Jacunski v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 09-524V

Filed: September 23, 2014

(Not to be published)

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CHARLOTTE JACUNSKI, * Vaccine Act Entitlement;

* Influenza Vaccine/Chronic

Petitioner, * Inflammatory Demyelinating

* Polyneuropathy (“CIDP”);

v. * Significant Aggravation

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SECRETARY OF HEALTH AND *

HUMAN SERVICES *

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Respondent. *

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DECISION

HASTINGS, Special Master.

This is an action in which the Petitioner, Charlotte Jacunski, seeks an award under the

National Vaccine Injury Compensation Program (hereinafter “the Program1 ), on account of an

ongoing neurological condition that she believes was aggravated by two influenza vaccinations.

For the reasons set forth below, I conclude that Petitioner is not entitled to an award.

I

APPLICABLE STATUTORY SCHEME AND CASELAW

Under the National Vaccine Injury Compensation Program, compensation awards are

made to individuals who have suffered injuries after receiving vaccines. In general, to gain an

award, a petitioner must make a number of factual demonstrations, including showings that an

1

The applicable statutory provisions defining the Program are found at 42 U.S.C. §300aa -10 et seq. (2006).

Hereinafter, for ease of citation, all “§” references will be to 42 U.S.C. (2006).

1

individual received a vaccination covered by the statute; received it in the United States; suffered

a serious, long-lasting injury; and has received no previous award or settlement on account of the

injury. Finally--and the key question in most cases under the Program--the petitioner must also

establish a causal link between the vaccination and the injury. In some cases, the petitioner may

simply demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be

shown that the vaccine recipient suffered an injury of the type enumerated in the “Vaccine Injury

Table” corresponding to the vaccination in question, within an applicable time period following

the vaccination also specified in the Table. If so, the Table Injury is presumed to have been

caused by the vaccination, and the petitioner is automatically entitled to compensation, unless it

is affirmatively shown that the injury was caused by some factor other than the vaccination.

§300aa-13(a)(1)(A); §300aa-11(c)(1)(C)(i); §300aa-14(a); §300aa-13(a)(1)(B).

In other cases, however, the vaccine recipient may have suffered an injury not of the type

covered in the Vaccine Injury Table. 2 In such instances, an alternative means exists to

demonstrate entitlement to a Program award. That is, the petitioner may gain an award by

showing that the recipient's injury was “caused-in-fact” by the vaccination in question.

§300aa-13(a)(l)(A); § 300aa-11(c)(1)(C)(ii). In such a situation, of course, the presumptions

available under the Vaccine Injury Table are inoperative. The burden is on the petitioner to

introduce evidence demonstrating that the vaccination actually caused the injury in question.

Althen v. HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. HHS, 940 F.2d 1518, 1525 (Fed.

Cir. 1991). The showing of “causation- in-fact” must satisfy the “preponderance of the evidence”

standard, the same standard ordinarily used in tort litigation. §300aa-13(a)(l)(A); see also

Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that standard, the petitioner must

show that it is “more probable than not” that the vaccination was the cause of the injury. Althen,

418 F.3d at 1279. The petitioner need not show that the vaccination was the sole cause or even

the predominant cause of the injury or condition, but must demonstrate that the vaccination was

at least a "substantial factor" in causing the condition, and was a “but for” cause. Shyface v.

HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999). Thus, the petitioner must supply “proof of a logical

sequence of cause and effect showing that the vaccination was the reason for the injury;” the

logical sequence must be supported by “reputable medical or scientific explanation, i.e., evidence

in the form of scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278; Grant v.

HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992).

The Althen court also provided additional discussion of the “causation- in- fact” standard,

as follows:

Concisely stated, Althen’s burden is to show by preponderant evidence that the

vaccination brought about her 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.

2

No Table Injury is alleged in this case. Petitioner’s theory in this case is that a vaccine “actually caused” a

“significant aggravation” of a preexisting condition.

2

If Althen satisfies this burden, she is “entitled to recover unless the [government]

shows, also by a preponderance of evidence, that the injury was in fact caused by

factors unrelated to the vaccine.”

Althen, 418 F.3d at 1278 (emphasis in original)(citations omitted). The Althen court noted that a

petitioner need not necessarily supply evidence from medical literature supporting the

petitioner’s causation contention, so long as the petitioner supplies the medical opinion of an

expert. Id. at 1279-80. The court also indicated that, in finding causation, a Program factfinder

may rely upon “circumstantial evidence,” which the court found to be consistent with the

“system created by

Congress, in which close calls regarding causation are resolved in favor of injured claimants.”

Id. at 1280.

Since Althen, the Federal Circuit has addressed the causation- in-fact standard in several

additional rulings, which have affirmed the applicability of the Althen test, and afforded further

instructions for resolving causation-in- fact issues. In Capizzano v. HHS, 440 F.3d 1317, 1326

(Fed. Cir. 2006), the court cautioned Program factfinders against narrowly construing the second

element of the Althen test, confirming that circumstantial evidence and medical opinion,

sometimes in the form of notations of treating physicians in the vaccinee’s medical records, may

in a particular case be sufficient to satisfy that second element of the Althen test. Both Pafford v.

HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006), and Walther v. HHS, 485 F.3d 1146, 1150 (Fed. Cir.

2007), discussed the issue of which party bears the burden of ruling out potential non-vaccine

causes. DeBazan v. HHS, 539 F.3d 1347 (Fed. Cir. 2008), concerned an issue of what evidence

the special master may consider in deciding the initial question of whether the petitioner has met

her causation burden.

Another important aspect of the causation-in-fact case law under the Program concerns

the factors that a special master should consider in evaluating the reliability of expert testimony

and other scientific evidence relating to causation issues. In Daubert v. Merrell Dow

Pharmaceuticals, Inc., 509 U.S. 579, 593-94 (1993), the Supreme Court listed certain factors that

federal trial courts should utilize in evaluating proposed expert testimony concerning scientific

issues. In Terran v. HHS, 195 F.3d 1302, 1316 (Fed. Cir. 1999), the Federal Circuit ruled that it

is appropriate for special masters to utilize Daubert’s factors as a framework for evaluating the

reliability of causation-in-fact theories presented in Program cases. One of the factors listed in

Daubert is whether the scientific theory “has been subjected to peer review and publication.”

509 U.S. at 593. The Court noted that while publication does not “necessarily” correlate with

reliability, since in some instances new theories will not yet have been published, nevertheless

“submission to the scrutiny of the scientific community is a component of ‘good science,’” so

that the “fact of publication (or lack thereof) in a peer reviewed journal thus will be a relevant,

though not dispositive, consideration in assessing the scientific validity” of a theory. Id. at 593-

94.

Here, Petitioner does not assert that her vaccinations initially caused her CIDP. Rather,

she asserts that they caused a significant aggravation of her CIDP. (Ex. 10, p. 4) According to

W.C. v. HHS, 704 F.3d 1352 (Fed. Cir. 2013), “The Vaccine Act created the National Vaccine

3

Injury Compensation Program, which allows certain petitioners to be compensated upon

showing, among other things, that a person ‘sustained, or had significantly aggravated’ a

vaccine-related ‘illness, disability, injury, or condition.’” Id. at 1355–56, quoting 42 U.S.C. §

300aa–11(c)(1)(C))(emphasis added.) In Whitecotton v. HHS, 81 F.3d 1099, 1103 (Fed. Cir.

1996), the U.S. Court of Appeals for the Federal Circuit stated that “the statutory requirements to

make out a prima facie significant aggravation claim are analogous to those required to make out

a prima facie initial onset claim.” The Vaccine Act states that “[t]he 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.”

'300aa-33(4).

The elements of an off-Table significant aggravation case are set forth in Loving v. HHS,

86 Fed. Cl. 135, 144 (2009). There, the court combined the test from Althen v. HHS, 418 F.3d

1274, 1278 (Fed. Cir. 2005), which defines off-Table causation cases, with a test from

Whitecotton v. HHS, 81 F.3d 1099, 1107 (Fed. Cir. 1996), which concerns on-Table significant

aggravation cases. The resultant test has six components, which are:

(1) the person's condition prior to administration of the vaccine, (2) the person's

current condition (or the condition following the vaccination if that is also

pertinent), (3) whether the person’s current condition constitutes a ‘significant

aggravation’ of the person’s condition prior to vaccination, (4) a medical theory

causally connecting such a significant worsened condition to the vaccination, (5) a

logical sequence of cause and effect showing that the vaccination was the reason

for the significant aggravation, and (6) a showing of a proximate temporal

relationship between the vaccination and the significant aggravation.

Loving, 86 Fed. Cl. at 144; see also W.C. v. HHS, 704 F.3d 1352, 1357 (Fed. Cir. 2013) (holding

that “the Loving case provides the correct framework for evaluating off-table significant

aggravation claims”).

II

PROCEDURAL HISTORY

On August 11, 2009, Petitioner filed a petition for compensation (“Petition”) under the

National Childhood Vaccine Injury Act of 1986, as amended, §§300aa-1 et seq. (“Vaccine Act”

or “Act”). Petitioner alleged that influenza vaccinations administered on December 4, 2006, and

November 16, 2007, “caused or triggered” her development of chronic inflammatory

demyelinating polyneuropathy (“CIDP”). (See Petition (“Pet”), pp. 1-3.) The petition was

initially assigned to Special Master Gary Golkiewicz.

On November 23, 2009, Respondent's counsel filed her “Rule 4(c) Report,” asserting

that Petitioner had failed to establish causation- in-fact by a preponderance of the evidence

because the onset of Petitioner’s CIDP occurred prior to her influenza vaccinations.

4

A fact hearing was held on November 1, 2010, concerning the onset of Petitioner’s CIDP.

Petitioner and witness Linda Heck testified. (See Transcript of Proceedings, November 1, 2010.)3

On November 3, 2010, Special Master Golkiewicz filed an Order rejecting Petitioner’s testimony

“concerning the correctness of the information contained in the medical records.” (Order, filed

Nov. 1, 2010, p. 1.) He found that Petitioner’s “memory was not sufficiently clear to be relied

upon.” (Id.) He directed the parties to file expert reports in support of their claims. However,

the special master emphasized that all experts would be expected to pay particular attention to

the information contained in the medical records, and to cite those records when discussing

whether Petitioner’s symptoms pre-dated her influenza vaccinations. (Id.) Special Master

Golkiewicz also noted a lack of evidence that Petitioner suffered a “worsening” of her condition

after her second vaccination, on November 16, 2007. He directed that any expert opinion that

discussed aggravation of Petitioner’s condition after that vaccination must “set forth, in detail,

what facts are being relied upon for such worsening.” (Id., p. 2.)(Emphasis in the original.)

The parties subsequently filed expert reports in support of their respective positions.

Petitioner filed the expert report of Dr. Thomas Morgan, on August 29, 2011, which

acknowledged Petitioner’s “pre-existent CIDP,” but argued that the two influenza vaccinations

that she received had both “aggravated and made worse her underlying CIDP.” (Ex. 10, p. 4.)4

Respondent filed the expert report of Dr. Elijah Stommel, on April 25, 2012, which contended

that there was “no evidence that the vaccines altered the course of Ms. Jacunski’s CIDP.” (Ex.

A, p. 6.)

On May 9, 2012, the case was reassigned from Special Master Golkiewicz to the

undersigned special master. By agreement of the parties, a second hearing was scheduled, to

determine Petitioner’s entitlement to compensation under the Vaccine Act. (See Order, filed

June 7, 2012.) Pursuant to my Order, dated June 7, 2012, both parties filed their pre-hearing

memoranda in September of 2012.

The second hearing was held on October 26, 2012, at which Dr. Morgan and

Dr. Stommel testified. (See 2-Tr.) Petitioner filed her Post-Hearing Brief on March 29, 2013,

and Respondent filed a Post-Hearing Brief on June 27, 2013. Petitioner filed a Reply on

September 10, 2013.

III

3

The record of this case includes transcripts for two hearings, which occurred on November 1, 2010, and October

26, 2012. I will refer to those transcripts as “1-Tr.,” and “2-Tr.”, respectively.

4

Both parties have filed numerous documents in this case. Petitioner filed Exhibits 1-3 in October of 2009, and

Exhibits 4-12 on several dates thereafter. I will refer to those exhibits as Ex. 1, Ex. 2, etc. Respondent filed

Exhibits A and B on April 25, 2012. I will refer to those exhibits as Ex. A and Ex. B. Respondent also filed

medical articles as attachments to Exhibit A, numbered 1 through 17. I will refer to these items as Ex. A-1, A-2, etc.

5

FACTS

Petitioner was born on February 6, 1955. (Ex. 1, p. 1.) She received an adult influenza

vaccination at fifty-one years of age, on December 4, 2006, and another about one year later, on

November 16, 2007. (Ex. 3, p. 1.) Prior to those influenza vaccinations, Petitioner had a past

history of irritable bowel syndrome, uterine fibroids, and a cystocele. (Ex. 1, pp. 63, 65.) More

importantly, Petitioner had previously experienced some neurological symptoms--namely,

weakness in her lower extremities--which began in August or September 2006 after Petitioner

returned from a trip to Germany. (Ex. 1, pp. 47, 51, 53; Ex. 6, p. 3; Ex. 10, p. 4; Ex. A, pp. 2, 6;

2-Tr., pp. 31, 123.) Around September 2006, Petitioner started having trouble getting upstairs,

especially when the steps were steeper. This problem “gradually became worse.” (Ex. 1, p. 47.)

These neurological symptoms, tragically, turned out to be the first symptoms of Petitioner’s

eventual diagnosis of “CIDP”--i.e., “chronic inflammatory demyelinating polyneuropathy.”

On December 4, 2006, Petitioner sought treatment at the Henry Ford Medical Center in

Novi, Michigan (“Ford Center”), primarily because she had a sensation of burning when

urinating, and her urine was cloudy. (Ex. 1, p. 65.) Petitioner also reported a rash on her neck

and a feeling of weakness in her thigh region. (Id.) Dr. Steven Fried examined Petitioner and

observed normal gait, normal strength in the legs, and “1+” reflexes, which he characterized as

“diminished.” (Id.) Dr. Fried’s “assessment” stated that that Petitioner suffered from a urinary

tract infection (UTI) and dermatitis, while he attributed her subjective leg weakness to a change

in her exercise regimen. (Id.) Dr. Fried recommended imaging of the spine or an

electromyogram (“EMG”) if her symptoms persisted. (Id.) At this visit, Petitioner received her

first influenza vaccination. (Id; Ex. 3, p. 1.)

Four days later, on December 8, 2006, Petitioner first saw a chiropractor, Stephen

Tepper, to seek treatment for discomfort in her hands and legs. He recorded her history of

constant numbness, tingling, stiffness, and weakness of both hands and both legs, which had

started about August 1, 2006, and became “progressively worse.” (Ex. 6, p. 3.) She made

subsequent visits to the chiropractor in December 2006 and January 2007. (Ex. 6, pp. 9-15.) On

December 13 and 15 of 2006, Dr. Tepper noted that her condition was “improving favorably,”

and “showing progress.” (Ex. 6, pp. 9-10.)

On December 19, 2006, Petitioner returned to the Henry Ford Medical Center to receive

her complete yearly physical examination. (Ex. 1, p. 63.) During this visit she reported her

recent treatment by a chiropractor for leg weakness, and that she had noticed improvement in her

symptoms since that visit. (Id.)5 Her treating provider, Dr. Mudita Malhotra, indicated that

Petitioner “will notify us if symptoms worsen at any time.” (Id.) Dr. Malhotra’s examination

revealed a normal gait, normal motor strength in both legs, and bilateral deep tendon reflexes of

2+ (normal). (Id.)

5

Dr. Malhota’s notes on December 19, 2006, state: “She was evaluated in the office early December for UTI, which

has completely resolved. She also complained of subjective leg weakness seco ndary to change in exercise regimen

at that time. Has been following up with chiropractor for the same and has noticed improvement in symptoms.” (Ex.

1, p. 63.)

6

Petitioner received chiropractic manipulation and/or moist heat treatments from Dr.

Tepper during a total of seven appointments in December 2006, and three more in early January

2007. (Ex. 6, pp. 3-15.) On January 9, 2007, her chiropractor noted that “there is relative

improvement in the patient’s symptomology.” (Ex. 6, p. 15.) Petitioner did not receive any

further chiropractic treatment for eleven months thereafter. (Id.)

The records do not indicate that Petitioner sought any other medical evaluation of leg

weakness or problems with her hands throughout most of 2007. On February 17, 2007,

Petitioner received a “screening colonoscopy.” (Ex. 2, p. 56.) At that time, she was described as

a 51 year old female “who does not have significant medical problems.” (Id.)

Petitioner returned to her general practitioner nine months later on November 16, 2007,

with a complaint of numbness in her legs, and that her legs felt “heavy.” (Ex. 1, p. 55.) Dr.

Malhotra indicated: “[Petitioner] comes in today with [a] one-year history of progressive

worsening of leg symptoms including numbness as well as ‘weakness.’ Symptoms are worse in

the left leg as compared to right.” (Id.) Petitioner informed Dr. Malhotra that she could not lift

herself up from a chair or from a squatting position without help, and that she experienced

difficulty climbing up stairs without the use of handrail support. (Id.) She also reported a

worsening of her symptoms in the winter and “less intense” symptoms during the summer

months. (Id.)

Petitioner’s physical examination at that time was normal. (Id.) Dr. Malhotra observed

normal gait, reflexes at 2+ bilaterally, and “good” bilateral motor strength in petitioner’s arms

and lower legs. (Id.) However, Petitioner had “subjective weakness” when asked to raise herself

up from a sitting position in a chair. (Id.) Dr. Malhotra’s assessment was bilateral leg numbness

and weakness. (Id.) He ordered laboratory studies and referred Petitioner to a rheumatology

specialist. (Id.) Petitioner also received her second influenza vaccination on November 16, 2007.

(Ex. 1, p. 56; Ex. 3, p. 1.)

Three weeks after the visit to Dr. Malhotra, on December 7, 2007, Petitioner resumed her

chiropractic treatments by Dr. Tepper. (Ex. 6, p. 15.) During that December, she received a total

of eight such treatments, and four more in the beginning of January 2008. (Id., pp. 15-23.) She

indicated that the severity of her pain was quite low, usually at the “zero” level. (Id.) Although

at some of these visits Dr. Tepper recorded “no change” in the patient’s condition (Ex. 6, pp. 15-

23), at three visits he noted some progress or improvement. (Id., pp. 16, 17, 19).

On December 18, 2007, Petitioner presented to the Ford Center for a rheumatology

evaluation by Dr. Michael Lubetsky. (Ex. 1, pp. 51-52.) Petitioner reported that,

[S]he has been having [a] numb feeling with weakness in the arms and legs

[since] last September. She actually had the same thing happen just in her thighs

last year. It lasted for 3 months. She went to a chiropractor and it resolved. This

year, it’s not only in the thighs, this numb feeling, but also all the way down her

legs to her feet. She will notice a fluttering or possible twitching or

fasciculations in the muscles.

7

(Ex. 1, p. 51.) Petitioner reported a tingling sensation in her fingers, numbness in her forearms,

and weakness in her hands. (Id.) She also had trouble raising her legs to climb stairs. (Id.)

Petitioner’s physical examination was normal except for absent reflexes throughout. (Id.)

Dr. Lubetsky did not think that “this is an inflammatory myopathy because of the fasciculations

and the paresthesias and numbness.” (Id.) Rather, Dr. Lubetsky suspected that Petitioner had a

neurologic disease, and referred her to neurology. (Id., p. 52.)

Later on that same day, December 18, 2007, neurologist Dr. Howard Feit examined

Petitioner. (Ex. 1, pp. 53-54.) Petitioner informed Dr. Feit that “about 2 years ago” she lost

power in her legs and could not get up out of a chair. (Id., p. 53.) She indicated that she saw a

chiropractor, and her symptoms improved but did not go away completely. (Id.) Petitioner

reported that in September 2007 she had experienced “a marked loss of power, which has

persisted since then.” (Id.) The examination on December 18, 2007 showed mild weakness at

4/5 of the arms and hands symmetrically, 4/5 strength in the legs, absent reflexes throughout, and

intact sensation despite a subjective sense of numbness. (Ex. 1, pp. 53-54.) Dr. Feit’s initial

impression was “either a myopathic or neuromuscular junction process.” (Id.)

On December 26, 2007, medical personnel at the Ford Center performed further studies

on Petitioner. (See Ex. 1, p. 114.)

Dr. Feit referred Petitioner to the neurology clinic at the Henry Ford Medical Center,

where, on January 14, 2008, she was examined by two doctors, Daniel S. Newman and Ximena

Arcilalondono, for “possible CIDP.” (Ex. 1, p. 47.) They recorded Petitioner’s recollection that

her problems had started two years previously, in September 2006, 6 when she started having

trouble getting up stairs. (Id.) One year later, around September of 2007, her leg symptoms

worsened--“she noticed that she was walking with shorter steps…” and “[h]er legs felt like there

were heavy weights in them.” (Id.) She also felt “flutters” in her legs, like “when they were

really tired,” and began to have problems carrying loads of clothing or doing things with both

hands. (Id.) Upon performing a physical examination, these doctors could not detect any

reflexes in her ankles and arms, and reflexes were only 1+ in her knees. (Id.) She had a few

areas of decreased sensation in the arms and legs. (Id.) Based on the entirety of Petitioner’s

symptoms and laboratory studies, on January 14, 2008, Drs. Newman and Arcilalondono

diagnosed Petitioner with “slowly progressive” CIDP, and they advised treatment with

intravenous immunoglobulin (“IVIG”). (Id., pp. 48-49.)

On April 1, 2008, Petitioner saw Dr. Newman for a follow-up visit. (Ex. 2, p. 16.)

Dr. Newman noted that since last seeing Petitioner, she had received two courses of IVIG

treatment. (Id.) He indicated that Petitioner “has done extremely well on IVIG and her strength

is now normal.” (Id.) After detailed testing, Dr. Newman observed normal bulk, tone, and

strength in all of Petitioner’s extremities. (Id.) His diagnosis remained CIDP, and he prescribed

continued IVIG therapy at tapered doses. (Id.)

6

Petitioner referred to the onset of her “weakness” in September 2006, “after coming back from a trip to Germany.”

(Ex. 1, p. 47.) This “trip to Germany” often served to mark the specific time of when her symptoms appeared.

8

Dr. Newman again examined Petitioner on September 29, 2008. (Ex. 2, p. 9.)

Petitioner’s physical examination was normal with hypoactive reflexes. (Id.) Dr. Newman

indicated that Petitioner had received IVIG therapy every seven weeks since April. (Id.) He

noted that Petitioner had subjectively normal strength with no numbness or tingling and was

walking two miles a day on a treadmill. (Id.) Dr. Newman prescribed IVIG every eight weeks

and recommended a follow-up in six months. (Id.) It appears that Petitioner received IVIG

treatments through April 28, 2009. (See, e.g., Ex. 2, p. 24; Ex. 1, pp. 3-43.)

IV

ISSUE TO BE DECIDED

Petitioner seeks a Program award, contending that her CIDP and related symptoms were

significantly aggravated by the influenza vaccinations she received on December 4, 2006, and

November 16, 2007. After careful consideration, I conclude that Petitioner has failed to

demonstrate that her influenza vaccinations caused a significant aggravation of her CIDP.

Petitioner’s theory of the case may be briefly summarized as follows. Petitioner contends

that each of the two influenza vaccinations that she received caused an immediate aggravation of

her CIDP symptoms. (Ex. 10, p. 4.) Further, Petitioner asserts that these aggravations “were

caused by a post vaccinial [sic] immune mediated mechanism known as rechallange [sic] based

on the immune concept of molecular mimicry” (Ex. 10, p. 5; see also Pet. Pre-Hearing

Memorandum, filed Sept. 21, 2012, pp. 3-4.)

Respondent disagrees. Respondent’s expert witness asserts that the first symptoms of

Petitioner’s CIDP first appeared “around August of 2006,” and that there was no indication of

“deterioration after the first flu vaccination.” (Ex. A, pp. 6-7) Further, her CIDP took a

significant turn for the worse only once, in September 2007, which was long after her first

influenza vaccination and well prior to her second influenza vaccination. (Resp. Post-Hearing

Brief, filed June 17, 2013, pp. 10-11.) Finally, Respondent contends that there is no reliable

scientific evidence that supports Petitioner’s theory that the influenza vaccine can aggravate

CIDP via molecular mimicry. (Ex. A, pp. 6-7.)

After carefully considering all of the evidence in the record, I must reject Petitioner's

claim that her CIDP was aggravated by her influenza vaccines, for two reasons. First, while

Petitioner’s expert, Dr. Morgan, based his causation opinion on an assumption that Petitioner

experienced two separate exacerbations, one immediately after each vaccination, that factual

assumption is contradicted by Petitioner’s medical records. The only significant exacerbation of

Petitioner’s CIDP symptoms actually occurred long after her first influenza vaccination, and well

before she received her second influenza vaccination. Second, Dr. Morgan failed to provide any

significant support for his theory that the influenza vaccine can cause an aggravation of CIDP.

9

V

SUMMARY OF EXPERT WITNESSES’ CREDENTIALS AND OPINIONS

In this case, each side presented the expert reports and hearing testimony of one medical

expert. At this point, I will briefly summarize both the credentials and the opinions of these

expert witnesses.

A. Petitioner’s expert

1. Dr. Morgan’s qualifications

Dr. Morgan received a B.A. in history and a B.S. in chemistry from St. Louis University

in 1966. (Ex. 11, p. 1; 2-Tr., p. 10.) Dr. Morgan received his medical degree from Meharry

Medical College in 1970. (Ex. 11, p. 1; 2-Tr., p. 10.) From 1970-1975, Dr. Morgan served

first as an internal medicine intern at the Brown University School of Medicine, and then as a

resident in neurology at the Boston University School of Medicine. (Ex 11, p. 2; 2-Tr., p. 10.)

Concurrent with his duties as a resident, he served as a Teacher Fellow in Neurology at the

Boston University School of Medicine. Thereafter, Dr. Morgan was a Clinical Instructor in

Neurology at the same medical school until 1978. (Ex. 11, p. 3.) Between 1978 and the present,

he served as Assistant Professor in the Department of Clinical Neuroscience at Brown University

School of Medicine. (Ex. 11, p. 3; 2-Tr., p. 13.)

Dr. Morgan is licensed to practice medicine in Rhode Island. He is board-certified in

psychiatry and neurology, and has been certified as a medical examiner by the American Board

of Medical Examiners, since 1996. (Ex. 11, pp. 2-3; 2-Tr., p. 15.) He has also been a member

of the medical staff of Rhode Island Hospital since 1975, and a senior member of the medical

staff at Kent County Hospital since 1996. Between 1996 and 1998, Dr. Morgan participated as a

researcher in ten clinical research trials for a variety of pharmaceutical products. He has

published seven medical journal articles. (Ex. 11, pp. 4-5.)

2. Summary of opinion of Petitioner's expert

Dr. Morgan asserts that Petitioner’s pre-existing CIDP “was aggravated by the first flu

vaccination on 12/04/06,” and that her “second flu immunization on 11/16/07, again, aggravated

and made worse her underlying CIDP.” (Ex. 10, p. 4; see also 2-Tr., p. 38.) Dr. Morgan opined

that Petitioner’s influenza vaccines exacerbated her CIDP “by a post vaccinial [sic] immune

mediated mechanism known as rechallange [sic] based on the immune concept of molecular

mimicry.” (Ex. 10, p. 5; see also 2-Tr., p. 57.)

According to Dr. Morgan, molecular mimicry occurs when the immune system mistakes

the myelin in a person’s peripheral nervous system for an “antigen”--i.e., an invading agent. The

immune system then mistakenly attacks the myelin, which can cause or exacerbate CIDP. (Ex.

10, p. 5; 2-Tr., pp. 56-60.) In Petitioner’s case, according to Dr. Morgan, her “preexisting CIDP

was activated by exposures to flu immunization antigens that cross reacted with the myelin of

10

her peripheral nerves,” which caused a “recurrence and worsening of her CIDP.” (Ex. 10, p. 5.)

Further, Dr. Morgan asserted that the time of onset of her recurrences of CIDP after each of the

two influenza immunizations, and the aggravation of Ms. Jacunski’s CIDP “is appropriate for

post vaccinial [sic] immune mediated reaction.” (Id.)

B. Respondent’s expert

1. Dr. Stommel’s qualifications

Dr. Elijah Stommel received a B.A. in Music from Bowdoin College in 1977. (Ex. B,

p. 1; 2-Tr., pp. 110-11.) In 1984, Dr. Stommel received a Ph.D. in Physiology from the Boston

University School of Medicine, where he also received his degree as a medical doctor, four years

later in 1987. (Ex. B, p. 1; 2-Tr., p. 111.)

Dr. Stommel served as a medical intern at St. Elizabeth’s Hospital in Boston,

Massachusetts, from 1987-1988, and as a resident in neurology from 1988-1990 at the

Dartmouth-Hitchcock Medical Center, where he also served as Chief Resident in neurology from

1990-1991. (Ex. B, p. 1.) Dr. Stommel is licensed to practice medicine in Massachusetts, New

Hampshire, and Vermont. (Id., pp. 1-2.) He is board-certified in electrodiagnostic medicine,

psychiatry, and neurology. (Id.; 2-Tr., pp. 111-12.)

Dr. Stommel commenced his academic career as an Instructor in Medicine at the

Dartmouth Medical School from 1990-1991, then advanced to Assistant Professor of Medicine

and served in that capacity from 1991 to June 2001. (Ex. B, p. 2.) Since 2001, he has served as

an Associate Professor of Medicine at the Dartmouth Medical School. (Ex. B, p. 2; 2-Tr., pp.

112-14.) In his clinical practice, Dr. Stommel has been the Staff Neurologist at the Hitchcock

Clinic in New Hampshire, since 1991. Concurrently, he served as a Consultant Neurologist at

several medical centers in New Hampshire and Vermont. (Ex. B, p. 2.) In 1999, he founded the

Neurology Neuromuscular Clinic at Dartmouth-Hitchcock Medical Center, where he continues

to practice and train medical residents. (Ex. B. p. 4.)

Dr. Stommel’s extensive involvement with research and clinical trials has focused on

neurological issues, particularly the investigation of amyotrophic lateral sclerosis. (Ex. B, pp. 8-

10.) He has authored eight chapters in a variety of medical texts, and published more than sixty

medical journal articles and abstracts. (Id., pp. 10-17.)

2. Summary of opinion of Respondent’s expert

Dr. Stommel disagreed with Dr. Morgan that either of Petitioner’s influenza vaccinations

caused an aggravation of her CIDP. In his view, the onset of her CIDP symptoms probably

occurred on or about August 1, 2006 (Ex. A, p. 6), that is, four months before her first flu

vaccination. Then, “her CIDP just continued to worsen in a progressive manner as it would

naturally.” (Id.) Further, he opined that there is no “reliable evidence for a deterioration after

the first flu vaccination, in any time frame that could be mechanistically linked in temporal

fashion.” (Ex. A, pp. 7-8; 2-Tr., pp. 124, 126.)

11

Dr. Stommel also asserted that there is no reliable evidence that the influenza vaccine can

cause CIDP via molecular mimicry. Likewise, Dr. Stommel opined that there is no reliable

evidence to support Dr. Morgan’s theory of “rechallenge.” (Ex. A, pp. 7-8; 2-Tr., pp. 127-32.)

VI

DR. MORGAN’S OPINION IS BASED ON A FLAWED ASSUMPTION AS

TO THE HISTORY OF PETITIONER’S CONDITION

Dr. Morgan’s causation opinion is predicated on his belief that Petitioner suffered two

distinct aggravations of her CIDP symptoms, one soon after each of her influenza vaccinations.

(See Ex. 10, p. 4; 2-Tr., pp. 33, 35-38, 49.) The record demonstrates, however, that Petitioner

did not suffer aggravations of her CIDP symptoms soon after either of her influenza

vaccinations. The record, rather, demonstrates that the only significant worsening of Petitioner's

CIDP symptoms occurred around September of 2007, long after her first vaccination in

December of 2006, but well before her second influenza vaccination in in November of 2007.

A. First alleged “exacerbation”

Petitioner received her first influenza vaccination on December 4, 2006.7 In the ensuing

weeks, Petitioner's neurological condition did not worsen. In fact, it improved. Petitioner visited

Dr. Tepper, the chiropractor, ten times between December 2006 and January 2007. (Ex. 6, pp. 9-

15.) Petitioner did not report that her condition had worsened at any of those visits. On

December 15, 2006, Dr. Tepper documented that Petitioner’s “condition is showing progress.”

(Ex. 6, p. 10.) Likewise, on December 19, 2006, Dr. Tepper noted “measurable improvement”

(id., p. 12), and on January 9, 2007, Dr. Tepper noted further improvement (id., p. 15).

Similarly, Petitioner’s treating physician, Dr. Malhotra, performed a “[c]omplete physical

exam” on December 19, 2006, and noted that Petitioner recently had “noticed improvement in

symptoms.” (Ex. 1, p. 64.)

Simply stated, there is no indication in the medical record that Petitioner's symptoms

worsened in the weeks after her influenza vaccination on December 4, 2006. Rather, the record

indicates that Petitioner’s symptoms either remained the same or improved during that time

period.

To be sure, Dr. Morgan urged repeatedly that Petitioner suffered a sharp downturn after

her flu vaccination of December 4, 2006. (Ex. 10, p. 4; 2-Tr., pp. 33, 47, 76.) But, as set forth

above, the overall medical records make it clear that Dr. Morgan was mistaken in that

7

The two experts agree that Petitioner suffers from CIDP, and that she suffered her first symptoms of her CIDP

about August or September of 2006, after a trip to Germany. (E.g., Ex. 10, p. 4; 2-Tr., pp. 37, 115, 123.)

12

assumption. Dr. Malhotra’s record from December 19, 2006, along with the overall chiropractor

records of December 2006/January 2007, make it clear that Petitioner was actually improving in

the weeks after the vaccination of December 4, 2006. (Ex. 1, p. 63; Ex. 63, pp. 1-15.)

In this regard, Dr. Morgan seemed to rely heavily on a single chiropractor record of

December 8, 2006, four days after the vaccination in question. (E.g., 2-Tr., pp. 47, 76.) But this

reliance was misplaced. The December 8 record does not indicate a sudden worsening of the

symptoms that Petitioner had already reported to Dr. Fried on December 4. (Ex. 1, p. 65.) The

December 8 record, rather, was simply the first time that Petitioner saw the chiropractor,

Dr. Tepper, and Dr. Tepper was recording essentially the same symptoms that Petitioner had

already reported to Dr. Fried on December 4. (Compare Ex. 1, p. 65, with Ex. 6, p. 3.) Note that

on December 8 Dr. Tepper wrote that Petitioner’s symptoms had been “progressively worse”

since August 1, 2006, not that such symptoms had significantly worsened in the prior four days. 8

Moreover, in this regard I have not ignored the testimony that Petitioner and her friend

presented during the first evidentiary hearing in this case, held before Special Master Golkiewicz

on November 1, 2010. To be sure, the oral testimony at that hearing indicated sharp downturns

in Petitioner’s neurological condition after each of her two influenza vaccinations. However,

Special Master Golkiewicz issued an Order on November 3, 2010, concluding that while

Petitioner was doing her best to accurately recall the events of years before, he found it

“perfectly evident that [Petitioner’s] memory was not sufficiently clear to be relied upon.”

(Order, p. 1.) Instead, Special Master Golkiewicz found the medical records to provide a much

more accurate history of Petitioner’s symptoms. (Id.) I have reviewed both the transcript of the

first hearing, and the medical records, and I concur completely with Special Master Golkiewicz.

I rely on the medical records for the history of Petitioner’s symptoms.

In short, I conclude that Petitioner did not suffer an exacerbation of her CIDP symptoms

soon after her first influenza vaccination.

B. Second alleged exacerbation

Next, Dr. Morgan assumed that a second sharp worsening of Petitioner’s neurological

symptoms occurred after Petitioner’s second influenza vaccination. But again, Dr. Morgan’s

assumption was wrong. The medical records simply do not show a sudden worsening of

Petitioner’s symptoms after the flu vaccination of November 16, 2007. The records, instead,

show that on November 16, 2007, Petitioner was already reporting a progressive worsening of

her symptoms over the preceding year. (Ex. 1, p. 55.)

Also, the chiropractor’s records again contradict Dr. Morgan’s assumption about the

period soon after November 16, 2007. Those records show that the chiropractor, Dr. Tepper,

saw Petitioner a number of times in December of 2007. (Ex. 6, pp.15-23.) Those records not

8

On cross-examination, Dr. Morgan himself admitted that Dr. Tepper’s records did not document an exarcerbation

after the first influenza vaccination. (2-Tr., p. 78.)

13

only fail to show an exacerbation of symptoms, but instead show progress or improvement. (Ex.

6, p. 16 (12-8-07) (“progressing favorably”); Ex. 6, p. 17 (12-10-07) (“improvement”); Ex. 6, p.

19 (12-17-07) (“progress”).)

Further, on December 18, 2007, Petitioner saw two different physicians. (Ex. 1, pp. 51-

52, 53-54.) Neither physician described a sudden increase in Petitioner’s neurological symptoms

since the November 16 vaccination. (Id.) To the contrary, both physicians wrote that the

exacerbation of Petitioner’s neurological symptoms took place in September of 2007, not after

the November vaccination. (Ex. 1, pp. 51, 53.) Then, again, on January 14, 2008, Petitioner

once more reported the same worsening in September 2007. (Ex. 1, p. 47.)

In sum, I conclude that the medical records indicate that the only time Petitioner's

symptoms sharply worsened was around September of 2007, two months before her influenza

vaccination of November 2007.

C. Summary

The record establishes that, in formulating his opinion, Dr. Morgan assumed plainly

incorrect facts concerning when Petitioner allegedly suffered exacerbations of her CIDP

symptoms. The record demonstrates that Petitioner did not suffer an exacerbation of her CIDP

symptoms shortly after her influenza vaccination of December 4, 2006, as Dr. Morgan assumed,

nor did she suffer an exacerbation of her CIDP symptoms shortly after her influenza vaccination

of November 16, 2007. Thus Petitioner’s causation theory must fail for this reason alone--

because Dr. Morgan relied upon a clearly mistaken assumption concerning the history of

Petitioner’s symptoms.

VII

ADDITIONAL REASONS TO CREDIT DR. STOMMEL’S

TESTIMONY OVER THAT OF DR. MORGAN

As noted above, Dr. Morgan’s causation opinion could be readily dismissed simply

because he based it on clearly flawed assumptions as to the timing of Petitioner’s CIDP

symptoms, as described in Section VI. However, I will also briefly discuss several additional

reasons to discount Dr. Morgan’s causation opinion.

A. Dr. Stommel’s testimony was more persuasive in general.

In general, Dr. Stommel’s presentation was substantially more persuasive than that of

Dr. Morgan, whose opinion was plagued by a lack of evidentiary support for his causation

theory.

Most importantly, Dr. Morgan simply failed to put forth any coherent presentation of

evidence or reasoning to support his causation conclusion. As explained above, Dr. Morgan

14

opined that Petitioner’s CIDP was exacerbated both by her first influenza vaccination in

December of 2006 and her second influenza vaccination in November of 2007. But Dr. Morgan

failed to offer any coherent evidence for the proposition that the influenza vaccination is even

capable of exacerbating CIDP. Dr. Morgan failed to point to any medical articles or other actual

evidence demonstrating that influenza inoculations can do so. (2-Tr., p. 60.) He failed to

persuasively explain by what mechanism influenza vaccinations could exacerbate CIDP.

Indeed, Dr. Morgan even acknowledged himself that he knows of no medical literature

indicating that the influenza vaccine can cause CIDP--and he does not believe that any such

literature exists. (2-Tr., p. 60.)

And Dr. Stommel, on the other hand, was persuasive in pointing out the lack of any

scientific support for Dr. Morgan’s speculations. He maintained that Dr. Morgan’s theory of the

case was not persuasive, and that Petitioner’s two vaccinations in question likely did not

influence the course of Petitioner’s CIDP in any way. (Ex. A, p. 6; 2-Tr., pp. 124, 134-35.)

B. Dr. Morgan’s presentation concerning “molecular mimicry” was not persuasive.

To support his causation theory, Dr. Morgan suggested that perhaps the influenza

vaccines caused Petitioner’s alleged exacerbations by a mechanism known as “molecular

mimicry.” (E.g., 2-Tr., p. 50.) CIDP is thought to be an autoimmune disease, meaning that the

patient’s own immune system is erroneously attacking the patient’s own tissue, mistaking that

tissue for an invasive agent. (Ex. A, p. 3; 2-Tr., pp. 50, 127-128.) Dr. Morgan’s expert report

argues that Petitioner’s preexistent CIDP could be activated “by exposures to flu immunization

antigens that cross reacted with the myelin of her peripheral nerves to cause recurrence and

worsening her CIDP.” (Ex. 10, p. 5; see also 2-Tr., p. 50 -- “there’s a cross reactivity of the

antigen that gets destructive and attacks her own system.”) Thus, Dr. Morgan appears to suggest

that an antigen9 within the influenza vaccine erroneously prompted Petitioner’s immune system

to attack her own tissues, thereby exacerbating her CIDP.

But, Dr. Morgan failed to offer any evidence or even any explanation to support this

vague suggestion. In his expert report and his testimony, Dr. Morgan introduced the concept of

an antigen that is part of the influenza vaccine, which may have caused a harmful response. (See

Ex. 10, p. 5; 2-Tr., p. 50.) However, when pressed for more details, he had no idea what

particular antigen within the vaccine might have caused the alleged molecular mimicry effect.

(2-Tr., p. 59.) Indeed, he acknowledged that he knows of no evidence to support the idea that a

flu vaccine can cause CIDP via molecular mimicry -- “it’s a theory” was the best he could offer.

(2-Tr., p. 57.)

Dr. Stommel, on the other hand, indicated that he saw no merit to Dr. Morgan’s

“molecular mimicry” suggestions. (Ex. A, p. 5; 2-Tr., pp. 127-31.) He testified that there is no

9

Antigen – “any substance capable, under appropriate conditions, of inducing a specific immune response and of

reacting with the products of that response, that is with specific antibodies or specifically sensitized T - lymphocytes

or both.” DORLAND’S ILLUST RAT ED M EDICAL DICT IONARY (31st ed. 2007), p. 104.)

15

evidence that modern day influenza vaccines “have any homology” with the parts of the nervous

system attacked by the immune system in CIDP--in other words, that there is no similarity

between vaccine components and neuronal or myelin structures that would prompt such an

erroneous immune system attack. (Ex. A, p. 4.) He reiterated that testimony at the hearing--that

he knows of no similarity between the proteins in the flu vaccine and the myelin proteins that are

attacked in CIDP. (2-Tr., pp. 129-30.) He testified that no medical researcher has ever shown

that the influenza vaccine could cause molecular mimicry resulting in an aggravation of CIDP.

(2-Tr., p. 130.) He acknowledged that some in the medical community have hypothesized that

CIDP might be caused through a process of molecular mimicry by “something” in the

environment (Id., line 24), but explained that there is no evidence that the influenza vaccine

could be the trigger of CIDP exacerbation (2-Tr., pp. 129-30, 131).

Viewing the overall record, I find no merit in Dr. Morgan’s “molecular mimicry” theory

in this case.

C. Dr. Morgan’s “challenge/rechallenge” theory was not persuasive.

Dr. Morgan also asserted that Petitioner’s case is an example of the “challenge/

rechallenge” theory, which supports a conclusion that Petitioner’s CIDP was vaccine-caused.

(E.g., 2-Tr., pp. 49, 57; Ex. 10, p. 5.) After closely studying the record of this case, I firmly

conclude that the “challenge/rechallenge” concept does not apply to this case.

To be sure, if a true instance of “challenge/rechallenge” occurs, that can indeed be

powerful evidence of causation. As Dr. Morgan explained, “challenge/rechallenge” refers to a

situation where a person has a clinical reaction to a particular stimulus (i.e. - administration of a

vaccine or drug), and then suffers increased symptoms after an additional exposure to that same

stimulus (i.e. - a second administration of a vaccine or drug). (2-Tr., p. 57.) For example, in one

Vaccine Act case, Capizzano v. HHS, 2004 WL 1399178 (Fed. Cl. Sp. Mstr. 2004), rev’d on

other grounds 440 F.3d 1317 (Fed. Cir. 2006), the special master stated that the

“challenge/rechallenge cases are such strong proof of causality that it is unnecessary to

determine the mechanism of cause -- it [causation] is understood to be occurring.” 2004 WL

1399178 at *15-16.

Unfortunately for Petitioner, however, the actual facts of Petitioner’s case clearly do not

fit the challenge/rechallenge scenario.

In this case, as explained above, and contrary to Dr. Morgan’s assumption, Petitioner

clearly did not suffer an exacerbation of her CIDP after her first influenza vaccination in

December of 2006, nor did she suffer a second rapid onset of symptoms after her second

influenza vaccination in November of 2007. Rather, as discussed above, the record of this case

makes it clear that Petitioner, unfortunately, was already experiencing the initial symptoms of

her CIDP during the months prior to her first influenza examination. To be sure, there is no

doubt that Petitioner’s disorder did significantly worsen one year later, around September of

2007. But the medical records do not point to any rapid worsening her symptoms after either of

the vaccinations in question.

16

Accordingly, I do not find that Petitioner’s case fits the “challenge/rechallenge” scenario.

Dr. Stommel reached the same conclusion. (2-Tr. 132.) The challenge/rechallenge argument is

not persuasive in this case.

D. Petitioner’s symptom history followed a typical course for CIDP.

Another factor leading me to credit Dr. Stommel over Dr. Morgan is the testimony

concerning the typical course of CIDP. CIDP can often follow a “relapsing/remitting” course, in

which symptoms often stay the same for a period of time, then get suddenly worse at various

times for no discernible reason, while sometimes gradually worsening over time. (Ex. A, pp.

2-3; 2-Tr., pp. 116, 123, 123, 126, 144.) Dr. Stommel opined that Petitioner’s condition was a

typical relapsing/remitting form of CIDP, and that her vaccinations have had no effect on the

course of her CIDP. (2-Tr., pp. 123, 126, 139-40.)

Dr. Morgan himself acknowledged that the natural course of CIDP is often a

relapsing/remitting course. (2-Tr., pp. 70-72, 96, 100, 106.)

My conclusion from the overall record is that Petitioner, unfortunately, suffers from a

typical form of relapsing/remitting CIDP, and that her vaccinations have had no effect on the

course of her disease.

E. The IOM committee report also is consistent with my conclusion.

Another factor in this case is the existence of a recent report of the prestigious Institute of

Medicine, regarding the possible adverse effects of vaccines, which specifically addressed the

issue of whether influenza vaccines can affect CIDP. (Ex. A, p. 6.) The IOM committee found

that the available evidence was insufficient to determine whether an association exists between

influenza vaccines and CIDP. (Ex. A, pp. 6-7.)10

Dr. Morgan acknowledged that this conclusion of the IOM committee did not support his

theory. (2-Tr., p. 58.)

Of course, this IOM committee conclusion is of very slight importance in this case, since

the committee did not find enough evidence to conclude either way as to whether the flu vaccine

can affect CIDP. But since the Petitioner bears the burden of proof to demonstrate causation,

this IOM committee conclusion could be said to add very slight additional weight against

Petitioner’s causation case.

F. Summary concerning causation issue

10

See Ex. A-14, Kathleen Stratton, et al., Institute of Medicine, A DVERSE EFFECT S OF VACCINES: EVIDENCE AND

CAUSALIT Y (The National Academies Press, pre-publication ed. 2011), excerpt of pp. 281-82, entitled Chronic

Inflammatory Disseminated Polyneuropathy (concluding that “The evidence is inadequate to accept or reject a

causal relationship between influenza vaccine and CIDP.”)

17

In short, I find Dr. Morgan’s causation argument to be wholly unpersuasive, and I find

the contrary testimony of Dr. Stommel to be persuasive.

VIII

PETITIONER’S CASE FAILS THE TESTS REQUIRED BY ALTHEN AND LOVING

In this part of my Decision, I will explain how this case fits specifically within the

interpretive standards set forth in the Althen and Loving decisions. The short answer is that I find

that Petitioner’s case clearly does not satisfy the standards presented in either Althen or Loving.

The U.S. Court of Appeals for the Federal Circuit declared in Althen that it is a

Petitioner’s burden

to show by preponderant evidence that the vaccination brought about her 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.

Althen, 418 F.3d at 1278 (emphasis in original)(citations omitted). There can be no doubt

whatsoever that the Althen test ultimately requires that, as an overall matter, a petitioner must

demonstrate that it is “more probable than not” that the particular vaccine was a substantial

contributing factor in causing the particular injury in question. That is clear from the statute

itself, which states that the elements of a petitioner’s case must be established by a

“preponderance of the evidence.” (§ 300aa-13(a)(l)(A).) The overall evidence here shows that

the onset of Petitioner’s CIDP occurred in August 2006, more than three months before her first

influenza vaccination, so it is clear that the influenza vaccines that she received were not the

initial cause of her preexisting CIDP. However, in this case, Petitioner does not assert that her

influenza vaccinations initially caused her CIDP. Rather, the injury that she alleges is that her

influenza vaccinations caused a significant aggravation of her CIDP. (Ex. 10, p. 4.)

A. Analysis of a “significant aggravation” issue is guided by the ruling in Loving.

The Vaccine Act states that “[t]he 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.” '300aa-33(4).

The elements of an off-Table significant aggravation case were set forth in Loving v.

HHS, 86 Fed. Cl. 135, 144 (2009). The Federal Circuit Court of Appeals acknowledged that “the

Loving case provides the correct framework for evaluating off-table significant aggravation

claims,” in W.C. v. HHS, 704 F.3d 1352, 1357 (Fed. Cir. 2013). Thus, the Federal Circuit Court

of Appeals, which sets binding precedent for decisions by the Office of Special Masters,

endorsed the use of a six-part test for significant aggravation, which was first elaborated in

18

Loving. A petitioner must prove by preponderant evidence that a vaccination caused significant

aggravation by showing:

(1) the person’s condition prior to administration of the vaccine, (2) the person's

current condition (or the condition following the vaccination if that is also

pertinent), (3) whether the person’s current condition constitutes a ‘significant

aggravation’ of the person’s condition prior to vaccination, (4) a medical theory

causally connecting such a significant worsened condition to the vaccination, (5) a

logical sequence of cause and effect showing that the vaccination was the reason

for the significant aggravation, and (6) a showing of a proximate temporal

relationship between the vaccination and the significant aggravation.

W.C. v. HHS, 704 F.3d at 1357 (Fed. Cir. 2013).

The standard elaborated in Loving, and affirmed in W.C. v. HHS, combines elements

from previous Federal Circuit decisions. W.C. v. HHS, 704 F.3d at 1537 (“The Loving test

combines the first three Whitecotton factors, which establish significant aggravation, with the

Althen factors, which establish causation.”) Since the last three elements of a Loving test include

the entirety of the Althen test, with insignificant wording modifications, the analysis of those

three elements would be the same using either standard.

One interpretive issue with the Althen test concerns the relationship between the first two

elements of that test (that is, prongs 4 and 5 of the Loving test). Initially, it was not absolutely

clear how the two prongs differed from each other. That is, on their faces, each of the two

prongs seems to require a demonstration of a “causal” connection between the “vaccination” and

“the aggravation.” However, a number of Program opinions concerning Althen have concluded

that these first two elements reflect the analytical distinction that has been described as the “can

cause” vs. “did cause” distinction. That is, in many Program opinions issued prior to Althen

involving “causation- in-fact” issues, special masters or judges stated that a petitioner must

demonstrate (1) that the type of vaccination in question can cause the type of injury in question,

and also (2) that the particular vaccination received by the specific vaccinee did cause the

vaccinee's own injury. (See, e.g. Kuperus v. HHS, 2003 WL 22912885, at *8 (Fed. Cl. Spec.

Mstr. Oct. 23, 2003); Helms v. HHS, 2002 WL 31441212, at *18 n. 42 (Fed. Cl. Spec. Mstr. Aug.

8, 2002).) Thus, a number of judges and special masters of this court have concluded that Prong

1 of Althen is the “can cause” requirement, and Prong 2 of Althen is the “did cause”

requirement. (See, e.g., Doe 11 v. HHS, 83 Fed. Cl. 157, 172-73 (2008); Nussman v. HHS, 83

Fed. Cl. 111, 117 (2008); Banks v. HHS, 2007 WL 2296047, at *24 (Fed. Cl. Spec. Mstr. July

20, 2007); Zeller v. HHS, 2008 WL 3845155, at *25 (Fed. Cl. Spec. Mstr. July 30, 2008).)

Most importantly, the Federal Circuit confirmed that interpretation in Pafford, ruling

explicitly that the “can it?/did it?” test, used by the special master in that case, was equivalent to

the first two prongs of the Althen test. (Pafford v. HHS, 451 F.3d at 1352, 1355-56 (Fed. Cir.

2006).) Thus, interpreting the first two prongs of Althen as specified in Pafford, under Prong 1 of

Althen, a petitioner must demonstrate that the type of vaccination in question can cause the type

of condition in question; and under Prong 2 of Althen, that petitioner must then demonstrate that

19

the particular vaccination did cause the particular condition of the vaccinee in question. If these

conclusions are applied to the analogous elements in the Loving test, then under Prong 4 of

Loving a petitioner must demonstrate that the type of vaccination in question can cause the type

of significant aggravation in question; while Prong 5 of Loving would require that the Petitioner

also demonstrate that the particular vaccination did cause the significant aggravation.

B. Analysis of this case, under the six-part Loving/Althen test.

In this Section, I will discuss whether Petitioner has satisfied the six-part Loving test to

establish the existence of a vaccine-related significant aggravation of a pre-existing condition.

1. What was Petitioner’s condition prior to the administration of the vaccine?

Petitioner’s expert witness, Dr. Morgan, opined in his report that, based on the medical

records, “Ms. Jacunski developed her first symptom of CIDP in August of 2006 characterized by

mild weakness of her lower extremity with abnormal sensations,” and “these symptoms waxed

and waned through the early fall of 2006.” (Ex. 10, p. 4.) Respondent’s expert, Dr. Stommel,

stated, “I would agree with Dr. Morgan’s assessment that Ms. Jacunski developed her first

symptom of CIDP around August of 2006.” (Ex. A, p. 6.) Thus, the experts representing both

parties agree that Petitioner’s CIDP was a pre-existing condition when she received her first flu

vaccination on December 4, 2006.

2. What is Petitioner’s current condition?

As discussed previously, in Section VI, I have concluded that Petitioner, in the weeks that

followed both of the influenza vaccinations she received, did not exhibit any significant “change

for the worse in a preexisting condition which result[ed] in markedly greater disability, pain or

illness accompanied by substantial deterioration of health.” '300aa-33(4). However, clearly

Petitioner’s condition got progressively worse during 2007. It also seems that since Petitioner’s

CIDP appears to be a condition that gradually worsens over time, then her current condition is,

more likely than not, significantly worse than it was prior to either her December 2006

vaccination or her November 2007 vaccination. Therefore, it appears that Petitioner’s case

fulfills Prong 2 of the six-part Loving test.

3. Petitioner’s current condition after her vaccinations technically is a

“significant aggravation.”

As noted in paragraph VIII(B)(2) of this Decision, immediately above, it appears that

Petitioner’s current condition is significantly worse than it was prior to either of the vaccinations

in question. Therefore, under Loving, it appears that Petitioner’s current condition does amount

to a “significant aggravation” of her preexisting CIDP (although for the reasons set forth above

and below, there is no reason to think that the “significant aggravation” was vaccine-caused).

4. Petitioner has failed to establish Prong 4 of Loving / Prong 1 of Althen.

20

As discussed above, Prongs 4, 5 and 6 of the Loving test are, in effect, the same as Prongs

1, 2, and 3 of the Althen standard. Under Prong 4 of Loving, and Prong 1 of Althen, a petitioner

must provide a medical theory demonstrating that the type of vaccine in question can cause a

significant worsening of the type of preexisting condition in question. In this case, however, the

Petitioner has wholly failed to show that influenza vaccinations can exacerbate a preexisting

CIDP.

Here, as described in Sections VII(B) and VII(C) above, Petitioner seems to rely on

“molecular mimicry” and “challenge-rechallenge” theories to establish that influenza

vaccinations are capable of aggravating CIDP. For the reasons described in Sections VII(B) and

VII(C), however, Petitioner’s reliance on those theories was clearly insufficient to meet

Petitioner’s burden of demonstrating a plausible medical theory. Petitioner plainly failed to

establish that influenza vaccinations can aggravate a preexisting CIDP, so Petitioner has failed to

satisfy Prong 4 of Loving / Prong 1 of Althen in this case.

5. Petitioner has failed to establish Prong 5 of Loving / Prong 2 of Althen.

Under Prong 5 of Loving / Prong 2 of Althen the Petitioner must “prove by preponderant

evidence” that Petitioner’s vaccinations did aggravate her own CIDP--i.e., she must demonstrate

“a logical sequence of cause and effect showing that the vaccination was the reason for the

significant aggravation.” W.C. v HHS, 704 F.3d at1357. However, Petitioner has completely

failed to make such a showing.

That is, for the reasons described in detail above, I find that Petitioner has failed to

establish (1) that the Petitioner’s CIDP was aggravated soon after either of her influenza

vaccinations; (2) that “molecular mimicry” aggravated her CIDP; or (3) that her case fits a

“challenge/ rechallenge” scenario. Therefore, I find that Petitioner plainly has failed to meet her

burden under the fifth prong of Loving and the second prong of Althen.

6. Petitioner has failed to establish Prong 6 of Loving / Prong 3 of Althen.

Finally, under Prong 6 of Loving, a petitioner must demonstrate “a proximate temporal

relationship between the vaccination and the significant aggravation.” W.C. v. HHS, 704 F.3d at

1357. The Federal Circuit has further clarified that the analogous Althen Prong 3 requires

“preponderant proof that the onset of symptoms occurred within a timeframe for which, given

the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation

in fact.” DeBazan v. HHS, 539 F.3d 1347, 1352 (Fed. Cir. 2008).

Since I have found that Petitioner has failed to meet her burden of proof concerning

Prongs 4 and 5 of Loving, I need not necessarily reach the question of whether she has also failed

to meet her burden under the final prong. But in the interest of completeness, I find that

Petitioner has also failed to establish Prong 6. For the reasons explained at Section VI above, I

find that Petitioner’s expert relied upon a flawed assumption of fact concerning the history of

Petitioner’s CIDP symptoms. Moreover, just as Dr. Morgan was totally unpersuasive in arguing

that there is any reason to think that influenza vaccinations even can aggravate CIDP, so he also

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failed to offer any persuasive evidence as to when the first symptoms of such an allegedly

vaccine-related aggravation might appear.

C. This is not a close case.

In Althen, the Federal Circuit indicated that the Vaccine Act involves a “system created

by Congress, in which close calls regarding causation are resolved in favor of injured claimants.”

(418 F.3d at 1280.) Accordingly, I note here that this case ultimately is not a close case. For all

the reasons set forth above, I find that Petitioner has failed to satisfy Prongs 4, 5, and 6 of the

Loving test. She has not only failed to demonstrate any vaccine-related significant aggravation

of her CIDP; she has also failed to find adequate support in the record for the medical theories

that she advanced. This is simply not a close case at all.

IX

CONCLUSION

The record of this case demonstrates plainly that Petitioner has been through an

unfortunate medical ordeal. She is certainly deserving of great sympathy. Congress, however,

designed the Program to compensate only the individuals whose injuries or deaths can be linked

causally, either by a Table Injury presumption or “causation-in- fact” evidence, to a listed

vaccine. In this case, as described above, no such link has been demonstrated. Accordingly, I

conclude that Petitioner in this case is not entitled to a Program award.11

IT IS SO ORDERED.

/s/ George L. Hastings, Jr.

George L. Hastings, Jr.

Special Master

11

In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter judgment

accordingly.

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