Case 2:18-md-02848-HB Document 1105 Filed 10/04/22 Page 1 of 23
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF PENNSYLVANIA
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`MDL No. 2848
`Master Docket No. 18-md-2848
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`IN RE: ZOSTAVAX (ZOSTER
`VACCINE LIVE) PRODUCTS
`LIABILITY LITIGATION
`________________________
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`This Pleading Relates to:
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`All Cases Identified on Ex. 1
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`Plaintiffs identified in Exhibit 1, who are represented by the law firm of Reich & Binstock,
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`LLP (“Plaintiffs”), file this response in opposition to Merck’s Motion to Dismiss brought pursuant
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`to Fed. R. Civ. P. 41(b). For the reasons set forth herein, particularly because PCR evidence is
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`not dispositive as to causation in any of their cases, Merck’s motion should be denied in its
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`entirety.1
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`I.
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`INTRODUCTION
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`In the instant motion, Merck is asking the Court to hold that laboratory testing (specifically
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`PCR testing of alleged Shingles injuries) must exist in every case as the only way to prove
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`causation, even though the Court has already applied the proper standard, which requires a
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`differential diagnosis and not definitive DNA evidence.
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`Granting Merck’s motion would result in the extreme sanction of dismissing more than
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`1,100 Shingles-injury cases on the sole basis that none of the doctors who treated these individuals’
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`Shingles rashes conducted an admittedly unhelpful PCR test to detect vaccine strain varicella-
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`1 Plaintiffs have the right to and can prove specific causation in their individual cases without PCR testing.
`To this end, Plaintiffs have addressed such in the Appendix that has been annexed hereto as Ex. 2. Neither
`the Court’s prior decision in the Group A Bellwether cases in which the Court found Dr. Poznansky’s
`opinion to be unreliable nor this Court’s Pretrial Order No. 426 affect Plaintiffs’ ability to do so.
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`1
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`Case 2:18-md-02848-HB Document 1105 Filed 10/04/22 Page 2 of 23
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`zoster virus (“VZV”) contained in Zostavax (“the Oka strain”) was present in their respective
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`Shingles rashes. But Merck’s motion fails both legally and factually—and Merck knows this—
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`making this motion a waste of everyone’s time and resources.
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`Dismissal under Federal Rule 41 is improper because the documents Merck argues
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`Plaintiffs failed to produce—PCR test reports—have never existed. Additionally Merck has
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`already admitted in its previous Group A Bellwether Daubert motion practice that PCR testing is
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`not and cannot be conclusive of whether Zostavax caused or contributed to an individual’s
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`Shingles outbreak.
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`Merck’s present motion only creates confusion by seeking dismissal under Rule 41(b).
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`Merck argues that dismissal is warranted because Plaintiffs failed to comply with Pretrial Order
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`No. 426 (“PTO 426”), which required Plaintiffs to produce records of laboratory testing (PCR
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`testing) on Shingles rashes, but no such testing has ever existed because not one of the Plaintiffs’
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`healthcare providers believed that such testing was the appropriate standard of care for the
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`diagnosis and treatment of Shingles. Moreover, Merck has never publicly warned any healthcare
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`provider of the need to test Shingles rashes after vaccination. Plaintiffs are not withholding
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`documents, nor did they destroy documents. Therefore, dismissal under Rule 41(b) is wholly
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`improper and Merck’s motion should be denied on this basis alone.2
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`Nonetheless, when applying all of the factors for dismissal under Rule 41(b), as set forth
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`in Poulis v. State Farm Fire & Cas. Co., 747 F.2d 863 (3d Cir. 1984), all of them weigh in favor
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`of denying Merck’s motion. The crux of Merck’s motion is that Plaintiffs’ claims are not
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`meritorious under Poulis because Plaintiffs cannot unequivocally prove beyond question that their
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`2 See Baier v. Princeton Office Park, L.P., 2018 U.S. Dist. LEXIS 180612, *9 (D.N.J. Oct. 22, 2018) (“It
`is axiomatic that a party can not be forced to produce documents that do not exist.”); Staff Builders of
`Philadelphia, Inc. v. Koschitzki, 1989 U.S. Dist. LEXIS 7027, *10 (E.D.Pa. Jun. 26, 1989.); Bracey v.
`Harlow, 2012 U.S. Dist. LEXIS 147216, *11 (W.D. Pa. Oct. 12, 2012)
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`2
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`Case 2:18-md-02848-HB Document 1105 Filed 10/04/22 Page 3 of 23
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`Shingles rashes had the vaccine-strain of the virus present, and that the only way to do so is by
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`PCR testing. Not only would accepting Merck’s argument heighten Plaintiff’s burden of proof
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`above the criminal standard of “beyond a reasonable doubt,” Merck’s argument is entirely an
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`attorney-created one that Merck’s counsel has been touting ever since the Court-ordered Science
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`Day presentations, even though Merck cannot offer any support for it. Not one of Merck’s experts
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`has adopted this position, and, in fact, Merck’s experts agree with the Plaintiffs’ experts when they
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`admit that PCR testing cannot definitively determine whether a rash sample contains the Oka
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`strain.
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`The most egregious issue with Merck’s motion (and what makes it a complete waste of the
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`Court’s time and resources), however, is the fact that Merck’s counsel has already admitted to this
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`Court that PCR is not going to be able to always detect Oka-strain when it is present in a Shingles
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`rash. Indeed, in defending its PCR expert’s opinions in the Group A Bellwether cases, Merck
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`stated the following regarding two of its experts:
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`“Drs. Ehrlich and Storch’s deposition testimony merely acknowledged the
`obvious fact that, at some infinitesimally low number of molecules
`approaching zero, detectability is no longer possible. No test is 100%
`sensitive and 100% specific. Plaintiffs seek to impose a standard of
`impossibility to an extreme, requiring Merck to try to prove the negative
`(i.e., there was no vaccine-strain VZV DNA in any sample tested) as part of
`an inappropriate effort to flip their burden of proof… Nor does it even
`matter whether the PCR Assay is capable of detecting each and every
`vaccine-strain virus molecule.” Doc. 906, p. 7.
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`These are Merck’s words. To be clear, months before the current motion was filed, Merck had
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`already admitted to the Court that PCR testing cannot prove that “there was no vaccine strain VZV
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`DNA in any sample tested”, id., making their entire motion frivolous.
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`The only evidence Merck offers in purported support of its position is in the form of
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`publications, and not expert opinion. For example, Merck relies on an article authored by Rafael
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`3
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`Case 2:18-md-02848-HB Document 1105 Filed 10/04/22 Page 4 of 23
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`Harpaz, a CDC employee, where he states that “Zoster caused by Oka/Merck strain VZV cannot
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`be distinguished on clinical grounds from zoster caused by wild-type VZV,” but this statement is
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`only commenting on the risk of Shingles in children who received the Oka strain from the
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`chickenpox vaccine, and not adults receiving Zostavax after already having experienced wild-type
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`chickenpox earlier in life. 3 This distinction is important because they are two different populations
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`with two different levels of immunity (i.e. healthy vs. weakened) where one population (the child)
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`has been exposed to VZV only once and the other has been exposed to VZV at least twice (the
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`adult).4
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`Moreover, the Harpaz publication never once states that PCR is the only way to determine
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`if the Oka strain caused a given Shingles outbreak. In fact, this same paper goes on to state: “The
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`risk for zoster caused specifically by Oka/Merck strain VZV is unknown because recipients of
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`varicella vaccine might have already been infected with wild-type VZV”, which is exactly what is
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`happening in the adult population who received Zostavax.5 None of the publications relied upon
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`by Merck deal with or support the absolute need for PCR to know if the Oka strain caused a given
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`Shingles rash.
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`Indeed, although not referenced by Merck in the present motion, the researchers at the
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`Veterans Administration (“VA”) and employees at Merck have already published a paper that
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`specifically states that PCR results are unreliable and that a clinical history is needed to fully
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`understand the etiology of a Shingles rash. Those researchers state:
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`“Since these specimens were from vaccine-associated rashes in VZV-naive recipients of
`varicella vaccine, mixtures of VZV-WT and VZV-Oka would be unlikely. However,
`because of the cross-reactivity between VZV-WT and VZV-Oka in this assay, it is
`theoretically possible that a very small proportion of the DNA in a clinical specimen may be
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`3 Ex. 3, Rafael Harpaz et al., Prevention of Herpes Zoster: Recommendations of the Advisory Committee
`on Immunization Practices (ACIP), 57 Morbidity & Mortality Wkly. Rep. 1, 6 (2008).
`4 Ex. 2.
`5 Id.
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`4
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`from the heterologous virus. Thus, in some situations, both laboratory and clinical (e.g.,
`epidemiologic history) data may be required to achieve an accurate diagnosis"6
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`Finally, Merck is suggesting that for a claim to have merit, Plaintiffs must conclusively
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`prove that the Oka strain virus was present in a given Shingles rash. While that may be a question
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`of interest in the academic community, it is not the issue at hand. It is not Plaintiffs’ burden to
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`prove with 100% certainty that Zostavax caused their Shingles rashes, yet that is the burden Merck
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`seeks to impose on Plaintiffs through its instant motion.
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`For these reasons, granting Merck’s motion would be reversible error, and Merck’s motion
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`should be swiftly denied.
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`II.
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`FACTUAL BACKGROUND
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`The Group A Bellwether Plaintiffs’ Experts’ General Causation Opinions Explain
`Why PCR Results Cannot be Dispositive in this Litigation.
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`A.
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`Merck’s previous concessions to the Court about the inability of PCR to detect minute
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`amounts of the vaccine strain are precisely why PCR results cannot be considered dispositive in
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`this litigation. The Group A Bellwether Plaintiffs’ experts, Drs. Pinghui Feng and Mark
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`Poznansky, offered general causation opinions that were never challenged by Merck under
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`Daubert.7 These experts opine that when Zostavax causes a mixed strain Shingles rash, there will
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`always be small traces of the Oka strain in that rash, and in many cases the amount will be so small
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`that it will not be detected by PCR.8 Thus, the fact that Merck admits that PCR will not be able to
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`6 Ex. 13 – Harbecke R., et al., A real-time PCR assay to identify and discriminate among wild-type and
`vaccine strains of varicella-zoster virus and herpes simplex virus in clinical specimens, and comparison
`with the clinical diagnoses. J Med Virol. 2009 Jul;81(7):1310-22. doi: 10.1002/jmv.21506. PMID:
`19475609; PMCID: PMC4217208.
`7 Expert discovery has not been conducted in any of Plaintiffs’ cases, but it is Plaintiffs’ intent to utilize
`and/or adopt the general causation opinions of Drs. Feng and Poznansky.
`8 The reason there will be smaller amounts of Oka strain when compared to the wild-type strain has to do
`with the fact that the Oka strain’s ability to replicate in skin is greatly reduced when compared with the
`wild-type strains’ ability to replicate in human skin. See Ex. 2.
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`5
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`Case 2:18-md-02848-HB Document 1105 Filed 10/04/22 Page 6 of 23
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`detect the Oka strain in all cases, is an admission that the lack of PCR evidence cannot be
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`dispositive.9
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`Dr. Feng’s report and rebuttal report state as follows:
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`“The robust replication of VZV very likely explains why the Oka vaccine
`was not detected, considering that the Oka vaccine-strain VZV is highly
`compromised in replication…In the event that a patient harbors both wild-
`type VZV and Oka vaccine-strain VZV, it is more likely than not that the
`Oka vaccine-strain VZV is out-competed by wild-type VZV during lytic
`replication, e.g., when rashes are formed.10
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` …
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`The low percentage of Oka vaccine VZV, ranging from 1-2%, is significant
`given that the Oka vaccine is highly attenuated when compared to wild-type
`for this PCR assay… When competing with wild-type VZV, the Oka
`vaccine VZV is gradually diminished during replication and the residual
`level (1-5%) of the total VZV DNA in lesion reflecting the ultimate result
`of this competitive replication between the Oka vaccine VZV and wild-type
`VZV. Thus, the low percentage of the Oka vaccine VZV in the lesion is
`significant and meaningful in educating the public on adverse effect.”11
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`Dr. Poznansky’s addendum report reinforces this point:
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`“The presence of Oka DNA in these rashes is additional evidence that
`Zostavax was a substantial contributing cause to the shingles outbreak
`suffered by the plaintiff in this case… Since Zostavax contains the live
`attenuated Oka virus, these PCR DNA results show that the Oka virus
`infects vaccinees and is able to establish latency even when those being
`vaccinated were previously infected with the wild varicella virus. I note that
`Merck did not believe that the Oka virus could establish latency in this
`situation.”12
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`9 Based upon the deposition testimony of Merck’s experts, the Group A Bellwether Plaintiffs moved to
`prevent Merck’s PCR experts from testifying that PCR could always detect the vaccine in a given rash. In
`response, Merck admitted that it could not do so and that their experts would not be testifying as such. [Doc.
`906.]
`10 Ex. 4, Feng Expert Report at p. 60.
`11 Ex. 5, Feng Rebuttal Report at p. 3.
`12 Ex. 6, Poznansky Addendum Report for Plaintiff Niedzialowski at p. 3. Dr. Poznansky prepared
`substantially similar reports for all five bellwether Plaintiffs and his opinion in this regard is virtually
`identical for each Plaintiff. For ease of reference and consistency with other briefing, Plaintiffs have only
`annexed the addendum report for Plaintiff Niedzialowski here.
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`6
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`Case 2:18-md-02848-HB Document 1105 Filed 10/04/22 Page 7 of 23
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`Thus, if the Court were to grant Merck’s motion, the Court would be creating a situation
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`where it would be rejecting the unchallenged expert opinions proffered by Plaintiffs’ general
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`causation experts, and the Court would have to overlook the fact that Merck has already admitted
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`that PCR evidence is not dispositive in these cases. Respectfully, such a result simply cannot be
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`allowed.
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`Laboratory Testing Cannot Reliably Determine Whether a Shingles Rash was Caused
`by Zostavax or Contained the Oka Strain,
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`B.
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`It is undisputed amongst the parties that laboratory testing, namely PCR testing, cannot
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`conclusively rule out that a Shingles rash was caused by Zostavax, or that a Shingles rash even
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`contained the Oka strain. And this inability to detect the Oka strain by PCR is critically important
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`because it is the Plaintiffs’ position, and that of their experts, that Zostavax can cause three kinds
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`of Shingles rashes: (1) those where only Oka strain is detected by PCR; (2) those where both Oka
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`and wild-type strains are detected by PCR; and (3) those where both wild-type and Oka strain are
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`present, but no Oka strain is detected by PCR.
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`1.
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`PCR Testing Cannot Reliability Identify Oka Strain Virus in Mixed Rashes
`and a PCR Test Result of Wild-Type Only Does Not Mean that the Rash Did
`Not Contain Oka-strain Virus or That Zostavax Did Not Cause the Shingles
`Rash
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`Because Merck specifically designed Zostavax to inhibit the ability of the Oka strain to
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`replicate in skin cells, it is an aberration when the Oka strain is detectable in human skin. The Oka
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`strain’s ability to replicate in skin cells is greatly reduced compared to the wild-type strain, so it is
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`unsurprising that rashes caused by Zostavax show a lower incidence of Oka virus than wild-type.
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`This does not mean, however, that Oka strain was not involved in causing the rash. Indeed, the
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`opposite is true, as explained in Plaintiffs’ Appendix. See Ex. 2.
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`7
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`Case 2:18-md-02848-HB Document 1105 Filed 10/04/22 Page 8 of 23
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`Plaintiffs have offered the expert opinion of Dr. Pinghui Feng, a virologist and professor
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`of molecular microbiology and immunology at the University of Southern California,13 who
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`detailed the substantial shortcomings with Merck’s PCR testing theory and explained why PCR
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`testing cannot reliably or accurately determine whether the Oka strain was present in any rash. Dr.
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`Feng unequivocally concluded that a PCR test could never rule out the presence of the Oka strain
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`in any Shingles rash that occurred any time after the administration of Zostavax. Stated otherwise,
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`a PCR test that only detected the wild-type strain does not mean that Zostavax did not cause the
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`Shingles rash. Notably, and as detailed above, Merck has not challenged the admissibility of Dr.
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`Feng’s opinions in this regard.
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`Moreover, Merck’s experts agree with Dr. Feng on this point. For example, Merck’s PCR
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`expert, Dr. Garth Ehrlich, testified that PCR can only detect the primary, or most populous,
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`organism in a sample with multiple organisms, and that PCR would not detect secondary
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`organisms present at a lower amount:
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`“We were talking about what happens when you have a specimen where
`you have thousands or tens of thousands of times more of one genotype than
`other. You know, can you distinguish those? And the answer is no. And
`you're not going to be able to distinguish those on gel electrophoresis either.
`You know, when something is present at, you know, infinitesimally small
`amounts, it is always a real challenge, you know, to detect it.”14
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`This shortcoming with Merck’s reliance on PCR testing makes the results of such testing
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`inherently flawed in terms of it being dispositive as to causation. Indeed, even before Merck began
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`its Zostavax clinical trials, Merck knew that subjects who received Zostavax could develop three
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`kinds of rashes: (1) those where only Oka strain is detected by PCR; (2) those where both Oka and
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`wild-type strains are detected by PCR; and (3) those where only wild-type is detected by PCR.15
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`13 https://profiles.sc-ctsi.org/pinghui.feng
`14 Ex. 7, Ehrlich deposition at pp. 291:15-292:3.
`15 Ex. 8, Merck Internal Study, MRK-ZOSMDL-00669233
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`8
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`Case 2:18-md-02848-HB Document 1105 Filed 10/04/22 Page 9 of 23
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`Specifically, the FDA told Merck as early as 2002 that it was concerned that Zostavax may cause
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`mixed rashes and required Merck to do testing to prove that its PCR could detect both wild and
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`Oka in the same sample.16
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`But even with this knowledge, Merck took advantage of the shortcomings inherent to PCR
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`testing in its clinical trials so that it did not report the presence of Oka in mixed strain rashes.
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`Merck’s own expert, Dr. Gregory Storch, testified that the parameters of the PCR used by Merck
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`would define a sample as being wild-type only, even when the Oka strain was also present in that
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`sample:
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`Q. Okay. So now but in any event that -- as we just discussed because there
`is this cross-reactivity between -- if I have a sample and the sample is, like
`I say, there's a million target molecules of wild-type and a hundred target
`molecules of Oka, we're going to see a huge delta Ct, but we're not going to
`detect Oka under -- under the validation parameters, right?
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`A. Well, you're going to have a delta Ct with a lower Ct for the wild-type,
`and that would result in this specimen being defined as positive for wild-
`type VZV.17
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`Given Merck’s experts’ agreement that PCR testing cannot definitively detect Oka strain
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`
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`if the wild-type strain is present in greater quantity, and how Merck misled the world by
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`purposefully excluding Oka when its PCR detected it, Plaintiffs moved the Court to prevent
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`Merck’s experts from opining that PCR testing always accurately detects Oka-strain if it is present
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`in a sample. [Doc. 912.] This motion was not ruled upon, but in Merck’s opposition to that motion,
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`it agreed that PCR would not detect the vaccine-strain in minute amounts. [Doc. 906, p. 7.] To
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`be clear, months before the current motion was ever filed, Merck had already admitted that PCR
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`cannot prove that “there was no vaccine strain VZV DNA in any sample tested”—making this
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`16 Id.
`17 Ex. 9, Storch deposition at pp. 171:10-171:22.
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`9
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`Case 2:18-md-02848-HB Document 1105 Filed 10/04/22 Page 10 of 23
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`entire motion frivolous. Id.
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`Additionally, it is also notable that there are physical limitations to relying on PCR testing.
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`PCR samples are done by swabbing one or two lesions, and not the entire rash. Therefore, even
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`though the entire rash contained both wild and Oka strain, it is possible that the sample collected
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`may only have little to no Oka strain present. Considering Oka’s limited ability to infect and
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`replicate in human skin cells, there is a much greater likelihood that a swab would pick up wild-
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`type than Oka.
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`III. LEGAL ARGUMENT
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`A.
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`Plaintiffs Did Not Violate a Court Order, Thus Rule 41(b) Does Not Apply
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`Federal Rule of Civil Procedure 41(b) provides that if a plaintiff fails to prosecute or to
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`comply with the Rules or court order, a defendant may move to dismiss the action or any claim
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`against it. Fed. R. Civ. P. 41(b).
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`Here, Plaintiffs did not fail to comply with PTO 426. They simply could not produce the
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`documentation identified therein because no such documentation exists. This is because PCR
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`testing is not the standard of care for the diagnosis and treatment of Shingles, and, as such, no
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`testing was performed on their rash lesions at the time when they were exhibiting a Shingles rash
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`that could be tested. Moreover, Merck has never warned about the presence of Oka in Shingles
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`rashes, so healthcare providers would not know that they should be performing testing based on
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`the need of it in future litigation.
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`Accordingly, Merck’s Rule 41(b) motion should be denied for this reason alone. See Baier,
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`2018 U.S. Dist. LEXIS 180612, *9 (“It
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`is axiomatic
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`that a party cannot be forced
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`to produce documents that do not exist.”); Staff Builders of Philadelphia, Inc. v. Koschitzki, 1989
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`U.S. Dist. LEXIS 7027, *10 (E.D.Pa. Jun. 26, 1989.); Bracey v. Harlow, 2012 U.S. Dist. LEXIS
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`10
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`Case 2:18-md-02848-HB Document 1105 Filed 10/04/22 Page 11 of 23
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`147216, *11 (W.D. Pa. Oct. 12, 2012).
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`B.
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`Plaintiffs’ Claims Should Not be Dismissed Pursuant to Rule 41(b)
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`Despite Plaintiffs having not violated any Court Order, Merck seeks to have their cases
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`dismissed for such a violation under Rule 41(b) arguing that their claims are non-meritorious
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`without PCR testing. Rule 41(b) is clearly not the appropriate legal avenue to address Merck’s
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`argument regarding the merits of each Plaintiffs’ respective claims, especially given that
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`substantial and complete discovery has not occurred in these Plaintiffs’ cases. Nevertheless,
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`Plaintiffs address Merck’s argument under Rule 41(b).
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`1.
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`Legal Standard
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`Dismissing an action for failure to prosecute under Rule 41(b) is a matter of a district
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`court’s discretion. Briscoe v. Klaus, 538 F.3d 252, 257 (3d Cir. 2008). While MDL judges bear an
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`“increased burden” in ensuring the advancement of the litigation they oversee, “the fact that a
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`proceeding occurred in a MDL setting ‘does not alter the substantive rights of the litigants.’” In re
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`Asbestos Prods. Liabl. Litig. (No.VI), 718 F.3d 236, 243 (3d. Cir. 2013); see also In re Fosamax
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`Sodium Prods. Liab. Litig., 852 F.3d 268, 302 (3rd Cr. 2017)(reversed on other grounds)(noting
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`that an MDL's “desire to streamline proceedings cannot override the Plaintiffs' basic trial rights”
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`and a defendant has an “actual burden at the summary judgment stage” to “prove that there is no
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`genuine dispute in every single MDL case.”)
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`Dismissals are “only appropriate in limited circumstances and doubts should be resolved
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`in favor of reaching a decision on the merits.” Briscoe, 538 F.3d at 257. Indeed, “efficiency must
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`not be achieved at the expense of preventing meritorious claims from going forward.” Hamer v.
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`LivaNova Deutschland GmbH, 994 F.3d 173, 178 (3d Cir. 2021).
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`The U.S. Supreme Court also describes dismissal with prejudice as an “extreme” sanction.
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`Case 2:18-md-02848-HB Document 1105 Filed 10/04/22 Page 12 of 23
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`Nat'l Hockey League v. Metro. Hockey Club, Inc., 427 U.S. 639, 643, 96 S.Ct. 2778, 49 L.Ed.2d
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`747 (1976). Along these lines, the Third Circuit has repeatedly acknowledged that “dismissals with
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`prejudice or defaults … must be a sanction of last, not first, resort.” Poulis, 747 F.2d at 867,
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`869; see also Briscoe, 538 F.3d at 258; Emerson, 296 F.3d at 190. If the case is close, “doubts
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`should be resolved in favor of reaching a decision on the merits.” Adams v. Trs. of the N.J. Brewery
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`Emps.’ Pension Tr. Fund, 29 F.3d 863, 870 (3d Cir. 1994) (quoting Scarborough v. Eubanks, 747
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`F.2d 871, 878 (3d Cir. 1984) ). In sum, cases should be decided on the merits barring substantial
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`circumstances in support of the contrary outcome. Hildebrand v. Allegheny Cnty., 923 F.3d 128,
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`132 (3d Cir. 2019).
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`Recognizing that dismissals with prejudice are “drastic sanctions,” the Third Circuit has
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`instructed district courts to apply a six-factor balancing test to determine whether dismissal with
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`prejudice is appropriate as a sanction for a litigant's non-compliance with court orders. Poulis v.
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`State Farm Fire & Cas. Co., 747 F.2d 863, 867-68 (3d Cir. 1984). These factors include: (1) the
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`extent of the party’s personal responsibility; (2) the prejudice to the adversary caused by the failure
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`to meet scheduling orders and respond to discovery; (3) a history of dilatoriness; (4) whether the
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`conduct of the party or the attorney was willful or in bad faith; (5) the effectiveness of sanctions
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`other than dismissal, which entails an analysis of alternative sanctions; and (6) the meritoriousness
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`of the claim or defense. Poulis, 747 F.2d at 868). Likewise, the Third Circuit requires a district
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`court to consider the Poulis factors before dismissing an action for failure to prosecute. Clarke v.
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`Nicholson, 153 Fed.Appx. 69, 72 (3d Cir.2005) (citing Poulis, 747 F.2d 863, 868 (3d Cir.1984)).
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`2.
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`The Poulis Factors Do Not Warrant Dismissal
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` In attempting to support dismissal under Rule 41(b), Merck claims that three of the six
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`Paolis factors – prejudice to the adversary; effectiveness of sanctions other than dismissal and
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`meritoriousness of the claim – warrant dismissal. Merck’s argument is unsupported, especially at
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`this stage of proceedings where neither complete fact nor expert discovery has been conducted in
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`any of these Plaintiffs’ cases. An analysis of the Poulis factors leads to the inevitable conclusion
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`that dismissal is not warranted.
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`a.
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`Plaintiffs’ Claims are Meritorious.
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`Merck’s sole basis for its claim that Plaintiffs’ claims are non-meritorious under Rule 41(b)
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`stems from the fact that Plaintiffs cannot produce PCR testing. Merck’s analysis misunderstands
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`the Poulis criteria.18 When conducting a Poulis analysis, the meritorious nature of a claim is
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`decided on the pleadings. In re Aetna UCR Litig., No. 07CV3541KSHCLW, 2020 WL 4199741,
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`at *3 (D.N.J. July 22, 2020). (Emphasis added.)
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`The standard for determining whether a plaintiff's claims are meritorious “is
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`moderate.” Adams, 29 F.3d at 876. “[W]e do not purport to use summary judgment standards. A
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`claim, or defense, will be deemed meritorious when the allegations of the pleadings, if established
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`at trial, would support recovery by plaintiff or would constitute a complete defense.” Poulis, 747
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`F.2d at 869-70; see also Briscoe, 538 F.3d at 263 (“[W]e use the standard for a Rule 12(b)(6)
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`motion to dismiss for failure to state a claim.” (citing Poulis, 747 F.2d at 869-70)). See also United
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`States v. $55,518.05 in U.S. Currency, 728 F.2d at 195; Feliciano v. Reliant Tooling Co., 691 F.2d
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`at 657; Farnese v. Bagnasco, 687 F.2d at 764.
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`Thus, this standard does not require Plaintiffs to produce a specific type of evidence, such
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`18 Case law cited by Merck in support of this factor is inapplicable to this action. For example, in In re
`Avandia, in addition to failure to submit a Rule 26 expert report, plaintiff’s attorney moved to withdraw
`from the case, stating that “presently available data and information do not support the great majority of
`Plaintiff's positions” and they were “not able to pursue many of the positions and claims and demands
`insisted upon by the Plaintiff.” Id. at 486. The court found that counsel’s explanation for his withdrawal
`“further suggests that [plaintiff’s] claims may lack merit.” Id. Here, neither Plaintiffs, their counsel, nor
`their experts have indicated that any of Plaintiffs’ claims lack merit.
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`as test results or affidavits, to affirm the merits of the claim. In fact, the Third Circuit recently
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`expressed that where a plaintiff merely alleges sufficient facts to plausibly state a claim, which can
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`be evident from “even a glance” at the complaint, the claims fulfill the Poulis merit requirement.
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`Hildebrand v. Allegheny Cnty., 923 F.3d 128, 137 (3d Cir. 2019).
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`Here, Merck asserts no argument regarding the sufficiency of the allegations contained in
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`Plaintiffs’ complaints. And no matter how much Merck would like it to be the case, Rule 41(b) is
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`simply not the appropriate avenue for dismissal of claims that an adversary believes to be non-
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`meritorious, especially where discovery has not concluded, no evidence has been introduced and
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`there has been no violation of a Court Order. The fact is that at this stage of proceedings, Plaintiffs
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`do have meritorious claims against Merck, and they do intend to introduce prima facie evidence
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`in support of their claims at the appropriate time.
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`Specifically, Plaintiffs intend to submit evidence of causation in the form that this Court
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`has already required in the Group A cases, a reliable differential diagnosis.19 Notably, Plaintiffs’
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`experts will offer opinions that are not the exact same as that of those that were offered by Dr.
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`Poznansky in the Group A Bellwether cases in that they will be based on additional sources of
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`information providing further support for causation.20
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`Also important and relevant for this motion is that PCR testing will not be necessary for
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`such a differential diagnosis to be made because the results of any such PCR testing will not affect
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`said opinions. As discussed above, this is because even if a test result were to detect only wild-
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`type, this does not rule out Zostavax as the cause and/or Oka strain from being present in the rash.
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`PCR testing is simply unreliable in detecting the presence of the Oka strain as conceded by Merck’s
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`19 The meritoriousness nature of Plaintiff’s claims outside of the pleadings is not at issue under Rule 41(b).
`However, because Merck has made it an issue, Plaintiffs have addressed how they can prove specific
`causation in their individual cases without PCR testing in the Appendix. See Ex. 2.
`20 Id.
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`own experts, Merck’s employees, and Merck’s attorneys in prior briefing; thus, the article by
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`Harpaz and others, cannot preclude Plaintiffs’ experts from concluding that Zostavax more likely
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`than not caused a Plaintiff’s Shingles outbreak.
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`Not only is this Plaintiffs’ position, but Merck, through its expert, Dr. Ian Frank, agreed
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`that a differential diagnosis should be made even with PCR testing when he conducted his own
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`such diagnosis in the Bellwether cases. For Dr. Frank, he opined the converse as Plaintiffs’ experts.
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`Specifically, he was of the opinion that even if a test result were to detect both Oka and wild-type,
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`he could rule out Zostavax as the cause:
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`“even if vOka DNA is present in small quantities in the setting of a herpes
`zoster outbreak in which wild-type DNA predominates, there is no reason
`to infer that the minority strain contributed to development of the illness. In
`this unreported scenario of a herpes zoster outbreak with small amounts of
`vOka present, I believe it is more likely than not that the predominant wild-
`type strain that is known to be the more pathogenic strain, caused the
`outbreak, rather than trace amounts of the attenuated vOka strain.”21
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`Thus, Merck’s own expert believes that finding Oka under these circumstances would