throbber
Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 1 of 42
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` UNITED STATES DISTRICT COURT
`THE EASTERN DISTRICT OF PENNSYLVANIA
`
`
`MDL No. 2848
`Civil Action No. 2:18-md-2848
`
`
`
`
`
`Case No. __________________
`
`JURY TRIAL DEMANDED
`
`IN RE: ZOSTAVAX (ZOSTER VACCINE
`LIVE) PRODUCTS LIABILITY
`LITIGATION
`
`
`This Document Relates to:
`
`CHERYL CINALLI and JAMES L. CINALLI,
`
` Plaintiffs,
`
` -against-
`
`MERCK & CO., INC.;
`MERCK SHARP AND DOHME CORP.; and
`McKESSON CORP.,
`
` Defendants
`
`
`
`
`COMPLAINT
`
`Plaintiffs, by and through the undersigned attorneys, hereby file this Complaint in
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`accordance with Case Management Order No. 2 and PTO No. 22, and are bound by the rights,
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`protections, privileges, and obligations of that PTO. Plaintiffs state that but for the Order
`
`permitting direct filing in the Eastern District of Pennsylvania pursuant to PTO no. 22, Plaintiffs
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`would have filed this Complaint in the United States District Court for the Northern District
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`Court of West Virginia as the place of remand as this case may have originally been filed there.
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`Plaintiffs further hereby allege as follows:
`
`PARTIES
`
`1.
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`At all times relevant to this action Plaintiff Cheryl Cinalli (“Plaintiff”) was and
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`is a citizen of the State of West Virginia, and resides in Fairmont, West Virginia.
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`
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`1
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 2 of 42
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`2.
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`Plaintiff James L. Cinalli is the spouse of Cheryl Cinalli, and was and is at all
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`relevant times a resident and citizen of West Virginia.
`
`3.
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`At all relevant times to this action, as further detailed herein, Defendants MERCK
`
`& CO., INC., MERCK SHARP & DOHME CORP., McKESSON CORP. (collectively,
`
`“Defendants”), and each of them, introduced into interstate commerce the ZOSTAVAX vaccine,
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`which was to be administered to individuals and consumers throughout the United States.
`
`4.
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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.
`
`5.
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`At all relevant times, Merck designed, researched, developed, manufactured, tested,
`
`labeled, advertised, promoted, marketed, sold, supplied, distributed, and/or introduced into the
`
`stream of commerce the ZOSTAVAX vaccine, to be administered to consumers throughout the
`
`United States. Merck has conducted and continues to conduct business in West Virginia and
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`derived and continues to derive substantial revenue from within West Virginia, from, including,
`
`but not limited to, its business activities related to ZOSTAVAX. Plaintiff’s claims arise out of
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`Merck’s contacts with West Virginia.
`
`6.
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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.
`
`7.
`
`MSD is a New Jersey corporation organized with its principal place of business
`
`located at 2000 Galloping Hill Road, Kenilworth, New Jersey 07033.
`
`8.
`
`At all relevant times, MSD, individually through its predecessors and through the
`
`actions of Merck, designed, researched, developed, manufactured, tested, labeled, advertised,
`
`promoted, marketed, sold, supplied, distributed, and/or introduced into the stream of commerce
`
`the ZOSTAVAX vaccine, to be administered to consumers throughout the United States. MSD
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`
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`2
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 3 of 42
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`has conducted and continues to conduct business in West Virginia and derived and continues to
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`derive substantial revenue from within West Virginia, from including, but not limited to, its
`
`business activities related to ZOSTAVAX. Plaintiff’s claims arise out of MSD’s contacts with
`
`West Virginia.
`
`9.
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`Defendant McKesson Corp. (“McKesson”) is a Delaware Corporation with its
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`principal place of business at 2710 Gateway Oaks Drive, Sacramento, California 95833.
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`10.
`
`At all relevant times, McKesson, individually as an agent of Merck and/or MSD,
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`packaged, labeled, re-packaged, marketed, promoted, supplied, distributed, sold, and/or introduced
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`into the stream of commerce the ZOSTAVAX vaccine to consumers nationwide including West
`
`Virginia, including to the Plaintiff and/or Plaintiff’s healthcare providers. McKesson conducts
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`business throughout the United States and regularly, continuously, and presently does business in
`
`West Virginia, including marketing, distributing, and selling ZOSTAVAX in West Virginia.
`
`McKesson derived and continues to derive substantial revenue from within West Virginia, from
`
`including, but not limited to, its business activities related to ZOSTAVAX. Plaintiff’s claims arise
`
`out of McKesson’s contacts with West Virginia.
`
`11.
`
`Defendants” where used hereinafter, shall refer to all subsidiaries, affiliates,
`
`divisions, franchises, partners, joint venturers, organizational units of any kind, predecessors,
`
`successors, assigns, officers, directors, employees, agents and representatives of Merck, MSD,
`
`McKesson, and each of them.
`
`12.
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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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`
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`3
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 4 of 42
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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
`
`13.
`
`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.
`
`14.
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`The District Court wth proper venue pursuant to 28 U.S.C. § 1391 is the Northern
`
`District of West Virginia.
`
`15.
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`Plaintiff is a resident and citizen of West Virginia.
`
`16. Merck and MSD are New Jersey corporations, each with its principal place of
`
`business in Kenilworth, New Jersey.
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`17.
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`Based upon information and belief, at all relevant times, each Defendant was and
`
`is duly authorized to conduct business in West Virginia as a registered foreign corporation.
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`18.
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`Defendants regularly conducted and solicited business within New Jersey and
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`continue to do so.
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`19.
`
`Defendants at all relevant times sold and distributed ZOSTAVAX in West Virginia
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`and continue to do so.
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`20.
`
`Defendants derive substantial revenue from goods used or consumed in West
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`Virginia.
`
`21.
`
`22.
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`Each Defendant engages in continuous and systematic activity in West Virginia.
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`Each Defendant’s continuous and system activity in West Virginia and its
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`minimum contacts within West Virginia gave rise to Plaintiff’s claims.
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`23.
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`Each Defendant purposefully avails itself of the privilege of conducting activities
`
`
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`4
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 5 of 42
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`within New Jersey, thus invoking the benefits and protections of its laws.
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`24.
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`Each Defendant has purposefully connected itself to West Virginia and has
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`sufficient minimum contacts with West Virginia such that West Virginia 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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`25.
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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:
`
`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.
`b. The ZOSTAVAX vaccine is not a vaccine listed in the Vaccine
`Injury Table.
`
`
`
`
`
`AGENCY, ALTER-EGO, VICARIOUS, SUCCESSOR, AND CO-CONSPIRATOR
`LIABILITY OF EACH DEFENDANT DUE TO THE RELATIONSHIPS BETWEEN
`MERCK, MSD, AND McKESSON
`
`26.
`
`27.
`
`Plaintiffs incorporate by reference all prior allegations.
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`Each Defendant is individually, as well as jointly and severally, liable to Plaintiffs
`
`for Plaintiffs’ damages.
`
`28.
`
`Plaintiffs would not have an adequate remedy if Merck, MSD, and McKesson were
`
`not named parties in this action.
`
`29.
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`There exists and, at all times herein mentioned, a unity of interest in ownership
`
`between Merck and MSD.
`
`30. Merck and MSD are not distinct corporate entities: the assets of Merck and MSD
`
`are common to both entities; Merck and MSD share and use facilities to conduct and engage in
`
`business activities; the business operations of Merck and MSD are the same; the employees and
`
`officers of Merck and MSD are largely the same people; the principal place of business of Merck
`
`
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`5
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 6 of 42
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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.
`
`31.
`
`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.
`
`32.
`
`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
`
`liability, vicarious liability, and/or successor liability.
`
`33.
`
`Adherence to the fiction of the separate existence Merck and MSD as entities
`
`distinct from each other will permit an abuse of corporate privilege and would sanction a fraud
`
`and/or promote injustice.
`
`34.
`
`At all times herein mentioned, the officers and/or directors of Merck and MSD
`
`mentioned or referred to herein participated in, authorized and/or directed the production and
`
`promotion of the ZOSTAVAX vaccine when they knew, or with exercise of reasonable care and
`
`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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`35. 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
`
`that McKesson has no separate mind, will or existence of its own.
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`36.
`
`The aforesaid control was used by Merck and/or MSD to negligently design,
`
`research, develop, manufacture, test, label, advertise, promote, market, sell, supply, distribute,
`
`and/or introduce ZOSTAVAX into the stream of commerce for use by individuals like Plaintiff
`
`and their healthcare providers.
`
`
`
`6
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 7 of 42
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`37.
`
`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,
`
`advertising, promotion, marketing, sale, supply, distribution, and/or introduction into the stream
`
`of commerce of ZOSTAVAX.
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`38. McKesson created, developed, and implemented the marketing strategy to promote
`
`and sell and distribute ZOSTAVAX nationwide.
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`39. McKesson, as Merck’s agent, created, developed, and implemented the marketing
`
`strategy to promote and sell and distribute ZOSTAVAX nationwide.
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`40. McKesson, as MSD’s agent, created, developed, and implemented the marketing
`
`strategy to promote and sell and distribute ZOSTAVAX nationwide.
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`41. McKesson developed the “Vaccine Information Statement” for ZOSTAVAX with
`
`Merck for distribution nationwide.
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`42. McKesson published the ZOSTAVAX “Vaccine Information Statement.”
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`43. McKesson disseminated the ZOSTAVAX “Vaccine Information Statement.”
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`44. 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,
`
`promotion, supply, distribution, sale, and/or introduction into the stream of commerce of
`
`ZOSTAVAX throughout the United States.
`
`45. Merck and MSD manifested McKesson’s authority to act on Merck’s and MSD’s
`
`behalf by allowing McKesson to create, develop, and implement the ZOSTAVAX marketing
`
`strategy and campaign.
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`
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`7
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 8 of 42
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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 create, develop, publish, and disseminate the
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`ZOSTAVAX “Vaccine Information Statement.”
`
`47. Merck and/or MSD manifested the authority of McKesson to act on Merck’s and/or
`
`MSD’s behalf by allowing McKesson to develop, publish, and disseminate marketing and
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`promotional materials for ZOSTAVAX.
`
`48. McKesson exercised, and continues to exercise, complete control, and/or equal
`
`participation in the policy and business practices of Merck and/or MSD regarding the packaging,
`
`labeling, re-packaging, marketing, promoting, supply, distribution, sale, and/or introduction of
`
`ZOSTAVAX into the stream of commerce to such an extent that Merck and McKesson have no
`
`separate mind(s), will or own existence in this regard.
`
`49. McKesson used the aforesaid control over Merck and MSD, acting as an agent of
`
`Merck and MSD, to negligently package, label, re-package, market, promote, supply, distribute,
`
`sell, and/or introduce into the stream of commerce ZOSTAVAX for use by consumers like Plaintiff
`
`and Plaintiff’s healthcare providers.
`
`50.
`
`As such, sufficient grounds exist to extend liability to Merck and/or MSD for the
`
`acts of McKesson regarding the packaging, labeling, re-packaging, marketing, promotion, supply,
`
`distribution, sale, and/or introduction into the stream of commerce of ZOSTAVAX.
`
`51. McKesson is liable for all misrepresentations made by Merck and/or MSD because
`
`McKesson is the business partner and agent of Merck and MSD.
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`52. McKesson knew or should have known that its misrepresentations and omissions
`
`regarding ZOSTAVAX as alleged herein were false.
`
`
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`8
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 9 of 42
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`53. McKesson knew or should have known that the ZOSTAVAX that it packaged,
`
`labeled, re-packaged, marketed, promoted, supplied, distributed, sold, and/or introduced into the
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`stream of commerce was not safe for human use and/or consumption.
`
`54.
`
`Sufficient grounds exist to extend liability for Merck’s acts and omissions to
`
`McKesson because Merck and McKesson are alter egos of each other.
`
`55.
`
`Sufficient grounds exist to extend liability for MSD’s acts and omissions to
`
`McKesson because MSD and McKesson are alter egos of each other.
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`56.
`
`Sufficient grounds exist to extend liability for McKesson’s acts and omissions to
`
`Merck because Merck and McKesson are agents of each other.
`
`57.
`
`Sufficient grounds exist to extend liability for McKesson’s acts and omissions to
`
`MSD because MSD and McKesson are agents of each other.
`
`58.
`
`“MSD” where used hereinafter, shall include and refer to all predecessor(s)-in-
`
`interest including but not limited to Schering Plough Corporation, successor(s)-in-interest, assigns,
`
`officers, directors, employees, agents, subsidiaries, affiliates, divisions, franchises, partners, joint
`
`venturers, and/or representatives of MSD.
`
`59.
`
`“Merck” where used hereinafter, shall refer to all subsidiaries, affiliates, divisions,
`
`franchises, partners, joint venturers, organizational units of any kind, predecessors-in-interest
`
`including but not limited to Schering-Plough Corporation, successors, assigns, officers, directors,
`
`employees, agents and representatives of Merck, and MSD.
`
`ESTOPPEL FROM PLEADING STATUTES OF LIMITATIONS OR REPOSE
`
`60.
`
`Plaintiffs incorporate by reference all prior allegations.
`
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 10 of 42
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`61.
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`Plaintiffs bring 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
`
`the defects and unreasonably dangerous condition of ZOSTAVAX.
`
`62.
`
`Plaintiff’s ignorance of the defective and unreasonably dangerous nature of
`
`ZOSTAVAX and the causal connection between these defects and Plaintiff’s injuries and damages
`
`is due to Defendants’ fraudulent conduct.
`
`63.
`
`Each Defendant’s fraudulent conduct includes intentional concealment of material
`
`information from the public, and intentional misrepresentation of material information and/or
`
`downplay of the serious threat to public safety that the ZOSTAVAX use presents.
`
`64.
`
`Defendants intentionally concealed material information including but not limited
`
`to the fact that ZOSTAVAX had not been demonstrated to be safe or effective; that ZOSTAVAX
`
`is not effective at permanently preventing shingles or any related injuries; and that ZOSTAVAX
`
`carried with it the serious risks and dangerous defects described herein.
`
`65.
`
`Defendants’ fraudulent conduct was directed at Plaintiff, Plaintiff’s healthcare
`
`providers, the medical community, the general consuming public, and the U.S. Food and Drug
`
`Administration (“FDA”).
`
`66.
`
`Each Defendant had a duty to disclose the fact that ZOSTAVAX was not safe or
`
`effective; was defective; was unreasonably dangerous; and using ZOSTAVAX as a measure of
`
`routine health maintenance and prevention carried serious, hidden risks.
`
`67.
`
`Any applicable statutes of limitations have been tolled by the knowing and active
`
`concealment and denial of the facts as alleged herein by the Defendants.
`
`68.
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`Plaintiffs have been kept ignorant of vital information essential to the pursuit of
`
`these claims, without any fault or lack of diligence on their part.
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`10
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 11 of 42
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`69.
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`Plaintiffs 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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`70.
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`Each Defendant is estopped from relying on any statutes of limitation or repose
`
`affirmative defense by virtue of each Defendant’s unclean hands, acts of fraudulent concealment,
`
`and affirmative misrepresentations and omissions of material fact.
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`FACTUAL BACKGROUND
`
`71.
`
`ZOSTAVAX was designed, developed, manufactured, marketed, distributed, and
`
`sold with the intended purpose of long-term prevention and protection against shingles and other
`
`zoster-related conditions and disease.
`
`Shingles
`
`Varicella-zoster virus (“VZV”) causes chickenpox.
`
`Once VZV causes chickenpox, the VZV remains inactive (dormant) in the nervous
`
`72.
`
`73.
`
`system, in the sensory neurons of dorsal root and cranial nerve ganglia, for many years.
`
`74. When reactivated, VZV causes shingles, also known as or herpes zoster (“HZ”).
`
`75.
`
`VZV can be reactivated due to factors such as disease, stress, aging, and immune
`
`modulation caused by vaccination.
`
`76.
`
`VZV reactivates in aging individuals whose immune responses against VZV
`
`decline, producing shingles.
`
`77.
`
`78.
`
`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.
`
`79.
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`Nearly one million cases of shingles are reported annually in the United States.
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`
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`11
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 12 of 42
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`80.
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`Shingles occurs at a rate of three to seven times higher in individuals age 50 years
`
`and older than in the rest of the population.
`
`81.
`
`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
`
`and skin; those suffering from post-herpetic neuralgia often complain of burning pain that lasts
`
`long after the visual rash and blisters from shingles go away.
`
`82.
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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.
`
`ZOSTAVAX Vaccine – A Live Vaccine
`
`83.
`
`The four main types of vaccines are live-attenuated vaccines; inactivated vaccines;
`
`toxoid vaccines; and subunit, recombinant, polysaccharide, and conjugate vaccines.
`
`84.
`
`Inactivated vaccines are vaccines that use the killed version of the germ that causes
`
`a disease.
`
`85.
`
`Live virus vaccines use a weakened (or attenuated) form of the virus that causes a
`
`disease.
`
`86.
`
`ZOSTAVAX is a live-attenuated vaccine which contains VSV in reduced
`
`virulence.
`
`87.
`
`One of the risks of using a live vaccine is transmission of the vaccine virus to the
`
`recipient.
`
`88.
`
`Live-attenuated vaccines carry a serious, high risk of transmitting the live virus’s
`
`disease to individuals with weakened immune systems, long-term health problems, or who have
`
`had an organ transplant.
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`12
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 13 of 42
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`89.
`
`Once injected, an attenuated live virus has been shown to recombine into more
`
`virulent strains causing disease.
`
`90.
`
`Because ZOSTAVAX is a live-attenuated vaccine, it experiences potency loss
`
`during its “shelf life” – after its manufacture but before its use.
`
`91.
`
`The ZOSTAVAX vaccine’s potency loss during a shelf life of eighteen (18) to
`
`twenty (20) months is between 50% and 80%.
`
`92. Merck and MSD knew that the end-expiry of eighteen months “is required to obtain
`
`CDC contracts” for ZOSTAVAX.
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`93. Merck and MSD knew that ZOSTAVAX’s 18-month shelf life’s potency loss
`
`“requires a significant overfill to remain portent at the end of the expiration period.”
`
`94. Merck and MSD acknowledged that “[t]his would necessitate a minimum release
`
`specification of 41,000 PFU (with a 67,000 PFU target and a 110,000 PFU maximum release
`
`potency).”
`
`95.
`
`Live-attenuated vaccines also risk being under-attenuated (not weakened enough)
`
`or over-attenuated (weakened too much).
`
`96.
`
`Under-attenuated vaccines carry the high risk of inducing the disease the vaccine is
`
`intended to prevent.
`
`97.
`
`98.
`
`Under-attenuated live VZV has been shown to reactivate.1
`
`Over-attenuated vaccines are not effective to offer protection against the disease
`
`the vaccine is designed to prevent.
`
`99.
`
`The vaccine virus in ZOSTAVAX is known to become dormant in nerve tissue.
`
`
`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.
`
`
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 14 of 42
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`100. ZOSTAVAX is manufactured from the same virus strain and by the same process
`
`used to produce Merck’s chicken-pox vaccine, VARIVAX.
`
`101. ZOSTAVAX is a highly concentrated version of Merck’s chickenpox vaccine,
`
`VARIVAX, containing 14 times the dose of the attenuated live VZV virus than VARIVAX.
`
`ZOSTAVAX’s FDA Approval
`
`102.
`
`In May of 2006, the FDA approved the ZOSTAVAX vaccine to be marketed and
`
`sold in the United States for the prevention of shingles in adults.
`
`103. ZOSTAVAX was initially approved to be marked for the “the prevention of herpes
`
`zoster (shingles) in individuals 60 years of age and older when administered as a single-dose.”2
`
`104.
`
`In March 2011, ZOSTAVAX was approved for prevention of shingles in adults
`
`aged fifty (50) years of age and older.
`
`105. The Center for Disease Control and Prevention (“CDC”) does not recommend
`
`Zostavax for people aged 50 to 59 years old.
`
`106.
`
`It is the CDC’s position that, “Protection from this shingles vaccine lasts about 5
`
`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.”
`
`107. The clinical studies for VARIVAX, a vaccine that was already approved by the
`
`FDA, were used to support Merck’s BLA to the FDA for approval of ZOSTAVAX.
`
`108. FDA approval of the ZOSTAVAX vaccine was based, in large part, on the results
`
`of the Shingles Prevention Study (“SPS”) supported by Merck.
`
`109. Merck’s SPS reported that ZOSTAVAX use reduced the incidence of postherpetic
`
`neuralgia by 66.5%.3
`
`
`2 FDA Approval Letter, May 25, 2006.
`3 Id.
`
`
`
`14
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`

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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 15 of 42
`
`110. The methods utilized in the SPS are unreliable.
`
`111. The methods utilized in the SPS to study and analyze the safety and efficacy of the
`
`ZOSTAVAX vaccine excluded material data regarding adverse events associated with
`
`ZOSTAVAX use, including suspected cases of shingles.
`
`112. The approval granted by the FDA to allow the selling and marketing of the
`
`ZOSTAVAX vaccine came with certain post-marketing commitments that Merck and/or MSD
`
`agreed to complete, among other things, to ensure the safety of this vaccine. These included the
`
`following:
`
`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.
`113. Shingles was a noted occurrence with ZOSTAVAX use during ZOSTAVAX’s
`
`clinical trials.
`
`114. ZOSTAVAX is not, and never has been, FDA-approved to be marketed or sold for
`
`the prevention of post herpetic neuralgia.
`
`115. ZOSTAVAX is not, and never has been, FDA-approved to be marketed or sold for
`
`pain management for shingles or post herpetic neuralgia.
`
`116. Documented adverse reactions to vaccines must be reported to the federal
`
`government in a compulsory and mandated database, VAERS.
`
`117. Since ZOSTAVAX’s introduction in 2006, VAERS regarding ZOSTAVAX use
`
`appeared in significant numbers, addressing various adverse effects including, but not limited to,
`
`viral infection resulting in disease of the central nervous system.
`
`
`
`15
`
`

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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 16 of 42
`
`118. As of September of 2015, VAERS received over 1,000 submissions received of
`
`serious adverse event reports regarding ZOSTAVAX, including but not limited to: recurrent
`
`instances of myalgia; arthralgia; lymphadenopathy; rash; actinic keratosis; severe cutaneous
`
`disease; peripheral neuropathy; cellulitis; herpes keratitis resulting in vision loss; facial paralysis;
`
`pneumonia; brain inflammation (encephalitis); and death.
`
`119. Since its approval, ZOSTAVAX’s package insert and/or prescribing information
`
`changed several times to include additional adverse reactions and/or risks associated with
`
`ZOSTAVAX use.
`
`120. On or about November 16, 2009, ZOSTAVAX’s package insert, patient
`
`information sheet, and prescribing information was changed to include the following risks:
`
`“injection site rash, injection site urticaria, arthralgia, and myalgia.”
`
`121. On or about July 13, 2011, CBER approved MSD’s proposed changes to the
`
`package insert to amend Section 6.2 of ZOSTAVAX’s package insert, which lists “VZV Rashes
`
`Following Vaccination,” to include the term "‘varicella’ referring to the 2 rashes previously
`
`identified as varicella-like.”
`
`122. On or about August 28, 2014, ZOSTAVAX’s Package Insert and prescribing
`
`information was approved for change to include: “infections and infestations: Herpes zoster
`
`(vaccine strain)” under Section 6.3 (“Post-Marketing Experience”), which lists adverse reactions
`
`identified during post-marking use of ZOSTAVAX,4 and to add “Shingles” in the “What are the
`
`possible side effects of ZOSTAVAX?” section.
`
`
`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.
`
`
`
`16
`
`

`

`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 17 of 42
`
`123. On or about February 17, 2016, the prescribing information for ZOSTAVAX was
`
`changed to add the following risk: “Eye Disorders: necrotizing retinitis (patients of
`
`immunosuppressive therapy).”
`
`124. The prescribing
`
`information for ZOSTAVAX contains a warning
`
`that
`
`“[t]ransmission of vaccine virus may occur between vaccinees and susceptible contacts.”
`
`125. The risk of transmission of the vaccine virus is due to active viral infection in
`
`individuals receiving ZOSTAVAX.
`
`126. The vaccine virus in ZOSTAVAX is known to become dormant in nerve tissue.
`
`127. The CDC states that live-attenuated virus vaccines should not be administered
`
`within four weeks of each other. Commonly administered live-vaccines, all of which are in the
`
`category of live-attenuated vaccinations posing potential interactions if administered too closely
`
`in time with ZOSTAVAX, include: Measles, Mumps and Rubella vaccine (“MMR”); Rotavirus
`
`vaccine; Vaccina vaccine; and the Influenza Vaccine (“Flumist”). Receiving any of these vaccines
`
`too closely together can decrease the efficacy of the ZOSTAVAX vaccine.
`
`128. Being inoculated with ZOSTAVAX too closely in time to the pneumococcal
`
`vaccine (“P23”) is known to reduce the immune system’s response to the ZOSTAVAX vaccine.
`
`129. While the prescribing information furnished with ZOSTAVAX mentions decreased
`
`efficacy with the pneumococcal vaccine, as of the present, the patient information sheet, label, and
`
`prescribing information distributed with ZOSTAVAX does not adequately, if at all, address the
`
`potential risk of interactions between ZOSTAVAX and other common vaccinations.
`
`Vaccine Efficacy of ZOSTAVAX
`
`130. Consumers and patients used ZOSTAVAX with the intention to have permanent
`
`protection from herpes zoster based on Defendants’ representations.
`
`
`
`17
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`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 18 of 42
`
`131. Merck’s study, the SPS, found that ZOSTAVAX was overall 51% effective at
`
`preventing shingles in adults aged 60 years and older.
`
`132. The effectiveness of ZOSTAVAX decreases with advancing age: the SPS results
`
`showed that ZOSTAVAX was 41% effective in adults aged 70 through 79 years and only 18%
`
`effective in adults aged 80 years and older.
`
`133. The effectiveness of ZOSTAVAX rapidly decreases over time after inoculation: its
`
`effectiveness four years post-inoculation has been reported to be as low as 19% effective,5 and
`
`after eight years post-inoculation, ZOSTAVAX’s effectiveness has been shown to be 4% and not
`
`statistically significant.
`
`134.
`
`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
`
`ZOSTAVAX’s efficacy after four or more years post-inoculation decreased from 51% to 39.6%,
`
`“although the differences were not statistically significant.” 6
`
`135. Merck reported that the STPS concluded that ZOSTAVAX’s efficacy was
`
`“statistically significant for the incidence of HZ and the HZ burden of illness through year 5” with
`
`its efficacy uncertain beyond that point.7
`
`136.
`
`In 2015, Merck’s post-FDA approval Long-Term Persistence Substudy (“LTPS”)
`
`regarding ZOSTAVAX showed that its efficacy after four or more years post-inoculation was as
`
`low as 21%.8
`
`
`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.
`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.
`
`
`
`18
`
`

`

`Case 2:20-cv-05622 Document 1 Filed 11/10/20 Page 19 of 42
`
`137.
`
` Merck’s LTPS nonetheless reported that ZOSTAVAX’s “statist

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