In the United States Court of Federal Claims
No. 07-36V
(Filed under seal January 14, 2013)
(Reissued February 26, 2013)
***********************
*
*
KEITH and BEVERLY LANGLAND,* Vaccine Act off-table case; Althen; DTaP;
on behalf of their daughter, * celiac disease; absence of plausible
[M.L.], * medical theory of causation; statements of
* treating physicians; document referenced
Petitioners, * in expert report as party admission; no
* appropriate temporal association without
v. * reputable explanation of mechanism.
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Defendant. *
*
***********************
Paul S. Dannenberg, Huntington, Vermont, for petitioners.
Melonie J. McCall, Trial Attorney, Torts Branch, Civil Division, Department of Justice,
with whom were Tony West, Assistant Attorney General, Timothy P. Garren, Director, Mark W.
Rogers, Deputy Director, and Vincent J. Matanoski, Assistant Director, all of Washington, D.C.,
for respondent.
OPINION AND ORDER1
WOLSKI, Judge.
1
Petitioners moved for the redaction of their names, and their daughter’s name and date
of birth, from this opinion prior to its publication. The government opposes the first part of this
request. The Court agrees with the reasoning of the then-Chief Special Master, who determined
that including petitioners’ names in the decision below did not result in an unwarranted invasion
of privacy under 42 U.S.C. § 300aa-12(d)(4)(B)(ii) (a determination which was not appealed),
given the nature of petitioners’ daughter’s illness. See Langland ex rel. M.L. v. Sec’y of HHS,
No. 07-36V, 2011 WL 802695, at *5-11 (Fed. Cl. Sp. Mstr. Feb. 3, 2011). Petitioners’ motion is
thus DENIED-IN-PART, to the extent they seek anonymity, and GRANTED-IN-PART
concerning their minor daughter’s name (which is replaced with her initials) and date of birth.
The opinion is reissued for publication with some minor, non-substantive corrections.
Petitioners Keith and Beverly Langland have moved for a review of Special Master
Richard B. Abell’s decision that petitioners are not entitled to compensation under the National
Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 - 300aa-34 (“Vaccine Act” or
“Act”). The petition was filed by Mr. and Mrs. Langland on behalf of their daughter, [M.L.],
contending that [M.L.] suffered from a “neurologically regressive reaction” and the onset of
celiac disease as a result of the diphtheria, tetanus and pertussis (“DTaP”) and inactivated polio
(“IPV”) vaccines administered on January 28, 2004. Pet. at 1-2. Petitioners raised three
objections to the Special Master’s decision, arguing that his decision was arbitrary and
capricious, an abuse of discretion, and not in accordance with the law. See Pet’rs’ Mot. For Rev.
at 2. According to petitioners, the Special Master disregarded statements of treating physicians
and an admission of respondent, rejected what they characterize as a biologically plausible theory
of causation, and failed to follow the standards of Althen v. Sec’y of Health & Human Servs., 418
F.3d 1274 (Fed. Cir. 2005). For the reasons stated below, the Court DENIES petitioners’ motion
and SUSTAINS the decision of the Special Master.
I. BACKGROUND
A. The Vaccination and Diagnosis of Celiac Disease
[M.L.], the daughter of Keith and Beverly Langland, was born on [XXXX], 2002. Pet’rs’
Ex. 12 at 15. She was fed soy formula as an infant, and her parents added rice cereal and sweet
potatoes to her diet by her six-month visit. Pet’rs’ Ex. 3 at 2018; Pet’rs’ Ex. 3 at 2009. At her
twelve-month visit, her parents reported a diet of whole milk. Pet’rs’ Ex. 3 at 2002. At [M.L.]’s
18-month visit, her growth and development were exhibited by the ability to use “mature
jargoning,” speak at least six words, point to five body parts, run and kick a ball. Pet’rs’ Ex. 3 at
1984. By that time, she had a diet of three meals a day. Id.
[M.L.] received her first dose of the DTaP vaccine on October 4, 2002. Pet’rs’ Ex. 8 at 1.
Subsequent shots were administered on December 13, 2002 and February 5, 2003. Id. During
[M.L.]’s 18-month visit on January 28, 2004, Dr. Pamela Carrington-Cooper noted that she had
no previous reaction to these vaccines.2 Pet’rs’ Ex. 3 at 1984. [M.L.] did, however, show
symptoms of fever, low appetite, coughing with vomiting, and an ear infection at an acute care
visit on December 24, 2003. Id. at 1985.
On January 28, 2004, [M.L.] received her fourth DTaP vaccination and third polio
vaccination. Pet’rs’ Ex. 8 at 1. After returning home, she vomited twice, and developed a low-
grade fever and diarrhea. Pet’rs’ Ex. 10 ¶ 5. She made a pediatric acute care visit on February
2
According to Mr. Langland, the normal reaction of his children to vaccinations was to
appear “dehydrated” and “lethargic” for a period of one or two days. Pet’rs’ Ex. 10, ¶ 5. The
parents also reported that, within two or three weeks after [M.L.] received a different vaccine in
October 2003, she suffered from vomiting, diarrhea, listlessness, and a low-grade fever, and was
sick for three to four weeks. See Pet’rs’ Ex. 6 at 1.
-2-
13, 2004, after two and a half weeks of intermittent vomiting and diarrhea. Pet’rs’ Ex. 3 at 1982.
During this time, she also “developed a yeast rash in the diaper area” and suffered from flu-like
symptoms. Pet’rs’ Ex. 7 at 6. She was reportedly not playing well, wanting only to sit on her
mother’s lap. Pet’rs’ Ex. 3 at 1982. Doctor Carrington-Cooper observed that she had abdominal
distension. Id. at 1983. A complete abdominal sonogram showed that her bowel had fluid-filled
segments, which appeared to contain gas. Pet’rs’ Ex. 5 at 3.
[M.L.] made another acute care visit on February 16, 2004, during which the Langlands
reported concerns about her development: she had not been speaking as much in the last two
weeks and did not want to play with siblings. Pet’rs’ Ex. 3 at 1980. Her vomiting and diarrhea
had persisted. Id. at 1981. [M.L.] returned to make another acute care visit on February 20,
2004. Id. at 3 at 1978. In addition to her previous symptoms, Dr. Cooper-Carrington also
reported staring spells, in which [M.L.] would look a couple of minutes into space with eyes
blinking but not otherwise responding. Id. at 1978-79. As part of her family history, the doctor
also noted that a maternal aunt of [M.L.]’s had celiac disease. Id. at 1978. The doctor referred
her to specialists. Id. at 1979.
On February 27, 2004, [M.L.] was examined by Dr. Julie Buckley, who found that she
had a bloated and tense abdomen. Pet’rs’ Ex. 7 at 6. Her parents reported to Dr. Buckley that
[M.L.] received vaccinations on January 28 and threw up on the way home. Id.3 She had
“diarrhea and intermittent vomiting that [the] parents have associated w[ith] immunizations
along w[ith] regressive behaviors.” Id. Her mother had stopped giving her milk and resumed
baby foods on February 16, and apparently stopped feeding her wheat on February 22. Id.
[M.L.] saw Dr. Jonathan Evans, a gastroenterologist, on March 3, 2004. Pet’rs’ Ex. 4 at
22. Her parents reported to Dr. Evans that she had a viral-type illness in December and became
ill again on January 28, 2004. Id. They also reported the child’s physical symptoms, as well as
the behavioral change from a happy, playful child to one who was often irritable. Id. Doctor
Evans noted [M.L.]’s allergy to milk and a maternal great aunt with celiac disease. Id. at 22-23.
The doctor recommended screening for celiac disease because of her family history. Id. at 23.
On March 16, 2004, [M.L.] had a panendoscopy, with a duodenal biopsy and a gastric biopsy.
Pet’rs’ Ex. 4 at 35-36. The biopsy found chronic duodenitis consistent with celiac disease. Id. at
36. Doctor Evans, who conducted the panendoscopy, shared the celiac disease diagnosis with
Mrs. Langland on March 18, 2004. Id. at 14.
Doctor William Turk, a neurologist, saw [M.L.] in consultation on March 12, 2004.
Pet’rs’ Ex. 4 at 16. According to Dr. Turk’s correspondence with Dr. Carrington-Cooper,
[M.L.]’s parents reported that all her difficulties began in January on the day she received some
immunizations. Id. The doctor recorded the impression that [M.L.] had a “history of an illness
3
They also apparently reported that vomiting and diarrhea began two weeks prior to
Christmas, “and toward end of Dec[ember 2003] bowels normalized although stomach stayed
bloated.” Pet’rs’ Ex. 7 at 6; see also Pet’rs’ Ex. 4 at 22.
-3-
that began coincident with immunizations in January.” Id. at 17. Both her MRI and EEG results
were normal. Id. He felt that [M.L.]’s change in behavior was linked to a systemic and chronic
illness, rather than autistic disorder. Id.
Subsequently, the Langlands switched to a gluten-free, casein-free diet for [M.L.]. Pet’rs’
Ex. 4 at 8; Pet’rs’ Ex. 7 at 4-5. Doctor Buckley recorded a visit on April 12, 2004, during which
[M.L.] was able to start climbing again and use more words, including two-word phrases. Pet’rs’
Ex. 7 at 3. Her parents reported that she was no longer sitting in the corner at daycare. Id.
Though her abdomen was still distended, [M.L.]’s ability to make eye contact improved through
the visit. Id. Check-ups through July 7, 2005 showed improved appetite; alert and playful
behavior; growth in height and weight; and nondistended, nontender abdomen. Pet’rs’ Ex. 4 at
1-7. Doctor Evans concluded that [M.L.] was doing well overall. Id. at 2.
B. The Petition and Hearing Before the Special Master
Petitioners filed a petition for compensation under the National Vaccine Injury
Compensation Program on January 18, 2007, claiming that the administration of DTaP and polio
vaccinations on January 28, 2004 caused [M.L.] to suffer from a “neurologically regressive
reaction” and celiac disease. Pet. at 1-2. In addition to medical records from treating physicians
and hospitals, petitioners filed an expert report from Dr. Oscar L. Frick, a physician specializing
in pediatrics, allergy, and immunology. Pet’rs’ Ex. 11 at 1. In Dr. Frick’s opinion, [M.L.]’s
vaccinations caused celiac disease by triggering an autoimmune response. Id. at 2. He believed
the causation was “evidenced first by the timing of her symptoms of vomiting, diarrhea, rash and
fever that occurred within hours of her vaccinations,” and stated that the “rash on [M.L.’s] left
thigh for two months where the [DTaP] was given makes that the likely agent.” Id.
Pursuant to Vaccine Rule 4(c) of the Rules of the United States Court of Federal Claims
(“RCFC”), the Secretary of Health and Human Services (“respondent”) filed a report on the
petition for vaccine compensation, arguing that petitioners failed to demonstrate by
preponderance of the evidence that [M.L.]’s vaccinations caused her celiac disease. Resp’t’s
Rule 4(c) Rep. at 10-11. The report challenged Dr. Frick’s theory of causation, contending that
Dr. Frick did not provide a link between the vaccinations and illness other than the timing of the
onset of symptoms and the “plausibility” that [M.L.] already had a partial immunodeficiency. Id.
at 10. The respondent also filed a report from Dr. Andrew Warner, a gastroenterologist who
specialized in Crohn’s disease and ulcerative colitis. Resp’t’s Ex. A at 1. Dr. Warner contended
that there was no medical or scientific evidence for the idea that DTaP or polio vaccines could
cause or aggravate celiac disease. Id. at 2.
On December 9, 2008, the Special Master held a hearing in this matter, with Dr. Frick
and Dr. Warner as expert witnesses. Transcript of Oral Argument Before Special Master (Dec. 9,
2008) (“Sp. Mstr. Tr.”) at 13, 46 (identifying the expert witnesses). Doctor Oscar Frick testified
on behalf of the petitioner and provided his background. With an M.D. from Cornell, a Master
of Medical Science degree in Pediatrics from the University of Pennsylvania Postgraduate School
-4-
of Medicine, and a Ph.D. in immunology from the Stanford University School of Medicine, Dr.
Frick was one of the founding members of the American Board of Allergy and Immunology and
is a professor emeritus of pediatrics at the University of California, San Francisco. Sp. Mstr. Tr.
at 14-16; see also Pet’rs’ Ex. 11 at 4. Post-retirement, he continued to run the pediatric allergy
clinic at the University of California, San Francisco. Sp. Mstr. Tr. at 17. Doctor Frick had also
written about allergies, particularly food allergies.4
Having reviewed her medical records and the affidavit from her father, Sp. Mstr. Tr. at
18, Dr. Frick testified that [M.L.]’s DTaP vaccination had “most likely” triggered her celiac
disease. Id. at 22. He noted that [M.L.] “probably” had an immunoglobulin A (“IgA”)
deficiency, which, along with family history, indicated a predisposition to autoimmune disease.
Id. at 19-20, 29. Petitioners’ expert witness based his opinion of causation on a rash in the
vicinity of the DTaP vaccination, which he believed was in an arm which “became very much
swollen”--- in contrast to the lack of reaction on the side where her polio vaccination was
administered. Id. at 20-21.5 Though Dr. Frick acknowledged that [M.L.] could have developed
celiac disease regardless of vaccination from some future event, he posited that the DTaP
immunization triggered the expression of or induced the means for the development of celiac
disease. Id. at 22-23, 29, 37.
Petitioners’ expert’s medical theory of causation was that the DTaP vaccine “just
triggered the reaction” leading to celiac disease, Sp. Mstr. Tr. at 35, since vaccines act as an
4
Respondent had filed a motion to exclude the testimony of Dr. Frick, arguing that Dr.
Frick’s theory of causation did not meet the Daubert requirements for reliability. Resp’t’s Mot.
to Exclude Evidence at 5. At the hearing, the Special Master accepted Dr. Frick’s testimony. Sp.
Mstr. Tr. at 27. Respondent’s motion to exclude Dr. Frick’s testimony was denied. Langland ex
rel. M.L. v. Sec’y of HHS, No. 07-36V, 2011 WL 386985, at *6 (Fed. Cl. Sp. Mstr. Oct. 21,
2010).
5
The witness was confused on this point, as [M.L.]’s DTaP was received in the left
thigh, not in the right arm as he testified. See Pet’rs’ Ex. 3 at 1973. He was also mistaken in
remembering that a measles shot was administered along with the polio vaccine. See id. at 1972.
Most curious was his detailed recounting of her right arm being “swollen from the shoulder all
the way down to the elbow,” which he says was “a huge reaction” requiring hospitalization
“about three days after the injection” and treatment with compresses, antihistamines, anti-
inflammatories, pain killers, and intravenous fluids. Sp. Mstr. Tr. 21, 23; see also id. at 44. No
swollen arm and associated hospital visit appears in her medical records or in her father’s
affidavit. See, e.g., Ex. 7 at 6 (Dr. Buckley’s note dated Feb. 27, 2004 describing [M.L.]’s
symptoms after the vaccination); Ex. 4 at 16 (Dr. Turk’s record dated March 12, 2004 describing
post-vaccine illness); Ex. 10 ¶ 5 (affidavit of Mr. Langland); see also Ex. 11 ¶ 7 (Dr. Frick’s
affidavit noting rash on [M.L.]’s “left thigh for two months where the D[T]aP was given make[s]
that the likely agent”). But in any event, petitioners focused on the DTaP vaccination, and
apparently abandoned any argument concerning the polio vaccination.
-5-
“insult” to the body. Id. at 29, 34-35. When the Special Master asked Dr. Frick to explain the
mechanism by which this triggering occurred, he replied, “I don’t think anybody really knows
that.” Id. at 29. And when asked the follow-up question whether there was any medical
literature that would support the contention that DTaP can cause or trigger celiac disease, Dr.
Frick conceded that after an “extensive literature search” he “wasn’t able to come up with a
specific reference” concerning it, and did not “have a direct link that way in the literature as
such.” Id. at 29-30; see also id. at 34. He referred to an article showing that a disproportionate
number of celiac patients did not respond to the hepatitis B vaccine, indicating a difference in the
immune systems of these individuals. Sp. Mstr. Tr. at 30.6 He also mentioned “some studies
about antibodies being raised to the pertactin” contained in the pertussis vaccine, remarking that
“it’s possible that maybe that was involved as well” in causing celiac disease. Id. Doctor Frick
later acknowledged that the studies showing these antibodies were of rabbits, and that researchers
“were not able to see the antibodies to pertactin in the humans” studied. Id. at 33. On this point,
he concluded: “I can’t say it’s a cause, but it’s a possibility.” Id.7
After noting that the removal of gluten from [M.L.]’s diet resolved her celiac disease, Dr.
Frick stated again his contention that the DTaP vaccine’s challenge to her immune system
triggered celiac disease. Sp. Mstr. Tr. at 34-35. The Special Master asked petitioners’ expert to
explain the connection between a vaccine injury and gluten intake, and Dr. Frick stated that
people with a genetic disposition for celiac disease have the human leukocyte antigens (“HLA”)
HLA-DQ2 or HLA-DQ8. Id. at 35. He further explained that an enzyme, tissue
transglutaminase (“tTG”), can change gluten into a substance that “actually hooks onto these two
HLA sites, and this is the thing then that triggers the [c]eliac disease in genetically disposed
people,”8 and hypothesized that “the thing that insults the body, such as a vaccination or possibly
a viral infection or even a bacterial infection, can trigger this reaction.” Id. Doctor Frick also
testified that the sonogram showing gas in [M.L.]’s intestine, two weeks after the DTaP
vaccination, “suggest[s] maybe the [c]eliac process already started,” and stated that he considered
two weeks to be a medically appropriate time period for the disease to develop. Id. at 36. He
added that his opinions were held to a reasonable degree of medical certainty. Id. at 38.
6
See Pet’rs’ Ex. 11 at 2 (discussing the article), 9, 22-25 (Kyung W. Noh et al., Hepatitis
B Vaccine Nonresponse and Celiac Disease, 98 Am. J. Gastroenterology 2289-92 (2003)).
7
A copy of the article discussing these studies was filed as Exhibit 15 after the hearing.
See Notice of Filing (Dec. 23, 2008).
8
This process is described in an article submitted with Dr. Frick’s affidavit. See Pet’rs’
Ex. 11 at 29-30 (Detlef Schuppan et al., Celiac Disease: Epidemiology, Pathogenesis, Diagnosis,
and Nutritional Management, 8 Nutrition in Clinical Care 54, 57-58 (2005) (“Schuppan”)). The
article, however, seems to indicate that for pediatric patients, celiac disease is a response
to“unmodified gluten peptides,” and not to the negatively-charged gluten peptides that were
modified by tTG. Id. at 29, 40 n.65 (Schuppan at 57, 68 n.65).
-6-
During cross-examination, Dr. Frick admitted that he had never treated a patient who
developed celiac disease as a result of a vaccination. Sp. Mstr. Tr. at 42. He also attempted to
clarify whether [M.L.]’s symptoms that began the day of vaccination, such as vomiting and
diarrhea, signified the beginning of celiac disease. Doctor Frick thought “that may have been the
beginning of it,” id., but he then explained that while diarrhea is often associated with celiac
disease, the rest of [M.L.]’s early symptoms were “[n]ot necessarily” associated with it. Id. at
42-43. When the Special Master asked if the apparent serum sickness and the triggering of the
celiac disease were two separate reactions or “all part and parcel,” Dr. Frick stated he thought
“it’s all part and parcel,” id. at 43-44, but later during redirect examination he stated that he did
not think the symptoms [M.L.] exhibited the day of the vaccination were related to celiac disease.
Id. at 71. He reiterated his belief that the reaction to the DTaP vaccination “was the insult that
brought out the [c]eliac disease and within two weeks she started to have the bloating . . . and the
whole process . . . was started subsequent to the DTaP injection.” Id. at 72.
Doctor Andrew Warner testified on behalf of the respondent. A graduate of Chicago
Medical School, Dr. Warner’s internship and residency training were performed at Harvard
Medical School’s Mount Auburn Hospital. Sp. Mstr. Tr. at 47. Doctor Warner followed this
training with a clinical fellowship in gastroenterology at Lahey Clinic, on whose staff he has
remained as a board-certified gastroenterologist. Id. He is a clinical instructor at Harvard
Medical School and an associate clinical professor at Tufts University School of Medicine. Id.
Respondent’s expert testified that in his opinion, to a reasonable degree of medical
certainty, the vaccinations did not cause or in any way aggravate [M.L.]’s celiac disease. Sp.
Mstr. Tr. at 49-50. He based this opinion on a review of [M.L.]’s medical records, a search of
medical and scientific literature, and a search of certain textbooks and websites. Id. at 49.
Doctor Warner first explained that there was no data to suggest a link between the vaccinations
[M.L.] received and celiac disease. Id. at 50. Second, he noted that celiac disease was a
common disorder for which there was always a latency. Id. Doctor Warner then testified that
[M.L.] exhibited symptoms of celiac disease the day of her vaccinations, which was too soon for
the vaccines to have caused celiac disease. Id. He also explained that physicians routinely
vaccinate children who have celiac disease, and there “has not been a single report in the
literature saying [any of the children] got sick after the vaccination.” Sp. Mstr. Tr. at 50-51. As
his last point, Dr. Warner argued that the only known thing to trigger celiac disease was ingested
gluten. Id. at 51. When the Special Master asked Dr. Warner to clarify how he came to the
conclusion that a same-day causation of celiac disease by a vaccination was not temporally
appropriate, he explained that selecting such a time period was a “problem,” as he knew of no
mechanism by which a shot could trigger the disease. Id. at 51. Respondent’s expert emphasized
that celiac disease was caused by “a direct toxic effect of” ingested “gluten on the small bowel.”
Id. at 52. It was “basically a contact phenomenon,” rather than something which could arise from
intramuscular vaccination. Id.
Referring to Dr. Frick’s testimony, Dr. Warner disputed that [M.L.] was immune-
deficient, since her records did not show “recurring sinusitis, bronchitis or other opportunistic
-7-
infections,” and her ear infections were normal for a child of her age. Sp. Mstr. Tr. at 53-54. He
also disagreed with the claim that patients with celiac disease had an immune system different
from the general population, as a celiac patient “on a gluten-free diet is no more likely to get an
infection than anyone else.” Id. at 54. When asked by the Special Master about the symptoms
exhibited by [M.L.] within hours of receiving the DTaP vaccination, Dr. Warner posited that her
reaction was normal for a child receiving such a shot. Id. at 55. He also testified that her
behavioral problems had been typical of a child who was ill with undiagnosed celiac disease. Id.
at 57. And Dr. Warner noted that Dr. Frick had not provided any literature linking the DTaP
vaccination and celiac disease. Id.
During cross-examination, petitioners’ counsel questioned Dr. Warner about a statement
the expert allegedly made in his report, to the effect that “gluten was introduced to [M.L.] early.”
Sp. Mstr. Tr. at 60.9 Referring to [M.L.]’s diet based on her medical records, Dr. Warner stated
that cereal was listed as the anticipatory diet on [M.L.]’s four-month visit record, and that sweet
potatoes --- which he believed to usually contain gluten --- were listed as part of her diet on her
six-month visit record. Id. at 62-64. He ultimately agreed that [M.L.] started eating gluten-based
food at the normal time for children, id. at 64-65, and that this was approximately six months
prior to the January 28, 2004 vaccinations. Id. at 67. When asked whether there was a specific
time period over which celiac patients develop the disease after gluten is added to their diets, Dr.
Warner explained that only fifteen to twenty percent of people with celiac disease are
symptomatic, and that symptoms could vary from iron-deficiency anemia to full diarrhea, weight
loss, and malabsorption --- making it difficult to pinpoint a time period. Id. at 65. He added that
patients who were diagnosed with the disease and felt recovered after switching to a gluten-free
diet would “start getting sick pretty soon” when gluten is reintroduced, with “changes on their
small bowel biopsies” within a month. Sp. Mstr. Tr. at 66. He reiterated that there had been no
studies or case reports linking celiac disease to vaccinations. Id. at 68. And on redirect
examination Dr. Warner emphasized “there’s simply nothing in the literature to suggest a link
that there’s any particular trigger that causes [c]eliac disease other than ingestible gluten.” Id. at
74-75.
Shortly after the hearing, petitioners filed copies of two articles mentioned by Dr. Frick in
his testimony --- one concerning antibody responses to pertactin and the other addressing the
increased prevalence of IgA deficiency among celiac disease patients. See Notice of Filing (Dec.
23, 2008) & Pet’rs’ Exs. 15 & 16. Several months later, coincident with the filing of their post-
hearing brief, petitioners filed as their Exhibit 17 a copy of another article. See Notice of Filing
(May 8, 2009) & Pet’rs’ Ex. 17 (Dariusz Stepniak & Frits Koning, Celiac Disease---Sandwiched
between Innate and Adaptive Immunity, 67 Human Immunology 460-68 (2006)) (“Stepniak”).
9
The premise of this line of questioning does not appear to be correct, as no such
statement appears in Dr. Warner’s report. See Resp’t’s Ex. A. The report states, accurately, that
[M.L.] was “[b]reastfed less than two months,” id. at 1 (citing Pet’rs’ Ex. 3 at 2018), and merely
notes that “the shorter an infant is breastfed the sooner they start eating foods that contain gluten
since gluten is present in most cereals.” Id. at 3; see also Sp. Mstr. Tr. at 70.
-8-
Quoting in part from the article’s abstract, the only explanation offered by petitioners concerning
this article was as follows:
This article indicates that both environmental and genetic factors have been
implicated in the contraction of celiac disease and, ‘viral infections and/or tissue
damage in the intestine may cause inflammation and induce protective Th1-
mediated immunity leading to loss of tolerance for gluten. Once tolerance is
broken, a broad gluten-reactive T cell repertoire may develop through determinant
spreading. This may be a critical step toward full-blown [celiac] disease.’
Notice of Filing (May 8, 2009) (quoting Stepniak at 460 (alteration by petitioners)).
In petitioners’ post-hearing brief, they argued that Dr. Warner was mistaken in stating
that sweet potatoes contained gluten. Post-Hr’g Br. at 8-9. They also noted that an information
pamphlet issued by the National Institutes of Health (“NIH”), which was referenced by and
attached to Dr. Warner’s report, stated that celiac disease was sometimes “triggered---or becomes
active for the first time---after surgery, pregnancy, childbirth, viral infection, or severe emotional
stress.” Id. at 9 (quoting from Attach. to Resp’t’s Ex. A, at 2). Petitioners argued that this
statement supported the theory testified to by Dr. Frick, and that treating physicians’ statements
in the record also “connect[ed] [M.L.]’s injury with celiac disease to her vaccinations on January
28, 2004.” Id. Applying the Althen factors to [M.L.]’s case, petitioners also contended that they
had met the burden of proof by offering Dr. Frick’s medical theory “that the D[T]aP vaccine
acted as a viral insult to the body of a genetically predisposed [individual] which caused the
development of celiac disease,” id. at 10; by presenting a logical sequence of cause and effect
that the DTaP shot was an insult to her immune-deficient state which triggered celiac disease, id.
at 11; and by showing a proximate temporal relationship between the vaccination and the allergic
reaction, serum sickness, and “intestinal difficulties” reflecting the onset of celiac disease. Id.
Respondent filed a post-hearing memorandum, arguing that petitioners failed to establish
the logical sequence of cause and effect between DTaP vaccination and onset of celiac disease.
Resp’t’s Post-Hr’g Mem. at 12. Challenging Dr. Frick’s testimony, respondent contended that
the expert witness’s theory of causation inappropriately relied on speculation and lacked support
from any medical literature. Id. at 13. Respondent maintained that neither Dr. Frick’s theory nor
the statements from [M.L.]’s treating physicians met the reliability standard of Daubert v.
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 593 (1993) or “another discernible test.”
Resp’t’s Post-Hr’g Mem. at 12 n.4, 13-14.
In their reply, petitioners disputed respondent’s characterization of Dr. Frick’s testimony
on the issue of when [M.L.]’s celiac disease symptoms materialized. Pet’rs’ Reply Br. to
Resp’t’s Post-Hr’g Mem. (“Pet’rs’ Reply”) at 1. While acknowledging that Dr. Frick had stated
that the diarrhea occurring the day of her vaccinations “may have been the beginning of” [M.L.]’s
celiac disease, petitioners note that their expert also stated that the disease developed “probably
within two weeks afterwards.” Pet’rs’ Reply at 2 (citing Sp. Mstr. Tr. at 42). Petitioners also
-9-
argued that the application of Daubert standards had been found inappropriate by the Special
Master; that the Special Master had found Dr. Frick qualified to testify; and that when
respondent’s counsel chose to forego voir dire of Dr. Frick, the government waived all objections
based on Dr. Frick’s competence --- including those based on Daubert. Id. at 3.
C. The Special Master’s Decision Denying Compensation
On September 8, 2010, the Special Master ruled from the bench, finding that petitioners
were not entitled to compensation and dismissing the petition with prejudice. Langland ex rel.
M.L. v. Sec’y of HHS, No. 07-36V, 2011 WL 386985, at *25 (Fed. Cl. Sp. Mstr. Oct. 21, 2010).
The Special Master found that petitioners had not demonstrated by a preponderance of the
evidence that the vaccination could have been a substantial factor causing [M.L.]’s injury. Id. at
*24. In the Special Master’s view, petitioners failed to explain how celiac disease would not
have occurred but for the vaccination. Id. The Special Master’s decision was publicly released
in redacted form on February 4, 2011.
As a preface to his ruling, the Special Master explained that in this non-Table case, the
petitioners would need to show by a preponderance of the evidence that the vaccination was “a
substantial factor in causing the illness, disability, injury or condition and that the harm would
not have occurred in the absence of the vaccination.” Langland ex rel. M.L., 2011 WL 386985,
at *3 (quoting Pafford v. Sec’y of HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006)). He noted that, to
meet the burden of proof, petitioners would have to provide: “(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.” Id. (quoting Althen v. Sec’y of HHS, 418 F.3d
1274, 1278 (Fed. Cir. 2005)).10
The Special Master began his ruling with a discussion of [M.L.]’s medical records. Id. at
*4-6. Included among these records was an email from Dr. Buckley dated February 27, 2005 and
sent to Dr. Valerie Miles, who began treating [M.L.] earlier that month. Pet’rs’ Ex. 9 at 18; id. at
1, 12. Doctor Buckley said of [M.L.], “I saw her in the worst of the worst and this kid’s gut took
a terrible hit.” Pet’rs’ Ex. 9 at 18. After recommending changes to the vitamins and nutrients
prescribed for the patient, Dr. Buckley added: “She was sick as an ever lovin[’] dog and Crohn’s
disease or not, she got that way in direct association with her shots.” Id. The Special Master
quoted from this email, which he determined was “not a diagnostic medical record.” Langland
10
The Special Master explained that he often “bifurcated the issue of actual causation
into the ‘can it’ prong and ‘did it’ prong,” which he described as “(1) whether there is a
scientifically plausible theory which explains that such injury could follow directly from
vaccination; and (2) whether that theory’s process was at work in the instant case, based on the
factual evidentiary record extant.” Langland ex rel. M.L., 2011 WL 386985, at *3. In Pafford,
the Federal Circuit “perceive[d] no significant difference between the Special Master’s test and
that established by [the] court in Althen and Shyface.” Pafford, 451 F.3d at 1356.
-10-
ex rel. M.L., 2011 WL 386985, at *5-6. He found it to be “of dubious quality and minimal
probative value regarding the issue of vaccine causation,” noting it was mistaken about the
child’s actual condition, substituting Crohn’s disease for celiac disease. Id. at *6. The Special
Master found that the email “just asseverates that [M.L.’s] condition was ‘in direct association
with her shots,’” based apparently on “temporal association alone.” Id. He later concluded that
“the curious ruminations in the email” were “not entitled to the presumption of reliability that
medical records enjoy, and thus, are also not entitled to the same weight as a treater’s conclusion
on causation.” Id. at *21. The Special Master noted that this “private email correspondence”
occurred “well after the period at issue” when Dr. Buckley first treated [M.L.], and found it
“neither helpful nor persuasive” --- as it did “not even mention the correct condition” and did
“not explain how the vaccine at issue could cause the injury alleged.” Id. at *24.
Concerning the other medical records highlighted by petitioners, the Special Master found
these to be merely “the recitation of parental histories temporally associating the 28 January 2004
vaccinations with the onset of symptoms.” Langland ex rel. M.L., 2011 WL 386985, at *6. He
found that “[n]one of those references blame the vaccine causally,” id., and that “no treating
physician actually rendered an explanation of diagnostic etiology in the medical records
concluding that the vaccine was the ca[u]se of [M.L.]’s [c]eliac disease,” in contrast to “the focus
of the Capizzano opinion.” Id. at *21 (citing Capizzano v. Sec’y of Dep’t of HHS, 440 F.3d 1317
(Fed. Cir. 2006)); see also id. at *24 (“Not one single medical record asserts an opinion of
causation, stating or implying that the vaccines administered caused or triggered [M.L.]’s [c]eliac
disease.”).
Discussing petitioners’ expert, the Special Master characterized Dr. Frick’s report as
positing that [M.L.] “had a genetic predisposition to a disease and that it was the vaccine that
triggered the appearance of symptomatic manifestation.” Langland ex rel. M.L., 2011 WL
386985, at *7. The Special Master found that this report “never clearly articulates how a vaccine
could trigger the onset of latent [c]eliac disease,” and that its “conclusion relies heavily on
temporal association in the clinical history.” Id. The Special Master then turned to Dr. Frick’s
testimony. He noted that petitioners’ expert believed that [M.L.]’s prior history of ear infections,
as well as those of her siblings, showed that she “probably” had an IgA deficiency, consistent
with test results taken a year after the vaccinations in question. Id. Doctor Frick testified that
this demonstrated “a predisposition to autoimmune disease, including [c]eliac disease.” Id.
The Special Master “found it odd that Dr. Frick mentioned measles vaccination twice” in
discussing [M.L.]’s reaction to the January 28, 2004 vaccinations, when this was not among the
vaccines administered that day. Langland ex rel. M.L., 2011 WL 386985, at *8. He also stated
he “did not follow Dr. Frick’s logic regarding how a swelling or rash reaction, which is a rather
common, benign reaction to DTaP vaccination, indicated that the DTaP caused an intolerance of
wheat gluten.” Id. The Special Master noted that Dr. Frick saw the “DTaP vaccine as a ‘trigger’
for the [c]eliac disease, but not an independent cause since it was dependent on genetic
abnormality and he could not rule out ‘that eventually she would develop it anyway with some
other future event.’” Id. Though he explained how rashes and hives resulted from [M.L.]’s
-11-
vaccination, Dr. Frick could not elaborate on how the DTaP vaccine could have triggered celiac
disease. Id. at *9. When the Special Master asked specifically how the vaccine could trigger the
disease, Dr. Frick acknowledged, “I don’t think anybody really knows that.” Id. (quoting Sp.
Mstr. Tr. at 29).
The Special Master also noted that Dr. Frick could not find any literature or references
supporting a link between the DTaP vaccine and celiac disease. Doctor Frick’s explanation of
the relevance of petitioners’ Exhibit 15 was found to be “frankly cryptic, and left unclarified.”
Langland ex rel. M.L., 2011 WL 386985, at *10. According to Dr. Frick, this article discussed
the presence, in rabbits, of antibodies to the pertactin proteins contained in the pertussis vaccine,
but noted these antibodies were not detected in humans. Id. The Special Master noted that,
concerning celiac disease and the reaction to pertactin, Dr. Frick merely stated “it’s possible that
maybe that was involved as well,” and later added he “can’t say it’s a cause, but it’s a
possibility.” Id. With “no linkage of the experimental model to humans,” the Special Master
found nothing of relevance in this article. Id.
Doctor Frick also posited that a low level of IgA could have predisposed [M.L.] to an
autoimmune disorder like celiac disease. He relied upon an article on immunoglobulin tests
used to diagnose celiac disease, of which the Special Master found “no patently relevant
portions.” Langland ex rel. M.L., 2011 WL 386985, at *10 (citing Pet’rs’ Ex. 16). In an
exchange with the Special Master, Dr. Frick gave his opinion that the vaccine was an insult to the
body, and [M.L.]’s subsequent reaction triggered her celiac disease. Id. at *11. The Special
Master found this explanation to be vague and determined that it did not meet petitioners’ burden
of proof under Althen, which requires “an articulated, plausible ‘medical theory causally
connecting the vaccination and the injury.’” Id. (quoting Althen, 418 F.3d at 1278).
The Special Master then recounted that he followed up with a question to Dr. Frick,
inquiring “how does ceasing gluten intake resolve a vaccine-related injury?” Id. He noted that
the response of petitioners’ expert was that the enzyme tTG converts gluten into a substance that
“hooks onto the HLA sites” of celiac disease patients, triggering the disease, and that “the thing
that insults the body, such as a vaccination or possibly a viral infection or even a bacterial
infection, can trigger this reaction.” Id. The Special Master found that this explanation “was not
really supported by any medical literature relied upon in the formation and composition of Dr.
Frick’s report,” and that the later-filed Exhibit 17 “did not raise vaccines as possible triggers.”
Id. The Special Master characterized Dr. Frick’s testimony as a “meager and hardly explained
ratiocination” that left him “at a loss as to how a vaccine might plausibly trigger an autoimmune
reaction to wheat gluten.” Langland ex rel. M.L., 2011 WL 386985, at *11.
On the medically-appropriate temporal relationship between vaccination and the onset of
celiac disease, the Special Master noted a contradiction in Dr. Frick’s testimony. The medical
records indicated that [M.L.] had experienced vomiting and diarrhea on the day of vaccination,
which Dr. Frick acknowledged can be symptoms of celiac disease, but he believed that her celiac
disease began two weeks later. Langland ex rel. M.L., 2011 WL 386985, at *11-12. In Dr.
-12-
Frick’s view, [M.L.] likely had a serum sickness reaction directly after the vaccination and
developed celiac disease symptoms later. Id. at *12. Yet, he also considered the short-term and
long-term symptoms to be “all part and parcel” of her celiac disease. Id. To the Special Master,
this explanation was “neither coherent, nor consistent, nor persuasive.” Id. at *13.
The Special Master also found Dr. Frick’s explanation of a medical article on celiac
patients’ non-response to the hepatitis B vaccine to be unpersuasive and unhelpful. Langland ex
rel. M.L., 2011 WL 386985, at *13. According to Dr. Frick, the article showed that celiac
patients had disturbed immune systems, because they did not respond to the hepatitis B vaccine.
Id. During cross-examination, respondent’s counsel asked whether the article suggested that the
DTaP vaccine would have even less impact on someone with celiac disease. Id. The Special
Master agreed with the premise of the question and considered Dr. Frick’s answer to be
“nonspecific and vague,” and thus “unpersuasive and unhelpful.” Id.
The Special Master also noted that “Dr. Frick conceded . . . that he’s never treated a
patient with vaccine-related [c]eliac disease.” Langland ex rel. M.L., 2011 WL 386985, at *13.
He also found petitioners’ expert’s rebuttal testimony on the purported “vaccine-related
autoimmune process” to consist of “rather obtuse comments.” Id. In this testimony, Dr. Frick
reiterated his explanation that [M.L.] “was prone to the autoimmune thing,” and that “[a]n insult
is often a viral infection or some sort of an infection that sets off the process and the thing starts.”
Id.
Respondent’s expert’s testimony was next addressed. The Special Master noted Dr.
Warner’s opinion “that the vaccinations did not cause or in any way aggravate” the celiac disease
suffered by [M.L.]. Langland ex rel. M.L., 2011 WL 386985, at *14. Doctor Warner testified
there was no data linking celiac disease and the vaccination; that the disease is common and
latent; that celiac disease symptoms were noticed the day of the vaccination, which was “simply
too soon” for causation; that children with the disease are routinely vaccinated, as “there is no
concern about an increase in [c]eliac symptoms following vaccination”; and that he knew of no
mechanism by which a shot could cause or aggravate the disease, which is only caused by “the
ingestion of gluten.” Id. The Special Master explained that with no postulated mechanism of
causation, Dr. Warner believed it was “impossible to know” the “appropriate time[]frame” that
“would be expected for onset.” Id. When asked “whether DTaP shared any chemical
commonality with wheat gluten,” respondent’s expert testified this would not matter, because
gluten had “direct toxic [e]ffect . . . on the small bowel,” a “contact phenomenon” that would not
be implicated by an injection. Id. He also testified that petitioners’ medical literature did not
support any link between DTaP and celiac disease, and that he knew of no medical literature that
even discussed a temporal association between vaccines and the disease. Id. at *15.
Turning to petitioners’ Exhibit 17, filed after the hearing, the Special Master found it
“interesting and helpful, but certainly not dispositive.” Langland ex rel. M.L., 2011 WL 386985,
at *17. The Special Master quoted at length the passages from the article that he found relevant.
See id. at *17-19. The article noted that some people develop celiac disease long after they begin
-13-
ingesting gluten, and that the default mode of the immune system cells in the small intestine is to
tolerate harmless antigens. Id. at *17-18. Because this identification of substances is a constant
process, the authors felt “it seems unlikely that gluten could initiate adaptive immune responses
by itself,” and that “inflammatory stimuli” were also needed. Id. at *18. Since cross-reactivity
involving pathogens can lead to autoimmunity, the authors considered whether gluten was
similar enough to certain viruses or bacteria such that molecular mimicry could trigger celiac
disease. Id. The Special Master noted that “inasmuch as nothing has been demonstrated in that
regard, the authors acknowledged that the hypothesis remains speculative.” Id.
The authors also thought it was “conceivable” that interferon-alpha, a protein produced in
response to diarrhea-causing intestinal viruses, could change the instruction of certain immune
system cells “to prime gluten-specific T cells and support inflammation instead of sustaining oral
tolerance,” triggering a process that could ultimately result in celiac disease. Langland ex rel.
M.L., 2011 WL 386985, at *18-19. The Special Master noted that “the only trigger for [c]eliac
disease discussed by this paper that was not merely speculative, was gluten itself.” Id. at *19.
After quoting a discussion of how the introduction of gluten into a diet can be managed to reduce
the incidence of the disease, he quoted from the paper’s conclusion. The authors questioned
whether it was genetic differences or “unrelated events, such as enteroviral infections,” that
explained why some people develop celiac disease later than others. Id. They believed “many
combinations of these two options are possible,” but recognized that an animal “model still does
not exist” to allow them to answer whether viral infections can trigger the disease’s onset. Id.
Summing up the article, the Special Master noted that its “discussion of triggering events
remains quite speculative and hypothetical with a lot of unexplained loose ends in their
hypothesis regarding the biologic process involved.” Langland ex rel. M.L., 2011 WL 386985, at
*19. He further noted “that vaccines are never mentioned as potential triggers,” but noted he was
“cognizant” that certain disorders could be triggered by both vaccines or “viral insults,” and that
if a mere “immune challenge” can trigger an autoimmune disorder, “certain vaccines” could have
that effect. Id.
In his final analysis of petitioners’ case, the Special Master found that petitioners failed to
satisfy the first prong of Althen, because they could not show “whether the vaccine at issue can
cause the injury alleged.” Id. at *22. He explained that without the identification of a biologic
mechanism that would work over a particular time frame, consideration of prongs two and three
--- “whether the facts, circumstances, and temporal period of the specific case matches the
postulated theoretical construct” --- would be impossible. Id. at *23. He found petitioners had
“not postulated a coherent and sufficiently detailed theory of how the vaccine or vaccines at issue
could have either caused or triggered [their daughter’s] [c]eliac disease.” Id. He did not find the
narrative that [M.L.]’s abnormal immune system “went haywire” in reaction to the DTaP
vaccination to be “detailed enough to be considered a plausible theory demonstrating biologic
causation.” Id. The Special Master concluded that “there was no source of further detail to be
found” in the record. Langland ex rel. M.L., 2011 WL 386985, at *23. Neither clinical
experience nor medical literature demonstrated a link between the vaccine and celiac disease. Id.
-14-
Rather than explain how a DTaP vaccination could trigger celiac disease, the medical literature
relied upon by petitioners’ expert “related to some other vaccine, some other injury, or some
other effect,” and was thus not applicable to the key question. Id. The literature submitted was
found to “support[] only the most general and undisputed propositions and not the central issue
in contention,” id. at *24, and the Special Master found Dr. Frick’s testimony to be
“nonresponsive, obtuse” or “unhelpful.” Id. at *23-24. The Special Master explained that, under
Capizzano, the opinions of treating physicians could only satisfy the second and third prongs of
Althen (or, in his formulation, the “‘did it’ prong”), and “cannot substitute for the explanation of
a plausible theory as to how a given vaccine can cause the alleged injury in the abstract.” Id. at
*24. Moreover, the medical records were not found to contain “an opinion of causation” or “to
explain how the vaccine at issue could cause the injury alleged,” but rather reflected petitioners’
recitations or temporal associations. Id. The Special Master thus concluded that petitioners did
not meet their burden of proof and dismissed the petition. Id. at *24-25.
D. Petitioners’ Motion for Review
Petitioners filed a motion for review in our court, raising three objections to the Special
Master’s decision. Pet’rs’ Mot. for Rev. (“Pet’rs’ Mot.”) at 2. First, they argue that the Special
Master was arbitrary and capricious and abused his discretion by allegedly disregarding medical
records --- particularly the e-mail from Dr. Buckley --- and a purported “admission” in the report
of Dr. Warner. See id. at 2-6. According to petitioners, Dr. Buckley’s e-mail to Dr. Miles,
Pet’rs’ Ex. 9 at 18, stating that [M.L.]’s illness was “in direct association with her shots,” should
not have been discounted but rather given significant weight as a record “which clearly implies
causation.” Pet’rs’ Mot. at 3-5. Petitioners identify other statements in the medical records
which, they believe, reflect opinions on causation. Id. at 3-4. And petitioners contend that the
statement that “[s]ometimes [celiac] disease is triggered---or becomes active for the first time---
after surgery, pregnancy, childbirth, viral infection, or severe emotional distress,” Attach. to
Resp’t’s Ex. A at 2, contained in the NIH pamphlet attached to and referenced in the report of
respondent’s expert, see Resp’t’s Ex. A at 3, should have been considered an important
admission confirming the theory of their own expert. Pet’rs’ Mot. at 5-6.11
Second, petitioners argue that the Special Master was arbitrary and capricious, abused his
discretion, and failed to act in accordance with law, in rejecting the theory of causation offered by
their expert, Dr. Frick. Pet’rs’ Mot. at 2, 6-10. Petitioners contend that Dr. Frick’s theory that
the vaccine was an insult to the immune system, which triggered an autoimmune response in the
form of celiac disease due to a genetic predisposition, was a biologically plausible theory. Id. at
6-7. In petitioners’ view, the Special Master impermissibly raised petitioners’ burden of proof by
requiring a scientific explanation of the mechanism of injury, and by rejecting petitioners’
11
Petitioners also contend that the Special Master erred in stating that [M.L.]’s
“behavioral problems had ceased” as of April 12, 2004, Pet’rs’ Mot. at 5 (quoting Langland ex
rel. M.L., 2011 WL 386985, at *5), but this does not appear to have any bearing on the question
of whether the decision was arbitrary.
-15-
explanation as “hypothetical” and suffering from “a lot of unexplained loose ends.” Id. at 7.
They argue that the decision was contrary to law, and to the Althen third prong in particular, in
rejecting the “highly probative” evidence of temporal association. Id. at 6, 15-16. Petitioners
reiterate that the Special Master ignored the alleged admission in the respondent’s expert’s report
and the causation findings in the medical records, and argue that the testimony of their expert
concerning the onset of symptoms was misinterpreted. Id. at 8-10.
Finally, petitioners contend that the Special Master’s decision required medical literature
to support Dr. Frick’s opinion. Pet’rs’ Mot. at 11. In doing so, they argue, the Special Master
violated the Federal Circuit’s holding in Althen. Id. at 11-12 (citing Althen, 418 F.3d at 1280-
82).
The Secretary of Health and Human Services responded to petitioners’ motion for review.
See Resp’t’s Resp. To Pet’rs’ Mot. for Rev. (“Resp.”) Respondent contends that the Special
Master properly concluded that petitioners failed to provide an explanation of how the vaccine
could cause celiac disease. Resp. at 6-7. According to respondent, Dr. Frick’s testimony
contained only “a general assertion that [M.L.] had an abnormal immune system which caused
her to develop celiac disease as a result of vaccination.” Id. at 7. The Secretary further argues
that Dr. Frick failed to provide any explanation for how the vaccine caused the disease or “any
prior instances when the vaccine was linked to the disease.” Id. at 7-8. In contrast, respondent
notes, Dr. Warner testified that there was no plausible mechanism for the vaccine to trigger celiac
disease, and the only thing known to cause celiac disease was the ingestion of gluten. Id. at 9.
In the Secretary’s view, the issue is not the scientific validity of petitioners’ explanation
of vaccine injury, but rather the absence of a coherently-articulated theory of vaccine causation in
the first place. Resp. at 10. Respondent agrees with the Special Master that an article stating that
“viral infection and/or tissue damage in the intestine” may trigger the disease does not support a
connection to the DTaP vaccine, which is neither viral nor is injected into the small intestine. Id.
at 10-11. The Secretary argues that the Special Master did not abuse his discretion in weighing
the statements of the treating physicians in light of the medical records, medical literature, and
expert testimony. Id. at 12-16. Respondent contends the Special Master properly found that the
statements of [M.L.]’s treating physicians failed to address the absence of a plausible theory as to
how the DTaP vaccine can cause celiac disease. Id. at 15-16.
Finally, respondent argues that the Special Master properly concluded that it was
impossible to use temporal association as an analytical tool for determining causation, because
petitioners did not first establish a coherent biological mechanism by which vaccination caused
celiac disease. Resp. at 16. Respondent contends that the Special Master could not determine
the medically-appropriate time frame in the absence of a plausible theory of causation. Id. at 16-
18.
-16-
The Court held oral argument on petitioners’ motion.12 After careful consideration of the
medical records, testimony, and submitted literature in the record, the decision below, and the
arguments of counsel, this opinion issues.
II. DISCUSSION
A. Legal Standards
1. Court’s Standard of Review of a Special Master’s Decision
Under the Vaccine Act, the special master must award compensation if, “on the record as
a whole,” he finds “that the petitioner has demonstrated by a preponderance of the evidence” the
claims of the petition. 42 U.S.C. § 300aa-13(a)(1)(A) (2006). By this same standard, the special
master must find that nothing else is responsible for causing the injury. Id. § 300aa-13(a)(1)(B).
“The special master or court may not make such a finding based on the claims of a petitioner
alone, unsubstantiated by medical records or by medical opinion.” Id. § 300aa-13(a)(1). The
special master must consider all the “relevant medical and scientific evidence contained in the
record,” including any “diagnosis, conclusion, medical judgment, or autopsy . . . regarding the
nature, causation, and aggravation of the petitioner’s illness, disability, injury, condition, or
death” and “the results of any diagnostic or evaluative test which are contained in the record and
the summaries and conclusions.” Id. § 300aa-13(b)(1). The Act further specifies that “[a]ny
such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the
special master or court.” Id. The special master is entrusted with evaluating the “weight to be
afforded to any” of these sources of information. Id. A special master’s “assessments of the
credibility of the witnesses” are “virtually unchallengeable on appeal.” Lampe v. Sec’y of HHS,
219 F.3d 1357, 1362 (Fed. Cir. 2000). This deference rests on the special master’s “broad
discretion in determining credibility because he saw the witnesses and heard the testimony,”
Bradley v. Sec’y of Dep’t of HHS, 991 F.2d 1570, 1575 (Fed. Cir. 1993), and extends to
assessments of expert testimony. See Moberly v. Sec’y of HHS, 592 F.3d 1315, 1325-26 (Fed.
Cir. 2010).
Medical records “warrant consideration as trustworthy evidence.” Cucuras v. Sec’y of
Dep’t of HHS, 993 F.2d 1525, 1528 (Fed. Cir. 1993). These records are “generally
contemporaneous to the medical events,” and “accuracy has an extra premium” because a
patient’s proper treatment is “hanging in the balance.” Id. Moreover, because medical records
are contemporaneous documentary evidence, conflicting oral testimony “deserves little weight.”
Id. (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947)).
In reviewing a special master’s decision, the Court may “set aside any findings of fact or
conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion,
or otherwise not in accordance with law and issue its own findings of fact and conclusions of
12
See Tr. (Feb. 15, 2011) (“Tr.”).
-17-
law.” 42 U.S.C. § 300aa-12(e)(2)(B) (2006). Findings of fact are to be reviewed under the
“arbitrary and capricious” standard; legal questions are to be reviewed under the “not in
accordance with law” standard; and an abuse of discretion standard is used for discretionary
rulings. See Munn v. Sec’y of Dep’t of HHS, 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). With
respect to the arbitrary and capricious review, “no uniform definition of this standard has
emerged,” but it is “a highly deferential standard of review” such that “[i]f the special master has
considered the relevant evidence of record, drawn plausible inferences and articulated a rational
basis for the decision, reversible error will be extremely difficult to demonstrate.” Hines ex rel.
Sevier v. Sec’y of Dep’t of HHS, 940 F.2d 1518, 1527-28 (Fed. Cir. 1991).
2. Standard of Causation in Vaccine Cases
A special master may award compensation through an “off-table” or “causation-in-fact”
case. Pafford v. Sec’y of HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006). Causation-in-fact --- the
basis for the legal entitlement to compensation when a petitioner’s injury is either not listed in
the Vaccine Injury Table or did not occur within the time period set forth in the Table --- must be
proven under two formulations adopted by the Federal Circuit. See Pafford, 451 F.3d at 1355.
Petitioners must establish that the vaccine was both a “but-for” cause of the injury and a
substantial factor in causing the injury. See Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed.
Cir. 1999). Under a three-part test more recently articulated by the Circuit, petitioners must
prove “(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 v. Sec’y
of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005).13 Petitioners bear the burden of proving causation
by preponderant evidence. See 42 U.S.C. § 300aa-13(a)(1)(A).
Petitioners must show more than a proximate temporal relationship between the
vaccination and the injury to meet their burden of showing actual causation. Althen, 418 F.3d at
1278; see also Grant v. Sec’y of Dep’t of HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992).
Furthermore, “[t]here may well be a circumstance where it is found that a vaccine can cause the
injury at issue and where the injury was temporally proximate to the vaccination, but it is
illogical to conclude that the injury was actually caused by the vaccine.” Capizzano v. Sec’y of
HHS, 440 F.3d 1317, 1327 (Fed. Cir. 2006). Petitioners could meet the first and third prongs of
the Althen test without “satisfying the second prong when medical records and medical opinions
do not suggest that the vaccine caused the injury, or where the probability of coincidence or
another cause prevents the claimant from proving that the vaccine caused the injury by
preponderant evidence.” Id. The sequence only has to be “‘logical’ and legally probable, not
medically or scientifically certain,” and thus can be established by “epidemiological evidence and
[a] clinical picture,” even “without detailed medical and scientific exposition on the biological
13
Although the Federal Circuit has described the Althen test as an “alternative,” the very
same opinion makes plain that the Althen “prongs must cumulatively show” that the Shyface
standard is met. See Pafford, 451 F.3d at 1355.
-18-
mechanisms.” Knudsen v. Sec’y of Dep’t of HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994).
Nonetheless, the Federal Circuit has stated that while “epidemiological studies are probative
medical evidence relevant to causation,” Grant, 956 F.2d at 1149, they are not necessarily
dispositive. See id.
If petitioners satisfy their burden, they are entitled to compensation “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 (quoting Knudsen, 35 F.3d at 547)
(alteration in original).
B. The Special Master Properly Reviewed the Record
Petitioners’ first objection is that the Special Master arbitrarily disregarded evidence in
the record. They claim that statements of causation by treating physicians were either ignored or
discounted, and that an important admission by respondent was ignored.
1. The Statements of Treating Physicians
Petitioners cite five examples of statements in the medical records that they contend “in
fact show a treating physician statement of vaccine causation.” Pet’rs’ Mot. at 3. There are
several problems with this aspect of the objection. First, the Special Master’s principal
determination was that petitioners failed to satisfy prong one of Althen, which requires “a
medical theory causally connecting the vaccination and the injury” that is based on a “‘reputable
medical or scientific explanation.’” Althen, 418 F.3d at 1278 (quoting Grant, 956 F.2d at 1148);
see Langland ex rel. M.L., 2011 WL 386985, at *24. The Special Master explained that a
treating doctor’s opinion that a vaccination caused a particular injury “cannot substitute for the
explanation of a plausible theory as to how a given vaccine can cause the alleged injury.”
Langland ex rel. M.L., 2011 WL 386985, at *24. In other words, in the absence of a theory
showing a vaccine could cause a particular injury, a doctor’s belief that it did will not prove
causation --- prong one of Althen must be demonstrated, for prongs two and three to matter. It is
not clear whether petitioners intended to argue that the Special Master erred as to the law on this
point, but it is clear that he did not. Federal Circuit precedent makes it evident that the first
prong of Althen must be proven before the opinions of treating physicians may clinch causation
under the other prongs. See, e.g., Andreu ex rel. Andreu v. Sec’y of HHS, 569 F.3d 1367, 1375
(Fed. Cir. 2009) (“If a claimant satisfies the first and third prongs of the Althen standard, the
second prong can be met through medical opinion testimony.”) (citing Capizzano, 440 F.3d at
1326).
The Court supposes, however, that in certain circumstances the opinion of a treating
physician could suffice to prove the existence of a plausible medical theory of causation. For
instance, a doctor’s diagnosis could express a belief as to how the vaccination caused the
particular injury. Or the treating physician could record that he had seen the same injury or
-19-
illness following the same vaccination on a number of occasions, tantamount to a review of case
reports which --- although not as rigorous as typical epidemiological studies, “designed to reveal
statistical trends,” Moberly, 592 F.3d at 1324 --- may be probative of a medical theory. Cf.
Campbell v. Sec’y of HHS, 90 Fed. Cl. 369, 385 (2009) (finding that case reports are not
“deprived of evidentiary value in support of [petitioner’s] medical theory”). But in this regard,
the Special Master scrutinized the physicians’ statements and properly found them wanting. See
Langland ex rel. M.L., 2011 WL 386985, at *5-6, *24. He determined that they were “mere
recitation of intake history given by Petitioners,” id. at *24, summaries of “the time[]line of
symptoms,” id., or --- in the case of the email from Dr. Buckley that petitioners particularly rely
upon --- correspondence that was “not a diagnostic medical record,” id. at *5, was “mistaken”
about [M.L.]’s “actual condition,” id. at *6, and in any event “does not explain how the vaccine
at issue could cause the injury alleged.” Id. at *24.
Taking the email from Dr. Buckley to Dr. Miles first, the Special Master found “it of
dubious quality and minimal probative value,” id. at *6, and determined it was a “private email
correspondence.” Id. at *24. In this email, Dr. Buckley stated that [M.L.] “was sick as an ever
lovin[’] dog and Crohn’s disease or not, she got that way in direct association with her shots,”
Pet’rs’ Ex. 9 at 18. This statement was not a contemporaneous medical record but was made
over one year after the vaccination in question, contained casual language, and referenced
personal topics. Id. (“Watch channel 12 next Friday newscasts and pray that my words don’t get
twisted . . .”). In this email, as the Special Master noted, Langland ex rel. M.L., 2011 WL
386985, at *5-6, *24, Dr. Buckley reported the wrong condition for [M.L.], calling it Crohn’s
disease rather than celiac disease. See Pet’rs’ Ex. 9 at 18. Although the results of the two
diseases may be similar, both associated with diarrhea and malabsorption, see Pet’rs’ Mot. at 4,
they operate in different ways, as Crohn’s disease has nothing to do with gluten. See Tr. at 76.
Thus, it is inconceivable that this message can be taken as even implying that its author had some
inkling of the process by which the vaccination received by [M.L.] could have resulted in the
disease allegedly triggered, as she had an entirely different disease in mind at the time. Cf.
Broekelschen v. Sec’y of HHS, 618 F.3d 1339, 1346 (Fed. Cir. 2010) (finding it was appropriate
to require the injury to be determined before the Althen test is applied, when conditions with
“overlapping symptoms” have “underlying causes or etiology [that] are completely different”).
The Special Master was not at all arbitrary in finding the statement did not support Althen prong
one. Nor, for that matter, was the Special Master arbitrary in finding the statement of “direct
association” to reflect nothing more than a temporal association, see Langland ex rel. M.L., 2011
WL 386985, at *6, which does not alone suffice to establish causation. See Althen, 418 F.3d at
1278.14
14
In this regard, the Court notes that the recipient of the email, Dr. Miles, did not appear
to attribute any significance to Dr. Buckley’s statement associating [M.L.]’s illness with the
vaccination. In her medical log discussing the email she did not mention that aspect of it, but
merely noted the vitamin recommendations. See Pet’rs’ Ex. 9 at 11.
-20-
The other physicians’ statements are no more probative of causation than the email. Not
one of them actually states that the DTaP vaccination caused [M.L.]’s celiac disease, let alone
explains a medical theory by which this could happen. See Pet’rs’ Ex. 1 at 2; Pet’rs’ Ex. 6 at 1-2;
Pet’rs’ Ex. 7 at 7. The Special Master properly concluded that these statements cannot make up
for the lack of a plausible medical theory of causation, making their value as proof of the other
Althen prongs beside the point. In any event, even considered under prongs two and three, the
Court cannot find arbitrary the Special Master’s determination that the records reflect no more
than intake histories or temporal associations. Doctor Buckley’s record that [M.L.] “had a
significant neurologically regressive reaction associated with vaccines given 1/28/03 [sic],”
Pet’rs’ Ex. 1 at 2, could reasonably be considered to be based on the mere temporal association
between the vaccination and illness. Her determination that a Vaccine Adverse Event Reporting
System report should be filed may also be based on the timing of the two, and her
recommendation against further vaccinations, see Pet’rs’ Ex. 7 at 7, does not seem to have much
probative value in the context of this particular case, given the theory that the vaccination
triggered a particular disease --- as it is hardly logical to fear a second triggering of the disease.15
The final two statements highlighted by petitioners were contained in an “Encounter
Note” dated August 4, 2004, in which Dr. Jerry Kartzinel recounted a phone conversation with
petitioners. See Pet’rs’ Ex. 6 at 1-2. On one page, the doctor wrote: “Shots in Jan 2004:
immediately developed fever, rash, vomiting, diarrhea, lethargic, this lasted 6 weeks. Diagnosed
her with [c]eliacs [sic] disease.” Id. at 1. On the next, he wrote: “Discussion: Vaccine VAERS
to be made out / Consider involving a lawyer.” Id. at 2. These statements easily fit within the
Special Master’s assessment of a “recitation of intake history” or a “time[]line of symptoms.”
See Langland ex rel. M.L., 2011 WL 386985, at *24.16 Particularly given the “great deference to
a Special Master’s determination on the probative value of evidence” that is owing, Pafford, 451
F.3d at 1359, the Court cannot find the Special Master’s assessment of medical records to have
been arbitrary. Rather, the Court concludes that he properly exercised his responsibility as the
fact-finder. See Moberly, 592 F.3d at 1325.
2. The Statement in the NIH Pamphlet
In his report, respondent’s expert wrote, “[f]or more information on [c]eliac disease
please see the enclosed patient information pamphlet on [c]eliac disease from the National
Institutes of Health.” Resp’t’s Ex. A at 3. The referenced pamphlet contains the following
sentence: “Sometimes the disease is triggered---or becomes active for the first time---after
surgery, pregnancy, childbirth, viral infection, or severe emotional stress.” Attach. to Resp’t’s
15
During oral argument, petitioners’ counsel speculated that Dr. Buckley may have
worried that subsequent vaccinations could cause other injuries. See Tr. at 31-32.
16
Another record, quoted but not highlighted by petitioners, see Pet’rs’ Mot. at 3, is
clearly of the same ilk. See Pet’rs’ Ex. 4 at 16-17 (record from Dr. Turk describing what
[M.L.]’s “parents report” and noting that he did “not have medical records available”).
-21-
Ex. A at 2.17 Petitioners maintain that this is an admission that celiac disease is triggered by viral
infections, and was ignored by the Special Master. Pet’rs’ Mot. at 5. They contend that it
supports the testimony of Dr. Frick that the DTaP vaccine can insult the body like a viral
infection, and note that the Special Master acknowledged that some illnesses may be caused by
both viral infections and vaccinations. Id. at 6, 8-9; Tr. at 9-10, 47; see also Langland ex rel.
M.L., 2011 WL 386985, at *11, 19. They argue that the Special Master erred in not recognizing
this admission, and fault him for not explaining why. Pet’rs’ Mot. at 9, 16.
The Court rejects this aspect of petitioners’ objection, for several reasons. As an initial
matter, the Court doubts that a single sentence in an informational pamphlet attached to an expert
report can be considered a party admission, particularly when the expert provides testimony to
the contrary, see Sp. Mstr. Tr. at 51 --- petitioners have failed to identify any case law supporting
such a claim. The Special Master certainly considered petitioners’ argument concerning the
sentence in this pamphlet. See Langland ex rel. M.L., 2011 WL 386985, at *20. While he may
not have explained why he did not agree with petitioners as to the significance of the sentence,
under the circumstances this is understandable. The sentence itself has nothing to do with
vaccines, which are conspicuously absent from the list it contains. Nor does it actually state that
the matters listed cause the onset of celiac disease --- at most, it says the disease is “triggered . . .
after” the things listed, not by them. Attach. to Resp’t’s Ex. A at 2. This leaves open the
possibility of other, independent causes for any triggering. The sentence reflects nothing more
than a temporal association, and is not supported or substantiated in the pamphlet --- no studies
or case reports are cited. Thus, even if it did represent the belief that viral infections can trigger
celiac disease, it does nothing to provide a biologic mechanism by which vaccinations may do
the same --- the absence of which was the overarching reason for the Special Master’s decision.
See Langland ex rel. M.L., 2011 WL 386985, at *23-24.
C. The Special Master Did Not Err in Concluding that Petitioners Failed to Present a
Plausible Theory Showing Biologic Causation
Petitioners’ second objection is best summed up in one sentence of their motion: “As
petitioner[s] do[] not need to prove a scientifically certain theory, they also do not need to prove
a scientific explanation of a mechanism of injury, as required by the [S]pecial [M]aster in this
decision.” Pet’rs’ Mot. at 6-7. Because the Special Master found petitioners’ expert’s testimony
on the mechanism by which a DTaP vaccination could trigger celiac disease to be confusing, and
found petitioners’ Exhibit 17 to have “a lot of unexplained loose ends,” Langland ex rel. M.L.,
2011 WL 386985, at *19, petitioners argue that the Special Master was impermissibly requiring
scientific certainty. Pet’rs’ Mot. at 7.
17
The pamphlet, entitled “Celiac Disease,” was issued by the National Digestive
Diseases Information Clearinghouse (NDDIC), and, as of September 5, 2007, was apparently
found at http://digestive.niddk.nih.gov/ddiseases/pubs/celiac/index.htm.
-22-
To be sure, to establish causation, the standard of proof is preponderance of evidence, not
scientific certainty. Bunting v. Sec’y of Dep’t of HHS, 931 F.2d 867, 873 (Fed. Cir. 1991). “A
persuasive medical theory is demonstrated by ‘proof of a logical sequence of cause and effect,’”
supported by “‘evidence in the form of scientific studies or expert medical testimony.’” Althen,
418 F.3d at 1278 (citation omitted). When a petitioner has an epidemiological study, showing a
statistically-significant correlation between a given vaccine and a particular injury, a detailed
theory of how the vaccine could cause the injury is not needed. See Knudsen, 35 F.3d at 549
(explaining that causation may be “based on epidemiological evidence and the clinical picture
regarding the particular child without detailed medical and scientific exposition on the biological
mechanisms”). But in the matter before us, the petitioners have no such epidemiological
evidence, and thus they need to present a “reputable medical or scientific explanation” of their
theory of causation. Grant, 956 F.2d at 1148. This may require an explanation of the steps by
which the vaccination was believed to result in the harm, so that what was actually observed by
treating physicians may be compared to the posited process and the appropriateness of the time
frame involved could be determined. Such a requirement does not raise the standard of proof,
but rather makes sure that there is one. In the absence of epidemiological evidence suggesting
causation, the Special Master did not commit a legal error by requiring a sufficiently-detailed
explanation of how a DTaP vaccination could trigger celiac disease.
The Special Master has the responsibility of “[w]eighing the persuasiveness of particular
evidence . . . to assess the reliability of testimony, including expert testimony.” Moberly, 592
F.3d at 1325. In this case, the Special Master was “confused by Dr. Frick’s lack of explanation
of mechanism” by which a DTaP vaccination could trigger celiac disease. Langland ex rel. M.L.,
2011 WL 386985, at *10. When asked by the Special Master to explain the triggering
mechanism, Dr. Frick replied, “I don’t think anybody really knows that.” Sp. Mstr. Tr. at 29. In
response to the Special Master’s query about medical literature that supports his theory, Dr. Frick
said he “did an extensive literature search” and “wasn’t able to come up with a specific reference
that the DTaP caused the [c]eliac disease.” Id. at 30. The Special Master concluded that Doctor
Frick’s “vague explanation” could not meet petitioners’ burden of proof under Althen. See
Langland ex rel. M.L., 2011 WL 386985, at *11, 23-24.
Petitioners object to the Special Master’s determination that Dr. Frick’s theory of
causation was “not detailed enough to be considered a plausible theory demonstrating biologic
causation.” See Langland ex rel. M.L., 2011 WL 386985, at *23. According to Dr. Frick’s
theory, [M.L.] had a genetic predisposition to develop celiac disease because of her family
history and low IgA immunoglobulin levels. Pet’rs’ Mot. at 6 (citing Langland ex rel. M.L.,
2011 WL 386985, at *7). With such a genetic predisposition, in Dr. Frick’s view, an insult to the
immune system such as an infection or vaccination would likely trigger an autoimmune response
to cause celiac disease. Id.; Pet’rs’ Ex. 11 at 2. But a review of the record shows that the closest
petitioners’ expert came to explaining how a vaccination could trigger this response was his
discussion of the ability of the enzyme tTG to convert gluten to a substance that would be
captured by HLA-DQ2 or HLA-DQ8, which “is the thing then that triggers the [c]eliac disease.”
See Sp. Mstr. Tr. at 35; Langland ex rel. M.L., 2011 WL 386985, at *11. Doctor Frick stated that
-23-
“the thing that insults the body, such as a vaccination or possibly a viral infection or even a
bacterial infection, can trigger this reaction.” Sp. Mstr. Tr. at 35; Langland ex rel. M.L., 2011
WL 386985, at *11. But petitioners’ expert failed to explain how the reaction could be triggered
by a vaccination, or even why he thought so. He did not reference the article attached to his
report which described the process involving tTG, see Pet’rs’ Ex. 11 at 29-30 (Schuppan at 57-
58), nor was that article among the seven identified in petitioners’ Post-Hearing Brief. See Post-
Hr’g Br. at 3.18
The Special Master carefully considered the testimony of Dr. Frick, see Langland ex rel.
M.L., 2011 WL 386985, at *6-13, 22-25, as well as the medical literature petitioners’ expert
discussed. See id. at *9-11. And he considered (and quoted from) at great length petitioners’
Exhibit 17. See id. at *17-19. The Special Master did not have the benefit of Dr. Frick’s
interpretation of this article and its relevance, as it was submitted after the hearing. See Notice of
Filing (May 8, 2009). Petitioners themselves merely explained that the article “indicates that
both environmental and genetic factors have been implicated in the contraction of celiac
disease,” and quote from the abstract that “‘viral infections and/or tissue damage in the intestine
may cause inflammation and induce protective Th1-mediated immunity leading to loss of
tolerance for gluten,’” after which “‘ a broad gluten-reactive T cell repertoire may develop
through determinant spreading’” that “‘may be a critical step toward full-blown [celiac]
disease.’” Id. (quoting Stepniak at 460); Post-Hr’g Br. at 3 (same). The interpretation of the
article, thus, was left in the hands of the Special Master --- which is entirely proper, as special
masters are themselves experts who can make their own assessments and provide their own
interpretations of medical literature. See Moberly v. Sec’y of HHS, 85 Fed. Cl. 571, 597-98
(2009), aff’d, 592 F.3d 1315 (Fed. Cir. 2010).
The Special Master found Exhibit 17 to be “interesting and helpful, but certainly not
dispositive.” Langland ex rel. M.L., 2011 WL 386985, at *17. The authors speculate that a viral
infection, such as rotavirus gastroenteritis and other enteroviruses that frequently cause diarrhea
in children, could shift immune responses from oral tolerance of gluten to support inflammation.
Stepniak at 463; see Langland ex rel. M.L., 2011 WL 386985, at *18. They ultimately state that
it is “possible” that “unrelated events” --- that is, non-genetic reasons --- could be responsible for
the “loss of tolerance” of gluten in celiac disease patients. Stepniak at 465; Langland ex rel.
M.L., 2011 WL 386985, at *19. The authors raise the question: “Are viral infections the
incriminated environmental factors directly triggering the onset?” Stepniak at 466; Langland ex
rel. M.L., 2011 WL 386985, at *19. They note that the question cannot at this time be addressed
using “an animal model,” and explain that they “will therefore continue to work with patients.”
Stepniak at 465; Langland ex rel. M.L., 2011 WL 386985, at *19.
Carefully considering Exhibit 17, the Special Master ultimately dismissed the authors’
speculation about viral infection as the trigger for celiac disease as “hypothetical,” with many
18
Perhaps the article was not cited because it seems to indicate that the process involving
tTG is not the manner in which celiac disease starts in pediatric patients. See n.8, supra.
-24-
“unexplained loose ends in their hypothesis regarding the biologic process involved.” Langland
ex rel. M.L., 2011 WL 386985, at *19. Petitioners argue that the Special Master should have
accepted the Stepniak article as a scientific explanation of the mechanism of causation. Pet’rs’
Mot. at 7. Despite conceding that the article was speculative, see Tr. at 47, petitioners contend
that the Special Master should have identified the connection between vaccine-triggered and
virus-triggered autoimmune disorders. Pet’rs’ Mot. at 8; see Langland ex rel. M.L., 2011 WL
386985, at *19. As the Special Master noted, Exhibit 17 never mentions vaccinations as
potential triggers of celiac disease. Langland ex rel. M.L., 2011 WL 386985, at *19. And even if
certain viral infections and certain vaccinations may cause the same injuries, a theory that
attempts to bootstrap onto speculation that infections or tissue damage in the small intestine can
cause a particular injury should, at the least, explain how the vaccination causes damage in that
same organ. No such explanation is found in the record, other than the general notion that a
vaccination causes an immune system response.
The Special Master found that other medical literature proffered by petitioners was not
applicable, “relat[ing] to some other vaccine, some other injury, or some other effect.” Id. at *23.
One study, for example, showed that children with celiac disease more frequently fail to respond
to the hepatitis B vaccine. See Pet’rs’ Ex. 11 at 9 (S. D. Park, et al., Failure to respond to
hepatitis B vaccine in children with celiac disease, 44 J. Pediatr. Gastroenterol. Nutr. 431-35
(2007)). “If anything,” the Special Master reasoned, the study supported “the proposition that
[c]eliac disease is an independent, free-standing disease that affects the body’s response to
vaccination, not the other way around.” Langland ex rel. M.L., 2011 WL 386985, at *24.
In reviewing the Special Master’s decision, the Court cannot “reweigh the factual
evidence” or examine the credibility of the witnesses. Munn, 970 F.2d at 871. The Court can
only ensure that the Special Master considered all relevant evidence, drew plausible inferences,
and articulated a rational basis for his decision. Hines, 940 F.2d at 1527. To meet the
preponderant evidence standard, petitioners provided Dr. Frick’s testimony and submitted
medical literature. Doctor Frick, however, could not report any incidence of celiac disease
following DTaP vaccination. Langland ex rel. M.L., 2011 WL 386985, at *23. Nor does any
literature in the record so much as mention vaccinations as a possible trigger for celiac disease.
With no epidemiological evidence upon which to base causation, the Special Master was
“entitled to require some indicia of reliability to support the assertion of the expert witness.”
Moberly, 592 F.3d at 1324. In asking for a scientific explanation of a mechanism of injury or for
medical literature, the Special Master was acting within his purview as the fact-finder. The
Special Master articulated his conclusions and the grounds for them, identifying the evidence
underpinning them. See Langland ex rel. M.L., 2011 WL 386985, at *19-25. His determination
that petitioners did not meet their burden of proof was not arbitrary or capricious, and cannot be
disturbed upon review.
Petitioners raise one subsidiary point under this objection --- that the Special Master
misinterpreted Dr. Frick’s testimony concerning the onset of [M.L.]’s celiac disease, and should
have found an appropriate temporal relationship established. Pet’rs’ Mot. at 9-10, 15-16. But to
-25-
satisfy the “proximate temporal relationship” prong of the Althen test, petitioners must
demonstrate, by a preponderance of the evidence, that the onset of symptoms occurred within a
time frame for which it is medically acceptable to infer causation-in-fact. de Bazan v. Sec’y of
HHS, 539 F.3d 1347, 1352 (2008). With no reputable theory as to how the vaccination could
cause the injury, this exercise is not possible. Moreover, the Special Master explained the
confusing aspects of Dr. Frick’s testimony concerning onset --- as petitioners’ expert did testify
that [M.L.]’s diarrhea and vomiting, both symptoms of celiac disease, began the day of her
vaccination and were “all part and parcel” of the disease. See Langland ex rel. M.L., 2011 WL
386985, at *12-13, 22, 25; Sp. Mstr. Tr. at 42-44. Reviewing the transcript below, the Court
concludes it was certainly reasonable for the Special Master to find the testimony contradictory
and confusing. See Munn, 970 F.2d at 871.
D. The Special Master Did Not Require Medical Literature to Support Causation
In their final objection to the Special Master’s decision, petitioners contend that the
Special Master required medical literature as proof of causation, contravening the holding of
Althen, 418 F.3d at 1280-82. See Pet’rs’ Mot. at 11. But in the decision below, he did nothing of
the sort. Petitioners base this objection on a statement in the decision which followed the
quotation of Dr. Frick’s surmise that a “thing that insults the body, such as a vaccination or
possibly a viral infection” could result in tissue transglutaminase changing gluten into a
substance which provokes an immune system reaction. See Langland ex rel. M.L., 2011 WL
386985, at *11; Pet’rs’ Mot. at 11. The Special Master considered petitioners’ expert’s attempts
at describing the biologic process by which a DTaP vaccination could trigger celiac disease to be
a “meager and hardly explained ratiocination,” which “was not really supported by any medical
literature relied upon in the formulation and composition of Dr. Frick’s report,” but instead
related to Exhibit 17, filed after the hearing --- which the Special Master would later discuss at
length. Langland ex rel. M.L., 2011 WL 386985, at *11, 17-19. The point was not that
petitioners’ expert did not back up his theory with medical literature, but rather that his theory
was not found to be coherent and persuasive, and its shortcomings were not rectified by any other
evidence submitted, including medical literature. The Special Master’s decision did not violate
Althen.
III. CONCLUSION
After reviewing the submissions and arguments of the parties, the evidence in the record,
the transcript of the hearing below, and the decision of the Special Master, for the foregoing
reasons the Court concludes that the Special Master did not err when he denied compensation to
petitioners under the Vaccine Act. The Special Master applied the correct legal standard and was
not arbitrary or capricious in his decision.
Accordingly, the petitioners’ motion for review is DENIED and the decision of the
Special Master is SUSTAINED. The Clerk of Court is directed to enter judgment for
respondent.
-26-
IT IS SO ORDERED.
s/ Victor J. Wolski
VICTOR J. WOLSKI
Judge
-27-