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Nature of Suit Code: 469
Nature of Suit: 
Cause of Action: 

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United States Court of Appeals 

for the Federal Circuit ______________________ 

 

DOUG PALUCK, RHONDA PALUCK, AS PARENTS 

AND NATURAL GUARDIANS, ON BEHALF OF 

THEIR MINOR SON, K.P.,

Petitioners-Appellees

v.

SECRETARY OF HEALTH AND HUMAN 

SERVICES,

Respondent-Appellant

______________________ 

2014-5080

______________________ 

Appeal from the United States Court of Federal 

Claims in No. 1:07-vv-00889-CFL, Judge Charles F. 

Lettow. 

______________________ 

Decided: May 20, 2015 

______________________ 

SHEILA A. BJORKLUND, Lommen, Nelson, Cole & 

Stageberg, P.A., Minneapolis, MN, argued for petitionersappellees. 

PATRICK NEMEROFF, Commercial Litigation Branch, 

Civil Division, United States Department of Justice, 

Washington, DC, argued for respondent-appellant. Also 

represented by JOYCE R. BRANDA; ALEXIS B. BABCOCK,

Vaccine/Torts Branch, Civil Division, United States 

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 2 PALUCK v. HHS

Department of Justice, Washington, DC; MICHAEL S.

RAAB, Appellate Staff, Civil Division, United States 

Department of Justice, Washington, DC.

______________________ 

Before REYNA, MAYER, and CHEN, Circuit Judges.

MAYER, Circuit Judge. 

The Secretary of Health and Human Services appeals 

a final judgment of the United States Court of Federal 

Claims setting aside the special master’s findings of fact 

and conclusions of law and granting entitlement to compensation under the National Childhood Vaccine Injury 

Act of 1986, 42 U.S.C. §§ 300aa–1 to –34. (“Vaccine Act”). 

See Paluck ex rel. Paluck v. Sec’y of Health & Human 

Servs., 113 Fed. Cl. 210 (2013) (“Court of Federal Claims 

Decision II”). We affirm.

BACKGROUND

The Court of Federal Claims provided a comprehensive account of the relevant facts and they need only be 

briefly summarized here. K.P. was born on January 15, 

2004. He exhibited no apparent signs of disability during 

the first six to eight months of his life, but in October 

2004 K.P.’s daycare provider referred him to K.I.D.S., an 

infant development service, for evaluation. Id. at 213. 

After extensive testing, K.I.D.S. determined that K.P. 

suffered from significant delays in his gross motor skills 

and some delays in his fine motor skills. Id. at 214. 

Evaluation conducted using the Bayley Scales of Infant 

Development protocol, however, determined that K.P.’s 

“cognitive skills (i.e., ability to remember, problem solve, 

use and understand language, and identify early number 

concepts)” were “within normal limits.” The evaluators 

from K.I.D.S. noted that K.P. was “a social boy with a 

bright smile” who made “a nice variety of sounds while 

babbling using both consonants and vowels.” The evaluators ultimately concluded that K.P. presented a “mixed 

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PALUCK v. HHS 3

picture,” and that his “gross motor delays [were] impacting his ability to achieve age-level skills in other areas of 

development.” 

K.P. experienced recurrent rashes, which were later 

identified as a symptom of erythema multiforme. He also 

suffered from repeated ear infections. On December 27, 

2004, K.P. saw Stephen L. McDonough, M.D., his pediatrician, for a check of his ears. McDonough evaluated 

K.P. as having normal muscle tone, noting that he had 

“good head control and fairly good truncal control.” 

McDonough stated, however, that K.P. was “not pulling 

himself to stand or crawling yet.” Although McDonough 

indicated that K.P. might have “possible mild gross motor 

delay,” he also noted that K.P. was rolling over, trying to 

crawl, and had “several words.” 

McDonough saw K.P. on January 19, 2005 for his oneyear well baby visit. At this appointment, K.P. received 

doses of the measles-mumps-rubella (“MMR”), pneumococcal, and varicella vaccines. After examining K.P., 

McDonough described K.P.’s neuromuscular condition as 

“abnormal,” noting increased tone1 in his upper extremities and the presence of ankle clonus, an abnormal reflex 

movement. Although K.P. could “bang [two] cubes held 

[in his] hands,” “play ball with [the] examiner,” “pull to 

stand,” “stand holding on,” “say single syllables,” and “say 

dada/mama,” he could not “get to sitting” or “stand alone.” 

On January 21, 2005, two days after he was vaccinated, K.P. had a temperature of 101.5 degrees. Seven days 

later, on January 28, 2005, K.P. had a recorded temperature of 101.3 degrees. In the two weeks following the 

1 As Richard Frye, M.D., the Palucks’ expert, explained, “tone” is a measurement of the ability of the 

muscles to maintain the body in proper posture in different positions, such as sitting or standing.

 

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 4 PALUCK v. HHS

vaccinations, K.P. was generally fussy and did not nap or 

eat well.

In February 2005, Rhonda and Doug Paluck (the 

“Palucks”), K.P.’s parents, took him to the Pokorny Chiropractic Clinic, hoping to address his gross motor problems. On February 11, 2005, the chiropractor reported 

that K.P. was “spastic.” On March 24, 2005, McDonough 

referred K.P. to Siriwan Kriengkrairut, M.D., a pediatric 

neurologist. In making the referral, McDonough noted 

that K.P. suffered from “gross motor delay, global developmental delay, and hypertonicity.” 

After evaluating K.P., Kriengkrairut concluded that 

he suffered from “marked spasticity of the extremities” 

and “[g]lobal delayed development.” Kriengkrairut suggested to the Palucks that K.P.’s muscular abnormalities 

and developmental delays were possibly the result of a 

“central nervous system pathology.” 

On April 27, 2005, K.P. had a magnetic resonance imaging (“MRI”) exam of his brain. The results of this MRI 

exam were initially deemed to be normal. Subsequently, 

however, the MRI results were reexamined, and it was 

determined that they evidenced a thinning of the corporal 

callosum. In May 2005, K.P. was evaluated by a speech 

therapist who determined that he possessed fewer language skills than he did in October 2004, and that his 

total language score was in the first percentile. 

In July 2005, K.P. suffered a series of seizures and 

was hospitalized for three weeks. While in the hospital, 

he underwent another MRI exam, which showed further 

thinning of the corporal callosum. Theodore J. Passe, 

M.D., a radiologist who reviewed K.P.’s April and July 

2005 MRI results, concluded that they were “consistent 

with a progressing leukodystrophy” which could have a 

“hereditary, toxic or metabolic etiolog[y].” 

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PALUCK v. HHS 5

On October 27, 2005, K.P. had another MRI exam. 

Michael Frost, M.D., a physician who began treating K.P. 

in the summer of 2005, determined that this exam showed 

no significant changes in K.P.’s brain since the July 2005 

MRI exam. Frost concluded that “the progression of a 

signal change” in K.P.’s brain “between 4/27/05 and 

07/22/05 may have represented evolution of [one] toxic/metabolic event, which is now stable.” 

K.P. was subsequently diagnosed with an unspecified 

mitochondrial disorder. All parties agree that this mitochondrial disorder was most likely present from the time 

of K.P.’s birth. K.P. now lives in a state of severe neurological disability. He has “no purposeful movements” and 

“no specific smiling or distinctive eye contact.” K.P. has a 

tracheotomy tube and breathes with the assistance of a 

ventilator.

In December 2007, the Palucks filed a petition for 

compensation under the Vaccine Act. They alleged that 

K.P. sustained a permanent injury to his brain as a result 

of the MMR, pneumococcal, and varicella vaccines he 

received on January 19, 2005. Frye, the Palucks’ expert, 

testified that K.P.’s underlying mitochondrial disorder 

prevented him from coping with the oxidative stress from 

the vaccines he received. According to Frye, this led to 

“metabolic decompensation,” and eventually caused 

neurodegeneration and developmental regression. The 

special master, however, rejected the Palucks’ claim, 

concluding that Frye failed to provide a plausible medical 

theory causally connecting K.P.’s injury to the vaccines he 

received. See Paluck ex rel. Paluck v. Sec’y of Health & 

Human Servs., No. 07-889V, 2011 WL 6949326, at *16 

(Fed. Cl. Dec. 14, 2011) (“Special Master Decision I”). The 

special master determined, moreover, that K.P.’s neurological symptoms emerged too late to be causally linked to 

the vaccinations he received. Id. at *24–27. In the special 

master’s view, if K.P.’s neurodegeneration was vaccineinduced, he would have exhibited symptoms of neurologiCase: 14-5080 Document: 56-2 Page: 5 Filed: 05/20/2015
 6 PALUCK v. HHS

cal injury within two weeks of the date of his vaccinations. Id. at *27.

On appeal, the Court of Federal Claims concluded 

that the special master had “required a higher level of 

proof . . . than the Vaccine Act demands.” Paluck ex rel. 

Paluck v. Sec’y of Health & Human Servs., 104 Fed. Cl. 

457, 473 (2012) (“Court of Federal Claims Decision I”). 

According to the court, the special master had no reasonable basis for rejecting Frye’s theory of causation. Id. at 

474. The court further determined that “[i]t was arbitrary 

and capricious for the special master to set a hard and 

fast limit of two weeks” between vaccination and the 

onset of symptoms of vaccine-induced neurological injury. 

Id. at 482. Because the special master “misapprehend[ed]

the testimony of Dr. Frye and ignor[ed] salient medicalrecord evidence of [K.P.’s] symptoms during the relevant 

time period,” id. at 483, the court vacated the special 

master’s decision and remanded for further proceedings.

On remand, the special master accepted the government’s apparent concession that Frye had presented a plausible medical theory explaining how vaccination could 

aggravate an underlying mitochondrial disorder.2 See Paluck 

ex rel. Paluck v. Sec’y of Health & Human Servs., No. 07-

889V, 2013 WL 2453747, at *42 (Fed. Cl. May 10, 2013)

(“Special Master Decision II”). The special master determined, however, that K.P.’s condition did not deteriorate in 

the manner predicted by Frye’s theory. In the special mas2 The special master determined that K.P.’s claim 

should be treated not as a new injury claim, but instead 

as a claim for the significant aggravation of his preexisting mitochondrial disorder. See 42 U.S.C. § 300aa–

33(4) (“The term ‘significant aggravation’ means any 

change for the worse in a preexisting condition which 

results in markedly greater disability, pain, or illness 

accompanied by substantial deterioration of health.”).

 

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PALUCK v. HHS 7

ter’s view, Frye’s theory predicted “a dramatic and continual 

deterioration, beginning within two to three weeks after” 

vaccination. Id. at *49. The special master concluded, however, that K.P. did not manifest any symptoms of neurological 

injury within three weeks of his vaccinations, id. at *55–62,

and did not experience the type of “linear” deterioration that 

Frye’s theory of causation required, id. at *49.

On appeal, the Court of Federal Claims held that the 

special master had misconstrued Frye’s theory of causation. 

Court of Federal Claims Decision II, 113 Fed. Cl. at 234–

35. According to the court, “[t]o fall within Dr. Frye’s

theory and the applicable medical literature, it [was]

sufficient if [K.P.’s] medical records show[ed] a decline in 

condition over time, notwithstanding periods of remission

or modest improvement.” Id. The court determined, 

moreover, that it was arbitrary and capricious for the 

special master to disregard probative medical record 

evidence showing that K.P. experienced progressive 

neurological deterioration in the months following his 

vaccinations. Id. at 235–39. Because the Palucks had 

demonstrated, “by a preponderance of the evidence, that 

[K.P.’s] existing medical setbacks were significantly 

aggravated by his receipt of the vaccinations within a 

medically acceptable time,” the Court of Federal Claims 

vacated the special master’s decision and remanded the 

case for a determination of the amount of compensation 

the Palucks were due. Id. at 241.

The government then filed a timely appeal to this 

court.3 We have jurisdiction under 42 U.S.C. § 300aa–

12(f). 

3 Contrary to the Palucks’ assertions, the government’s appeal to this court was not untimely filed. The 

government filed its notice of appeal on April 25, 2014, 

which was within sixty days of the Court of Federal 

 

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DISCUSSION

A. Standard of Review

“In reviewing an appeal from a judgment of the Court 

of Federal Claims in a Vaccine Act case, we apply the 

same standard of review as the Court of Federal Claims 

applied to the special master’s decision.” Andreu ex rel. 

Andreu v. Sec’y of Dep’t of Health & Human Servs., 569 

F.3d 1367, 1373 (Fed. Cir. 2009); see also Koehn ex rel. 

Koehn v. Sec’y of Health & Human Servs., 773 F.3d 1239, 

1243 (Fed. Cir. 2014). Although we review legal determiClaims’ entry of judgment on February 28, 2014. See id.

§ 300aa–12(f) (providing that an appeal to this court must 

be filed “within 60 days of the date” the Court of Federal 

Claims enters judgment).

The Palucks contend that the Court of Federal 

Claims’ October 29, 2013, decision—which set aside the 

special master’s decision denying entitlement and remanded for a determination of compensation—was a 

“final judgment” that triggered the running of the sixtyday appeal period. This argument is without merit. 

Because the Court of Federal Claims’ October 29, 2013, 

decision determined entitlement, but remanded to the 

special master for consideration of the appropriate 

amount of compensation to be awarded, see Court of 

Federal Claims Decision II, 113 Fed. Cl. at 241, it was not 

an appealable final judgment. See Flanagan v. United 

States, 465 U.S. 259, 263 (1984) (The “final judgment rule 

requires that a party must ordinarily raise all claims of 

error in a single appeal following final judgment on the 

merits.” (citations and internal quotation marks omitted)); Teledyne Cont’l Motors v. United States, 906 F.2d 

1579, 1582 (Fed. Cir. 1990) (emphasizing that “a judgment limited to the issue of liability, where the assessment of damages or other relief remains open, is not 

final”).

 

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PALUCK v. HHS 9

nations without deference, we review findings of fact 

under the arbitrary and capricious standard. Griglock v. 

Sec’y of Health & Human Servs., 687 F.3d 1371, 1374 

(Fed. Cir. 2012); see also Moberly ex rel. Moberly v. Sec’y of 

Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 

2010).

B. The Vaccine Act

“Childhood vaccinations, though an important part of 

the public health program, are not without risk.” Terran 

ex rel. Terran v. Sec’y of Health & Human Servs., 195 F.3d 

1302, 1306 (Fed. Cir. 1999). Recognizing that “a small 

but significant number” of individuals will be “gravely 

injured” as a result of inoculation, H.R. Rep. No. 99–908, 

99th Cong., 2d Sess. 4 (1986), reprinted in 1986 

U.S.C.C.A.N. 6345, Congress created a federal no-fault 

compensation scheme under which awards were to “be 

made to vaccine-injured persons quickly, easily, and with 

certainty and generosity.” H.R. Rep. No. 99–908, at 3, 

1986 U.S.C.C.A.N. at 6344; see Shalala v. Whitecotton, 

514 U.S. 268, 269 (1995) (explaining that the Vaccine Act 

compensation system was “designed to work faster and 

with greater ease than the civil tort system”).

A petitioner seeking compensation under the Vaccine

Act must establish, by a preponderance of the evidence, 

that a covered vaccine caused the claimed injury. See

Moberly, 592 F.3d at 1321. Where, as here, the claimed 

injury is not listed in the Vaccine Injury Table, see 42 

U.S.C. § 300aa–14, a claimant may obtain compensation 

by showing that his injury was “caused in fact” by the 

vaccine or vaccines he received. See Andreu, 569 F.3d at 

1374. In order to prove causation in fact, a petitioner 

must: (1) provide a medical theory causally connecting the 

vaccination to the injury; (2) demonstrate a logical sequence of cause and effect showing that the vaccination

was the reason for the injury; and (3) establish a proximate temporal relationship between the vaccination and 

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 10 PALUCK v. HHS

the injury. Althen v. Sec’y of Health & Human Servs., 418 

F.3d 1274, 1278 (Fed. Cir. 2005). If the petitioner satisfies this burden, he is entitled to compensation unless the 

government demonstrates by a preponderance of the 

evidence that the injury was in fact caused by factors 

unrelated to the vaccine. 42 U.S.C. § 300aa–13(a)(1)(B). 

The Palucks assert that their son suffered severe 

neurodegeneration as a result of the vaccines he received 

on January 19, 2005. They contend that these vaccines 

caused a significant aggravation of K.P.’s underlying 

mitochondrial disorder, leading to alterations in his brain 

development and subsequent neurodevelopmental regression. In support of their claim, the Palucks proffered 

several medical articles, including: (1) an article discussing four children suffering from both a mitochondrial 

disorder and autism who experienced developmental 

regression following vaccination, see John Shoffner et al., 

Fever Plus Mitochondrial Disease Could Be Risk Factors 

for Autistic Regression, J. Child Neurology 3 (2009) 

(“Shoffner”); (2) an article discussing a link between 

infection and subsequent neurodegenerative events in 

persons with mitochondrial disorders, see Joseph L. 

Edmonds et al., The Otolaryngological Manifestations of 

Mitochondrial Disease & the Risk of Neurodegeneration 

with Infection, 128 Archives of Otolaryngology-Head & 

Neck Surgery 30 (2002) (“Edmonds”); and (3) a case study 

of Hannah Poling, a child with a mitochondrial disorder, 

who experienced fever and severe developmental regression shortly after vaccination, see Jon S. Poling et al., 

Developmental Regression and Mitochondrial Dysfunction 

in a Child with Autism, 21(2) J. Child Neurology 170 

(2006) (the “Poling case study”). The Palucks also relied 

upon reports and testimony from Frye, a pediatric neurologist, who explained that in a child with an underlying 

mitochondrial disorder, vaccination can lead to an “overwhelming immune response” and subsequent neurodegeneration. Frye explained that “vaccines, by intention, 

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PALUCK v. HHS 11

activate the immune system,” leading to “potentially 

toxic” reactive oxygen species and reactive nitrogen 

species. In an individual with a mitochondrial disorder, 

these potentially toxic elements can accumulate, causing 

oxidative stress, and setting off “a cascade of intracellular 

events” that leads to “apoptosis or cellular death.” Frye 

asserted that because cells in the brain are particularly 

vulnerable to oxidative stress, vaccination can cause 

persons with underlying mitochondrial disorders to experience neurodegeneration and developmental regression. 

Frye emphasized, moreover, that “the interaction between 

oxidative stress and mitochondria [is] something that’s 

progressive over time.”

On appeal, the government does not meaningfully 

dispute that Frye’s theory of causation is medically plausible. Indeed, before the special master the government 

conceded that vaccination could have, in theory, exacerbated K.P.’s underlying mitochondrial disorder. See 

Special Master Decision II, 2013 WL 2453747, at *42. The 

government contends, however, that the Court of Federal 

Claims erred in setting aside the special master’s finding 

that K.P.’s health did not deteriorate as quickly or as 

consistently as anticipated by Frye’s medical theory. In 

the government’s view, because the special master had a 

“rational basis” for “concluding that K.P.’s condition did 

not change following his vaccinations in the manner 

predicted by [Frye’s] medical theory,” the Court of Federal 

Claims exceeded its authority by reweighing the evidence 

and “second guess[ing]” the special master’s “factintensive conclusions.”

We do not find this argument persuasive. By statute, 

the Court of Federal Claims is empowered 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 conclusions of law . . . .” 

42 U.S.C. § 300aa–12(e)(2)(B). Where, as here, a special 

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 12 PALUCK v. HHS

master misapprehends a petitioner’s theory of causation, 

misconstrues his medical records, and makes factual 

inferences wholly unsupported by the record, the Court of 

Federal Claims is not only authorized, but obliged, to set 

aside the special master’s findings of fact and conclusions 

of law. See Andreu, 569 F.3d at 1375 (concluding that a 

special master erred in disregarding probative testimony 

from a petitioner’s treating physicians); Capizzano v. Sec’y 

of Health & Human Servs., 440 F.3d 1317, 1325 (Fed. Cir. 

2006) (concluding that a special master “impermissibly 

raise[d] a claimant’s burden under the Vaccine Act”); 

Althen, 418 F.3d at 1280–81 (concluding that a special 

master improperly required medical literature linking a 

particular vaccine to the claimant’s injury). While review 

of the factual findings made by a special master is highly 

deferential, see Porter v. Sec’y of Health & Human Servs., 

663 F.3d 1242, 1249 (Fed. Cir. 2011), both this court and 

the Court of Federal Claims have a duty to ensure that 

the special master has properly applied Vaccine Act 

evidentiary standards, “considered the relevant evidence 

of record, drawn plausible inferences and articulated a 

rational basis for [his] decision.” Hines ex rel. Sevier v. 

Sec’y of Dep’t of Health & Human Servs., 940 F.2d 1518, 

1528 (Fed. Cir. 1991).

C. Progressive Neurological Decline

The special master acknowledged that K.P. experienced significant neurodevelopmental regression between 

January 19, 2005, the date he was vaccinated, and July 

30, 2005, the date he was discharged from the hospital. 

See Special Master Decision II, 2013 WL 2453747, at *42

(“By virtually any metric, [K.P.] was worse.”). He concluded, however, that K.P.’s post-vaccination deterioration did not align with Frye’s medical theory because that 

deterioration was not “linear,” id. at *49, and K.P. did not 

manifest identifiable symptoms of neurologic injury 

within three weeks of his vaccinations, id. at *62. In an 

exceptionally thorough and well-reasoned opinion, the 

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PALUCK v. HHS 13

Court of Federal Claims correctly determined that the 

special master misapprehended Frye’s medical theory and 

acted arbitrarily and capriciously in disregarding significant probative evidence showing that K.P. experienced 

rapid and progressive neurological deterioration within a 

medically acceptable interval following his vaccinations.

Frye testified that in a person suffering from a mitochondrial disorder, vaccine-induced neurodegeneration 

would proceed in two phases. In the first phase, “an 

inciting event,” such as an immunization, activates the 

immune system and causes it “to get to the point where it 

initiate[s] the cascade of events that cause[s] dysfunction 

between the mitochondria and oxidative stress.” According to Frye, in a child with a mitochondrial defect, an 

“adverse reaction” to a vaccine would be expected to 

appear within a week of vaccination. K.P. exhibited 

symptoms of an adverse reaction to inoculation shortly 

after his January 2005 vaccinations. Within forty-eight 

hours of being vaccinated, K.P. “showed signs of irritability, fever, and fatigue.” Court of Federal Claims Decision 

II, 113 Fed. Cl. at 216. K.P. had a recorded temperature 

of 101.5 degrees two days after being vaccinated and a 

recorded temperature of 101.3 degrees seven days later. 

As experts for both sides agreed, fever is evidence of 

immune activation.4

The second phase of vaccine-induced neurodegeneration, Frye explained, is “something that’s progressive over 

time,” occurring over a period of “weeks and months.” In 

this phase, there is a “downward spiral of activity between the mitochondria and oxidative stress,” leading to 

4 Although S. Robert Snodgrass, M.D., the government’s expert, acknowledged that K.P.’s fever was evidence of immune activation, he suggested that the fever 

could have been caused by an infection rather than the 

vaccines K.P. received.

 

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the death of brain cells and neurodegeneration. Frye 

emphasized that there was no rigid timeframe for when 

the clinical symptoms of vaccine-induced neurodegeneration would be expected to appear, explaining that the 

progression of neurological deterioration would “depend 

on the severity and type of mitochondrial disorder.”

As the Court of Federal Claims correctly determined, 

the rapid and devastating neurological regression K.P. 

experienced in the wake of his vaccinations was fully 

consistent with Frye’s medical theory. See id. at 238–39. 

Although K.P. “was not a completely healthy child when 

he received the vaccinations,” id. at 228, there was no 

credible evidence that he suffered from any significant 

problems in his central nervous system. At the time of 

the January 2005 vaccinations, McDonough observed that 

K.P. had some gross motor delays and exhibited some 

increased tone in his upper extremities. McDonough also 

reported, however, that K.P. was able to “play ball with 

[the] examiner,” “bang [two] cubes held by [the] hands,” 

“pull to stand,” “stand holding on,” and say “dada/mama.” 

Significantly, there was no persuasive evidence that 

K.P.’s increased tone and gross motor delays were caused 

by a central nervous system problem rather than by his 

underlying mitochondrial disorder. See id. at 222 (“The 

parties agreed that [K.P.’s] mitochondrial defect was 

likely affecting his health before the vaccinations.”). To 

the contrary, given Frye’s unrebutted testimony that 

mitochondrial disorders can impair muscle function and 

development, and the fact that K.P. did not exhibit any 

pronounced pre-vaccination language or cognitive delays,

the Court of Federal Claims had ample support for its 

conclusion that K.P. had no significant neurological 

problems in the pre-vaccination period. Id. at 228 (“If 

[K.P.’s] problems prior to the vaccinations on January 19, 

2005, were neurological, the impairment was small and 

not evident to the treating physicians.”). 

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In the wake of his January 2005 vaccinations, K.P. 

experienced a precipitous and well-documented neurological decline. By February 11, 2005, twenty-three days 

after the date of the vaccinations, K.P.’s chiropractor 

determined that he was “spastic.” As the special master 

acknowledged, “‘[s]pasticity’ means that the muscles are 

so hypertonic (that is, rigid) that movements are limited.” 

Special Master Decision I, 2011 WL 6949326, at *21. The 

February 11, 2005, chiropractic report was the first time 

that any therapist or medical professional had found that 

K.P. suffered from spasticity, and, as Frye correctly noted, 

showed “that there was a very rapid change in [K.P.’s] 

central nervous system.” According to Frye, the fact that 

K.P. developed spasticity within a month of vaccination 

indicated that the neurons in the motor cortex of his brain

had been “severely damaged and [were] no longer controlling the neurons in the spinal cord.” Thus, as the Court of 

Federal Claims properly concluded, “the chiropractor’s 

notation that [K.P.] was ‘spastic’ on February 11, 2005,” 

was “an identifiable neurodegenerative event” showing 

that “the neurodegenerative process [had] begun.” Court 

of Federal Claims Decision II, 113 Fed. Cl. at 240.

K.P.’s pronounced neurodevelopmental regression was 

confirmed by both McDonough and Kriengkrairut, K.P.’s 

neurologist. On March 24, 2005, McDonough reported 

that K.P. was “hypertonic[]” and suffered from “global 

developmental delay.” When Kriengkrairut evaluated 

K.P. in April 2005, she confirmed that he suffered from 

global developmental delay, noting that he was “unable to 

sit alone” and did “not babble.” She determined, moreover, that K.P. suffered from “marked spasticity of the 

extremities,” which was likely due to a “central nervous 

system pathology.” By May 2005, K.P.’s speech therapist 

concluded that he had fewer language skills than he 

displayed in October 2004, and that his total language 

score was in the first percentile. By October 2005, K.P. 

had “no purposeful movements” and “no specific smiling 

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 16 PALUCK v. HHS

or distinctive eye contact.” MRI exams—conducted in 

April and July 2005—showed thinning of the corporal 

callosum of K.P.’s brain and were consistent with progressive brain degeneration.

In the face of this compelling evidence of postvaccination neurodevelopmental regression, the special 

master had no reasonable basis for concluding that K.P. 

did not experience the progressive neurodegeneration 

predicted by Frye’s medical theory. As noted previously, 

Frye asserted that a child experiencing vaccine-induced 

neurodegeneration would decline in a manner that was 

“progressive over time.” Contrary to the special master’s 

assertions, nothing in Frye’s testimony mandated a 

“linear” deterioration with no instances of slight or temporary improvement in symptoms. See 113 Fed. Cl. at 

234 (explaining that neither the relevant medical literature nor Frye’s theory required “a linear, downward slope” 

of injury). In concluding that K.P. did not experience the 

progressive decline predicted by Frye’s theory, the special 

master noted that K.P.’s February 2005 chiropractic 

records indicated that he was “less rigid” on some days 

than on others. Special Master Decision II, 2013 WL 

2453747, at *44. In focusing on the fact that K.P.’s muscle tone fluctuated somewhat in February 2005, the 

special master failed in his duty to consider “the record as 

a whole.” 42 U.S.C. § 300aa–13(a)(1). Although K.P.’s 

chiropractic records indicate that he was “less rigid” on 

some days than on others, those records, when viewed as 

a whole, do not reflect any sustained improvement in his 

condition. To the contrary, the chiropractor evaluated 

K.P. as “spastic” on February 11, 2005, and he “never 

appeared to improve above his initial assessment.” Court 

of Federal Claims Decision II, 113 Fed. Cl. at 236; see also 

id. at 241 (emphasizing that K.P. “did not continue to 

develop in any way after the vaccinations”). It was arbitrary and capricious for the special master to give short 

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PALUCK v. HHS 17

sion—reflected in the chiropractor’s finding of spasticity—

and to place undue emphasis on the relatively insignificant variations in muscle tone recorded in the February 

2005 chiropractic records. Indeed, because physical 

therapy can stretch muscles, the fact that K.P.’s muscle 

tone fluctuated during the period when he was receiving 

chiropractic therapy was “expected,” and did not mean 

that his overall condition was improving. Id. 

Significantly, moreover, the special master misread 

the handwritten notes from K.P.’s chiropractor. According to the special master, “[t]he chiropractor’s opinion was 

that [K.P.] did not have an adverse reaction to a vaccine.” 

Special Master Decision II, 2013 WL 2453747, at *46. As 

the government now acknowledges, the special master 

misread the chiropractor’s notes and nothing they contain 

suggests that he had concluded that K.P.’s spasticity was 

not caused by the vaccines he received on January 19, 

2005. Instead, the chiropractor had only concluded that 

K.P.’s injury was not the result of child abuse. K.P.’s 

chiropractic records are very significant in that they are 

“the most comprehensive contemporaneous records of 

[K.P.’s] condition in the several months after the vaccinations.” Court of Federal Claims Decision I, 104 Fed. Cl. at 

480; see Cucuras ex rel. Cucuras v. Sec’y of Dep’t of Health 

& Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993) 

(emphasizing the importance of contemporaneous medical 

records in evaluating Vaccine Act cases). The fact that 

the special master misconstrued those records undercuts 

his analysis and buttresses the Court of Federal Claims’ 

decision to set aside his findings of fact and conclusions of 

law.

D. Timeframe for the Onset of Neurological Symptoms

The special master further erred in setting a hard and 

fast deadline of three weeks between vaccination and the 

onset of clinically apparent symptoms of neurological 

injury. See Special Master Decision II, 2013 WL 2453747, 

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 18 PALUCK v. HHS

at *55 (“The important time is within three weeks of 

January 19, 2005 . . . . Thus, for the Palucks to meet their 

burden of proof they must show that [K.P.] manifested 

signs or symptoms of neurodegeneration within this 

timeframe.”). As the Court of Federal Claims correctly 

determined, the special master had no reasonable basis 

for concluding that an individual suffering from vaccineinduced neurodegeneration would necessarily manifest 

clinical symptoms of neurologic injury within three weeks 

of vaccination. See Court of Federal Claims Decision II, 

113 Fed. Cl. at 240 (“Neither the medical literature nor 

the expert testimony stated with any certainty when 

neurodegeneration can be expected to begin in all cases.”). 

The Shoffner study described twelve patients with both 

autism and a mitochondrial disorder who experienced 

developmental regression within two weeks of the onset of 

a fever. In four of those patients, the elevated temperature was determined to be “a febrile response to vaccination.” The Edmonds article collected information about 

thirteen patients with mitochondrial disease who experienced “neurodegenerative events” following an infection. 

In most patients, the neurodegenerative event occurred 

within three to seven days after the onset of the infection, 

but in at least one patient it did not occur until nineteen

days after infection. The Poling case study described a 

young girl with a mitochondrial disorder who developed a 

fever and lost the ability to climb stairs a few days after 

being vaccinated. Over the next three months, she lost 

the ability to communicate and developed autistic behaviors.

The Shoffner article, the Edmonds article, and the 

Poling case study—which collectively discuss only a very 

small number of patients—do not purport to establish any 

definitive timeframe for the onset of clinical symptoms of 

neurological regression in individuals afflicted with 

mitochondrial disorders. There is a wide variety of mitochondrial disorders and those disorders are as yet poorly 

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PALUCK v. HHS 19

understood by the medical community. See id. at 238–41. 

Indeed, as the special master properly acknowledged, 

“mitochondrial disorders are variegated. What happens 

in one mitochondrial disorder may not happen in the next 

person with a mitochondrial disorder.” Special Master 

Decision I, 2011 WL 6949326, at *13. Given the heterogeneity of mitochondrial defects and the paucity of scientific literature discussing the impact that vaccination has 

on persons suffering from such defects, the special master 

had no reasonable basis for setting a hard and fast deadline of three weeks for the onset of neurological symptoms. See Althen, 418 F.3d at 1280 (emphasizing that 

“the purpose of the Vaccine Act’s preponderance standard 

is to allow the finding of causation in a field bereft of 

complete and direct proof of how vaccines affect the 

human body”). Accordingly, the fact that K.P.’s first 

clinically evident sign of neurodegeneration—spasticity—

was documented twenty-three days, rather than twentyone days, after vaccination does not preclude a finding 

that it was a symptom of vaccine-induced neurologic 

injury. See Andreu, 569 F.3d at 1380 (emphasizing that 

relevant medical “evidence must be viewed . . . not 

through the lens of the laboratorian, but instead from the 

vantage point of the Vaccine Act’s preponderant evidence 

standard”).

E. Unsupported Inferences

As the Court of Federal Claims correctly determined, 

moreover, the special master made inferences unsupported by the record when he concluded that K.P. did not 

experience progressive neurological deterioration in the 

immediate aftermath of his January 19, 2005 vaccinations. First, the special master reasoned that if K.P.’s 

condition had been significantly deteriorating in February 

2005, the Palucks would have taken him to a medical 

doctor more frequently. See Special Master Decision II, 

2013 WL 2453747, at *60 (“The Palucks have . . . not 

provided any evidence to explain why, if [K.P.] was as sick 

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 20 PALUCK v. HHS

as they claim, they did not take him to a medical doctor in 

February.”). As the Court of Federal Claims correctly 

noted, however, K.P.’s “parents actually were taking him 

frequently to a medical provider, i.e., the chiropractor” in 

February 2005. Court of Federal Claims Decision II, 113 

Fed. Cl. at 236. Indeed, the Palucks took K.P. to the 

chiropractor nine times in three weeks during February 

2005, apparently believing that his developmental problems were caused by a pinched nerve. Id. It was arbitrary and capricious for the special master to infer that 

K.P.’s condition did not deteriorate in February 2005 

simply because his parents were attempting to ameliorate 

their son’s symptoms through chiropractic therapy.

It was also arbitrary and capricious for the special 

master to infer that McDonough referred K.P. to a pediatric neurologist in March 2005 only because he was “frustrated” with the Palucks. In making the referral, 

McDonough stated that K.P. was “hypertonic[]” and 

suffered from “global developmental delay.” The special 

master’s suggestion that McDonough made the referral 

not because he believed K.P. was getting worse, but 

instead because he was “frustrated that the Palucks were 

not following his recommendations for physical therapy 

[and] occupational therapy,” Special Master Decision II,

2013 WL 2453747, at *47, is devoid of any credible support in the record.

F. MRI Evidence and Contemporaneous Physician Statements

The special master also had no reasonable basis for 

disregarding MRI evidence indicating that K.P. experienced progressive post-vaccination neurological deterioration. An April 2005 MRI exam of K.P.’s brain showed a 

subtle thinning of the corporal callosum. An MRI exam 

conducted three months later, in July 2005, showed 

further thinning of the corporal callosum. Passe, the 

radiologist who evaluated these MRIs, concluded that 

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PALUCK v. HHS 21

they were “consistent with a progressing leukodystrophy,” 

i.e., consistent with progressive neurodegeneration.5 

Frost, a physician who began treating K.P. in the summer 

of 2005, likewise concluded that K.P.’s April and July 

MRI exams evidenced “neurodegenerative disease,” which 

was “likely progressing leukodystrophy.” As the Court of 

Federal Claims correctly concluded, moreover, the fact 

that K.P.’s April 2005 MRI exam showed only a very 

“subtle” thinning of the corporal callosum suggested that 

the thinning had only recently begun. Court of Federal 

Claims Decision II, 113 Fed. Cl. at 238. K.P.’s MRI records are consistent with a finding that his neurological 

decline began at the time of his vaccinations, and the 

special master provided no reasonable justification for 

discounting their significance.6 

Finally, the special master erred in disregarding contemporaneous statements from K.P.’s treating physicians 

regarding the cause of his neurodegeneration. As we 

explained in Andreu, “treating physicians are likely to be 

in the best position to determine whether a logical sequence of cause and effect show[s] that the vaccination 

was the reason for the injury.” 569 F.3d at 1375 (citations 

5 “Leukodystrophy” refers to a group of disorders 

characterized by degeneration of the white matter of the 

brain. See Dorland’s Illustrated Med. Dictionary 1029 

(32nd ed. 2012).

6 Snodgrass contended that the thinning of K.P.’s 

corporal callosum may have begun even prior to the date 

of his vaccinations. See Special Master Decision II, 2013 

WL 2453747, at *48. In support, he suggested that the 

thinning of the corporal callosum shown in the April 2005 

MRI exam could have been the result of a prenatal infection. Id. There is, however, no credible evidence in the 

record demonstrating that any type of prenatal infection 

might have caused an injury to K.P.’s brain.

 

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 22 PALUCK v. HHS

and internal quotation marks omitted). After reviewing 

the results of K.P.’s April and July 2005 MRI exams, 

Passe stated that K.P.’s neurodegeneration could have a 

“hereditary, toxic or metabolic etiolog[y].” Frost, after 

reviewing the April and July exams—as well as the 

results from a third MRI exam conducted in October 2005 

which showed no further significant changes in K.P.’s 

brain—agreed that K.P.’s condition could have a “toxic” 

etiology. Frost concluded that “the progression of a signal 

change” in K.P.’s brain “between 4/27/05 and 07/22/05 

may have represented evolution of [one] toxic/metabolic 

event, which is now stable.” 

As the special master acknowledged, “the term ‘toxic’ 

is broad enough to include an injury caused by a vaccine 

. . . . ” Special Master Decision II, 2013 WL 2453747, at 

*48. Thus, the Palucks were entitled to rely on the 

statements from K.P.’s physicians that his condition could 

be due to a “toxic . . . event” as evidence supporting a 

causal nexus between K.P.’s vaccinations and his subsequent neurological regression. It was arbitrary and 

capricious for the special master to wholly discount the 

probative value of these statements simply because K.P.’s 

physicians suggested that his condition could also potentially be due to alternative causes. See id. at *49 (“While 

the Palucks have cited Dr. Passe’s July 22, 2005 report as 

a statement of a treating doctor showing that the reason 

for [K.P.’s] decline was the vaccination . . . [this] argument is not persuasive because the Palucks have not 

addressed the other possible causes listed by Dr. Passe.”). 

The Palucks’ burden was to show, by a preponderance of 

the evidence, that K.P.’s mitochondrial disorder was 

significantly aggravated by the vaccines he received, not 

to rule out every other potential cause of his injury. See

de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 

1347, 1352 (Fed. Cir. 2008) (“So long as the petitioner has 

satisfied all three prongs of the Althen test, she bears no 

burden to rule out possible alternative causes.” (footnote 

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PALUCK v. HHS 23

omitted)); Walther v. Sec’y of Health & Human Servs., 485 

F.3d 1146, 1151 (Fed. Cir. 2007) (emphasizing that “the 

government bears the burden of establishing alternative 

causation by a preponderance of the evidence once the 

petitioner has established a prima facie case”).

CONCLUSION

Accordingly, the judgment of the United States Court 

of Federal Claims is affirmed.

AFFIRMED

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