Doles v. Secretary of Health and Human Services ( 2022 )


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  •            In the United States Court of Federal Claims
    No. 17-642V
    (Filed Under Seal: April 1, 2022)
    (Reissued: April 26, 2022)
    FOR PUBLICATION
    ***************************************
    ELIZABETH DOLES,                      *
    *
    Petitioner,         *
    *
    v.                                    *
    *
    SECRETARY OF HEALTH AND               *
    HUMAN SERVICES,                       *
    *
    Respondent.         *
    *
    ***************************************
    Jennifer G. Maglio, Maglio Christopher & Toale Law Firm, Sarasota, FL, for
    Plaintiff.
    Catherine E. Stolar, Trial Attorney, Torts Branch, Civil Division, United
    States Department of Justice, Washington, D.C. for Defendant, United States. With
    her on briefs were Brian M. Boynton, Acting Assistant Attorney General, C. Salvatore
    D’Alessio, Acting Director, Heather L. Pearlman, Deputy Director, Darryl R. Wishard,
    Assistant Director, Torts Branch, Civil Division, United States Department of
    Justice, Washington, D.C.
    OPINION AND ORDER
    Petitioner Elizabeth Doles experienced various neurological symptoms after
    receiving two vaccinations — first for polio, then for tetanus, diphtheria, and
    pertussis (“Tdap”). She sought relief under the National Childhood Vaccine Injury
    Compensation Program, 42 U.S.C. §§ 300aa-10 to 34 (“Vaccine Act”), and the Special
    Master awarded damages. See Special Master’s Ruling on Entitlement (“Ruling”) at
    1 (ECF 73); Special Master’s Decision Awarding Damages (“Decision”) at 2 (ECF 83).
    The government moved for review, raising arguments about the nature of Petitioner’s
    medical condition and about whether and how the vaccines relate to her condition.
    
    This Opinion was issued under seal on April 1, 2022. The parties were directed to propose redactions
    by April 15, 2022. No proposed redactions were submitted. The Court hereby releases publicly the
    Opinion and Order of April 1 in full.
    Finding errors in the Special Master’s Ruling, I REMAND for additional
    proceedings.1
    BACKGROUND
    To obtain compensation under the Vaccine Act, a petitioner must prove that a
    vaccine caused an injury. Althen v. Sec’y of Health & Hum. Servs., 
    418 F.3d 1274
    ,
    1278 (Fed. Cir. 2005). There are two ways to show causation: (1) through “a
    statutorily-prescribed presumption of causation upon a showing that the injury falls
    under the Vaccine Injury Table (‘Table injury’),” 
    id.
     (citing 42 U.S.C. § 300aa-14(a)),
    or (2) by proof of causation in fact “where the complained-of injury is not listed in the
    Vaccine Injury Table (‘off-Table injury’),” id. (citing 42 U.S.C. §§ 300aa-13(a)(1),
    300aa-11(c)(1)(C)(ii)(I)). For off-Table injuries, causation in fact has three elements:
    “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical
    sequence of cause and effect showing that the vaccination was the reason for the
    injury; and (3) a showing of a proximate temporal relationship between vaccination
    and injury.” Id.
    While some Vaccine Act petitioners claim novel injuries resulting from
    vaccines, others claim that an existing medical condition was “significantly
    aggravated” by a vaccine. 42 U.S.C. § 300aa-11(c)(1)(C)(i)–(ii); see Loving ex rel.
    Loving v. Sec’y of Dept. of Health & Hum. Servs., 
    86 Fed. Cl. 135
    , 143 (2009) (“[T]he
    Vaccine Act specifies that significant-aggravation and new-injury circumstances
    constitute separate avenues to potential recovery.”). Petitioners in the latter category
    must prove three additional elements: “(1) the person’s condition prior to
    administration of the vaccine, (2) the person’s current condition (or the condition
    following the vaccination if that is also pertinent), [and] (3) whether the person’s
    current condition constitutes a ‘significant aggravation’ of the person’s condition prior
    to vaccination[.]” Loving, 86 Fed. Cl. at 144; W.C. v. Sec’y of Health & Hum. Servs.,
    
    704 F.3d 1352
    , 1357 (Fed. Cir. 2013).
    A petitioner always must prove causation of off-Table injuries by
    preponderance of the evidence. See, e.g., Hibbard v. Sec’y of Health & Hum. Servs.,
    
    698 F.3d 1355
    , 1366 (Fed. Cir. 2012); Althen, 
    418 F.3d at 1278
    .2 Although the
    petitioner’s burden does not “require identification and proof of specific biological
    mechanisms,” Knudsen, 35 F.3d at 549, “a ‘plausible’ or ‘possible’ causal theory” is
    1 This Court has jurisdiction. See 42 U.S.C. §§ 300aa-11(c), 300aa-16(a). The government timely moved
    for review. See 42 U.S.C. § 300aa-12(e)(1).
    2 The government can rebut proof of causation by showing, “also by a preponderance of evidence, that
    the injury was in fact caused by factors unrelated to the vaccine.” Althen, 
    418 F.3d at 1278
     (quoting
    Knudsen v. Sec’y of Health & Hum. Servs., 
    35 F.3d 543
    , 547 (Fed. Cir. 1994)); see 42 U.S.C § 300aa-
    13(a)(1)(B).
    -2-
    not enough, see Boatmon v. Sec’y of Health & Hum. Servs., 
    941 F.3d 1351
    , 1360 (Fed.
    Cir. 2019) (quoting Moberly ex rel. Moberly v. Sec’y of Health & Hum. Servs., 
    592 F.3d 1315
    , 1322 (Fed. Cir. 2010)). Proof of causation requires “a reputable medical or
    scientific explanation that pertains specifically to the petitioner’s case.” See
    Broekelschen v. Sec’y of Health & Hum. Servs., 
    618 F.3d 1339
    , 1345 (Fed. Cir. 2010);
    Moberly, 
    592 F.3d at 1322
    ; see also Knudsen, 
    35 F.3d at 549
     (“[C]ausation can be
    found in vaccine cases based on epidemiological evidence and the clinical picture
    regarding the particular [patient] without detailed medical and scientific exposition
    on the biological mechanisms.”).
    This Court may set aside a special master’s conclusions as “arbitrary,
    capricious, an abuse of discretion, or otherwise not in accordance with law.” 42 U.S.C.
    § 300aa-12(e)(2)(B). “Fact findings are reviewed … under the arbitrary and capricious
    standard; legal questions under the ‘not in accordance with law’ standard; and
    discretionary rulings under the abuse of discretion standard.” Munn v. Sec’y of Dep’t
    of Health & Hum. Servs., 
    970 F.2d 863
    , 870 n.10 (Fed. Cir. 1992). When this Court
    finds error, it may either substitute its own findings and conclusions or remand for
    additional proceedings. 42 U.S.C. § 300aa-12(e)(2)(B)–(C).
    The relevant facts and history of the case are as follows. Petitioner — a 67-
    year-old woman at the time of her vaccinations — alleged in her Amended Petition
    that she suffers from central nervous system demyelination “best characterized” as
    multiple sclerosis (“MS”). Am. Pet. ¶¶ 5–6 (ECF 44). She does not plead exactly when
    her symptoms began, but she went to the emergency room 44 days after her second
    vaccination for symptoms that began two nights before. Id. at ¶¶ 1–3; Ruling at 6.
    She claims that her vaccines “actually caused, or, alternatively, significantly
    aggravated” her injury. Am. Pet. at ¶ 10.
    Because Petitioner’s alleged injury does not appear on the Table for the
    relevant vaccines, 42 U.S.C. § 300aa-14(a); 
    42 C.F.R. § 100.3
    (a)(I), (II), (VI), (VII), she
    must prove causation rather than benefit from the statutory presumption. Althen,
    
    418 F.3d at 1278
    . Central nervous system demyelination is a general term describing
    a number of medically distinct conditions — including MS, acute disseminated
    encephalomyelitis (“ADEM”), and focal myelitis or transverse myelitis (“TM”), among
    others, see Steel Rebuttal Report at 2 (ECF 57-2) — so Petitioner presented two
    experts to explain her theory of injury in more detail.
    The first was Dr. Slavenka Kam-Hansen, one of Petitioner’s treating
    physicians, who opined in a letter that Petitioner suffered from ADEM because of the
    vaccines. Kam-Hansen Letter at 2 (ECF 23-2). Dr. Kam-Hansen opined “that ADEM
    was more likely to cause [Petitioner’s] symptoms” than MS. Id. at 1. But then
    -3-
    Petitioner changed course. Her second expert, Dr. John G. Steel, submitted reports
    arguing that Petitioner did not have ADEM, but instead experienced focal myelitis or
    TM because of the vaccines. Steel Rebuttal Report at 1, 7; see Steel Report at 3, 5
    (ECF 34-2). Dr. Steel opined that Petitioner has MS, but — although the record of his
    opinions is not entirely clear — he did not appear to argue that the vaccines caused
    or aggravated that condition. Rather, he seems to have argued that her MS put her
    at heightened risk for TM when she received vaccinations. Steel Rebuttal Report at
    1–2, 6–7.3 “Although there is little evidence that vaccinations cause multiple sclerosis
    in healthy patients,” he wrote, “there is convincing evidence that vaccinations
    occasionally trigger single attacks of TM[] [and other conditions], and there is good
    reason to think that such an event is more likely in patients with subclinical MS.”
    Steel Report at 5.
    Defendant submitted an expert report from Dr. Subramaniam Sriram, who
    agreed with Dr. Steele that Petitioner has MS, not ADEM, Sriram Report at 7, 13
    (ECF 52-1), but concluded that Petitioner’s MS was not caused or exacerbated by the
    vaccines. Id. at 16; Sriram Rebuttal Report at 7 (ECF 62-1). He opined that the
    diagnosis of MS made it inappropriate to diagnose TM as a separate condition. Sriram
    Rebuttal Report at 1–2.
    In response, Dr. Steel emphatically objected not only to Dr. Sriram’s
    characterization of Petitioner’s condition, but to Dr. Sriram discussing MS in the first
    place. Dr. Steel referred to MS as a “red herring” that “has served to confuse the
    issue,” insisting that he “made no assertion of a causal relationship between the
    vaccines and MS” and that his opinion was “regarding the myelitis only.” Steel
    Rebuttal Report at 1. He criticized Dr. Sriram for addressing MS at all: “Dr. Sriram’s
    rebuttal … focused on MS but did not address the actual causal relationship that I
    have asserted, between Ms. Doles’ April 2016 vaccinations and her subsequent attack
    of spinal myelitis. By discussing MS only, he failed to address our central point.” Id.
    at 1–2.
    Petitioner’s own argument before the Special Master was in the same vein as
    Dr. Steel’s. Petitioner maintained that “Dr. Steel’s theory of general causation” was
    that her vaccines “can provoke an autoimmune process leading to central nervous
    system demyelination which manifests as [a form of TM] and this is more likely to
    occur in patients who are already undergoing another autoimmune process, such as
    clinically silent MS.” Reply Mem. in Supp. of Pet.’s Mot. for Findings of Fact and
    3 Dr. Steel also opined that “[t]he vaccinations likely did not cause the MS but rather unmasked it, i.e.
    caused it to become clinically significant during her medical evaluation.” Steel Report at 3. That
    language could be read as opining that Petitioner’s vaccinations aggravated her MS, but it is difficult
    to understand in the context of Dr. Steel’s other opinions.
    -4-
    Conclusions of Law (“Reply Mem.”) at 2 (ECF 72). Petitioner identifies no place in her
    expert reports or briefing where she plainly argued that her MS itself had been
    aggravated by the vaccines. Rather, she argued consistently that her MS was an
    underlying risk factor that put her at risk for other conditions. Pet.’s Mem. in Supp.
    of Her Mot. for Findings of Fact and Conclusions of Law at 18–20 (ECF 68); Reply
    Mem. at 2.
    The Special Master — who resolved the parties’ arguments on the papers,
    without a hearing — took a tack different from either of the parties. He specifically
    rejected both Dr. Kam-Hansen’s view that Petitioner experienced ADEM and Dr.
    Steel’s view that Petitioner experienced TM, instead agreeing with Dr. Sriram that
    Petitioner has MS alone. Ruling at 18, 20–22. But unlike Dr. Sriram (or Petitioner
    and her experts, for that matter), the Special Master determined that Petitioner’s MS
    had been significantly aggravated by her vaccines. Id. at 19. The Special Master’s
    main support for that conclusion was a study by Langer-Gould et al., which he
    interpreted as providing “evidence tending to show that vaccines did contribute to
    significantly aggravate subclinical autoimmunity into overt MS among the examined
    population.” See id. at 24 n.11 (citing Annette Langer-Gould et al., Vaccines and the
    Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases,
    71 JAMA Neurol. 1506 (2014) (“Langer-Gould”) (ECF 57-10)). The Special Master
    thus issued a Ruling on Entitlement and a Decision based on a theory of injury (MS)
    and a theory of causation (significant aggravation) that Petitioner never advanced in
    her expert reports or briefing.4 The Special Master placed the date of Petitioner’s
    condition “approximately 60 days following her … polio vaccination and 42 days
    following her … Tdap vaccination.” Id. at 29.
    DISCUSSION
    The Special Master’s resolution was erroneous for at least two reasons.
    First, it was unfair to the parties and frustrates this Court’s review. Although
    the formal requirements of this Court’s Rules and the Federal Rules of Civil
    Procedure and Evidence do not apply to proceedings before the special masters, see
    42 U.S.C. § 300aa-12(d)(2); RCFC App. B, Rule 8(b)(1), the special masters are bound
    by an obligation to be fair to both parties, and to provide both parties the opportunity
    to present a case. See RCFC App. B, Rule 8(b)(1) (“In receiving evidence, the special
    master … must consider all relevant and reliable evidence governed by principles of
    fundamental fairness to both parties.”); id. Rule 3(b)(2) (“The special master is
    responsible for … affording each party a full and fair opportunity to present its
    4Petitioner even conceded before the Special Master that “the studies cited by Dr. Steel do not involve
    vaccines triggering MS[.]” Reply Mem. at 4.
    -5-
    case[.]”); see also Dickerson v. Sec’y of Dep’t of Health & Hum. Servs., 
    35 Fed. Cl. 593
    ,
    598 (1996) (“[T]he Court of Federal Claims has promulgated rules of procedure for
    use by special masters governed by the principles of fundamental fairness to both
    parties.”). The special masters must also conduct their proceedings in a way that
    “create[es] a record sufficient to allow review of” their decisions. See RCFC App. B,
    Rule 3(b)(2). Given those principles, this Court has required special masters to give
    parties notice and an opportunity to comment on the evidence and issues the special
    master considers. See, e.g., Davis v. Sec’y of Health & Hum. Servs., 
    94 Fed. Cl. 53
    , 65–
    66 (2010).
    The Special Master failed to do so. As explained, the Special Master adopted a
    theory of injury and causation that Petitioner never advanced and that does not
    appear to have been obvious from the evidence submitted. Compare Sword v. United
    States, 
    44 Fed. Cl. 183
    , 190 (1999) (finding no surprise where “the Special Master’s
    explanation was hardly out of left field”). As a result, the government never had its
    opportunity to explain why those theories were mistaken. Compare Hines ex rel.
    Sevier v. Sec’y of Dep’t of Health & Hum. Servs., 
    940 F.2d 1518
    , 1525–26 (Fed. Cir.
    1991) (finding that the special master taking judicial notice of a “[w]ell-known
    medical fact[]” without “inform[ing] the parties in advance that he intended to do so”
    did not “violate[] the principles of fundamental fairness” because the objecting party
    could have raised her concerns on review before the Court of Federal Claims and did
    not do so) (quotes omitted), with Campbell ex rel. Campbell v. Sec’y of Health & Hum.
    Servs., 
    69 Fed. Cl. 775
    , 781–82 (2006) (finding it “patently unfair” for the special
    master to rely on extra-record articles of dubious reliability without giving the parties
    an adequate opportunity to respond to them). To the extent the Special Master relied
    on evidence in the record, the government addressed that evidence as it related to
    Petitioner’s characterization of her injury, not the Special Master’s different
    characterization. Both parties agree that they were “surprise[d]” — Petitioner’s word
    — by the Special Master’s decision to treat this case as one of significant aggravation
    of an existing condition. Pet.’s Mem. in Resp. to Resp’s. Mot. for Rev. (“Pet.’s Resp.”)
    at 1 (ECF 89). And because of the lack of adversarial development of the Special
    Master’s theory, I cannot be sure that the record is adequate for review.
    Second — possibly because of the departure from ordinary adversarial
    processes — the Special Master’s Ruling misinterpreted its primary medical
    authority, the Langer-Gould study. A summary of that study will show why.
    The Langer-Gould investigators used the records of a large health system to
    investigate the association between vaccinations of any type and central nervous
    system demyelinating conditions, including MS. Langer-Gould at 2. The investigators
    -6-
    bifurcated their findings between patients younger than 50 and those 50 or older. Id.
    at 3.
    The investigators expressed the association between vaccination and
    conditions such as MS in terms of an odds ratio, plus a 95% confidence interval, for
    developing demyelinating conditions during different time periods (up to three years)
    after vaccination. Id. at 3, 6 (Figure 2). An odds ratio is a way of expressing the
    relative risk of a condition in a “case” group exposed to a given factor versus a
    “control” group that was not exposed. Fed. Jud. Ctr., Reference Manual on Scientific
    Evidence 568 (3d ed. 2011). “An odds ratio of 1 indicates no association” between the
    disease and the factors investigated: The risk of the disease is the same whether the
    group was exposed or not. Id. at 291. “A confidence interval is a range of values within
    which the true value is likely to fall.” Germaine v. Sec’y of Health & Hum. Servs., 
    155 Fed. Cl. 226
    , 229 (2021) (quotes and alterations omitted) (quoting Reference Manual
    on Scientific Evidence 621). “By definition, when a statistician uses a 95% confidence
    interval, that statistician estimates that a sample to be drawn from the population
    will fail to capture the mean population 1 out of 20 times.” Lax v. APP of N.M. ED,
    PLLC, CIV No. 20-264 SCY/JFR, 
    2022 WL 715735
    , at *8 n. 9 (D.N.M. Mar. 10, 2022).
    A confidence interval that straddles an odds ratio of 1.0 is “statistically insignificant,”
    meaning that it is statistically indistinguishable from no change in risk. Germaine,
    155 Fed. Cl. at 228–29 (citation omitted) (quoting Reference Manual on Scientific
    Evidence 621) (discussing the related concept of relative risk).
    Looking at all types of vaccines combined, the investigators found no
    association between vaccinations and MS. For every time period after vaccination,
    the confidence interval for developing MS straddled an odds ratio of 1.0. Langer-
    Gould at 6 (Figure 2). There was one statistically significant association between
    vaccines and the broader universe of demyelinating conditions — an odds ratio of
    2.32, with a confidence interval of 1.18 to 4.57 — but only for patients under age 50,
    and only within 14 days of the vaccine. Id. There was no association between vaccines
    and demyelinating conditions for patients 50 or older for any time period post-
    vaccination. Id. For patients younger than 50, the association between vaccinations
    and demyelinating conditions disappeared after 14 days. Id.
    In short, Langer-Gould found no association between MS — the condition the
    Special Master identified as Petitioner’s injury — and vaccinations. The only
    association found involved demyelinating conditions generally, i.e., conditions other
    than the demyelinating condition Petitioner has. Even if there were an association
    between Petitioner’s personal condition and vaccinations, it did not exist for patients
    in Petitioner’s age group, only younger patients. And even if there were an association
    for her age group, the effect disappears soon after vaccination, such that there is no
    -7-
    association between vaccinations and demyelinating conditions for either age group
    at the time the Special Master found Petitioner’s symptoms in fact developed. In
    short, there is no way to look at the study’s data and find an association between
    vaccinations and Petitioner’s own condition.5
    Although there can be association without causation, there cannot be causation
    without association. See, e.g., Olaf M. Dekkers, The Long and Winding Road to
    Causality, 34 European J. of Epidemiology 533 (2019) (“[T]he fundamental
    prerequisite before judging causality is the presence of an association. …. In short:
    no causation without association.”); Handbook of Causal Analysis for Social Research
    285 (Stephen L. Morgan ed., 2013) (“Typically, all we can observe in data is whether
    or not two or more variables are associated, either unconditionally or after
    conditioning on some other set of other variables. Causality is not observed but must
    be inferred from these associations. … [I]f two variables are causally related, they
    must be associated. As the old adage goes, ‘no causation without association.’”).6 The
    fact that the Langer-Gould study shows no association relevant to Plaintiff means
    that it does not evidence causation: A finding of causation would have to be despite
    the Langer-Gould study, not because of it. It was therefore error for the Special
    Master to treat the Langer-Gould study as supporting Petitioner’s proof of causation.
    The Special Master’s Ruling acknowledged that Langer-Gould “found no long-
    term association between vaccination and MS,” Ruling at 23, but dismissed the point
    as “only a statistical observation” because a possible mechanism for causation —
    specifically, “vaccine involvement as an inflammatory cofactor” — might
    hypothetically take effect later than 30 days after vaccination or in patients older
    than 50. Id. at 24 & n.11, 30. That hypothesis, however, is not evidence; it was a theory
    the Langer-Gould study was supposed to test by looking for an association. The
    Special Master was not permitted to adopt a hypothesis as a theory of causation
    without evidence to support it. See Germaine, 155 Fed. Cl. at 227–28 (citing Knudsen,
    
    35 F.3d at 549
    , and Boatmon, 941 F.3d at 1360). And the Langer-Gould study, again,
    provided no such evidence: It found an association in some circumstances, but not
    circumstances like Petitioner’s.
    One might argue that the study supports an inference of causation in the
    limited circumstance where there was a statistical association. But because
    association is a prerequisite for conclusions about causation, the Langer-Gould study
    5Dr. Sriram raised some of these points in a supplemental report. See Sriram Rebuttal Report at 5.
    6But see Stephen L. Morgan & Christopher Winship, Counterfactuals and Causal Inference: Methods
    and Principles for Social Research 447 n.9 (2d ed. 2015) (noting “cases for which this may not be true,
    such as when individual-varying causal effects perfectly cancel out each other or when suppression
    effects exist”).
    -8-
    provides no support for a hypothesis of causation in circumstances where an
    association was lacking. See Broekelschen, 
    618 F.3d at 1345
     (“[A] petitioner must
    provide a reputable medical or scientific explanation that pertains specifically to the
    petitioner’s case[.]”). To dismiss that finding as a “statistical observation” thus
    misunderstands what the Langer-Gould study was investigating and the conclusions
    it reached.
    That is not to say that the Langer-Gould study disproves causation in
    Petitioner’s case. Scientific studies sometimes yield different results, so perhaps some
    other study shows an association that Langer-Gould did not. When scientific studies
    differ, the proper course is to weigh them, in which case a special master’s conclusions
    about inconsistent medical evidence would be upheld unless arbitrary or capricious.
    See Broekelschen, 
    618 F.3d at 1349
    ; Greene v. Sec’y of Health & Hum. Servs., 
    146 Fed. Cl. 655
    , 665, aff’d, 841 F. App’x 195 (Fed. Cir. 2020); Moreno v. Sec’y of Dept. of Health
    & Hum. Servs., No. 95–706V, 
    2005 WL 6120645
    , at *6–7, 9–10 (Fed. Cl. 2005).
    Likewise, the Federal Circuit has made clear that published research is not strictly
    necessary to show causation in the first place. See Andreu ex rel. Andreu v. Sec’y of
    Dep’t of Health & Hum. Servs., 
    569 F.3d 1367
    , 1378 (Fed. Cir. 2009); Althen 
    418 F.3d at 1280
    . But when the Court or a special master does resort to medical literature, a
    study’s findings must be interpreted using correct statistical methods — just as its
    words must be assigned their correct common or technical meanings.7
    Because of the importance the Special Master attached to the Langer-Gould
    study and the government’s lack of opportunity to respond to the Special Master’s
    treatment of the rest of the record, I cannot conclude that the Special Master’s errors
    are harmless. See Davis, 94 Fed. Cl. at 65–66. But for the same reason, the record is
    insufficient for me to issue new findings. 42 U.S.C. § 300aa-12(e)(2)(B); RCFC App.
    B, Rule 3(b)(2). The best course is therefore to remand for further proceedings. 42
    U.S.C. § 300aa-12(e)(2)(C). On remand, the Special Master should give the parties
    the opportunity for briefing — and, if appropriate, new written or live evidence — on
    7 Another possible error in the Special Master’s Ruling deserves brief attention. The Special Master
    wrote that his conclusion about the Langer-Gould study was “consistent with petitioner’s burden of
    proof for a significant aggravation claim” because “Petitioner need only demonstrate that her
    vaccination affected her condition; she does not have a burden to demonstrate that her ultimate
    condition is worse than her expected outcome.” Ruling at 24–25 (citing Sharpe v. Sec’y of Health &
    Hum. Servs., 
    964 F.3d 1072
    , 1081 (Fed. Cir. 2020)). As the parties agree, that is not the law for
    causation. Resp’s. Mem. in Supp. of Mot. for Rev. at 9 (ECF 86-1); Pet.’s Resp. at 5–6. Petitioner argues
    that in context, the Special Master meant to refer to the standard for aggravation of injuries. Pet.’s
    Resp. at 6–7. I find the Ruling’s language too cryptic to be sure. Be that as it may, the Special Master
    should use the correct standard on remand.
    -9-
    whether Petitioner’s vaccinations aggravated her MS. The Special Master should
    interpret the medical evidence under the correct legal and scientific standards.
    CONCLUSION
    For the foregoing reasons, the government’s motion for review is GRANTED
    and the Special Master’s Decision (ECF 83) is VACATED. The case is REMANDED
    for the Special Master to consider the parties’ arguments on aggravation of MS and
    to re-evaluate the medical evidence under the correct legal and scientific standards.
    The Special Master shall issue a new entitlement decision within ninety days of this
    decision. See 42 U.S.C. § 300aa-12(e)(2); RCFC App. B, Rule 28(b).
    IT IS SO ORDERED.
    s/ Stephen S. Schwartz
    STEPHEN S. SCHWARTZ
    Judge
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