number of peptide sequences with human proteins, so that the human immune
system does not react against HPV in order to not harm self-proteins. Immunotolerance thus blocks
reactions against HPV in order to avoid autoimmune attacks against the human proteins.
267.

To induce anti-HPV immune reactions, Merck added various adjuvants, including

amorphous aluminum hydroxyphosphate sulfate (AAHS), to the Gardasil vaccine. Adjuvants, such asaluminum, are inflammatory substances that hyperactivate the immune system. Adjuvants are thus the“secret sauce” used by Merck to hyperactivate the immune system and make HPV immunogenic.

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268.

While adjuvants are added with the intent of destroying the HPV virus, they also canhave the unintended result of rendering the immune system “blind” and unable to distinguish humanproteins from HPV proteins – accordingly, human proteins that share peptide sequences with HPV areat risk of also being attacked by the vaccine.
269.

While Gardasil causes immune hyperactivation and production of anti-HPV antibodies

to fend off certain strains of the HPV virus, it can also result in the immune system losing its ability todifferentiate human proteins from foreign proteins causing the immune system to attack the body’s
own proteins and organs. Because of the massive peptide commonality between HPV and humanproteins, the indiscriminate attack triggered by the Gardasil adjuvants will cause massive crossreactions and dangerous attacks against human proteins, leading to a number of autoimmune diseases
manifested throughout the different organs of the body – this process is sometimes referred to as“molecular mimicry.”270.

In addition to “molecular mimicry,” other mechanisms of action that explain how

Gardasil can induce autoimmune disease are “epitope spreading,” whereby invading Gardasil antigens,including the toxic aluminum adjuvant, accelerate autoimmune process by location activation of
antigen presenting cells and “bystander activation” wherein antigens and the aluminum adjuvants in
the Gardasil vaccine activate pre-primed autoreactive T cells, which can initiate autoimmune disease(bystander activation of autoreactive immune T cells), or where virus-specific T cells initiate bystander
activation resulting in the immune system killing uninfected and unintended neighboring cells.
271.

Relevant to the injuries at issue in this case, when a person is lying down,

approximately one-quarter of their blood volume resides in the chest area. When the person stands up,a significant amount of that blood shifts to the lower extremities. This causes impaired return of bloodflow to the heart which also reduces blood pressure. In healthy individuals, the autonomic nervous
system adjusts the heartrate to counteract this effect and the hemodynamic changes are negligible.

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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 46 of 91

However, in individuals (such as Walker) who are now suffering from dysautonomia or autonomic
ailments, such as POTS or OI, the body’s ability to adjust the heartrate and compensate for the bloodflow is corrupted resulting in a host of wide ranging symptoms, including but not limited to, dizziness,lightheadedness, vertigo, woozy sensation, chronic headaches, vision issues due to the loss of bloodflow to the brain, light and sound sensitivity, loss of consciousness, shortness of breath, chest pain,
gastrointestinal issues, body pains, insomnia, confusion and/or difficulty sleeping. In certain cases ofPOTS, patients will also be diagnosed with other medical conditions, including but not limited to,chronic fatigue syndrome and fibromyalgia.
272.

Medical research has determined that certain dysautonomia diseases such as POTS andOI have an autoimmune etiology. Norepinephrine, a key neurotransmitter of the sympathetic (“fight offlight”) system, exerts its mechanism of action by binding to receptors located in the smooth muscle ofthe blood vessels and various organs, including the heart. These receptors include alpha-1, alpha-2,
beta-1, beta-2 and beta-3 receptors and, as a group, are generally known as the adrenergic receptors.
The adrenergic receptors, and other receptors, including but not limited to, the ganglionic andmuscarinic acetylcholine receptors are believed to be affected in certain cases of POTS and OI. Seee.g., Hongliang Li et al., Autoimmune Basis for Postural Tachycardia Syndrome, 3 J. AMERICAN
HEART ASSOC. e000755 (2014); Artur Fedorowski et al., Antiadrenergic Autoimmunity in Postural
Tachycardia Syndrome, 19 EUROPACE 1211 (2017); Mohammed Ruzieh et al., The Role ofAutoantibodies in the Syndromes of Orthostatic Intolerance: A Systematic Review, 51 SCANDINAVIANCARDIOVASCULAR J. 243 (2017); Shu-ichi Ikeda et al., Autoantibodies Against Autonomic Nerve
Receptors in Adolescent Japanese Girls after Immunization with Human Papillomavirus Vaccine, 2
ANNALS OF ARTHRITIS AND CLINICAL RHEUMATOLOGY 1014 (2019); William T. Gunning, Postural
Orthostatic Tachycardia Syndrome is Associated With Elevated G-Protein Coupled Receptor
Autoantibodies, 8 J. AMERICAN HEART ASSOC. e013602 (2019).

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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 47 of 91

273.

A variety of published medical journal articles have discussed the association between

Gardasil and a myriad of serious injuries and have reported on patients developing POTS, OI,
fibromyalgia and other symptoms of autonomic impairment following Gardasil vaccination. See
Svetlana Blitshetyn, Postural Tachycardia Syndrome After Vaccination with Gardasil, 17 EUROPEAN J.
OF NEUROLOGY e52 (2010); Svetlana Blitshetyn, Postural Tachycardia Syndrome Following Human

Papillomavirus Vaccination, 21 EUROPEAN J. OF NEUROLOGY 135 (2014); Tomomi Kinoshita et al.,Peripheral Sympathetic Nerve Dysfunction in Adolescent Japanese Girls Following Immunization With
Human Papillomavirus Vaccine, 53 INTERNAL MEDICINE 2185 (2014); Louise S. Brinth et al.,Orthostatic Intolerance and Postural Tachycardia Syndrome As Suspected Adverse Effects ofVaccination Against Human Papilloma Virus, 33 VACCINE 2602 (2015); Manuel Martinez-Lavin et al.,HPV Vaccination Syndrome. A Questionnaire Based Study, 34 J. CLINICAL RHEUMATOLOGY 1981(2015); Louise S. Brinth et al., Is Chronic Fatigue Syndrome/Myalgic Encephalomyelitis a Relevant
Diagnosis in Patients with Suspected Side Effects to Human Papilloma Virus Vaccine, 1 INT. J. OF
VACCINE & VACCINATION 3 (2015); Jill R. Schofield et al., Autoimmunity, Autonomic Neuropathy, and
HPV Vaccination, A Vulnerable Subpopulation, CLINICAL PEDIATRICS (2017); Rebecca E. Chandler etal., Current Safety Concerns With Human Papillomavirus Vaccine: A Cluster Analysis of Reports in
VigiBase, 40 DRUG SAFETY 81 (2017); Svetlana Blitshetyn et al., Autonomic Dysfunction and HPVImmunization An Overview, IMMUNOLOGIC RESEARCH (2018); and Svetlana Blitshetyn, Human
Papilloma Virus (HPV) Vaccine Safety Concerning POTS, CRPS and Related Conditions, CLINICALAUTONOMIC RESEARCH (2019).
274.

In a 2017 review, Drs. Tom Jefferson and Lars Jørgensen criticized the European

Medicines Agency (EMA) for turning a blind eye to the debilitating autoimmune injuries, including
CRPS and POTS that young women had suffered following vaccination with HPV vaccine. Tom
Jefferson et al., Human Papillomavirus Vaccines, Complex Regional Pain Syndrome, Postural

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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 48 of 91

Orthostatic Tachycardia Syndrome, and Autonomic Dysfunction – A Review of the Regulatory
Evidence from the European Medicines Agency, 3 INDIAN J. OF MED. ETHICS 30 (Jan. – March 2017).
275.

In a separate article, the same authors describe their process for extracting data from not

only peer-reviewed journal publications, but also unpublished data from pharmaceutical company
clinical study reports and trial register entries from ClinicalTrials.gov, under the assumption that “morethan half of all studies are never published, and the published studies’ intervention effects are often
exaggerated in comparison to the unpublished studies. This introduces reporting bias that undermines
the validity of systematic reviews. To address reporting bias in systematic reviews, it is necessary to
use industry and regulatory trial registers and trial data—in particular, the drug manufacturers’
complete study programs.” They found that 88% of industry studies were solely industry funded andfound serious deficiencies and variability in the availability of HPV vaccine study data. For example,
only half of the completed studies listed on ClinicalTrials.gov posted their results. The clinical study
reports the authors obtained confirmed that the amount of information and data are vastly greater thanthat in journal publications. When the authors compared the data the European Medical Agency used(which was provided by GlaxoSmithKline and Merck Sharp and Dohme) to conduct their review of therelationship between HPV vaccination and both POTS and CRPS, the authors found that only 48% of
the manufacturers’ data were reported. According to the authors, “we find this very disturbing.” Lars
Jørgensen et al., Index of the Human Papillomavirus (HPV) Vaccine Industry Clinical Study
Programmes and Non-Industry Funded Studies: A Necessary Basis to Address Reporting Bias in a
Systematic Review, 7 SYSTEMATIC REVIEW 8 (2018).
276.

Likewise, in a recently released February 2020 peer-reviewed study, researchers whoanalyzed the available clinical trial data for all HPV vaccines, which include the Gardasil vaccines andanother HPV vaccine currently only available in Europe, concluded that “HPV vaccines increased
serious nervous disorders.” Lars Jørgensen et al., Benefits and Harms of the Human Papillomavirus

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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 49 of 91(HPV) Vaccines: Systemic Review with Meta-Analyses of Trial Data from Clinical Study Reports, 9
SYSTEMATIC REVIEWS 43 (February 2020).
277.

In addition, Jørgensen and his co-authors observed that, in reanalyzing the association

between HPV vaccines and one specific autoimmune disease, postural orthostatic tachycardia
syndrome (POTS), the HPV vaccines were associated with a nearly two-fold increased risk of POTS.
Id.
278.

Jørgensen and his co-authors also noted many of the same shortcomings associated with

the Gardasil clinical trials as have already been discussed in this Complaint, including for example, thefact that no true placebo was utilized by Merck as a comparator (i.e., the comparator/control used by
Merck in the Gardasil clinical trials contained aluminum adjuvant). The researchers noted that “[t]heuse of active comparators may have underestimated harms related to HPV vaccines” and that “[t]hedegree of harms might therefore be higher in clinical practice than in the trials.” Id.
279.

Jørgensen and his co-authors also noted that the clinical trials revealed that Gardasil 9

induced more harms than Gardasil, which could be explained by the fact that Gardasil 9 contains moreof the AAHS aluminum adjuvant (500 micrograms of AAHS in Gardasil-9 vs. 225 micrograms of
AAHS in Gardasil), and this dose-response relationship further corroborates that the AAHS aluminum
adjuvant is a culprit in causing adverse events. Id.
280.

Other researchers, including Tomljenovic and Shaw, who have closely looked into

Gardasil, have opined that risks from the Gardasil vaccine seem to significantly outweigh the as yet

unproven long-term benefits. In their view, vaccination is unjustified if the vaccine carries any
substantial risk, let alone a risk of death, because healthy teenagers face an almost zero percent risk ofdeath from cervical cancer.
K. Merck has Concealed the Fact that Gardasil Increases the Risk of Fertility
Problems
281.

Merck has never tested the impact of the Gardasil vaccines on human fertility.
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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 50 of 91

282.

Nevertheless, study volunteers reported devastating impacts on human fertility during

combined trials, offering substantial evidence that the vaccine may be causing widespread impacts onhuman fertility, including increases in miscarriage, birth defects, premature ovarian failure andpremature menopause in girls and young women.
283.

One of the serious adverse events now emerging in vaccinated girls, including teens, ispremature ovarian failure. See, e.g., D. T. Little and H. R. Ward, Adolescent Premature OvarianInsufficiency Following Human Papillomavirus Vaccination: A Case Series Seen in General Practice,
JOURNAL OF INVESTIGATIVE MEDICINE HIGH IMPACT, Case Reports 1-12 (Oct.-Dec. 2014); D. T. Little
and H. R. Ward, Premature ovarian failure 3 years after menarche in a 16-year-old girl following
human papillomavirus vaccination, BMJ CASE REPORTS (September 30, 2012).
284.

Premature ovarian failure can occur after aluminum destroys the maturation process ofthe eggs in the ovaries.
285.

Fertility has plummeted among American women following the 2006 mass introductionof the Gardasil vaccine. This is most evident in teen pregnancy statistics where numbers have morethan halved since 2007.
286.

The total fertility rate for the United States in 2017 continued to dip below what isneeded for the population to replace itself, according to a report by the National Center of Health
Statistics issued in January 2019, and the rate for women 15-44 fell another 2% between 2017 and2018.
L. There were an Increase Number of Deaths in the Gardasil Studies
287.

Merck’s own preliminary studies predicted that Gardasil would kill and injure far more

Americans than the HPV virus, prior to the introduction of the vaccine.
288.

The average death rate in young women in the U.S. general population is 4.37 per

10,000. See Brady E. Hamilton et al., “Births: Provisional Data for 2016,” Vital Statistics Rapid
50
COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 51 of 91

Release, Report No. 002, June 2017.
289.

The Gardasil pooled group had a death rate of 8.5 per 10,000, or almost double thebackground rate in the U.S.

290.

When Merck added in deaths from belated clinical trials, the death rate jumped to 13.3

per 10,000 (21 deaths out of 15,706).
291.

Merck dismissed all deaths as coincidences.

292.

The total number of deaths was 21 in the HPV vaccine group and 19 in the comparator(AAHS) groups.
293.

The death rate among vaccine recipients was 13.3 per 10,000, or 133 per 100,000(21/15,706).
294.

To put this in perspective, the death rate from cervical cancer in the United States is 2.3

per 100,000 women. This means that, according to Merck’s own data, a girl is 58 times more likely todie from Gardasil than from cervical cancer.
M. Post-Marketing Injuries -- The Raft of Injuries Seen in Merck’s Clinical Trials
Has Now Become A Population-Wide Chronic Disease Epidemic
295.

By 2010, reports coming in from all over the world linked the Gardasil vaccine to

51
COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 52 of 91

bizarre and troubling symptoms.
296.

Many Gardasil survivors will have lifelong handicaps.

297.

The severe adverse events from the Gardasil vaccination, seen since its widespread

distribution, are similar to those injuries that Merck covered up during its clinical trials. They include
autoimmune diseases, suicides, deaths, premature ovarian failures, reproductive problems, infertility,
cervical cancer, sudden collapse, seizures, multiple sclerosis, strokes, heart palpitations, chronicmuscle pain, complex regional pain syndrome, and weakness.
298.

Other frequently reported injuries include disturbances of consciousness; systemic pain

including headache, myalgia, arthralgia, back pain and other pain; motor dysfunction, such asparalysis, muscular weightiness, and involuntary movements; numbness, and sensory disturbances;autonomic symptoms including hypotension, tachycardia, nausea, vomiting, and diarrhea; respiratory
dysfunction, including dyspnea, and asthma; endocrine disorders, such as menstrual disorder andhypermenorrhea; hypersensitivity to light, heart palpitations, migraine headaches, dizziness, cognitive
deficits, personality changes, vision loss, joint aches, headaches, brain inflammation, chronic fatigue,
death and severe juvenile rheumatoid arthritis.
299.

The data show that Gardasil is yielding far more reports of adverse events than any

other vaccine. For example, Gardasil had 8.5 times more emergency room visits, 12.5 times more
hospitalizations, 10 times more life-threatening events, and 26.5 more disabilities than Menactra,
another vaccine with an extremely high-risk profile.
300.

As of December 2019, there have been more than 64,000 Gardasil adverse events

reported to the FDA’s Vaccine Adverse Event Reporting System (VAERS) since 2006.
301.

Moreover, studies have shown that only approximately 1% of adverse events are

actually reported to FDA’s voluntary reporting systems, thus, the true number of Gardasil adverse
events in the United States may be as high as 6.4 million incidents.

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302.

The Vaccine Injury Compensation Program has paid out millions of dollars in damages

for Gardasil-induced injuries and deaths.
303.

Gardasil now has more reported injuries than any other vaccine.

304.

As of December 2019, some 10% of the serious injuries reported to VAERS are

attributed to Gardasil and Gardasil 9.
305.

The adverse events also include deaths. Parents, doctors, and scientists have reported

hundreds of deaths from the Gardasil vaccine, post-marketing.
306.

In order to conceal Gardasil’s link to the deaths of teenagers, Merck has submitted

fraudulent reports to VAERS, and posts fraudulent and misleading statements on its Worldwide
Adverse Experience System.
307.

For example, Merck attributed the death of a young woman from Maryland, Christina

Tarsell, to a viral infection. Following years of litigation, a court determined that Gardasil caused
Christina’s death. There was no evidence of viral infection. Merck invented this story to deceive thepublic about Gardasil’s safety.
308.

Merck submitted fraudulent information about Christina Tarsell’s death to its

Worldwide Adverse Experience System and lied to the FDA through the VAERS system. Merck
claimed that Christina’s gynecologist had told the company that her death was due to viral infection.
Christina’s gynecologist denied that she had ever given this information to Merck. To this day, Merck
has refused to change its false entry on its own reporting system.
N. The Gardasil Vaccines’ Harms Are Not Limited to the United States, Rather
the Vaccines Have Injured Patients All Over the World
309.

Gardasil is used widely in the international market. Widespread global experience has

likewise confirmed that the vaccine causes serious adverse events with minimal proven benefit.
310.

According to the World Health Organization’s Adverse Event Databases, there have

53
COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 54 of 91

been more than 100,000 serious adverse events associated with Gardasil, outside the Americas. See
WHO Vigibase database, keyword Gardasil: http://www.vigiaccess.org.
i.

311.

In Light of Gardasil’s Serious and Debilitating Adverse Events, theJapanese Government Rescinded Its Recommendation that Girls
Receive Gardasil

In Japan, a country with a robust history of relative honesty about vaccine side effects,

the cascade of Gardasil injuries became a public scandal.
312.

Japan’s health ministry discovered adverse events reported after Gardasil were manytimes higher than other vaccines on the recommended schedule. These included seizures, severe
headaches, partial paralysis, and complex regional pain syndrome. See Hirokuni Beppu et al., Lessons
Learnt in Japan From Adverse Reactions to the HPV Vaccine: A Medical Ethics Perspective, 2 INDIAN
J MED ETHICS 82 (April-June 2017).
313.

Japanese researchers found that the adverse events rate of the HPV vaccine was as highas 9%, and that pregnant women injected with the vaccine aborted or miscarried 30% of their babies.
See Ministry of Health, Labour and Welfare, Transcript “The Public Hearing on Adverse Events
following HPV vaccine in Japan,” February 26, 2014
314.

The injuries caused the Japanese government to rescind its recommendation that girls

receive the HPV vaccine.
315.

Japan withdrew its recommendation for Gardasil three months after it had added thevaccine to the immunization schedule, due to “an undeniable causal relationship between persistent

pain and the vaccination.”
316.

Uptake rates for the vaccine in Japan are now under 1%, compared to 53.7% fully

vaccinated teenaged girls in the United States.
317.

In late 2016 Japanese industry watchdog, MedWatcher Japan issued a scathing letter

54
COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 55 of 91

faulting the World Health Organization for failing to acknowledge the growing body of scientificevidence demonstrating high risk of devastating side effects.
318.

In 2015, the Japanese Association of Medical Sciences issued official guidelines for

managing Gardasil injuries post-vaccination.
319.

That same year, the Japanese Health Ministry published a list of medical institutions

where staffs were especially trained to treat patients who had sustained Gardasil-induced injuries.
320.

The Japanese government also launched a series of special clinics to evaluate and treat

illnesses caused by the Gardasil vaccines.
321.

The president of the Japanese Association of Medical Sciences stated that there was no

proof that the vaccines prevent cancer.
322.

These were developments that Merck was extremely anxious to suppress.

323.

Merck hired the think tank, the Center for Strategic and International Studies (CSIS)

and Professor Heidi Larson of the Vaccine Confidence Project in London, to assess the reasons for theJapanese situation. The overall conclusion was that the symptoms the girls were suffering from werepsychogenic in nature and were as a result of rumors spread online. In essence, Merck blamed thevictims for the Gardasil-induced adverse events in Japan.
ii.

324.

Denmark Has Opened Specialized Clinics Specifically Focused on
Treating Gardasil-Induced Injuries, Including Gardasil-Induced
Autoimmune Diseases

In March 2015, Denmark announced the opening of five new “HPV clinics” to treat

children injured by Gardasil vaccines. Over 1,300 cases flooded the HPV clinics shortly after opening.
See Zosia Chustecka, Chronic Symptoms After HPV Vaccination: Danes Start Study, MEDSCAPE(November 13, 2015).
//
//

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iii.

325.

Gardasil-Induced Adverse Events Caused the Government in
Colombia to Conclude that Gardasil Would No Longer Be
Mandatory

In Colombia, more than 800 girls in a single town of El Carmen de Bolivar reported

reactions ranging from fainting to dizziness and paralysis in March of 2014 following vaccination with
Gardasil.
326.

With protests erupting across the country, the Colombian attorney general asked theConstitutional Court to rule on a lower court ruling on the outcome of a case of an injured girl.
327.

In 2017, in response to an unresolved case, Colombia’s constitutional court, ruled that

the Colombian government could not infringe on the bodily integrity of its citizens. This decision
meant that the government could not consider the HPV vaccine to be mandatory.
iv.
328.

India Halts Gardasil Trials and Accuses Merck of Corruption Afterthe Death of Several Young Girls Who were Participants in the Trial

Seven girls died in the Gardasil trials in India coordinated by Merck and the Gates

Foundation. A report by the Indian Parliament accused the Gates Foundation and Merck of conducting“a well-planned scheme to commercially exploit” the nation’s poverty and powerlessness and lack of
education in rural India in order to push Gardasil. See 72nd Report on the Alleged Irregularities in the
Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine by Programme for Appropriate
Technology in Health (PATH) in India (August 2013).
329.

The report alleges that Merck (through PATH, to whom it supplied vaccines) and theGates Foundation resorted to subterfuge that jeopardized the health and well-being of thousands ofvulnerable Indian children. The parliamentary report makes clear that the clinical trials could not haveoccurred without Merck corrupting India’s leading health organizations. Id.
330.

The Report accused PATH, which was in collaboration with Merck, of lying to illiterate

tribal girls to obtain informed consent, widespread forging of consent forms by Merck operatives,offering financial inducements to participate, and providing grossly inadequate information about
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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 57 of 91

potential risks. Id.
331.

Many of the participants suffered adverse events including loss of menstrual cycles andpsychological changes including depression and anxiety. According to the report: PATH’s “sole aim
has to been to promote the commercial interests of HPV vaccine manufacturers, who would havereaped a windfall of profits had they been successful in getting the HPV vaccine included in theuniversal immunization program of the country... This [conduct] is a clear-cut violation of the humanrights of these girls and adolescents.” Id.
332.

A 2013 article in the South Asian Journal of Cancer concludes that the HPV vaccine

program is unjustifiable. “It would be far more productive to understand and strengthen the reasons
behind the trend of decreasing cervical cancer rates than to expose an entire population to an uncertain
intervention that has not been proven to prevent a single cervical cancer or cervical cancer death todate.” See Sudeep Gupta, Is Human Papillomavirus Vaccination Likely to be a Useful Strategy inIndia? 2 SOUTH ASIAN J CANCER 194 (October-December 2014).
333.

The article goes on to say: “A healthy 16-year-old is at zero immediate risk of dying

from cervical cancer, but is faced with a small, but real risk of death or serious disability from avaccine that has yet to prevent a single case of cervical cancer... There is a genuine cause for concern
regarding mass vaccination in this country.” Id.
334.

On April 2017, the Indian government blocked the Gates Foundation from further

funding of the Public Health Foundation of India and other non-governmental organizations,effectively barring them from influencing India’s national vaccine program. See Nida Najar, India’s
Ban on Foreign Money for Health Group Hits Gates Foundation, THE NEW YORK TIMES, April 20,
2017.
O. Merck’s Fraud Has Paid Off Handsomely Resulting in Over $3 Billion in
Gardasil Sales Annually
335.

Merck’s corruption and fraud in researching, testing, labeling, and promoting Gardasil
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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 58 of 91

have paid off handsomely.
336.

Presently, two doses of Gardasil 9 typically cost about $450, plus the cost of two office337.

By comparison, the cost of the DTaP vaccine is about $25 per dose.

338.

The HPV vaccine is the most expensive vaccine on the market.

339.

Since approximately 1 in 42,000 American women die of cervical cancer annually, thevisits.

cost of avoiding a single death is over $18 million, assuming the Gardasil vaccine is 100% effective.
340.

In 2018, the Gardasil vaccines made $2.2 billion for Merck in the U.S. alone.

341.

In 2019, Merck made $3.7 billion in worldwide revenues from the Gardasil vaccines.

342.

Gardasil is Merck’s most lucrative vaccine and its third-highest selling product.

343.

Gardasil is crucial to Merck’s overall financial health. Merck identifies Gardasil as oneof its “key products,” meaning that any change in Gardasil’s cash flow affects the corporation as awhole.
344.

Merck’s 10-K financial reports note that, for example, the discovery of a previously

unknown side effect, or the removal of Gardasil from the market, would hurt Merck’s bottom line.
III.

Sahara Walker Sustained Autoimmune Disease, Including Postural Orthostatic
Tachycardia Syndrome (“POTS”), Orthostatic Hypotension (“OH”),
Neurocardiogenic Syncope (“NCS”), Dysautonomia and Other Serious Injuries,
Including but Not Limited to, Autonomic Neuropathy, as A Result of Her Gardasil
Injection
A. Gardasil and Its Ingredients Caused Walker’s Autoimmune Disease and Other
Related Injuries and Has Resulted in Her Suffering From Severe, Debilitating
and Painful Chronic Ailments

345.

Walker was 11 years-old when she received her first and only shot of Gardasil on

September 25, 2013.
346.

Walker’s mother, Melissa Roglitz-Walker, agreed to her daughter receiving the Gardasil

injection after having been convinced by years of relentless online, in print and television marketing by

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Merck, that Gardasil is very safe, that Gardasil prevents cancer and that good mothers must vaccinate
their teenage daughters with the Gardasil vaccine. Walker’s mother relied upon Merck’s ubiquitous
representations concerning the safety and efficacy of the Gardasil vaccine, in consenting to herdaughter’s Gardasil vaccination.
347.

On September 25, 2013, during a routine well-visit, Walker’s family doctor, Dr.

Jennifer Philbin, in Lake Mills, Wisconsin, recommended that Walker receive the Gardasil vaccine,which she stated was a safe and effective vaccine for preventing cervical cancer. In light of thedoctor’s recommendations, as well as Merck’s relentless marketing and advertising messages, to which
Walker’s mother had been exposed concerning the safety and efficacy of Gardasil, Walker’s motherconsented to her daughter being injected with the “cervical cancer vaccine,” Gardasil.
348.

Prior to receiving her Gardasil injection, Walker had no autoimmune diseases, noautonomic issues and no orthostasis. Walker was a happy, healthy 11-year old girl who had just scoredin the top 97th percentile of all Wisconsin students in math. She consistently performed wellacademically and was active in sports.
349.

Two days following her Gardasil injection in September 2013, Walker began toexperience vomiting and headaches. One week later, on October 3, 2013, Walker began to experience
severe body aches, along with vomiting and headaches from the week prior. On October 17 throughOctober 18, 2013, Walker began to have fevers as well. She began sleeping excessively and had
extreme fatigue while awake. She was dizzy, weak, and pale.
350.

As the months progressed, so did Walker’s injuries. She was seen by multiple

physicians and specialists for her complaints which now included: daily migraines; severe body aches;sensitivity to light; dizziness and lightheadedness; nausea; fainting; pallor; dark circles under her eyes;
constant abdominal pain; constant stomach upset; decreased appetite; severe joint, muscle, and bone
pain; leg weakness, tingling, numbness, and legs giving out; vision impairment and occasional blurry

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vision; cognitive processing impairment where she would become easily confused; problems withconcentration; short-term memory loss; chest pain; shortness of breath, occasional lower back pain;
extreme fatigue; altered sense of taste; pins and needles in the extremities; always feeling cold andhaving chills; low-grade fevers; trouble hearing and tinnitus; generalized weakness; becoming easily
agitated; and hypersomnia.
351.

As a result of her post-Gardasil symptoms, Walker was unable to engage in normal

activities that a normal child would enjoy. She could no longer attend school in the same manner she
used to prior to her Gardasil injection, and had to be withdrawn from public school due to her injuries
and homeschooled -- missing out on most of her junior high and all of her high school.
352.

By 2016, Walker’s medication regimen was up to 55 pills per day. After seeing

numerous specialists and trying dozens of medications, Walker is now taking about 13-14 prescription
medications. Walker receives a very expensive Intravenous Immune Globulin (IVIg) treatment athome every 3 weeks through a central line chest port. If the IVIg treatment ceases to be administeredon a 3-week basis, Walker experiences a dramatic decline in health to the point of becoming
bedridden, much like she was in the first several years after sustaining her vaccine-related injury.
353.

Studies, including serum samples from September 2016, demonstrated that Walker had

tested positive for the anti-beta-1 adrenergic antibodies, the anti-muscarinic cholinergic receptor 3 andreceptor 4 antibodies, and an “at risk” result for anti-beta-2 adrenergic antibodies. These adrenergic
and cholinergic autoantibodies play a role in the pathogenesis of POTS and OI and are linked tomuscle and blood vessel contraction, heart rate, heart excitability and the force of heart contraction. As
previously discussed, medical research has demonstrated that certain POTS and OI patients haveautoantibodies to these receptors thus confirming the autoimmune etiology of these diseases. See e.g.,
Hongliang Li et al., Autoimmune Basis for Postural Tachycardia Syndrome, 3 J. AMERICAN HEARTASSOC. e000755 (2014); Artur Fedorowski et al., Antiadrenergic Autoimmunity in Postural

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COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 61 of 91

Tachycardia Syndrome, 19 EUROPACE 1211 (2017); Mohammed Ruzieh et al., The Role ofAutoantibodies in the Syndromes of Orthostatic Intolerance: A Systematic Review, 51 SCANDINAVIANCARDIOVASCULAR J. 243 (2017); Shu-ichi Ikeda et al., Autoantibodies Against Autonomic Nerve
Receptors in Adolescent Japanese Girls after Immunization with Human Papillomavirus Vaccine, 2
ANNALS OF ARTHRITIS AND CLINICAL RHEUMATOLOGY 1014 (2019).
354.

Based upon her chronic and severe post-Gardasil symptoms and adverse events asoutlined above and the tests performed by her medical providers, Walker has been diagnosed withvarious medical conditions, including but not limited to, Neurocardiogenic Syncope (“NCS”), Postural
Orthostatic Tachycardia (“POTS”), a form of Orthostatic Intolerance (“OI”) called Orthostatic
Hypotension (“OH”), Autoimmune Autonomic Neuropathy, and Small Fiber Neuropathy.
355.

As previously discussed, the medical literature has documented other patients who, like

Walker, have suffered serious autonomic dysfunctions, POTS, and who experienced the same side
effects as those Walker has suffered, were diagnosed with Gardasil-induced autonomic diseases. See
Svetlana Blitshetyn, Postural Tachycardia Syndrome After Vaccination with Gardasil, 17 EUROPEAN J.
OF NEUROLOGY e52 (2010); Svetlana Blitshetyn, Postural Tachycardia Syndrome Following Human

Papillomavirus Vaccination, 21 EUROPEAN J. OF NEUROLOGY 135 (2014); Tomomi Kinoshita et al.,Peripheral Sympathetic Nerve Dysfunction in Adolescent Japanese Girls Following Immunization With
Human Papillomavirus Vaccine, 53 INTERNAL MEDICINE 2185 (2014); Louise S. Brinth et al.,Orthostatic Intolerance and Postural Tachycardia Syndrome As Suspected Adverse Effects ofVaccination Against Human Papilloma Virus, 33 VACCINE 2602 (2015); Manuel Martinez-Lavin et al.,HPV Vaccination Syndrome. A Questionnaire Based Study, 34 J. CLINICAL RHEUMATOLOGY 1981(2015); Louise S. Brinth et al., Is Chronic Fatigue Syndrome/Myalgic Encephalomyelitis a Relevant
Diagnosis in Patients with Suspected Side Effects to Human Papilloma Virus Vaccine, 1 INT. J. OF
VACCINE & VACCINATION 3 (2015); Jill R. Schofield et al., Autoimmunity, Autonomic Neuropathy, and61
COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 62 of 91

HPV Vaccination, A Vulnerable Subpopulation, CLINICAL PEDIATRICS (2017) (Published case study
about Walker); Rebecca E. Chandler et al., Current Safety Concerns With Human Papillomavirus
Vaccine: A Cluster Analysis of Reports in VigiBase, 40 DRUG SAFETY 81 (2017); Svetlana Blitshetyn
et al., Autonomic Dysfunction and HPV Immunization An Overview, IMMUNOLOGIC RESEARCH (2018);
and Svetlana Blitshetyn, Human Papilloma Virus (HPV) Vaccine Safety Concerning POTS, CRPS and
Related Conditions, CLINICAL AUTONOMIC RESEARCH (2019); Lars Jørgensen et al., Benefits andHarms of the Human Papillomavirus (HPV) Vaccines: Systemic Review with Meta-Analyses of Trial
Data from Clinical Study Reports, 9 SYSTEMATIC REVIEWS 43 (February 2020).
356.

Walker contends that her Gardasil injection caused her to develop serious anddebilitating injuries, including but not limited to autonomic, neurological, heterogenous autoimmune
disease, POTS, as well as a constellation of adverse symptoms, complications, injuries, and otheradverse events, many of which are alleged herein and all of which were caused by Gardasil orotherwise linked to her Gardasil-induced autoimmune disorder.
B. “It is Not Revolutions and Upheavals That Clear the Road to New and BetterDays, But Revelations, Lavishness and Torments of Someone’s Soul, Inspired
and Ablaze.” – Boris Pasternak, After the Storm
357.

Pursuant to Section 300aa-11(a) of the National Vaccine Injury Compensation

Program: “No person may bring a civil action for damages ...... against a vaccine administrator or
manufacturer in a State or Federal court for damages arising from a vaccine-related injury ... associatedwith the administration of a vaccine ....... unless a petition has been filed, in accordance with section
300aa-16 of this title, for compensation under the Program for such injury ... and (I) the United Stated
Court of Federal Claims has issued a judgment under section 300aa-12 of this title on such petition and(II) such person elects under section 300aa-21(a) to file such an action.” See 42
U.S.C. §§ 300aa–11(a)(2)(A).
358.

Title 42, Section 300aa-16 (c) further states: “If a petition is filed under section 300aa-

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11 of this title for a vaccine-related injury or death, limitations of actions under State law shall bestayed with respect to a civil action brought for such injury or death for the period beginning on thedate the Petition is filed and ending on the date…an election is made under section 300aa-21(a) of thistitle to file the civil action ...” See 42 U.S.C. §§ 300aa–16(c).
359.

In full compliance with the aforementioned federal law, Walker, while still a minor,

duly filed her petition with the U.S. Court of Federal Claims seeking compensation for her Gardasil
vaccine-related injuries under the National Vaccine Injury Compensation Program. A judgement
thereon was rendered on or about August 25, 2020 and Walker duly filed her election to file a civil
action on August 25, 2020.
360.

Having complied with National Vaccine Injury Compensation Program administrative

procedure and having duly filed her election to proceed with a civil action, Walker hereby timely
initiates the instant action against Merck, the manufacturer, designer and promoter of the Gardasil
vaccines which caused her debilitating injuries, including her autoimmune disease. Through this civil
action, Walker seeks to hold Merck accountable for its negligent, reckless, and fraudulent conduct andshe seeks full compensation from Merck for the physical and emotional injuries and harms she
sustained as a result of Gardasil. Moreover, by engaging in conduct that Merck knew was unsafe andlikely to injure patients and by placing Gardasil’s profits ahead of patient safety, Merck has engaged in
the same fraudulent and evil conduct it engaged in with respect to Vioxx. Walker, therefore, requests
that exemplary damages be assessed against Merck, so as to, once again, attempt to deter Merck andother would-be defendants from engaging in similar reprehensible conduct.
//
//
//
//

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CAUSES OF ACTION
COUNT ONENEGLIGENCE
361.

Walker incorporates by reference all other paragraphs of this Complaint as if fully set

forth herein and further alleges:
362.

Merck is the researcher, designer, manufacturer, labeler, and promoter of the Gardasil

and the subsequent Gardasil 9 vaccines.
363.

Merck marketed Gardasil to patients, including pre-teen girls such as Walker, herparents and her medical providers.
364.

Merck had a duty to exercise reasonable care in the design, research, manufacture,marketing, advertisement, supply, promotion, packaging, sale, and distribution of Gardasil, including
the duty to take all reasonable steps necessary to research, manufacture, label, promote and/or sell a
product that was not unreasonably dangerous to consumers, users, and other persons coming into
contact with the product.
365.

At all times relevant to this litigation, Merck had a duty to exercise reasonable care in

the marketing, advertising, and sale of Gardasil. Merck’s duty of care owed to consumers and thegeneral public included providing accurate, true, and correct information concerning the efficacy andrisks of Gardasil and appropriate, complete, and accurate warnings concerning the potential adverse
effects of Gardasil and its various ingredients and adjuvants.
366.

At all times relevant to this litigation, Merck knew or, in the exercise of reasonable care,should have known of the hazards and dangers of Gardasil and specifically, the serious, debilitating
and potentially fatal adverse events associated with Gardasil, including but not limited to autoimmune
diseases (including, but not limited to, POTS and OI), fertility complications, increased risk of cancer(including cervical cancer, which was the very cancer it was promoted as preventing) and death.

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367.

Accordingly, at all times relevant to this litigation, Merck knew or, in the exercise ofreasonable care, should have known that use of Gardasil could cause Walker’s injuries and thus createda dangerous and unreasonable risk of injury to the users of these products, including Walker.
368.

Merck knew or, in the exercise of reasonable care, should have known that its

negligently and poorly designed clinical trials and studies were insufficient to test the true long-term
safety and efficacy of Gardasil.
369.

Merck also knew or, in the exercise of reasonable care, should have known that its

targeted consumers and patients (who were pre-teen and teen children), the parents of these patientsand the children’s medical providers were unaware of the true risks and the magnitude of the risks
associated with Gardasil and the disclosed and undisclosed ingredients of Gardasil.
370.

As such, Merck breached its duty of reasonable care and failed to exercise ordinary carein the research, development, manufacturing, testing, marketing, supply, promotion, advertisement,
packaging, labeling, sale, and distribution of Gardasil, in that Merck manufactured and produced adefective and ineffective vaccine, knew or had reason to know of the defects and inefficacies inherent
in its products, knew or had reason to know that a patient’s exposure to Gardasil created a significant
risk of harm and unreasonably dangerous side effects, and failed to prevent or adequately warn of these
defects, risks and injuries.
371.

Merck failed to appropriately and adequately test the safety and efficacy of Gardasil andits individual ingredients and adjuvants.
372.

Despite the ability and means to investigate, study, and test its products and to provide

adequate warnings, Merck has failed to do so. Indeed, Merck has wrongfully concealed informationand has further made false and/or misleading statements concerning the safety and efficacy of
Gardasil.
373.

Merck’s negligence is outlined in detail in this Complaint and included, among others:

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Manufacturing, producing, promoting, creating, researching, labeling, selling,
and/or distributing Gardasil without thorough and adequate pre-and post-market
testing and studies;b)

Manufacturing, producing, promoting, researching, labeling, selling, and/or
distributing Gardasil while negligently and intentionally concealing and failingto accurately and adequately disclose the results of the trials, tests, and studies of
Gardasil, and, consequently, the lack of efficacy and risk of serious harm
associated with Gardasil;c)

Failing to undertake sufficient studies and conduct necessary tests to determine
the safety of the ingredients and/or adjuvants contained within Gardasil, and thepropensity of these ingredients to render Gardasil toxic, increase the toxicity of
Gardasil, whether these ingredients are carcinogenic or associated with
autoimmune diseases and other injures;d)

Negligently designing and conducting its clinical trials so as to prevent theclinical trials from revealing the true risks, including but not limited to, longterms risks and risks of autoimmune diseases associated with Gardasil;e)

Negligently designing and conducting its clinical trials so as to mask the truerisks, including but not limited to, long terms risks and risks of autoimmune
diseases and cancers associated with Gardasil;f)

Failing to test Gardasil against a true inert placebo and lying to the public that
Gardasil was tested against a placebo, when in reality, all, or nearly all, studies
used a toxic placebo that included the aluminum adjuvant AAHS;

g)

Failing to have a sufficient number of studies for the targeted patient population
which included pre-teen girls (and boys) between the ages of 9 and 12;

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Not using the commercial dosage (and instead using a lower dosage of the
adjuvant and ingredients) in one of the key clinical trials used to obtain licensing
for the commercial dosage of Gardasil;i)

Using restrictive exclusionary criteria in the clinical study patient population(including for example excluding anyone who had prior abnormal Pap tests, who
had a history of immunological or nervous system disorders or was allergic toaluminum or other ingredients), but then not revealing or warning about theseexclusionary criteria in the label and knowing that, for most of these ingredientsand allergies, there are limited resources for the public to test for such allergies
in advance of being vaccinated;j)

Negligently designing and conducting its trials so as to create the illusion ofefficacy when in reality the Gardasil Vaccines have not been shown to beeffective against preventing cervical cancer;k)

Failing to use reasonable and prudent care in the research, manufacture, labelingand development of Gardasil so as to avoid the risk of serious harm associatedwith the prevalent use of Gardasil;l)

Failing to provide adequate instructions, guidelines, warnings, and safety
precautions to those persons who Merck could reasonably foresee would use
and/or be exposed to Gardasil;m)

Failing to disclose to Walker, her parents, her medical providers and to thegeneral public that Gardasil is ineffective when used in patients who havepreviously been exposed to HPV, and also failing to disclose that Gardasil
actually increases the risk of cervical cancer, including in any child or patient
who has previously been exposed to HPV;67
COMPLAINTCase: 3:20-cv-01048 Document #: 1 Filed: 11/18/20 Page 68 of 91n)Failing to disclose to Walker, her parents, her medical providers and to thegeneral public that use of and exposure to Gardasil presents severe risks ofcancer (including cervical cancer, the very cancer it is promoted as preventing),
fertility problems, autoimmune diseases and other grave illnesses as alleged
herein;o)

Failing to disclose to Walker, her parents, her medical providers and to thegeneral public that use of and exposure to Gardasil presents severe risks oftriggering and increasing the risk of various autoimmune diseases, including but
not limited to POTS and OI;

p)

Failing to disclose to Walker, her parents, her medical providers and to thegeneral public that, contrary to Merck’s promotion of the vaccine, Gardasil has
not been shown to be effective at preventing cervical cancer and that the safest
and most effective means of monitoring and combating cervical cancer isregular testing, including Pap tests;

q)

Representing that Gardasil was safe and effective for its intended use when, in
fact, Merck knew or should have known the vaccine was not safe and noteffective for its intended use;r)

Falsely advertising, marketing, and recommending the use of Gardasil, while
concealing and failing to disclose or warn of the dangers Merck knew to be
associated with or caused by the use of Gardasil;s)

Falsely promoting Gardasil as preventing cervical cancer when Merck knowsthat it has not done any studies to demonstrate that Gardasil prevents cervicalcancer and, indeed, its clinical studies revealed that Gardasil actually increases
the risk of cervical cancer;

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Engaging in false advertising and disease mongering by scaring parents andchildren into believing that cervical cancer is far more prevalent than it really is;that all cervical cancer was linked to HPV; that Gardasil prevented cervicalcancer, when in reality none of these representations were true as cervical cancer
rates were declining in the United States due to Pap testing and Gardasil has notbeen shown to prevent against all strains of HPV that are associated withcervical cancer and, indeed, it has never been shown to prevent cervical cancer;u)

Failing to disclose all of the ingredients in Gardasil, including but not limited to
the fact that Gardasil contains dangerous HPV L1-DNA fragments and thatthese DNA fragments could act as a Toll-Like Receptor 9 (TLR9) agonist –further adjuvanting the vaccine and making it more potent and dangerous;v)

Declining to make any changes to Gardasil’s labeling or other promotional
materials that would alert consumers and the general public of the true risks anddefects of Gardasil;w)

Systemically suppressing or downplaying contrary evidence about the risks,
incidence, and prevalence of the side effects of the Gardasil Vaccines by, interalia, orchestrating the retraction of peer-reviewed and published studies andvilifying and attempting to ruin the careers of any scientists who openly question
Gardasil’s safety and efficacy.

374.

Merck knew and/or should have known that it was foreseeable that patients, such as

Walker, would suffer injuries as a result of Merck’s failure to exercise ordinary care in the
manufacturing, marketing, labeling, distribution, and sale of Gardasil.
375.

Walker and her parents, and upon information and belief, her medical providers, did notknow the true nature and extent of the injuries that could result from the intended use of and/or

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exposure to Gardasil or its adjuvants and ingredients.
376.

Merck’s negligence was the proximate cause of the injuries, harm, and economic losses

that Walker suffered, and will continue to suffer, as described herein.
377.

Had Merck not engaged in the negligent and fraudulent conducted alleged herein and/or

had Merck via its labeling, advertisements and promotions provided adequate and truthful warnings
and properly disclosed and disseminated the true risks, limitations and lack of efficacy associated with
Gardasil to medical providers, patients and the public, then upon information and belief, Walker’s
medical providers would not have offered or recommended Gardasil to Walker. Moreover, even if
after Merck’s dissemination of truthful information concerning the true risks and efficacy limitation of
Gardasil, Walker’s medical providers had offered Gardasil, then upon information and belief, theproviders would have heeded any warnings issued by Merck and relayed to Walker and her motherthe safety risks and efficacy limitations that Merck should have warned them about, but failed to doso. Had Walker and her mother been informed of the true risks and efficacy limitation concerning
Gardasil, either through her medical providers or through Merck’s ubiquitous direct-to-consumer
promotional marketing, on which Walker’s mother relied, then neither Walker nor her mother would
have consented to Walker being injected with Gardasil.
378.

As a proximate result of Merck’s wrongful acts and omissions and its negligent andfraudulent testing, labeling, manufacturing, marketing and promotion of Gardasil, Walker has sufferedand continues to suffer severe and permanent physical injuries, including her autoimmune disease andassociated symptomology and has suffered severe and permanent emotional injuries, including pain
and suffering. Walker also has a substantial fear of suffering additional and ongoing harms, including
but not limited to now being at an increased risk of cancer, fertility problems and future symptoms
and harms associated with her autoimmune disease as a result of her exposure to Gardasil.
379.

As a direct and proximate result of her Gardasil-induced injuries, Walker has suffered

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and continues to suffer economic losses, including considerable financial expenses for medical careand treatment, diminished income capacity and she will continue to incur these losses and expenses in
the future.
380.

Merck’s conduct, as described above, was aggravated, outrageous and evil. Merck

regularly risks the lives of children, including Walker, with full knowledge of the limited efficacy of
Gardasil and the severe and sometimes fatal dangers of Gardasil. Merck has made conscious
decisions to not warn, or inform the unsuspecting public, including Walker, her parents and her
medical providers. Merck’s conduct, including its false promotion of Gardasil and its failure to issue
appropriate warnings concerning the severe risks of Gardasil, created a substantial risk of significant
harm to children and patients who were being injected with Gardasil, and therefore warrants an awardof punitive damages.
381.

WHEREFORE, Walker requests that the Court enter judgment in her favor forcompensatory and punitive damages, together with interest, costs herein incurred, attorney’s fees, andall such other and further relief as this Court deems just and proper. Walker also demands a jury trial
on the issues contained herein.
COUNT TWOSTRICT LIABILITY(FAILURE TO WARN)
382.

Walker incorporates by reference all other paragraphs of this Complaint as if fully set

forth herein, and further alleges:
383.

Walker brings this strict liability claim against Merck for failure to warn.

384.

At all times relevant to this litigation, Merck engaged in the business of researching,testing, developing, designing, manufacturing, marketing, selling, distributing, and promoting
Gardasil, which is defective and unreasonably dangerous to consumers, including Walker, because it

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does not contain adequate warnings or instructions concerning the dangerous characteristics of
Gardasil and its ingredients and adjuvants. These actions were under the ultimate control andsupervision of Merck.
385.

Merck researched, developed, designed, tested, manufactured, inspected, labeled,distributed, marketed, promoted, sold, and otherwise released into the stream of commerce Gardasil,
and in the course of same, directly advertised or marketed the vaccine to consumers and end users,
including Walker, her parents and medical providers, and Merck therefore had a duty to warn of therisks associated with the reasonably foreseeable uses of Gardasil and a duty to instruct on the proper,
safe use of these products.
386.

At all times relevant to this litigation, Merck had a duty to properly research, test,develop, design, manufacture, inspect, package, label, market, promote, sell, distribute, provide proper
warnings, and take such steps as necessary to ensure that Gardasil did not cause users and consumers
to suffer from unreasonable and dangerous risks. Merck had a continuing duty to instruct on theproper, safe use of these products. Merck, as manufacturer, seller, or distributor of vaccines, is held to
the knowledge of an expert in the field.
387.

At the time of manufacture, Merck could have provided warnings or instructions

regarding the full and complete risks of Gardasil because it knew or should have known of theunreasonable risks of harm associated with the use of and/or exposure to these products.
388.

At all times relevant to this litigation, Merck failed to properly investigate, study,

research, test, manufacture, label or promote Gardasil. Merck also failed to minimize the dangers tochildren, patients, and consumers of Gardasil products and to those who would foreseeably use or beharmed by Gardasil, including Walker.
389.

Despite the fact that Merck knew or should have known that Gardasil posed a grave andunreasonable risk of harm (including but not limited to increased risk of autoimmune disease,

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including POTS, OI, increased risks of cervical cancer, and fertility problems), it failed to warn of therisks associated with Gardasil. The dangerous propensities of Gardasil and the carcinogenic
characteristics and autoimmune-inducing characteristics of Gardasil, as described in this Complaint,
were known to Merck, or scientifically knowable to Merck through appropriate research and testing by
known methods, at the time it distributed, supplied, or sold Gardasil, and not known to end users andconsumers, such as Walker, her parents and medical providers.
390.

Merck knew or should have known that Gardasil and its ingredients and adjuvants

created significant risks of serious bodily harm to children and patients, as alleged herein, and Merck
failed to adequately warn patients, parents, medical providers and reasonably foreseeable users of therisks and lack of efficacy of Gardasil. Merck has wrongfully concealed information concerning
Gardasil’s dangerous nature and lack of efficacy and has further made false and misleading statements
concerning the safety and efficacy of Gardasil.
At all times relevant to this litigation, Merck’s Gardasil products reached the intended consumers,
handlers, and users or other persons coming into contact with these products throughout the UnitedStates, including Walker, without substantial change in their condition as designed, manufactured,sold, distributed, labeled, and marketed by Merck.
391.

Walker was injected with Gardasil in its intended or reasonably foreseeable mannerwithout knowledge of its unreasonable dangerous and inefficacious characteristics.
392.

Walker could not have reasonably discovered the defects and risks associated with

Gardasil before or at the time of her injection. Walker and her parents relied upon the skill, superior
knowledge, and judgment of Merck.
393.

Merck knew or should have known that the warnings disseminated with Gardasil were

inadequate, and failed to communicate adequate information concerning the true risks and lack ofefficacy of Gardasil and failed to communicate warnings and instructions that were appropriate and73
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adequate to render the products safe for their ordinary, intended, and reasonably foreseeable uses,
including injection in pre-teen girls.
394.

The information that Merck did provide or communicate failed to contain relevant

warnings, hazards, and precautions that would have enabled patients, parents of patients and the
medical providers of patients to properly utilize, recommend or consent to the utilization of Gardasil.
Instead, Merck disseminated information that was inaccurate, false, and misleading and which failed tocommunicate accurately or adequately the lack of efficacy, comparative severity, duration, and extent
of the serious risk of injuries associated Gardasil; continued to aggressively promote the efficacy andsafety of its products, even after it knew or should have known of Gardasil’s unreasonable risks andlack of efficacy; and concealed, downplayed, or otherwise suppressed, through aggressive marketingand promotion, any information or research about the risks, defects and dangers of Gardasil.
395.

To this day, Merck has failed to adequately and accurately warn of the true risks ofWalker’s injuries, including but not limited to, fibromyalgia, and autoimmune diseases, including
POTS and OI, associated with the use of and exposure to Gardasil, and has failed to warn of theadditional risks that Walker is now exposed to, including, but not limited to, the increased risk ofcancer, fertility problems and other potential side effects and ailments.
396.

As a result of Merck’s failure to warn and false promotion, Gardasil is and was

defective and unreasonably dangerous when it left the possession and/or control of Merck, wasdistributed by Merck, and used by Walker.
397.

Merck is liable to Walker for injuries caused by its failure, as described above, toprovide adequate warnings or other clinically relevant information and data regarding Gardasil, thelack of efficacy and serious risks associated with Gardasil and its ingredients and adjuvants.
398.

The defects in Merck’s Gardasil vaccine were substantial and contributing factors incausing Walker’s injuries, and, but for Merck’s misconduct and omissions and Gardasil’s defects,

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including its defective labeling and false promotion, Walker would not have sustained her injuries
which she has sustained to date, and would not have been exposed to the additional prospective risk
and dangers that are associated with Gardasil.
399.

Had Merck via its labeling, advertisements and promotions provided adequate andtruthful warnings and properly disclosed and disseminated the true risks, limitations and lack ofefficacy associated with Gardasil to medical providers, patients and the public, then upon information
and belief, Walker’s medical providers would not have offered or recommended Gardasil to Walker.
Moreover, even if after Merck’s dissemination of truthful information concerning the true risks andefficacy limitation of Gardasil, Walker’s medical providers had offered Gardasil, then upon
information and belief, the providers would have heeded any warnings issued by Merck and relayed toWalker and her mother the safety risks and efficacy limitations that Merck should have warned them
about, but failed to do so. Had Walker and her mother been informed of the true risks and efficacy
limitation concerning Gardasil, either by her medical providers or via Merck’s ubiquitous direct-toconsumer promotional marketing, on which her mother relied, then neither Walker nor her motherwould have consented to Walker being injected with Gardasil.
400.

As a proximate result of Merck’s wrongful acts and omissions and its defective labelingand false promotion concerning the safety and efficacy of Gardasil, Walker has suffered and continues
to suffer severe and permanent physical injuries, including, but not limited to, her autoimmune disease
and associated symptomology and has suffered severe and permanent emotional injuries, including
pain and suffering. Walker also has a substantial fear of suffering additional and ongoing harms,
including but not limited to now being at an increased risk of cancer, fertility problems and future
symptoms and harms associated with her autoimmune disease as a result of her exposure to Gardasil.
401.

As a direct and proximate result of her Gardasil-induced injuries, Walker has sufferedand continues to suffer economic losses, including considerable financial expenses for medical care

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and treatment, diminished income capacity and she will continue to incur these losses and expenses in
the future.
402.

Merck’s conduct, as described above, was aggravated, outrageous and evil. Merck

regularly risks the lives of children, including Walker, with full knowledge of the limited efficacy of
Gardasil and the severe and sometimes fatal dangers of Gardasil. Merck has made conscious decisions
to not warn, or inform the unsuspecting public, including Walker, her parents and her medical
providers. Merck’s conduct, including its false promotion of Gardasil and its failure to issue
appropriate warnings concerning the severe risks of Gardasil, created a substantial risk of significant
harm to children and patients who were being injected with Gardasil, and therefore warrants an awardof punitive damages.
403.

WHEREFORE, Walker requests that the Court enter judgment in her favor forcompensatory and punitive damages, together with interest, costs herein incurred, attorney’s fees, andall such other and further relief as this Court deems just and proper. Walker also demands a jury trial
on the issues contained herein.
COUNT THREESTRICT LIABILITY(MANUFACTURING DEFECT)404.

Walker incorporates by reference all other paragraphs of this Complaint as if fully set

forth herein, and further alleges:
405.

Walker brings this strict liability claim against Merck for manufacturing defect.

406.

At all times relevant to this litigation, Merck engaged in the business of researching,testing, developing, designing, manufacturing, marketing, selling, distributing, and promoting
Gardasil, which is defective and unreasonably dangerous to consumers, including Walker, because of
manufacturing defects, which patients, including Walker, her parents and her medical providers did

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not expect.
407.

Upon information and belief, the Gardasil vaccines injected into Walker were defective

and unreasonably dangerous because they failed to comply with manufacturing specifications requiredby the governing manufacturing protocols and also required by the regulatory agencies, including but
not limited to the FDA, by among other things, containing ingredients and toxins that were notdisclosed in the FDA-approved specifications and/or otherwise not disclosed in the package insert.
408.

Upon information and belief, and as way of example, the Gardasil injected into Walker

was defective and unreasonably dangerous because it failed to comply with the approved
manufacturing specifications, by containing dangerous and undisclosed HPV L1-DNA fragments, andthese DNA fragments could act as a Toll-Like Receptor 9 (TLR9) agonist, further adjuvanting thevaccine and making it more potent and dangerous than intended.
409.

Upon information and belief, and as way of example, the Gardasil injected into Walker

was defective and unreasonably dangerous because it failed to comply with the approved
manufacturing specifications, by containing dangerous and undisclosed ingredients and neurotoxins,
including but not limited to, phenylmethylsulfonyl fluoride (PMSF), a toxic nerve agent that is notintended for human consumption or injection.
410.

At all times relevant to this litigation, Merck’s Gardasil products reached the intended

consumers, handlers, and users or other persons coming into contact with these products throughout
the United States, including Walker, without substantial change in their condition as designed,
manufactured, sold, distributed, labeled, and marketed by Merck.
411.

Walker was injected with Gardasil in its intended or reasonably foreseeable mannerwithout knowledge of its dangerous and inefficacious characteristics.
412.

Walker, her parents and her medical providers could not reasonably have discovered thedefects, including the manufacturing defects, and risks associated with Gardasil before or at the time77
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of her injection. Walker and her parents relied upon the skill, superior knowledge, and judgment ofMerck.
413.

Merck is liable to Walker for injuries caused as a result of its manufacturing defects.

414.

The defects in Merck’s Gardasil vaccine were substantial and contributing factors incausing Walker’s injuries, and, but for Merck’s misconduct and omissions and Gardasil’s defects,
including but not limited to its manufacturing defects, Walker would not have sustained the injuries
she has sustained to date, and would not have been exposed to the additional prospective risk anddangers associated with Gardasil.
415.

As a proximate result of Merck’s wrongful acts and omissions and Gardasil’s

manufacturing defects, Walker has suffered and continues to suffer severe and permanent physicalinjuries, including her autoimmune disease and associated symptomology and has suffered severe andpermanent emotional injuries, including pain and suffering. Walker also has a substantial fear of
suffering additional and ongoing harms, including but not limited to now being at an increased risk ofcancer, fertility problems and future symptoms and harms associated with her autoimmune disease asa result of her exposure to Gardasil.
416.

As a direct and proximate result of her Gardasil-induced injuries, Walker has sufferedand continues to suffer economic losses, including considerable financial expenses for medical careand treatment, diminished income capacity and she will continue to incur these losses and expenses in
the future.
417.

Merck’s conduct, as described above, was aggravated, outrageous and evil. Merck

regularly risks the lives of children, including Walker, with full knowledge of the limited efficacy of
Gardasil and the severe and sometimes fatal dangers of Gardasil. Merck has made conscious
decisions to not warn, or inform the unsuspecting public, including Walker, her parents and her
medical providers. Merck’s conduct, including its false promotion of Gardasil and its failure to issue

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appropriate warnings concerning the severe risks of Gardasil, created a substantial risk of significant
harm to children and patients who were being injected with Gardasil, and therefore warrants an awardof punitive damages.
418.

WHEREFORE, Walker requests that the Court enter judgment in her favor forcompensatory and punitive damages, together with interest, costs herein incurred, attorney’s fees, andall such other and further relief as this Court deems just and proper. Walker also demands a jury trial
on the issues contained herein.
COUNT FOUR
BREACH OF EXPRESS WARRANTY
419.

Walker incorporates by reference all other paragraphs of this Complaint as if fully set

forth herein, and further alleges:
420.

Merck engaged in the business of testing, researching, developing, designing,

manufacturing, labeling, marketing, selling, distributing, and promoting Gardasil, which is defective
and unreasonably dangerous to consumers, including Walker.
421.

At all times relevant to this litigation, Merck expressly represented and warranted

through statements made in its Gardasil label, publications, television advertisements, billboards, print
advertisements, online advertisements and website, and other written materials intended for
consumers, patients, parents of minor-aged patients, medical providers and the general public, that
Gardasil was safe and effective at preventing cancer. Merck advertised, labeled, marketed, andpromoted Gardasil, representing the quality to consumers, patients, medical providers and the public
in such a way as to induce their purchase or use, thereby making an express warranty that Gardasil
would conform to the representations.
422.

These express representations included incomplete warnings and instructions that

purport, but fail, to include the complete array of risks associated with Gardasil. Merck knew and/or

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should have known that the risks expressly included in Gardasil’s promotional material and labels did
not and do not accurately or adequately set forth the risks of developing the serious injuries
complained of herein. Nevertheless, Merck falsely and expressly represented that Gardasil was “safe”
for use by individuals such as Walker, and/or that Gardasil was “effective” in preventing cervicalcancer and that any young girl who was vaccinated with Gardasil would be “one less” woman withcervical cancer.
423.

The representations about Gardasil, as set forth herein, contained or constituted

affirmations of fact or promises made by the seller to the buyer, which related to the goods andbecame part of the basis of the bargain, creating an express warranty that the goods would conform to
the representations.
424.

Merck breached these warranties because, among other things, Gardasil is ineffective atpreventing cervical cancer, defective, dangerous, unfit for use, and is associated with a myriad of
dangerous and undisclosed risks, including, but not limited to, the risk of autoimmune disease,including POTS, the risk of developing cervical cancer (even though Merck promoted it aspreventing cervical cancer), OI, fibromyalgia and the risk of fertility problems for young girls.
Specifically, Merck breached the warranties in the following ways:a)Representing to patients and the medical community, including Walker, herparents and her medical providers that Gardasil is effective in preventing
cervical cancer, when Merck knew that contrary to these representations (i) no
clinical studies were performed to test if Gardasil prevents cervical cancer; (ii)the clinical studies confirmed that Gardasil is indeed ineffective when used inpatients who have previously been exposed to HPV, and that Gardasil actually
increases the risk of cervical cancer in any child or patient who has beenpreviously exposed to HPV; and (iii) there are safer and more effective methods

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of monitoring for and attempting to prevent cervical cancer, including but notlimited to regular testing, such as regular Pap smears.
b)

Representing to patients and the medical community, including Walker, herparents and her medical providers that Gardasil is safe, when in reality, Gardasil
causes and presents serious risks of cancer (including cervical cancer, the very
cancer it is promoted as preventing), fertility problems, autoimmune disease,including but not limited to POTS, and other grave illnesses;c)Engaging in false advertising and disease mongering by scaring parents andchildren into believing that cervical cancer is far more prevalent than it really is;that all cervical cancer was linked to HPV; that Gardasil prevented cervicalcancer, when in reality none of these representations were true as cervical cancer
rates were declining in the United States due to Pap testing and Gardasil has notbeen shown to prevent against all strains of HPV that are associated withcervical cancer and indeed it has never been shown to prevent cervical cancer.

425.

Merck had sole access to material facts concerning the nature of the risks and defects

associated with Gardasil as expressly stated within its promotional material and labels, and Merckknew that patients and users such as Walker, her parents and her medical providers could not havereasonably discovered the truth about the inefficacies and serious risks associated with Gardasil as
alleged herein.
426.

Walker and her parents had no knowledge of the falsity or incompleteness of Merck’s

statements and representations concerning Gardasil.
427.

Walker’s mother was exposed to and relied upon the ubiquitous promotional material

and representations Merck made in its direct-to-consumer advertisements and marketing materials
concerning the safety and efficacy of Gardasil, including: that Gardasil prevents cervical cancer and81
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cervical cancer is prevalent (even though children rarely get cervical cancer and Pap tests are the best
frontline defense in detecting and fighting cervical cancer); that “good mothers” vaccinate theirchildren and that Gardasil is perfectly safe; that, if her daughter received the Gardasil vaccine, herdaughter would become “one less” woman with cervical cancer; however, had Merck in theseadvertisements not engaged in disease mongering and deception, but instead had informed her the truth
about the serious risks of Gardasil (as outlined in this Complaint) and its lack of efficacy, she would
never have consented to her minor daughter being injected with Gardasil.
428.

As a proximate result of Merck’s wrongful acts and omissions and it breaches ofwarranties concerning the safety and efficacy of Gardasil, Walker has suffered and continues to suffer
severe and permanent physical injuries, including her autoimmune disease and associatedsymptomology and has suffered severe and permanent emotional injuries, including pain and suffering.
Walker also has a substantial fear of suffering additional and ongoing harms, including but not limited
now to being at an increased risk of cancer, fertility problems and future symptoms and harms
associated with her autoimmune disease as a result of her exposure to Gardasil.
429.

As a direct and proximate result of her Gardasil-induced injuries, Walker has sufferedand continues to suffer economic losses, including considerable financial expenses for medical careand treatment, diminished income capacity and she will continue to incur these losses and expenses in
the future.
430.

Merck’s conduct, as described above, was aggravated, outrageous and evil. Merck

regularly risks the lives of children, including Walker, with full knowledge of the limited efficacy of
Gardasil and the severe and sometimes fatal dangers of Gardasil. Merck has made conscious decisions
to not warn, or inform the unsuspecting public, including Walker, her parents and her medical
providers. Merck’s conduct, including its false promotion and false warranties concerning the safety
and efficacy of Gardasil and its failure to issue appropriate warnings concerning the severe risks of

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Gardasil, created a substantial risk of significant harm to children and patients who were being injectedwith Gardasil, and therefore warrants an award of punitive damages.
431.

WHEREFORE, Walker requests that the Court enter judgment in her favor forcompensatory and punitive damages, together with interest, costs herein incurred, attorney’s fees, andall such other and further relief as this Court deems just and proper. Walker also demands a jury trial
on the issues contained herein.
COUNT FIVECOMMON LAW FRAUD
432.

Walker incorporates by reference all other paragraphs of this Complaint as if fully set

forth herein, and further alleges:
433.

Merck is the researcher, designer, manufacturer, labeler, and promoter of Gardasil.

434.

Merck marketed Gardasil to and for the benefit of patients, including pre-teen girls suchas Walker, her parents and her medical providers.
435.

Merck had a duty to deal honestly and truthfully with regulators, patients, consumers

and medical providers in its development, testing, marketing, promotion, and sale of Gardasil.
436.

Merck’s duty of care owed to patients and medical providers included providing

accurate, complete, true, and correct information concerning the efficacy and risks of Gardasil in its
direct-to-consumer advertisements, promotional material, and labeling.
437.

At all times relevant to this litigation, Merck knew or should have known of the hazards

and dangers of Gardasil and specifically, the serious, debilitating and potentially fatal adverse events
associated with Gardasil, including but not limited to autoimmune diseases (including, but not limited
to, POTS), OI, fertility complications, increased risk of cancer (including cervical cancer, which was
the very cancer it was promoted as preventing) and death.
438.

At all times relevant to this litigation, Merck knew or should have known that its poorly

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designed clinical trials and studies were insufficient to test the true long-term safety and efficacy of
Gardasil.
439.

At all times relevant to this litigation, Merck expressly represented through statements it

made in its publications, ubiquitous television advertisements, billboards, print advertisements, online
advertisements and website, and other written materials intended for consumers, patients, parents ofminor-aged patients, medical providers and the general public, that Gardasil was safe and effective atpreventing cancer.
440.

These express representations included incomplete warnings and instructions that

purport, but fail, to include the complete array of risks associated with Gardasil. As way of example
Merck’s marketing material, including its “One Less” television and print advertisement campaign(including but not limited to Gardasil posters in medical facilities and doctors’ offices), which
Walker’s mother saw and on which she relied, stated that Gardasil was safe for young girls, that
Gardasil was effective in preventing cervical cancer, that Gardasil was a “cervical cancer vaccine”
and that any young girl who was vaccinated with Gardasil would be “one less” woman with cervicalcancer. The only safety warnings Merck provided in these marketing materials was that a patient
could get pain, swelling or redness at injection site, fever, and/or nausea.
441.

The ubiquitous nature of these Gardasil commercials and the Gardasil marketing

campaign gave the impression that cervical cancer was on the rise and more prevalent than it actually
was, and that all good mothers vaccinate their daughters with the “cervical cancer vaccine.” Themarketing was indeed designed to make mothers feel guilty if they did not vaccinate their children.
One such Gardasil print campaign Merck ran stated in colorful bold and all caps letters: “Yourdaughter can’t possibly know the importance of a cervical cancer vaccine, but thankfully, she has hermother.” And, another print campaign in similar bold and all caps letters proclaimed: “The power tohelp prevent cervical cancer is in your hands and on your daughter’s arm.”

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442.

Merck knew or should have known that the risks expressly included in Gardasil’s

promotional material and labels did not and do not accurately or adequately set forth the true andcomplete risks of developing the serious injuries that are associated with Gardasil, as previously
alleged herein, and which include but are not limited to, autoimmune diseases (including, but notlimited to, POTS), OI, fertility complications, increased risk of cancer (including cervical cancer,
which was the very cancer it was promoted as preventing) and death.
443.

The same promises of efficacy and limited and incomplete warnings Merck relayed inits direct-to-consumer advertising, were what Walker’s medical providers relayed to her when they
recommended Gardasil – i.e., that Gardasil prevents cervical cancer and the only risks associated with
Gardasil are soreness, redness, swelling and itching at the injection site and that a fever may develop.
444.

Walker’s mother had been exposed to Merck’s marketing material concerning Gardasil,

including the aforementioned “One Less” marketing campaign and other print advertisements andposters at doctors’ offices, and the representations made by Merck therein that Gardasil is effective atpreventing cervical cancer, that Gardasil is safe and that its only side-effects are essentially minor
injection site pain and swelling and the possible onset of a fever or nausea. Prior to providing consent
to inject Walker with the Gardasil vaccine, Walker and her mother were never informed by Merck, oranyone else, that Gardasil is linked to a host of serious debilitating and chronic adverse events
including, autoimmune diseases (including, but not limited to, POTS), fibromyalgia, fertility
complications, increased risk of cancer (including cervical cancer, which was the very cancer it was
promoted as preventing) and death.
445.

Prior to providing consent to inject Walker with the Gardasil vaccine, Walker and hermother were never informed by Merck, or anyone else, that Merck had not conducted the proper
testing necessary to demonstrate the efficacy and full safety of Gardasil.
446.

Prior to providing consent to inject Walker with the Gardasil vaccine, Walker and her

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mother were never informed by Merck, or anyone else, that Merck had, as alleged herein, manipulated
its clinical studies to mask and conceal the adverse events associated with Gardasil.
447.

Prior to providing consent to inject Walker with the Gardasil vaccine, Walker and hermother were never informed by Merck, or anyone else, that the Gardasil clinical trials neverestablished that Gardasil can prevent cervical cancer, even though Merck in its promotional material
to Walker’s mother falsely represented that Gardasil was a “cervical cancer vaccine” and that a child
who received Gardasil would become “one less” woman to get cervical cancer.
448.

Merck’s representations were false, because in truth, Gardasil has not been proven toprevent cervical cancer and is associated with a myriad of dangerous and undisclosed risks, including,but not limited to, the risk of autoimmune disease, including POTS, OI, the risk of developing cervicalcancer (even though Merck falsely promoted Gardasil as preventing cervical cancer) and the risk offertility problems for young girls. The false representations Merck made to the children, the parents ofchildren, the medical community, including to Walker and her mother, included:a)that Gardasil is effective in preventing cervical cancer for all young girls, when
Merck knew that, contrary to these representations (i) no clinical studies were
performed to test whether Gardasil prevents cervical cancer; and (ii) the clinicalstudies confirmed that Gardasil is indeed ineffective when used in patients who
have previously been exposed to HPV, and that Gardasil actually increases therisk of cervical cancer in any child or patient who has been previously exposed
to HPV;b)that Gardasil is safe, when in reality, Gardasil causes and presents severe risksof cancer (including cervical cancer, the very cancer it is promoted as
preventing), fertility problems, autoimmune disease, including POTS, OI andother grave illnesses;

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c)false advertising and disease mongering by scaring parents (including Walker’s
mother) into believing that cervical cancer was far more prevalent than it really
was; that Gardasil prevented cervical cancer; and that Gardasil only had risks ofinjection site pain and fever, when in reality none of these representations weretrue as cervical cancer rates were declining in the United States due to Pap
testing and Gardasil has not been shown to prevent cervical cancer and indeed
some studies demonstrated that it actually increased the risk of cervical cancer;
and Gardasil was linked to a host of serious, chronic and sometimes fatal
diseases, including autoimmune diseases, as previously outlined in thisComplaint.

449.

These representations and other similar representations were made by Merck to the

public, including to Walker and her mother, with the intent that girls and mothers of young girls would
either seek out Gardasil from their medical providers or otherwise would provide their consent when
they were offered Gardasil.
450.

At the time they provided their consent to the Gardasil injection, Walker and her motherwere not aware of the falsity of Merck’s aforementioned representations concerning the safety andefficacy of Gardasil.
451.

Walker’s mother reasonably and justifiably relied upon the truth of the assurance madeby Merck in its direct to consumer marketing concerning the efficacy and safety of Gardasil (whichwere also echoed by Walker’s medical providers), when she provided her consent to have herdaughter, Sahara Walker, injected with the Gardasil vaccine.
452.

Had Merck’s advertisements and promotional material, which Merck targeted to young

girls and the parents of young girls, and which Walker’s mother received and on which she relied,
provided complete and truthful warnings and properly disclosed and disseminated the true risks,

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limitations and lack of efficacy associated with Gardasil, then neither Walker nor her mother would
have consented to Walker being injected with Gardasil.
453.

Merck also engaged in a number of additional fraudulent activities that led to regulators,

medical providers (upon information and belief, including but not limited Walker’s medical providers),
and the general public (including directly and/or indirectly Walker and her mother) into being duped
believing that Gardasil is safe and effective. These fraudulent acts are outlined in greater detail in thepreceding paragraphs of this Complaint, and included, among others:d)Failing to test Gardasil against a true inert placebo and lying to the public that
Gardasil was tested against a placebo, when in reality, all, or nearly all, studies
used a toxic placebo that included the dangerous aluminum adjuvant AAHS.

e)

Failing to conduct a sufficient number of studies for the targeted patient
population which included pre-teen girls (and boys) between the ages of 9 and
12.

f)

Not using the commercial dosage (and instead using a lower dosage of the
adjuvant and ingredients) in one of the key clinical trials, which was used toobtain licensing for the commercial dosage of Gardasil;g)Using very restrictive exclusionary criteria in the clinical study patient
population (including for example excluding anyone who had prior abnormal
Pap tests, who had a history of immunological or nervous system disorders or

was allergic to aluminum or other ingredients), but then not revealing or
warning about these exclusionary criteria in the label and knowing that for mostof these ingredients and allergies, there are limited resources for the public totest for such allergies in advance of being vaccinated;h)Failing to disclose all of the ingredients in Gardasil, including but not limited to88
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the fact that Gardasil contains dangerous HPV L1-DNA fragments and thatthese DNA fragments could act as a Toll-Like Receptor 9 (TLR9) agonist –further adjuvanting the vaccine and making it more potent and dangerous.
454.

Merck engaged in the above mentioned fraudulent conduct as well as the additional

fraudulent conduct detailed throughout this Complaint with the intent to enhance Gardasil’s safety andefficacy profile and to conceal Gardasil’s serious risks and efficacy shortcomings in order to secure
regulatory approval and more importantly, so as to encourage physicians and medical providers torecommend Gardasil to patients and to prepare and encourage patients to request and consent to
Gardasil injection.
455.

Walker and her mother could not reasonably have discovered the falsity of Merck’s

representations, the fraudulent nature of Merck’s conduct and the defects and risks associated with
Gardasil before or at the time of her injection. Walker and her parents relied upon the skill, superior
knowledge, and judgment of Merck, the manufacturer, labeler, and promoter of Gardasil and they
detrimentally relied upon Merck’s fraudulent, false, and misleading statements, omissions, andconduct.
456.

As a proximate result of Merck’s fraudulent, false, and misleading statements,

omissions, and conduct concerning the safety and efficacy of Gardasil, Walker has suffered andcontinues to suffer severe and permanent physical injuries, including autoimmune disease andassociated symptomology and has suffered severe and permanent emotional injuries, including pain
and suffering. Walker also has a substantial fear of suffering additional and ongoing harms, including
but not limited to now being at an increased risk of cancer, fertility problems and future symptoms andharms associated with her autoimmune disease as a result of her exposure to Gardasil.
457.

As a direct and proximate result of her Gardasil-induced injuries, Walker has sufferedand continues to suffer economic losses, including considerable financial expenses for medical care

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and treatment, diminished income capacity and she will continue to incur these losses and expenses in
the future.
458.

Merck’s conduct, as described above, was aggravated, outrageous and evil. Merck

regularly risks the lives of children, including Walker, with full knowledge of the limited efficacy of
Gardasil and the severe and sometimes fatal dangers of Gardasil. Merck has made conscious decisions
to not warn, or inform the unsuspecting public, including Walker, her parents and her medical
providers. Merck’s conduct, including its false promotion of Gardasil and its failure to issue
appropriate warnings concerning the severe risks of Gardasil, created a substantial risk of significant
harm to children and patients who were being injected with Gardasil, and therefore warrants an awardof punitive damages.
459.

WHEREFORE, Walker requests that the Court enter judgment in her favor forcompensatory and punitive damages, together with interest, costs herein incurred, attorney’s fees, andall such other and further relief as this Court deems just and proper. Walker also demands a jury trial
on the issues contained herein.
PRAYER FOR RELIEF
WHEREFORE, Plaintiff, Sahara Walker, requests that the Court enter judgment in her favor
and against Merck & Co., Inc., and Merck, Sharp and Dohme Corporation (collectively “Merck”) as toall causes of action, and awarding as follows:A.

For compensatory damages, in an amount exceeding this Court’s jurisdictional
minimum and to be proven at trial;

B.

For economic and non-economic damages in an amount to be proven at trial;

C.

For medical, incidental, hospital, psychological and other expenses in an amount to be
proven at trial;

D.

For loss of earnings and earnings capacity, in an amount to be proven at trial;

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E.

For an award of pre-judgment and post-judgment interest as provided by law;F.

For exemplary and punitive damages against Merck;G.

For preliminary and/or permanent injunctive relief;

H.

For an award providing for payment of reasonable attorneys’ fees, court costs, and otherlitigation expenses as permitted by law;I.

For such other and further relief as this Honorable Court may deem just and proper.
DEMAND FOR JURY TRIAL

Pursuant to Rule 38(b) of the Federal Rules of Civil Procedure, plaintiff, Sahara Walker,
hereby demands a jury trial on all of her claims, causes of action and issues that are triable by jury.

Dated: November 18, 2020

BAUM, HEDLUND, ARISTEI, & GOLDMAN, P.C.
By: /s/ Michael L. Baum
Michael L. Baum
mbaum@baumhedlundlaw.com
Bijan Esfandiari (Admission to be filed)besfandiari@baumhedlundlaw.com
Nicole K.H. Maldonado (Admission to be filed)
nmaldonado@baumhedlundlaw.com
10940 Wilshire Blvd., 17th Floor
Los Angeles, CA 90024
Telephone: (310) 207-3233
Facsimile: (310) 820-7444
Robert F. Kennedy, Jr. (Admission to be filed)robert.kennedyjr@childrenshealthdefense.org
Children's Health Defense
1227 N Peachtree Parkway
Suite 202
Peachtree City, GA 30269
Telephone: (845) 481-2622
Attorneys for Plaintiff

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COMPLAINT