Milik v. Secretary of Health & Human Services , 822 F.3d 1367 ( 2016 )

United States Court of Appeals
for the Federal Circuit
______________________
MAREK MILIK, JOLANTA MILIK, LEGAL
GUARDIANS AND PARENTS OF A.M.,
Petitioners-Appellants
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee
______________________
2015-5109
______________________
Appeal from the United States Court of Federal
Claims in No. 1:01-vv-00064-PEC, Chief Judge Patricia E.
Campbell-Smith.
______________________
Decided: May 20, 2016
______________________
ROBERT JOEL KRAKOW, Law Office of Robert J. Kra-
kow, New York, NY, argued for petitioners-appellants.
ROBERT PAUL COLEMAN III, Torts Branch, Civil Divi-
sion, United States Department of Justice, Washington,
DC, argued for respondent-appellee. Also represented by
GABRIELLE M. FIELDING, VINCENT J. MATANOSKI, RUPA
BHATTACHARYYA, BENJAMIN C. MIZER, LISA WATTS.
______________________
2 MILIK v. HHS
Before O’MALLEY, WALLACH, and HUGHES, Circuit Judges.
O’MALLEY, Circuit Judge.
Petitioners Marek and Jolanta Milik (collectively, “the
Miliks”), on behalf of their son, A.M., appeal the final
judgment of the United States Court of Federal Claims
affirming a special master’s decision denying compensa-
tion under the National Childhood Vaccine Injury Act of
1986 (codified as amended at 42 U.S.C. §§ 300aa-1 to -34)
(“the Vaccine Act”). Milik v. Sec’y of Health & Human
Servs., 121 Fed. Cl. 68 (2015). The special master found
that the Miliks failed to prove by a preponderance of the
evidence that a measles, mumps, and rubella (“MMR”)
vaccine caused A.M. to develop a severe neurological
condition, involving developmental delay, spastic diplegia,
and motor difficulties. Milik v. Sec’y of Health & Human
Servs., No. 01-64V, 2014 WL 6488735 (Fed. Cl. Spec.
Mstr. Oct. 29, 2014) (“Special Master Decision”). Because
the Court of Federal Claims correctly concluded that the
special master’s decision was not arbitrary, capricious, an
abuse of discretion, or otherwise not in accordance with
law, we affirm.
I. BACKGROUND
A. Factual Background
The relevant facts are primarily those found by the
special master in his detailed October 29, 2014 decision.
A.M. was born on December 5, 1993, and was raised in a
predominately Polish-speaking household. Special Master
Decision, 2014 WL 6488735, at *3. At A.M.’s fifteen-
month routine examination, the pediatrician noted that
A.M. was “doing well” and was a “well child.” Id. In
December 1995, when A.M. was two years old, his pedia-
trician noted that “A.M. responded to sound, used 4 to 10
words (‘mama’ and ‘dada’ were noted specifically), walked
up stairs, and walked independently.” Id. During subse-
quent visits in 1996, A.M.’s new pediatrician, Dr. Mitchell
MILIK v. HHS 3
Weiler, noted that A.M. could speak several words in
English. Id.
On January 29, 1998, when A.M. was four years and
one month old, he received his second MMR vaccination.
Id. Eleven days later, A.M. returned to Dr. Weiler’s office
complaining of a sore throat. “Dr. Weiler diagnosed A.M.
with pharyngitis (throat swelling) and otitis media (ear
infection), and treated him with an antibiotic.” Id. Dr.
Weiler rechecked A.M.’s ears on February 23, 1998. His
notes from that appointment stated that A.M. had a
“Trauma. Slipped/Fell” and that he had a limp, but he
was seen by a podiatrist and the x-rays were negative. Id.
at *4.
On March 2, 1998, A.M. saw Dr. Joseph Maytal, a pe-
diatric neurologist, for complaints of limping. Id. Dr.
Maytal made several observations during the examina-
tion, including that A.M. did not know his last name, he
only spoke single words in English, and his parents were
unsure if he could use plurals. Id. Dr. Maytal gave A.M.
a provisional diagnosis of “Ataxia/Unsteadiness and
Developmental Delay.” Id. He also opined that A.M. had
two issues:
One is the longstanding issue of this youngster
who is globally delayed mostly in the lan-
guage/communicative skills but also in his fine
motor and possibly in his gross motor skills . . . .
The second issue is his acute symptoms of “limp-
ing.” As a precaution I would like to consider the
reason for his limping . . . with an MRI.
Id. (emphasis added). According to Dr. Maytal, the MRI
showed “diffuse white matter demyelination which is
consistent with demyelinating process most likely some
form of leukodystrophy.” Id.
In July 1998, A.M. saw Dr. Krystyna Wisniewski, a
pediatric neurologist who was part of an interdisciplinary
4 MILIK v. HHS
team of specialists at the George A. Jervis Clinic, New
York State Institute for Basic Research in Developmental
Disabilities (“IBR”). Dr. Wisniewski noted that A.M.’s
“cognitive function seems to be appropriate for his chrono-
logical age. He knows colors, numbers, and follows three
step commands. His visual perception seems to be im-
paired.” Milik, 121 Fed. Cl. at 75. Dr. Wisniewski diag-
nosed A.M. with “spastic diplegia, more right than left.”
Special Master Decision, 2014 WL 6488735, at *4.
Dr. Maria Malinowska, a bilingual psychologist,
evaluated A.M. in September 1998. Id. at *5. She deter-
mined that, at four years and nine months of age, A.M.
had “motor and speech/language difficulties as well as
attentional problems.” Id. Dr. Malinowska concluded
that these difficulties “are most likely due to an organic
brain dysfunction interfere [sic] with his intellectual and
adaptive functioning.” Id. A.M. also saw Dr. Ricardo
Madrid for a neuromuscular evaluation. Dr. Madrid
opined that A.M.’s condition was “suggestive but not
diagnostic of post infectious or post vaccination acute
encephalomyelitis.” Id. But because A.M. did not experi-
ence seizure, fever, and altered mental state—symptoms
that are typically expected with a vaccine complication—
Dr. Madrid doubted that A.M.’s disorder arose from a
“neurological complication associated with MMR vaccina-
tion.” Id.
The medical records provide little information regard-
ing A.M.’s care after 1998. A group of physicians re-
evaluated A.M.’s condition beginning in 2011. At that
time, A.M. was wheelchair-bound and unable to care for
himself. In March 2012, when he was eighteen years old,
A.M. saw a specialist in medical genetics who opined that
“[t]he finding of apparently normal development followed
by a sudden loss of abilities following an insult with
severe demyelination is suggestive of vanishing white
matter disease. This often presents during childhood with
ataxia following infection or fright.” Id. at *6.
MILIK v. HHS 5
B. Procedural History
The Miliks filed a petition for compensation on Janu-
ary 31, 2001, on behalf of A.M., alleging that he “suffered
injuries including spastic diplegia (paraplegia) causing
[him] to walk with a permanent and debilitating limp,
severe gross and fine motor difficulties as well as difficul-
ties learning, all of which were ‘caused-in-fact by admin-
istration of the MMR vaccination.’” Milik, 121 Fed. Cl. at
70-71. The Secretary filed a report opposing the petition
for compensation. At the Miliks’ request, proceedings
were delayed for several years to allow time to obtain
counsel and file expert reports.
The Miliks filed two expert reports, the first of which
was a one-page letter from Dr. Logush, a pediatric neurol-
ogist at the IBR where A.M. was treated. In that letter,
Dr. Logush stated that A.M.’s history was “suggestive but
not diagnostic of post infectious or post vaccine, immuno-
logically induced acute disseminated encephalitis vs.
encephalomyelitis.” Special Master Decision, 2014 WL
6488735, at *25. Dr. Logush offered the same conclusion
after he conducted a follow-up examination of A.M. in
February 2011. Milik, 121 Fed. Cl. at 77. Although Dr.
Logush participated in a telephone conference with the
special master where he stated that it was “very probable”
that the MMR vaccine caused A.M.’s injury, he did not
ultimately testify as the Miliks’ expert. Special Master
Decision, 2014 WL 6488735, at *25.
The Miliks’ second expert report, filed in November
2011, was from Dr. Nizar Souayah, the neurologist who
testified as their expert witness. Dr. Souayah is board-
certified in neurology, electrodiagnostic medicine, and
neuromuscular medicine. Id. at *8. Dr. Souayah opined
that A.M.’s condition was “consistent with an extensive
white matter disease that started approximately 3 weeks
after MMR vaccination” and that “A.M. suffered an ‘en-
cephalopathy or encephalitis,’ caused by the MMR vac-
6 MILIK v. HHS
cine, at that time.” Id. at *9. In both his written report
and his testimony, Dr. Souayah opined that the MMR
vaccine caused A.M.’s injury because: (1) A.M. experi-
enced normal health and development before the vaccine;
(2) 22 days after receiving the MMR vaccination, A.M.
developed a limp; (3) no other cause for A.M.’s injury was
identified, despite extensive testing; and (4) the MMR
vaccine has been suspected of causing central nervous
system damage. Id.
In response, the government filed two expert reports
from Dr. Michael Kohrman, who is “board-certified in
neurology and psychiatry, with a special competency in
child neurology and sleep medicine, and also board-
certified in pediatrics.” Id. Dr. Kohrman opined that
A.M. had a pre-existing global developmental delay, and
that his condition is “likely to be a result of a ‘vanishing
white matter’ disease, such as an unidentified form of
leukodystrophy, that began around two years of age when
the first signs of developmental delay appeared.” Id. In
the alternative, Dr. Kohrman submitted that, even if
A.M.’s symptoms did not appear until after the MMR
vaccination, “the cause would still more likely have been
an infection from which A.M. was suffering at the time,
rather than his vaccination.” Id.
In March 2013, the special master held an evidentiary
hearing and heard testimony from Dr. Souayah and Dr.
Kohrman. Both parties filed post-hearing briefs. A year
after the hearing, the Miliks filed a motion for considera-
tion of new medical evidence, seeking to introduce a letter
from Dr. Maytal, A.M.’s pediatric neurologist. Id. at *7.
In that letter, Dr. Maytal sought to clarify that his use of
the term “longstanding” in reference to A.M.’s global delay
should be interpreted as “a condition existing prior to
examination,” and that his group was “unable to deter-
mine the time length of symptoms.” Id. at *12. The
special master admitted the letter over the government’s
objection.
MILIK v. HHS 7
On October 29, 2014, the special master issued a de-
tailed decision denying the Miliks’ petition for compensa-
tion. At the outset, the special master noted that,
although both experts agreed that A.M. suffers from a
severe developmental disorder, they disagreed as to the
cause. Weighing the expert testimony, the special master
found Dr. Kohrman—the government’s expert—more
persuasive, and credited his opinion that the onset of
A.M.’s developmental delay preceded the MMR vaccina-
tion. Id. at *10.
Recognizing that the parties presented A.M.’s condi-
tion as a single global entity involving both mental delay
and physical problems, and that the Miliks never argued
that they were distinct injuries, the special master found
no evidentiary basis to conclude that part of A.M.’s disa-
bility was vaccine-caused. Id. at *27. 1 Accordingly, the
special master concluded that the Miliks had not shown
by preponderant evidence that the MMR vaccination
caused A.M.’s disorder. Id. at *27-28 (citing Althen v.
Sec’y of Health & Human Servs., 418 F.3d 1274, 1278
(Fed. Cir. 2005)). In the alternative, the special master
found that: (1) A.M. did not suffer an encephalopathy or
encephalitis; (2) even if he did, the more likely cause was
an infection A.M. had at the time; and (3) the onset of
A.M.’s limping was outside the medically accepted
timeframe. Id. at *17-20.
The Miliks sought review of the special master’s deci-
sion in the Court of Federal Claims, asserting three
primary arguments. First, they argued that the Court of
1 During oral argument before this court, counsel
for the Miliks reiterated that they did not attempt to
separate A.M.’s condition into two distinct issues. Oral
Argument at 19:17-20:08, available at http://
oralarguments.cafc.uscourts.gov/default.aspx?fl=2015-
5109.mp3.
8 MILIK v. HHS
Federal Claims is constitutionally required to conduct a
de novo review of the special master’s decision. Milik, 121
Fed. Cl. at 72 n.11 (citing Bruesewitz v. Wyeth LLC, 562
U.S. 223 (2011)). Second, the Miliks objected to the
special master’s onset finding, and his determination that
Dr. Kohrman was more credible and persuasive than Dr.
Souayah. Id. at 72. Finally, the Miliks objected to the
special master’s alternative findings.
In a decision dated April 29, 2015, the Court of Feder-
al Claims sustained the special master’s decision. The
court began by dismissing the Miliks’ constitutional
argument regarding the applicable standard of review in
a footnote, agreeing with the government that the Vaccine
Act “does not bar a petitioner from later filing a claim in
an Article III federal court, and that petitioners’ reliance
on Bruesewitz is misplaced.” Id. at 72 n.11.
The court then considered the Miliks’ objections to the
special master’s onset finding that A.M.’s global develop-
mental delay preceded his MMR vaccination. Although
the court found that some of Dr. Kohrman’s inferences
based on A.M.’s well-child examinations were not well-
supported, it concluded that the special master’s decision
“was not based solely, or even largely, on those records.”
Id. at 86. Instead, the special master based his decision
on a number of other records, including: (1) Dr. Maytal’s
March 1998 diagnosis of longstanding global delay; (2) Dr.
Malinowska’s September 1998 diagnosis of delay in
communication, daily living skills, and motor skills;
(3) A.M.’s parents’ repeated reports that he suffered no
cognitive regression; and (4) Dr. Kohrman’s interpretation
of two MRI studies of A.M.’s brain taken in 1998. Id.
Because the special master’s onset decision was based on
reliable evidence in the record, the court concluded that it
was not arbitrary or capricious. And, because the court
sustained that decision, it found it unnecessary to consid-
er the Miliks’ objection to the special master’s alternative
findings. Id. at 87.
MILIK v. HHS 9
The Miliks timely appealed to this court, and we have
jurisdiction pursuant to 28 U.S.C. § 1295(a)(3) and 42
U.S.C. § 300aa-12(f).
II. DISCUSSION
On appeal, the Miliks argue that: (1) the Vaccine Act,
and its attendant arbitrary and capricious standard of
review, is unconstitutional because it deprives petitioners
of their right to de novo review in an Article III court; and
(2) even if the standard of review is constitutional, the
special master’s decision denying compensation is arbi-
trary and capricious because it is unsupported in the
record. We address each argument in turn.
A. Jurisdiction and Standard of Review
“Childhood vaccinations, though an important part of
the public health program, are not without risk.” Terran
v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1306
(Fed. Cir. 1999). Recognizing that vaccines can cause
serious adverse side effects in rare circumstances, “Con-
gress became concerned that tort liability and related
costs might drive up the prices of vaccines and discourage
vaccine manufacturers from staying in this market, and
that normal tort litigation might leave many sufferers of
vaccine-caused injuries uncompensated.” Id. at 1307
(citing H.R. Rep. No. 99-908, at 1, 4, 6-7 (1986), reprinted
in 1986 U.S.C.C.A.N. 6287, 6345, 6347-48).
Accordingly, Congress enacted the Vaccine Act in
1986 to increase the safety and availability of vaccines.
Id. at 1307. The Vaccine Act created the National Vac-
cine Injury Compensation Program (“the Program”),
through which claimants can petition for compensation
for vaccine-related injury or death. See 42 U.S.C.
§ 300aa-10(a). In doing so, the Act established a no-fault
compensation program “designed to work faster and with
greater ease than the civil tort system.” Shalala v. White-
cotton, 514 U.S. 268, 269 (1995). The Act requires claim-
10 MILIK v. HHS
ants to seek relief through the Program before filing a
civil action in a state or federal court against a vaccine
administrator or manufacturer for damages in an amount
greater than $1,000. 42 U.S.C. § 300aa-11(a)(2)(A).
As originally enacted, the Vaccine Act provided the
“district courts of the United States” jurisdiction to de-
termine if a petitioner was entitled to compensation under
the Program. National Childhood Vaccine Injury Act of
1986, Pub. L. No. 99-660, § 2112(a), 100 Stat. 3743, 3761.
The district court would designate a special master to
prepare proposed findings of fact and conclusions of law.
Id. at § 2112(c), 100 Stat. at 3761-62. The Act provided
that, “upon objection . . . to the proposed findings of fact or
conclusions of law prepared by the special master or upon
the court’s own motion, the court shall undertake a review
of the record of the proceedings and may thereafter make
a de novo determination of any matter and issue its
judgment accordingly, including findings of fact and
conclusions of law, or remand for further proceedings.”
Id. at § 2112(d)(1), 100 Stat. at 3762.
The Vaccine Compensation Amendments of 1987
transferred jurisdiction from “district courts of the United
States” to “the United States Claims Court.” See Omni-
bus Budget Reconciliation Act of 1987, Pub. L. No. 100-
203, § 4307, 101 Stat. 1330, 1330-224 to 1330-225 (amend-
ing 42 U.S.C. § 300aa-11). 2 Congress subsequently
amended the Act to establish, within the United States
Claims Court, an office of special masters to review com-
pensation claims. See Omnibus Budget Reconciliation Act
of 1989, Pub. L. No. 101-239, § 6601(e), 103 Stat. 2106,
2 Congress later replaced the references to the
“United States Claims Court” with the “United States
Court of Federal Claims.” See Court of Federal Claims
Technical and Procedural Improvements Act of 1992, Pub.
L. No. 102-572, § 902, 106 Stat. 4506, 4516.
MILIK v. HHS 11
2286-89 (amending 42 U.S.C. § 300aa-12). At the same
time, Congress changed the standard of review. Rather
than de novo review, the amendment provided that the
Claims Court “shall have jurisdiction to . . . 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 and issue its own
findings of fact and conclusion of law.” Id. at
§ 6601(h)(2)(B), 103 Stat. at 2289-90 (codified at 42 U.S.C.
§ 300aa-12(e)(2)(B)). By statute, the Court of Federal
Claims’ judgment may be reviewed in this court. 42
U.S.C. § 300aa-12(f).
We review an appeal from the Court of Federal
Claims in a Vaccine Act case de novo, applying the same
standard of review that court applied in reviewing the
special master’s decision. Broekelschen v. Sec’y of Health
& Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010)
(citing Andreu v. Sec’y of Health & Human Servs., 569
F.3d 1367, 1373 (Fed. Cir. 2009)). Although we review
legal determinations without deference, we review the
special master’s factual findings under the arbitrary and
capricious standard. Griglock v. Sec’y of Health & Human
Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012); see Hines v.
Sec. of Health & Human Servs., 940 F.2d 1518, 1524 (Fed.
Cir. 1991) (“In effect, then, we review the underlying
decision of the special master under the arbitrary and
capricious standard of § 300aa-12(e)(2)(B).”).
The arbitrary and capricious standard is “difficult for
an appellant to satisfy with respect to any issue, but
particularly with respect to an issue that turns on the
weighing of evidence by the trier of fact.” Lampe v. Sec’y
of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir.
2000). If the special master “has considered the relevant
evidence of record, drawn plausible inferences and articu-
lated a rational basis for the decision,” then reversible
error is “extremely difficult to demonstrate.” Hines, 940
F.2d at 1528. As this court has recognized:
12 MILIK v. HHS
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 accumu-
lated 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 pro-
cess. Our cases make clear that, on our review of
the judgment of the Court of Federal Claims, we
remain equally deferential. That level of defer-
ence is especially apt in a case in which the medi-
cal evidence of causation is in dispute.
Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958,
961 (Fed. Cir. 1993) (internal citations omitted). Accord-
ingly, we “do not reweigh the factual evidence, assess
whether the special master correctly evaluated the evi-
dence, 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) (citing Broekelschen, 618 F.3d at 1349). Rather, as
long as the special master’s “conclusion [is] based on
evidence in the record that [is] not wholly implausible, we
are compelled to uphold that finding as not being arbi-
trary or capricious.” Cedillo v. Sec’y of Health & Human
Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010) (citation
omitted).
On appeal, the Miliks argue that the Vaccine Act un-
constitutionally denies them access to de novo review in
an Article III court. Specifically, they argue that, by
limiting a vaccine injury claimant to filing a claim against
the Secretary in an Article I court, “the Vaccine Act has
deprived petitioners of the rights granted in Article III of
the United States Constitution and the common law
MILIK v. HHS 13
protections afforded in state courts for tortious injuries
against the manufacturers of vaccines.” Pet’rs Br. 14-15.
The Miliks point to two recent Supreme Court decisions
which they argue, when taken together, support their
argument that the Vaccine Act is unconstitutional:
Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011), and Stern
v. Marshall, 564 U.S. 462 (2011).
In Bruesewitz, the Court held that the Vaccine Act
“pre-empts all design-defect claims against vaccine manu-
facturers brought by plaintiffs who seek compensation for
injury or death caused by vaccine side effects.” 562 U.S.
at 243. There, the Court considered 42 U.S.C. § 300aa-
22(b)(1), which provides that:
No vaccine manufacturer shall be liable in a civil
action for damages arising from a vaccine-related
injury or death associated with the administration
of a vaccine after October 1, 1988, if the injury or
death resulted from side effects that were una-
voidable even though the vaccine was properly
prepared and was accompanied by proper direc-
tions and warnings.
Given the statutory text, the Court concluded that, as
long as “there was proper manufacture and warning, any
remaining side effects, including those resulting from
design defects, are deemed to have been unavoidable.
State-law design-defect claims are therefore preempted.”
Id. at 231-32.
The Miliks also cite the Supreme Court’s decision in
Stern, which reiterated that:
Congress may not “withdraw from judicial cogni-
zance any matter which, from its nature, is the
subject of a suit at the common law, or in equity,
or admiralty.” Murray’s Lessee v. Hoboken Land
& Improvement Co., 59 U.S. 272 (1856). When a
suit is made of “the stuff of the traditional actions
14 MILIK v. HHS
at common law tried by the courts at Westminster
in 1789,” . . . and is brought within the bounds of
federal jurisdiction, the responsibility for deciding
that suit rests with Article III judges in Article III
courts. The Constitution assigns that job—
resolution of “the mundane as well as the glamor-
ous, matters of common law and statute as well as
constitutional law, issues of fact as well as issues
of law”—to the Judiciary.
564 U.S. at 484 (citation omitted). Applying these princi-
ples in Stern, the Court held that an Article I bankruptcy
court “lacked the constitutional authority to enter a final
judgment on a state law counterclaim that is not resolved
in the process of ruling on a creditor’s proof of claim.” Id.
at 503. In reaching this conclusion, the Court noted that
it was not dealing with “a situation in which Congress
devised an ‘expert and inexpensive method for dealing
with a class of questions of fact which are particularly
suited to examination and determination by an adminis-
trative agency specially assigned to that task.’” Id. at 494
(citation omitted). Instead, the “‘experts’ in the federal
system at resolving common law counterclaims such as
Vickie’s [tortious interference counterclaim] are the
Article III courts, and it is with those courts that her
claim must stay.” Id. 3
3 Stern was recently narrowed in Wellness Interna-
tional Network v. Sharif, 135 S. Ct. 1932 (2015). There,
the Court made clear that “Article III is not violated when
the parties knowingly and voluntarily consent to adjudi-
cation by a bankruptcy judge.” Id. at 1939. The Court
explained that “allowing Article I adjudicators to decide
claims submitted to them by consent does not offend the
separation of powers so long as Article III courts retain
supervisory authority over the process.” Id. at 1944.
MILIK v. HHS 15
The Miliks’ briefing on Stern is sparse, and the gov-
ernment’s response does not address it. At oral argu-
ment, counsel for the Miliks clarified their position as
follows:
Under the original understanding of the Act, there
was an opportunity for a petitioner to reject the
judgment in the Vaccine court or elect to proceed
in a state or federal court under common law or
under state statutes. That is now gone. We sub-
mit that a litigant bringing these kinds of claims
is entitled to de novo review in an Article III
court, as it traditionally would be available.
Oral Argument at 3:02-3:37, available at http://
oralarguments.cafc.uscourts.gov/default.aspx?fl=2015-
5109.mp3. The Miliks suggest that, in light of Stern—
which says that, unless certain exceptions apply, Con-
gress cannot take away access to Article III courts for
resolution of common law claims—the Supreme Court’s
decision in Bruesewitz rendered the Vaccine Act unconsti-
tutional because it does just that. We disagree.
The separation of powers concerns at play in Stern
are not implicated by Bruesewitz. In the Vaccine context,
the only questions the special master addresses are those
related to the fact of injury and causation. No liability
issues are determined by the special master; it is a no
fault statute that assumes the right to recovery whenever
injury and causation are established. The “design defect”
question is never addressed by the Article I court or its
special master program.
The issues that are addressed are not barred from
subsequent Article III review. While the legal theories
under which questions of injury and causation may be
reconsidered by the Article III court may be narrowed by
Bruesewitz’s reading of the Vaccine Act, those questions
nonetheless can be revisited. Indeed, the Miliks could
revisit the very issues decided by the special master in the
16 MILIK v. HHS
context of a manufacturing defect claim, breach of express
or implied warranty claims, or even a contract claim if the
predicate for such claims exists. Thus, even if Stern were
applicable to these facts, its limitations would not be
violated.
More importantly, however, is the fact that Stern is
not applicable here. The only constitutional question
Bruesewitz implicates is whether Congress may preempt a
cause of action altogether, such that no court may decide
the claim. There is no doubt Congress has the authority
under the Supremacy Clause to preempt state law causes
of action which conflict with the federal standards and
policies set forth in a duly authorized federal statute. See
Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 541 (2001)
(“State action may be foreclosed by express language in a
congressional enactment, by implication from the depth
and breadth of a congressional scheme that occupies the
legislative field, or by implication because of a conflict
with a congressional enactment.” (internal citations
omitted)). That is precisely what the Court in Bruesewitz
said Congress did when it passed the Vaccine Act. See
Bruesewitz, 562 U.S. at 231-33. We have no authority to
disagree with that conclusion, and do not believe Stern
provides a vehicle for doing so. Stern simply does not
address the preemption of state law claims; it only ad-
dresses who may decide claims that are not otherwise
preempted.
Because the Court’s decision in Stern does not apply
in these circumstances, and because the Court’s decision
in Bruesewitz has no bearing on the applicable standard
of review, we continue to review the special master’s
findings of fact under the deferential arbitrary and capri-
cious standard.
MILIK v. HHS 17
B. The Special Master’s Decision Was
Neither Arbitrary Nor Capricious
A petitioner seeking compensation under the Vaccine
Act must show, by a preponderance of the evidence, “that
the injury or death at issue was caused by a vaccine.”
Broekelschen, 618 F.3d at 1341 (citing 42 U.S.C. §§ 300aa-
11(c)(1), -13(a)(1)). A petitioner can establish causation in
one of two ways. Id. If the petitioner shows that he or
she received a vaccination listed on the Vaccine Injury
Table, 42 U.S.C. § 300aa-14, and suffered an injury listed
on that table within a statutorily prescribed time period,
then the Act presumes the vaccination caused the injury.
Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367,
1374 (Fed. Cir. 2009). Where, as here, the injury is not on
the Vaccine Injury Table, the petitioner may seek com-
pensation by proving causation-in-fact. Id.
To prove causation, a petitioner must show that the
vaccine was “not only a but-for cause of the injury but also
a substantial factor in bringing about the injury.” Shyface
v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352
(Fed. Cir. 1999). Specifically, the petitioner must show
the following by a preponderance of the evidence: (1) a
medical theory causally connecting the vaccination to the
injury; (2) a logical sequence of cause and effect demon-
strating that the vaccination caused the injury; and (3) a
proximate temporal relationship between the vaccine and
the injury. Althen v. Sec’y of Health & Human Servs., 418
F.3d 1274, 1278 (Fed. Cir. 2005). If the petitioner satis-
fies this burden, he is “entitled to compensation unless
the government can show by a preponderance of the
evidence that the injury is due to factors unrelated to the
vaccine.” Broekelschen, 618 F.3d at 1341 (citing Doe v.
Sec’y of Health & Human Servs., 601 F.3d 1349, 1351
(Fed. Cir. 2010)).
The special master found that the Miliks met their
burden of establishing the first prong of the Althen test,
18 MILIK v. HHS
but failed to meet prongs two and three. Indeed, as to the
first prong, both parties’ experts agreed that the MMR
vaccination is capable of causing an encephalitis or en-
cephalopathy. Special Master Decision, 2014 WL
6488735, at *28. As to prong two, the special master
found that the Miliks failed to show that the MMR vac-
cine caused A.M.’s condition because the record evidence
revealed that A.M. had a preexisting developmental
delay. Id. 4 Although the special master deemed it unnec-
essary to address the third Althen prong, given his finding
that the Miliks did not satisfy the second, he nonetheless
found that A.M.’s condition did not fit the timeframe
discussed in the medical literature of record, thus preclud-
ing a finding of a proximate temporal relationship be-
tween the vaccine and injury. Id.
On appeal, the Miliks allege that there was “no credi-
ble evidence supporting the special master’s finding that
A.M. had a developmental disorder preceding the admin-
istration of the MMR vaccination.” Pet’rs Br. 11. Specifi-
cally, they argue that the special master erred in:
(1) determining that the onset of A.M.’s condition predat-
ed the vaccine; (2) rejecting Dr. Maytal’s clarification of
the term “longstanding”; and (3) crediting Dr. Kohrman’s
opinion over that of Dr. Souayah. As to the alternative
findings, the Miliks contend that the special master erred
in finding that they failed to show a medically appropriate
temporal relationship between A.M.’s condition and the
MMR vaccine.
The Miliks’ essentially ask this court to reweigh the
factual evidence and assess the credibility of the witness-
es. As an appellate tribunal, we can do neither. See
4 The special master clarified that the Miliks “failed
to show that A.M.’s condition was either initially caused
by his vaccinations, or was aggravated in any way by his
vaccinations.” Id. at *28 n.31.
MILIK v. HHS 19
Porter, 663 F.3d at 1249. And, as explained below, be-
cause the special master’s onset decision was based on
reliable evidence of record, it was neither arbitrary nor
capricious.
First, the Miliks argue that the contemporaneous
medical records reveal that A.M.’s pre-vaccination devel-
opment was normal, and that none of his treating physi-
cians noted any developmental delay. The Miliks further
note that the Court of Federal Claims found “multiple
instances where the record failed to support the special
master’s findings” with respect to A.M.’s pre-vaccination
development. Pet’rs Br. 17.
While it is true that the court found some of Dr.
Kohrman’s inferences unsupported, the special master
considered all of the evidence of record and relied sub-
stantially on one of the first contemporaneous medical
records created: Dr. Maytal’s diagnosis that A.M. suffered
from “longstanding” global developmental delay. See
Special Master Decision, 2014 WL 6488735, at *10. The
special master also relied on records from A.M.’s bilingual
psychologist—Dr. Malinowska—showing that, at age four
years and nine months, A.M. was delayed in his commu-
nication, daily living, and motor skills. Id. at *14. These
reports, coupled with the Miliks’ own representation that
A.M. did not experience cognitive regression post-
vaccination, supported the inference that A.M.’s develop-
mental delay must have preceded the vaccination. Id.
The special master further considered two of A.M.’s
post-vaccination MRI studies conducted in 1998, both of
which showed no interval changes. Id. at *15. Dr.
Kohrman opined that those studies were “consistent with
a demyelinating or dysmyelinating process that produced
longstanding developmental delay dating back to his
examination at the age of two years.” Id. In light of the
foregoing, we agree with the Court of Federal Claims that
“the special master based his finding that the onset of
20 MILIK v. HHS
A.M.’s global developmental delay preceded his MMR
vaccination on reliable evidence in the record.” Milik, 121
Fed. Cl. at 86.
Next, the Miliks argue that the special master unfair-
ly rejected as “litigation driven” Dr. Maytal’s letter clari-
fying his use of the term “longstanding.” As noted, in
March 1998, Dr. Maytal examined A.M. and identified
two issues: “longstanding” global delay and “acute” symp-
toms of limping. Roughly sixteen years later, Dr. Maytal
sent a letter stating that the “term ‘longstanding’ should
be interpreted as ‘a condition existing prior to examina-
tion.’ We are unable to determine the time length of
symptoms.” Special Master Decision, 2014 WL 6488735,
at *12.
Recognizing that Dr. Maytal’s letter was “not contem-
poraneous to the events to which it sp[oke],” and was
“outside the context of diagnosis and treatment,” the
special master found that it was “entitled to less defer-
ence.” Id. at *12 n.14. Although the special master
classified Dr. Maytal’s letter as “litigation driven,” he did
not reject it for that reason. Instead, the special master
“found that the meaning of longstanding urged by peti-
tioners simply did not make sense within the context of
Dr. Maytal’s original diagnosis.” Milik, 121 Fed. Cl. at 82.
The special master began by looking to the dictionary
definition of “longstanding,” which is “of long duration.”
Special Master Decision, 2014 WL 6488735, at *12 n.15.
He then noted that Dr. Maytal performed his initial
examination only one month after A.M. received the MMR
vaccination. The special master found that the “ordinary
use of the term ‘longstanding’ would indicate that the
delay had lasted substantially longer than one month.”
Id. at *12. Next, the special master found it significant
that Dr. Maytal’s original report contrasted A.M.’s
“longstanding” delay with his “acute” onset of limping,
which began ten days prior to the examination. To accept
MILIK v. HHS 21
Dr. Maytal’s clarification of “longstanding” to mean “a
condition existing prior to the examination,” would “erase
the distinction he originally drew between the ‘longstand-
ing’ global delay and the ‘acute’ symptom of limping, and
would make the original record incoherent as written.”
Id. On this record, we conclude that the special master
reasonably chose to credit the plain meaning of
“longstanding” over Dr. Maytal’s belated clarification.
Finally, the Miliks argue that the special master
erred in finding Dr. Kohrman, the government’s expert,
more persuasive than Dr. Souayah. It is well established
that “[f]inders of fact are entitled—indeed, expected—to
make determinations as to the reliability of the evidence
presented to them and, if appropriate, as to the credibility
of the persons presenting that evidence.” Moberly v. Sec’y
of Health & Human Servs., 592 F.3d 1315, 1326 (Fed. Cir.
2010). We have recognized that “special masters have
that responsibility in Vaccine Act cases.” Id. at 1325. We
have further recognized that a “special master’s decision
often times is based on the credibility of the experts and
the relative persuasiveness of their competing theories,”
and that the special master’s credibility findings “‘are
virtually unchallengeable on appeal.’” Broekelschen, 618
F.3d at 1347 (quoting Lampe, 219 F.3d at 1361).
The record reveals that the special master considered
the conflicting testimony from the parties’ experts and
reasonably concluded that Dr. Kohrman’s opinion was
entitled to more weight. To begin, the special master
found that Dr. Souayah’s testimony was based on a
“flawed assumption as to the time of onset of A.M.’s
neurological dysfunction.” Special Master Decision, 2014
WL 6488735, at *16. The special master also found that
Dr. Kohrman was more qualified to address the issues in
this case, given that he is a pediatric neurologist who sees
children with neurological problems on a regular basis.
In contrast, Dr. Souayah generally treats adults and “has
22 MILIK v. HHS
not diagnosed developmental delay in a child since his
residency in 2002.” Id.
The special master further found Dr. Kohrman more
persuasive because his testimony evinced a more detailed
understanding of the Denver Developmental Screening
Test (“the Denver test”), which Dr. Maytal applied in his
examination of A.M. Id. at *11-12. Dr. Kohrman ex-
plained that failing one of the Denver test’s language
domains is cause for concern, and that “Dr. Maytal noted
that A.M. failed three language domains—A.M. could not
use plurals, could not use his last name, and failed to
comprehend cold.” Id. at *12. While Dr. Kohrman ana-
lyzed A.M.’s scoring under the Denver criteria, Dr.
Souayah “did not touch on any of the specifics of the
Denver test.” Id. We find nothing arbitrary or capricious
about the special master’s determination that Dr.
Kohrman’s testimony was more persuasive than that of
Dr. Souayah. See Locane v. Sec’y of Health & Human
Servs., 685 F.3d 1375, 1379-80 (Fed. Cir. 2012) (finding
“nothing arbitrary or capricious” about the special mas-
ter’s decision to credit the government expert’s testimony
regarding the onset of injury).
This case, like so many in the Vaccine Act context,
turns on its facts. While we agree with the Court of
Federal Claims that some of the inferences Dr. Kohrman
drew from A.M.’s pre-vaccination records were unsup-
ported, we also agree that the special master’s decision
“was not based solely, or even largely, on those records.”
Milik, 121 Fed. Cl. at 86. We conclude that the special
master thoroughly reviewed all of the relevant evidence,
including the expert witnesses’ testimonies and reports,
and that the record supports his finding that A.M.’s
developmental delay predated the MMR vaccination. We
therefore cannot say that the special master’s onset
decision was arbitrary or capricious. Because the Miliks
failed to show that the MMR vaccination caused A.M.’s
injury, they did not meet their burden under the second
MILIK v. HHS 23
Althen prong, and the special master correctly denied the
petition for compensation. Given this conclusion, we need
not address the special master’s alternative findings.
III. CONCLUSION
While we certainly sympathize with the Milik family,
we conclude that the special master’s decision was not
“arbitrary, capricious, an abuse of discretion, or otherwise
not in accordance with law.” 42 U.S.C. § 300aa-
12(e)(2)(B). For the foregoing reasons, and because we
find the Miliks’ remaining arguments unpersuasive, we
affirm the judgment of the Court of Federal Claims.
AFFIRMED
COSTS
No costs.