Case: 20-1021   Document: 33     Page: 1   Filed: 08/28/2020




        NOTE: This disposition is nonprecedential.


   United States Court of Appeals
       for the Federal Circuit
                 ______________________

      JORDIA NUNEZ, JOHN DIAZ, AS LEGAL
     REPRESENTATIVES OF J.J.D., AN INFANT,
                  DECEASED,
              Petitioners-Appellants

                            v.

       SECRETARY OF HEALTH AND HUMAN
                   SERVICES,
               Respondent-Appellee
              ______________________

                       2020-1021
                 ______________________

     Appeal from the United States Court of Federal Claims
 in No. 1:14-vv-00863-LAS, Senior Judge Loren A. Smith.
                  ______________________

                Decided: August 28, 2020
                 ______________________

     SYLVIA CHIN-CAPLAN, Law Office of Sylvia Chin-
 Caplan LLC, Boston, MA, argued for petitioners-appel-
 lants.

    LISA WATTS, Vaccine/Torts Branch, Civil Division,
 United States Department of Justice, Washington, DC, ar-
 gued for respondent-appellee. Also represented by ETHAN
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 2                                              NUNEZ   v. HHS



 P. DAVIS, ALEXIS B. BABCOCK, C. SALVATORE D'ALESSIO,
 CATHARINE E. REEVES.
                 ______________________

  Before NEWMAN, LOURIE, and O’MALLEY, Circuit Judges.
     Opinion for the court filed by Circuit Judge LOURIE.
     Dissenting opinion filed by Circuit Judge NEWMAN.
 LOURIE, Circuit Judge.
     Jordia Nunez and John Diaz (collectively, “Nunez”), the
 parents of a deceased minor child (“J.J.”), appeal from the
 decision of the United States Court of Federal Claims
 (“Claims Court”) upholding the Special Master’s Decision
 on Entitlement, which denied vaccine injury compensation
 after J.J.’s death from Sudden Infant Death Syndrome
 (“SIDS”). See Nunez v. Sec’y of Health & Human Servs.,
 144 Fed. Cl. 540 (2019) (“Claims Court Decision”); Nunez v.
 Sec’y of Health & Human Servs., No. 14-863V, 2019 WL
 2462667 (Fed. Cl. Mar. 29, 2019) (“Special Master Deci-
 sion”). We affirm.
                        BACKGROUND
     On the afternoon of November 14, 2012, J.J. visited his
 doctor for his four-month well-baby examination. During
 that visit, J.J. received hepatitis B virus, rotavirus, Diph-
 theria-Tetanus-acellular Pertussis, haemophilus influenza
 type B, inactivated polio, and pneumococcal conjugate vac-
 cinations. The following morning, J.J. was found unre-
 sponsive by his parents. He was taken to the hospital and
 pronounced dead shortly after arrival. It is undisputed
 that the cause of death was SIDS.
     Nunez petitioned for vaccine injury compensation pur-
 suant to the National Vaccine Injury Compensation Pro-
 gram, 42 U.S.C. §§ 300aa-10–34 (2012) (“Vaccine Act”),
 alleging that J.J.’s death from SIDS was caused by adverse
 effects from the vaccinations he received. The Special
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 NUNEZ   v. HHS                                              3



 Master assigned to the case held an entitlement hearing
 and applied the three-prong test set forth in Althen v. Sec’y
 of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir.
 2005), which is used to determine whether a petitioner has
 established a causal link between a vaccine and the
 claimed injury. That test requires that a petitioner set
 forth “(1) a medical theory causally connecting the vaccina-
 tion and the injury; (2) a logical sequence of cause and ef-
 fect showing that the vaccination was the reason for the
 injury; and (3) a showing of a proximate temporal relation-
 ship between vaccination and injury.” Id. In applying the
 Althen test, the Special Master considered the evidence
 presented by Nunez’s expert witness, Dr. Douglas Miller,
 and the Secretary’s expert witness, Dr. Christine
 McCusker, both of whom have testified in numerous prior
 cases involving petitions for compensation under the Vac-
 cine Act for incidents of SIDS.
      For the first prong of the Althen test, Dr. Miller pro-
 posed the Triple Risk Model as the relevant medical theory
 causally connecting J.J.’s vaccinations to his death from
 SIDS. The Triple Risk Model proposes that SIDS results
 from the intersection of three overlapping factors: (1) a vul-
 nerable infant; (2) a critical developmental period; and (3)
 an exogeneous stressor. For purposes of this appeal, it is
 not disputed that J.J. was a vulnerable infant because of
 his gender, prematurity, and because he had a defective
 brainstem. It is also undisputed that J.J. died at the age
 of four months, which was within the critical developmen-
 tal period that occurs during the first year of life. The dis-
 pute in this appeal is regarding the third factor of the
 Triple Risk Model, and specifically Dr. Miller’s theory that
 vaccinations act as an exogeneous stressor. According to
 Dr. Miller, vaccinations cause the body’s immune system
 to produce cytokines that enter the brain and impair the
 medullary serotonin system’s ability to rouse the body in
 response to elevated levels of carbon dioxide during sleep.
 Dr. McCusker challenged Dr. Miller’s theory based on the
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 4                                              NUNEZ   v. HHS



 current state of scientific knowledge about cytokine pro-
 duction, transport, and expression.
      After weighing the evidence, the Special Master found
 two primary problems with Dr. Miller’s application of the
 Triple Risk Model to explain causation in this case. First,
 the Special Master found that Dr. Miller failed to provide
 evidence of a transport mechanism for cytokines to enter
 the brain. Special Master Decision, 2019 WL 2462667,
 at *41.    Second, the Special Master found that Dr.
 McCusker persuasively explained that J.J.’s defective
 brainstem would not have allowed cytokines to affect the
 brain in a manner consistent with Dr. Miller’s proposed
 theory. Id. (“[C]ytokines need a normal brainstem to affect
 the 5-HT system because it is through functioning recep-
 tors that their messages are received.”). Ultimately, the
 Special Master denied compensation, finding that Nunez
 failed to carry her legal burden of establishing causation.
 Id. at *42.
     Nunez moved the Claims Court to review the Special
 Master’s decision. The Claims Court denied Nunez’s mo-
 tion, finding that the Special Master “neither abused her
 discretion nor acted contrary to law, as she appropriately
 considered the record as a whole and adequately explained
 her determinations as to the reliability of the evidence and
 credibility of the expert witnesses.” Claims Court Decision,
 144 Fed. Cl. at 547. The Claims Court entered judgment
 dismissing the petition, and Nunez appealed to this court.
 We have jurisdiction under 28 U.S.C. § 1295(a)(3) and 42
 U.S.C. § 300aa-12(f).
                        DISCUSSION
      In Vaccine Act cases, we review the Claims Court’s de-
 cision de novo. LaLonde v. Sec’y of Health & Human Servs.,
 746 F.3d 1334, 1338 (Fed. Cir. 2014) (citing Moberly ex rel.
 Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315,
 1321 (Fed. Cir. 2010)). In so doing, we apply the same
 standard that the Claims Court applies in reviewing a
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 NUNEZ   v. HHS                                                5



 special master’s decision. Id. We review a special master’s
 factual findings under the arbitrary and capricious stand-
 ard, and we review legal rulings to determine whether they
 are in accordance with law. Id. at 1339.
       Less than a year ago, this court decided Boatmon v.
 Sec’y of Health & Human Servs., 941 F.3d 1351 (Fed. Cir.
 2019), which presented the same issue we have in this case,
 i.e., a petitioner claiming compensation under the Vaccine
 Act after a child died from SIDS. In Boatmon, the peti-
 tioner relied on the testimony of Dr. Miller, who presented
 the Triple Risk Model as the theory of causation linking
 vaccinations to SIDS. Affirming the decision of the Claims
 Court, which had reversed the decision of a special master,
 we held that Dr. Miller’s theory was an “unsound and un-
 reliable theory that constitutes a significant extension of
 the Triple Risk Model . . . .” Id. at 1361. We faulted the
 special master in that case for accepting Dr. Miller’s theory
 “in the absence of any indicia of reliability.” Id.
     In this case, Dr. Miller has again presented the same
 theory of causation based on the Triple Risk Model. Thus,
 the question before us boils down to whether the record in
 this case contains the “indicia of reliability” for Dr. Miller’s
 theory that we found lacking in Boatmon. Indeed, under
 the appropriate standard of review, we must consider
 whether the evidence in this case so persuasively demon-
 strates the reliability of Dr. Miller’s theory that it renders
 the Special Master’s rejection of the theory arbitrary and
 capricious. See Lampe v. Sec’y of Health & Human Servs.,
 219 F.3d 1357, 1360 (Fed. Cir. 2000) (“In effect, this court
 performs the same task as the Court of Federal Claims and
 determines anew whether the special master’s findings
 were arbitrary or capricious.”). We see no such indicia of
 reliability.
     Nunez attempts to distinguish this case by arguing
 that there is additional evidence in the record that was not
 present in Boatmon.           See Oral Arg. at 2:03,
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 6                                               NUNEZ   v. HHS



 http://oralarguments.cafc.uscourts.gov/default.aspx?fl=20-
 1021.mp3. For example, Nunez argues that medical liter-
 ature was presented in this case demonstrating that the
 effects of vaccinations, specifically cytokine production, are
 comparable to the effects of mild infections. See, e.g., id.;
 J.A. 367 (2014 study by Kashiwagi); J.A. 457 (2007 meta
 study by Vennemann). Ultimately, however, the record re-
 flects no major advances in the state of medical knowledge
 concerning a relationship between vaccinations and SIDS
 in the short time that has passed since this court decided
 Boatmon less than a year ago. And we have no basis to
 conclude that studies from 2006 and 2014 are the type of
 new evidence that is so indicative of the reliability of Dr.
 Miller’s theory that it makes the Special Master’s factual
 findings arbitrary and capricious for having rejected it.
     Beyond the medical literature, Nunez attempts to dis-
 tinguish this case from Boatmon by pointing to one addi-
 tional piece of evidence that is present here, namely, that
 “physical evidence obtained during a neuropathological
 evaluation supported the presence of the anatomical de-
 fect” in J.J.’s brainstem. See Appellant Br. 42 n.8 (citing
 J.A. 115–17). But after both parties’ experts addressed
 that evidence, the Special Master found that, not only does
 the evidence of J.J.’s defective brainstem not support Dr.
 Miller’s theory, it actually cuts against the theory. That
 finding was based on the logical chain of evidence demon-
 strating that Dr. Miller’s theory is based on the premise
 that cytokines affect the medullary serotonin system by
 sending messages through functioning—i.e., non-defec-
 tive—receptors in the brain. See Special Master Decision,
 2019 WL 2462667, at *41. It was thus logical and reason-
 able for the Special Master to find that, because J.J.’s
 brainstem was defective, the medullary serotonin system
 would not be affected by the cytokines in the way that Dr.
 Miller proposed and that “[t]he ultimate cause of death is
 the cause of the increased CO2 that leads to the cessation
 of breathing and not the cytokines’ effect on the arousal
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 NUNEZ   v. HHS                                             7



 system.” See id.; see also id. at *40 (citing Dr. McCusker’s
 testimony in a prior case that “cytokines could not suppress
 the respiratory response in a brain with a defective 5-HT
 system because, by the nature of the defect, the system is
 incapable of responding to the cytokines”).
     During oral argument, Nunez’s counsel attempted to
 address the Special Master’s finding by arguing that be-
 cause J.J. had a defective brainstem, he “was not able to
 respond to the cytokines that were generated as a result of
 the immunizations.” Oral Arg. at 4:15. First and foremost,
 that characterization of the evidence appears to be attor-
 ney argument that is unsupported by Dr. Miller’s actual
 testimony. Even if it were supported by the evidence, how-
 ever, it demonstrates only that Nunez disagrees with the
 Special Master’s factual findings, not that those findings
 were arbitrary or capricious. Ultimately, the Special Mas-
 ter agreed with the Secretary’s expert that J.J.’s defective
 brainstem would not have allowed cytokines to affect the
 medullary serotonin system in the manner necessary to
 support Dr. Miller’s theory. Special Master Decision, 2019
 WL 2462667, at *41. We see no basis to abandon that find-
 ing in favor of Nunez’s alternative factual explanation. De-
 ciding between factual explanations was the job of the
 Special Master, and her findings were reasonable and sup-
 ported by the evidence.
     Moreover, whether or not J.J. had a defective brain-
 stem, the Special Master’s decision was also based on her
 separate finding that Dr. Miller had not presented suffi-
 cient evidence of a transport mechanism for cytokines to
 cross the blood-brain barrier into the brain. Special Master
 Decision, 2019 WL 2462667, at *41. For that finding, the
 Special Master weighed Dr. Miller’s general testimony on
 how cytokines can enter the brain against Dr. McCusker’s
 specific testimony concerning the localized cytokine re-
 sponse to vaccinations, the short half-life of cytokines, and
 the need for the cytokines to have an active transport sys-
 tem to enter the brain for a specific purpose. Id. The
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 8                                              NUNEZ   v. HHS



 Special Master’s finding in favor of the Secretary on this
 point was not arbitrary or capricious, and we thus have no
 basis to reweigh the evidence.
      We conclude by noting that we recognize the timing in
 this case of a child having died from SIDS within a day of
 receiving his vaccinations. We are sympathetic to the trag-
 edy of SIDS and to the policy goals of the compensation
 programs under the Vaccine Act. We are aware of the sig-
 nificant medical uncertainty surrounding SIDS, and we do
 not doubt that further research can be done to investigate
 whether there are possible relationships between vaccina-
 tions and SIDS. But these concerns are not within our pur-
 view as it pertains to our consideration of this case. Here,
 we are tasked only with reviewing the decisions of the
 Claims Court and the Special Master under the appropri-
 ate standard of review. We find that the Special Master’s
 factual findings were not arbitrary or capricious, and the
 decisions of both the Claims Court and the Special Master
 were in accordance with the law, specifically this court’s
 decision in Boatmon. And, finally, contrary to the dissent,
 it is not the law that, in the absence of evidence of causa-
 tion, the burden of proof is reversed. Therefore, we must
 affirm.
                        CONCLUSION
     We have considered Nunez’s remaining arguments but
 find them unpersuasive. Accordingly, we affirm the deci-
 sion of the Claims Court.
                        AFFIRMED
                           COSTS
     No costs.
Case: 20-1021    Document: 33     Page: 9   Filed: 08/28/2020




        NOTE: This disposition is nonprecedential.


   United States Court of Appeals
       for the Federal Circuit
                  ______________________

      JORDIA NUNEZ, JOHN DIAZ, AS LEGAL
     REPRESENTATIVES OF J.J.D., AN INFANT,
                  DECEASED,
              Petitioners-Appellants

                             v.

       SECRETARY OF HEALTH AND HUMAN
                   SERVICES,
               Respondent-Appellee
              ______________________

                        2020-1021
                  ______________________

     Appeal from the United States Court of Federal Claims
 in No. 1:14-vv-00863-LAS, Senior Judge Loren A. Smith.
                  ______________________
 NEWMAN, Circuit Judge, dissenting.
     Infant J.J.D., at his 4-month well-baby check-up, was
 inoculated with vaccines derived from pathogens of viral
 and bacterial diseases hepatitis B, rotavirus, diphtheria,
 tetanus, acellular pertussis, haemophilus, influenza type
 B, polio, and pneumococcal conjugate. J.J.D. came home,
 his lips turned blue, and he was declared dead the next
 morning. The Medical Examiner could not determine the
 “cause of death,” and therefore listed the cause as Sudden
 Infant Death Syndrome, or SIDS.
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 2                                               NUNEZ   v. HHS



     SIDS is not a “cause” of death; SIDS is an announce-
 ment that the cause is unknown. 1 Yet the court holds that
 because the physiologic/medical cause was not explained,
 it must be held that there was no causative relation to the
 immunizations—or anything else—that preceded J.J.D.’s
 death. That is not a reasonable presumption, and it con-
 travenes the text and purpose of the National Childhood
 Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34, as
 amended (“Vaccine Act”). From the court’s contrary ruling,
 I respectfully dissent.
                         DISCUSSION
      When death occurs within hours after a healthy baby
 is inoculated with powerful pathogens, it is at least reason-
 ably possible that the material injected into the baby, or
 the baby’s reaction to that material, contributed to the fatal
 event. The occurrence of unpredictable vaccine injury is
 what led to the need for the Vaccine Act, for some parents
 were withholding vaccinations out of concern about un-
 knowable, unpredictable vaccine injury. In addition, Con-
 gress “recognize[d] that because of many States’ standards
 of proof of liability, many vaccine-injured persons are pres-
 ently without legal remedy under current tort law.” H.R.
 Rep. No. 99-908, at 13 (1986), reprinted in 1986
 U.S.C.C.A.N. 6344, 6354.
     The mechanism of vaccine injury is not well under-
 stood, although scientific progress is being reported. Here,
 the experts for each side presented different theories, and
 agreed on nothing except that J.J.D. died after his



     1    The Department of Health and Human Services de-
 fines SIDS as “the sudden, unexplained death of an infant
 younger than 1 year of age that remains unexplained after
 a complete investigation.” NIH, Sudden Infant Death Syn-
 drome (SIDS), https://www.nichd.nih.gov/health/
 topics/sids.
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 NUNEZ   v. HHS                                               3



 vaccinations, and that this event was unforeseen and un-
 foreseeable. When an extreme event such as death follows
 the administration of powerful antigens, it is reasonably
 possible that there was a relation between these events.
 Such a possibility should affect the placement of the bur-
 den of proof in Vaccine Cases.
     “There are no hard-and-fast standards governing the
 allocation of the burden of proof in every situation. The
 issue, rather ‘is merely a question of policy and fairness
 based on experience in the different situations.’” Keyes v.
 School Dist. No. 1, 413 U.S. 189, 209 (1973) (quoting 9 J.
 Wigmore, Evidence § 2486, at 275 (3d ed. 1940)). Congress
 intended to establish a “compensation program under
 which awards can be made to vaccine-injured persons
 quickly, easily, and with certainty and generosity.” H.R.
 Rep. No. 99-908, at 3. Therefore, the burden should be on
 the opponent to show that there was not a causal relation-
 ship. Such placement conforms to the Vaccine Act:
     42 U.S.C. § 300aa-13(a)(1). Compensation shall be
     awarded under the Program to a petitioner if the
     special master or court finds on the record as a
     whole—
     (A) that the petitioner has demonstrated by a pre-
     ponderance of the evidence the matters required in
     the petition by section 300-aa11(c)(1) of this title,
     and
     (B) that there is not a preponderance of the evi-
     dence that the illness, disability, injury, condition,
     or death described in the petition is due to factors
     unrelated to the administration of the vaccine de-
     scribed in the petition.
                             ***
     § 300aa-13(a)(2)(A). For purposes of paragraph (1),
     the term “factors unrelated to the administration
     of the vaccine” . . . does not include any idiopathic,
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 4                                               NUNEZ   v. HHS



     unexplained, unknown, hypothetical, or undocu-
     mentable cause, factor, injury, illness, or condition.
 Thus the statute states that to negate entitlement to com-
 pensation, “unrelated factors” must be proved by a prepon-
 derance of the evidence; that is, the burden of proof is on
 the government. See Walther v. Sec’y of Health & Human
 Servs., 485 F.3d 1146, 1150 (Fed. Cir. 2007) (explaining
 that to negate compensation “[a] plain reading of the stat-
 utory text more naturally places the burden on the govern-
 ment to establish that there is an alternative cause by a
 preponderance of the evidence”).
     This court has recognized that it is incorrect to require
 “general acceptance in the scientific or medical communi-
 ties” of every vaccine injury, for such requirement, on the
 present state of scientific knowledge, “impermissibly raises
 a claimant’s burden under the Vaccine Act and hinders the
 system created by Congress, in which close calls regarding
 causation are resolved in favor of injured claimants.” An-
 dreu v. Sec’y of Health and Human Servs., 569 F.3d 1367,
 1378 (Fed. Cir. 2009).
     It is encouraging to read of scientific progress in under-
 standing vaccine behavior and response, for the hope is
 that eventually vulnerable infants (and others) can be
 identified in advance, and steps taken to avoid injury, as
 well as sudden infant death. However, until such re-
 sponses can be predicted in advance, whereby injury might
 be avoided, “to require identification and proof of specific
 biological mechanisms would be inconsistent with the pur-
 pose and nature of the vaccine compensation program.”
 Knudsen v. Sec’y of Health and Human Servs., 35 F.3d 543,
 549 (Fed. Cir. 1994).
     In Knudsen this court warned against requiring the
 special masters to diagnose how and why some vaccines
 cause some injury to some children. The court stated:
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 NUNEZ   v. HHS                                               5



     This research is for scientists, engineers, and doc-
     tors working in hospitals, laboratories, medical in-
     stitutes,    pharmaceutical        companies,      and
     government agencies. The special masters are not
     “diagnosing” vaccine-related injuries. The sole is-
     sues for the special master are, based on the record
     evidence as a whole and the totality of the case,
     whether it has been shown by a preponderance of
     the evidence that a vaccine caused the child’s in-
     jury or that the child’s injury is a table injury, and
     whether it has not been shown by a preponderance
     of the evidence that a factor unrelated to the vac-
     cine caused the child’s injury.
 Id. (citing 42 U.S.C. § 300aa-13(a)(1), (b)(1)).
      The panel majority states that “it is not the law that,
 in the absence of evidence of causation, the burden of proof
 is reversed.” Maj. Op. at *8. However, the burden of proof
 under the Vaccine Act is not consistently placed:
     The Vaccine Act currently requires petitioners to
     prove their cases by the “more likely than not” or
     “preponderance of the evidence” standard. There
     is substantial confusion and uncertainty in apply-
     ing this standard today. Several recent Federal
     Circuit decisions, emphasizing Congress’s compas-
     sionate intent in the statute, have held that “close
     calls regarding causation” should be resolved in fa-
     vor of petitioners, while other recent Federal Cir-
     cuit cases have emphasized that traditional tort
     causation standards should be strictly applied in
     off-Table cases. This has created an unpredictable
     and confusing situation. Congress should act to
     clarify the burden of proof requirement central to
     the resolution of off-Table cases.
 Peter H. Meyers, Fixing the Flaws in the Federal Vaccine
 Injury Compensation Program, 63 Admin. L. Rev. 785,
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 6                                              NUNEZ   v. HHS



 845–46 (2011) (citations omitted). Clarification of the
 placement of the burden of proof is warranted.
      At the hearing on J.J.D.’s claim, the government’s ex-
 pert stated that J.J.D. was found on autopsy to have a “de-
 fective brainstem” and thus was “vulnerable” to the
 “stressors” of vaccines. The Special Master held that this
 observation required denial of compensation, for no vac-
 cine-related cause of death was shown. But if there indeed
 was an unknown vulnerability whereby the immunizations
 were immediately and suddenly fatal, reasonable interpre-
 tation of the Vaccine Act would deem this to be grounds for
 grant of compensation, rather than denial of compensation,
 for “the purpose of the Vaccine Act’s preponderance stand-
 ard is to allow the finding of causation in a field bereft of
 complete and direct proof of how vaccines affect the human
 body.” Althen v. Sec’y of Health and Human Servs., 418
 F.3d 1274, 1280 (Fed. Cir. 2005). Placement of the burden
 of proof on the government conforms to this purpose.
     From the court’s contrary ruling, I respectfully dissent.
