1

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 11-689V

Filed: April 26, 2013

* * * * * * * * * * * * * * * * * 

JACOB HENDERLONG, a minor by his * UNPUBLISHED

next friend, SUSAN HENDERLONG, *

* Chief Special Master

Petitioner, * Campbell-Smith 

*

v. * Dismissal of Claim for 

* Insufficient Proof; Denial Without

SECRETARY OF HEALTH * a Hearing; Varicella Zoster and 

AND HUMAN SERVICES, * Influenza Vaccines; Alleged 

* Injury of Chronic Inflammatory

* Demyelinating Polyneuropathy

Respondent. * (CIDP); Diagnosed Condition of 

* Charcot-Marie-Tooth Disease

* (CMT). 

* * * * * * * * * * * * * * * * *

Scott W. Rooney, Nemes, Rooney P.C., Farmington Hills, MI, for petitioner.

Julia W. McInerny, Department of Justice, Washington, D.C., for respondent.

DECISION1

I. Introduction

On October 18, 2011, petitioner filed a petition for compensation under the 

National Vaccine Injury Compensation Program (“the Program”),2alleging that the 

 

1 Because this decision contains a reasoned explanation for the undersigned’s action 

in this case, the undersigned intends to post this decision on the website of the United 

States Court of Federal Claims, in accordance with the E-Government Act of 2002, Pub. 

L. No. 107-347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 

note (2006)). As provided by Vaccine Rule 18(b), each party has 14 days within which 

to request redaction “of any information furnished by that party: (1) that is a trade secret 

or commercial or financial in substance and is privileged or confidential; or (2) that 

includes medical files or similar files, the disclosure of which would constitute a clearly 

unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the entire decision 

will be available to the public. Id.
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varicella zoster and influenza vaccinations that her son Jacob received on November 13, 

2008,

3

caused him to suffer a chronic inflammatory demyelinating polyneuropathy 

(CIDP). Petition at ¶¶ 5, 6, 12. The information in the record, however, does not 

preponderate in favor of entitlement to a Program award.

To receive compensation under the Program, petitioner must prove either: (1) that 

Jacob suffered a “Table Injury” – that is, an injury falling within the Vaccine Injury Table 

– corresponding to one of Jacob’s vaccinations, or (2) that Jacob suffered an injury that 

was in fact caused by an administered vaccine. See §§ 300aa-13(a)(1)(A) and 300aa11(c)(1). An examination of the record does not uncover any evidence that Jacob 

suffered a “Table Injury.” Further, the record does not contain a medical expert’s opinion 

that is sufficient to prove that Jacob’s alleged injury was vaccine-related.

Respondent filed her Rule 4(c) report on March 21, 2013, after petitioner had filed 

all her medical records and an expert opinion from Dr. Axelrod. Respondent requested 

dismissal of the petition, asserting petitioner had failed to support a claim for a Table 

injury as CIDP is not a listed injury for either of the two vaccinations Jacob received. 

Resp’t’s Rule 4(c) at 8. Respondent further asserted that petitioner failed to state a prima 

facie case of causation for an off-Table claim, as she failed to provide sufficient evidence 

to establish either Althen prongs one or two. Resp’t’s Rule 4(c) at 7.

Respondent asserted that deficiencies in Dr. Axelrod’s expert report render it 

“unreliable and inadequate to meet petitioner’s burden of proof,” pointing to medical 

records indicating that Jacob’s possible weakness began in 2006, two years prior to his 

vaccinations, or in the alternative, that symptoms began in Summer 2009. Id. at 11-12. 

Finally, respondent observed that Dr. Axelrod’s opinion that it was “conceivable” that 

CIDP symptoms could appear more than 65 days after a triggering event falls “far short” 

of petitioner’s burden to prove that each Althen factor is more likely than not satisfied. 

Id. at 12-13.

Under the Act, a petitioner may not receive a Program award based solely on the 

petitioner’s claims alone. Rather, the petition must be supported by either medical 

records or the opinion of a competent physician proving a causal relationship. § 300aa13(a)(1). In this case, because there are insufficient medical records supporting 

 

2

The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 

1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 et

seq. (hereinafter “Vaccine Act” or “the Act”). Hereafter, individual section references 

will be to 42 U.S.C. § 300aa of the Act. 

3

Jacob also received a meningococcus vaccine on Nov. 13, 2008, Pet’r’s Ex. 3, 

however, petitioner alleged no injury as a result of this vaccine. 
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petitioner’s claim, a medical opinion must be offered in support. Petitioner has offered 

the opinion of Dr. David Axelrod, a clinical immunologist who “ha[s] participated in the 

diagnosis and treatment of [CIDP] . . . .”

4

 Pet’r’s Ex. 13 at 1. However, as the 

undersigned explains in more detail below, Dr. Axelrod’s report fails to establish 

causation under Program standards, and petitioner declined the opportunity to file a 

supplemental expert report from Dr. Axelrod--notwithstanding the multiple opportunities 

afforded to do so and after repeated notice that on the current record--petitioner’s claim 

was subject to dismissal for insufficient proof on its face. See Order, ECF Docket No. 

36, filed June 28, 2012; Order, ECF Docket No. 38, filed July 27, 2012, at 1; Order, ECF 

Docket No. 40, filed Dec. 13, 2012, at 2; and Order, ECF Docket No. 45, filed Feb. 5, 

2013, at 1. 

In light of earlier discussions with counsel during status conferences regarding the 

need to address the shortcomings in petitioner’s expert report, the undersigned construes

petitioner’s decision not to file a supplemental expert report from Dr. Axelrod, which was 

communicated in a status report,

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as a motion for a ruling on the record. As noted in 

previously issued orders, without more from petitioner, Dr. Axelrod’s report is

inadequate to meet petitioner’s evidentiary burden. See Althen v. Sec’y of Health & 

Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Accordingly, the petition must be

DISMISSED.

II. Factual Background

Petitioner’s medical records indicate that Jacob suffered from intermittent 

weakness, painful headaches and speech issues, well before he received the subject 

vaccinations. See Pet’r’s Ex. 6 at 59, 64; Pet’r’s Ex. 12 at 2, 11. In June 2006, Jacob saw 

his pediatrician, Dr. Mo El-Fouly, with a history of “a lot of headaches.” Pet’r’s Ex. 12 

at 2. In June 2008, Jacob returned to Dr. El-Fouly for a well-child visit, during which it 

was reported that he had been having headaches, and had speech issues. Id. at 11. 

Jacob’s parents also reported that he exhibited subtle signs of weakness a couple of years 

before he received the subject vaccinations. Pet’r’s Ex. 6 at 64.

On November 13, 2008, Jacob received the vaccines at issue here. On December 

11, 2008, four weeks later, Jacob presented to Dr. El-Fouly with complaints of dizziness, 

shaking legs, and having vomited approximately twelve times that day. Pet’r’s Ex. 12 at 

12. He also complained of a “severe” headache similar to the type of headache he had 

experienced roughly six to eight times over the course of several years. Id.

 

4

ECF Docket No. 39, filed Sept. 25, 2012. 

5

Pet’r’s Status Report, ECF Docket No. 44, filed Feb. 1, 2013. 
4

Approximately six months later, on June 18, 2009, Jacob was seen by Dr. ElFouly for a well-child examination. During the visit, the doctor recorded no raised

“concerns or questions.” Pet’r’s Ex.12 at 13. Dr. El-Fouly’s visit notes indicate that 

Jacob was involved in hockey, football, and baseball. Id. 

Three months later, on September 10, 2009, Jacob’s parents returned to Dr. ElFouly with complaints that Jacob had been suffering from a “degradation of motor 

skills,” with Jacob’s father reporting that he believed Jacob’s “condition ha[d] 

deteriorated [in the] past two weeks.” Id. at 14. Detecting low muscle tone (hypotonia) 

in Jacob’s “pelvic girdle,” as well as a “gait disturbance,” Dr. El-Fouly referred Jacob to

Dr. Brian Woodruff, a neurologist, for further evaluation. Id. 

Dr. Woodruff examined Jacob four days later, on September 14, 2009. Pet’r’s 

Ex.11 at 1. As reported by both Jacob’s parents, Dr. Woodruff noted “[g]eneralized 

weakness ... throughout his ‘entire body.’ It appears to be a slow process. He has always 

been tired with long walks.” Id. Dr. Woodruff ordered an electromyography and nerve 

conduction study to be performed that day. The nerve conduction study (NCS) results

were “abnormal and consistent” with Charcot-Marie Tooth disease. Id. at 1, 4. CharcotMarie-Tooth disease is “a group of hereditary conditions characterized by chronic motor 

and sensor polyneuropathy . . . [which presents as] progressive symmetric distal muscle 

weakness and atrophy starting in the feet and legs, gait disturbance, and absent stretch 

reflexes.” Dorland’s Illustrated Medical Dictionary 530 (32d ed. 2012). Upon review of 

the nerve conduction test results, Dr. Woodruff ordered a “genetic CMT complete panel” 

test, Pet’r’s Ex.11 at 1, 12, and referred Jacob for occupational and physical therapy to 

address his CMT-like symptoms. Pet’r’s Ex. 6 at 110, 119. 

The CMT genetic evaluation performed on Jacob was inconclusive. But the test 

results informed that Jacob possessed a DNA sequence variant “whose significance [was] 

unknown,” and that “[i]t [was] unknown whether th[is] sequence variant[] m[ight] lead 

to, or be causative of, CMT.” Pet’r’s Ex. 8 at 5, 7. The genetic testing service observed 

that “[t]esting of [Jacob’s] parents and family members [was] likely to improve the 

clinical utility of this test result.” Id. at 7.

The next month, Jacob was seen for a physical therapy evaluation and an 

occupational therapy evaluation at the University of Michigan’s Health Center. Pet’r’s 

Ex. 6 at 59-69. At both evaluations, Jacob’s parents reported--presumably in an earnest 

effort to obtain treatment for Jacob--that he was functioning typically for his age, until 

about three years ago. Id. at 59, 64. Jacob’s father reported that he first noticed 

weakness in Jacob “approx[imately] 3 years ago.” Id. at 64. He explained that “at first 

the weakness was not really that noticeable,” but gradually it became more obvious. Id. 

Jacob’s mother reported that “at the start of the fall [2009] sport season, [Jacob] . . . had 

to stop actively participating in sports due to safety concerns.” Id. at 59. 
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Both the physical therapist and the occupational therapist identified the onset date 

for Jacob’s illness as “3 years ago.” Id. at 59, 64. Jacob’s father’s report of the first sign 

of weakness places the onset of Jacob’s CIDP in October 2006, nearly two years prior to 

the vaccinations at issue. 

In November 2009, one year after his vaccinations, Jacob consulted with a second 

neurologist, Dr. Gyula Acsadi; Jacob’s parents sought another neurologic opinion 

because they questioned Dr. Woodruff’s diagnostic impression of CMT. Pet’r’s Ex. 1 at 

¶¶ 19-25; Pet’r’s Ex. 2 at ¶¶ 19-25. The Henderlongs reported to Dr. Acsadi that Jacob’s 

“slowly worsening weakness . . . possibly start[ed] in early 2009[,] but . . . wasn’t really

apparent until th[e] summer” of 2009. Pet’r’s Ex. 4 at 3 (emphasis added). Dr. Acsadi 

diagnosed Jacob with CIDP. Id. at 5, 32. CIDP is “a slowly progressive, autoimmune 

type of demyelinating polyneuropathy characterized by progressive weakness and 

impaired sensory function in the limbs . . . .” Dorland’s at 1491. Presenting symptoms 

often include “tingling or numbness of the digits, weakness of the limbs, hyporeflexia6or

areflexia,7fatigue, and abnormal sensations.” Id. After receiving the CIDP diagnosis, 

Jacob continued to receive the same occupational and physical therapy he had begun to 

receive earlier. Pet’r’s Ex. 6 at 2-46. 

III. Expert Opinion 

Persuaded that Jacob had suffered a vaccine-related injury, petitioner filed a 

vaccine claim and an expert report from Dr. Axelrod, addressing the immunologic 

mechanism of harm caused by the complement of vaccines given to Jacob. Pet’r’s Ex.

13. Dr. Axelrod opined that “it is within a reasonable degree of medical certainty that 

Jacob Henderlong developed a demyelinating disorder as a result of the vaccinations he 

received on November 13, 2008.” Id. at 4. 

In his report, Dr. Axelrod offered an immunologically-based theory regarding how 

Jacob’s vaccinations could have caused his CIDP, positing that Jacob was harmed by

circulating immune complexes that mimicked his molecular structure and led to an 

autoimmune attack (a process referred to as “molecular mimicry”). Id. at 3-4. As 

evidence of Jacob’s vaccine-related harm, Dr. Axelrod asserted that he “suffered 

progressive weakness from early 2009” based on a report from Jacob’s parents contained 

in the records of Jacob’s treating neurologist, Dr. Acsadi Id. at 1. 

 

6 Hyporeflexia is “dysreflexia characterized by weakening of the reflexes.” 

Dorland’s at 905.

7 Areflexia is an “absence of reflexes.” Dorland’s at 130.
6

Dr. Axelrod asserted that Jacob’s “first manifestation of his [CIDP]” occurred 

around December 11, 2008 (four weeks after his vaccinations) in the form of shaking 

legs, as was noted in Jacob’s pediatric records. Pet’r’s Ex. 13 at 1; see Pet’r’s Ex. 12 at 

12. Dr. Axelrod also pointed to Dr. Acsadi’s neurologic evaluation of Jacob in 

November 2009 to place the onset of Jacob’s symptoms in the weeks immediately 

following his vaccinations.

Jacob’s treater, Dr. Acsadi, does not appear to have been aware of Jacob’s earlier 

(and pre-vaccinal) neurologic symptoms of severe headache, speech difficulties, and 

weakness. Nor does it appear that Jacob’s parents addressed those symptoms during their 

initial office visit with Dr. Ascadi.

Moreover, petitioner’s expert, Dr. Axelrod, was silent in his offered expert report 

regarding the significance of Jacob’s neurologic issues -- in particular his weakness -- in 

the years preceding his vaccination. The reason for Dr. Axelrod’s silence is unclear but 

perhaps is informed by the fact that although he has “participated in” the diagnosis of the 

neurologic disorder of CIDP, he is not a neurologist and thus defers in his report to the

notations and findings made by Jacob’s treating neurologist, Dr. Acsadi.

Focused primarily on the symptoms of post-vaccinal weakness that Jacob’s 

parents reported to Dr. Acsadi, Dr. Axelrod asserts in his expert report that “it is 

conceivable that symptoms [of Jacob’s CIDP]” would have occurred more than two 

months (following “day 65”) after Jacob’s vaccination. Pet’r’s Ex. 13 at 3. Dr. Axelrod 

added that it is also “conceivable” that the appearance of Jacob’s ataxia on September 10, 

2009 (301 days after the date of vaccination) could be consistent with an immunemediated injury precipitated by Jacob’s vaccinations. Id. at 1, 3. Dr. Axelrod cited 

eighteen articles that, in his estimation, supported the proposition that Jacob’s 

vaccinations caused his CIDP. Id. at 4-5.

IV. Discussion

Because petitioner’s injury is not listed on the Vaccine Injury Table, petitioner 

cannot establish a Table injury but instead must establish that Jacob’s received vaccines 

caused his alleged injury. See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 

1328, 1335 (Fed. Cir. 2010). To do so, petitioner must show by preponderant evidence 

that the vaccines brought about his injury by providing: (1) a medical theory causally 

connecting the vaccination and the alleged 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 the vaccination and the injury. Althen, 418 

F.3d at 1278. Petitioner satisfies the preponderant evidence standard by showing that a 

proposition is more likely than not. Moberly v. Sec’y of Health & Human Servs., 592 

F.3d 1315, 1322 n.2 (Fed. Cir. 2010). 
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As addressed below, Dr. Axelrod’s report is insufficient on its face to establish 

Program entitlement. Even if Dr. Axelrod’s report offered a “medical theory causally 

connecting the vaccination and the injury,” it fails to satisfy the second and third prongs 

of the Althen test. Because petitioner has failed to satisfy all three Althen prongs, 

petitioner cannot establish she is entitled to compensation. See de Bazan v. Sec’y of 

Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).

Whether Jacob’s presenting symptoms--which were substantially separated in 

time--were part of the same neurologic injury is the threshold question in this case, and 

because timing is the dispositive issue here, undersigned addresses the Althen prongs in 

reverse order.

A. Althen Prong Three

Petitioner cannot prevail on her vaccine claim because Dr. Axelrod’s report is 

facially deficient with regards to Althen prong three. Prong three of the Althen test 

requires petitioner to provide preponderant evidence of “a proximate temporal 

relationship between [Jacob’s] vaccination and [his] injury.” Althen, 418 F.3d at 1278; 

de Bazan, 539 F.3d at 1352-53. Dr. Axelrod’s report fails to do so.

Dr. Axelrod posits that both Jacob’s post-vaccinal symptom of leg shaking and his 

much later symptom of gait disturbance were frank symptoms of his evolving CIDP. 

Pet’r’s Ex. 13 at 1. Dr. Axelrod further posits that each of these symptoms resulted from 

circulating immune complexes that were triggered by Jacob’s vaccination. Id. Dr. 

Axelrod insists that as a general proposition, “it is conceivable” that symptoms of CIDP

could develop more than two months (or 65 days) after the triggering immunologic event

of vaccination. Id. at 3. The linchpin of Dr. Axelrod’s theory is the “conceivable” 

impact of circulating immune complexes more than nine months after the immunologic

trigger of vaccination. “Although the ‘preponderant evidence’ standard [required under 

the Program] does not demand scientific certainty, neither is it satisfied by mere 

speculation.” Hennessey v. Sec’y of Health & Human Servs., 91 Fed. Cl. 126, 133 

(2010). As the plain language of Dr. Axelrod’s opinion indicates, the term “conceivable”

means merely “imaginable.” See Definition of Conceivable, Merriam-Webster 

Dictionary, available at http://www.merriam-webster.com/dictionary/ conceivable (last 

visited April 23, 2013). As that term is used by Dr. Axelrod, a “conceivable” impact 

offers petitioner very weak support, at most, for “a proximate temporal relationship 

between [Jacob’s] vaccination and [his] injury.” Althen, 418 F.3d at 1278. See also

Moberly, 592 F.3d at 1324 (“recognizing that a special master may “require some indicia 

of reliability to support the assertion of the expert witness.”). 

The speculative nature of the timing aspect of Dr. Axelrod’s opinion is further 

revealed by the medical literature he references. The cited literature fails to provide the 

requisite support for his theory, especially the 1984 Lawley article on which Dr. Axelrod 
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most heavily relies.

8 He relies on that article for the particular proposition that symptoms 

of CIDP could manifest more than 65 days after vaccination. Pet’r’s Ex. 13 at 2-3. 

The authors of the 1984 Lawley article studied and recorded the circulating 

immune complex levels “in a [r]epresentative [p]atient . . . with [s]erum [s]ickness after 

[t]reatment with [a]ntithymocyte [g]lobulin (ATG).” Pet’r’s Ex. 16 at 1410. Dr. Axelrod 

claims that the authors’ findings of “clinical manifestations of disease [that] appeared to 

relate to the elevated levels of [circulating] immune complexes” furnish support for a

finding here that Jacob’s vaccinations caused his CIDP. Pet’r’s Ex. 13 at 3. But, the

Lawley article authors’ findings provide questionable support, at best, for Dr. Axelrod’s 

hypothesis because the authors recorded immune responses for a period of 65 days

only—without extending beyond that time frame. Id. at 13; see also Pet’r’s Ex. 16 at

1410. Dr. Axelrod’s opinion here is based on his own conjecture that the authors’ 

findings in the 1984 Lawley article could apply beyond 65 days. Because his theory 

proposing “a proximate temporal relationship between [Jacob’s] vaccination and [his] 

injury” is merely “conceivable,” and not more likely than not, Dr. Axelrod’s medical 

opinion does not assist petitioner in meeting her evidentiary burden required under prong 

three of Althen. The gap between what is known and what petitioner asks the 

undersigned to accept is simply too great, Althen, 418 F.3d at 1278; Pet’r’s Ex. 13 at 3, 

and without the requisite element of timing, petitioner’s claim must fail on prong three.

B. Althen Prong Two

Prong two of the Althen test requires petitioner to show that Jacob reacted to his 

vaccinations in a manner consistent with Dr. Axelrod’s theory. But the issue of Jacob’s 

symptom onset calls into question the vaccine-relatedness of Jacob’s ongoing health 

conditions. 

Dr. Axelrod pointed to Dr. Acsadi’s evaluation of Jacob in November 2009 to 

place the onset of Jacob’s symptoms in December 2008 -- less than one month after the 

vaccination at issue -- when Jacob reported that his legs had been shaking. Pet’r’s Ex. 13 

at 1. But Dr. Axelrod fails to address in his expert report the apparently conflicting 

aspects of the record regarding the onset of Jacob’s neurologic symptoms. According to 

several reports from his parents, Jacob’s weakness first presented in 2006 (two years 

before his vaccinations). He had a instance of leg shaking in December of 2008 (one 

month after his vaccinations), but according to Jacob’s mother’s report during a June 

2009 well-child visit (seven months after Jacob’s vaccinations), there were no expressed 

concerns about Jacob’s health. The weakness that evolved later during the summer of 

2009 progressed to the point of disturbing Jacob’s gait. Very concerned about Jacob’s 

 

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T.J. Lawley et al., A Prospective Clinical and Immunologic Analysis of Patients 

with Serum Sickness, 311 New Eng. J. of Med. 1407 (1984).
9

condition, the Henderlongs sought a neurologic evaluation for Jacob in September of 

2009.

As proposed by Dr. Axelrod, the pertinent aspects of the record are the singular

instance of post-vaccinal leg shaking followed by--approximately eight months later-- 

a documented impairment in Jacob’s stride. According to Dr. Axelrod, these events 

conceivably present an appropriate clinical picture of the evolution of a vaccineprecipitated CIDP. Dr. Axelrod’s theory of causation is recognizably speculative on this 

record, and while aware of the shortcomings identified in Dr. Axelrod’s report, petitioner

repeatedly has declined the opportunity to address Jacob’s entire neurologic picture as 

requested. 

Dr. Axelrod’s expert report is further weakened by an inadequate discussion of 

Jacob’s CIDP diagnosis. As defined in the 2003 Toyka article Dr. Axelrod cited in his 

report, CIDP is a “demyelinating disease . . . characterized by relapsing or progressive 

proximal and distal muscle weakness with possible sensory loss.” 9 Pet’r’s Ex. 15 at S2. 

Whether Jacob’s CIDP is “relapsing” or “progressive” is not known from the record and 

is not addressed in Dr. Axelrod’s report. Whether petitioner’s symptoms manifested in a 

timeframe and manner consistent with Dr. Axelrod’s theory of causation also is unclear

from petitioner’s expert report because Dr. Axelrod does not adequately describe CIDP, 

how it manifests, or whether Jacob’s complete medical history properly aligns with the 

neurologic community’s understanding of CIDP’s clinical features. Rather, he focuses

on the immunologic mechanism of vaccine causation without elucidating how Jacob’s

overall neurologic course implicated a vaccine injury.

Petitioner has failed to address Jacob’s medical records as a whole, which describe 

the appearance (and absence) of Jacob’s various neurologic symptoms. Instead,

petitioner has offered a carefully circumscribed opinion from Dr. Axelrod that considers 

only a selective and partial view of the record. Although Dr. Axelrod represented that he 

had “participated in the diagnosis . . . of [CIDP],” Pet’r’s Ex. 13 at 1, he did not discuss 

in his expert report the relevance (or irrelevance) of a number of Jacob’s medical records 

and documented neurologic symptoms (including weakness) which pre-dated the subject 

vaccinations. Even with Dr. Axelrod’s report, this record on its face does not establish, 

by preponderant evidence, a logical causal sequence between Jacob’s received vaccines 

and his neurologic problems. Thus, petitioner’s claim fails on prong two of Althen.

 

9 Klaus V. Toyka & Ralf Gold, The Pathogenesis of CIDP: Rationale for Treatment 

with Immunomodulatory Agents, 60 Neurology S2 (2003).
10

C. Althen Prong One

Dr. Axelrod has offered the theory that Jacob’s received vaccines led to a 

circulating immune complex that resulted in his neurologic injury. According to Dr. 

Axelrod, “[i]mmune reactions to vaccines depend upon the individual’s immune system’s 

ability to recognize the vaccine as a foreign substance.” Pet’r’s Ex. 13 at 3. He opined 

that Jacob’s vaccinations caused an “immune response . . . [that] result[ed] in an 

unwanted immune response against otherwise normal tissues,” Id. at 3, and Jacob’s 

“activated immune system” caused “immune mediated damage” in the form of 

“demyelinated or thinly myelinated axons.” Id. at 2. Dr. Axelrod asserted that this 

damage ultimately led to Jacob’s CIDP. Id. at 4. 

Even if the undersigned were to accept Dr. Axelrod’s theory of causation in 

satisfaction of Althen prong one, his report is insufficient on its face, as previously 

discussed, for petitioner to meet her evidentiary burden under prongs two and three of 

Althen. Accordingly, petitioner cannot prevail on the record as presented.

V. Conclusion

Petitioner has not met her evidentiary burden under Althen. Petitioner has 

declined multiple opportunities to file a supplemental expert report from Dr. Axelrod to 

address the deficiencies the undersigned has identified in petitioner’s expert report. 

Because petitioner has failed to demonstrate either that Jacob suffered a “Table Injury” or 

that his injuries were in fact caused by his vaccinations, this case is dismissed for 

insufficient proof. The Clerk shall enter judgment accordingly.

IT IS SO ORDERED.

s/ Patricia E. Campbell-Smith

Patricia E. Campbell-Smith

Chief Special Master