Court Opinion

ID: 2819300
Source: CourtListenerOpinion
Date Created: 2015-07-22 20:03:39.363497+00
Date Added: 2024-06-11T12:11:36.587718
License: Public Domain

In the United States Court of Federal Claims
                             OFFICE OF SPECIAL MASTERS
                                           No. 13-960V
                                       Filed: June 30, 2015

* * * * * * * * * * * * * * * *                      UNPUBLISHED
ERIC WATERMAN and TAREE                 *
WATERMAN, as parents and natural        *            Special Master Hamilton-Fieldman
Guardians of A.T.W., a minor, deceased, *
                                        *
              Petitioners,              *            Ruling on the Record; Decision Denying
                                        *            Entitlement; Polio Vaccine; Diphtheria,
v.                                      *            Tetanus, and Pertussis (“DTAP”) Vaccine;
                                        *            Hepatitis B Vaccine; Pneumococcal Vaccine
SECRETARY OF HEALTH                     *            (“Prevnar”); Rotavirus Vaccine (“Rotateq”);
AND HUMAN SERVICES,                     *            Haemophilus influenzae type B (“HiB”)
                                        *            Vaccine; Injuries Resulting in Death.
              Respondent.               *
* * * * * * * * * * * * * * * *

Lorraine J. Mansfield, Law Office of Lorraine Mansfield, Las Vegas, NV, for Petitioners.
Gordon Shemin, U.S. Department of Justice, Washington, DC, for Respondent.

                                           DECISION 1

        On December 6, 2013, Eric Waterman and Taree Waterman (“Petitioners”) filed a
petition seeking compensation under the National Vaccine Injury Compensation Program (“the
Program”), 42 U.S.C. §300aa-10 et seq. (2006), 2 on behalf of their minor child, A.T.W.
Petitioners allege that, as a result of the administration of Polio; Diphtheria, Tetanus, and

1
  Because this decision contains a reasoned explanation for the undersigned’s action in this case,
the undersigned intends to post this ruling on the website of the United States Court of Federal
Claims, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116
Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). As provided by Vaccine
Rule 18(b), each party has 14 days within which to file a motion for redaction “of any
information furnished by the party (1) that is trade secret or commercial or financial information
and is privileged or confidential, or (2) that are medical files and similar files the disclosure of
which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). In the
absence of such motion, the entire decision will be available to the public. Id.
2
 The National Vaccine Injury Compensation Program comprises Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§300aa-10 et seq. (2006). All citations in this decision to individual sections of the
Vaccine Act are to 42 U.S.C. §300aa.

                                                 1
Pertussis (“DTAP”); Hepatitis B; Haemophilus influenzae type B (“HiB”); Pneumococcal
(“Prevnar”); and Rotavirus (“Rotateq”) vaccines on August 20, 2013, A.T.W. suffered injuries
that resulted in his death. Petition (Pet.) at 1–2. For the reasons set forth below, the undersigned
finds that the record does not support entitlement to an award under the Program.

                                    PROCEDURAL HISTORY

        In addition to their petition, Petitioners filed ten exhibits – including medical records, two
affidavits, and a VAERS Report – on December 6, 2013. See Petitioners’ Exhibits (“Pet. Ex.”)
1-10. 3 On February 12, 2014, Petitioners filed an Autopsy Report, a toxicology report, and a
Medical Examiner’s Report (Petitioners’ Exhibits (Pet. Ex.) 11, 12, and 13, respectively); on
March 13, 2014, they filed a police report (Pet. Ex. 14); and on March 18, 2014, they filed an
expert report authored by pediatrician Leroy Bernstein (Pet. Ex. 15). In his report, Dr. Bernstein
opines that “[t]he multiple vaccination [sic] administered to infant [A.T.W.] was a possible cause
of death. To my reasonable knowledge, the six vaccines administered the same day could have
caused a reaction which caused his death.” Pet. Ex. 15 at 2. Petitioners filed a statement of
completion on March 19, 2014.

        At a status conference held on March 25, 2014, the undersigned encouraged Petitioners’
counsel to file a supplemental expert report that articulated the nature of the injury allegedly
caused by the vaccinations. The undersigned explained that, if A.T.W. did not suffer an alleged
injury that qualified as an encephalopathy or anaphylaxis under the Vaccine Table (“Table”),
causation would not be presumed, and Petitioners would be required to make an argument
regarding causation-in-fact. The undersigned also clarified that death, in and of itself, is not a
Table injury, though it may be a sequela of a Table injury.

        On April 17, 2014, Respondent filed a Rule 4(c) Report (“Report”). In the Report,
Respondent argued that Petitioners had not alleged a Table injury, and that Petitioners had failed
to “establish a more likely than not causal connection between A.T.W.’s vaccinations on August
20, 2013, and his subsequent death later that night.” Report at 10. Respondent argued that “Dr.
Bernstein’s report is insufficient to meet petitioners’ burden in that it does not offer a reliable
medical theory causally connecting any of the vaccinations A.T.W. received to an injury that
resulted in death.” Id.

        On June 10, 2014, Petitioners filed Exhibit 17, entitled “L. Bernstein, M.D. Report.” The
entirety of Dr. Bernstein’s supplemental report consists of the following sentences: “The baby
possibly would not have died had he not received multiple vaccinations on the same day. The
vaccinations could have been a factor. Medicine is an imperfect science. No doctor could state

3
 Petitioners’ Exhibits 1 through 10 were originally filed on paper, attached to the petition.
When these exhibits were uploaded to the electronic docket, Exhibit 5 was inadvertently omitted.
All page references to these exhibits will be to the originally filed versions rather than the
electronic versions.

                                                  2
conclusively that the vaccination caused the baby’s death.” Pet. Ex. 17 at 1. Dr. Bernstein
attached to his report an article published in the Journal of Human & Experimental Toxicology.
Pet. Ex. 17 at 2-11. 4 The article concludes, based on the studied epidemiology, that “nations that
require more vaccine doses tend to have higher infant mortality rates.” Pet. Ex. 17 at 11. The
article’s authors do not attempt to identify a causal mechanism for these infants’ deaths.

        Also on June 10, 2014, the undersigned convened a second status conference during
which the undersigned reiterated that Petitioners had yet to file an expert report that articulated a
theory of causation or identified the type of reaction being alleged. The undersigned referred
Petitioners’ counsel to the seminal case of Althen v. Sec’y of Health and Human Servs., 418 F.3d
1274 (Fed. Cir. 2005). Petitioners’ counsel opined that Dr. Bernstein’s supplemental expert
report was sufficient to meet the requirements of Althen.

        A third and final status conference was held on August 14, 2014. During the status
conference, Respondent argued, as she had in her Rule 4 Report, that a “possible” causal
connection between the vaccines and the alleged injury is insufficient to prove causation under
Moberly v. HHS, 592 F.3d 1315, 1322 (Fed. Cir. 2010). The undersigned again reiterated that a
temporal connection between vaccination and injury is insufficient, without a causal theory, to
prove causation under Althen. Acknowledging these comments, Ms. Mansfield indicated that
Petitioners intended to rely on their previously filed expert reports. Because Petitioners were
disinclined to file additional documentation regarding their causal theory, the undersigned set
deadlines for the parties to file motions regarding how to proceed on the then-existing record.

        On September 11, 2014, Respondent filed a Motion for Ruling on the Record or, in the
alternative, for Summary Judgment (“Resp’t’s Mot.”). Petitioners filed Petitioner’s Response to
Motion for Ruling on the Record or in the Alternative for Summary Judgment (“Pet. Resp.”) on
September 29, 2014. Respondent filed a Reply to Response to Motion for Ruling on the Record
or in the Alternative for Summary Judgment (“Resp’t’s Rep.”) on October 10, 2014. This case is
now ripe for a decision on the record.

                                      FACTUAL HISTORY

        Petitioners’ child, A.T.W., was born at term on June 11, 2013. Pet. Ex. 4 at 6-7. A.T.W.
was healthy at birth and the pregnancy was “uncomplicated.” Id. at 4; see generally Pet. Ex. 5 at
5, Pet. Ex. 13 at 4. Ms. Waterman would later report to the police that, prior to immunization,
“he had been very healthy with the exception of some previous slight jaundice.” Pet. Ex. 13 at 2.

       A.T.W. received six vaccinations – DTAP, Hep B, Polio, HiB, Prevnar, and Rotateq –
during an August 20, 2013 well-child check-up. Pet. Ex. 6 at 18. A.T.W. was two months old at

4
 Neil Miller and Gary Goldman, Infant mortality rates regressed against number of vaccine
doses routinely given: Is there a biochemical or synergistic toxicity?, 30(9) Hum Exp Toxicol
1420-28 (2011).

                                                  3
the time of vaccination. Id. During the check-up, A.T.W. was noted to have been healthy, except
for a possible heart murmur for which he was referred to a cardiologist, and he “appear[ed] to be
in no acute distress.” Pet. Ex. 6 at 2-3; Pet. Ex. 13 at 4.

         The records filed by Petitioners are internally contradictory regarding A.T.W.’s health
and behavior during the afternoon following vaccine administration. After A.T.W.’s death, Taree
Waterman reported to police that “[h]e appeared to tolerate the [two month well-check]
appointment and the rest of the day with no apparent distress or complications …. He was eating,
sleeping, and having normal bowel movements.” Pet. Ex. 13 at 4. In the affidavit filed in support
of his vaccine claim, however, Eric Waterman noticed that, during the afternoon of August 20,
2013, A.T.W. “seemed different from his normal appearance and behavior,” taking half of his
usual bottle and appearing sleepy. Pet. Ex. 9 at 2. According to Eric Waterman’s vaccine claim
affidavit, he took three ounces of his bottle and went down to sleep between 8:00 and 8:30 p.m.;
according to Taree Waterman’s affidavit, A.T.W. “looked as though he was still sleeping by
7:00p.m.,” took only three (3) ounces of his bottle instead of his usual six (6) ounces,” and “went
down to sleep between 8:00 and 8:30 p.m.;” according to Taree Waterman’s statements to police,
A.T.W. took approximately 4 ounces of formula at 7:00 p.m., then fell asleep. Compare Pet. Ex.
9 at 2, 5; Pet. Ex. 13 at 4.

        At approximately 11:00 p.m., Mr. Waterman observed that A.T.W.’s skin appeared “pale
and mottled,” that his body was “stiff and abnormal,” that he was “wheezing and seemed to have
difficulty breathing,” and that he was lying face down with vomit around his nose and mouth. Pet
Ex. 9 at 2, 5; Pet. Ex. 11 at 1. Family members called 911 at approximately 11:05 p.m., and Mr.
Waterman began CPR while awaiting the ambulance. Pet. Ex. 9 at 2, 5-6. Attempts to resuscitate
A.T.W. failed, and A.T.W. was pronounced dead at the hospital. Pet. Ex. 8 at 2.

        A.T.W.’s autopsy report concludes that A.T.W.’s manner of death was natural and the
cause of death was Sudden Infant Death Syndrome (“SIDS”). Pet. Ex. 11 at 1. The autopsy found
scattered petechiae of the thymus, epicardial surface and visceral pleura; a bilateral pulmonary
edema; and bilateral pulmonary congestion. Id. The coroner noted that A.T.W. had received “an
Octavalent Vaccination” on August 20, 2013, but concluded that “the current medical literature
does not support such a causal connection to a reasonable degree of medical certainty.” Id.

                             APPLICABLE LEGAL STANDARDS

        To receive compensation under the Program, Petitioners must prove either: (1) that the
A.T.W. suffered a “Table Injury” – i.e., an injury included in the Vaccine Injury Table –
corresponding to his vaccinations, or (2) that A.T.W. suffered an injury that was actually caused
by his vaccination. See 42 U.S.C. §§ 300aa-13(a)(1)(A) and 300aa-(11)(c)(1). Pursuant to
Vaccine Rule 8(d), “[t]he special master may decide a case on the basis of written submissions
without conducting an evidentiary hearing.” See Vaccine Rule 8(d).

                                                4
        To establish that a Table Injury occurred as a result of a vaccination, Petitioners must
demonstrate the occurrence of a Table Injury, meaning that the injury is one of the types of
injuries enumerated in the Vaccine Injury Table, the injury corresponds to the vaccination
A.T.W. received, and the injury occurred within the appropriate time period following the
vaccination specified by the Table. See 42 U.S.C. §§ 300aa-11(c)(1), 300aa-13(a)(1)(A). If
Petitioners meet this burden, then the Table Injury is presumed to have been caused by the
vaccination and Petitioners are entitled to compensation absent a showing by Respondent that the
injury was caused by some factor other than the vaccine. See 42 U.S.C. § 300aa-13(a)(1)(B). If
the medical records do not disclose a diagnosis of a Table Injury, Petitioners must submit a
medical expert’s opinion interpreting A.T.W.’s symptoms as a Table injury. See Schneider v.
Sec’y of Health and Human Servs., 2005 WL 318697 at *2 (Fed. Cl. Feb. 1, 2005) (denying the
existence of a Table Injury where no medical expert has opined such an injury occurred). A lay
opinion that a Table Injury occurred is not sufficient to establish that a Table injury in fact
occurred. Id.

        Petitioners may also seek compensation for a non-Table injury by establishing that the
vaccine caused-in-fact A.T.W.’s injury. To establish causation in fact, Petitioners must
demonstrate by a preponderance of the evidence that the vaccine was the cause of the injury. 42
U.S.C. § 300aa-13(a)(1)(A). Petitioners are required to prove that the vaccine was “not only [the]
but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly v.
Sec’y of Health and Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010) (quoting Shyface v.
Sec’y of Health and Human Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999). In the seminal case
of Althen v. Sec’y of Health and Human Servs., the Federal Circuit set forth a three-prong test
used to determine whether a petitioner has established a causal link between a vaccine and the
claimed injury. Althen v. Sec’y of Health and Human Servs., 418 F.3d at 1278. The Althen test
requires the petitioner to set forth: “(1) a medical theory causally connecting the vaccine 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. To establish entitlement to compensation under the Program, Petitioners are required
to establish each of the three prongs of Althen by a preponderance of the evidence. See id.

         Specifically, under the first prong of Althen, Petitioners must offer a scientific or medical
theory that answers in the affirmative the question “can the vaccine(s) at issue cause the type of
injury alleged?” See Pafford v. Sec’y of Health and Human Servs., No. 01-0165V, 2004 WL
1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004). This prong may be satisfied in a number of
ways, for instance, by “providing evidence that at least a sufficient minority in the medical
community has accepted the theory, [so] as to render it credible.” Id. In addition, epidemiological
studies and an expert’s experience, while not dispositive, lend significant credence to the claim
of plausibility; articles published in respected medical journals, which have been subjected to
peer review, are also persuasive. Id. However, publication “does not necessarily correlate with
reliability,” because “in some instances well-grounded but innovative theories will not have been

                                                  5
published.” Id. (quoting Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 593–94
(1993) (emphasis in original)).

        Under Althen’s second prong, Petitioners must prove that the vaccine actually did cause
the alleged injury in a particular case. See Pafford, 2004 WL at *4; Althen, 418 F.3d at 1278.
Petitioners do not meet this obligation by showing only a temporal association between the
vaccination and the injury; rather, Petitioners must explain how and why the injury occurred.
Pafford, 2004 WL at *4. In order to explain how an injury occurred, Petitioners must advance a
medical theory with a logical sequence of cause and effect demonstrating the vaccine was the
reason for the injury. Id. (citing Grant v. Sec’y of Health and Human Servs., 956 F.2d 1144, 1148
(Fed. Cir. 1992).

         Under the third prong of Althen, Petitioners must show that the timing of the injury fits
with the causal theory. See Althen, 418 F.3d at 1278. The special master cannot infer causation
from temporal proximity alone. Where a petitioner’s expert views the temporal relationship as
the “key” indicator of causation, the claim must fail. See, e.g., Grant, 956 F.2d at 1148 (holding
that a lack of direct evidence of causation is weighted more strongly than a temporal
relationship); Hasler v. United States, 718 F.2d 202, 205 (6th Cir. 1983) (holding that
inoculation is not the cause of every event that occurs within a ten-day period following it);
Thibaudeau v. Sec’y of Health and Human Servs., 24 Cl. Ct. 400, 403 (Oct. 23, 1991).

                                          DISCUSSION

        In this case, Petitioners seek compensation for A.T.W.’s death under multiple theories: 1)
as a sequela of the Table Injury anaphylaxis; 2) as a sequela of the Table Injury encephalopathy,
and 3) under an off-Table injury theory. The undersigned now finds that Petitioners are not
entitled to compensation under the Program.

    A. Table Injuries

       1. Anaphylaxis

       Petitioners’ first theory is that A.T.W.’s death occurred as a sequela of anaphylaxis from
the DTAP, IPV (Polio), or Hepatitis B vaccine. 5 Pet. Resp. at 4–7, 9-10. Anaphylaxis is listed on
the Vaccine Injury Table as a covered condition for the DTAP, IPV (Polio), and Hepatitis B
vaccines. 42 C.F.R. § 100.3(a). However, the time period for the first symptom or manifestation
of onset of anaphylaxis for any vaccine for which anaphylaxis is a covered condition is four

5
  Petitioner does not specify which vaccine caused the alleged anaphylaxis, but rather inserted
into Petitioner’s response the portions of the Vaccine Injury Table that correspond to the
vaccines A.T.W. received for which anaphylaxis is a covered condition. Pet. Resp. at 5–8, ECF
No. 23.

                                                 6
hours or less. Id. Anaphylaxis is “an acute, severe, and potentially lethal systemic allergic
reaction” that begins “minutes to a few hours after exposure.” 42 C.F.R. § 100.3(b)(1).

        A.T.W. received the vaccinations at approximately 11:20 a.m. Pet. Ex. 9 at 2, 5. Eight
hours later, between 7:00 and 8:30 p.m., A.T.W. was put down to sleep, and was discovered in
distress around 11:00 p.m. Id.; Pet. Ex. 13 at 2. Although A.T.W.’s behavior may have been
somewhat different from normal on the afternoon following vaccination, see Pet. Ex. 9 at 2, 5
(noting that A.T.W. took half of his usual bottle and appeared sleepy), he was not suffering from
an “acute, severe reaction” until approximately twelve hours after vaccine administration. See id.
A.T.W.’s acute distress occurred far too long after the vaccinations to be considered anaphylaxis.
See Hellenbrand-Sztaba v. Sec’y of Health and Human Servs., No. 91-572V, 1995 WL 650678 at
*4-5 (Fed. Cl. Spec. Mstr. Oct. 19, 1995) (holding that death was not a sequela of anaphylaxis
where death occurred more than 14 hours after a DPT vaccination and no symptoms of an
allergic reaction had manifested prior to the child’s death during sleep). Further, neither
A.T.W.’s treating physicians nor Dr. Bernstein diagnosed A.T.W. as suffering from anaphylaxis.

       For these reasons, the undersigned finds that Petitioners have failed to prove that A.T.W.
suffered from anaphylaxis, as defined by the Table, or that A.T.W.’s death was a sequela of such
anaphylaxis.

       2. Encephalopathy

        Petitioners’ second theory is that A.T.W.’s death occurred as a sequela of encephalopathy
from the DTAP vaccine. Encephalopathy is listed on the Vaccine Injury Table as a covered
condition for the DTAP vaccine. 6 42 C.F.R. § 100.3(a). The applicable time period for the first
symptom or manifestation of onset of encephalopathy is 72 hours or less. Id. Encephalopathy in
children less than 18 months of age without any corresponding seizures is indicated by a
“significantly decreased level of consciousness.” 42 C.F.R. § 100.3(c)(2)(i)(A). A significantly
decreased level of consciousness is present when there is decreased or absent response to the
environment (responds, if at all, only to loud voice or painful stimuli), decreased or absent eye
contact (failure to fix gaze upon family members or other individuals), or inconsistent or absent
responses to external stimuli (failure to recognize familiar people or things). 42 C.F.R. §
100.3(b)(2)(i)(D). According to the Vaccine Injury Table, the following symptoms are not
enough, standing alone, to rise to the level of acute encephalopathy: sleepiness, irritability
(fussiness), high-pitched and unusual screaming, and poor feeding. 42 C.F.R. § 100.3(b)(2)(i)(E).

      There is no evidence in the record that A.T.W. had symptoms of encephalopathy.
Encephalopathy is a disease of the brain, and the autopsy indicates nothing abnormal about
A.T.W.’s brain. See generally Pet. Ex. 11. Moreover, although A.T.W. was found in distress,

6
  Petitioners do not explicitly argue that A.T.W. suffered from encephalopathy as a result of the
DTAP vaccine. They do, however, refer to the DTaP portion of the Vaccine Injury Table, which
lists encephalopathy as a covered condition. Pet. Resp. at 9-10.

                                                 7
with vomit around his mouth and nose and having difficulty breathing, he is not documented to
have been “unresponsive;” the unresponsiveness that characterizes encephalopathy is marked by
a significantly decreased level of consciousness featuring a decreased or absent response to
stimuli. Pet. Ex. 9 at 2, 5; 42 C.F.R. §§ 100.3(b)(2)(i)(A), 100.3(b)(2)(i)(D)(1). Petitioners’
expert, Dr. Bernstein, has never diagnosed A.T.W. with encephalopathy or suggested that he
displayed symptoms consistent with encephalopathy.

        The symptoms that A.T.W. may have exhibited following vaccination – sleepiness and
feeding changes – have been explicitly identified by the Vaccine Table as insufficient to indicate
encephalopathy. 42 C.F.R. § 100.3(b)(2)(i)(E); see also Marlow v. Sec’y of Health and Human
Servs., No. 90-701V, 1991 WL 202226 at *4 (Fed. Cl. Spec. Mstr. Sept. 20, 1991) (holding that
a SIDS death was not attributable to encephalopathy from DPT vaccination where there was an
intervening period of normal behavior including a period of fussiness, irritability, screaming, and
vomiting).

       Petitioners’ bare assertions are insufficient to meet their burden. Accordingly, the
undersigned finds that Petitioners have failed to prove that A.T.W. suffered from
encephalopathy, as defined by the Table, or that A.T.W.’s death was a sequela of such
encephalopathy.

    B. Off-Table Injury

        Petitioners also argue an alternative off-Table injury theory of causation. The
undersigned finds that Petitioners’ theory of causation-in-fact fails because Petitioners’ expert
has not advanced a medical theory that connects A.T.W.’s death to the vaccinations A.T.W.
received.

       1. Althen Prong 1

        The first prong of Althen requires Petitioners to set forth a scientific or medical theory to
demonstrate that the vaccination can cause the type of injury A.T.W. suffered. Althen, 418 F.3d
at 1278. The undersigned finds that Petitioners have not provided a sound or reliable medical
theory causally connecting the A.T.W.’s vaccinations with his death later that evening. The
undersigned acknowledges that Petitioners’ expert, Dr. Bernstein, believes that the
administration of multiple vaccines at once was a “possible” cause of A.T.W.’s death, and that,
in his pediatric practice, he limits the number of vaccines given to a child at once. Pet. Ex. 15 at
2. The undersigned finds, however, that Dr. Bernstein’s belief has little evidentiary value in the
absence of a medical explanation. Dr. Bernstein provides no theory that specifically explains
how any of the vaccinations that A.T.W. received could have caused A.T.W.’s death. 7

7
 The undersigned repeatedly warned Petitioners’ counsel that Dr. Bernstein’s reports were
inadequate to prove causation. See procedural history, supra, at 2-3.

                                                  8
        The single article submitted in support of Dr. Bernstein’s report merely demonstrates a
correlation between the number of vaccine doses on a nation’s immunization schedule and the
nation’s infant mortality rate. See generally Pet. Ex. 17. This article fails to document any causal
link between multiple vaccinations and an infant’s death or SIDS. These mere generalized
possibilities, with no explanation of how vaccines can cause injuries that progress to the point of
death, are wholly insufficient as a medical theory proving the vaccines caused-in-fact A.T.W.’s
death.

        For these reasons, Petitioners’ claim fails to meet the first prong of Althen. No further
analysis under Althen is required, as Petitioners must meet all prongs in order to successfully
establish a claim to entitlement under the Program.

                                          CONCLUSION

        Under the Act, a petitioner may not be given a Program award based solely on the
petitioner’s claims alone. 42 U.S.C. § 300aa-13(a)(1). Rather, the petition must be supported by
either medical records or by the opinion of a competent physician. Id. In this case, because there
are insufficient medical records supporting Petitioners’ claim, a medical expert opinion must be
offered in support, establishing either the existence of a Table Injury, or, in the alternative, a
sound and reliable medical theory linking vaccination to injury, and demonstrating a logical
sequence of cause and effect between said vaccination and injury. Petitioners’ expert has offered
no such opinion.

        Under the law, the undersigned can authorize compensation only if a medical condition
or injury either falls within one of the Table Injury categories, or is shown by medical records or
a competent medical opinion to be vaccine-caused. See Lombardi v. Sec’y of Health and Human
Servs., 656 F.3d 1343, 1353 (Fed. Cir. 2011) (affirming a special master’s dismissal of a petition
where the petitioner could not establish that she had any of the three diagnoses alleged). No such
proof exists in the record. Thus, this case is dismissed for insufficient proof. In the absence of
a timely-filed motion for review of this decision (see Appendix B to the Rules of the Court),
the Clerk shall enter judgment in accord with this decision.

       IT IS SO ORDERED.

                                                              s/Lisa D. Hamilton-Fieldman
                                                              Lisa D. Hamilton-Fieldman
                                                              Special Master

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