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(Not to be published)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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