Waterman v. Secretary of Health and Human Services

In the United States Court of Federal Claims
No. 13-960V
E-Filed Under Seal: October 2, 2015
E-Filed for Publication: October 23, 2015 1
)
ERIC WATERMAN and TAREE )
WATERMAN, parents and natural )
guardians of A.T.W., a minor, deceased, )
) Vaccine Injury; Motion for Review;
Petitioners, ) Table Injury; DTaP Vaccine;
) Encephalopathy
v. )
)
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
Lorraine J. Mansfield, Las Vegas, NV, for petitioners.
Gordon Shemin, Trial Attorney, with whom were Benjamin C. Mizer, Principal Deputy
Assistant Attorney General, Rupa Bhattacharyya, Director, Vincent J. Matanoski, Deputy
Director, and Gabrielle M. Fielding, Assistant Director, Torts Branch, Civil Division,
United States Department of Justice, Washington, D.C., for respondent.
OPINION and ORDER
CAMPBELL-SMITH, Chief Judge
Petitioners, Eric and Taree Waterman, seek review of the special master’s decision
dismissing their claim for compensation under the National Childhood Vaccine Injury
Act of 1986 (Vaccine Act), codified as amended at 42 U.S.C. § 300aa-1 to -34 (2012).
Petitioners allege that as a result of the administration of a Diphtheria, Tetanus, and
Pertussis (DTaP) vaccination, their son, A.T.W., suffered a Vaccine Injury Table (Table)
1
Pursuant to Vaccine Rule 18(b) of the Rules of the United States Court of Federal
Claims, this Opinion initially issued under seal to provide the parties the opportunity to
object to the public disclosure of information contained within it. Neither party requested
any redactions. The Opinion is thus reissued for publication in its entirety.
encephalopathy that led to his death. A.T.W. received the DTaP vaccination on August
20, 2013. Approximately two months old at the time, A.T.W. died later that evening.
On review, the question for the court is whether the special master’s decision that
petitioners failed to show that their son suffered from encephalopathy prior to his death
was arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law.
The court finds that the special master’s decision was not. Thus, the court DENIES
petitioners’ motion for review and SUSTAINS the decision of the special master.
I. Background
A. Procedural History
On December 6, 2013, petitioners filed a petition under the Vaccine Act, in which
they alleged, inter alia, that A.T.W. “suffered the ‘Table Injury’ known as death” within
hours of his receipt of the DTaP and five other vaccinations. 2 Pet. 1–3, ECF No. 1
(emphasis omitted). Attached to their petition were ten exhibits, consisting of a birth and
death certificate, Exs. 1, 3, medical records, Exs. 2, 4–8, affidavits of both Eric and Taree
Waterman, Ex. 9, and a Vaccine Adverse Event Reporting System (VAERS) Report, Ex.
10. On February 12, 2014, petitioners filed exhibits 11 through 13, consisting of an
autopsy report, Ex. 11, ECF No. 6; a toxicology report, Ex. 12, ECF No. 6-1; and a
Medical Examiner’s report, Ex. 13, ECF No. 6-2. On March 13, 2014, petitioners filed
exhibit 14, a police report. ECF No. 9. On March 18, 2014, they filed exhibit 15, a
report authored by petitioners’ expert, pediatrician Dr. Leroy Bernstein (Dr. Bernstein),
ECF No. 10, and on March 19, 2014, petitioners filed a statement of completion, ECF
No. 11.
On March 25, 2014, the special master held the first of three telephonic status
conferences with counsel for the parties. 3 See ECF No. 12. During the status conference,
the special master advised petitioners’ counsel that “death is not, in and of itself, [a]
Table injury,” although it may be a complication or sequela of a Table injury. EDR
1:41:52–43:07. The special master then instructed petitioners’ counsel to file a
supplemental expert report that identified the Table injury(s) that ultimately led to
2
For the purpose of awarding compensation under the National Vaccine Injury
Compensation Program, the Vaccine Injury Table (Table) “is a table of vaccines, the
injuries, . . . and deaths resulting from the administration of such vaccines, and the time
period in which the first symptom or manifestation of onset or of the significant
aggravation of such injuries . . . and deaths is to occur after vaccine administration.” 42
U.S.C. § 300aa-14(a) (2012); see also infra Part II.A.
3
The telephonic status conferences were recorded by the court’s Electronic Digital
Recording (EDR) system. The times noted in citations to the status conferences refer to
the EDR record.
2
A.T.W.’s death. EDR 1:45:02–27; see also EDR 1:49:25–43 (addressing scheduling of
petitioners’ supplemental expert report).
On April 17, 2014, respondent, the Secretary of Health and Human Services, filed
a Vaccine Rule 4(c) report opposing the petition for compensation. Resp’t’s Rpt., ECF
No. 13.
On May 29, 2014, petitioners filed exhibit 16, which purported to be Dr.
Bernstein’s supplemental report. Ex. 16, ECF No. 15. Although exhibit 16 is titled “Dr.
L. Bernstein Supplemental Report,” it consists only of an article published in Human &
Experimental Toxicology, a journal. Id.
On June 10, 2014, the special master held a second telephonic status conference
with counsel for the parties, see ECF No. 17, during which counsel for petitioners
notified the special master that exhibit 16 was in fact missing Dr. Bernstein’s signed
report, EDR 4:41:17–40. The special master again advised petitioners that Dr.
Bernstein’s original expert report (exhibit 15) failed to offer any theory of causation.
EDR 4:42:17–32. Following the status conference, petitioners filed Dr. Bernstein’s
supplemental expert report as exhibit 17. Ex. 17, ECF No. 16.
The following day, on June 11, 2014, the special master issued an order directing
respondent to advise whether Dr. Bernstein’s supplemental expert report modified
respondent’s case. ECF No. 17. Further to the court’s order, respondent filed a status
report on July 22, 2014 stating that “the supplemental report and literature from Dr.
Bernstein [did] not change respondent’s position regarding th[e] case.” Resp’t’s Status
Rpt., ECF No. 18.
On August 14, 2014, the special master held a third and final telephonic status
conference with counsel for the parties, see ECF No. 17, during which the special master
set deadlines for the parties to brief respondent’s motion for ruling on the record and/or a
motion for summary judgment, EDR 3:17:14–33; 3:20:44–21:07.
Respondent filed a motion for ruling on the record or, in the alternative, for
summary judgment on September 11, 2014, Resp’t’s Mot., ECF No. 22; petitioners filed
a response to respondent’s motion on September 29, 2014, Pet’rs’ Resp., ECF No. 23;
and respondent filed a reply to petitioner’s response on October 22, 2014, Resp’t’s Reply,
ECF No. 24.
In its response, petitioners advanced, for the first time, the theory at issue in their
motion for review: that A.T.W. suffered from a Table encephalopathy. Pet’rs’ Resp. 9.
Petitioners alleged that “A.T.W. presented with encephalopathy within the stated time
period after vaccination,” and that they were “entitled to a presumption that [A.T.W.’s]
death was caused by the vaccine.” Id. at 11.
3
On June 30, 2015, the special master issued her sealed decision denying
compensation, allowing time for the parties to propose redactions. Decision, ECF No.
25. Neither party proposed redactions, and the special master publicly reissued her
decision on July 22, 2015. 4 ECF No. 26. The special master found, inter alia, that
“[t]here [was] no evidence in the record that A.T.W. had symptoms of encephalopathy.”
Decision 7; see infra Part III.B (discussing the special master’s findings in more detail).
As such, the special master concluded that petitioners had “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 5 of such encephalopathy.” 6 Decision 8 (footnote added).
Petitioners filed a motion for review on July 24, 2015, Pet’rs’ Mot., ECF No. 27,
to which respondent filed a response on August 24, 2015, Resp’t’s Resp., ECF No. 29.
“Petitioners challenge only the special master’s decision that [A.T.W.’s] death was not a
Vaccine Table Injury,” asserting that A.T.W. “suffered death from encephalopathy well
within” the seventy-two hour time frame as required by the Table. Pet’rs’ Mot. 7
(internal citations omitted).
Respondent responds that the special master’s conclusion is well-supported and
thus entitled to deference. See Resp’t’s Resp. 1–2, 6, 8.
B. Evidence Before the Special Master
The special master’s decision sets forth A.T.W.’s medical history and petitioners’
expert’s opinion. See Decision 2–4. The court focuses on that information that is
4
Although unpublished, the special master’s decision is available through
commercial electronic databases. See, e.g., Waterman v. Sec’y of Health & Human
Servs., No. 13-960V, 2015 WL 4481244 (Fed. Cl. June 30, 2015). As both parties cited
to the page numbers in the decision filed on the court’s CM/ECF system, ECF No. 25, the
court follows suit.
5
“The term ‘sequela’ means a condition or event which was actually caused by a
condition listed in the Vaccine Injury Table.” 42 C.F.R. § 100.3(b)(5); cf. id. § 100.3(a)
(listing death as a possible sequela of Table encephalopathy).
6
The special master also denied petitioners’ alternative theories for compensation:
that A.T.W. suffered from Table anaphylaxis and that A.T.W.’s death was caused-in-fact
by the vaccinations he received. Decision 6–9, ECF No. 25. In their motion for review,
petitioners do not contest those portions of the special master’s decision; they challenge
only the finding that A.T.W. did not suffer from a Table encephalopathy. See generally
Pet’rs’ Mot., ECF No. 27.
4
relevant to its review, and is informed by the special master’s decision and the exhibits
filed by petitioners. See Decision 3–4; Exs. 1–17. 7
1. Medical History
A.T.W. was born at term on June 11, 2013, by scheduled cesarean section. Ex. 1;
Ex. 4 at 4. Ms. Waterman’s pregnancy was “uncomplicated,” and A.T.W. was healthy at
birth, weighing seven pounds and eleven ounces. Ex. 4 at 4, 6; see also Ex. 9 at 2, 5. Ms.
Waterman later reported to the police that A.T.W. was a “very healthy [baby] with the
exception of some previous slight jaundice.” Ex. 13 at 4.
On August 20, 2013, at approximately 11:00 a.m., A.T.W. received six
vaccinations—DTaP, Hep B, IPV, HiB, Prevnar 13, and RotaTeq—during a two-month
well-child check-up. 8 Ex. 6 at 2–4, 18; Ex. 2. A.T.W. was administered 40 mg of
Tylenol following the vaccines. Ex. 6 at 2. Records from the check-up indicate that
A.T.W. was “healthy” and “appear[ed] to be in no acute distress.” Id. at 2–3. A.T.W’s
pediatrician did detect a possible hurt murmur, id. at 3, and Mrs. Waterman subsequently
reported to the police that A.T.W.’s doctor intended to refer him to a cardiologist, Ex. 13
at 4.
As the special master observed, see Decision 4, there are some discrepancies and
inconsistencies in the record as to A.T.W.’s behavior, feeding, and sleep schedule the
afternoon and evening following vaccine administration. A few hours after A.T.W.’s
death, Mrs. Waterman informed the police that “[A.T.W.] appeared to tolerate the
[check-up] appointment and the rest of the day with no apparent distress or
complications.” Ex. 13 at 4, 6. Mrs. Watermen also related that “he was eating, sleeping,
and having normal bowel movements.” Id. at 4. Mrs. Waterman added that, at 7:00 p.m.,
“she fed him approximately 4 ounces of formula before he fell asleep.” Id. But see id.
(stating that A.T.W. “was fed approximately four ounces of [powder formula] mixed
with water, per directions during that day and six ounces [of powder formula] mixed with
water and Gerber Rice Cereal for his nighttime feeding”). But Mr. and Mrs. Waterman
stated in the affidavits filed in support of their vaccine claim that A.T.W. “seemed
different from his normal appearance and behavior,” and that “[h]e looked as though he
was still sleeping by 7:00 p.m.” Ex. 9 at 2, 5. Mr. and Mrs. Waterman averred further
7
When citing to exhibits 1–10, the court refers to the Bates number(s) assigned by
Petitioners, which appear in the bottom right corner of each page. When citing to
exhibits 11–17, some of which do not have Bates numbers, the court refers to the page
number(s) assigned by the court’s electronic case management system, which appear in
the top right corner of each page.
8
Hep B, IPV, HiB, Prevnar 13, and RotaTeq protect against hepatitis B, polio,
haemophilius influenza b, pneumococcal pneumonia, and rotavirus, respectively. See Ex.
2.
5
that A.T.W. “only took three (3) ounces of his bottle instead of his usual six (6) ounces,”
and that A.T.W. “went down to sleep between 8:00 and 8:30 p.m.” Id.
According to the police report, Mrs. Waterman related that, at approximately 9:30
p.m., she moved A.T.W. to “a full[-]sized bed with approximately 4 pillows surrounding
him with his head turned to the right.” Ex. 13 at 4. Mrs. Watermen also related that at
around 10:50 p.m., a family friend entered the bedroom and noticed that A.T.W. was
lying face-down. Id. After observing “what appeared to be vomit on the bedding and . . .
his mouth and nose,” the family friend called the family into the bedroom for assistance. 9
Id. In their affidavits, Mr. and Mrs. Waterman averred that, at approximately 11:00 p.m.,
Mr. Waterman “observed that [A.T.W.’s] skin appeared pale and mottled white and that
his body appeared stiff and abnormal. He was wheezing and seemed to have much
difficulty breathing. He was laying in vomit, with vomit around his nose.” Ex. 9 at 2, 5.
Cardiopulmonary Resuscitation was immediately administered, and the family called
911. Id. at 2, 6; Ex. 13 at 4. Paramedics arrived approximately twenty minutes later and
transported A.T.W. to St. Rose Dominican Hospital where attempts to resuscitate A.T.W.
failed. Ex. 9 at 3, 6; see also Ex. 7 at 1; Ex. 8 at 2; Ex. 13 at 4. A.T.W. was pronounced
dead at 11:28 p.m. Ex. 13 at 4; Ex. 3.
A.T.W.’s autopsy report lists the following as his “diagnoses”:
1. Scattered Petechiae of the Thymus, Epicardial Surface and Visceral
Pleura . . . .
2. Pulmonary Edema, Bilateral, Lungs.
3. Pulmonary Congestion, Bilateral, Lungs.
4. Status Post – Octavalent Vaccination (20 August 2013).
Ex. 11 at 3. Notably, the medical examiner did not identify any abnormalities associated
with A.T.W.’s brain: “The leptomeninges and the surfaces of the cerebral hemispheres
are unremarkable. The vessels at the base of the brain have a normal configuration. The
base of the skull shows no evidence of injury. On serial sectioning the brain reveals no
grossly visible changes of natural disease.” Id. at 8.
Under the “comment” portion of the autopsy report, the medical examiner wrote:
The possibility of a true causal connection between the administration of an
Octavalent Vaccination (20 August 2013) and the death cannot be
eliminated, however, the current medical literature does not support such a
9
The record is inconsistent as to who first discovered A.T.W. in a state of distress.
Compare Ex. 13 at 4 (indicating that a family friend found A.T.W.), and Ex. 14 at 4
(same), with Ex. 7 at 2 (stating that Mr. Waterman found A.T.W.), Ex. 8 at 2 (same), and
Ex. 9 at 2, 5 (suggesting same). The identity of the individual who initially discovered
A.T.W. in distress is not determinative to the outcome of this case.
6
causal connection to a reasonable degree of medical certainty. This case is
formally reported to Vaccine Adverse Event Reporting System (aka
VAERS) . . . .
Additionally, the fact that [A.T.W.] was found face-down in the context of a
firm bed with an absence of obstruction in moving head side-to-side . . . and
the known normal ability of [A.T.W.] to move his head side-to-side easily
does not support the possibility of suffocation as cause of death.
Id. at 3. The autopsy report concludes that A.T.W.’s manner of death was “natural” and
that he died as a result of Sudden Infant Death Syndrome (SIDS). 10 Id.; accord Ex. 8 at
2. A.T.W.’s death certificate lists SIDS as his immediate cause of death. Ex. 3.
2. Petitioners’ Expert
Dr. Bernstein has been a practicing pediatrician for over forty-two years. Ex. 15 at
3, 5. His curriculum vitae states that “[h]e has been the physician for thousands of
infants, children and adolescents.” Id. at 5; see also id. at 3 (stating that he “regularly
diagnose[s] and treat[s] infants, children and adolescents”). As of March 2014, Dr.
Bernstein was a staff member at Sunrise Hospital and Medical Center in Las Vegas,
Nevada, and an Assistant Professor of Pediatrics at both the Touro University School of
Medicine and the University of Nevada School of Medicine. Id.
In March 2014, Dr. Bernstein provided petitioners with an expert report in which
he opined that:
A.) Multiple vaccination[s] should not be given on the same day to infants.
In my pediatric practice I limit, at most, two vaccines at a time. Many
pediatricians do not give vaccines all at once.
B.) A subset of infants may be more susceptible to reactions to
immunizations. I do not administer multiple vaccines at the same time
because one infant in perhaps thousands will have a reaction.
C.) The multiple vaccination[s] administered to infant [A.T.W.] was a
possible cause of his death. To my reasonable knowledge, the six
vaccines administered the same day could have caused a reaction which
caused his death.
10
Sudden Infant Death Syndrome (SIDS) is defined as “the sudden and unexpected
death of an apparently healthy infant, typically occurring between the ages of three weeks
and five months, and not explained by careful postmortem studies.” Dorland’s Illustrated
Medical Dictionary 1850 (32d ed. 2012).
7
Id. at 4. Dr. Bernstein’s opinion was based upon his review of the available medical
records and the affidavits of Mr. and Mrs. Waterman. Id. at 3.
In May 2014, Dr. Bernstein provided petitioners with a supplemental expert
report, which stated in full:
1.) The baby possibly would not have died had he not received multiple
vaccinations on the same day.
2.) The vaccinations could have been a factor.
3.) Medicine is an imperfect science.
4.) No doctor could state conclusively that the vaccination caused the baby’s
death.
Ex. 17 at 3. Attached to Dr. Bernstein’s supplemental expert report was an article
published in Human & Experimental Toxicology. Id. at 4–13 (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)). Employing a linear regression analysis, the article concludes that “nations that
require more vaccine doses tend to have higher infant mortality rates.” Id. at 11
(italicization omitted).
II. Legal Standards
A. Recovery Under the Vaccine Act
The Vaccine Act was enacted to create “a federal no-fault compensation scheme
under which awards were to ‘be made to vaccine-injured persons quickly, easily, and
with certainty and generosity.’” Paluck v. Sec’y of Health & Human Servs., 786 F.3d
1373, 1378 (Fed. Cir. 2015) (quoting H.R. Rep. No. 99–908, at 3 (1986) reprinted in
U.S.C.C.A.N. 6344). “A petitioner seeking compensation under the Vaccine Act must
establish, by a preponderance of the evidence, that a covered vaccine caused the claimed
injury.” Id. at 1379; see 42 U.S.C. § 300aa-13(a)(1)(A). A petitioner can recover in one
of two ways: either by proving an injury listed on the Table or by proving causation-in-
fact (off-Table). See 42 U.S.C. §§ 300aa-11(c)(1)(C), -13(a)(1); Andreu ex rel. Andreu
v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1374 (Fed. Cir. 2009).
Where, as here, a petitioner alleges a Table injury, the petitioner must prove by a
preponderance of the evidence that “he or she received a vaccine listed in the Table, that
he or she suffered an injury listed in the Table, and that the injury occurred within the
prescribed time period.” Nuttall v. Sec’y of Health & Human Servs., 122 Fed. Cl. 821,
829 (2015) (citing Andreu, 569 F.3d at 1374), appeal docketed, No. 15-5153 (Fed. Cir.
Sept. 29, 2015). “If petitioner can make such a showing, causation is presumed and
petitioner is deemed to have made out a prima facie case of entitlement to compensation
8
under the Act.” 11 Whitecotton v. Sec’y of Health & Human Servs., 81 F.3d 1099, 1102
(Fed. Cir. 1996); see Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1147
(Fed. Cir. 1992) (“The Vaccine Table, in effect, determines by law that the temporal
association of certain injuries with the vaccination suffices to show causation.”). The
petitioner is then entitled to recover unless the respondent can show, by a preponderance
of the evidence, that the injury was caused by a factor unrelated to the vaccine. 42 U.S.C.
§ 300aa–13(a)(1)(B)); Shalala v. Whitecotton, 514 U.S. 268, 270–71 (1995); de Bazan v.
Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). A special
master may not award compensation under the Act “based on the claims of a petitioner
alone, unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa-
13(a).
B. Standard of Review of the Special Master’s Decision
In response to a motion for review of a decision issued by a special master, the
court has jurisdiction “to undertake a review of the record of the proceedings,” and may
“set aside any findings of fact or conclusion of law of the special master found to be
arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 42
U.S.C. § 300aa–12(e)(2)(B); Markovich v. Sec’y of Health & Human Servs., 477 F.3d
1353, 1355–56 (Fed. Cir. 2007). “These standards vary in application as well as degree
of deference,” and “[e]ach standard applies to a different aspect of the judgment.” Munn
v. Sec’y of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992); see also
Masias v. Sec’y of Health & Human Servs., 634 F.3d 1283, 1287–88 (Fed. Cir. 2011).
Of relevance here, findings of fact are reviewed under the highly deferential arbitrary and
capricious standard, and legal questions are reviewed de novo under the “not in
accordance with law” standard. 12 See Masias, 634 F.3d at 1287–88; Munn, 970 F.2d at870 n.10.
With respect to the arbitrary and capricious standard of review, “[i]f the special
master has considered the relevant evidence of record, drawn plausible inferences and
articulated a rational basis for the decision, reversible error will be extremely difficult to
demonstrate.” Hines on Behalf of Sevier v. Sec’y of Health & Human Servs., 940 F.2d
11“In an off-Table case, a petitioner who received a vaccine listed in the Table but
suffered an injury not listed in the [T]able does not receive a presumption of causation,
and instead must prove causation by a preponderance of the evidence.” Nuttall v. Sec’y
of Health & Human Servs., 122 Fed. Cl. 821, 829 (2015) (citing Moberly ex rel. Moberly
v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010)), appeal
docketed, No. 15-5153 (Fed. Cir. Sept. 29, 2015).
12
The abuse of discretion standard “rarely come[s] into play except where the
special master excludes evidence.” Munn v. Sec’y of Health & Human Servs., 970 F.2d
863, 870 n.10 (Fed. Cir. 1992).
9
1518, 1528 (Fed. Cir. 1991); Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357,
1360 (Fed. Cir. 2000) (quoting same). As the Federal Circuit has stated,
Congress assigned to a group of specialists, the Special Masters within the
Court of Federal Claims, the unenviable job of sorting through these painful
cases and, based upon their accumulated expertise in the field, judging the
merits of the individual claims. The statute makes clear that, on review, the
Court of Federal Claims is not to second guess the Special Masters fact-
intensive conclusions; the standard of review is uniquely deferential for what
is essentially a judicial process.
Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). That is,
the court must not “reweigh the factual evidence, assess whether the special master
correctly evaluated the evidence, or examine the probative value of the evidence or the
credibility of the witnesses—these are all matters within the purview of the fact finder.”
Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011).
III. Discussion
Petitioners allege that A.T.W. experienced a Table encephalopathy, which resulted
in his death, that was attributable to the DTaP vaccine he received earlier in the day.
Pet’rs’ Mot. 7, 10. The Table identifies encephalopathy as an injury covered by the
DTaP vaccine if it arose within seventy-two hours of the vaccination. 42 C.F.R. §
100.3(a). The alleged injury suffered by A.T.W. arose within twelve hours of receiving
the DTaP vaccine. See Ex. 13 at 4. It is beyond dispute that petitioners have established
that A.T.W. “received a vaccine listed in the Table, . . . and that the [alleged] injury
occurred within the prescribed time period.” See Nuttal, 122 Fed. Cl. at 829. Thus, the
question upon review is whether the Special Master’s determinations that A.T.W. did not
suffer from a Table Encephalopathy and that his death was not a sequela thereof were
arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law.
A. Encephalopathy
The Table defines encephalopathy as “any significant acquired abnormality of, or
injury to, or impairment of function of the brain.” 42 U.S.C. § 300aa-14(b)(3)(A). The
Table further provides, in relevant part, that a “vaccine recipient shall be considered to
have suffered an encephalopathy only if such recipient manifests, within the applicable
period, an injury meeting the description . . . of an acute encephalopathy.” 42 C.F.R. §
100.3(b)(2).
An acute encephalopathy, in turn, is defined as “one that is sufficiently severe so
as to require hospitalization (whether or not hospitalization occurred).” Id. §
100.3(b)(2)(i). “Increased intracranial pressure may be a clinical feature of acute
encephalopathy in any age group.” Id. § 100.3(b)(2)(i)(C). An acute encephalopathy in
10
children under the age of eighteen months, “who present without an associated seizure
event, . . . is indicated by a significantly decreased level of consciousness lasting for at
least 24 hours.” Id. § 100.3(b)(2)(i)(A). And a “significantly decreased level of
consciousness” is indicated by the presence of one or more of the following signs: “(1)
[d]ecreased or absent response to environment (responds, if at all, only to loud voice or
painful stimuli); (2) [d]ecreased or absent eye contact (does not fix gaze upon family
members or other individuals); or (3) [i]nconsistent or absent responses to external
stimuli (does not recognize familiar people or things).” Id. § 100.3(b)(2)(i)(D).
Notably, “[s]leepiness, irritability (fussiness), high-pitched and unusual screaming,
[and] persistent inconsolable crying” are not, standing alone or in combination, signs of
an acute encephalopathy. Id. § 100.3(b)(2)(i)(E); see also 42 U.S.C. § 300aa-14(b)(3)(A)
(providing that “[s]igns and symptoms such as high pitched and unusual screaming,
persistent [i]nconsolable crying, and bulging fontanel are compatible with an
encephalopathy, but in and of themselves are not conclusive evidence of
encephalopathy”).
B. Relevant Findings of the Special Master
Based on the evidence in the record, the special master determined that A.T.W.
did not suffer from a Table encephalopathy. First, the special master found that
“encephalopathy is a disease of the brain, and the autopsy indicates nothing abnormal
about A.T.W.’s brain.” Decision 7 (citing Ex. 11); see 42 U.S.C. § 300aa-14(b)(3)(A).
Next, the special master observed that “although A.T.W. was found in distress, with
vomit around his mouth and nose and having difficulty breathing,” this state did not
qualify as “unresponsive” within the meaning of the Table. Decision 7–8 (citing, inter
alia, 42 C.F.R. § 100.3(b)(2)(i)(A), (D)(1)). 13 The special master noted that the
symptoms A.T.W. may have exhibited following vaccine administration, to include
feeding changes and sleepiness, are explicitly identified in the Table “as insufficient to
indicate encephalopathy.” Id. at 8 (citing, inter alia, 42 C.F.R. § 100.3(b)(2)(i)(E)).
Having concluded that “there [were] insufficient medical records supporting
Petitioners’ claim,” id. at 9, the special master next turned to whether petitioners’ expert
opinion supported the existence of a Table encephalopathy, id. at 8; see id. at 5 (stating
that “[i]f the medical records do not disclose a diagnosis of a Table [i]njury, Petitioners
must submit a medical expert’s opinion interpreting A.T.W.’s symptoms as a Table
injury” (citing Schneider ex rel. Schneider v. Sec’y of Health & Human Servs., 2005 WL
318697 at *2 (Fed. Cl. Feb. 1, 2005)); id. at 9 (similar). The special master observed that
“Dr. Bernstein[] has never diagnosed A.T.W. with encephalopathy or suggested that he
displayed symptoms consistent with encephalopathy.” Id. at 8. The special master
13
The court understands that the special master equated “unresponsive” with “[a]
‘significantly decreased level of consciousness’ [as] indicated by the presence of . . .
[d]ecreased or absent response to environment.” 42 C.F.R. § 100.3(b)(2)(D)(1).
11
concluded that Dr. Bernstein failed to offer an opinion that established the existence of a
Table injury. Id. at 9.
Based on the foregoing, the special master found that the petitioners “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.” Id. at 8.
C. Petitioners’ Objection to the Special Master’s Findings
Petitioners object to the Special Master’s reading of the requirements of
encephalopathy as set forth in the Table. Pet’rs’ Mot. 4. Specifically, petitioners argue
that the special master erred in concluding that A.T.W.’s “death was not a Vaccine Table
Injury.” Id. at 7. Petitioners allege that the medical records reflect that the symptoms
experienced by A.T.W., and his ultimate death, establish that A.T.W. suffered from a
Table encephalopathy. See id. at 4 (claiming that A.T.W. “suffered and died from
encephalopathy”); id. at 10 (claiming that “A.T.W.’s condition satisfied the requirements
of an encephalopathy set forth in the [Table]” (citing 42 C.F.R. § 100.3(b))). Petitioners
appear to raise both a legal and factual challenge to the special master’s decision. See,
e.g., id. at 6 (“This review argues that the special master made a legal error when she
denied Petitioners claim for compensation.”); id. at 7–9 (challenging the special master’s
findings of fact).
Petitioners allege that A.T.W. experienced a significantly decreased level of
consciousness, as defined by 42 C.F.R. § 100.3(b)(2)(i)(D). Pet’rs’ Mot. 8–9. As
support, petitioners point to medical records that suggest that A.T.W. was in cardiac
arrest, which rendered him unconscious, and that both his blood pressure and heart rate
were zero. Id.; see id. at 9 (claiming that “[b]eing in a coma is the quintess[ential]
definition of decreased level of consciousness”). Petitioners also address each of the
clinical signs identified in 42 C.F.R. § 100.3(b)(2)(i)(D) as indicative of a significantly
decreased level of consciousness:
1.) Decreased or absent response to environment (responds, if at all, only to
loud voice or painful stimuli); – A.T.W. responded to nothing in the
environment – not to pounding on his chest for CPR, not to being injected
with epinephrine, not to the screech of the ambulance sirens.
2.) Decreased or absent eye contact (does not fix gaze upon family members
or other individuals); – A.T.W. did not respond to his own father, [let]
alone paramedics or emergency room doctors.
3.) or Inconsistent or absent responses to external stimuli (does not recognize
familiar people or things). – A.T.W. did not respond to people, lights,
sounds, noises, nothing.
Id. at 9–10.
12
Petitioners also challenge the special master’s observation that an
“[e]ncephalopathy is a disease of the brain, and [that] the autopsy indicates nothing
abnormal about A.T.W.’s brain.” Id. at 7 (citing Decision 7). Petitioners argue that there
was no visible swelling to A.T.W.’s brain because he died rapidly. See id. (“When a
person dies rapidly[,] the brain cannot swell if blood has stopped circulating.”).
Petitioners add that A.T.W. in fact suffered from “neurological damage to [his] brain due
to deprivation of oxygen to the brain for several minutes.” Id.; see id. (“Brain anoxia
leads to death in a few minutes.”).
D. The Court’s Review of the Special Master’s Decision
The special master’s determination that A.T.W. did not suffer from a Table
encephalopathy, or that his death was a sequela thereof, was well-supported by the record
and in accordance with law. A.T.W. was never diagnosed with encephalopathy, there is
no indication in his medical records that he suffered any of the symptoms of
encephalopathy—to include a decreased level of consciousness, see 42 C.F.R. §
100.3(b)(2)—and his autopsy report indicates nothing abnormal about his brain, Ex. 11 at
8. 14 Moreover, to the extent that A.T.W. exhibited symptoms of sleepiness or fussiness
following vaccine administration, see Ex. 9 at 2, 5, these symptoms are not, standing
alone or in combination, signs of an encephalopathy, 42 C.F.R. § 100.3(b)(2)(i)(E).
Having failed to find sufficient support in A.T.W.’s medical records for
petitioners’ claim that A.T.W. suffered from a Table encephalopathy, the special master
looked to whether petitioners’ expert supported their claim. See 42 U.S.C. § 300aa-13(a)
(providing that a special master may not award compensation under the Act “based on the
claims of a petitioner alone, unsubstantiated by medical records or by medical opinion”);
Dickerson v. Sec’y of Health & Human Servs., 35 Fed. Cl. 593, 599 (1996) (referring to
“the firm requirement that medical opinion evidence is . . . necessary . . . to support an
on-Table theory” where medical records fail to establish the existence of a Table injury
by a preponderance of the evidence); Schneider, 2005 WL 318697, at *2 (stating that
numerous cases construing 42 U.S.C. § 300aa-13(a) “hold uniformly that if an injured
person’s medical records do not disclose a diagnosis that the injured person’s symptoms
constitute a Table injury, then the petitioner must submit a medical expert’s opinion
interpreting the injured person’s symptoms as a Table injury” (emphasis omitted)).
The special master correctly observed that “Dr. Bernstein[] has never diagnosed
A.T.W. with encephalopathy or suggested that he displayed symptoms consistent with
14
Petitioners’ claim that A.T.W. in fact suffered from “neurological damage to [his]
brain due to deprivation of oxygen to the brain for several minutes,” Pet’rs’ Mot. 7, is
unsubstantiated, see 42 U.S.C. § 300aa-13(a) (providing that compensation may not be
awarded under the Act “based on the claims of a petitioner alone, unsubstantiated by
medical records or by medical opinion”).
13
encephalopathy.” Decision 8. Rather, Dr. Bernstein opined that A.T.W. “possibly would
not have died had he not received multiple vaccinations on the same day.” Ex. 17 at 3;
see also Ex. 15 at 4 (stating that the multiple vaccinations A.T.W. received were “a
possible cause of his death”). As respondent suggests, Resp’t’s Resp. 6, Dr. Bernstein’s
contention that a possible connection exists between A.T.W.’s vaccination and his death
does not approach the preponderance of the evidence standard necessary to recover under
the Vaccine Act, see 42 U.S.C. § 300aa-13(a)(1)(A); see also Moberly ex rel. Moberly v.
Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010) (stating that
“proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and the injury” does
not equate to proof of causation by a preponderance of the evidence).
Moreover, the court finds that the special master’s conclusion that “death, in and
of itself, is not a Table injury, though it may be a sequela of a Table injury,” Decision 2;
see also Mar. 25, 2014, EDR 1:41:52–43:07 (similar), is in accordance with law. As the
U.S. Court of Appeals for the Federal Circuit has stated, “death alone is not compensable
if a [T]able injury has not been established.” Hodges, 9 F.3d at 960. Instead, in order to
recover for a death based on an alleged Table injury, a petitioner must establish two
things by a preponderance of the evidence: “First, the petitioner must show that one of
the four injuries or conditions listed in the Table occurred within the time period
specified in the Table for that injury or condition. Second, the petitioner must show that
death occurred as a sequela of that injury or condition.” Hellebrand v. Sec’y of Health &
Human Servs., 999 F.2d 1565, 1569 (Fed. Cir. 1993). Thus, to the extent that petitioners’
contend that A.T.W.’s death, alone, was a Table injury, see Pet’rs’ Mot. 7, such a
contention is contrary to law.
The court now turns to petitioners’ attempt to characterize A.T.W.’s presentation
immediately prior to his death as symptoms of encephalopathy. See Pet’rs’ Mot. 8–10.
Petitioners suggest that because A.T.W. was unconscious prior to being pronounced
dead, he was experiencing a “significantly decreased level of consciousness” as defined
by 42 C.F.R. § 100.3(b)(2)(i)(D). However, the facts of this case and binding case law do
not support petitioners’ claim.
As petitioners acknowledge, A.T.W. “died rapidly,” id. at 7, and was unconscious
for approximately forty minutes prior to his death, see Ex. 13 at 4 (stating that A.T.W.
was found at 10:50 p.m.); Ex. 13 at 4 (stating that A.T.W. was pronounced dead at 11:28
p.m.). That death is preceded by a loss of consciousness is not unusual, and petitioners
have not pointed to any evidence that suggests that A.T.W.’s loss consciousness was a
result of an encephalopathy. See Carraggio v. Sec’y of Health & Human Servs., No. 93-
0438V, 1997 WL 74694, at *5 (Fed. Cl. Jan. 31, 1997) (observing that “any death is
accompanied by . . . loss of consciousness and cardiovascular and respiratory arrest,” and
noting that the Vaccine Act “is intended to reimburse only those deaths in which it has
been shown, by a preponderance, that a listed Table injury occurred and death was a
sequela of that injury or condition”), aff’d sub nom. Carraggio v. Sec’y of Health &
Human Servs., 38 Fed. Cl. 211 (1997).
14
Although “nothing in the Vaccine Act . . . precludes death from being used as
evidence of a [T]able injury,” Jay v. Sec’y of Health & Human Servs., 998 F.2d 979, 983
(Fed. Cir. 1993), it is well-established that symptoms of death do not independently
establish the existence of a Table injury, Hodges, 9 F.3d at 960. To conclude otherwise
would result in recovery for any death that occurs within seventy-two hours of receipt of
a DTaP vaccine—a result that “is at odds with the plain language of the [Vaccine] Act.”
Hellebrand, 999 F.2d at 1571; see Hodges, 9 F.3d at 960 (“[D]eath alone is not
compensable if a [T]able injury has not been established.”). Thus, as respondent
correctly observes:
[T]he flaw with petitioners’ contention is that in every case involving death
(SIDS or otherwise) a vaccine recipient would exhibit a decreased level of
consciousness immediately preceding death. This would require the special
master to reflexively find a Table encephalopathy in any SIDS case occurring
within 72 hours of receipt of a DTaP vaccine.
Resp’t’s Resp. 7. The record supports a conclusion that the loss of consciousness A.T.W.
suffered prior to his death was a consequence of the dying process.
The special master ultimately determined that “[p]etitioners’ bare assertions
[were] insufficient to meet their burden.” Decision 8. In light of the foregoing, the court
concludes that “the special master has considered the relevant evidence of record, drawn
plausible inferences and articulated a rational basis for [the] decision.” Hines, 940 F.2d
at 1528. The court does not find the special master’s determination to be arbitrary and
capricious. Nor does the court find that the special master’s decision was contrary to law.
Accordingly, the court upholds the special master’s decision.
IV. Conclusion
The special master’s denial of petitioners’ claim was not arbitrary, capricious, an
abuse of discretion or otherwise not in accordance with law. Accordingly, the court
DENIES petitioners’ motion for review and SUSTAINS the decision of the special
master. The Clerk of the Court shall enter judgment accordingly.
IT IS SO ORDERED.
s/ Patricia Campbell-Smith
PATRICIA CAMPBELL-SMITH
Chief Judge
15