Opinion ID: 2802189
Heading Depth: 2
Heading Rank: 3

Heading: Progressive Neurological Decline

Text: 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  (“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 , and K.P. did not manifest identifiable symptoms of neurologic injury within three weeks of his vaccinations, id. at . In an exceptionally thorough and well-reasoned opinion, the 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 govern- ment’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. 14 PALUCK v. HHS 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.”). PALUCK v. HHS 15 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 . 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 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 post- vaccination 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 . 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 shrift to the evidence of K.P.’s sudden neurological regresPALUCK 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 . 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, 18 PALUCK v. HHS at  (“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 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 . 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  (“The Palucks have . . . not provided any evidence to explain why, if [K.P.] was as sick 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 , 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 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 . 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. 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 . 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  (“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 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”).