        In the United States Court of Federal Claims
                                          No. 14-699V

                                  (E-Filed: January 24, 2020)1

                                                      )
    JAMILEH BERENJI and BAHMAN                        )
    YOUSEFI, on behalf of S.Y.,                       )       Vaccinations (Influeza,
                                                      )       Measles-Mumps-Rubella
                        Petitioners,                  )       (MMR), Varicella,
                v.                                    )       Pneumococcal Conjugate
                                                      )       (Prevnar)); National Childhood
    SECRETARY OF HEALTH                               )       Vaccine Injury Act of 1986, 42
    AND HUMAN SERVICES,                               )       U.S.C. §§ 300aa-1 to -34
                                                      )       (2012); Deferential Review of
                        Respondent.                   )       Special Master’s Fact Finding
                                                      )       and Weighing of Evidence.

Mark T. Sadaka, Englewood, NJ, for petitioner.

Kyle E. Pozza, Trial Attorney, with whom were Joseph H. Hunt, Assistant Attorney
General, C. Salvatore D’Alessio, Acting Director, Catharine E. Reeves, Deputy Director,
Torts Branch, Civil Division, United States Department of Justice, Washington, DC, for
respondent.

                                            OPINION

CAMPBELL-SMITH, Judge.

       On August 30, 2019, the special master denied compensation to petitioners under
the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2012)
(the Vaccine Act). See ECF No. 111. 2 On September 27, 2019, petitioners filed a

1
         Pursuant to Rule 18(b) of the Vaccine Rules of the United States Court of Federal Claims
(Appendix B to the Rules of the United States Court of Federal Claims), this opinion was
initially filed under seal on January 6, 2020. Pursuant to ¶ 4 of the ordering language, the parties
were to propose redactions of the information contained therein on or before January 21, 2020.
No proposed redactions were submitted to the court.
2
       The court notes that proceedings before the special master in this case were unusually
complex. For clarity, the court emphasizes that its review in this opinion is limited to the special
master’s August 30, 2019 decision denying compensation to petitioners, ECF No. 111.
motion for review of the special master’s August 30, 2019 decision and a memorandum
in support of their motion for review. 3 See ECF No. 114, ECF No. 115. Respondent
filed its response brief on October 23, 2019. See ECF No. 119. Petitioners’ motion is
fully briefed and ripe for decision. As explained below, the special master’s entitlement
decision survives this court’s review. Accordingly, the court must DENY petitioners’
motion for review.

I.     Background

        On August 4, 2014, petitioners filed this case seeking compensation for an injury
allegedly suffered by their minor child as the result of receiving influenza (flu), measles-
mumps-rubella (MMR), varicella, and pneumococcal conjugate (Prevnar) vaccinations,
on October 17, 2011. See ECF No. 1. In reaching his decision, the special master
reviewed the child’s medical history in great detail, including the following facts relevant
to the court’s analysis of petitioners’ motion for review. 4

       Petitioners’ son was born in October 2010. See ECF No. 111 at 6. He developed
normally and was generally healthy prior to his well-child examination on October 17,
2011. See id. at 7. At that appointment, the child received “his first MMR vaccination
and first influenza vaccination . . . as well as his first varicella vaccination and his fourth
pneumococcal vaccination.” Id. The child’s mother reported to the pediatrician that she
had a history of anemia. Accordingly, the doctor recommended that the child undergo a
hemogram (complete blood count). See id. The child’s blood was drawn the same
afternoon, and results showed that his platelet count was “significantly low,” his
hemoglobin count and hematocrit levels were “low,” and that his white blood cell count
was “normal.” Id. Repeated testing showed a decrease in all levels, most dramatically in
the platelet count. See id.

       In light of these test results, the pediatrician referred the child to a specialist at the
Lucile Packard Children’s Hospital at Stanford University. See id. at 7-8. Following
additional testing, on October 19, 2011, the specialist diagnosed the child with Evans
syndrome, “‘an autoimmune process that results in hemolytic anemia and

3
       Although petitioners’ memorandum is properly titled on the document, petitioners’
counsel selected the motion event when filing petitioners’ memorandum in the court’s case
management/electronic case filing (CM/ECF) system. For proper case management purposes
and docket clarity, the court must rule separately on petitioners’ memorandum and motion for
review in the final ordering language of this opinion.
4
        For clarity of the narrative, the court cites to the special master’s decision and omits
direct citations to the record therein. The court also notes that the special master’s decision
includes a more detailed description of the child’s medical history than is necessary for the
analysis in this opinion.


                                                  2
thrombocytopenia.’” Id. at 8. On October 23, 2011, the child was “presented for
emergency attention following a one-day history of vomiting and diarrhea, as well as a
fever which had risen to approximately 104 degrees Fahrenheit.” Id. The child received
antibiotics, but two days later, he still had a fever of 102 degrees Fahrenheit. See id. On
October 25, 2011, the child’s pediatrician administered a second dose of antibiotics, and
discussed the cause of the child’s condition with petitioners. The doctor noted:

       “Parents understandably very devastated by his recent diagnosis and mom
       still very concerned that his recent 12-month vaccines, most notably, the
       MMR, was the etiology of his current condition. Discussed that while the
       stress of the vaccines may have triggered the disease to surface, it certainly
       was not the cause of his Evan[s] syndrome.”

Id. (special master’s decision quoting doctor’s note).

       On October 28, 2011, the child’s hematologist-oncologist noted that his fever had
resolved, but also recorded that the child had developed a rash. See id. at 9. The doctor
believed the rash was “‘probably post-viral,’” and advised the child’s mother that if the
child had developed measles after receiving the MMR vaccination “‘this rare occurrence,
concurrent with an apparently autoimmune pancytopenia, may raise a question of
previously undiagnosed immune deficiency.’” Id. Following additional testing, the
doctor recommended that the child be admitted to the hospital for observation. See id. On
his way to the hospital, the child experienced a seizure. See id. While at the hospital, the
child underwent still more testing which showed further decreases in his platelets,
hemoglobin, and hematocrit levels, but a slight increase in his white blood cell count,
though it remained lower than normal. See id. On October 29, 2011, the child received
additional antibiotics and intravenous immunoglobulin (IVIg). See id.

        The child’s pediatric infectious disease specialist recorded, on October 29, 2011,
that the child’s “‘vaccinations could not have caused his anemia and thrombocytopenia,
which were documented less than one hour afterwards.’” Id. She also noted that “‘it is
possible that [the child’s] fever and rash (and less likely, afebrile seizure) were caused by
MMR, and that these are unrelated to the cause of his underlying bone marrow
suppression/autoimmune hemolytic anemia.’” Id.

         On October 31, 2011, the child was evaluated by an immunologist who noted that
“‘[i]t is possible that he had two distinct processes happening simultaneously.’ First,
Evans syndrome probably represented a ‘true autoimmune process.’ Second, the MMRV
vaccine may have caused a self-limited febrile seizure episode.” Id. (citations omitted).
The child was discharged from the hospital, with a steroid prescription, on November 2,
2011. See id.




                                              3
       On November 4, 2011, the child was seen by a pediatrician as a follow-up to his
hospitalization. She found that the child was “doing well without further rash, fever, or
seizure activity.” Id. at 10. She further noted:

       “[A]fter extensive workup by Infectious Disease and Immunology, the
       general thought is that [the child] developed some rare but known
       complication from his measles, mumps, and rubella vaccine which included
       fever, a rash and seizure . . . . It is therefore likely that [the child] had two
       different processes that occurred at the same time. We also believe that [the
       child’s] Evans syndrome did not stem from this measles, mumps, and rubella,
       as his thrombocytopenia was noted just one hour after his vaccine.”

Id. (special master’s decision quoting doctor’s note). And on November 10, 2011, the
hematologist-oncologist noted that the child’s “‘apparent vaccine-related illness has since
resolved.’” Id.

       In December 2011, the child’s doctors “tried to taper him off steroids,” but he was
admitted to the hospital again on December 27, 2011, after tests showed low hemoglobin
and platelets. See id. “On December 31, 2011 [the child] started a five-day course of
IVIg which was associated with improved blood counts,” and “[h]e was discharged with
steroids on January 5, 2012.” Id.

       “Due to continued thrombocytopenia on oral steroids, [the child] received four
infusions of Rituximab (an immunosuppressant) between February 13 and March 15,
2012. However, due to a lack of sustained response, on April 17, 2012, he was started on
cyclosporine (another immunosuppressant).” Id. In what doctors concluded was likely
an adverse reaction to the cyclosporine, the child experienced “an episode of non-
responsiveness and shaking lasting approximately 15 minutes,” on June 1, 2012. The
child experienced another seizure later the same month, and “[c]yclosporine was
discontinued and he was started on Keppra (an anti-seizure medication).” Id.

       On July 17, 2012, the child “was started on CellCept (another
immunosuppressant).” Id. He was admitted to the hospital again from September 8-11,
2012, due to rectal bleeding. See id. While hospitalized “he received a platelet
transfusion and IVIg.” Id.

      Test results on February 12, 2013, indicated that his “T and B cell subsets . . . were
normal,” meaning that “he had recovered from the Rituximab therapy in February-March
2012.” Id. at 11. Also on February 12, 2013, CellCept was discontinued. Id.
“Afterwards, [the child] was increasingly fatigued and less interested in playing and
ambulating. A non-productive cough present since November 2012 seemed to worsen in
frequency and productivity.” Id.



                                              4
       On February 22, 2013, the child underwent a bone marrow biopsy, and was
admitted to the hospital and began using supplemental oxygen due to his difficulty
breathing. See id. Because the results of the initial biopsy were “suspicious for
malignancy,” a repeat biopsy was performed on March 1, 2013, and showed:

       While platelets are markedly decreased with circulating giant forms, the bone
       marrow aspirates and biopsy sections show an abundant megakaryocytic
       hyperplasia, including small immature forms. The finding of hyperplastic
       megakaryocytes suggests the etiology of the thrombocytopenia is not poor
       platelet production, but rather peripheral destruction and/or sequestration.
       Both red cell and megakaryocyte/platelet findings are consistent with
       immune-mediated destruction of red cells and platelets and have been
       described in Evans syndrome.

Id.

       The child was transferred to pediatric intensive care on March 7, 2013, “after he
developed seizure-like activities with tonic-clonic movements and ineffective breathing.
He was stabilized with non-invasive respiratory support.” Id. After experiencing another
seizure on March 9, 2013, he was started on Keppra, and the seizure activity subsided for
the remainder of his hospitalization. On March 28, 2013, a lung biopsy confirmed that
the child had pulmonary veno-occlusive disease (PVOD) “which related back to and
explained the respiratory problems which had begun in mid-February 2013.” Id. He was
“discharged with supplemental oxygen on April 8, 2013.” Id.

       In August 2013, the child was admitted to the hospital “due to a pulmonary
infection that exacerbated his PVOD.” Id. The child was hospitalized again on
September 26, 2013, “for worsening jaundice, difficulty breathing, and high levels of
bilirubin and transaminases (liver enzymes).” Id. at 12. The child tested positive for
rhinovirus and parainfluenza, and a “liver cell biopsy showed syncytial giant cell
hepatitis, suggestive of autoimmune hepatitis.” Id. He was discharged on December 26,
2013. See id. 5

       On August 4, 2014, petitioners filed their claim alleging that their son suffered
injuries as a result of receiving the flu, MMR, varicella, and Prevnar vaccinations. See
ECF No. 1. The special master agreed with the parties from the outset that “expert
reports would be necessary to understand the complex issues concerning [the child’s]
medical condition and the timing in this case.” ECF No. 111 at 2. Petitioners filed three
reports from Dr. M. Eric Gershwin, M.D., in support of vaccine causation. See id. at 2-3.

5
        After the child was diagnosed with hepatitis, he continued to struggle with
hospitalizations and serious medical complications. No further recitation of the child’s condition
is necessary for purposes of this court’s analysis, however, because petitioners’ motion for
review addresses a narrow aspect of the special master’s decision.

                                                5
Respondent filed two reports from Dr. Mehrdad Matloubian, M.D., and one report from
Dr. Joan Cox Gill, M.D., in which they disagreed with Dr. Gershwin on the causation
issue. See id. The special master held an entitlement hearing on August 14, 2017, at
which he heard testimony from petitioner Jamileh Berenji, Dr. Gershwin, Dr. Matloubian,
and Dr. Gill. See id. at 3.

      After a lengthy consideration of the facts and argument, the special master’s
August 30, 2019 decision concluded as follows:

       [T]here can be little question that [the child’s] condition became markedly
       worse after receiving the vaccines on October 17, 2011. His treating doctors
       generally thought that the process including fever, seizure and full body rash
       were likely attributable to the vaccine. However, that short-term injury, if
       attributed to the vaccines, did not last for more than six months. It is
       significantly more difficult to find a logical and temporal association
       between [the child’s] vaccinations and his long-term course which is at least
       somewhat similar to other patients with Evans syndrome. The available
       literature on this very rare disease suggests that Evans syndrome is chronic
       and refractory to treatment. [The child’s] development of anitnuclear
       antibodies, antiphospholipid antibodies, hepatitis, and PVOD seems
       particularly rare. However, those conditions are unlikely to be caused by B
       cells stimulated by the vaccines, which were eliminated and replaced in the
       intervening time period. Thus, there is not a logical sequence of cause and
       effect or an acceptable temporal association between the vaccinations and
       [the child’s] long-term course.

Id. at 24-25 (footnote omitted). For these reasons, the special master ruled to dismiss
petitioners’ complaint. Id. On September 27, 2019, petitioners filed their motion for
review.

II.    Legal Standards

       This court has jurisdiction to review the decision of a special master in a Vaccine
Act case. 42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court of Federal
Claims reviews the decision of the special master to determine if it is ‘arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law[.]’” de Bazan
v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1350 (Fed. Cir. 2008) (quoting 42
U.S.C. § 300aa-12(e)(2)(B) and citing Althen v. Sec’y Health & Human Servs., 418 F.3d
1274, 1277 (Fed. Cir. 2005)) (alteration in original).

      This court uses three distinct standards of review in Vaccine Act cases, depending
upon which aspect of a special master’s judgment is under scrutiny.



                                             6
       These standards vary in application as well as degree of deference. Each
       standard applies to a different aspect of the judgment. 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 & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir.
1992).

        The third standard of review, abuse of discretion, is applicable when the special
master excludes evidence or otherwise limits the record upon which he or she relies. See
id. at 870. As this court has stated, the third standard applies to the special master’s
evidentiary rulings. Stillwell v. Sec’y of Health & Human Servs., 118 Fed. Cl. 47, 55
(2014) (citation omitted), aff’d, 607 F. App’x 997 (Fed. Cir. 2015). Determinations
subject to review for abuse of discretion must be sustained unless “manifestly erroneous.”
Piscopo v. Sec’y of Health & Human Servs., 66 Fed. Cl. 49, 53 (2005) (citations
omitted); see also Milmark Servs., Inc. v. United States, 731 F.2d 855, 860 (Fed. Cir.
1984) (holding that decisions within the trial court’s discretion are to be sustained unless
“manifestly erroneous”) (citation omitted).

       A petitioner may obtain compensation if he or she “sustained, or had significantly
aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury
Table but which was caused by” certain vaccines, including the HPV vaccine. 42 U.S.C.
§ 300aa-11(c)(1)(C)(ii). A case for significant aggravation of an off-Table claim requires
proof, by a preponderance of the evidence, of:

       (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), (3) whether the person’s current condition constitutes a
       “significant aggravation” of the person’s condition prior to vaccination, (4)
       a medical theory causally connecting such a significantly worsened condition
       to the vaccination, (5) a logical sequence of cause and effect showing that
       the vaccination was the reason for the significant aggravation, and (6) a
       showing of a proximate temporal relationship between the vaccination and
       the significant aggravation.

Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144 (2009); see also W.C. v.
Sec’y of Health & Human Servs., 704 F.3d 1352, 1360 (Fed. Cir. 2013) (referring to the
Loving test as “the correct law”).




                                              7
III.   Analysis

        In their motion for review, petitioners challenge a narrow aspect of the special
master’s decision. Petitioners argue that the special master improperly “stops short of
finding that lung (veno-occlusive disease) and liver (autoimmune hepatitis) injuries that
[the child] suffered could have been caused by the vaccines largely based on one
undisclosed unsupported opinion made by respondent’s expert Dr. Matloubian on the
activity of [the] medication Rituximab in this specific case.” ECF No. 114 at 5.
Petitioners divide this objection into two parts. First, they claim that “[r]eliance on an
undisclosed net opinion impermissibly heightened petitioner’s burden in proving
causation.” 6 Id. at 6. And second, petitioners contend that “[a]ccepting unsupported
testimony at [the] hearing on key scientific issues was arbitrary, capricious, and an abuse
of the Special Master’s discretion.” Id. at 7. The court will address each argument in
turn.

       A.      The Special Master Applied the Correct Standard in Evaluating Petitioner’s
               Causation Evidence

        Petitioners argue that their “burden in prov[ing] causation was impermissibly
heightened by requiring a higher scientific standard beyond what is required under Althen
and its progeny.” Id. at 6. Specifically, they claim that “[p]etitioner’s burden was
heightened by crediting Dr. Matloubian’s net opinion that 99% of [the child’s] B cells
were destroyed by treatment with Rituximab.” Id. at 6-7 (citing ECF No. 111 at 24).
Petitioners’ argument on this point consists of the following:

       First, Dr. Matloubian’s opinion regarding Rituximab was never disclosed and
       should be stricken from the record. Second, he provided zero supporting
       evidence for his testimony about the action of Rituximab in this specific case
       making his opinion a net opinion and unreliable. . . . Not only does Dr.
       Matloubian fail to provide any support generally about the activity of
       Rituximab on B cells in a pediatric patient, he also fails to point to any
       support for his opinion in the medical record again making it an inadmissible
       net opinion. In fact, the current FDA approved prescription drug label for
       Rituximab provides the following:

       8.4 Pediatric Use



6
        Petitioners repeatedly use the term “net opinion” to refer to Dr. Matloubian’s opinion at
issue, but they fail to define it. See, e.g., ECF No. 114 at 6-7. To the court’s knowledge, “net
opinion” is not a term of art, nor is it a term in common usage such that familiarity with the term
may be presumed. For this reason, the court does not include any specific discussion of what
petitioners mean to argue on this point.

                                                 8
       The safety and effectiveness of RITUXAN in pediatric patients have not been
       established.

       Source: https://www.gene.com/download/pdf/rituxan_prescribing.pdf

       Given the fact that it was not clear how instrumental Dr. Matloubian’s
       undisclosed opinion was to the Special Master’s decision in this case until he
       issued his decision, petitioner should be given the opportunity to address the
       undisclosed opinion.

Id. at 7 (citations and footnotes omitted).

        This argument does not articulate how the special master’s treatment of Dr.
Matloubian’s opinion affected petitioner’s burden of proof. It does suggest, however,
that: (1) respondent failed to meet a disclosure obligation; (2) the special master
improperly failed to require documentation in support of Dr. Matloubian’s oral
testimony; and (3) that the special master was required to notify the parties of the
evidence he found persuasive prior to issuing his decision. None of these requirements
are reflected in the rules or practices of the vaccine program.

        The special master repeatedly affirmed the correct burden of proof, stating that
petitioners were required to prove their case by a preponderance of the evidence. See,
e.g., ECF No. 111 at 4, 15, 18 (citing Loving, 86 Fed. Cl. at 144). Indeed, the special
master was expressly cognizant of avoiding the very issue nominally raised by
petitioners. He wrote that “special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury.” Id. at 15
(citing Contreras v. Sec’y of Health & Human Servs., 121 Fed. Cl. 230, 245 (2015),
vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017)). He also noted, however, that
“this does not negate or reduce a petitioner’s ultimate burden to establish his overall
entitlement to damages by preponderant evidence.” Id. (citing W.C., 704 F.3d at 1356).

        In addition, the special master diligently reviewed the evidence and arguments
presented by the parties, and emphasized that he had considered the entire record in
reaching his ultimate decision. See ECF No. 111 at 15-24 (discussing the various expert
theories at length); id. at 2 n.3 (“Pursuant to Section 13(a)(1), in order to reach my
decision, I have considered the entire record, including all of the medical records, expert
testimony, and literature submitted by the parties.”). And in reaching that decision, the
special master was “entitled—indeed, expected—to make determinations as to the
reliability of the evidence presented to [him] and . . . as to the credibility of the persons
presenting that evidence,” including experts. Moberly v. Sec’y of Health & Human
Servs., 592 F.3d 1315, 1326 (Fed. Cir. 2010)). As the special master stated, “[w]here
both sides offer expert testimony, a special master’s decision may be ‘based on the
credibility of the experts and the relative persuasiveness of their competing theories.’”


                                              9
See ECF No. 111 at 6 (quoting Broekelschen v. Sec’y of Health & Human Servs., 618
F.3d 1339, 1347 (Fed. Cir. 2010)). See also Vaccine Rule 8(b)(1), Rules of the United
States Court of Federal Claims, Appendix B (“ In receiving evidence, the special master
will not be bound by common law or statutory rules of evidence but must consider all
relevant and reliable evidence governed by principles of fundamental fairness to both
parties.”).

       The court concludes that the special master’s consideration of Dr. Matloubian’s
testimony was not only proper, but because he found the testimony relevant and reliable,
such consideration was required.

       B.     The Special Master’s Consideration of Dr. Matloubian’s Testimony Was
              Not Arbitrary, Capricious, or an Abuse of Discretion

       Petitioner’s second argument is one sentence long: “As articulated above, the
Special Master’s decision to rely on Dr. Matloubian’s undisclosed unsupported decision
on the issue of logical sequence of cause and effect was arbitrary and capricious.” ECF
No. 114 at 8. The court disagrees. For the reasons explained above, the special master’s
decision was well-founded and appropriately rendered.

IV.    Conclusion

       In the conclusion of his decision, the special master stated: “I wish to extend my
sympathy to [the child] and his family in the light of the enormous suffering they have
experienced in association with his Evans syndrome.” ECF No. 111 at 25. The court
likewise acknowledges the child’s and the family’s suffering and echoes the special
master’s sympathy. For the above-stated reasons, however, the court sustains the
entitlement decision of the special master.

       Accordingly, it is hereby ORDERED that:

       (1)    Petitioners’ motion for review, filed as ECF No. 114 (memorandum) and
              ECF No. 115 (motion), is DENIED;

       (2)    The August 30, 2019 decision of the special master, ECF No. 111, is
              SUSTAINED;

       (3)    The clerk’s office is directed to ENTER final judgment in accordance
              with the special master’s August 30, 2019 decision, ECF No. 111; and




                                            10
(4)   The parties shall separately FILE any proposed redactions to this opinion,
      with the text to be redacted clearly blacked out, on or before January 21,
      2020.

IT IS SO ORDERED.

                                     s/Patricia E. Campbell-Smith
                                     PATRICIA E. CAMPBELL-SMITH
                                     Judge




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