MEGAN MARIE ROEDER
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`Plaintiff,
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`v.
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`Defendants.
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`MERCK & CO., INC., a New Jersey Corporation;
`and MERCK SHARP & DOHME CORP., a New
`Jersey Corporation,
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`Case No.
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`
`COMPLAINT FOR
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`(1) Negligence
`(2) Strict Liability (Failure to Warn)
`(3) Strict Liability (Manufacturing Defect)
`(4) Breach of Warranty
`(5) Common Law Fraud
`(6) Violation of California’s Unfair
`Competition Law
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`DEMAND FOR JURY TRIAL
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`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 1 of 81 Page ID #:1
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`Paul Adrian Green (SBN: 237707)
`LAW OFFICE OF PAUL GREEN
`1055 E. Colorado Blvd., 5th Floor
`Pasadena, CA 91106
`Telephone: (626) 381-9893
`Facsimile: (626) 521-5117
`pgreen@pgreenlaw.com
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`Attorney for Plaintiff
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`UNITED STATES DISTRICT COURT
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`CENTRAL DISTRICT OF CALIFORNIA
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`1
`COMPLAINT
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`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 2 of 81 Page ID #:2
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION ................................................................................................................................... 5
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`PARTIES AND VENUE......................................................................................................................... 5
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`GENERAL ALLEGATIONS.................................................................................................................. 7
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`I. “History Doesn’t Repeat Itself, But It Often Rhymes” – Mark Twain ........................................ 7
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`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 ......................................................................................................... 9
`
`A.
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`B.
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`C.
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`D.
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`E.
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`F.
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`G.
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`Overview of the Human Papillomavirus ........................................................................ 10
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`Overview of the Gardasil Vaccine and Its Fast-Tracked Approval................................ 11
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`Merck Engaged in Disease Mongering and False Advertising to Enhance Gardasil Sales
` ........................................................................................................................................ 16
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`Merck Used Scare Tactics and Provided Financial Incentives to Legislatures to Attempt
`to make the Gardasil Vaccine Mandatory for All School Children ............................... 18
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`Merck Pushed Gardasil Using Trusted Doctors and Third-Party Front Groups ............ 20
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`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 ..................................................................................................................... 20
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`The Gardasil Vaccines Contain Numerous Hazardous Ingredients, Including At Least
`One Ingredient Merck Failed to Disclose to Regulators and the Public ........................ 23
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`i. Gardasil Contains A Toxic Aluminum Adjuvant ........................................................... 23
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`ii.
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`iii.
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`iv.
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`v.
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`Merck Lied About a Secret DNA Adjuvant Contained in The Gardasil Vaccines .. 24
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`Gardasil Contains Borax ........................................................................................... 25
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`Gardasil Contains Polysorbate 80............................................................................. 26
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`Gardasil Contains Genetically Modified Yeast ........................................................ 26
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`H.
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`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 .............................. 26
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`i. Small Clinical Trials ....................................................................................................... 29
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`ii.
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`Merck Used a Highly Toxic “Placebo” to Mask Gardasil Injuries .......................... 29
`2
`COMPLAINT
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`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 3 of 81 Page ID #:3
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`iii. Merck Used Exclusionary Criteria to Further Conceal Gardasil Risks .................... 30
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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.. 31
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`v.
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`Merck Manipulated the Study Protocols to Block Participants and Researchers from
`Reporting Injuries and Designed the Studies to Mask Any Long-Term Adverse
`Events ....................................................................................................................... 32
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`vi. Merck Deceived Regulators and the Public About Its Pivotal Gardasil Clinical Trial
`(Protocol 018) ........................................................................................................... 34
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`I.
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`J.
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`K.
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`L.
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`M.
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`N.
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`Contrary to Merck’s Representations, Gardasil May Actually Cause and Increase the
`Risk of Cervical and Other Cancers ............................................................................... 36
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`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.................................................................................... 38
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`Merck has Concealed the Fact that Gardasil Increases the Risk of Fertility Problems .. 44
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`There were an Increased Number of Deaths in the Gardasil Studies ............................. 45
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`Post-Marketing Injuries -- The Raft of Injuries Seen in Merck’s Clinical Trials Has
`Now Become A Population-Wide Chronic Disease Epidemic ...................................... 46
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`The Gardasil Vaccines’ Harms Are Not Limited to the United States, Rather the
`Vaccines Have Injured Patients All Over the World ...................................................... 47
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`In Light of Gardasil’s Serious and Debilitating Adverse Events, the Japanese
`Government Rescinded Its Recommendation that Girls Receive Gardasil .............. 48
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`Denmark Has Opened Specialized Clinics Specifically Focused on Treating
`Gardasil-Induced Injuries, Including Gardasil-Induced Autoimmune Diseases ...... 49
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`Gardasil-Induced Adverse Events Caused the Government in Colombia to Conclude
`that Gardasil Would No Longer Be Mandatory ....................................................... 49
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`India Halted Gardasil Trials and Accused Merck of Corruption After the Death of
`Several Young Girls Who were Participants in the Trial ......................................... 50
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`i.
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`ii.
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`iii.
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`iv.
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`O.
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`Merck’s Fraud Has Paid Off Handsomely Resulting in Over $3 Billion in Gardasil Sales
`Annually ......................................................................................................................... 51
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`III. Megan Marie Roeder Sustained Autoimmune Disease, Autonomic Dysfunction and Other
`Serious Injuries, as A Result of Her Gardasil Injection(s) ......................................................... 51
`
`A.
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`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.................................................................................................. 52
`3
`COMPLAINT
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`

`

`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 4 of 81 Page ID #:4
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`B.
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`“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..................................................................................... 54
`
`CAUSES OF ACTION ......................................................................................................................... 55
`
`COUNT ONE NEGLIGENCE ............................................................................................... 55
`COUNT TWO STRICT LIABILITY (FAILURE TO WARN) ............................................. 62
`COUNT THREE STRICT LIABILITY (MANUFACTURING DEFECT) .......................... 66
`COUNT FOUR BREACH OF EXPRESS WARRANTY ..................................................... 68
`COUNT FIVE COMMON LAW FRAUD ............................................................................ 72
`COUNT SIX VIOLATION OF CALIFORNIA’S UNFAIR COMPETITION LAW ........... 78
`PRAYER FOR RELIEF ........................................................................................................................ 80
`
`DEMAND FOR JURY TRIAL ............................................................................................................. 81
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`4
`COMPLAINT
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`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 5 of 81 Page ID #:5
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`COMES NOW Plaintiff, MEGAN MARIE ROEDER, who by and through counsel Law
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`Office of Paul Green, and alleges against defendants MERCK & CO., INC., and MERCK, SHARP
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`AND DOHME CORPORATION, and each of them, as follows:
`
`INTRODUCTION
`This common-law products liability, negligence, strict liability, breach of warranty and
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`1.
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`fraud action arises out of serious and debilitating injuries, including but not limited to autonomic,
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`neurological and heterogenous autoimmune injuries and resulting sequalae that plaintiff, Megan Marie
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`Roeder (“Plaintiff”), sustained as a result of receiving the Gardasil vaccine, which was manufactured,
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`labeled, and promoted by defendants Merck & Co., Inc., and Merck, Sharp and Dohme Corporation
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`(collectively “Merck”).
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`PARTIES AND VENUE
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`2.
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`Plaintiff, Megan Marie Roeder (“Roeder” or “Plaintiff”), is an adult and a resident and
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`citizen of California.
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`3.
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`Defendant Merck & Co., Inc., is a New Jersey corporation with its principal place of
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`business at One Merck Drive, Whitehouse Station, New Jersey.
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`4.
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`Defendant Merck, Sharp and Dohme Corporation, is a New Jersey corporation with its
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`principal place of business at One Merck Drive, Whitehouse Station, New Jersey.
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`5.
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`Defendants Merck & Co., Inc., and Merck, Sharp and Dohme Corporation shall
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`hereinafter collectively be referred to as “Merck.”
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`6.
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`At all times herein mentioned, each defendant was the agent, servant, partner, aider and
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`abettor, co-conspirator and/or joint venturer of the other defendants named herein and was at all times
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`operating and acting within the purpose and scope of said agency, service, employment, partnership,
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`conspiracy and/or joint venture and rendered substantial assistance and encouragement to the other
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`defendants, knowing that their collective conduct constituted a breach of duty owed to Plaintiff.
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`7.
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`At all times herein mentioned, defendants were fully informed of the actions of their
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`agents and employees, and thereafter no officer, director or managing agent of defendants repudiated
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`those actions, which failure to repudiate constituted adoption and approval of said actions and all
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`defendants and each of them, thereby ratified those actions.
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`5
`COMPLAINT
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`

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`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 6 of 81 Page ID #:6
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`8.
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`There exists and, at all times herein mentioned there existed, a unity of interest in
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`ownership between the named defendants, such that any individuality and separateness between the
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`defendants has ceased and these defendants are the alter-ego of each other and exerted control over
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`each other. Adherence to the fiction of the separate existence of these two named defendants as
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`entities distinct from each other will permit an abuse of the corporate privilege and would sanction a
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`fraud and/or would promote injustice.
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`9.
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`At all times herein mentioned, the two Merck defendants were engaged in the business
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`of, or were successors in interest to, entities engaged in the business of researching, formulating,
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`compounding, testing, manufacturing, producing, processing, assembling, inspecting, distributing,
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`marketing, labeling, promoting, packaging, prescribing and/or advertising for sale, and selling
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`products for use by patients such as Plaintiff and her medical providers. As such, the two Merck
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`defendants are each individually, as well as jointly and severally, liable to Plaintiff for her damages.
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`10.
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`The harm caused to Plaintiff resulted from the conduct of one or various combinations
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`of the two Merck defendants, and through no fault of Plaintiff. There may be uncertainty as to which
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`one or which combination of the two Merck defendants caused the harm. The two Merck defendants
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`have superior knowledge and information on the subject of which one or which combination of the
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`two defendants caused Plaintiff’s injuries. Thus, the burden of proof should be upon each of the two
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`Merck defendants to prove that the defendant has not caused the harms Plaintiff has suffered. As
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`previously stated, the two named Merck defendants shall hereinafter and throughout this Complaint
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`be collectively referred to as “Merck.”
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`11. Merck is the manufacturer, labeler and promoter of the Gardasil and Gardasil-9
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`vaccines, which are purported to be “cervical cancer vaccines” and “anal cancer vaccines” by
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`preventing a handful of the hundreds of strains of the Human Papillomavirus (“HPV”). Merck
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`regularly conducts and transacts business in California and has promoted Gardasil to consumers,
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`patients, hospitals, physicians, nurses and medical professionals, including but not limited to Plaintiff,
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`and the medical facility and medical professionals who prescribed and/or injected Plaintiff with
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`Gardasil. This Court has personal jurisdiction over Merck because defendants have sufficient
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`minimum contacts with California to render the exercise of jurisdiction by this Court proper.
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`6
`COMPLAINT
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`

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`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 7 of 81 Page ID #:7
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`12. This Court has subject matter jurisdiction over the parties pursuant to 28 U.S.C.
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`§1332(a) because Plaintiff and the defendants are citizens of different states and the amount of
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`controversy exceeds $75,000.00, exclusive of interest and costs.
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`13. Venue is proper in this Court pursuant to 28 U.S.C. §1391 because a substantial portion
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`of the events and omissions giving rise to the claims asserted herein occurred in this District.
`GENERAL ALLEGATIONS
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`“History Doesn’t Repeat Itself, But It Often Rhymes” – Mark Twain
`I.
`14. Merck traces its history back to 1668, when the original founder of the company,
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`Friedrich Jacob Merck, bought an apothecary in Darmstadt, Germany. The company operated as a
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`pharmacy for approximately the next 150+ years when, in 1827, Friedrich’s descendant, Heinrich
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`Emmanuel Merck, converted the company into a drug manufacturing enterprise. Merck’s first
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`products included morphine and cocaine.
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`15. Merck later manufactured a number of controversial products including Fosamax (a
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`purported bone density drug that caused bone fractures), Nuvaring (a birth control device associated
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`with life-threatening blood clots and death), and probably its most infamous drug, Vioxx (a pain
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`medication Merck was forced to pull from the market due to its cardiovascular risks), all of which
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`landed Merck in litigation hot water.
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`16. With regard to Vioxx, Merck was sued by tens of thousands of patients who alleged
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`they suffered heart attacks and other cardiovascular injuries as a result of ingesting the blockbuster
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`pain medication.
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`17. Documents unsealed during the Vioxx litigation in the early 2000s revealed a culture
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`wherein Merck knew early on that Vioxx was linked to fatal cardiovascular adverse events but
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`nonetheless intentionally chose to conceal these risks from the public and medical community and,
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`instead, orchestrated a scheme to downplay the severity of the risks. Merck misrepresented the results
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`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,
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`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
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`7
`COMPLAINT
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`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 8 of 81 Page ID #:8
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`ENGLAND JOURNAL OF MEDICINE 1193 (2006); Aaron S. Kesselheim et al., Role of Litigation in
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`Defining Drug Risks, 17 JAMA 308 (2007); Harlan M. Krumholz et al., What We Have Learnt From
`Vioxx, 334 BRITISH MED. J. 120 (2007).
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`18. The British Medical Journal reported that internal documents and communications
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`obtained from Merck during litigation revealed that Merck scientists internally acknowledged the
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`existence of Vioxx’s risks very early on: “Since the early development of [Vioxx], some scientists at
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`Merck were concerned that the drug might adversely affect the cardiovascular system … In internal
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`emails made public through litigation, Merck officials sought to soften the academic authors’
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`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,
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`334 BRITISH MED. J. 120 (2007). And, despite Merck’s knowledge of the risk, Merck never
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`conducted the necessary studies designed to evaluate cardiovascular risk. Id.
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`19.
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`In an article published in the Journal of the American Medical Association, it was
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`reported that Merck worked to “diminish the impact of reported cardiovascular adverse effects by not
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`publishing adverse events and failing to include complete data on myocardial infarctions that occurred
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`during a key clinical trial. The information came to the public attention through a subpoena 5 years
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`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
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`studies indicate that clinical trials and routine regulatory oversight as currently practiced often fail to
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`uncover important adverse effects for widely marketed products. In each instance, the litigation
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`process revealed new data on the incidence of adverse events, enabled reassessment of drug risks
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`through better evaluation of data, and influenced corporate and regulatory behavior.” Id.
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`20.
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`It was also revealed and reported that, in order to control the public narrative that Vioxx
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`was safe and risk free, “Merck issued a relentless series of publications…complemented by numerous
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`papers in peer-reviewed medical literature by Merck employees and their consultants. The company
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`sponsored countless continuing medical ‘education’ symposiums at national meetings in an effort to
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`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,
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`8
`COMPLAINT
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`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 9 of 81 Page ID #:9
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`Merck “selectively targeted doctors who raised questions about [Vioxx], going so far as pressuring
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`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
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`Medicine at the Cleveland Clinic, commented: “Sadly, it is clear to me that Merck’s commercial
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`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
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`OF MEDICINE 1707 (2004).
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`21. Once Merck’s misdeeds vis-à-vis Vioxx were revealed in various jury trials, Merck paid
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`nearly $5 billion to settle the tens of thousands of personal injury actions that had been brought
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`against it as a result of its concealment of Vioxx’s cardiovascular risks. Merck paid an additional $1
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`billion to settle a securities class action brought by investors who had lost money when Merck’s stock
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`tanked following revelations of the drug’s risks and subsequent lost sales. Merck was also forced to
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`pay $950 million in civil and criminal fines to the Department of Justice and other governmental
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`entities as a result of various criminal activities Merck had engaged in with respect to Vioxx.
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`22.
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`In 2005, Merck pulled Vioxx from the market and was desperate to find a replacement
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`for its previous multi-billion-dollar blockbuster.
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`23. Gardasil was viewed as the answer to the financial woes Merck had suffered from
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`Vioxx.
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`24.
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`Indeed, some have euphemistically noted that HPV stood for “Help Pay for Vioxx.”
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`In the aftermath of the Vioxx scandal, and seeking a replacement product, Merck’s
`25.
`senior director of clinical research, Eliav Barr, M.D., proclaimed of Gardasil: “This is it. This is the
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`Holy Grail!”
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`II.
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`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
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`26. As outlined herein, in researching, developing, and marketing its new Holy Grail,
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`Gardasil, Merck engaged in the same unscrupulous tactics it had so infamously engaged in with
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`Vioxx.
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`9
`COMPLAINT
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`

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`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 10 of 81 Page ID #:10
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`27. Certain Merck employees, scientists and executives involved in the Vioxx scandal were
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`also involved with Gardasil, and it appears they employed the very same methods of manipulating
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`science and obscuring risks as they did with Vioxx.
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`28. According to Merck’s marketing claims, Gardasil (and, later, next-generation Gardasil
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`9) provided lifetime immunity to cervical, anal and other HPV-associated cancers.
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`29. As discussed more fully below, whether Gardasil prevents cancer (not to mention
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`lifetime immunity), is unproven. In fact, it may be more likely to cause cancer in those previously
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`exposed to HPV than to prevent it.
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`30. Moreover, Merck knows and actively conceals the fact that Gardasil can cause a
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`constellation of serious adverse reactions and gruesome diseases, including autoimmune diseases, and
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`death in some recipients.
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`31. As a result of Merck’s fraud, Gardasil today is wreaking havoc on a substantial swath of
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`an entire generation of children and young adults on a worldwide scale.
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`A. Overview of the Human Papillomavirus
`32. Human Papillomavirus (“HPV”) is a viral infection that is passed between people
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`through skin-to-skin contact. There are more than 200 strains of HPV, and of those, more than 40
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`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
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`majority of sexually active people will get it at some point in their lives, even if they have few sexual
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`partners.
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`34. HPV, for the most part, is benign. More than 90 percent of HPV infections cause no
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`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
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`Freitas et al., Susceptibility to cervical cancer: An Overview, 126 GYNECOLOGIC ONCOLOGY 306
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`(August 2012).
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`35. Approximately 12 to 18 of the over 200 strains of HPV are believed to be associated
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`with cervical cancer, and approximately six of the strains are believed to be associated with anal
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`cancer.
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`10
`COMPLAINT
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`

`

`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 11 of 81 Page ID #:11
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`36. Not every HPV infection puts one at risk for cervical cancer. Only persistent HPV
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`infections – not short-term or transient infections or sequential infections with different HPV types –
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`in a limited number of cases with certain strains of the virus may cause the development of
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`precancerous lesions. With respect to cervical cancer, these precancerous lesions are typically
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`diagnosed through Pap smears and then removed through medical procedures. However, when
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`undiagnosed, they may in some cases progress to cervical cancer in some women. Other risk factors,
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`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).
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`Infection with certain types of HPV are also associated with other diseases, such as genital warts.
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`37.
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`Public health officials have long recommended the Pap test (also known as Pap Smear),
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`which detects abnormalities in cervical tissue, as the most effective frontline public health response to
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`the disease.
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`38.
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`Since its introduction, cervical cancer screening through the Pap test has reduced the
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`rates of cervical cancer in developed countries by up to 80 percent. Id.
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`39.
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`Incidences of cervical cancer have been declining dramatically worldwide as countries
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`have implemented Pap screening programs.
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`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
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`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
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`ONCOLOGY 305 (August 2012). Anal cancer is even more rare, and according to the current data,
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`approximately 0.2 percent of people will be diagnosed with anal cancer in their lifetime.
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`41. Although the incidence of cervical cancer was in rapid decline as a result of the
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`implementation of routine testing and screening, including the Pap test and various DNA testing
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`measures, Merck sought to fast-track a vaccine onto the market to prevent infection from four types of
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`HPV (only two of which are associated with cancer).
`B. Overview of the Gardasil Vaccine and Its Fast-Tracked Approval
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`11
`COMPLAINT
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`

`

`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 12 of 81 Page ID #:12
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`42. While there are over 200 types of the HPV virus, only 12 to 18 types currently are
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`considered potentially associated with cervical or anal cancer. Merck’s original Gardasil vaccine
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`claimed to prevent infections from four strains (HPV Strain Types 6, 11, 16 and 18) and only two of
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`those (Types 16 and 18) were associated with cervical and anal cancer.
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`43. Under Food and Drug Administration (“FDA”) requirements, to obtain approval for
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`marketing a vaccine, the manufacturer must conduct studies to test the effectiveness and safety of the
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`vaccine. Once FDA approval is obtained, the manufacturer has a duty to perform any further
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`scientific and medical investigation as a reasonably prudent manufacturer would perform, and to
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`engage in any necessary post-marketing pharmacovigilance related to the product.
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`44. The FDA approved Gardasil on June 8, 2006, after granting Merck fast-track status and
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`speeding the approval process to a six-month period, leaving unanswered material questions relating
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`to its effectiveness and safety as well as when and to whom the Gardasil vaccine ought to be
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`administered.
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`45. Merck failed, during the preapproval processing period and thereafter, to disclose (to
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`the FDA and/or the public), material facts and information relating to the effectiveness and safety of
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`Gardasil, as well as to whom the vaccine should or should not be administered.
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`46. Merck failed to perform in the preapproval processing period and thereafter, scientific
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`and medical investigations and studies relating to the safety, effectiveness and need for the Gardasil
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`vaccine as either required by and under FDA directives and regulations, and/or those which a prudent
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`manufacturer should have conducted unilaterally.
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`47.
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`In June 2006, after the FDA’s fast-tracked review, Gardasil was approved for use in
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`females ages nine through 26 for the purported prevention of cervical cancer and, almost immediately
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`thereafter, the Advisory Committee on Immunization Practices (“ACIP”), a committee within the
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`Centers for Disease Control (“CDC”), recommended Gardasil for routine vaccination of adolescent
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`girls ages eleven and twelve years old, but also allowed it to be administered to girls as young as nine
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`years old.
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`48. On October 16, 2009, the FDA approved Gardasil for use in boys ages nine through 26
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`12
`COMPLAINT
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`

`

`Case 2:22-cv-04284 Document 1 Filed 06/22/22 Page 13 of 81 Page ID #:13
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`for the prevention of genital warts caused by HPV types 6 and 11, and in December 2010, it approved
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`Gardasil for the purported prevention of anal cancer in males and females ages nine through 26.
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`49.
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`Subsequently, Merck sought approval for Gardasil 9 (containing the same ingredients as
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`Gardasil, but in higher quantities), which purportedly guarded against five additional HPV strains
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`currently associated with cervical cancer and anal cancer (HPV Types 31, 33, 45, 52 and 58) than the
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`original Gardasil, for a total of nine strains.
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`50. The FDA approved Gardasil 9 in December 2014, for use in girls ages nine through 26
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`and boys ages nine through 15 for the purported prevention of cervical, vaginal, and anal cancers.
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`Presently, Gardasil 9 has been approved for and is being promoted by Merck to males and females
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`who are between nine and 45 years of age, with an emphasis by Merck on marketing to pre-teen
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`children and their parents. With little evidence of efficacy, the FDA also recently approved, on an
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`accelerated basis, Gardasil 9 for prevention of oropharyngeal and other head and neck cancers.
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`51. After the approval of the Gardasil 9 vaccine, the original Gardasil vaccine was phased
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`out of the U.S. Market; and the original Gardasil vaccine is no longer available for sale in the United
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`States.
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`52. According to data from the National Cancer Institute’s (“NCI”) Surveillance,
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`Epidemiology and End Results Program (“SEER”), the incidence of deaths from cervical cancer prior
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`to Gardasil’s introduction in the United States had been steadily declining for years and, in 2006, was
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`2.4 per 100,000 women or approximately 1 in every 42,000 women. The currently available rate is
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`essentially unchanged, 2.2 per 100,000 women, based on data through 2017.
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`53. The median a