Case 2:21-cv-05651 Document 1 Filed 12/29/21 Page 1 of 41
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`UNITED STATES DISTRICT COURT
`THE EASTERN DISTRICT OF PENNSYLVANIA
`
`
`IN RE: ZOSTAVAX (ZOSTER VACCINE
`LIVE) PRODUCTS LIABILITY
`LITIGATION
`
`MDL No. 2848
`Civil Action No. 2:18-md-2848
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`
`
`
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`Case No. __________________
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`JURY TRIAL DEMANDED
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`
`This Document Relates to:
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`LASKA MOAK,
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` Plaintiff,
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` -against-
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`MERCK & CO., INC.; and
`MERCK SHARP & DOHME CORP.
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` Defendants
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`
`
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`COMPLAINT
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`Plaintiff, by and through the undersigned attorneys, hereby files this Complaint in
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`accordance with Case Management Order No. 2 and Pretrial Order No. (“PTO”) 22, and is bound
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`by the rights, protections, privileges, and obligations of PTO 22. Plaintiff states that but for the
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`Order permitting direct filing in the Eastern District of Pennsylvania pursuant to PTO 22,
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`Plaintiff would have filed this Complaint in the United States District Court for the District Court
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`South Carolina, and designates this Court as the place of remand as this case may have
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`originally been filed there.
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`Plaintiff further hereby alleges as follows:
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`PARTIES
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`1.
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`At all times relevant to this action Plaintiff Laska Moak (“Plaintiff”) was and is
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`a citizen of the State of South Carolina, and resides in Chapin, South Carolina.
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`2.
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`At all relevant times to this action, as further detailed herein, Defendants MERCK
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`& CO., INC. and MERCK SHARP & DOHME CORP., (collectively, “Defendants”), and each of
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`them, introduced into interstate commerce the ZOSTAVAX vaccine, which was to be administered
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`to individuals and consumers throughout the United States.
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`3.
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`Defendant MERCK & CO., INC. (“Merck”) is a New Jersey corporation with its
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`principal place of business located at 2000 Galloping Hill Road, Kenilworth, New Jersey 07033.
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`4.
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`At all relevant times, Merck designed, researched, developed, manufactured, tested,
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`labeled, advertised, promoted, marketed, sold, supplied, distributed, and/or introduced into the
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`stream of commerce the ZOSTAVAX vaccine, to be administered to consumers nationwide,
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`including in South Carolina. Merck has conducted and continues to conduct business in
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`South Carolina and derived and continues to derive substantial revenue from within South
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`Carolina, from, including, but not limited to, its business activities related to ZOSTAVAX.
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`Plaintiff’s claims arise out of Merck’s contacts with South Carolina.
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`5.
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`Defendant MERCK SHARP & DOHME CORP. (“MSD”), is a wholly-owned
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`subsidiary of Merck and part of the Merck family of companies.
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`6.
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`MSD is a New Jersey corporation organized with its principal place of business
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`located at 2000 Galloping Hill Road, Kenilworth, New Jersey 07033.
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`7.
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`At all relevant times, MSD, individually through its predecessors and through the
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`actions of Merck, designed, researched, developed, manufactured, tested, labeled, advertised,
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`promoted, marketed, sold, supplied, distributed, and/or introduced into the stream of commerce
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`the ZOSTAVAX vaccine, to be administered to consumers nationwide, including in
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`South Carolina. MSD has conducted and continues to conduct business in South Carolina and
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`derived and continues to derive substantial revenue from within South Carolina, from including,
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`Case 2:21-cv-05651 Document 1 Filed 12/29/21 Page 3 of 41
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`but not limited to, its business activities related to ZOSTAVAX. Plaintiff’s claims arise out of
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`MSD’s contacts with South Carolina.
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`8.
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`At all relevant
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`times,
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`the non-party distributor, McKesson Corporation
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`(“McKesson”), as an agent of Merck and/or MSD, packaged, labeled, re-packaged, marketed,
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`promoted, supplied, distributed, sold, and/or introduced into the stream of commerce the
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`ZOSTAVAX vaccine to consumers nationwide including South Carolina, including to the
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`Plaintiff and/or Plaintiff’s healthcare providers.
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`9.
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`“Defendants” where used hereinafter, shall refer to all subsidiaries, affiliates,
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`divisions, franchises, partners, joint venturers, organizational units of any kind, predecessors,
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`successors, assigns, officers, directors, employees, agents and representatives of Merck and MSD,
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`and each of them.
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`10.
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`“Healthcare providers” where used hereinafter, shall refer to all pharmacists,
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`prescribing physicians, treating physicians, nurse practitioners, person who administered
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`ZOSTAVAX to Plaintiff, and any other medical professional who saw, diagnosed, treated, and or
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`prescribed medications or vaccinations to Plaintiff in connection with ZOSTAVAX, shingles,
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`zoster-related conditions, and/or the injuries alleged herein.
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`JURISDICTION AND VENUE
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`11.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. § 1332 because
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`there is complete diversity of citizenship between the parties and the amount in controversy
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`exceeds $75,000.00 exclusive of interests and costs.
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`12.
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`The District Court with proper venue pursuant to 28 U.S.C. § 1391 is the District
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`of South Carolina.
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`13.
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`Plaintiff is a resident and citizen of South Carolina.
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`14. Merck and MSD are New Jersey corporations, each with its principal place of
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`business in Kenilworth, New Jersey.
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`15.
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`16.
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`South Carolina has personal jurisdiction over Merck and MSD.
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`Based upon information and belief, at all relevant times, each Defendant was and
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`is duly authorized to conduct business in South Carolina as a registered foreign corporation.
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`17.
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`Defendants regularly conducted and solicited business within South Carolina and
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`continue to do so.
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`18.
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`Defendants at all relevant times sold and distributed ZOSTAVAX in South
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`Carolina and continue to do so.
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`19.
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`Defendants derive substantial revenue from goods used or consumed in South
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`Carolina.
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`20.
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`21.
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`Each Defendant engages in continuous and systematic activity in South Carolina.
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`Each Defendant’s continuous and system activity in South Carolina and its
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`minimum contacts within South Carolina gave rise to Plaintiff’s claims.
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`22.
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`Each Defendant purposefully avails itself of the privilege of conducting activities
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`within South Carolina, thus invoking the benefits and protections of its laws.
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`23.
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`Each Defendant has purposefully connected itself to South Carolina and has
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`sufficient minimum contacts with South Carolina such that South Carolina courts’ assertion of
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`jurisdiction here is reasonable and does not offend the traditional notions of fair play and
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`substantial justice.
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`24.
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`The National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”), 42 U.S.C. §§
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`300aa-1 et seq. does not preempt Plaintiff from filing this Complaint:
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`a. Pursuant to §11(c)(1)(A) of the Vaccine Act, the Vaccine Court has
`jurisdiction to only hear cases listed on the Vaccine Injury Table.
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`b. The ZOSTAVAX vaccine is not a vaccine listed in the Vaccine
`Injury Table.
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`
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`
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`AGENCY, ALTER-EGO, VICARIOUS, SUCCESSOR, AND CO-CONSPIRATOR
`LIABILITY OF EACH DEFENDANT DUE TO THE RELATIONSHIPS BETWEEN
`DEFENDANTS, MERCK AND MSD, AND THE DISTRIBUTOR, MCKESSON
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`25.
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`26.
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`Plaintiff incorporates by reference all prior allegations.
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`Each Defendant is individually, as well as jointly and severally, liable to Plaintiff
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`for Plaintiff’s damages.
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`27.
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`Plaintiff would not have an adequate remedy if Merck and MSD, were not named
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`parties in this action.
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`28.
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`There exists and, at all times herein mentioned, a unity of interest in ownership
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`between Merck and MSD.
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`29. Merck and MSD are not distinct corporate entities: the assets of Merck and MSD
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`are common to both entities; Merck and MSD share and use facilities to conduct and engage in
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`business activities; the business operations of Merck and MSD are the same; the employees and
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`officers of Merck and MSD are largely the same people; the principal place of business of Merck
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`and MSD is the same; the same bank accounts are used by Merck and MSD for business and other
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`operations; Merck and MSD have no separate corporate formalities that exist or are observed.
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`30.
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`No individuality and separateness exist between Merck and MSD; and any
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`individuality and separateness of Merck and MSD that may have formerly existed has ceased.
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`31.
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`As such, sufficient grounds exist for disregarding the corporate form and extending
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`liability to MSD and Merck, for the acts of the other, through piercing the corporate veil, alter ego
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`liability, vicarious liability, and/or successor liability.
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`32.
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`Adherence to the fiction of the separate existence Merck and MSD as entities
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`distinct from each other will permit an abuse of corporate privilege and would sanction a fraud
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`and/or promote injustice.
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`33.
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`At all times herein mentioned, the officers and/or directors of Merck and MSD
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`mentioned or referred to herein participated in, authorized and/or directed the production and
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`promotion of the ZOSTAVAX vaccine when they knew, or with exercise of reasonable care and
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`diligence should have known, of the hazards and dangerous propensities of said products, and
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`thereby actively participated in the tortious conduct that results in the injuries suffered by Plaintiff.
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`34. MSD and Merck exercised, and continues to exercise, complete and domination of
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`the finances, policy, and business practices regarding ZOSTAVAX of McKesson to such an extent
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`that McKesson has no separate mind, will or existence of its own.
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`35.
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`The aforesaid control was used by Merck and/or MSD to negligently design,
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`research, develop, manufacture, test, label, advertise, promote, market, sell, supply, distribute,
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`and/or introduce ZOSTAVAX into the stream of commerce for use by individuals like Plaintiff
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`and their healthcare providers.
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`36.
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`As such, sufficient grounds exist to extend liability to Merck and/or MSD for the
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`acts of McKesson regarding the design, research, development, manufacture, testing, labeling,
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`advertising, promotion, marketing, sale, supply, distribution, and/or introduction into the stream
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`of commerce of ZOSTAVAX.
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`37. McKesson, as Defendants’ agent, created, developed, and implemented the
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`marketing strategy to promote and sell and distribute ZOSTAVAX nationwide.
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`38. McKesson, as Merck’s agent, created, developed, and implemented the marketing
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`strategy to promote and sell and distribute ZOSTAVAX nationwide.
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`39. McKesson, as MSD’s agent, created, developed, and implemented the marketing
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`strategy to promote and sell and distribute ZOSTAVAX nationwide.
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`40. McKesson, as Defendants’ agent, developed prescribing information and content
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`about “Varicella-Zoster Vaccine” describing Zostavax as a “vaccine given by injection (a shot) to
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`provide protection against herpes zoster (shingles)” for distribution nationwide.
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`41. McKesson, as Defendants’ agent, published prescribing information and content
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`about “Varicella-Zoster Vaccine” describing Zostavax as a “vaccine given by injection (a shot) to
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`provide protection against herpes zoster (shingles).”
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`42. McKesson, as Defendants’ agent, disseminated prescribing information and content
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`about “Varicella-Zoster Vaccine” describing Zostavax as a “vaccine given by injection (a shot) to
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`provide protection against herpes zoster (shingles)” nationwide.
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`43. Merck and/or MSD impliedly and explicitly consented to have McKesson act on
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`Merck and/or MSD’s behalf with regard to the packaging, labeling, re-packaging, marketing,
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`promotion, supply, distribution, sale, and/or introduction into the stream of commerce of
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`ZOSTAVAX throughout the United States.
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`44. Merck and MSD manifested McKesson’s authority to act on Merck’s and MSD’s
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`behalf by allowing McKesson to create, develop, and implement the ZOSTAVAX marketing
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`strategy and campaign.
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`45. Merck and/or MSD manifested the authority of McKesson to act on Merck’s and/or
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`MSD’s behalf by allowing McKesson to create, develop, publish, and disseminate the
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`ZOSTAVAX “Vaccine Information Statement.”
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`46. Merck and/or MSD manifested the authority of McKesson to act on Merck’s and/or
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`MSD’s behalf by allowing McKesson to develop, publish, and disseminate marketing and
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`promotional materials for ZOSTAVAX.
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`47. McKesson exercised, and continues to exercise, complete control, and/or equal
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`participation in the policy and business practices of Merck and/or MSD regarding the packaging,
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`labeling, re-packaging, marketing, promoting, supply, distribution, sale, and/or introduction of
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`ZOSTAVAX into the stream of commerce to such an extent that Merck and McKesson have no
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`separate mind(s), will or own existence in this regard.
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`48. McKesson used the aforesaid control over Merck and MSD, acting as an agent of
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`Merck and MSD, to negligently package, label, re-package, market, promote, supply, distribute,
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`sell, and/or introduce into the stream of commerce ZOSTAVAX for use by consumers like Plaintiff
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`and Plaintiff’s healthcare providers.
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`49.
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`As such, sufficient grounds exist to extend liability to Merck and/or MSD for the
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`acts of McKesson regarding the packaging, labeling, re-packaging, marketing, promotion, supply,
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`distribution, sale, and/or introduction into the stream of commerce of ZOSTAVAX.
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`50.
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`Sufficient grounds exist to extend liability for McKesson’s acts and omissions to
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`Merck because Merck and McKesson are agents of each other.
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`51.
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`Sufficient grounds exist to extend liability for McKesson’s acts and omissions to
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`MSD because MSD and McKesson are agents of each other.
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`52.
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`“MSD” where used hereinafter, shall include and refer to all predecessor(s)-in-
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`interest including but not limited to Schering Plough Corporation, successor(s)-in-interest, assigns,
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`officers, directors, employees, agents, subsidiaries, affiliates, divisions, franchises, partners, joint
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`venturers, and/or representatives of MSD.
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`53.
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`“Merck” where used hereinafter, shall refer to all subsidiaries, affiliates, divisions,
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`franchises, partners, joint venturers, organizational units of any kind, predecessors-in-interest
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`including but not limited to Schering-Plough Corporation, successors, assigns, officers, directors,
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`employees, agents and representatives of Merck, and MSD.
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`ESTOPPEL FROM PLEADING STATUTES OF LIMITATIONS OR REPOSE
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`54.
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`55.
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`Plaintiff incorporates by reference all prior allegations.
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`Plaintiff brings these claims within the applicable statute of limitations because
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`Plaintiff and Plaintiff’s healthcare providers did not discover and could not reasonably discover
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`the defects and unreasonably dangerous condition of ZOSTAVAX.
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`56.
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`Plaintiff’s ignorance of the defective and unreasonably dangerous nature of
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`ZOSTAVAX and the causal connection between these defects and Plaintiff’s injuries and damages
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`is due to Defendants’ fraudulent conduct.
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`57.
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`Each Defendant’s fraudulent conduct includes intentional concealment of material
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`information from the public, and intentional misrepresentation of material information and/or
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`downplay of the serious threat to public safety that the ZOSTAVAX use presents.
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`58.
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`Defendants intentionally concealed material information including but not limited
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`to the fact that ZOSTAVAX had not been demonstrated to be safe or effective; that ZOSTAVAX
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`is not effective at permanently preventing shingles or any related injuries; and that ZOSTAVAX
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`carried with it the serious risks and dangerous defects described herein.
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`59.
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`Defendants’ fraudulent conduct was directed at Plaintiff, Plaintiff’s healthcare
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`providers, the medical community, the general consuming public, and the U.S. Food and Drug
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`Administration (“FDA”).
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`60.
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`Each Defendant had a duty to disclose the fact that ZOSTAVAX was not safe or
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`effective; was defective; was unreasonably dangerous; and using ZOSTAVAX as a measure of
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`routine health maintenance and prevention carried serious, hidden risks.
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`61.
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`Any applicable statutes of limitations have been tolled by the knowing and active
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`concealment and denial of the facts as alleged herein by the Defendants.
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`62.
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`Plaintiff has been kept ignorant of vital information essential to the pursuit of these
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`claims, without any fault or lack of diligence on Plaintiff’s part.
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`63.
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`Plaintiff could not reasonably have discovered the injury and/or its cause until
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`shortly before the initiation of this action.
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`64.
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`Each Defendant is estopped from relying on any statutes of limitation or repose
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`affirmative defense by virtue of each Defendant’s unclean hands, acts of fraudulent concealment,
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`and affirmative misrepresentations and omissions of material fact.
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`FACTUAL BACKGROUND
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`65.
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`ZOSTAVAX was designed, developed, manufactured, marketed, distributed, and
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`sold with the intended purpose of long-term prevention and protection against shingles and other
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`zoster-related conditions and disease.
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`Shingles
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`Varicella-zoster virus (“VZV”) causes chickenpox.
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`Once VZV causes chickenpox, the VZV remains inactive (dormant) in the nervous
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`66.
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`67.
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`system, in the sensory neurons of dorsal root and cranial nerve ganglia, for many years.
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`68. When reactivated, VZV causes shingles, also known as or herpes zoster (“HZ”).
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`69.
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`VZV can be reactivated due to factors such as disease, stress, aging, and immune
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`modulation caused by vaccination.
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`70.
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`VZV reactivates in aging individuals whose immune responses against VZV
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`decline, producing shingles.
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`71.
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`72.
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`One in three people in the United States will develop shingles during their lifetime.
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`Approximately 99% of persons aged fifty years and older are infected with VZV.
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`This is because nearly all of us had chickenpox as children.
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`73.
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`74.
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`Nearly one million cases of shingles are reported annually in the United States.
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`Shingles occurs at a rate of three to seven times higher in individuals age 50 years
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`and older than in the rest of the population.
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`75.
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`Shingles can often lead to additional complications, such as post herpetic neuralgia,
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`which is a painful and long-lasting and recurrent neurological condition that affects nerve fibers
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`and skin; those suffering from post-herpetic neuralgia often complain of burning pain that lasts
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`long after the visual rash and blisters from shingles go away.
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`76.
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`In addition to post herpetic neuralgia, shingles can lead to other serious
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`complications, such as scarring, bacterial superinfection, ocular and neurological injuries,
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`allodynia, cranial and motor neuron palsies, pneumonia, encephalitis, hearing loss, and death.
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`ZOSTAVAX Vaccine – A Live Vaccine
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`77.
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`The four main types of vaccines are live-attenuated vaccines; inactivated vaccines;
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`toxoid vaccines; and subunit, recombinant, polysaccharide, and conjugate vaccines.
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`78.
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`Inactivated vaccines are vaccines that use the killed version of the germ that causes
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`a disease.
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`79.
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`Live virus vaccines use a weakened (or attenuated) form of the virus that causes a
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`disease.
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`80.
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`ZOSTAVAX is a live-attenuated vaccine which contains VSV in reduced
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`virulence.
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`81.
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`One of the risks of using a live vaccine is transmission of the vaccine virus to the
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`recipient.
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`82.
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`Live-attenuated vaccines carry a serious, high risk of transmitting the live virus’s
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`disease to individuals with weakened immune systems, long-term health problems, or who have
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`had an organ transplant.
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`83.
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`Once injected, an attenuated live virus has been shown to recombine into more
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`virulent strains causing disease.
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`84.
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`Because ZOSTAVAX is a live-attenuated vaccine, it experiences potency loss
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`during its “shelf life” – after its manufacture but before its use.
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`85.
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`The ZOSTAVAX vaccine’s potency loss during a shelf life of eighteen (18) to
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`twenty (20) months is between 50% and 80%.
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`86. Merck and MSD knew that the end-expiry of eighteen months “is required to obtain
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`CDC contracts” for ZOSTAVAX.
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`87. Merck and MSD knew that ZOSTAVAX’s 18-month shelf life’s potency loss
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`“requires a significant overfill to remain portent at the end of the expiration period.”
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`88. Merck and MSD acknowledged that “[t]his would necessitate a minimum release
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`specification of 41,000 PFU (with a 67,000 PFU target and a 110,000 PFU maximum release
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`potency).”
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`89.
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`Live-attenuated vaccines also risk being under-attenuated (not weakened enough)
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`or over-attenuated (weakened too much).
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`90.
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`Under-attenuated vaccines carry the high risk of inducing the disease the vaccine is
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`intended to prevent.
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`91.
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`92.
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`Under-attenuated live VZV has been shown to reactivate.1
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`Over-attenuated vaccines are not effective to offer protection against the disease
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`the vaccine is designed to prevent.
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`93.
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`94.
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`The vaccine virus in ZOSTAVAX is known to become dormant in nerve tissue.
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`ZOSTAVAX is manufactured from the same virus strain and by the same process
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`used to produce Merck’s chicken-pox vaccine, VARIVAX.
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`95.
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`ZOSTAVAX is a highly concentrated version of Merck’s chickenpox vaccine,
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`VARIVAX, containing 14 times the dose of the attenuated live VZV virus than VARIVAX.
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`ZOSTAVAX’s FDA Approval
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`96.
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`In May of 2006, the FDA approved the ZOSTAVAX vaccine to be marketed and
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`sold in the United States for the prevention of shingles in adults.
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`97.
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`ZOSTAVAX was initially approved to be marked for the “the prevention of herpes
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`zoster (shingles) in individuals 60 years of age and older when administered as a single-dose.”2
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`98.
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`In March 2011, ZOSTAVAX was approved for prevention of shingles in adults
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`aged fifty (50) years of age and older.
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`99.
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`The Center for Disease Control and Prevention (“CDC”) does not recommend
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`Zostavax for people aged 50 to 59 years old.
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`1 Leggiadro, R. J. (2000). “Varicella Vaccination: Evidence for Frequent Reactivation of the Vaccine Strain in Healthy
`Children.” The Pediatric Infectious Disease Journal, 19(11), 1117–1118; Krause, P. R., & Klinman, D. M. (2000).
`Nature Medicine, 6(4), 451–454.
`2 FDA Approval Letter, May 25, 2006.
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`100.
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`It is the CDC’s position that, “Protection from this shingles vaccine lasts about 5
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`years, so adults vaccinated before they are 60 years old might not be protected later in life when
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`the risk for shingles and its complications are greatest.”
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`101. The clinical studies for VARIVAX, a vaccine that was already approved by the
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`FDA, were used to support Merck’s BLA to the FDA for approval of ZOSTAVAX.
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`102. FDA approval of the ZOSTAVAX vaccine was based, in large part, on the results
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`of the Shingles Prevention Study (“SPS”) supported by Merck.
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`103. Merck’s SPS reported that ZOSTAVAX use reduced the incidence of postherpetic
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`neuralgia by 66.5%.3
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`104. The methods utilized in the SPS are unreliable.
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`105. The methods utilized in the SPS to study and analyze the safety and efficacy of the
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`ZOSTAVAX vaccine excluded material data regarding adverse events associated with
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`ZOSTAVAX use, including suspected cases of shingles.
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`106. The approval granted by the FDA to allow the selling and marketing of the
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`ZOSTAVAX vaccine came with certain post-marketing commitments that Merck and/or MSD
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`agreed to complete, among other things, to ensure the safety of this vaccine. These included the
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`following:
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`i. A randomized, placebo-controlled safety study to assess the rates of
`serious adverse events in 6,000 people receiving the vaccine as compared
`to 6,000 who receive a placebo.
`ii. An observational study using a health maintenance organization
`(“HMO”) and 20,000 vaccinated people to address safety issues in the
`course of clinical practice. This study is specifically to detect “potential
`safety signals following administration of ZOSTAVAX.” This study was
`to be submitted to the FDA by December 2008.
`
`3 Id.
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`14
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`Case 2:21-cv-05651 Document 1 Filed 12/29/21 Page 15 of 41
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`107. Shingles was a noted occurrence with ZOSTAVAX use during ZOSTAVAX’s
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`clinical trials.
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`108. ZOSTAVAX is not, and never has been, FDA-approved to be marketed or sold for
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`the prevention of post herpetic neuralgia.
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`109. ZOSTAVAX is not, and never has been, FDA-approved to be marketed or sold for
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`pain management for shingles or post herpetic neuralgia.
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`110. Documented adverse reactions to vaccines must be reported to the federal
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`government in a compulsory and mandated database, VAERS.
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`111. Since ZOSTAVAX’s introduction in 2006, VAERS regarding ZOSTAVAX use
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`appeared in significant numbers, addressing various adverse effects including, but not limited to,
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`viral infection resulting in disease of the central nervous system.
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`112. As of September of 2015, VAERS received over 1,000 submissions received of
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`serious adverse event reports regarding ZOSTAVAX, including but not limited to: recurrent
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`instances of myalgia; arthralgia; lymphadenopathy; rash; actinic keratosis; severe cutaneous
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`disease; peripheral neuropathy; cellulitis; herpes keratitis resulting in vision loss; facial paralysis;
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`pneumonia; brain inflammation (encephalitis); and death.
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`113. Since its approval, ZOSTAVAX’s package insert and/or prescribing information
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`changed several times to include additional adverse reactions and/or risks associated with
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`ZOSTAVAX use.
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`114. On or about November 16, 2009, ZOSTAVAX’s package insert, patient
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`information sheet, and prescribing information was changed to include the following risks:
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`“injection site rash, injection site urticaria, arthralgia, and myalgia.”
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`15
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`Case 2:21-cv-05651 Document 1 Filed 12/29/21 Page 16 of 41
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`115. On or about July 13, 2011, CBER approved MSD’s proposed changes to the
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`package insert to amend Section 6.2 of ZOSTAVAX’s package insert, which lists “VZV Rashes
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`Following Vaccination,” to include the term "‘varicella’ referring to the 2 rashes previously
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`identified as varicella-like.”
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`116. On or about August 28, 2014, ZOSTAVAX’s Package Insert and prescribing
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`information was approved for change to include: “infections and infestations: Herpes zoster
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`(vaccine strain)” under Section 6.3 (“Post-Marketing Experience”), which lists adverse reactions
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`identified during post-marking use of ZOSTAVAX,4 and to add “Shingles” in the “What are the
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`possible side effects of ZOSTAVAX?” section.
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`117. On or about February 17, 2016, the prescribing information for ZOSTAVAX was
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`changed to add the following risk: “Eye Disorders: necrotizing retinitis (patients of
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`immunosuppressive therapy).”
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`118. The prescribing
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`information for ZOSTAVAX contains a warning
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`that
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`“[t]ransmission of vaccine virus may occur between vaccinees and susceptible contacts.”
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`119. The risk of transmission of the vaccine virus is due to active viral infection in
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`individuals receiving ZOSTAVAX.
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`120. The vaccine virus in ZOSTAVAX is known to become dormant in nerve tissue.
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`121. The CDC states that live-attenuated virus vaccines should not be administered
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`within four weeks of each other. Commonly administered live-vaccines, all of which are in the
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`category of live-attenuated vaccinations posing potential interactions if administered too closely
`
`in time with ZOSTAVAX, include: Measles, Mumps and Rubella vaccine (“MMR”); Rotavirus
`
`
`4 All versions of the ZOSTAVAX vaccine’s Package Insert, Section 6.3, expressly state that “Because these reactions
`are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their
`frequency or establish a causal relationship to the vaccine” implying that no causal relationship should be drawn from
`the list of reactions identified therein.
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`
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`16
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`Case 2:21-cv-05651 Document 1 Filed 12/29/21 Page 17 of 41
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`vaccine; Vaccina vaccine; and the Influenza Vaccine (“Flumist”). Receiving any of these vaccines
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`too closely together can decrease the efficacy of the ZOSTAVAX vaccine.
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`122. Being inoculated with ZOSTAVAX too closely in time to the pneumococcal
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`vaccine (“P23”) is known to reduce the immune system’s response to the ZOSTAVAX vaccine.
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`123. While the prescribing information furnished with ZOSTAVAX mentions decreased
`
`efficacy with the pneumococcal vaccine, as of the present, the patient information sheet, label, and
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`prescribing information distributed with ZOSTAVAX does not adequately, if at all, address the
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`potential risk of interactions between ZOSTAVAX and other common vaccinations.
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`Vaccine Efficacy of ZOSTAVAX
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`124. Consumers and patients used ZOSTAVAX with the intention to have permanent
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`protection from herpes zoster based on Defendants’ representations.
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`125. Merck’s study, the SPS, found that ZOSTAVAX was overall 51% effective at
`
`preventing shingles in adults aged 60 years and older.
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`126. The effectiveness of ZOSTAVAX decreases with advancing age: the SPS results
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`showed that ZOSTAVAX was 41% effective in adults aged 70 through 79 years and only 18%
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`effective in adults aged 80 years and older.
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`127. The effectiveness of ZOSTAVAX rapidly decreases over time after inoculation: its
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`effectiveness four years post-inoculation has been reported to be as low as 19% effective,5 and
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`after eight years post-inoculation, ZOSTAVAX’s effectiveness has been shown to be 4% and not
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`statistically significant.
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`128.
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`In 2012, the results of Merck’s Short-Term Persistence Substudy (“STPS”) were
`
`evaluated, utilizing Merck’s selective “case determination” in its method, and Merck reported that
`
`
`5 Izurieta, HS, et al. (2017). “Effectiveness and Duration of Protection Provided by the Live-attenuated Herpes Zoster
`Vaccine in the Medicare Population Ages 65 Years and Older.” Clin Infect Dis. 2017 Mar 15;64(6):785-793.
`17
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`Case 2:21-cv-05651 Document 1 Filed 12/29/21 Page 18 of 41
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`ZOSTAVAX’s efficacy after four or more years post-inoculation decreased from 51% to 39.6%,
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`“although the differences were not statistically significant.” 6
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`129. Merck reported that the STPS concluded that ZOSTAVAX’s efficacy was
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`“statistically significant for the incidence of HZ and the HZ burden of illness through year 5” with
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`its efficacy uncertain beyond that point.7
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`130.
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`In 2015, Merck’s post-FDA approval Long-Term Persistence Substudy (“LTPS”)
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`regarding ZOSTAVAX showed that its efficacy after four or more years post-inoculation was as
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`low as 21%.8
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`131.
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` Merck’s LTPS nonetheless reported that ZOSTAVAX’s “statistically significant
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`vaccine efficacy for incidence of HZ persisted” for eight years post-vaccination.9
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`132.
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`In 2016, a CDC-funded retrospective cohort study showed that the ZOSTAVAX
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`vaccine’s efficacy four or more years post-inoculation was approximately 24%, rendering it
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`useless to prevent shingles at that time.10
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`133.
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`In 2017, Merck’s own retrospective cohort study found that the ZOSTAVAX
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`vaccine’s efficacy four or more years post-inoculation was as low as 34% in 60 to 69-year-old
`
`adults and 29% in 70 to 79-year-old adults.11
`
`
`6 Schmader KE (2012). “Persistence of the efficacy of zoster vaccine in the shingles prevention study and the short-
`term persistence substudy.” Clin Infect Dis. 2012 Nov 15; 55(10):1320-8.
`7 Id.
`8 Morrison, VA, et al. (2015). “Long-term persistence of zoster vaccine efficacy.” Clin Infect Dis. 2015 Mar
`15;60(6):900-9.
`9 Id. (emphasis added).
`10 Tseng, HF, et al. (2016). “Declining Effectiveness of Herpes Zoster Vaccine in Adults Aged ≥60 Years.” J Infect
`Dis. 2016 Jun 15; 213(12):1872-5.
`11 Baxter, R., et al. (2018). “Long-Term Effectiveness of the Live Zoster Vaccine in Preventing Shingles: A Cohort
`Study.” Am J Epidemiol. 2018 Jan 1;187(1):161-169.
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`
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`18
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`Case 2:21-cv-05651 Document 1 Filed 12/29/21 Page 19 of 41
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`134. Merck’s retrospective cohort study’s 2017 re