1 

COMPLAINT 

UNITED STATES DISTRICT COURT 

NORTHERN DISTRICT OF TEXAS 

PAIGE GRAVES, Individually 

and as Next Friend on Behalf of 

D.G., a Minor Child, 

 

 Plaintiff, 

v. 

MERCK & CO., INC., a New Jersey Corporation; 

and MERCK SHARP & DOHME CORP., a New 

Jersey Corporation, 

 

 Defendants. 

Case No. 3:22-cv-01432 

COMPLAINT FOR 

(1) Negligence 

(2) Strict Liability (Failure to Warn) 

(3) Strict Liability (Manufacturing Defect) 

(4) Breach of Warranty 

(5) Common Law Fraud 

DEMAND FOR JURY TRIAL 

 

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COMPLAINT 

TABLE OF CONTENTS 

Page

INTRODUCTION .......................................................................................................................... 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 

and Debilitating Adverse Events .......................................................................................10

A. Overview of the Human Papillomavirus ............................................................... 10

B. Overview of the Gardasil Vaccine and Its Fast-Tracked Approval ...................... 12

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 ........ 19

E. Merck Pushed Gardasil Using Trusted Doctors and Third-Party Front Groups ... 21

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 ..................................................................... 22

G. The Gardasil Vaccines Contain Numerous Hazardous Ingredients, Including At 

Least One Ingredient Merck Failed to Disclose to Regulators and the Public ..... 25

i. Gardasil Contains A Toxic Aluminum Adjuvant ..................................................25

ii. Merck Lied About a Secret DNA Adjuvant Contained in The Gardasil 

Vaccines ...........................................................................................................26

iii. Gardasil Contains Borax ..................................................................................27

iv. Gardasil Contains Polysorbate 80 ....................................................................27

v. Gardasil Contains Genetically Modified Yeast ...............................................28

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 ......... 28

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COMPLAINT 

i. Small Clinical Trials ..............................................................................................31

ii. Merck Used a Highly Toxic “Placebo” to Mask Gardasil Injuries ..................31

iii. Merck Used Exclusionary Criteria to Further Conceal Gardasil Risks ...........32

iv. Merck Deceived Regulators and The Public by Classifying Many Serious 

Adverse Events, Which Afflicted Nearly Half of All Study Participants, As 

Coincidences ....................................................................................................34

v. Merck Manipulated the Study Protocols to Block Participants and Researchers 

from Reporting Injuries and Designed the Studies to Mask Any Long-Term 

Adverse Events ................................................................................................35

vi. Merck Deceived Regulators and the Public About Its Pivotal Gardasil Clinical 

Trial (Protocol 018)..........................................................................................36

I. Contrary to Merck’s Representations, Gardasil May Actually Cause and Increase 

the Risk of Cervical and Other Cancers ................................................................ 39

J. Merck has Concealed the Fact that Gardasil Induces and Increases the Risk of 

Autoimmune Diseases, and Other Injuries, Including But Not Limited to, Postural 

Orthostatic Tachycardia Syndrome, Chronic Fatigue Syndrome, Neuropathy, 

Fibromyalgia and Dysautonomia .......................................................................... 41

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

Problems ............................................................................................................... 48

L. There were an Increased Number of Deaths in the Gardasil Studies ................... 49

M. Post-Marketing Injuries – The Raft of Injuries Seen in Merck’s Clinical Trials 

Has Now Become A Population-Wide Chronic Disease Epidemic ...................... 50

N. The Gardasil Vaccines’ Harms Are Not Limited to the United States, Rather the 

Vaccines Have Injured Patients All Over the World ............................................ 51

i. In Light of Gardasil’s Serious and Debilitating Adverse Events, the Japanese 

Government Rescinded Its Recommendation that Girls Receive Gardasil .....51

ii. Denmark Has Opened Specialized Clinics Specifically Focused on Treating 

Gardasil-Induced Injuries, Including Gardasil-Induced Autoimmune Diseases

..........................................................................................................................53

iii. Gardasil-Induced Adverse Events Caused the Government in Colombia to 

Conclude that Gardasil Would No Longer Be Mandatory ..............................53

iv. India Halted Gardasil Trials and Accused Merck of Corruption After the 

Death of Several Young Girls Who were Participants in the Trial ..................53

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O. Merck’s Fraud Has Paid Off Handsomely Resulting in Over $3 Billion in Gardasil 

Sales Annually ...................................................................................................... 55

III. D.G. Sustained Autoimmune Disease, Autonomic Dysfunction and Other Serious 

Injuries, as a Result of Her Gardasil Injections .................................................................56

A. Gardasil and Its Ingredients Caused Plaintiff’s Autoimmune Disease and Other 

Related Injuries and Has Resulted in Her Suffering From Severe, Debilitating, 

Disabling and Painful Chronic Injuries ................................................................. 56

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 .................................................. 59

CAUSES OF ACTION ................................................................................................................. 60

COUNT ONE NEGLIGENCE ..................................................................................... 60

COUNT TWO STRICT LIABILITY (FAILURE TO WARN) ................................... 67

COUNT THREE STRICT LIABILITY (MANUFACTURING DEFECT) ................ 72

COUNT FOUR BREACH OF EXPRESS WARRANTY............................................ 74

COUNT FIVE COMMON LAW FRAUD ................................................................... 78

PRAYER FOR RELIEF ............................................................................................................... 84

DEMAND FOR JURY TRIAL .................................................................................................... 85

 

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COMPLAINT 

COMES NOW Plaintiff, Paige Graves, Individually and as Next Friend on Behalf of D.G., 

a minor child, by and through her undersigned counsel 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 

and fraud action arises out of serious and debilitating injuries, including but not limited to 

autonomic, neurological and heterogenous autoimmune injuries and resulting sequalae that minor 

child D.G., sustained as a result of receiving the Gardasil vaccine, which was manufactured, 

labeled, and promoted by defendants Merck & Co., Inc. and Merck, Sharp and Dohme Corporation 

(collectively “Merck”). 

PARTIES AND VENUE 

2. Paige Graves, Individually and as Next Friend on Behalf of D.G., a minor child, is 

an adult and a resident and citizen of Texas. 

3. Defendant Merck & Co., Inc., is a New Jersey corporation with its principal place 

of business 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 shall 

hereinafter collectively be referred to as “Merck.” 

6. At all times herein mentioned, each defendant was the agent, servant, partner, aider 

and abettor, 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 other defendants, knowing that their collective conduct constituted a breach 

of duty owed to Plaintiff. 

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

their agents and employees, and thereafter no officer, director or managing agent of defendants 

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COMPLAINT 

repudiated those 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 in 

ownership 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 

over each other. Adherence to the fiction of the separate existence of these two named defendants 

as entities distinct from each other will permit an abuse of the corporate privilege and would 

sanction a fraud and/or would promote injustice. 

9. At all times herein mentioned, the two Merck defendants were engaged in the 

business of, or were successors in interest to, entities engaged in the business of researching, 

formulating, compounding, testing, manufacturing, producing, processing, assembling, 

inspecting, distributing, marketing, labeling, promoting, packaging, prescribing and/or 

advertising for sale, and selling products for use by patients such as Plaintiff and D.G.’s medical 

providers. As such, the two Merck defendants are each individually, as well as jointly and 

severally, liable to Plaintiff for her damages. 

10. The harm caused to Plaintiff resulted from the conduct of one or various 

combinations of the two Merck defendants, and through no fault of Plaintiff. There may be 

uncertainty as to which one or which combination of the two Merck defendants caused the harm. 

The two Merck defendants have superior knowledge and information on the subject of which one 

or which combination of the two defendants caused Plaintiff’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 Plaintiff has suffered. As previously stated, the two named Merck defendants shall 

hereinafter and throughout this Complaint be collectively referred to as “Merck.” 

11. Merck is the manufacturer, labeler and promoter of the Gardasil and Gardasil 9 

vaccines, which are purported to be “cervical cancer vaccines” and “anal cancer vaccines” by 

preventing a handful of the hundreds of strains of the Human Papillomavirus (“HPV”). Merck 

regularly conducts and transacts business in Texas and has promoted Gardasil to consumers, 

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COMPLAINT 

patients, hospitals, physicians, nurses and medical professionals, including but not limited to 

Plaintiff, and the medical facility and medical professionals who prescribed and/or injected D.G. 

with Gardasil. This Court has personal jurisdiction over Merck because defendants have 

sufficient minimum contacts with Texas 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 Plaintiff and the defendants are citizens of different states and the amount of 

controversy 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 

portion of the events and omissions giving rise to the claims asserted herein occurred in this 

District. 

GENERAL ALLEGATIONS 

I. “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 

a pharmacy for approximately the next 150+ years when, in 1827, Friedrich’s descendant, Heinrich 

Emmanuel Merck, converted the company into a drug manufacturing enterprise. Merck’s first 

products included morphine and cocaine. 

15. Merck later manufactured a number of controversial products including Fosamax 

(a purported bone density drug that caused bone fractures), Nuvaring (a birth control device 

associated with life-threatening blood clots and death), and probably its most infamous drug, 

Vioxx (a pain 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 in the early 2000s revealed a 

culture wherein Merck knew early on that Vioxx was linked to fatal cardiovascular adverse events 

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COMPLAINT 

but nonetheless 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 the 

existence 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 make less of the apparent risk] ...” Harlan M. Krumholz et al., What We Have Learnt 

From Vioxx, 334 BRITISH MED.J. 120 (2007). And, despite Merck’s knowledge of the risk, Merck 

never conducted the necessary studies designed to evaluate cardiovascular risk. Id. 

19. In an article published in the Journal of the American Medical Association, it was 

reported 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 case studies 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, 

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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 to debunk 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 pressuring some 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 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 to settle 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 a result 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. Gardasil was viewed as the answer to the financial woes Merck had suffered from 

Vioxx. 

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24. Indeed, some have euphemistically noted that HPV stood for “Help Pay for Vioxx.” 

25. 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 

the Holy 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 and Which Can Cause Serious and Debilitating Adverse Events 

26. 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. 

27. Certain Merck employees, scientists and executives involved in the Vioxx scandal 

were also involved with Gardasil, and it appears they employed the very same methods of 

manipulating science and obscuring risks as they did with Vioxx. 

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

Gardasil 9) provided lifetime immunity to cervical, anal and other HPV-associated cancers. 

29. 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. 

30. Moreover, Merck knows and actively conceals the fact that Gardasil can cause a 

constellation of serious adverse reactions and gruesome diseases, including autoimmune diseases, 

and death in some recipients. 

31. As a result of Merck’s fraud, Gardasil today is wreaking havoc on a substantial 

swath of an entire generation of children and young adults on a worldwide scale. 

A. Overview of the Human Papillomavirus 

32. 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. 

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33. 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. 

34. HPV, for the most part, is benign. More than 90 percent of HPV infections cause 

no clinical symptoms, are self-limited, and 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 

GYNECOLOGIC ONCOLOGY 306 (August 2012). 

35. Approximately 12 to 18 of the over 200 strains of HPV are believed to be associated 

with cervical cancer, and approximately six of the strains are believed to be associated with anal 

cancer. 

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

infections – not short-term or transient infections or sequential infections with different HPV types 

– in a limited number of cases with certain strains of the virus may cause the development of 

precancerous lesions. With respect to cervical cancer, these precancerous lesions are typically 

diagnosed through Pap smears and then removed through medical procedures. However, when 

undiagnosed, they may in some cases progress to cervical cancer in some women. Other risk 

factors, such as smoking, are also associated with cervical cancer. See Antonio C. de Freitas et 

al., Susceptibility to cervical cancer: An Overview, 126 GYNECOLOGIC ONCOLOGY 305 (August 

2012). Infection with certain types of HPV are also associated with other diseases, such as genital 

warts. 

37. 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. 

38. Since its introduction, cervical cancer screening through the Pap test has reduced 

the rates of cervical cancer in developed countries by up to 80 percent. Id. 

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39. Incidences of cervical cancer have been declining dramatically worldwide as 

countries have implemented Pap screening programs. 

40. New cases of cervical cancer in the U.S. affect approximately 0.8 percent of women 

in their lifetime. See Cancer Stat Facts: Cervical Cancer, NIH, at 

https://seer.cancer.gov/statfacts/html/cervix.html. For those who are diagnosed, cervical cancer is 

largely treatable, with a five-year survival rate of over 90 percent when the cancer is caught early. 

See Antonio C. de Freitas et al., Susceptibility to cervical cancer: An Overview, 126 GYNECOLOGIC 

ONCOLOGY 305 (August 2012). Anal cancer is even more rare, and according to the current data, 

approximately 0.2 percent of people will be diagnosed with anal cancer in their lifetime. 

41. Although the incidence of cervical cancer was in rapid decline as a result of the 

implementation of routine testing and screening, including the Pap test and various DNA testing 

measures, 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). 

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

42. While there are over 200 types of the HPV virus, only 12 to 18 types currently are 

considered potentially associated with cervical or anal 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 and 18) were associated with cervical and anal cancer. 

43. Under Food and Drug Administration (“FDA”) requirements, to obtain approval 

for marketing a vaccine, the manufacturer must conduct studies to test the effectiveness and safety 

of the vaccine. Once FDA approval is obtained, the manufacturer has a duty to perform any further 

scientific and medical investigation as a reasonably prudent manufacturer would perform, and to 

engage in any necessary post-marketing pharmacovigilance related to the product. 

44. The FDA approved Gardasil on June 8, 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 

be administered. 

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45. 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. 

46. Merck failed to perform in the preapproval processing period and thereafter, 

scientific and 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 

which a prudent manufacturer should have conducted unilaterally. 

47. In June 2006, after the FDA’s fast-tracked review, Gardasil was approved for use 

in females ages nine through 26 for the purported prevention of cervical cancer and, almost 

immediately thereafter, the Advisory Committee on Immunization Practices (“ACIP”), a 

committee within the Centers for Disease Control (“CDC”), recommended Gardasil for routine 

vaccination of adolescent girls ages eleven and twelve years old, but also allowed it to be 

administered to girls as young as nine years old. 

48. On October 16, 2009, the FDA approved Gardasil for use in boys ages nine through 

26 for the prevention of genital warts caused by HPV Types 6 and 11, and in December 2010, it 

approved Gardasil for the purported prevention of anal cancer in males and females ages nine 

through 26. 

49. 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 and anal cancer (HPV Types 31, 33, 45, 52 

and 58) than the original Gardasil, for a total of nine strains. 

50. The FDA approved Gardasil 9 in December 2014, for use in girls ages nine through 

26 and boys ages nine 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 nine and 45 years of age, with an emphasis by Merck on marketing 

to pre-teen children and their parents. With little evidence of efficacy, the FDA also recently 

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approved, on an accelerated basis, Gardasil 9 for prevention of oropharyngeal and other head and 

neck cancers. 

51. After the approval of the Gardasil 9 vaccine, the original Gardasil vaccine was 

phased out of the U.S. Market; and the original Gardasil vaccine is no longer available for sale in 

the United States. 

52. 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. 

53. The median age of death from cervical cancer is 58, and death from anal cancer is 

66, and teenagers (who are the target population of Gardasil) essentially have zero risk of dying 

from cervical or anal cancer. 

54. 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 of drugs, and to expedite their review, in order to treat serious conditions and fill an 

unmet medical need. 

55. 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 and 

side-effect free intervention, Pap smears, with no evidence that Gardasil was potentially superior 

to Pap smears in preventing cervical cancer. 

56. In fact, the clinical trials Merck undertook did not even examine Gardasil’s 

potential to prevent 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. 

Likewise, the clinical trials from Gardasil did not examine Gardasil’s potential to prevent anal 

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COMPLAINT 

cancer, rather, the trials similarly only look at anal intraepithelial neoplasia (“AIN”) lesions graded 

1 through 3, and the Gardasil 9 studies did not even include any studies concerning the efficacy of 

Gardasil in preventing anal lesions. 

57. 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 

progress from a less severe condition to a more serious one.” 

58. As previously discussed, over 90 percent of HPV infections and the majority of 

cervical dysplasia, resolve without intervention. 

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

CIN3 inexorably result in cancer. 

60. Federal law allows fast-track approval when there is no existing intervention to treat 

the targeted disease or where the proposed treatment is potentially superior to an existing 

treatment. 

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

Pap tests in preventing cervical cancer. 

62. 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 (“ACIP”) to win both an FDA license and a CDC/ACIP approval and 

recommendation that all 11 and 12 year old girls should be vaccinated with Gardasil. 

63. That ACIP “recommendation” was, effectively, a mandate to doctors to sell 

Merck’s very expensive vaccine, thereby 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 demand through 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. 

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64. 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. 

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

Vaccines in 2010. 

66. 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 

to oversee the commercial success of the vaccine she previously approved), it is also worth noting 

some of the other conflicts of interest that exist within governmental agencies in relation to the 

facts surrounding Gardasil. Scientists from the National Institute of Health (“NIH”), which is a 

division of the United States Department of Health and Human Services (“HHS”), discovered a 

method of producing “virus-like-particles” (“VLPs”) that made creation of the Gardasil vaccine 

possible. The NIH scientists’ method of producing VLPs was patented by the Office of 

Technology Transfer (“OTT”), which is part of the NIH, 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, the Gardasil patents have earned 

HHS, NIH and the scientists who invented the technology millions of dollars in revenue. 

67. Moreover, members of 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 of interest. The Chairman of ACIP served on 

Merck’s Immunization Advisory Board and a number of the other ACIP members had received 

grants, salaries, or other forms of remuneration from Merck 

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C. Merck Engaged in Disease Mongering and False Advertising to Enhance 

Gardasil Sales 

68. 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. 

69. Prior to Merck’s aggressive marketing campaign, there was no HPV public health 

emergency in high-resource countries, such as the United States. 

70. 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 40 

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. 

71. The stage was set for Merck to “educate” the public about HPV, cervical cancer, 

and Gardasil, all to Merck’s advantage. 

72. Merck preceded its rollout of Gardasil with years of expensive disease awareness 

marketing. Merck ran “Tell Someone” commercials, designed to strike fear in people about HPV 

and cervical 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 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 the vaccine. See Angela Zimm and Justin Blum, Merck Promotes Cervical Cancer 

Shot by Publicizing Viral Cause, BLOOMBERG NEWS, May 26, 2006. 

73. 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 the Year, PHARMEXEC.COM, February 1, 2007. 

http://www.pharmexec.com/brand-year-0

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74. Merck also engaged in a relentless propaganda campaign aimed at frightening and 

guilting parents who failed to inoculate their children with Gardasil. 

75. 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. 

76. Prior to the FDA’s 2006 approval of Gardasil, the mainstream media – under 

direction of Merck and its agents – dutifully reported alarming cervical cancer stories, 

accompanied by the promotion of an auspicious vaccine. 

77. Merck intended its campaign to create fear and panic and a public consensus that 

“good mothers vaccinate” their children with Gardasil. According to Merck propagandists, the 

only choice was to “get the vaccine immediately” or “risk cervical or anal cancer.” 

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

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

79. 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. 

80. Merck negligently and fraudulently deprived parents and children of their right to 

informed consent. 

81. 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 that caused 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-hpv-hpv-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 the ad’s release to encourage them to share it with 

their patients: 

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82. Merck’s fraudulent message was that cervical cancer and anal cancer were real-life 

killers of young men and women, notwithstanding the fact that the average age for development 

of cervical cancer is 50 years old, average age of development of anal cancer is 60 years old and 

that the cancer is virtually nonexistent in men and women under 20. 

83. Other television marketing campaigns Merck launched falsely proclaimed that 

Gardasil was a “cervical cancer vaccine” and that any young girl vaccinated with Gardasil would 

become “one less” woman with cervical cancer. The “One Less” marketing campaign portrayed 

Gardasil as if there were no question as to the vaccine’s efficacy in preventing cervical cancer, and 

it disclosed none of Gardasil’s side effects. 

84. Merck marketed Gardasil with the most aggressive campaign ever mounted to 

promote a vaccine, spending more on Gardasil advertising than any previous vaccine advertising 

campaign. 

D. Merck Used Scare Tactics and Provided Financial Incentives to 

Legislatures to Attempt to make the Gardasil Vaccine Mandatory for All 

School Children 

85. An ACIP recommendation of a vaccine, adopted by individual states, opens the 

door to mandates affecting as many as four million children annually. 

86. 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 

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the cost of doctor’s visits), Merck stood to earn billions of dollars per year, in the US alone, with 

little marketing costs. 

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

to aid in the passage of mandatory vaccination laws. 

88. 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. 

89. 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). 

90. In 2006, Democratic Assembly leader Sally Lieber of California introduced a bill 

that would 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. 

91. Prior to the introduction of the bill, Lieber met with WIG representatives. In an 

interview, the President of WIG, Susan Crosby, confirmed that WIG funders have direct access to 

state legislators, in part through the organization’s Legislative Business Roundtable, of which WIG 

funders are a part. See Judith Siers-Poisson, The Gardasil Sell Job, in CENSORED 2009: THE TOP 

25 CENSORED STORIES OF 2007-08, 246 (Peter Philips ed. 2011). 

92. 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 “the 

Merck 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.” 

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

push HPV vaccine mandates.

94. Another group, the National Association of County and City Health Officials 

(NACCHO), was also pushing HPV vaccine mandates in all 50 states. 

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

organizations. By February 2007, 24 states and the District of Columbia had introduced mandate 

legislation. 

96. Several states passed laws allowing preteen children as young as age 12 to 

“consent” to vaccination with an HPV vaccine without parental consent or knowledge. 

97. One New York state county offered children free headphones and speakers to 

encourage them to consent to the Gardasil vaccine. See Mary Holland et al., THE HPV VACCINE 

ON TRIAL: SEEKING JUSTICE FOR A GENERATION BETRAYED 131 (2018). 

98. 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 GAZETTE, August 14, 2018, at https://www.capitalgazette.com/opinion/columns/ac-cecolumn-mazer-20180814-story.html. 

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

Groups 

99. 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, a disclaimer 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 and Sanofi Pasteur US.” 

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

every Gardasil lecture they gave. 

101. 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, the Jewish Healthcare Foundation, the American Dental Association, the American 

College of Obstetricians and Gynecologists, and the American Cancer Society. 

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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 

102. Merck faced a daunting problem in convincing regulators, doctors, and the public 

to accept the Gardasil vaccine. 

103. Merck recommends the vaccine for children aged 11 to 12 years old, to provide 

protection against a disease that, in the United States, is not generally diagnosed until a median 

age of 50. Moreover, in those rare instances of death, the median age is 58. 

104. There are no studies proving that Gardasil prevents cancer. 

105. Because it can take decades for a persistent HPV infection to proceed to 

development of cervical or anal cancer, and because cervical and anal cancers are so rare, a true 

efficacy study would require decades and likely hundreds of thousand – if not millions – of trial 

participants to demonstrate that eliminating certain HPV infections would actually prevent the 

development of cervical and anal cancer. 

106. 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 and anal cancer. 

107. 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 and anal cancer. 

108. The clinical trials therefore did not test whether HPV vaccines prevent cervical, 

anal or other cancers. Instead, Merck tested the vaccines against development of certain cervical 

lesions, which some researchers suspect are precursors to cancer, although the majority of these 

lesions – even the most serious – regress on their own. See, e.g., Jin Yingji et al., Use of 

Autoantibodies Against Tumor-Associated 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). 

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109. The Department of Health and Human Services (HHS), which oversees the FDA, 

and which also stood to make millions of dollars on the vaccine from patent royalties, allowed the 

use of Merck’s proposed surrogate endpoints. 

110. The surrogate endpoints chosen by Merck to test the efficacy of its HPV vaccine 

were cervical and anal intraepithelial neoplasia (CIN) grades 2 and 3 and adenocarcinoma in situ. 

111. 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. 

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

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 at that. 

113. The use of these surrogate endpoints allowed Merck to shorten the clinical trials to 

a few years and gain regulatory approvals of the vaccines without any evidence the vaccines would 

prevent cancer in the long run. 

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 in 

coverage [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 and anal cancer, while 

dogmatically asserted, is not proven. 

116. Research indicates that cervical and anal 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 and anal cancer is associated with HPV 

types in the vaccines and not all cervical and anal cancer is associated with HPV at all. 

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117. Despite the lack of proof, Merck claimed that Gardasil could eliminate cervical and 

anal cancer and other HPV-associated cancers. 

118. However, Merck knows that the Gardasil vaccines cannot eliminate all cervical and 

anal 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 to nine 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 associated with cancer. 

120. Even assuming these vaccine-targets are the types solely responsible for 100 

percent of cervical and anal cancer – which they are not – the vaccines have not been followed 

long enough to prove that Gardasil protects girls and boys from cancer that would strike them 40 

years later. 

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

translate to fewer cases of cervical and anal cancer in 30 to 40 years. 

122. Cervical and anal 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 many 

methodological 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: “The 

reason for choosing vaccination against HPV was to prevent cancer but there’s no clinical evidence 

to prove it will do that.” 

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

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126. Yet Merck has marketed the Gardasil vaccines as if there is no question regarding 

their efficacy at preventing cervical and anal cancer. In reality, they are at best protective against 

only four to nine of the 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 Public 

i. Gardasil Contains A Toxic Aluminum Adjuvant 

127. 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 

not been proven safe. 21 C.F.R. § 610.15(a). 

131. AAHS has never been proven safe. AAHS is a recent proprietary blend of 

aluminum and 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 

the host’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 function; fostering development of abnormal tau proteins; and altering DNA. 

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ii. Merck Lied About a Secret DNA Adjuvant Contained in The 

Gardasil Vaccines 

134. 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 potentially 

hazardous 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 

illegally omitted 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 

the ingredients 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 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 

in 2006 to explore DNA adjuvants to further develop and commercialize Idera’s toll-like receptors 

in Merck’s vaccine program. 

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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 administration of 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 to injecting DNA into the human body. 

iii. Gardasil Contains Borax 

146. 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 

millions of 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, 

and increased fetal malformations in rats, mice, and rabbits. 

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

states 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. 

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154. Polysorbate 80 is used in drugs to open up the blood brain barrier in order to allow 

the active ingredients in a drug to reach the brain and to elicit the intended response. It acts as an 

emulsifier 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, of 

anaphylaxis 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 

et al., Anti-Saccharomyces Cerevisiae Autoantibodies in Autoimmune Diseases: from Bread 

Baking to Autoimmunity, 45 CLINICAL REVIEWS IN ALLERGY AND IMMUNOLOGY 152 (October 

2013). 

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

160. Merck has performed no studies to determine the safety of injecting yeast into 

millions of 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 

Gardasil 

161. 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 to 

conceal 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. 

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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 the 

vaccination, 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 the 

vaccine during the clinical studies. 

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

suffered. 

169. In early 2018, Lars Jørgensen, M.D., Ph.D. and Professor Peter Gøtzsche, M.D. 

(then with the Nordic Cochrane Centre), and Professor Tom Jefferson, M.D., of the Centre for 

Evidence-Based 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 HPV vaccines. 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 (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 

found that the trial data were “largely inadequate.” 

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

studied.” 

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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 

human papillomavirus (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 the record.” 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 

complicates the interpretation of efficacy and safety results in trials ... We consider the omission 

in journal articles, of any rationale for the selection of AAHS-containing control, to be a form of 

incomplete 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 error that 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 and independently. Id. 

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i. Small Clinical Trials 

176. Although nine 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 protocol comparing children receiving a vaccine to those who did not. In that study, Merck 

looked at results of fewer 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. Merck Used a Highly Toxic “Placebo” to Mask Gardasil 

Injuries 

178. 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 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 

that using 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 no true 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. 

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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 

clinical study volunteers, telling them that the placebo was an inert saline solution – when in reality 

the placebo 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, 

this scheme allowed Merck to falsely conclude that Gardasil’s safety profile was comparable to 

the “placebo.” 

187. The scheme worked and enabled Merck to secure FDA licensing. 

188. Merck lied to the 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 

the saline placebo, but only after they had already received three doses of Gardasil for the Gardasil 

9 trial. 

iii. Merck Used Exclusionary Criteria to Further Conceal Gardasil 

Risks 

191. 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. 

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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 a history of immunological or nervous system disorders. 

193. Women could also be excluded for “[a]ny condition which in the opinion of the 

investigator 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 are limited 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 

not they suffer from a serious medical condition. 

196. Merck sought to exclude from the study all subjects who might be part of any 

subgroup that would suffer injuries or adverse reactions to any of Gardasil’s ingredients. 

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 a contraindication, rather than an allergy to any other component. Nonetheless, for most of the 

ingredients, it is almost impossible to determine if such an allergy exists prior to being vaccinated 

and Merck does not recommend allergy testing before administering the vaccine. 

198. Instead of testing the vaccine on a population representative of the cross-section of 

humans 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 

the vulnerable 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. 

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iv. Merck Deceived Regulators and The Public by Classifying 

Many Serious Adverse Events, Which Afflicted Nearly Half of 

All Study Participants, As Coincidences 

199. 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 the discretion 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 dismiss and fraudulently conceal infections, reproductive disorders, neurological symptoms, 

and autoimmune conditions, which affected a troubling 50 percent of all clinical trial participants. 

201. Merck’s researchers systematically dismissed reports of serious adverse events 

from 49 percent of trial participants in order to mask the dangers of the vaccine.

202. Instead of reporting these injuries as “adverse events,” Merck dismissed practically 

all of 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” (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-billiondollar 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 of grave vaccine injuries, injuries that sickened half of the trial volunteers, as coincidental. 

205. Almost half (49 percent) of all trial participants, regardless of whether they received 

the vaccine or Merck’s toxic placebo, reported adverse events, including serious illnesses such as 

blood, lymphatic, cardiac, gastrointestinal, immune, musculoskeletal, reproductive, neurological 

and psychological conditions, chronic illnesses such as thyroiditis, arthritis and multiple sclerosis, 

and conditions 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. 

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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 

and Researchers 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 percent 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 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 or 

delayed 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, all of 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. 

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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. 

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 

to under-report entries. 

220. During its Gardasil clinical trials, Merck failed to adequately capture and properly 

code adverse events and symptoms, including but not limited to adverse events and symptoms that 

were indicative of autoimmune or neurological injuries, including but not limited to POTS and 

CRPS, so as to prevent the medical community, regulators and patients from learning about these 

adverse events and to avoid the responsibility of having to issue appropriate warnings concerning 

these adverse events. 

vi. Merck Deceived Regulators and the Public About Its Pivotal 

Gardasil Clinical Trial (Protocol 018) 

221. 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 

the regulators licensing Gardasil. See Lars Jørgensen, et al., Index of the Human Papillomavirus 

(HPV) Vaccine Industry Clinical Study Programmers and Non-Industry Funded Studies: a 

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Necessary Basis to Address Reporting Bias in a Systematic Review, 7 SYSTEMATIC REVIEWS 8 

(January 18, 2018). 

222. 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 

believed 1) it was the only trial where Merck used a “true saline placebo,” and 2) it was the only 

trial with a comparator group that included girls aged 11 to 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).

223. Merck lied to regulators, to the public and to subjects in its clinical trials by 

claiming that the Protocol 018 “placebo” group received an actual saline or inert placebo. 

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

saline placebo.” 

225. 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. 

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

approximately 600 nine to 15-year-old children. 

227. In fact, Merck did not give even this modest control group a true saline placebo, 

but rather, the group members 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 possibly a fragmented DNA adjuvant. 

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

antigens and the aluminum adjuvant. 

229. Despite the witches’ brew of toxic chemicals in the carrier solution, those children 

fared much better than any other study or control group participants, all of whom received the 

AAHS aluminum adjuvant. 

230. Only 29 percent of the vaccinated children and 31 percent of control recipients in 

Protocol 018 reported new illnesses from Day 1 through Month 12, compared to an alarming 49.6 

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percent of those vaccinated and 49 percent 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 to those who received either a vaccine with a full dose of AAHS or 

those who received an AAHS control. 

231. Few of the participants in the Protocol 018 control group got systemic autoimmune 

diseases, compared to 2.3 percent (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 the number of girls in the placebo group as stated in the original 2006 clinical 

review, fewer than 1 percent of girls in the carrier solution group reported autoimmune disease. 

232. 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 to 

fifteen-year-old children in its Protocol 018 study group.

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

compared to other protocols.

234. 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. 

235. Upon information and belief, Merck had cut the adjuvant in half, knowing that this 

would artificially and fraudulently lower the number of adverse events and create the illusion that 

the vaccine was safe. 

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

237. 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. 

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

of Gardasil’s most toxic component. 

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239. 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. 

240. As set forth above, upon information and belief, Merck’s deception served its 

purpose: Only 29 percent of the vaccinated children in Protocol 018 reported new illness, 

compared to an alarming 49.6 percent in the pooled group to receive the full dose adjuvant in the 

vaccine.

I. Contrary to Merck’s Representations, Gardasil May Actually Cause and 

Increase the Risk of Cervical and Other Cancers 

241. 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 

evaluated for the potential to cause carcinogenicity, genotoxicity or impairment of male fertility. 

242. 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 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 

HUMAN VACCINES & 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 of getting cancer. 

243. In short, the Gardasil vaccines, which Merck markets as anti-cancer products, may 

themselves cause cancer or mutagenetic changes that can lead to cancer. 

244. Merck concealed from the public data from its clinical trials indicating that the 

vaccines enhance the risk of cervical cancers in many women. 

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

44.6 percent more likely to develop cancerous lesions compared to unvaccinated women, even 

within a few years of receiving the vaccine. 

246. In other words, Merck’s studies suggest that its HPV vaccines may cause cancer in 

women who have previously been exposed to HPV, particularly if they also have a current 

infection. 

247. In some studies, more than 30 percent of girls show evidence of exposure to HPV 

before age ten, 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). 

248. Even in light of the data demonstrating that Gardasil can increase the risk of cancer 

in girls who previously have been exposed to HPV, in order to increase profits, Merck’s Gardasil 

labels and promotional material do not inform patients and medical doctors of this important risk 

factor. 

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

250. Numerous women have reported a sudden appearance of exceptionally aggressive 

cervical cancers following vaccination. 

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

high uptake. 

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

had the highest cervical cancer rates. 

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

young women aged 25 to 29 has risen 54 percent. 

254. 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 percent increase in 25 to 29 year-olds and a 30 percent increase in 30 

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to 34 year-old girls contracting cervical cancer, 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). 

255. In addition to the belief that Gardasil may create and open an ecological niche for 

replacement 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. 

256. Cervical screening is proven to reduce the cases of cervical cancer, and girls who 

have taken the vaccine are less likely to undergo cervical screenings. 

257. 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. 

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

with screening. 

259. 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 of Autoimmune Diseases, and Other Injuries, Including But Not 

Limited to, Postural Orthostatic Tachycardia Syndrome, Chronic Fatigue 

Syndrome, Neuropathy, Fibromyalgia and Dysautonomia 

260. Gardasil induces and increases the risk of autoimmune disease. 

261. Gardasil has been linked to a myriad of autoimmune disorders, including but not 

limited, to: Guillain–Barré syndrome (“GBS”), postural orthostatic tachycardia syndrome 

(“POTS”), Orthostatic Intolerance (“OI”), 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. 

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262. Gardasil has also been linked to a myriad of diseases and symptoms that are 

associated with induced-autoimmune disease, including for example, fibromyalgia, dysautonomia, 

premature ovarian failure, chronic fatigue syndrome (“CFS”), chronic regional pain syndrome 

(“CRPS”), cognitive dysfunction, migraines, severe headaches, persistent gastrointestinal 

discomfort, widespread pain of a neuropathic character, encephalitis syndrome, autonomic 

dysfunction, joint pain, and brain fog. 

263. 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, the scientists concluded that Gardasil can cause autoimmune disorders because of the 

vaccine’s strong immune stimulating ingredients. See Lucija Tomljenovic & Christopher A. Shaw, 

Adverse Reactions to Human Papillomavirus Vaccines, VACCINES & AUTOIMMUNITY 163 

(Yehuda Shoenfeld et al. eds., 2015). 

264. Medical experts have opined that the mixture of adjuvants contained in vaccines, 

in particular in the Gardasil vaccines, is responsible for post-vaccination induced autoimmune 

diseases in select 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 the spectrum of immune-mediated diseases triggered by an adjuvant stimulus contained 

in vaccines, such as aluminum. See e.g., YEHUDA SHOENFELD ET AL, EDS., VACCINES &

AUTOIMMUNITY 2 (2015). 

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

induce autoimmune disease in tested animals. By 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. 

266. Specific to the Gardasil vaccines, which contain adjuvants, including amorphous 

aluminum 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 

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Gardasil induces autoimmune disease in select patients. 

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

has HPV, however, HPV by itself is generally not immunogenic, and generally does not evoke 

immune responses. Indeed, HPV shares a high number of peptide sequences with human proteins, 

so that the human immune system generally does not react against HPV in order to not harm selfproteins. Immunotolerance thus generally blocks reactions against HPV in order to avoid 

autoimmune attacks against the human proteins. 

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

amorphous aluminum hydroxyphosphate sulfate (AAHS), to the Gardasil vaccine. Adjuvants, 

such as aluminum, 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. 

269. While adjuvants are added with the intent of destroying the HPV virus, they also 

can have the unintended result of rendering the immune system “blind” and unable to distinguish 

human proteins from HPV proteins – accordingly, human proteins that share peptide sequences 

with HPV are at risk of also being attacked by the vaccine. 

270. 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 to differentiate 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 human proteins, the indiscriminate attack triggered by the Gardasil adjuvants 

will cause massive cross-reactions 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.” 

271. 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 

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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 virusspecific T cells initiate bystander activation resulting in the immune system killing uninfected and 

unintended neighboring cells. 

272. 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 blood flow 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. However, in individuals (such as Plaintiff) 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 blood flow 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 blood flow to the brain, light and sound sensitivity, loss of consciousness, 

shortness of breath, chest pain, gastrointestinal issues, body pains, insomnia, and confusion and/or 

difficulty sleeping. In certain cases of POTS, patients will also be diagnosed with other medical 

conditions, including but not limited to, chronic fatigue syndrome and fibromyalgia. 

273. Medical research has determined that certain dysautonomia diseases such as POTS 

and OI have an autoimmune etiology. Norepinephrine, a key neurotransmitter of the sympathetic 

(“fight or flight”) system, exerts its mechanism of action by binding to receptors located in the 

smooth muscle of the 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 and muscarinic acetylcholine receptors are believed to be affected in 

certain cases of POTS and OI. See e.g., Hongliang Li et al., Autoimmune Basis for Postural 

Tachycardia Syndrome, 3 J. AMERICAN HEART ASSOC. e000755 (2014); Artur Fedorowski et al., 

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Antiadrenergic Autoimmunity in Postural Tachycardia Syndrome, 19 EUROPACE 1211 (2017); 

Mohammed Ruzieh et al., The Role of Autoantibodies in the Syndromes of Orthostatic Intolerance: 

A Systematic Review, 51 SCANDINAVIAN CARDIOVASCULAR 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). 

274. 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 of Vaccination 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 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 

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(HPV) Vaccine Safety Concerning POTS, CRPS and Related Conditions, CLINICAL AUTONOMIC 

RESEARCH (2019). 

275. 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 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). 

276. 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 “more than 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 

percent of industry studies were solely industry funded and found 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 than that in journal 

publications. When the authors compared the data the EMA used (which was provided by 

GlaxoSmithKline and Merck Sharp and Dohme) to conduct their review of the relationship 

between HPV vaccination and both POTS and CRPS, the authors found that only 48 percent 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 

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Programmes and Non-Industry Funded Studies: A Necessary Basis to Address Reporting Bias in 

a Systematic Review, 7 SYSTEMATIC REVIEW 8 (2018). 

277. Likewise, in a recently released February 2020 peer-reviewed study, researchers 

who analyzed the available clinical trial data for all HPV vaccines, which include the Gardasil 

vaccines and another 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 (HPV) Vaccines: Systemic Review with Meta-Analyses of Trial Data from 

Clinical Study Reports, 9 SYSTEMATIC REVIEWS 43 (February 2020). 

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

association between HPV vaccines and one specific autoimmune disease, POTS, the HPV vaccines 

were associated with a nearly two-fold increased risk of POTS. Id. 

279. 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, the fact 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]he use of active comparators may have underestimated harms related 

to HPV vaccines,” and that “[t]he degree of harms might therefore be higher in clinical practice 

than in the trials.” Id. 

280. 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 

more of 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 the 

plausible claim that the AAHS aluminum adjuvant is a culprit in causing adverse events. Id. 

281. 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 

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substantial risk, let alone a risk of death, because healthy teenagers face an almost zero percent 

risk of death from cervical cancer. 

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

Problems 

282. Merck has never tested the impact of the Gardasil vaccines on human fertility. 

283. Nevertheless, study volunteers reported devastating impacts on human fertility 

during combined trials, offering substantial evidence that the vaccine may be causing widespread 

impacts on human fertility, including increases in miscarriage, birth defects, premature ovarian 

failure and premature menopause in girls and young women. 

284. One of the serious adverse events now emerging in vaccinated girls, including 

teens, is premature ovarian failure. See, e.g., D. T. Little and H. R. Ward, Adolescent Premature 

Ovarian Insufficiency 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). 

285. Premature ovarian failure can occur after aluminum destroys the maturation process 

of the eggs in the ovaries. 

286. Fertility has plummeted among American women following the 2006 mass 

introduction of the Gardasil vaccine. This is most evident in teen pregnancy statistics where 

numbers have more than halved since 2007. 

287. The total fertility rate for the United States in 2017 continued to dip below what is 

needed 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 to 44 fell another 2 percent between 

2017 and 2018. 

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L. There were an Increased Number of Deaths in the Gardasil Studies 

288. 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. 

289. 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 

Release, Report No. 002, June 2017. 

290. The Gardasil pooled group had a death rate of 8.5 per 10,000, or almost double the 

background rate in the U.S. 

291. 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).

292. Merck dismissed all deaths as coincidences. 

293. The total number of deaths was 21 in the HPV vaccine group and 19 in the 

comparator (AAHS) groups.

294. The death rate among vaccine recipients was 13.3 per 10,000, or 133 per 100,000 

(21/15,706). 

295. 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 to die from Gardasil than from cervical cancer.

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M. Post-Marketing Injuries – The Raft of Injuries Seen in Merck’s Clinical 

Trials Has Now Become A Population-Wide Chronic Disease Epidemic 

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

bizarre and troubling symptoms. 

297. Many Gardasil survivors will have lifelong handicaps. 

298. 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, 

chronic muscle pain, complex regional pain syndrome, and weakness. 

299. Other frequently reported injuries include disturbances of consciousness; systemic 

pain including headache, myalgia, arthralgia, back pain and other pain; motor dysfunction, such 

as paralysis, 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 and hypermenorrhea; and lastly, 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. 

300. 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. 

301. 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. 

302. Moreover, studies have shown that only approximately 1 percent 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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303. The Vaccine Injury Compensation Program has paid out millions of dollars in 

damages for Gardasil-induced injuries and deaths. 

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

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

305. 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. 

306. 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 the public about Gardasil’s safety. 

307. 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 

308. 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. 

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

have 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. In Light of Gardasil’s Serious and Debilitating Adverse Events, 

the Japanese Government Rescinded Its Recommendation that 

Girls Receive Gardasil 

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

effects, the cascade of Gardasil injuries became a public scandal. 

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311. Japan’s health ministry discovered adverse events reported after Gardasil were 

many times 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). 

312. Japanese researchers found that the adverse events rate of the HPV vaccine was as 

high as 9 percent, and that pregnant women injected with the vaccine aborted or miscarried 30 

percent 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. 

313. The injuries caused the Japanese government to rescind its recommendation that 

girls receive the HPV vaccine. 

314. Japan withdrew its recommendation for Gardasil three months after it had added 

the vaccine to the immunization schedule, due to “an undeniable causal relationship between 

persistent pain and the vaccination.” 

315. Uptake rates for the vaccine in Japan are now under 1 percent, compared to 53.7 

percent fully vaccinated teenaged girls in the United States. 

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

letter faulting the WHO for failing to acknowledge the growing body of scientific evidence 

demonstrating high risk of devastating side effects. 

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

for managing Gardasil injuries post-vaccination. 

318. 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. 

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

treat illnesses caused by the Gardasil vaccines. 

320. The president of the Japanese Association of Medical Sciences stated that there was 

no proof that the vaccines prevent cancer. 

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321. These were developments that Merck was extremely anxious to suppress. 

322. 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 the Japanese situation. The overall conclusion was that the symptoms the girls were 

suffering from were psychogenic in nature and were a result of rumors spread online. In essence, 

Merck blamed the victims for the Gardasil-induced adverse events in Japan. 

ii. Denmark Has Opened Specialized Clinics Specifically Focused 

on Treating Gardasil-Induced Injuries, Including GardasilInduced Autoimmune Diseases 

323. 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). 

iii. Gardasil-Induced Adverse Events Caused the Government in 

Colombia to Conclude that Gardasil Would No Longer Be 

Mandatory 

324. In Colombia, more than 800 girls in the town of El Carmen de Bolivar reported 

reactions ranging from fainting to dizziness to paralysis in March of 2014, following vaccination 

with Gardasil. 

325. With protests erupting across the country, the Colombian attorney general asked 

the Constitutional Court to rule on a lower court ruling on the outcome of a case of an injured girl. 

326. 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 require the HPV vaccine to be mandatory. 

iv. India Halted Gardasil Trials and Accused Merck of Corruption 

After the Death of Several Young Girls Who were Participants 

in the Trial 

327. 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 

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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). 

328. The report alleges that Merck (through PATH, to whom it supplied vaccines) and 

the Gates Foundation resorted to subterfuge that jeopardized the health and well-being of 

thousands of vulnerable Indian children. The parliamentary report makes clear that the clinical 

trials could not have occurred without Merck corrupting India’s leading health organizations. Id. 

329. 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 potential risks. Id. 

330. Many of the participants suffered adverse events including loss of menstrual cycles 

and psychological changes like 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 

have reaped a windfall of profits had they been successful in getting the HPV vaccine included in 

the universal immunization program of the country... This [conduct] is a clear-cut violation of the 

human rights of these girls and adolescents.” Id.

331. 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 to date.” See Sudeep Gupta, Is Human Papillomavirus Vaccination Likely to be a 

Useful Strategy in India? 2 SOUTH ASIAN J CANCER 194 (October-December 2014). 

332. 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 a 

vaccine 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.

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333. In 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 

334. Merck’s corruption and fraud in researching, testing, labeling, and promoting 

Gardasil have paid off handsomely. 

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

office visits. 

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

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

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

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

percent effective. 

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

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

vaccines. 

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

342. Gardasil is crucial to Merck’s overall financial health. Merck identifies Gardasil 

as one of its “key products,” meaning that any change in Gardasil’s cash flow affects the 

corporation as a whole. 

343. 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. 

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III. D.G. Sustained Autoimmune Disease, Autonomic Dysfunction and Other 

Serious Injuries, as a Result of Her Gardasil Injections 

A. Gardasil and Its Ingredients Caused Plaintiff’s Autoimmune Disease and 

Other Related Injuries and Has Resulted in Her Suffering From Severe, 

Debilitating, Disabling and Painful Chronic Injuries 

344. D.G. was 13 years old when she received her first Gardasil vaccine on August 14, 

2018, and second on September 10, 2019. 

345. D.G.’s mother, Paige Graves, agreed to her daughter receiving the Gardasil 

injection(s) after having been exposed to marketing by Merck, that Gardasil is very safe, that 

Gardasil prevents cancer and that teenagers must get the Gardasil vaccine. D.G’s mother relied 

upon Merck’s ubiquitous representations concerning the safety and efficacy of the Gardasil 

vaccine, in consenting to her daughter’s Gardasil vaccination(s). 

346. Prior to receiving her Gardasil injection, D.G. had no autoimmune diseases and no 

autonomic issues. Prior to vaccination, D.G. was active in music, theatre and dancing, having 

performed on stage since she was 5 years old. She aspired to go to college and get her BFA with 

her end goal being to perform on Broadway one day. 

347. D.G.’s normal routine included full-time school including theatre rehearsal and 

then to community theatre rehearsal. After returning from rehearsal she would complete her 

homework which often kept her up late. Through all this hard work, D.G. was able to maintain 

good grades and attend honors classes. 

348. On August 14, 2018, D.G.’s health care provider in Dallas, Texas recommended 

that D.G. receive the Gardasil vaccine, which was stated as a safe and effective vaccine for 

preventing cervical cancer. In light of the doctor’s recommendations, as well as Merck’s relentless 

marketing and advertising messages, to which D.G.’s mother had been exposed, concerning the 

safety and efficacy of Gardasil, D.G.’s mother consented to D.G. being injected with the “cervical 

cancer vaccine,” Gardasil. 

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349. On September 10, 2019, D.G. received her second HPV vaccination. That evening, 

during a dance rehearsal, she began falling out of her turns. Later that week, D.G. began to 

experience tremors and dizzy spells. 

350. As the months progressed, so did D.G.’ injuries, she was seen by multiple 

physicians for her complaints which now included: tunnel vision, headaches, tremors, dizziness, 

severe lethargy, anxiety, elevated heart rate and painful periods. 

351. As a result of her post-Gardasil symptoms, D.G. was unable to engage in normal 

activities that a normal young person could enjoy. Due to her unrelenting stomach aches, 

headaches, constant dizziness, tremors, fatigue, and extremely elevated heart rate, D.G. now 

struggles in school and cannot complete tasks she could before the Gardasil vaccine. Because it 

is so difficult for her to learn, her grades in school have suffered and that is affecting her ability to 

attend college. In addition, she can no longer engage in theater and dance as she did before her 

Gardasil injections. 

352. Based upon her chronic and severe post-Gardasil symptoms, D.G. has been 

diagnosed with various medical conditions, including but not limited to, functional neurological 

disorder, functional limb weakness, functional movement disorder, functional vision disorder, 

functional speech symptoms, central and vestibular abnormalities, and Postural Orthostatic 

Tachycardia (“POTS”). 

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

like D.G., have suffered serious autonomic dysfunctions, and who experienced the same side 

effects as those D.G. has suffered, and who were diagnosed with Gardasil-induced autonomic 

diseases. See E. Israeli et al., Adjuvants and Autoimmunity, 18 LUPUS 1217 (2009); Darja Kanduc, 

Quantifying the Possible Cross-Reactivity Risk of an HPV16 Vaccine, 8 JOURNAL OF 

EXPERIMENTAL THERAPEUTICS AND ONCOLOGY 65 (2009); Svetlana Blitshetyn, Postural 

Tachycardia Syndrome After Vaccination with Gardasil, 17 EUROPEAN J. OF NEUROLOGY e52 

(2010); Darja Kanduc, Potential Cross-Reactivity Between HPV16 L1 Protein and Sudden Death 

Associated Antigens, 9 JOURNAL OF EXPERIMENTAL THERAPEUTICS AND ONCOLOGY 159 (2011); 

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Deirdre Little et al., Premature ovarian failure 3 years after menarche in a 16-year-old girl 

following human papillomavirus vaccination, BRIT. MED. J. CASE REPORTS (2012); Serena 

Colafrancesco et al., Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another 

Facet of the Autoimmune Inflammatory Syndrome Induced by Adjuvants, 70 AM.J.REPRODUCTIVE 

IMMUNOLOGY 309 (2013); Maurizo Rinaldi et al., Anti-Saccharomyces Cerevisiae Autoantibodies 

in Autoimmune Diseases: from Bread Baking to Autoimmunity, 45 CLINICAL REVIEWS IN ALLERGY 

AND IMMUNOLOGY 152 (October 2013); 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); Christopher A. Shaw et al., Aluminum-Induced Entropy in Biological Systems: 

Implications for Neurological Disease, JOURNAL OF TOXICOLOGY (2014); Louise S. Brinth et al., 

Orthostatic Intolerance and Postural Tachycardia Syndrome As Suspected Adverse Effects of 

Vaccination 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 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 

and Harms of the Human Papillomavirus (HPV) Vaccines: Systemic Review with Meta-Analyses 

of Trial Data from Clinical Study Reports, 9 SYSTEMATIC REVIEWS 43 (February 2020). 

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354. D.G. contends that her Gardasil injections caused her to develop serious and 

debilitating injuries, including but not limited to, functional neurological disorder, functional limb 

weakness, functional movement disorder, functional vision disorder, functional speech symptoms, 

central and vestibular abnormalities, and POTS, as well as a constellation of adverse symptoms, 

complications, injuries, and other adverse events, many of which are alleged herein and all of 

which were caused by Gardasil or otherwise linked to her Gardasil-induced autoimmune disorder. 

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

355. 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 ... 

associated with 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). 

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

300aa-11 of this title for a vaccine-related injury or death, limitations of actions under State law 

shall be stayed with respect to a civil action brought for such injury or death for the period 

beginning on the date the Petition is filed and ending on the date...an election is made under 

section 300aa-21(a) of this title to file the civil action ...” See 42 U.S.C. §§ 300aa–16(c). 

357. In full compliance with the aforementioned federal law, D.G., 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. The Order 

Concluding Proceedings was filed on April 21, 2022. 

358. Having complied with National Vaccine Injury Compensation Program 

administrative procedure and having duly filed her election to proceed with a civil action, Plaintiff 

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hereby timely initiates the instant action against Merck, the manufacturer and promoter of the 

Gardasil vaccines which caused her debilitating injuries. Through this civil action, Plaintiff seeks 

to hold Merck accountable for its negligent, reckless, and fraudulent conduct and she seeks full 

compensation from Merck for the physical and emotional injuries and harms she sustained as a 

result of Gardasil. 

359. Moreover, by engaging in conduct that Merck knew was unsafe and likely to injure 

patients and by placing Gardasil’s profits ahead of patient safety, Merck has engaged in the same 

fraudulent, malicious and oppressive conduct it engaged in with respect to Vioxx. Plaintiff, 

therefore, requests that exemplary damages be assessed against Merck, so as to, once again, 

attempt to deter Merck and other would-be defendants from engaging in similar reprehensible 

conduct. 

CAUSES OF ACTION 

COUNT ONE 

NEGLIGENCE

360. Plaintiff incorporates by reference all other paragraphs of this Complaint as if fully 

set forth herein and further alleges: 

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

the subsequent Gardasil 9 vaccines. 

362. Merck marketed Gardasil to patients, including teenagers such as D.G. and her 

medical providers. 

363. Merck had a duty to exercise reasonable care in the 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. 

364. 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 

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the general public included providing accurate, true, and correct information concerning the 

efficacy and risks of Gardasil and appropriate, complete, and accurate warnings concerning the 

potential adverse effects of Gardasil and its various ingredients and adjuvants. 

365. 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 OT), fibromyalgia, increased risk 

of cancer (including cervical cancer, which was the very cancer it was promoted as preventing), 

and death. 

366. Accordingly, at all times relevant to this litigation, Merck knew or, in the exercise 

of reasonable care, should have known that use of Gardasil could cause D.G.’s injuries and thus 

created a dangerous and unreasonable risk of injury to the users of these products, including D.G.. 

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

negligently and poorly performed clinical trials and studies were insufficient to test the true longterm safety and efficacy of Gardasil. 

368. 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 

patients and 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. 

369. As such, Merck breached its duty of reasonable care and failed to exercise ordinary 

care in the research, development, manufacturing, testing, marketing, supply, promotion, 

advertisement, packaging, labeling, sale, and distribution of Gardasil, in that Merck manufactured 

and produced a defective 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. 

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370. Merck failed to appropriately and adequately test the safety and efficacy of Gardasil 

and its individual ingredients and adjuvants. 

371. 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 

information and has further made false and/or misleading statements concerning the safety and 

efficacy of Gardasil. 

372. Merck’s negligence is outlined in detail in this Complaint and included, among 

other things: 

a) 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 

failing to 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 the propensity 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 the 

clinical trials from revealing the true risks, including but not limited to, long 

terms risks and risks of autoimmune diseases associated with Gardasil; 

e) Negligently designing and conducting its clinical trials so as to mask the 

true risks, including but not limited to, long terms risks and risks of 

autoimmune diseases and cancers associated with Gardasil; 

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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 

nine and 12; 

h) 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, the exclusion of 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 most of these ingredients and 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 

of efficacy when in reality the Gardasil Vaccines have not been shown to 

be effective against preventing cervical and anal cancer; 

k) Failing to use reasonable and prudent care in the research, manufacture, 

labeling and development of Gardasil so as to avoid the risk of serious harm 

associated with 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; 

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m) Failing to disclose to Plaintiff and D.G.’s medical providers and to the 

general public that Gardasil is ineffective when used in patients who have 

previously 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; 

n) Failing to disclose to Plaintiff and D.G.’s medical providers and to the 

general public that use of and exposure to Gardasil presents severe risks of 

cancer (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 Plaintiff and D.G.’s medical providers and to the 

general public that use of and exposure to Gardasil presents severe risks of 

triggering and increasing the risk of various autoimmune diseases, including 

but not limited to POTS and OI; 

p) Failing to disclose to Plaintiff and D.G.’s medical providers and to the 

general 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 is regular 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 not 

effective 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 

knows that it has not done any studies to demonstrate that Gardasil prevents 

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cervical cancer and, indeed, its clinical studies revealed that Gardasil 

actually increases the risk of cervical cancer; 

t) Engaging in false advertising and disease mongering by scaring parents and 

children into believing that cervical and anal cancer is far more prevalent 

than it really is; that all cervical and anal cancer was linked to HPV; that 

Gardasil prevented cervical and anal cancer, 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 not been shown to prevent 

against all strains of HPV that are associated with cervical and anal cancer 

and, indeed, it has never been shown to prevent cervical and anal 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 that these 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 

and defects of Gardasil; 

w) Systemically suppressing or downplaying contrary evidence about the risks, 

incidence, and prevalence of the side effects of the Gardasil Vaccines by, 

inter alia, orchestrating the retraction of peer-reviewed and published 

studies and vilifying and attempting to ruin the careers of any scientists who 

openly question Gardasil’s safety and efficacy. 

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

as D.G., would suffer injuries as a result of Merck’s failure to exercise ordinary care in the 

manufacturing, marketing, labeling, distribution, and sale of Gardasil. 

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374. Plaintiff and, upon information and belief, D.G.’s medical providers, did not know 

the true nature and extent of the injuries that could result from the intended use of and/or exposure 

to Gardasil or its adjuvants and ingredients. 

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

losses that Plaintiff suffered, and will continue to suffer, as described herein. 

376. Had Merck not engaged in the negligent and fraudulent conduct 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, Plaintiff’s medical providers would not have offered or recommended Gardasil to Plaintiff. 

Moreover, even if after Merck’s dissemination of truthful information concerning the true risks 

and efficacy limitation of Gardasil, D.G.’s medical providers had offered Gardasil, then upon 

information and belief, the providers would have heeded any warnings issued by Merck and 

relayed to Plaintiff the safety risks and efficacy limitations that Merck should have warned her 

about, but failed to do so. Had Plaintiff been informed of the true risks and efficacy limitation 

concerning Gardasil, either through D.G.’s medical providers or through Merck’s ubiquitous 

direct-to-consumer promotional marketing, on which Plaintiff relied, then Plaintiff would never 

have consented to D.G. being injected with Gardasil. 

377. As a proximate result of Merck’s wrongful acts and omissions and its negligent and 

fraudulent testing, labeling, manufacturing, marketing and promotion of Gardasil, D.G. has 

suffered and continues to suffer severe and permanent physical injuries, and associated 

symptomology and has suffered severe and permanent emotional injuries, including pain and 

suffering. D.G. also has a substantial fear of suffering additional and ongoing harms, including 

but not limited to now being at an increased risk of cancer, and future symptoms and harms 

associated with her autoimmune disease and other injuries caused by Gardasil. 

378. As a direct and proximate result of her Gardasil-induced injuries, Plaintiff has 

suffered and continues to suffer economic losses, including considerable financial expenses for 

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medical care and treatment, and diminished income capacity, and she will continue to incur these 

losses and expenses in the future. 

379. Merck’s conduct, as described above, was aggravated, oppressive, fraudulent, and 

malicious. Merck regularly risks the lives of patients, including D.G., 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 Plaintiff, and 

D.G.’s 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 award of punitive damages. 

380. WHEREFORE, Plaintiff requests that the Court enter judgment in her favor for 

compensatory damages and punitive damages, together with interest, and costs herein incurred, 

and all such other and further relief as this Court deems just and proper. Plaintiff also demands a 

jury trial on the issues contained herein. 

COUNT TWO 

STRICT LIABILITY 

(FAILURE TO WARN)

381. Plaintiff incorporates by reference all other paragraphs of this Complaint as if fully 

set forth herein, and further alleges: 

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

383. At all times relevant to this litigation, Merck engaged in the business of researching, 

testing, developing, manufacturing, marketing, selling, distributing, and promoting Gardasil, 

which is defective and unreasonably dangerous to consumers, including Plaintiff, because it 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 and supervision 

of Merck. 

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384. Merck researched, developed, 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 Plaintiff and D.G.’s medical providers, and Merck therefore had a duty to warn of the 

risks associated with the reasonably foreseeable uses of Gardasil and a duty to instruct on the 

proper, safe use of these products. 

385. At all times relevant to this litigation, Merck had a duty to properly research, test, 

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 the proper, 

safe use of these products. Merck, as manufacturer, seller, or distributor of vaccines, is held to the 

knowledge of an expert in the field. 

386. 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 the 

unreasonable risks of harm associated with the use of and/or exposure to these products. 

387. 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 

to children, patients, and consumers of Gardasil products and to those who would foreseeably use 

or be harmed by Gardasil, including Plaintiff. 

388. Despite the fact that Merck knew or should have known that Gardasil posed a grave 

and unreasonable risk of harm (including but not limited to increased risk of autoimmune disease, 

and the various other Gardasil induced injuries that Plaintiff has sustained), it failed to warn of the 

risks 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 and consumers, such as Plaintiff and D.G.’s medical providers. 

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389. 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 the risks 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. 

390. 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 Plaintiff, without substantial change in their condition as 

manufactured, sold, distributed, labeled, and marketed by Merck. 

391. D.G. was injected with Gardasil in its intended or reasonably foreseeable manner 

without knowledge of its unreasonable dangerous and inefficacious characteristics. 

392. Plaintiff could not have reasonably discovered the defects and risks associated with 

Gardasil before or at the time of D.G.’s injection(s). Plaintiff 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 of efficacy of Gardasil and failed to communicate warnings and instructions that were 

appropriate and adequate to render the products safe for their ordinary, intended, and reasonably 

foreseeable uses, including injections in teenagers. 

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 to communicate 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 and safety of its products, even after it knew or should have known of 

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Gardasil’s unreasonable risks and lack of efficacy; and concealed, downplayed, or otherwise 

suppressed, through aggressive marketing and 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 of 

D.G.’s injuries, including but not limited to, autoimmune diseases, including POTS and 

dysautonomia, associated with the use of and exposure to Gardasil, and has failed to warn of the 

additional risks that D.G. is now exposed to, including, but not limited to, the increased risk of 

cancer, 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, was 

distributed by Merck, and used by D.G.. 

397. Merck is liable to Plaintiff for injuries caused by its failure, as described above, to 

provide adequate warnings or other clinically relevant information and data regarding Gardasil, 

the lack 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 

in causing D.G.’s injuries, and, but for Merck’s misconduct and omissions and Gardasil’s defects, 

including its defective labeling and false promotion, D.G. 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 not engaged in the negligent and fraudulent conduct 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, D.G.’s medical providers would not have offered or recommended Gardasil to Plaintiff. 

Moreover, even if after Merck’s dissemination of truthful information concerning the true risks 

and efficacy limitation of Gardasil, D.G.’s medical providers had offered Gardasil, then upon 

information and belief, the providers would have heeded any warnings issued by Merck and 

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relayed to Plaintiff the safety risks and efficacy limitations that Merck should have warned her 

about, but failed to do so. Had Plaintiff been informed of the true risks and efficacy limitation 

concerning Gardasil, through D.G.’s medical providers or through Merck’s ubiquitous direct-toconsumer promotional marketing, on which she relied, then Plaintiff would not have consented to 

D.G. being injected with Gardasil. 

400. As a proximate result of Merck’s wrongful acts and omissions and its negligent and 

fraudulent testing, labeling, manufacturing, and promotion of Gardasil, D.G. 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. D.G. also has a substantial fear of suffering 

additional and ongoing harms, including but not limited to now being at an increased risk of cancer, 

and future symptoms and harms associated with her autoimmune disease and other injuries caused 

by Gardasil. 

401. As a direct and proximate result of her Gardasil-induced injuries, Plaintiff has 

suffered and continues to suffer economic losses, including considerable financial expenses for 

medical care and treatment, and diminished income capacity and she will continue to incur these 

losses and expenses in the future. 

402. Merck’s conduct, as described above, was oppressive, fraudulent, and malicious. 

Merck regularly risks the lives of teenagers, including D.G., 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 Plaintiff and D.G.’s 

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, teenagers, and patients who were being injected with Gardasil, and 

therefore warrants an award of punitive damages. 

403. WHEREFORE, Plaintiff requests that the Court enter judgment in her favor for all 

compensatory and punitive damages, together with interest, and costs herein incurred, and all such 

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other and further relief as this Court deems just and proper. Plaintiff also demands a jury trial on 

the issues contained herein. 

COUNT THREE 

STRICT LIABILITY 

(MANUFACTURING DEFECT)

404. Plaintiff incorporates by reference all other paragraphs of this Complaint as if fully 

set forth herein, and further alleges: 

405. Plaintiff 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, manufacturing, marketing, selling, distributing, and promoting Gardasil, 

which is defective and unreasonably dangerous to consumers, including Plaintiff, because of 

manufacturing defects, which patients, including Plaintiff and D.G.’s medical providers did not 

expect. 

407. Upon information and belief, the Gardasil vaccines injected into D.G. were 

defective and unreasonably dangerous because they failed to comply with manufacturing 

specifications required by 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 not disclosed 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 

D.G. was defective and unreasonably dangerous because it failed to comply with the approved 

manufacturing specifications, by containing dangerous and undisclosed HPV L1-DNA fragments, 

and these DNA fragments could act as a Toll-Like Receptor 9 (TLR9) agonist, further adjuvanting 

the vaccine and making it more potent and dangerous than intended. 

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

D.G. was defective and unreasonably dangerous because it failed to comply with the approved 

manufacturing specifications, by containing dangerous and undisclosed ingredients and 

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COMPLAINT 

neurotoxins, including but not limited to, phenylmethylsulfonyl fluoride (PMSF), a toxic nerve 

agent that is not intended for human consumption or injections. 

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 D.G., without substantial change in their condition as 

designed, manufactured, sold, distributed, labeled, and marketed by Merck. 

411. Plaintiff and D.G.’s medical providers could not reasonably have discovered the 

defects, including the manufacturing defects, and risks associated with Gardasil before or at the 

time of her injection(s). Plaintiff relied upon the skill, superior knowledge, and judgment of 

Merck. 

412. Merck is liable to Plaintiff for injuries caused as a result of its manufacturing 

defects. 

413. The defects in Merck’s Gardasil vaccine were substantial and contributing factors 

in causing D.G.’s injuries, and, but for Merck’s misconduct and omissions and Gardasil’s defects, 

including but not limited to its manufacturing defects, D.G. would not have sustained the injuries 

she has sustained to date, and would not have been exposed to the additional prospective risk and 

dangers associated with Gardasil. 

414. As a proximate result of Merck’s wrongful acts and Gardasil’s manufacturing 

defects, D.G. has suffered and continues to suffer severe and permanent physical injuries and 

associated symptomology and has suffered severe and permanent emotional injuries, including 

pain and suffering. D.G. also has a substantial fear of suffering additional and ongoing harms, 

including but not limited to now being at an increased risk of cancer, and future symptoms and 

harms associated with her autoimmune disease and other injuries caused by Gardasil. 

415. As a direct and proximate result of her Gardasil-induced injuries, Plaintiff has 

suffered and continues to suffer economic losses, including considerable financial expenses for 

medical care and treatment, and diminished income capacity, and she will continue to incur these 

losses and expenses in the future. 

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416. Merck’s conduct, as described above, was oppressive, fraudulent, and malicious. 

Merck regularly risks the lives of patients, including D.G., 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 D.G., 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 award of punitive damages. 

417. WHEREFORE, Plaintiff requests that the Court enter judgment in her favor for 

compensatory and punitive damages, together with interest, and costs herein incurred, and all 

such other and further relief as this Court deems just and proper. Plaintiff also demands a jury 

trial on the issues contained herein. 

COUNT FOUR 

BREACH OF EXPRESS WARRANTY 

418. Plaintiff incorporates by reference all other paragraphs of this Complaint as if fully 

set forth herein, and further alleges: 

419. Merck engaged in the business of testing, researching, manufacturing, labeling, 

marketing, selling, distributing, and promoting Gardasil, which is defective and unreasonably 

dangerous to consumers, including Plaintiff. 

420. 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, 

and promoted 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. 

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421. 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 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 D.G., and/or that Gardasil was “effective” in 

preventing cancer and that anyone who was vaccinated with Gardasil would be “one less” person 

with cancer. 

422. 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 and 

became part of the basis of the bargain, creating an express warranty that the goods would 

conform to the representations. 

423. Merck breached these warranties because, among other things, Gardasil is 

ineffective at preventing 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 in women (even though Merck 

promoted it as preventing cervical cancer), 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 D.G., her 

parents and/or her medical providers that Gardasil is effective in preventing 

cancer, including anal and cervical cancer, when Merck knew that contrary 

to these representations (i) no clinical studies were performed to test if 

Gardasil prevents cancer; (ii) the clinical studies confirmed that Gardasil is 

indeed ineffective when used in patients who have previously been exposed 

to HPV, and that Gardasil actually increases the risk of cancer in a patient 

who has been previously exposed to HPV; and (iii) there are safer and more 

effective methods of monitoring for and attempting to prevent cervical or 

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anal cancer, including but not limited to regular testing, such as regular Pap 

smears for cervical cancer, and monitoring for anal cancer; 

b) Representing to patients and the medical community, including Plaintiff and 

D.G.’s medical providers, that Gardasil is safe, when in reality, Gardasil 

causes and presents serious risks of cancer, autoimmune disease, including 

but not limited to POTS, and other grave illnesses as outlined herein; 

c) Engaging in false advertising and disease mongering by scaring parents and 

teenagers into believing that cervical and anal cancer is far more prevalent 

than it really is; that all cervical and anal cancer was linked to HPV; that 

Gardasil prevented cervical cancer, 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 not been shown to prevent 

against all strains of HPV that are associated with cervical cancer and 

indeed it has never been shown to prevent cervical or anal cancer. 

424. 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 

Merck knew that patients and users such as D.G. could not have reasonably discovered the truth 

about the inefficacies and serious risks associated with Gardasil as alleged herein. 

425. Plaintiff had no knowledge of the falsity or incompleteness of Merck’s statements 

and representations concerning Gardasil. 

426. Plaintiff 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 and anal 

cancer and these cancers are prevalent (even though children rarely get cervical or anal cancer and 

Pap tests are the best frontline defense in detecting and fighting cervical cancer); that “good 

mothers” vaccinate their children and that Gardasil is perfectly safe. However, had Merck in these 

advertisements not engaged in disease mongering and deception, but instead had informed him the 

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truth about the serious risks of Gardasil (as outlined in this Complaint) and its lack of efficacy, 

D.G.’s mother would never have consented to D.G. being injected with Gardasil, nor would 

Plaintiff have consented to the Gardasil injection(s) had she been adequately informed about the 

questionable efficacy and serious risks associated with Gardasil. 

427. As a proximate result of Merck’s wrongful acts and breaches of warranties 

concerning the safety and efficacy of Gardasil, D.G. has suffered and continues to suffer severe 

and permanent physical injuries, and associated symptomology and has suffered severe and 

permanent emotional injuries, including pain and suffering. D.G. also has a substantial fear of 

suffering additional and ongoing harms, including but not limited to now being at an increased risk 

of cancer, and future symptoms and harms associated with her autoimmune disease and other 

injuries caused by Gardasil. 

428. As a direct and proximate result of her Gardasil-induced injuries, Plaintiff has 

suffered and continues to suffer economic losses, including considerable financial expenses for 

medical care and treatment, and diminished income capacity and she will continue to incur these 

losses and expenses in the future. 

429. Merck’s conduct, as described above, was oppressive, fraudulent, and malicious. 

Merck regularly risks the lives of patients, including D.G., 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 Plaintiff and D.G.’s 

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 award of punitive damages. 

430. WHEREFORE, Plaintiff requests that the Court enter judgment in her favor for 

compensatory and punitive damages, together with interest, and costs herein incurred, and all such 

other and further relief as this Court deems just and proper. Plaintiff also demands a jury trial on 

the issues contained herein. 

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COUNT FIVE 

COMMON LAW FRAUD 

431. Plaintiff incorporates by reference all other paragraphs of this Complaint as if fully 

set forth herein, and further alleges: 

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

433. Merck marketed Gardasil to and for the benefit of patients, including teenagers such 

as D.G. and her medical providers. 

434. 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. 

435. 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. 

436. 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, 

increased risk of cancer, and death. 

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

poorly designed clinical trials and studies were insufficient to test the true long-term safety and 

efficacy of Gardasil. 

438. 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 of minor-aged patients, medical providers and the general public, 

that Gardasil was safe and effective at preventing cancer. 

439. These express representations included incomplete warnings and instructions that 

purport, but fail, to include the complete array of risks associated with Gardasil. By way of 

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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 Plaintiff had been exposed to, stated that Gardasil was safe, that Gardasil was effective in 

preventing cancer, that Gardasil was a “cervical cancer vaccine,” and that any young child or 

teenager who was vaccinated with Gardasil would lead to “one less” person with cervical or anal 

cancer. 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. 

440. 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 children with the “cervical cancer vaccine.” 

441. 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 and 

complete risks of developing the serious injuries that are associated with Gardasil, as previously 

alleged herein, and which include but are not limited to POTS, systemic adverse events, 

autoimmune disease, increased risk of cancer, and death. 

442. The same promises of efficacy and limited and incomplete warnings Merck relayed 

in its direct-to-consumer advertising, were what D.G.’s medical providers relayed to Plaintiff 

when they recommended Gardasil – i.e., that if D.G. got vaccinated with Gardasil, it would 

prevent cancer, and the only risks associated with Gardasil are soreness, redness and minor pain, 

and a headache may develop. 

443. Plaintiff had been exposed to Merck’s marketing material concerning Gardasil, 

including the aforementioned “One Less” marketing campaign and other print advertisements and 

posters at doctors’ offices, and the representations made by Merck therein that Gardasil is 

effective at preventing cervical and anal 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 D.G. with the Gardasil vaccine, Plaintiff was never informed 

by Merck, or anyone else, that Gardasil is linked to a host of serious debilitating and chronic 

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COMPLAINT 

adverse events including, autoimmune diseases (including, but not limited to, POTS), increased 

risk of cancer, and death. 

444. Prior to providing consent to inject D.G. with the Gardasil vaccine, Plaintiff was 

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. 

445. Prior to providing consent to inject D.G. with the Gardasil vaccine, Plaintiff was 

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. 

446. Prior to providing consent to inject D.G. with the Gardasil vaccine, Plaintiff was 

never informed by Merck, or anyone else, that the Gardasil clinical trials never established that 

Gardasil can prevent cervical or anal cancer, even though Merck in its promotional material 

falsely represented that Gardasil was a “cervical cancer vaccine” and that a patient who received 

Gardasil would result in “one less” woman or man getting cancer. 

447. Merck’s representations were false, because in truth, Gardasil has not been proven 

to prevent cervical or anal cancer and is associated with a myriad of dangerous and undisclosed 

risks, including, but not limited to, the risk of autoimmune disease, including POTS, increased risk 

of developing cancer, and other serious side effects. The false representations Merck made to the 

patients, children, teenagers, the parents of children and teenagers, the medical community, 

including to Plaintiff, included: 

a) that Gardasil is effective in preventing cervical and anal cancer, when 

Merck knew that, contrary to these representations (i) no clinical studies 

were performed to test whether Gardasil prevents cancer; and (ii) the 

clinical studies confirmed that Gardasil is indeed ineffective when used in 

patients who have previously been exposed to HPV, and that Gardasil 

actually increases the risk of cervical cancer in any child or patient who has 

been previously exposed to HPV; 

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COMPLAINT 

b) that Gardasil is safe, when in reality, Gardasil causes and presents severe 

risks of cancer (including cervical cancer, the very cancer it is promoted as 

preventing), fertility problems, autoimmune disease, including POTS, OI, 

and other grave illnesses; 

c) false advertising and disease mongering by scaring parents into believing 

that cervical and anal cancer were far more prevalent than it really was; that 

Gardasil prevented cervical and anal cancer; and that Gardasil only had risks 

of injection site pain and fever, 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 not been shown to prevent cervical or anal 

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 this Complaint. 

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

public, including to Plaintiff, with the intent that parents would either seek out Gardasil from their 

medical providers or otherwise would provide their consent when they were offered Gardasil. 

449. At the time she provided her consent to the Gardasil injection(s), Plaintiff was not 

aware of the falsity of Merck’s aforementioned representations concerning the safety and efficacy 

of Gardasil. 

450. Plaintiff reasonably and justifiably relied upon the truth of the assurance made by 

Merck in its direct-to-consumer marketing concerning the efficacy and safety of Gardasil (which 

were also echoed by D.G.’s medical providers), when she provided consent for D.G. to be injected 

with the Gardasil vaccine. 

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

teenagers and the parents of teenagers, and which D.G. received and on which she relied, provided 

complete and truthful warnings and properly disclosed and disseminated the true risks, limitations 

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COMPLAINT 

and lack of efficacy associated with Gardasil, then Plaintiff would not have consented to D.G. 

being injected with Gardasil. 

452. Merck also engaged in a number of additional fraudulent activities that led to 

regulators, medical providers (upon information and belief, including but not limited D.G.’s 

medical providers), and the general public (including directly and/or indirectly Plaintiff) to be 

duped into believing that Gardasil is safe and effective. These fraudulent acts are outlined in 

greater detail in the preceding paragraphs of this Complaint, and included, among others: 

a) 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; 

b) Failing to conduct a sufficient number of studies for the targeted patient 

population which included pre-teen girls (and boys) between the ages of 

nine and 12; 

c) 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 

to obtain licensing for the commercial dosage of Gardasil; 

d) Using very restrictive exclusionary criteria in the clinical study patient 

population (including for example, exclusion of 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 most of these ingredients and allergies, there are limited 

resources for the public to test for such allergies in advance of being 

vaccinated; 

e) Failing to disclose all of the ingredients in Gardasil, including but not 

limited to the fact that Gardasil contains dangerous HPV L1-DNA 

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COMPLAINT 

fragments and that these DNA fragments could act as a Toll-Like Receptor 

9 (TLR9) agonist – further adjuvanting the vaccine and making it more 

potent and dangerous. 

453. 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 

and efficacy 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 to recommend Gardasil to patients and to prepare and encourage patients to request and 

consent to Gardasil injections. 

454. Plaintiff 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(s). Plaintiff relied upon the skill, superior 

knowledge, and judgment of Merck, the manufacturer, labeler, and promoter of Gardasil, and 

detrimentally relied upon Merck’s fraudulent, false, and misleading statements, omissions, and 

conduct. 

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

omissions, and conduct concerning the safety and efficacy of Gardasil, D.G. has suffered and 

continues to suffer severe and permanent physical injuries, and associated symptomology and has 

suffered severe and permanent emotional injuries, including pain and suffering. D.G. also has a 

substantial fear of suffering additional and ongoing harms, including but not limited to now being 

at an increased risk of cancer, and future symptoms and harms associated with her autoimmune 

disease and other injuries caused by Gardasil. 

456. As a direct and proximate result of her Gardasil-induced injuries, Plaintiff has 

suffered and continues to suffer economic losses, including considerable financial expenses for 

medical care and treatment, and diminished income capacity and she will continue to incur these 

losses and expenses in the future. 

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COMPLAINT 

457. Merck’s conduct, as described above, was oppressive, fraudulent, and malicious. 

Merck regularly risks the lives of patients, including D.G., 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 Plaintiff and D.G.’s 

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. 

458. WHEREFORE, Plaintiff requests that the Court enter judgment in her favor for 

compensatory and punitive damages, together with interest, and costs herein incurred, and all such 

other and further relief as this Court deems just and proper. Plaintiff also demands a jury trial on 

the issues contained herein. 

459.

PRAYER FOR RELIEF 

WHEREFORE, Plaintiff, Paige Graves, Individually and as Next Friend on Behalf of D.G., 

a minor child, requests that the Court enter judgment in her favor and against Merck & Co., Inc., 

and Merck, Sharp and Dohme Corporation (collectively “Merck”) as to all 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; 

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 against Merck; 

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COMPLAINT 

H. For an award providing for payment of reasonable fees, court costs, and other 

litigation 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, Paige Graves, 

Individually and as Next Friend on Behalf of D.G., a minor child, hereby demands a jury trial on 

all of her claims, causes of action and issues that are triable by jury. 

Dated: July 1, 2022 Respectfully submitted, 

ALLEN & NOLTE, PLLC 

 /s/ Jennifer Nolte 

 John H. “Trey” Allen, III 

Texas Bar No. 00788798 

trey@allennolte.com 

Jennifer Nolte 

Texas Bar No. 24007755 

jnolte@allennolte.com 

5445 La Sierra Drive, Suite 350 

Dallas, Texas 75231 

Tel: (214) 521-2300 

Fax: (214) 452-5637 

Attorneys for Plaintiff 

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