           In the United States Court of Federal Claims
                                          No. 15-1016V
                               Filed Under Seal: February 12, 2020
                                   Reissued: February 27, 2020*
                                    NOT FOR PUBLICATION


 MARYELLEN KOTTENSTETTE and
 NICHOLAS KOTTENSTETTE as best
 friends of their daughter, C.K.,

                     Petitioners,                          Keywords: Vaccine Act;
                                                           Motion for Review; Off-table;
 v.                                                        Actual Causation; Legal
                                                           Standard
 SECRETARY OF HEALTH AND
 HUMAN SERVICES,

                    Respondent.


John F. McHugh, Law Office of John McHugh, New York, New York, for the petitioners.

Camille Michelle Collett, Torts Branch, Civil Division, U.S. Department of Justice, Washington,
D.C., for the respondent.

                          MEMORANDUM OPINION AND ORDER

HERTLING, Judge

       The Secretary of Health and Human Services (HHS) moves this court to review the
decision of a special master under the Vaccine Act, 42 U.S.C. § 300aa-11 et seq. See
Kottenstette v. Sec’y of HHS [hereinafter Decision], No. 15-1016V, 2017 WL 6601878 (Fed. Cl.
Spec. Mstr. Dec. 12, 2017). The special master found that a pertussis vaccine administered to
Maryellen and Nicholas Kottenstette’s then-four-month old daughter, C.K., substantially caused
C.K.’s developmental disabilities. The Court grants the Secretary’s motion, vacates the special
master’s decision, and remands the case for reconsideration under the correct legal standard in




      *
      Pursuant to Vaccine Rule 18(b), this opinion was initially filed on February 12, 2020, and
the parties were afforded 14 days after the filing of this opinion within which to notify the court
of any information that should be redacted from this decision for reasons of privilege or
confidentiality. The parties did not propose any redactions. Accordingly, this opinion is
reissued in its original form for posting on the Court’s website.
light of the Federal Circuit’s intervening decision in Boatmon v. Secretary of HHS, 941 F.3d
1351 (Fed. Cir. 2019).

I.       BACKGROUND

         A.     Facts Underlying the Petitioners’ Claim

        C.K. received the DTaP formulation of the pertussis vaccine, along with other vaccines,
at her four-month wellness visit in October 2012. That same day, and again four days later,
C.K.’s parents observed her moving her arms, legs, and shoulders in a manner that a treating
neurologist determined was consistent with infantile spasms, a seizure disorder. As of June
2017, C.K. had physical disabilities that “impact her functional mobility, postural stability, eye-
hand coordination, fine motor control, pre-writing skills, and self-care skills.” Decision at *3.
The special master found that the DTaP vaccine was a “substantial cause” of C.K.’s
developmental disabilities because the vaccine hastened the onset of the brain-damaging infantile
spasms that C.K. otherwise might only have experienced later in her development.

         B.     The Special Master’s Decision

      The special master found that C.K.’s vaccinations caused C.K.’s “afebrile infantile
spasms and a non-Table chronic encephalopathy” (brain damage).1 Decision at *1.

        The special master’s decision, first, summarized the facts of C.K.’s vaccination,
symptoms, and treatment along with the expert reports, medical literature, and testimony
submitted as evidence of causation. The decision then described the Vaccine Act’s preponderant
evidence standard and introduced the standard Althen “prongs” used to analyze actual causation
under that standard. See Moberly v. Sec’y of HHS, 592 F.3d 1315, 1321-22 (Fed. Cir. 2010)
(citing Althen v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005)). Then, without reference
to the specific Althen prongs, the special master articulated the following nine premises related to
proof of vaccine causation:

1.       Showing an absence of alternate causes or mere temporal association is insufficient to
         prove causation in fact. Decision at *12 (citing Grant v. Sec’y of Dept. of HHS, 956 F.2d
         1144, 1149 (Fed. Cir. 1992)).

2.       Petitioners must show that C.K.’s vaccinations were “substantial factors in causing,” not
         merely a but-for cause, of C.K.’s infantile spasms and “chronic neuropathy.” Decision at
         *12 (citing Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999)).

3.       “[R]equiring either epidemiologic studies . . . or general acceptance in the scientific or
         medical communities to establish a logical sequence of cause and effect” is contrary to
         the Federal Circuit’s Althen decision, which approved the use of circumstantial evidence


     1
     The special master also found that the petitioners had failed to prove a Table
encephalopathy. Decision at *1.

                                                  2
     to prove causation. Decision at *12 (citing Capizzano v. Sec’y of HHS, 440 F.3d 1317,
     1325 (Fed. Cir. 2006)).

4.   The Vaccine Act’s preponderant evidence standard does not require “objective
     confirmation” of causation. Decision at *12 (citing Althen, 418 F.3d at 1279).

5.   “‘[T]he purpose of the Vaccine Act’s preponderance standard is to allow the finding of
     causation in a field bereft of complete and direct proof of how vaccines affect the human
     body.’” Decision at *12 (quoting Althen, 418 F.3d at 1280).

6.    “[C]lose calls are to be resolved in favor of petitioners.” Decision at *12 (citing
     Capizzano, 1440 F.3d at 1327; Althen, 418 F.3d at 1280). As an example, the special
     master explained that the Althen decision found a causal link between a vaccine and two
     conditions that the Federal Circuit recognized was “‘a sequence hitherto unproven in
     medicine.’” Decision at *12 (quoting Althen, 418 F.3d at 1280).

7.   An explanation of causation must have “biologic credibility” rather than proof of an exact
     causal mechanism. Decision at *12. The special master explained that she looked for a
     “medical explanation of cause and effect and medical probability rather than certainty.”
     Decision at *12 (citations omitted) (emphasis added). The special master offered her
     definition of “medical probability” as “biologic credibility rather than specification of an
     exact biologic mechanism.” To support this conclusion, the special master quoted
     language from the Federal Circuit’s decision in Knudsen v. Secretary of the Department
     of HHS providing that a requirement to identify and prove “specific biological
     mechanisms would be inconsistent with the Vaccine Act’s purpose and nature” as an
     easier and more generous alternative to “full-blown tort litigation” and not a “‘vehicle for
     ascertaining precisely how and why DTP and other vaccines sometimes destroy the
     health and lives of certain children while safely immunizing most others.’” Decision at
     *12 (quoting Knudsen v. Sec’y of the Dep’t of HHS, 35 F.3d 543, 549 (Fed. Cir. 1994)
     (citing H. Rep. No. 99-908, at 3, reprinted in 1986 U.S.C.C.A.N. 6344, 6348)).

8.   “Bare statitistical” evidence is not probative of alternate causation. Decision at *13
     (citing Knudsen, 35 F.3d at 550).

9.   “[W]hen a vaccine fits within an epidemiological study, that alone is sufficient proof of
     vaccine causation[.]” Decision at *13. The special master quoted language from
     Knudsen to support this proposition:

            Causation in fact under the Vaccine Act is thus based on the
            circumstances of the particular case, having no hard and fast per se
            scientific or medical rules. The determination of causation in fact
            under the Vaccine Act involves ascertaining whether a sequence of
            cause and effect is “logical” and legally probable, not medically or
            scientifically certain. [citing cases] Thus, for example, causation can
            be found in vaccine cases based on epidemiological evidence and
            the clinical picture regarding the particular child without detailed
                                              3
               medical and scientific exposition on the biological mechanisms.
               [citing case].

       Decision at *13 (quoting Knudsen, 35 F.3d at 548-49) (alterations in original).

        Relying on Knudsen and another special master’s decision, the special master asserted
that “when a [vaccine recipient] would fit within an epidemiological study, that alone is
sufficient proof of vaccine causation.” Decision at *13, 14; see Knudsen, 35 F.3d at 548-49; H.J.
v. Sec’y of HHS, No. 11-301V, 2015 WL 6848357 (Fed. Cl. Spec. Mstr. Nov. 6, 2015). The
special master then concluded, “because CK would have qualified to have been in the Bellman
and Melchior studies, the undersigned finds that her four-month vaccinations triggered the onset
of her cryptogenic seizures.”

        The special master concluded her decision with a short paragraph titled “Althen Analysis”
that dedicated one sentence to each prong:

               Under Althen Prong One, the undersigned finds that DTaP vaccine
               can trigger the onset of infantile spasms. Under Althen Prong Two,
               the undersigned finds that there was a logical sequence of cause and
               effect in DTaP causing CK’s onset of infantile spasms. Under
               Althen Prong Three, the undersigned finds that an onset within hours
               of DTaP vaccination is consistent with the effect of the vaccine’s
               triggering an abrupt onset.

Decision at *15.

II.    STANDARD OF REVIEW

          Under the Vaccine Act, this Court reviews a special master’s decision only to determine
if it is “‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.’”
Althen, 418 F.3d at 1277 (quoting 42 U.S.C. § 300aa–12(e)(2)(B)). More specifically, the Court
considers a special master’s interpretation of statutes and other legal rules anew, without
deference to the special master. Hines on Behalf of Sevier v. Sec’y of Dep’t of HHS, 940 F.2d
1518, 1528 (Fed. Cir. 1991). The Court defers, however, to the special master’s factual findings
as long as the special master has (1) “considered the relevant evidence of record,” (2) “drawn
plausible inferences,” and (3) “articulated a rational basis for the decision.” Id.

        Under the arbitrary and capricious standard, the Court does not “reweigh” or re-evaluate
the evidence. Porter v. Sec’y of HHS, 663 F.3d 1242, 1249 (Fed. Cir. 2011). The Court does not
re-examine the probative value of the evidence or a witness’s credibility. Id.

III.   ANALYSIS

        The “biologic credibility” standard the special master applied to proof of the petitioners’
causal theory under Althen’s first prong is not sufficiently distinguishable from the “plausible” or
“reasonable” standard that the Federal Circuit rejected in Boatmon. Without reweighing
particular evidence, the Court finds apparent from the special master’s description of the
                                                  4
evidence that the petitioners’ causal theory was only plausibly linked to the DTaP vaccine at
issue, and only plausibly linked to the developmental injury C.K. suffered. This approach, along
with the special master’s alternative approach to proof of causation that fit the petitioners’ case
into an existing study—the study itself only plausibly applicable to the vaccine at issue—
indicates that the wrong standard for proof of causation, clarified by the Federal Circuit after the
special master’s decision under review, was applied in this case.

       The Vaccine Act requires preponderant evidence of causation. 42 U.S.C. § 300aa-
13(a)(1)(A). A petitioner must show the harm was more likely than not caused by the vaccine.
Althen’s three prongs, together, enumerate the facts that are relevant and essential to prove
causation in cases such as this one, in which the possibility of injury is not already recognized in
the Vaccine Table. Althen requires “(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.” 418 F.3d at 1278.

        The first Althen prong steps back from the question of whether the vaccine caused a
petitioner’s injury in the particular case and requires a causal theory that explains how the kind
of vaccine the petitioner received could cause the same kind of injury the petitioner alleged.
After proving the first Althen prong, a petitioner must still prove a logical sequence of events
(the second prong) and a degree of temporal proximity between vaccination and injury (the third
prong) that fit the first prong’s causal theory. The first-prong causal theory, then, influences
which facts are relevant in proving the second and third prongs. Without a general first-prong
causal theory to show the fact-finder what vaccine causation is most likely to look like, the fact-
finder has no criteria to measure the specific facts of a petitioner’s case.

        Language in earlier decisions suggested that Althen’s first prong could be satisfied by
showing it was “reasonable” or “plausible” that a vaccine can cause the same kind of injury a
petitioner alleged. The Federal Circuit has now explicitly rejected that proposition in Boatmon.
941 F.3d at 1359-60. More specifically, the first prong’s medical or scientific causal theory must
be “‘reputable.’” Id. at 1359 (quoting Moberly, 592 F.3d at 1322). “While it does not require
medical or scientific certainty, it must still be ‘sound and reliable.’” Id. (quoting Knudsen, 35
F.3d at 548).

       The standard of proof required for a first-prong causal theory is the fulcrum of Althen’s
usefulness. If a petitioner could satisfy Althen’s first prong with any causal theory that is merely
plausible—understood here to mean “reasonably possible”—proving the second and third Althen
prongs would only show that the petitioner’s injury was plausibly caused by receipt of the
vaccine. Evidence that the petitioner’s facts under prongs two and three are consistent with a
general causal theory does not make the general causal theory itself more likely to be true.

       The special master’s explicit discussion of Althen’s first prong spanned only one
sentence. Decision at *15. This sentence and other relevant parts of the special master’s
discussion, taken together, reveal that the special master adopted the causal theory that
unexplained infantile spasms are not caused by vaccines, but that the DTaP vaccine “can trigger
the onset of infantile spasms,” id., and this earlier onset of the seizure disorder causes more
                                                 5
severe damage to the brain’s psychomotor development than the seizures would have caused at
their natural, later time of onset. Decision at *14. The special master cited the conclusions of
the Bellman and Melchior studies and the opinion of the petitioners’ expert, Dr. Marcel
Kinsbourne, as support for this theory.2

        The special master’s stated reasons for adopting critical elements of the petitioners’
causal theory could only have been sufficient under a lower legal standard than the “reputable,
sound and reliable” standard required by Boatmon. First, the special master relied on an expert’s
unsupported assertion that studies of infantile spasms caused by another vaccine applied to the
vaccine at issue in this case. Second, the special master relied on an expert’s opinion that the
overall causal theory, including the ultimate link to developmental disabilities, was—in the
special master’s own words—“plausible.” The special master’s reliance on the fit between the
facts of C.K.’s case and the cited epidemiological studies, however, is not an adequate substitute
for the analysis required under Althen’s three prongs.

       A.      Causal Link to the DTaP Vaccine

        The special master relied on two studies as evidence connecting the pertussis vaccine
with infantile spasms. The Bellman and Melchior studies analyzed infants’ reactions to the DTP
formulation of the pertussis vaccine. The study suggested that DTP could trigger, but not cause,
unexplained infantile spasms in infants who were predisposed to have them. Decision at *13, 14.

        The special master, however, offered no basis for connecting the DPT formulation of the
pertussis vaccine tested in the cited studies to the DTaP formulation of the pertussis vaccine at
issue in this case. The special master asked Dr. Kinsbourne “if he agreed that the results of the
Bellman . . . study . . . [were] applicable to children who receive [DTaP], just at a lower
incidence.” Decision at *9. The special master reported that Dr. Kinsbourne “absolutely
agreed.” Id.

        The special master did not explain the basis of Dr. Kinsbourne’s opinion and did not offer
an independent basis for applying the DPT-study findings to the DTaP vaccine. Without any
explanation for the special master’s acceptance of this conclusion, the Court finds the special
master’s inference that the DPT study applies to the DTaP formulation at lower rates to be
arbitrary and capricious. See Boatmon, 941 F.3d 1360-61 (“Here there is nothing more than the
assertion of [the expert witness].”).

       B.      Causal Link to Developmental Injuries

      The special master summarized Dr. Kinsbourne’s testimony on the connection between
the DTaP vaccine and developmental injuries. This summary implicitly addressed all three

2
  See M.H. Bellman et al., Infantile Spasms and Pertussis Immunisation, 321 Lancet 1031-34
(1983); J.C. Melchior, Infantile Spasms and Early Immunization Against Whooping Cough:
Danish Survey from 1970 to 1975, 52 Archives of Disease in Childhood 134-37 (1977).


                                                6
Althen prongs, describing a causal link between C.K.’s disabilities and the infantile spasms,
discussing the temporal proximity, and explicitly finding the causal link “plausible”:

                . . . CK has severe and mainly refractory seizures that degraded her
                mental development so that she is now profoundly mentally
                retarded.
                        Dr. Kinsbourne concludes that, but for her vaccinations,
                CK’s cryptogenic infantile spasms would not have led to such a
                devastating result. He also writes that the one-day interval between
                vaccinations and first infantile spasms is medically reasonable since
                her innate immune system rapidly responded to the vaccinations.
                He also states that it is plausible that routine vaccinations can trigger
                infantile spasms in a susceptible child, resulting in severe
                psychomotor regression.

Decision at *5-6 (citations omitted) (emphasis added).

       The special master’s characterization of Dr. Kinsbourne’s conclusion is indistinguishable
from the reasoning rejected as contrary to law in Boatmon. See Boatmon, 941 F.3d at 1359-60.

        C.      Proof by Epidemiological Evidence

        In general, the special master’s nine premises, including the premise that articulation of
an exact biological mechanism is not necessary to prove vaccine causation, are well-taken. The
special master’s articulation of these premises, however, suggests they were offered as
alternative support for the petitioners’ causal theory, which, as discussed above, was plausible or
reasonable, but insufficient to satisfy Althen’s first prong. The special master appears to have
relied on these nine premises to put a thumb on the scale, without explicitly analyzing under
Althen’s first prong the applicability of the petitioners’ causal theory to the vaccine and the kind
of injury at issue.

        Specifically, the special master noted that the close match between the immediate onset
of C.K.’s infantile spasms and the similarly immediate onset of infantile spasms among subjects
in the Bellman study were dispositive as to the issue of causation in this case. The special master
interpreted the Federal Circuit’s opinion in Knudsen to signify that causation could be found
“based on epidemiological evidence and the clinical picture regarding the particular child
without detailed medical and scientific exposition on the biological mechanisms.” Decision at
*14. The special master provided that this principle “governs the outcome of this decision.” Id.
As support, the special master cited similar reasoning in H.J. v. Sec’y of HHS, No. 11-301V,
2015 WL 6848357, at *9 (Fed. Cl. Nov. 6, 2015).

        Knudsen held that the government may defeat a petitioner’s claim of vaccine causation
with a theory of viral infection even if the virus is not identified “in the particular case” by a
specific type or name. Knudsen, 35 F.3d at 549. The government still must prove, however,
“that there was in fact a viral infection, and that the viral infection ‘in the particular case [was]

                                                   7
. . . principally responsible for causing the petitioner’s illness, disability, injury, condition, or
death.’” Id. (quoting 42 U.S.C. § 300aa–13(a)(2) (emphasis in original)).

        Open-ended statements in Knudsen’s reasoning rejecting the need for “scientific
certainty” or “specific biological mechanisms” in proof of vaccine causation should not be
applied beyond that case’s narrow holding and should not be taken to loosen the requirements of
Althen, which was decided almost 11 years later. Althen cites the relevant part of Knudsen as
indirect support (“see”) for Althen’s conclusion that requiring that literature objectively confirm
the medical plausibility of a petitioner’s claim would be inconsistent with the Vaccine Act’s
legislative purpose. Althen, 418 F.3d at 1279 (citing Knudsen, 35 F.3d at 549).

        As an example of causation based on fitting the petitioner’s case to an epidemiological
study, Knudsen cites Jay v. Secretary of the Department of HHS. 998 F.2d 979, 984 (Fed. Cir.
1993). In Jay, however, the Federal Circuit found a table injury, and then it found that the
vaccine caused death as a sequela of the table injury. Id. For table injuries, the mechanism may
not be known or the theory may be more uncertain, but their formal recognition by rulemaking
places them outside of the Vaccine Act’s standard of proof for actual causation for non-table
injuries. See Moberly, 592 F.3d at 1322.

       In summary, the court finds no support in Federal Circuit or this Court’s case law for
proving actual causation by fitting a petitioner’s case into an epidemiological study without also
providing a “reputable,” “sound and reliable” causal theory to satisfy Althen’s first prong.

IV.     CONCLUSION

         The special master erred by applying the wrong legal standard to the petitioners’ causal
theory. The respondent’s motion for review is GRANTED, the special master’s decision is
VACATED, and the case is REMANDED so that the special master may consider the
petitioners’ theory and evidence under the correct legal standard.

        It is so ORDERED.


                                                                         s/ Richard A. Hertling
                                                                         Richard A. Hertling
                                                                         Judge




                                                    8
