Patton v. Secretary of Health and Human Services

In the United States Court of Federal Claims

No. 15-1553V

(Filed: November 22, 2021) 1

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*

JONATHAN PATTON, * National Childhood Vaccine Injury

* Act, 42 U.S.C. §§300aa-1 et seq.;

Petitioner, * Brachial Neuritis; Causation-in-fact;

* Althen Prong One; Burden of Proof;

v. *

Case Reports; Remand.

*

SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

*

Respondent. *

*

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Michael Andrew London, Douglas & London, P.C., 59 Maiden Lane, 6th Floor, New York,

NY 10038, for Petitioner.

Brian M. Boynton, C. Salvatore D’Alessio, Heather L. Pearlman, Darryl R. Wishard,

Claudia B. Gangi, United States Department of Justice, Civil Division, Torts Branch, P.O. Box

146, Benjamin Franklin Station, Washington, DC 20044, for Respondent.

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OPINION AND REMAND ORDER

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WILLIAMS, Senior Judge.

In the underlying action before the Special Master, Petitioner claimed that he developed

two neurological disorders, radiculomyelitis and brachial neuritis, as a result of receiving an

influenza (“flu”) vaccine. The Special Master ruled that Petitioner suffered from brachial neuritis,2

1 Pursuant to Vaccine Rule 18(b) of the Rules of the United States Court of Federal Claims,

the Court’s issued its Opinion under seal to provide the parties an opportunity to submit redactions.

The parties did not propose any redactions. Accordingly, the Court publishes this Opinion.

2 Brachial neuritis or Parsonage Turner Syndrome is a peripheral nerve disorder, which is

“characterized by severe onset of regional pain and muscle weakness and wasting.” ECF No. 65-

1 at 4.

which is also known as Parsonage Turner Syndrome, but that he failed to establish that the flu

vaccine caused his condition. Petitioner timely filed the instant petition for review. 3

Background 4

On January 11, 2013, Petitioner received a flu vaccine at his primary care provider’s office.

At the time of the vaccination, Petitioner was 15 years old and had no significant recorded health

concerns other than an ankle laceration and a history of nosebleeds. On January 17, 2013, six days

after receiving the flu vaccine, Petitioner woke up with a heavier-than-normal nosebleed and was

unable to move his arms, describing them as “dead weight.” ECF No. 83 at 5; ECF No. 12-2 at

59. He also experienced neck pain and bilateral shoulder pain. Petitioner alerted his parents and

was immediately taken to the emergency room at All Children’s Hospital (“ACH”). Petitioner’s

arm weakness was so severe that he was unable to fasten his seat belt, and he developed an occipital

headache on the way to the hospital.

Dr. Ricardo Jiminez, M.D., examined Petitioner at around 3:42 a.m. on January 17, 2013,

at the ACH Emergency Department and recorded differential diagnoses of central nervous system

mass, carbon monoxide poisoning, dehydration, electrolyte abnormality, unspecified headache,

migraine, tension headache, intracranial hemorrhage, meningitis, post-concussion syndrome,

shunt malfunction, and stroke. Petitioner was later examined by Dr. Leslie Carrol who listed

differential diagnoses of spinal cord compression, spinal cord ischemia, acute demyelinating

process, Guillain-Barre Syndrome, and carbon monoxide toxicity.

The following morning, neurologist Steven Winesett, M.D. evaluated Petitioner at ACH.

Dr. Winesett noted “[p]ossible Parsonage-Turner Syndrome with an autoimmune brachial plexitis”

and that the “weakness in his shoulders predominantly 3 days after the flu shot could be consistent

with an autoimmune process related to a reaction to the influenza vaccine,” however “other

autoimmune processes are also possible.” ECF No. 12-2 at 74.

During his three-day hospitalization at ACH, Petitioner was also evaluated by attending

physician Dr. Ronald M. Ford, M.D., who noted “[b]rachial plexus MRI pending to observe for

brachial plexopathy secondary to influenza vaccine; most likely etiology of this patient’s

symptoms.” Id. at 78, 80. After Petitioner underwent the MRI, Dr. Jordan R. Larsen, a Doctor of

Osteopathic Medicine, evaluated Petitioner and recorded that the most likely differential diagnosis

was “brachial plexopathy secondary to flu vaccination.” Id. at 80, 83. Petitioner underwent

physical and occupational therapy while admitted, and his occupational therapist noted Petitioner’s

“significant loss of function to both [upper extremities] due to recent diagnosis of Parsonage

Turner Syndrome.” Id. at 47, 162. Petitioner’s condition continued to improve, and he was

discharged from ACH on January 20, 2013, with Parsonage Turner Syndrome and neuropathic

pain.

On January 21, 2013, Petitioner was seen by his primary care physician, Dr. Lynne Ellis,

M.D., who noted that Petitioner “had a reaction to our flu vaccine,” went to the ER and was

3 The Special Master determined that Petitioner did not suffer from radiculomyelitis, and

Petitioner did not challenge this finding.

4 This background is derived from the record before the Special Master and this Court.

2

diagnosed with Parsonage Turner Syndrome. ECF No. 8-1 at 2. Dr. Ellis referred Petitioner to

physical therapy for clinically diagnosed Parsonage Turner Syndrome that was the “[r]esult of flu

shot 1.11.13.” ECF No. 8-4 at 4. Petitioner underwent physical therapy from January 22, 2013

until September 24, 2013.

After his discharge, Petitioner returned to his neurologist, Dr. Winesett, for several follow-

up examinations. At the first follow-up visit on January 30, 2013, Dr. Winesett noted Petitioner’s

“probable Parsonage Turner Syndrome after influenza vaccine with bilateral shoulder and arm

weakness.” ECF No. 8-3 at 6. After the second follow-up visit on April 15, 2013, Dr. Winesett

reported to Petitioner’s primary care physician that Petitioner’s shoulder weakness “took months,

but eventually did resolve, and he says he is back to normal except . . . his right leg has continued

to be numb.” Id. at 1. Dr. Winesett stated that his impression was “[d]ecreased sensation with a

right T4 level,” and his treatment plan was to “proceed with doing a MRI of the entire spine with

an[d] without contrast to look to see if [he could] find a cause of this.” Id. at 2.

The results of the MRI were normal, apart from some bulging of the C5-C6 disc as

previously observed in an earlier MRI. Id. at 3; ECF No. 12-2 at 63, 71. After Petitioner’s final

follow-up on November 13, 2013, Dr. Winesett wrote to Dr. Ellis that “[f]or the most part, things

have gotten better, although he still has some numbness in his mid chest.” ECF No. 12-3 at 17.

Dr. Winesett recorded that Petitioner suffered from “Parsonage Turner syndrome, slowly

recovering.” Id. Dr. Winesett concluded that Petitioner could be seen in the future as needed and

that “[u]nfortunately, he may have to live with the area of numbness in his mid chest.” Id. at 18.

Discussion

Jurisdiction and Standard of Review

This Court has jurisdiction under the Vaccine Act to review the decision of a special master

and:

(A) uphold the findings of fact and conclusions of law of the special master and

sustain the special master’s decision, (B) set aside any of the findings of fact or

conclusions 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, or (C) remand the petition to the special master for

further action in accordance with the court’s direction.

42 U.S.C. § 300aa-12(e)(2)(A)-(C); Doe 93 v. Sec’y of Health & Hum. Servs., 98 Fed. Cl. 553,

564-65 (2011).

“Findings of fact of the special master are reviewed under the arbitrary and capricious

standard, conclusions of law are reviewed under the not in accordance with law standard, and

discretionary rulings are reviewed under the abuse of discretion standard.” Broekelschen v. Sec’y

of Health & Hum. Servs., 89 Fed. Cl. 336, 343 (2009), aff’d, 618 F.3d 1339 (Fed. Cir. 2010)

(citations omitted).

The Court’s role is not to “reweigh the factual evidence,” “assess whether the special

master correctly evaluated the evidence,” or “examine the probative value of the evidence or the

credibility of the witnesses.” Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1360 (Fed.

3

Cir. 2000) (citation omitted). However, the Court has “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.’” Paluck v. Sec’y of

Health & Hum. Servs., 786 F.3d 1373, 1380 (Fed. Cir. 2015) (quoting Hines ex rel. Sevier v. Sec’y

of Health & Hum. Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)). Conclusions of law are reviewed

de novo by this Court. See 42 U.S.C. § 300aa–12(e)(2)(B); Althen v. Sec’y of Health & Hum.

Servs., 418 F.3d 1274, 1278-79, 1281 (Fed. Cir. 2005).

Burden of Proof under the Vaccine Act

In the seminal case of Althen v. Secretary of Health & Human Services, the Federal Circuit

articulated the petitioner’s burden to demonstrate causation-in-fact as follows:

[Petitioner’s] burden is to show by preponderant evidence that the vaccination

brought about [his] injury by providing: (1) a medical theory causally connecting

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

that the vaccination was the reason for the injury; and (3) a showing of a proximate

temporal relationship between vaccination and injury.

418 F.3d at 1278.

Petitioner must prove causation-in-fact “by a preponderance of the evidence.” 42 U.S.C. §

300aa–13(a)(1)(A). The Federal Circuit “has interpreted the preponderance of the evidence

standard referred to in the Vaccine Act as one of proof by a simple preponderance, of more

probable than not causation.” Althen, 418 F.3d at 1279 (citation omitted). Petitioner’s claim must

be “substantiated by medical records or medical opinion.” Id.

The Federal Circuit “adopt[ed] the Restatement rule for purposes of determining vaccine

injury, that an action is the ‘legal cause’ of harm if that action is a ‘substantial factor’ in bringing

about the harm, and that the harm would not have occurred but for the action.” Shyface v. Sec’y

of Health & Hum. Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999) (citing Restatement (Second) of

Torts § 431)).

Causation is determined on a case-by-case basis, as follows:

Causation in fact under the Vaccine Act is thus based on the circumstances of the

particular case, having no hard and fast per se scientific or medical rules. The

determination of causation in fact under the Vaccine Act involves ascertaining

whether a sequence of cause and effect is “logical” and legally probable, not

medically or scientifically certain. Thus, for example, causation can be found in

vaccine cases based on epidemiological evidence and the clinical picture regarding

the particular child without detailed medical and scientific exposition on the

biological mechanisms.

Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994) (citations

omitted).

The Vaccine Act permits proof of causation through “the use of circumstantial evidence

envisioned by the preponderance standard.” Capizzano v. Sec’y of Health & Hum. Servs., 440

4

F.3d 1317, 1325 (Fed. Cir. 2006) (citation omitted). As the Federal Circuit has consistently

reiterated, under the Vaccine Act, “close calls regarding causation are resolved in favor of injured

claimants.” Althen, 418 F.3d at 1280; Capizzano, 440 F.3d at 1325-26; Andreu v. Sec’y of Health

& Hum. Servs., 569 F.3d 1367, 1378 (Fed. Cir. 2009).

If the petitioner proves by a preponderance of the evidence that the vaccine caused

petitioner’s injury, the burden then shifts to the Government to prove, by a preponderance of the

evidence, that a factor unrelated to the vaccination actually caused the injury. de Bazan v. Sec’y

of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008); 42 U.S.C. § 300aa–13(a)(1)(B).

If the Government fails to meet this burden, the petitioner is entitled to compensation. de Bazan,

539 F.3d at 1352. “So long as the petitioner has satisfied all three prongs of the Althen test, [he]

bears no burden to rule out possible alternative causes.” Id. (footnote omitted) (citation omitted).

Under Althen’s prong one, a petitioner must provide a sound and reliable medical theory

demonstrating that the vaccine can cause the petitioner’s injury. Boatmon v. Sec’y of Health &

Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019). A petitioner must provide a reputable medical

or scientific explanation of his theory. Id.; see Doe 11 ex rel. Estate of Doe. v. Sec’y of Health &

Hum. Servs., 83 Fed. Cl. 157, 172-73 (2008), aff’d, 601 F.3d 1349 (Fed. Cir. 2010).

Here, the Special Master concluded that Petitioner did suffer from brachial neuritis,

adopting the opinion of Dr. Salvatore Napoli, Petitioner’s expert. 5 Dr. Napoli opined that after

receiving the flu vaccine, Petitioner had an autoimmune reaction causing muscle weakness and

wasting in his upper extremities, which was diagnosed as brachial neuritis. Dr. Napoli opined that

Petitioner’s body began attacking his nerves as a result of molecular mimicry, brought on by the

flu vaccine. He supported his opinion by relating brachial neuritis, a peripheral nerve disorder, to

Guillain-Barre syndrome (“GBS”), another peripheral nerve disorder, that has been linked to

various types of vaccines.

Respondent’s expert, Dr. Vinay Chaudhry, 6 opined that because Petitioner’s clinical

presentation did not fit neatly into any single diagnosis, his condition was not caused by either

radiculomyelitis or brachial neuritis. However, Dr. Chaudhry was unable to offer an opinion on

what Petitioner’s diagnosis was. Tr. 254. According to Dr. Chaudhry, Petitioner’s clinical

presentation was inconsistent with either brachial neuritis or radiculomyelitis because he did not

5 Dr. Napoli is a board-certified neurologist who completed his neurology residency at

Albany Medical Center in 2003. ECF No. 86 at 7. He is licensed to practice in Massachusetts and

certified by the American Board of Psychiatry and Neurology. Id. at 8. Dr. Napoli regularly treats

individuals suffering from brachial neuritis, including cases of vaccine-induced brachial neuritis.

He has participated in 17 clinical trials and research projects focused on a variety of neurological

disorders. Id.

6 Dr. Chaudhry is a professor of neurology at Johns Hopkins University School of Medicine.

ECF No. 40-1 at A-1. He is board certified in Neurology, Neuromuscular diseases,

Electrodiagnostic Medicine, and Clinical Neurophysiology. Id. He evaluates over 2,000 patients

a year, mostly related to peripheral nerve disease. Id. He is also involved in clinical research and

has had over 120 publications. Id.

5

believe Petitioner had pain in his upper extremities, only weakness.7 The Special Master credited

Dr. Napoli’s opinion that Petitioner suffered from brachial neuritis.

The Special Master determined, however, that Petitioner had not met Althen’s prong one

as he failed to show that the flu vaccine “can cause” this condition, reasoning:

Dr. Napoli has acknowledged that he has provided no evidence -- no study apart

from anecdotal case reports (Exs. 28-31) -- directly indicating that the flu vaccine

can cause brachial neuritis. (Tr. 93, 97) Instead, Dr. Napoli relies on the notion

that brachial neuritis is theorized to be an autoimmune condition associated with

multiple triggers, both known and unknown, including infections. (Tr. 16.) Thus,

Dr. Napoli opined that the flu vaccine can cause brachial neuritis via molecular

mimicry. (ECF No. 77, pp. 35-39; Tr. 38-39.)

However, special masters have repeatedly held in varying contexts that it is

insufficient for petitioners to merely invoke molecular mimicry without more. See,

e.g., W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1361 (Fed Cir. 2016)

(finding that the “special master reasonably considered the lack of evidence

connecting the cross-reactivity observed by Wuncherpfenning to the facts of

petitioner’s case to weigh ‘against finding that Dr. Tornatore’s opinion is

perusaisve [sic].’”); Issac v. Sec’y of Health & Human Servs., No. 08-601V, 2012

WL 3609993, at *3-5, *21-22 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for rev.

denied, 108 Fed. Cl. 743 (2013), aff’d, 540 Fed. Appx. 999 (Mem.) (Fed. Cir.

2013); Tullio v. Sec’y of Health & Human Servs., No. 15-51V, 2019 WL 7580149,

at *12-14 (Fed. Cl. Spec. Mstr. Dec. 19, 2019), mot. for rev. denied, 149 Fed. Cl.

448 (2020).

ECF No. 83 at 28 (emphasis added) (footnotes omitted).

But the record here contains “more” than Petitioner’s superficial invocation of molecular

mimicry as a mechanism for causing brachial neuritis. Dr. Napoli characterized the theory of

molecular mimicry as a “well-known response in immunology” and explained:

And to me, the immune system is really the military of your body. You

have an innate and an adaptive immune system. The innate . . . immune system is

your frontline defense, so when you stub your toe, you have macrophages,

cytokines that attack the potential bacteria on that nail where you stub your toe.

But then there’s an adaptive immune system which is a little bit more

eloquent, and what happens with the adaptive immune system is that tends to then

memorize what you’ve been exposed to in the past. So for a vaccine, it’s not your

innate immune system that’s really in overdrive. It’s your adaptive immune system.

The adaptive immune system involves your T cells, your B cells, and there’s an

interplay between those cells to develop an immune response, so that it memorizes

7 The record, however, indicates that Petitioner experienced neck pain and bilateral shoulder

pain when he awoke on January 17, 2013, the day he was admitted to ACH. ECF 12-2 at 59. Upon

admission to the ACH Emergency Department, Petitioner’s pain scale score was a 7. Id. at 58.

6

a protein that you’ve been exposed to, say, a vaccine or any virus you’ve been

exposed to, and then it creates these memory military members that when it gets

exposed to a foreign substance or what it perceives to be a foreign substance, it then

attacks.

. ..

So, you’ve developed that military in your body, and the way I like to

describe it to patients, including my [multiple sclerosis] patients, to, Why did this

happen, Doctor, well, you know, there’s five members of the military that have

gone rogue and believe that the protein that’s actually normal to yourself, your self

antigen, is similar to an antigen that it’s been exposed to that thinks it’s foreign. So

it creates a friendly fire scenario in your own body. What they think is foreign is

actually yourself, and it creates friendly fire. And that’s basically what happened,

I believe, to [Petitioner].

Tr. 38-39; see ECF No. 65-1 at 21-5.

Dr. Napoli opined that the flu vaccine can cause brachial neuritis via molecular mimicry

because brachial neuritis is an autoimmune condition associated with multiple triggers, including

infections. 8 In support of his opinion Dr. Napoli relied upon his actual experience treating patients

with brachial neuritis caused by the flu vaccine. Dr. Napoli testified that every three to six months

he treats individuals suffering from brachial neuritis and that some cases he saw were induced by

the flu vaccine. ECF No. 86 at 8. 9

Dr. Napoli supported his theory that the flu vaccine can cause brachial neuritis with four

case reports finding that vaccines, including the flu vaccine, actually caused brachial neuritis. A

case report is a report written and published by a medical professional to document a patient’s

case. As Dr. Napoli explained:

And the importance of these case reports isn’t necessarily to say that there is kind

of this huge incidence of this occurring. The importance of the case report is to say

it can occur, though I can’t prove that the flu vaccine will cause this 3 percent of

the time it’s given because incidences are so rare. But what this is helpful in is

when I’m seeing a patient, I can say, yes, this has happened in a rare situation, and

it can happen.

8 The Special Master’s wholesale rejection of molecular mimicry as a theory linking the flu

vaccine to brachial neuritis based upon earlier Vaccine Program cases with different experts and

different records was not warranted. See ECF No. 83 at 28. A different evidentiary record can

lead to different outcomes. Compare Andreu, 569 F.3d at 1370 with Moberly v. Sec’y of Health

& Hum. Servs., 592 F.3d 1315, 1325-26 (Fed. Cir. 2010). Changing technological advances and

medical breakthroughs can alter the viability of a particular theory. Cf. Rickett v. Sec’y of Health

& Hum. Servs., 468 Fed. App’x 952, 959 (Fed. Cir. 2011).

9 Dr. Napoli was not asked precisely how many brachial neuritis cases he found to be

vaccine-induced.

7

Tr. 96.

One case report published in 2019, described a 61-year-old male who received two flu

vaccines, one in 2010 the other in 2013. ECF No. 65-11 at 31-1. Within six weeks of the second

flu vaccine, he began to experience shoulder and neck pain and weakness in his upper left

extremity, which was eventually diagnosed by a neurologist as brachial neuritis. Id. “Using

accepted standard rules for determining causation in the vaccine industry and the [Food and Drug

Administration], the author has determined that this rare neurologic event adverse (AE) was

probably causally related to the influenza vaccination.” Id.

The other three case reports also described the onset of brachial neuritis within several

weeks after the patient’s receipt of a flu vaccination. A 2000 case report, authored by a private

physician who completed a residency in neurosurgery, described a 66-year-old male patient who

had received a flu vaccination and was diagnosed several weeks later with acute brachial plexus

neuritis. ECF No. 65-8 at 28-1. A 2012 case report published by three physicians in the

Department of Rheumatology at Whipps Cross University Hospital in London detailed a finding

of “[a]cute brachial neuritis following influenza vaccination.” ECF No. 65-9 at 29-1. Finally, in

a 2005 case report, “[a] case of acute brachial neuropathy in a male person, age 65, with severe

pain, muscle weakness and atrophy of the shoulder and arm muscles six days after influenza

vaccination with Vaxigrip is described.” ECF No. 65-10 at 30-1.

Dr. Napoli also submitted medical literature identifying other peripheral nerve disorders,

such as GBS as being causally related to the flu vaccine, and opined that the evidence linking GBS

to flu vaccinations is broadly applicable to the context of brachial neuritis. In support of his theory,

Dr. Napoli relied on an article by Haber et al. that relates the flu vaccine to the Acute Inflammatory

Demyelinating Polyneuropathy (AIDP) form of GBS, which results from an autoimmune process

believed to involve a cross-reaction affecting myelin tissue, resulting in demyelinating damage.

ECF No. 83 at 29. In addition, the Haber article cited case reports of GBS following the

administration of vaccines for influenza, rabies, polio, and hepatitis. Id. at 15.

In response to Dr. Napoli’s expert opinion, Dr. Chaudhry opined that even if Petitioner did

have brachial neuritis, it could not have been caused by the flu vaccine because the case reports

cited by Petitioner were unreliable, 10 and brachial neuritis and GBS are too dissimilar for there to

be similar autoimmune reactions. Dr. Chaudhry noted that GBS results in demyelinating nerve

damage while brachial neuritis overwhelmingly results in axonal nerve damage.

Petitioner submits that the Special Master erred in his Althen prong one analysis by giving

little weight to the case reports and medical literature submitted by Dr. Napoli, basing his decision

in part on the fact that no epidemiological studies currently exist linking brachial neuritis to the flu

vaccine, and disregarding the opinions of four of Petitioner’s treating physicians. ECF No. 86 at

2-3.

10 Dr. Chaudhry admitted that case reports can be helpful if they “are very typical and

detailed.” Tr. 195. However, Dr. Chaudhry only read two of these case reports and did not give

them much weight saying that it was difficult to tell whether the case reports would be helpful

because “they didn’t even mention what nerves were damaged.” Id.

8

In considering Petitioner’s case reports, the Special Master concluded that “Dr. Napoli has

acknowledged that he has provided no evidence -- no study apart from anecdotal case reports (Exs.

28-31) -- directly indicating that the flu vaccine can cause brachial neuritis,” ECF No. 83 at 28

(footnote omitted), and stated:

“[C]ase reports ‘do not purport to establish causation definitively, and this

deficiency does indeed reduce their evidentiary value’ . . . . [but] ‘the fact that case

reports can by their nature only present indicia of causation does not deprive them

of all evidentiary weight.” See Paluck v. Sec’y of Health & Human Servs., 104

Fed. Cl. 457, 475 (2012) (quoting Campbell v. Sec’y of Health & Human Servs.,

97 Fed. Cl. 650, 668 (2001), aff’d, 786 F.3d 1373 (Fed. Cir. 2015)).

ECF No. 83 at 28 n. 20 (alterations in original). It thus appears that the Special Master accorded

these case reports little weight, noting that Petitioner’s expert had not cited any “study” except for

these “anecdotal” case reports.

Given the additional evidence here, the Special Master’s requirement that Petitioner submit

a “study” to meet Althen prong one was legal error. As the Federal Circuit concluded in

Capizzano, “requiring either epidemiologic studies . . . or general acceptance in the scientific or

medical communities to establish a logical sequence of cause and effect” is contrary to Althen.

440 F.3d at 1325. Such an approach is “inconsistent with allowing the use of circumstantial

evidence envisioned by the preponderance standard” and “impermissibly raises the claimant’s

burden under the Vaccine Act.” Id.

In a similar vein, the Court of Federal Claims in Paluck v. Secretary of Health & Human

Services, found that it was error for the special master to discount case reports, reasoning that

while this additional evidence was “not scientifically certain” it was “sufficiently worthy and

reliable to merit an extensive scientific inquiry” because the standard of proof set forth in Althen

and the Vaccine Act requires no more. 104 Fed. Cl. at 475 (discussing Althen prong one); see

Contreras v. Sec’y of Health & Hum. Servs., 107 Fed. Cl. 280, 304 (rejecting the special master’s

apparent finding that case reports held no evidentiary value and stating that “epidemiological

studies are not required, and that circumstantial evidence is sometimes enough to prove causation

in a Vaccine Act case.”) (citing Capizzano, 440 F.3d at 1325-26 and Andreu, 569 F.3d at 1378-

79). Here, as in Paluck and Contreras, the Special Master erred in his prong one analysis by

discounting the evidentiary value of the case reports Dr. Napoli submitted. As the Federal Circuit

recognized in Andreu: “[i]n a field bereft of complete and direct proof of how vaccines affect the

human body, a paucity of medical literature supporting a particular theory of causation cannot

serve as a bar to recovery.” 569 F.3d at 1379 (quoting Capizzano, 440 F.3d at 1325-26).

It also appears that the Special Master rejected Dr. Napoli’s opinion that the flu vaccine

can cause brachial neuritis because he adopted Respondent’s expert Dr. Chaudhry’s opinion “that

cases of brachial neuritis overwhelmingly result in axonal damage and not demyelination.” ECF

No. 83 at 33 (citing Tr. 131-33, 279-80 and ECF No. 40-3 at 7). Further, it appears that the Special

Master assumed that Petitioner suffered from a demyelinating injury, not axonal damage -- even

though he found that Petitioner had brachial neuritis. See ECF No. 83 at 29-30. 11 The Special

11 However, in his prong two analysis, the Special Master stated: “Petitioner has failed to

show by preponderant evidence a logical sequence of cause and effect whereby the flu vaccine

9

Master concluded that Dr. Napoli did not provide evidence that a vaccine causing one type of nerve

damage (demyelination) via molecular mimicry should be assumed capable of causing the other

(axonal). See ECF No. 83 at 30. But this distinction that Dr. Chaudhry drew between

demyelinating nerve damage versus axonal damage cannot be applied to Petitioner on this record.

As the Special Master found, “there is no evidence on this record distinguishing whether

petitioner’s symptoms were caused by demyelination or axonal damage.” Id. at 33. The record

establishes that Dr. Napoli suspected that Petitioner had demyelinating lesions, but the EMG was

done too early to tell, and there is no evidence in the record indicating whether or to what extent

Petitioner had a demyelinating injury or axonal damage. Tr. 107; see also Tr. 254; ECF No. 86 at

16. Thus, the Special Master’s adoption of Dr. Chaudhry’s opinion based upon an apparent

assumption that Petitioner had a demyelinating injury, not axonal damage, was not supported by

the evidence.

The diagnoses of four treating physicians that Petitioner suffered from brachial neuritis

caused by the flu vaccine further supports the reliability of Petitioner’s theory that the flu vaccine

can cause brachial neuritis. Dr. Winesett, a neurologist, evaluated Petitioner at ACH and noted a

“possible” diagnosis of brachial neuritis three days after the flu shot that “could be consistent with

an autoimmune process related to a reaction to the influenza vaccine.” ECF No. 12-2 at 74. At a

follow-up visit on January 30, 2013, 13 days after his initial evaluation, Dr. Winesett recorded

Petitioner’s “probable Parsonage Turner Syndrome [or brachial neuritis] after influenza vaccine

with bilateral shoulder and arm weakness.” ECF No. 8-3 at 3-6 (emphasis added). Also during

his hospitalization at ACH, both Dr. Ford, an attending physician, and Dr. Larsen, an osteopathic

doctor, evaluated Petitioner and concluded a likely diagnosis of “brachial plexopathy secondary to

flu vaccination.” ECF 12-2 at 7-78, 7-80, 7-83. Finally, Petitioner’s primary care physician, Dr.

Ellis, stated in Petitioner’s medical record that he “had a reaction to our flu vaccine” and noted

“Do not give flu vaccine” to Petitioner. ECF No. 8-1 at 1-2. The Special Master erred in failing

to accord these medical records weight in analyzing prong one. Cf. Capizzano, 440 F.3d at 1326

(stating that “medical records and medical opinion testimony are favored in vaccine cases, as

treating physicians are likely to be in the best position to determine whether a logical sequence of

cause and effect shows that the vaccination was the reason for the injury.”).

Finally, the medical literature Petitioner submitted supports his theory that the flu

vaccination can cause brachial neuritis. According to the Ferrante article, one of the consistent

and documented “recognized trigger[s]” for brachial neuritis is vaccinations, and another trigger

is flu-like illness. ECF No. 65-3 at 3. While vaccine-caused brachial neuritis is rare, the Ferrante

article found that vaccination acts as a trigger in 5% of cases. Id. Other articles cited by Petitioner

documented GBS in patients who had received the flu vaccine prior to the onset of symptoms. The

article by Haber et al. published in 2009 found case reports of GBS following various types of

vaccine administrations, including the flu vaccine. ECF No. 65-6 at 3. Another article by

Schonberger et al. published in the 1970s found that 532 GBS patients had received a flu vaccine

prior to the onset of their neurologic symptoms and GBS diagnoses. ECF No. 65-5 at 1.

In sum, Petitioner demonstrated a sound and reliable medical theory that the flu vaccine

can cause brachial neuritis via molecular mimicry. This theory is supported by the expert opinion

would have induced an autoimmune reaction that caused his axonal-loss lesion resulting in brachial

neuritis.” ECF No. 83 at 33.

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of an experienced neurologist, four case reports, three medical articles, and the diagnoses of four

treating physicians that the flu vaccine likely did cause Petitioner’s brachial neuritis. By

disregarding this evidence and noting the absence of studies supporting Petitioner’s theory, the

Special Master placed too high an evidentiary burden on Petitioner with respect to Althen’s prong

one.

The Special Master’s imposition of a heightened burden on Petitioner as to prong one

impacted his Althen prong two analysis. With respect to prong two, the Special Master stated:

The parties agree that brachial neuritis can occur within days of an antecedent

trigger. (Medlink, supra, at Ex. 23, pp. 2-7; Van Eijk, Groothuis & Van Alfen,

supra, Ex. C, pp. 1-2.) Here, petitioner presented with symptoms of brachial

neuritis within days of his flu vaccination. This timing of onset fits squarely within

the accepted timeline for brachial neuritis to develop following an antecedent event.

Standing alone, however, a temporal association is not sufficient to satisfy Althen

prong two.

. ..

Petitioner’s initial presentation seemed to confuse his treating physicians who

initially listed 13 differential diagnoses including central nervous system mass,

carbon monoxide poisoning, dehydration, electrolyte abnormality, unspecified

headache, migraine, tension headache, intracranial hemorrhage, meningitis, post-

concussion syndrome, shunt malfunction, and stroke. (Ex. 7, p. 60.) However, as

petitioner was further examined, his treating physicians and physical therapists

settled on a diagnosis of possible or probable brachial neuritis (referenced as

Parsonage-Turner Syndrome) that they related to his flu vaccination. (Ex. 7, pp.

17, 47, 53, 85.) Importantly, however, petitioner’s medical records show no

evidence of any diagnostic labs such as lumbar puncture which may have helped

support a casual, and not merely temporal, link between the vaccine and his injury.

Thus, although petitioner’s treating physicians did ultimately settle on the diagnosis

of brachial neuritis, their further opinion that the condition was caused by

petitioner’s flu vaccination relies exclusively on the temporal relationship and the

lack of any known alternative triggers. This conclusion carries little weight in light

of my finding that petitioner has not satisfied Althen prong one relative to brachial

neuritis.

ECF No. 83 at 32 (emphasis added) (citations omitted). Thus, the Special Master’s prong two

analysis was colored by his finding that Petitioner failed to satisfy Althen prong one.

Conclusion

Petitioner’s Motion for Review is GRANTED. The decision of the Special Master is

VACATED, and this matter is REMANDED to the Special Master for further proceedings. On

remand, the Special Master shall reassess entitlement in particular whether Petitioner satisfied

Althen’s prong two in light of this Court’s finding that Petitioner met Althen’s prong one.

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Pursuant to 42 U.S.C. § 300aa-12(e)(2), the Special Master shall complete proceedings on

remand within 90 days.

The Clerk shall not disclose this decision publicly for 14 days.

s/Mary Ellen Coster Williams

MARY ELLEN COSTER WILLIAMS

Senior Judge

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