                     In the United States Court of Federal Claims
                                         OFFICE OF SPECIAL MASTERS
                                                  No. 09-0039V
                                               Filed: April 7, 2014
                                             (TO BE PUBLISHED) 1

*************************
                           *
AMY CRUTCHFIELD,           *
                           *
               Petitioner, *
                           *                                              Vaccine Act Entitlement;
          v.               *                                              Causation-in-fact; MMR vaccine;
                           *                                              Diabetes Type I
SECRETARY OF HEALTH        *
AND HUMAN SERVICES,        *
                           *
               Respondent. *
                           *
*************************


John F. McHugh, New York, NY, for Petitioner.

Michael P. Milmoe, U.S. Department of Justice, Washington, D.C., for Respondent


                                                        DECISION

HASTINGS, Special Master

       This is an action in which the Petitioner, Amy Crutchfield, seeks an award under the National
Vaccine Injury Compensation Program (hereinafter “the Program” 2), because Petitioner believes that
the measles-mumps-rubella (“MMR”) vaccination that she received on January 26, 2006, caused her to
develop Type 1 diabetes. For the reasons set forth below, I conclude that the Petitioner has failed to
demonstrate that the vaccination contributed in any way to the causation of her Type 1 diabetes.



1
         Because I have designated this document to be published, this document will be made available to the public
unless petitioner files, within fourteen days, an objection to the disclosure of any material in this decision that would
constitute “medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of
privacy.” See 42 U.S.C. §300aa-12(d)(4)(B); Vaccine Rule 18(b).
2
        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). I will also sometimes refer to the Act of
Congress that created the Program as the “Vaccine Act.”

                                                               1
                                                             I

                  THE APPLICABLE STATUTORY SCHEME AND CASE LAW

        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 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. 3 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. 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)(1)(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)(1)(A); see also Althen, 418 F.3d at 1278; 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:



3
       As will be detailed below, no Table Injury is alleged in this case.

                                                             2
       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. 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 (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
instruction 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. The issue of the temporal relationship
between vaccination and the onset of an alleged injury was further discussed in Locane v. HHS, 685
F.3d 1375 (Fed. Cir. 2012), and W.C. v. HHS, 704 F.3d 1352 (Fed. Cir. 2013). Moberly v. HHS, 592
F.3d 1315 (Fed. Cir. 2010), concluded that the “preponderance of the evidence” standard that applies to
Vaccine Act cases is the same as the standard used in traditional tort cases, so that conclusive proof
involving medical literature or epidemiology is not needed, but demonstration of causation must be
more than “plausible” or “possible.” Both Andreu v. HHS, 569 F.3d 1367 (Fed. Cir. 2009), and Porter
v. HHS, 663 F.3d 1242 (Fed. Cir. 2011), discussed the circumstances under which determination
concerning an expert’s “credibility” may reasonably affect the outcome of a causation inquiry.
Broekelschen v. HHS, 618 F.3d 1339 (Fed. Cir. 2010), found that it was appropriate for a special
master to determine the reliability of a diagnosis before analyzing the the likelihood of vaccine
causation. Lombardi v. HHS, 656 F.3d 1343 (Fed. Cir. 2011), and Hibbard v. HHS, 698 F.3d 1355
(Fed. Cir. 2012), both again explored the importance of assessing the accuracy of the diagnosis that
supports a claimant’s theory of causation. Doe 11 v. HHS, 601 F.3d 1349 (Fed. Cir. 2010)
and Deribeaux v. HHS, 717 F.3d 1363 (Fed. Cir. 2013), both discuss the burden of proof necessary to
establish that a “factor unrelated” to a vaccine may have caused the alleged injury.

        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 (1993), the Supreme Court listed certain factors that federal trial courts should utilize in
                                                    3
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.

                                                               II

                                     FACTS AND PROCEDURAL HISTORY

A. Facts 4

        Amy Crutchfield was born on October 17, 1970. (Petition at ¶3.) During her childhood, she
received the vaccinations typically recommended; including the live measles vaccine on October 18,
1971, with a booster measles vaccine on May 24, 1978; the mumps vaccine on May 21, 1972; and the
rubella live virus vaccine on January 31, 1972. (Ex. 7, p. 119.)

4
         Petitioner filed Exhibits 1 through 7 with the petition, and filed Exhibits 8 through 84, and 100 through 102, on
several occasions thereafter. Respondent filed Exhibits A through Z, AA through OO, and AAA through NNN, at various
times. “Ex.” references will be to those exhibits. “Tr.” references will be to the pages of the transcript of the evidentiary
hearing held on March 30, 2011.

          It should be noted that both parties sometimes assigned the same exhibit number or letter to more than one
document in the record. Specifically, there is more than one version of Exhibits 1 through 8, and more than one version of
Exhibits A through T. In this Decision, all references to Exhibits 1 through 7 will pertain to Petitioner’s Exhibits 1 through
7 filed in paper format on January 16, 2009. All references to Exhibits A through G, will pertain to the expert reports and
curriculum vitae filed on several occasions.

          On March 31, 2009, and July 17, 2009, Petitioner filed a total of 69 medical articles, as addenda to Dr. Shoenfeld’s
expert report. These items were sometimes identified as “Exhibits” 1-69 by the parties, which may result in confusion due
to the repetition of certain exhibit numbers (i.e. – numbers 1-8.). In this Decision, I will refer to any medical articles
labeled as duplicate Exs. 1 through 8 as “Article 1,” “Article 2”, etc. Petitioner later filed additional medical articles as Exs.
70-80 on May 12, 2011.

          On August 21, 2009, Respondent filed Exhibits A to Z and AA to OO, which are medical articles relevant to Dr.
Bercu’s expert report. Some of the letters of identification (i.e. – letters A through G) had previously been used to identify
other exhibits. Moreover, Respondent later filed, on August 4, 2011, additional medical articles, labeled as Exs. H through
T, creating further duplication of exhibit identification. Accordingly, when referring to medical articles filed by
Respondent, I will refer to the exhibit letter followed by the date of filing (either 8-21-09 or 8-4-11).

          Likewise, both parties sometimes passed over the next consecutive number or letter, leaving gaps in their exhibit
lists. For example, there are no Petitioner’s Exhibits 85 through 99, and no Respondent’s Exhibits PP through ZZ.

          While this case was pending, the U.S. Court of Federal Claims implemented a transition in document format from
paper to electronic format. Therefore, the docket of this case lists some exhibits that were filed via paper, some that were
filed as electronic documents, and some filed on compact discs.

                                                                4
        In the course of routine health care as an adult, occasionally Ms. Crutchfield’s blood glucose
was tested. Prior to 2006, Ms. Crutchfield did not experience any significant problems with her health.
(Ex. 6, pp. 93-113.)

        During a medical visit on October 5, 2005, Ms. Crutchfield reported that she was trying to
conceive a child. (Ex. 6, p. 93.) Her gynecologist, Dr. Julie Beyers, examined Ms. Crutchfield on
December 15, 2005, and recorded “normal exam.” (Ex. 2, p. 4.) That evaluation included laboratory
blood tests, which revealed her lack of immunity to measles (Ex. 2, p. 9), an “equivocal” immune
response to mumps, and a response to rubella indicating immunity. (Ex. 2, p. 6.) A repeat blood test on
January 6, 2006, produced an “equivocal” result for measles, a “non-immune” result for mumps, and a
result for rubella again indicating immunity. (Ex. 2, p. 11.) As part of her pre-conception planning,
therefore, Ms. Crutchfield received a measles-mumps-rubella (“MMR”) vaccination on January 26,
2006, 5 when she was 35 years old. (Ex. 4, p. 19.)

        On April 4, 2006, Dr. Beyers noted that Ms. Crutchfield had used Monistat to self-treat an
episode of vaginal pruritis, about two weeks previously. Since that problem persisted, Dr. Beyers
prescribed treatment with Diflucan. (Ex. 2, p. 10.) On April 20, and May 4, 2006, Dr. Beyers noted
recurrent episodes of pruritis and subsequent treatments for a vaginal yeast infection. (Ex. 2, pp. 13,
16.) According to laboratory analysis, by May 5, 2006, there were no indications of any urogenital
infections present. (Ex. 2, p. 18). Dr. Beyers commenced treatment of Ms. Crutchfield with Clomid,
on May 30, 2006, to promote fertility.

        Ms. Crutchfield visited her internist, Dr. Orli Etingin, on June 19, 2006, to report a problem
with increased thirst, unintentional weight loss, and hair loss, over the past three to four months. (Ex. 6,
p. 90.) Based on her own internet research of these symptoms, Ms. Crutchfield states, she insisted on
blood tests to determine whether she had diabetes. (Pet. at ¶17, 18.) Tests performed at that time
indicated that Petitioner was, in fact, suffering from diabetes.

        Dr. Carol Levy, an endocrinologist, evaluated Ms. Crutchfield on June 23, 2006, and described
her as a thirty-five-year-old female with a family history of autoimmune issues, who complained of
three months of recurrent yeast infections and weight loss. (Ex. 6, p. 79.) That family history included
rheumatoid arthritis in her mother and aunt, myasthenia gravis afflicting her maternal grandmother, and
celiac disease afflicting a maternal cousin. No one else in Ms. Crutchfield’s family suffered from
diabetes mellitus. (Ex. 5, p. 33.) 6 Dr. Levy’s impression, on June 22, 2006, was Type 1 diabetes. (Ex.
5, p. 34.) She commenced treatment with insulin. (Ex. 5, p. 35.)

       By July 5, 2006, Dr. Levy noted that Ms. Crutchfield’s condition had improved; that is, her
“sugars” were “better.” (Ex. 5, p. 31.) Dr. Levy continued to provide regular care for
5
         Respondent acknowledges the administration of a MMR vaccination around January 26, 2006, but suggests that
the actual date may have been two days earlier, on January 24, 2006. (Resp. Report at 3; Resp. Pre-Hearing Memo at 2.)
The exact date, however, is not relevant--it is relevant only that she definitely received a MMR vaccination on or about
January 26, 2006.


6
           The notes in the medical record at this cite are not easily legible. However, both Dr. Shoenfeld, for petitioner (Ex.
1, p. 2), and Dr. Bercu, for respondent (Ex. A, p. 2), agree on at least those aspects of the family history presented here.

                                                               5
Ms. Crutchfield’s diabetic condition, and she prescribed continuous treatment via insulin pump,
beginning in February 2007. (Ex. 6, p. 77; Ex. 5, p. 24.)

        On January 24, 2011, Dr. Noel Maclaren, respondent’s expert, recommended that certain
laboratory tests of Ms. Crutchfield’s blood be performed, to determine for certain whether she suffered
from Type 1 or Type 2 diabetes. (Ex. F, p. 2.) These tests were performed on January 31, 2011, and
the results, submitted as Exs. 101 and 102, confirmed that Petitioner suffered from Type 1 diabetes.

B. Procedural history

        Petitioner filed her Program petition on January 16, 2009, along with the expert report of Dr.
Yehuda Shoenfeld (Ex. 1) and various medical records (Exs. 2-7). The case was assigned to Special
Master Richard Abell. The petition alleged that the measles-mumps-rubella (“MMR”) vaccination that
Petitioner received on January 6, 2006, caused her to develop diabetes. Respondent filed a “Rule 4
report” and an expert report of Dr. Barry Bercu on May 8, 2009 (Ex. A), contending that
compensation is not appropriate.

        Dr. Bercu’s report described Respondent’s concern that the medical records were ambiguous as
to whether Ms. Crutchfield’s final diagnosis was Type 1 or Type 2 diabetes. He opined that if the
correct diagnosis was actually Type 1 diabetes, then the expected latency period for the development of
that disease was far too long to causally connect Petitioner’s diabetes onset to the MMR vaccination of
January 26, 2006. (Ex. A, pp. 3, 7.) Petitioner filed a second report by Dr. Shoenfeld, on July 6,
2009, 7 asserting that the correct diagnosis was, in fact, Type 1 diabetes, and arguing that in petitioner’s
situation the rapid onset of that disease would be consistent with vaccine injury because it was a
“secondary” immunological response to the vaccine. Specifically, Dr. Shoenfeld characterized the
onset of Type 1 diabetes in this case as an “anamnestic” response to Ms. Crutchfield’s second exposure
to the MMR vaccine components. On August 21, 2009, Respondent filed a large volume of medical
articles, Tabbed from A to Z and AA to OO. On September 9, 2009, Respondent filed another report
by Dr. Bercu (Ex. C), which reiterated his opinion that the typical period for the development of of
Type 1 diabetes, before symptoms occur, is far longer than the time period between Petitioner’s MMR
vaccination on January 26, 2006, and the onset of Petitioner’s diabetes symptoms one to two months
later.

        Given the complexities of this case, the parties were allowed additional time to file
supplemental expert reports. (Order, Oct. 1, 2009.) Respondent indicated the desire to file the report
of an additional endocrinologist. (Order, Dec. 10, 2009.)

       On March 29, 2010, this case was reassigned to my docket, on account of the pending
retirement of Special Master Abell.

        Respondent filed the expert report of Dr. Noel Maclaren (Ex. D) on April 1, 2010, who opined
that the appropriate diagnosis of Petitioner’s condition was most likely Type 1 diabetes. Dr. Maclaren

7
          The “Reply Report” of Dr. Shoenfeld (ECF Doc. #11) is a paper document, without an exhibit number. I will refer
to this report as “ECF #11.” I have reviewed this very brief report of Dr. Shoenfeld, but it does not add anything of
persuasive value to Petitioner’s case.


                                                            6
repeated Dr. Bercu’s opinion that Type 1 diabetes requires an extended period of time to develop into a
symptomatic disease. Petitioner then submitted a letter (Ex. 100) from her treating endocrinologist, Dr.
Carol Levy, who opined that Ms. Crutchfield suffered from Type 1 diabetes. On January 12, 2011,
respondent filed another report of Dr. Maclaren (Ex. F), which proposed that certain laboratory tests
could be performed that would distinguish for certain between Type 1 and Type 2 diabetes in
Petitioner’s case. Blood samples were drawn from Petitioner on January 31, 2011, and the results,
filed as Exhibits 101 and 102, confirmed that she has Type 1 diabetes.

         Pre-hearing memoranda were filed by both Respondent and Petitioner, on March 4 and
March 7, 2011, respectively. An evidentiary hearing convened on March 30, 2011. Dr. Shoenfeld
testified on behalf of Petitioner, while Drs. Maclaren and Bercu testified on behalf of Respondent.
Various items of medical literature were introduced by Petitioner during the hearing. Petitioner filed
copies of those medical articles, along with several others, on May 12, 2011. (See Articles 70 – 80.)
Respondent was allowed to submit a response. (Order, June 28, 2011.) On July 18, 2011, Respondent
filed the supplemental expert report of Dr. Maclaren (Ex. G), which discussed the medical literature
recently filed by Petitioner. On August 4, 2011, Respondent also filed additional medical articles,
intended to support Dr. Maclaren’s supplemental report. 8

        On August 31, 2011, Petitioner filed a Post-Hearing Memorandum that summarized Petitioner’s
allegations concerning vaccine-causation of her diabetes. Respondent filed a Post-Hearing
Memorandum on October 31, 2011. Within that document, respondent noted the publication of a new
report by the Institute of Medicine (“IOM”), which had not been available at the time of the evidentiary
hearing. (See Resp. Post-Hearing Memo, p. 11.) Respondent argued that the IOM report was highly
relevant to the Crutchfield case because it specifically examined the issue of a possible causal
relationship between the MMR vaccine and Type 1 diabetes. On January 31, 2012, respondent filed a
motion to introduce that IOM report, with a copy of the relevant portion attached, labeled as Ex.
NNN. 9

       On February 13, 2012, petitioner filed an “Objection” to the inclusion of Exhibit NNN in the
record of this case. On May 14, 2012, I filed an abbreviated Ruling, that Exhibit NNN would be
considered as part of the evidentiary record in this case.

        In response to the filing of Ex. NNN, the IOM report, Petitioner was permitted to file another
report by Dr. Shoenfeld, on October 27, 2012, which critiqued the validity and relevance of the 2011
IOM Report. (Ex. 84.) Petitioner was also allowed additional time to file a reply to the Respondent’s
post-hearing brief. Finally, on April 18, 2013, Petitioner filed a Reply to Respondent’s Post-Hearing
Memorandum.




8
        The filing of medical articles and other exhibits in this case is summarized above in fn. 4.
9
        Respondent filed numerous medical articles on January 17, 2012, in support of the contentions set forth in
Respondent’s Post-Hearing Memorandum. These filings were identified as Exs. AAA – MMM. Those exhibits, however,
played no significant role in my analysis of this case.


                                                              7
                                                            III

                                             ISSUE TO BE DECIDED

        In this case, Petitioner seeks a Program award, contending that she developed Type 1 Diabetes
as a result of an MMR vaccination received on January 26, 2006. For the reasons set forth below, I
conclude that Petitioner has failed to show that it is “more probable than not 10 that her MMR
vaccination contributed to causing her diabetes.

                                                            IV

                      SUMMARY OF EXPERT WITNESSES’ QUALIFICATIONS

        In this case, each side relies upon the expert reports and hearing testimony of medical experts.
At this point, I will briefly summarize the qualifications of those expert witnesses.

A. Petitioner’s expert – Yehuda Shoenfeld, M.D.

        Dr. Yehuda Shoenfeld graduated from the Hadassa Medical School, in Israel in 1972. He was
appointed lecturer in internal medicine at the Tel-Aviv University Medical School in 1975, then
advanced to senior lecturer in 1980. He received a diploma, cum laude, for his studies in internal
medicine at the Postgraduate Medical School of Tel Aviv University in 1978. Beginning in 1976, he
served as senior resident in the Department of Internal Medicine and the Out-Patient Clinic of
Hematology and Immunology of Beilinson Medical Center in Israel. He conducted research in
hematology and internal medicine there, and became head of those departments in 1985. Between
1976 and 1982, Dr. Shoenfeld also participated in clinical fellowships in hematology/oncology at City
of Hope, in Duarte, California; at the Tufts New England Medical Center of Boston, Massachusetts;
and at the Cornell Medical Center of New York. (Ex. 1, pp. 22-24)

       In 1984, Dr. Shoenfeld became head of the Department of Medicine at the Sheba Medical
Center of Tel-Aviv University, where he continued to serve at the time of his testimony in this case.
He received an academic appointment as Associate Professor in 1985, then Professor of Medicine in
1990, at the Tel-Aviv University Medical School, Sackler Faculty of Medicine. Concurrently, he was
the head of the Hybridoma Unit and Research Laboratory for Autoimmune Diseases of the Soroku
Medical Center of Ben-Gurion University of the Negev. In that capacity, he founded the Center for
Autoimmune Diseases, and continues to serve as its Director. (Ex. 1, pp. 1-2 and 22-24.)

       Dr. Shoenfeld’s curriculum vitae, as of 2006, listed over 1,200 professional articles, 43 books,
and 130 chapters in medical texts, which he authored or co-authored, many of them focusing on
autoimmune diseases. (Ex. 1, pp. 41-120.) He has served on the editorial boards of numerous medical
journals, primarily concerning autoimmunology and rheumatic diseases. (Ex. 1, pp. 30-31.) He has
also been an organizer of many medical conferences, and a member of numerous professional
organizations, both in Israel and internationally. (Ex. 1, pp. 25-29.)
10
          Petitioners have the burden of demonstrating the facts necessary for entitlement to an award by a “preponderance
of the evidence.” § 300aa-12(a)(1)(A). Under that standard, the existence of a fact must be shown to be “more probable
than its nonexistence.” In re Winship, 397 U.S. 358, 371 (1970) (Harlan, J., concurring).
                                                              8
        In his testimony before this court, Dr. Shoenfeld described his ongoing clinical work as head of
the Department of Medicine at the largest hospital in Israel, the Sheba Medical Center. In that
capacity, over the previous 27 years, he collaborated with other specialists daily in treating all types of
patients, including 15 to 20 percent who were diagnosed with diabetes mellitus. (Tr., pp. 5-7.)

B. Respondent’s experts

       1. Barry B. Bercu, M.D.

         Dr. Barry Bercu received his medical degree at the University of Maryland in 1969. He
performed his medical internship at Boston City Hospital in 1969-70, and his residency in pediatrics at
the Massachusetts General Hospital in Boston, from 1970 to 1972. He served in the U.S. Air Force as
a pediatrician in 1972-74. Dr. Bercu participated in two post-graduate research fellowships
concurrently, between 1974 and 1977; one in pediatric endocrinology and metabolism at Massachusetts
General Hospital, and the other in endocrinology at Tufts University Medical School in Boston. (Ex.
A, p.1; Ex. B, pp. 2-4.) He is board-certified in the fields of pediatrics and pediatric endocrinology.
(Tr., p. 161.)

        Dr. Bercu joined the U.S. Public Health Service in 1974, as a senior surgeon, and continued in
that role until 1984. In addition, beginning in 1977, he was appointed to a series of positions involving
children’s health at the National Institutes of Health (“NIH”). From 1982 to 1984, he served as head of
the Pediatric Endocrine Unit of the NIH, while concurrently teaching as an Associate Research
Professor of Child Health and Development at the George Washington University School of Medicine
and Health Sciences. (Ex. B, p. 4.)

        In 1984, Dr. Bercu began his affiliation with the University of South Florida College of
Medicine, in Tampa, Florida, where he was still employed as a Professor at the time of his testimony in
this case. During that time period, his area of specialization expanded from pediatrics, to include
pharmacology and therapeutics. Along with this academic employment, Dr. Bercu maintained a
clinical practice at the Tampa General Hospital and the Shriner’s Hospital of Tampa. (Ex. B, pp. 2, 7.)
He was also a participant in more than sixty medical and pharmaceutical research grants. (Ex. B, pp.
7-10.) Dr. Bercu has published the results of his scientific research in over 170 articles in medical
journals, many of them focused on endocrine disorders. (Ex. B, pp. 14-23.) He holds several patents
concerning growth hormones. (Ex. B, p. 10.)

       2. Noel Maclaren, M.D.

        Dr. Noel Maclaren received his medical degree at the University of Otago, in New Zealand, in
1963. His early medical training specialized in Medicine and Pediatrics, primarily at the Wellington
Hospital in New Zealand, between 1963 and 1968. He also served as senior resident Medical Officer
of the Queen Elizabeth Hospital for Sick Children, in London, in 1969. Dr. Maclaren participated in a
Fellowship in Pediatric Endocrinology and Metabolism at the University of Maryland School of
Medicine and Johns Hopkins School of Medicine, from 1972 to 1973. Between 1973 and 1978, he
continued his practice in the fields of pediatrics, endocrinology, and metabolism as an Associate
Professor at the University of Maryland School of Medicine. (Ex. E, pp. 1-2.) Dr. Maclaren became

                                                     9
board-certified in pediatrics in 1976, then received a certification in pediatric endocrinology in 1978.
(Ex. E, p. 5.)

       In 1978, Dr. Maclaren began his affiliation with the College of Medicine of the University of
Florida, in Gainesville, as a Professor of Pathology and Pediatrics, then served as Chairman of the
Department of Pathology from 1987 to 1997. In 1997, he was appointed Professor of Pediatrics at
Louisiana State University College of Medicine, then became a Professor of Biometry and Genetics in
1998. Concurrently, Dr. Maclaren served as Director of the Research Institute for Children at the
Children’s Hospital of New Orleans, Louisiana, from 1997 to 1999. In 1999, he commenced five
years of service as a Professor of Pediatrics at the Weill College of Medicine of Cornell University, in
New York. During that same time period, Dr. Maclaren was Director of the Cornell Juvenile Diabetes
Program, and a member of the medical staff at both the Rockefeller University Hospital and the
Hospital of Special Surgery. From 2004 until the time of his testimony in this case, Dr. Maclaren was a
Professor of Pediatrics at the Weill-Cornell College of Medicine and New York Hospital. (Ex. E, p. 2.)

       In his testimony in this case, Dr. Maclaren stated that the emphasis of all of his training was
endocrinology, with a primary focus on Diabetes, Type 1. (Tr., pp. 108-09.) His curriculum vitae lists
him as author or co-author of over 200 articles in medical journals, and more than 80 books or book
chapters, concerning mostly endocrinology and Diabetes, Type 1. (Ex. E, pp. 8-28.)

        Dr. Maclaren has participated in the development of several reports published by the Institute of
Medicine. (Tr. 109-10, 115.) He is listed as one of the reviewers of an IOM report that was filed in this
case as Exhibit U, titled Immunization Safety Review: Multiple Vaccinations and Immune Dysfunction
(National Academy Press 2002).

                                                    V

            DESCRIPTION OF PETITIONER’S CONDITION AND THE OPINIONS
                            OF THE PARTIES’ EXPERTS

A. Petitioner’s Type 1 Diabetes Mellitus

        The parties ultimately agreed, as noted above, that Petitioner suffers from “Type 1 diabetes
mellitus”; I will use the term “Type 1 diabetes” for short. Type 1 diabetes is a condition in which
certain cells in the patient’s pancreas, known alternatively as “islet cells” or “beta cells,” have been
destroyed to an extent that causes serious damage to the pancreas’ function, so that the patient needs
insulin to survive. (Ex. 1, p. 4; Ex. A, p. 3; Ex. B filed 8-21-09, p. 333; Tr. 197-98.) Type 1 diabetes is
an “autoimmune” disease, meaning that the patient’s own immune system is mistakenly attacking and
destroying the islet cells. (Ex. 1, p. 4; Tr. 148, 197-98.)

        For many years, the onset of Type 1 diabetes symptoms was usually seen in patients during
their childhood years, not during adulthood, so that the disease was formerly known as “juvenile
diabetes.” (Tr. 117.) However, in recent years the onset of Type 1diabetes symptoms has often been
seen in adults as well as children. (Tr. 117-18.) When the first symptoms of Type 1 diabetes are seen
in an adult, the condition is sometimes described as “latent autoimmune diabetes in adulthood,” or
“LADA.” (Ex. A, p. 3; Tr. 21.)

                                                    10
         The causation of Type 1 diabetes is not well understood, as the experts in this case agreed. (Ex.
1, p. 4; Ex. A, p. 6; see also Ex. A, filed 8-21-09, p. 1.) The experts in this case also agreed that certain
persons are genetically susceptible to autoimmune disease, and thus more likely than average to
experience Type 1 diabetes. (Ex. A, p. 6; Tr. 8, 21-22, 59, 96; see also Ex. A filed 8-21-09, pp. 1, 2.)
The experts also agree that environmental factors can play a role in causation. (Ex. 1, p. 4; Ex. A, p. 7;
Tr. 8, 148; see also Ex. A filed 8-21-09, pp. 1-2.)

B. Summary of opinion of Dr. Shoenfeld

       Dr. Shoenfeld stated the opinion that Petitioner’s Type 1 diabetes was caused by her MMR
vaccination of January 26, 2006. He relied upon several factors. First, he noted that Petitioner’s Type
1 diabetes is an autoimmune condition, so that Petitioner’s family history of autoimmune disease made
her more likely to develop an autoimmune disease. (Tr. 22, 59, 96.) He also asserted that it is “widely
accepted” that environmental factors, such as infections, can cause Type 1 diabetes, and that the
mumps virus in its “wild” form has been reported as preceding the onset of Type 1 diabetes; he
concludes therefrom that the wild mumps virus can cause Type 1 diabetes, and that therefore the
mumps vaccine can also likely cause Type 1 diabetes. (Ex. 1, pp. 4-7; Tr. 28-33.)

        Dr. Shoenfeld opined that one of the components of the MMR vaccine caused Petitioner’s Type
1 diabetes by a process known as “molecular mimicry,” in which a body part (here, the islet cells) has a
similar molecular structure to an invasive agent that the immune system has been programmed to
attack. The immune system, mistaking that body part for the invasive agent, mistakenly attacks the
body part. (Ex. 1, pp. 7-8; Ex. 84, p. 3; Tr. 48-49.)

       Dr. Shoenfeld also relied heavily on the fact that the first symptoms of Petitioner’s Type 1
diabetes were noticed one to two months after the vaccination in question, which circumstance he
believes to be supportive of a conclusion that the vaccination caused the disease. (Tr. 24-26, 44-47.)
He stressed that Petitioner had displayed no symptoms of diabetes prior to the vaccination. (Tr. 24,
26.)

C. Summary of the opinions of Respondent’s experts

        Drs. Maclaren and Bercu both opined that there is no good reason to believe that Petitioner’s
MMR vaccination played a role in causing her diabetes. The chief reason for their position is their
assertion that the process of destruction of islet cells in Type 1 diabetes by necessity takes a lengthy
period, at least a year or more likely years; therefore, since Petitioner’s diabetes symptoms began only
one to two months after her MMR vaccination, that vaccination could not possibly have been a cause
of her diabetes. (Ex. A, pp. 3, 7; Ex. D, p. 3; Tr. 118, 129, 131, 139-40, 152, 163-64, 169.)

        Secondly, Respondent’s experts rely heavily on the fact that many studies have been done on
the issue of whether vaccines can cause autoimmune disease in general, or Type 1 diabetes in
particular, and such studies have failed to find any association between any vaccines and any
autoimmune disease, much less Type 1 diabetes. (Ex. A, pp. 3-4; Ex. D, p. 3; Ex. G, p. 2; Tr. 112-13,
132, 191.)



                                                     11
                                                    VI

                                   SUMMARY OF MY ANALYSIS

        After fully considering the record, I conclude that Petitioner has failed to demonstrate that it is
“more probable than not” that Petitioner’s MMR inoculation of January 26, 2006, played any role in
causing her Type 1 Diabetes. The shortest summary of my reasoning is that I find the testimony of
Respondent’s experts to be substantially more persuasive than that of Petitioner’s expert, as well as
better supported by the filed medical articles.

       More specifically, there are many different factors leading to my conclusion. First, I find that
the most persuasive point in the record is the Respondent’s argument that in Type 1 diabetes it takes a
lengthy period, usually years, for the destruction of enough islet cells in the pancreas to produce
noticeable symptoms. Thus, since Petitioner’s diabetes symptoms began only one to two months post-
vaccine, it is not credible that the Petitioner’s diabetes was caused by her MMR vaccination. (See
Section VII of this Decision below.)

       Second, there were many flaws in Dr. Shoenfeld’s testimony, which made his opinion
unpersuasive in general. (See Section VIII of this Decision, below.)

        Third, the record of this case demonstrates that many studies have been done seeking evidence
of an association between vaccinations and autoimmune diseases, yet all of the credible studies have
failed to find any association. (See Section IX of this Decision below.)

        Fourth, committees of the prestigious Institute of Medicine have on several occasions studied
the issue of whether vaccines can cause Type 1 diabetes, and concluded ultimately that the medical
evidence preponderates against the proposition that there is a causal connection between the MMR
vaccine and Type 1 diabetes. (See Section X of this Decision below.)

       Fifth, there are a number of other reasons to reject Petitioner’s causation claim in this case.
(See Section XI of this Decision below.)

       Sixth, the Petitioner’s case clearly fails the Althen test. (See Section XII of this Decision
below.)

                                                    VII

          TYPE 1 DIABETES REQUIRES YEARS OF ISLET CELL DESTRUCTION
                            TO PRODUCE SYMPTOMS

         Respondent’s experts, Drs. Maclaren and Bercu, both stressed that the process of destruction of
islet cells in Type 1 diabetes by necessity takes a considerable period of time, usually years, before
diabetes symptoms occur; therefore, since Petitioner’s diabetes symptoms began only one to two
months after her MMR vaccination, that vaccination could not possibly have been a cause of her
diabetes. (Ex. A, pp. 3, 7; Ex. C, p. 1; Ex. D, p. 3; Tr. 118, 129, 131, 139-40, 152, 163-64, 169, 191.)
                                                     12
        I found this argument to be the most persuasive item of evidence in this case. This is
particularly true since Dr. Maclaren has exceptional qualifications in the specific area of Type 1
diabetes. As Dr. Maclaren testified, in his 50-year medical career he has spent most of his time in
academic pursuits, especially in the field of Type 1 diabetes. (Tr. 108.) He has studied that particular
disease for three decades. (Id.) In his clinical practice, Dr. Maclaren has seen about 20,000 patients
who suffer from diabetes, about 25% of which had Type 1 diabetes. (Tr. 116.) Further, Dr. Maclaren
has participated in a number of studies concerning Type 1 diabetes, and published numerous articles
concerning that condition. (Ex. D, p. 1; Ex. E, pp. 8-28.) Therefore, Dr. Maclaren’s testimony, that
Type 1 diabetes necessarily requires a year-long or longer period of islet cell destruction prior to the
onset of symptoms, is very persuasive.

        To be sure, Dr. Shoenfeld for the Petitioner also has a very impressive overall medical
background, as set forth in detail above. Moreover, Dr. Shoenfeld has tremendous experience with
autoimmune disease in general, which is certainly quite relevant to this case. However, Dr. Shoenfeld
clearly does not have the type of specialized knowledge of Type 1 diabetes itself that makes
Dr. Maclaren’s testimony so credible.

        Moreover, the testimony of Drs. Maclaren and Bercu in this regard was well supported by their
citation of studies and medical articles filed in this case. For example, Dr. Maclaren explained that
careful studies have been made of people with Type 1 diabetes in their families. Such studies have
shown that in individuals who ultimately exhibit Type 1 diabetes, there was actually a years-long
process of islet cell destruction before diabetes symptoms began. (Ex. D, pp. 2-3; Tr. 121-22, 129.)
Further, a medical text excerpt filed into the record in this case confirms that when adults exhibit Type
1 diabetes, the process of islet cell destruction has typically taken years before clinical symptoms
manifest. (Ex. B, filed 8-21-09; p. 333.)

        To be sure, Dr. Shoenfeld did testify emphatically that an MMR vaccination could cause the
onset of Type 1 diabetes symptoms only one to two months post-vaccine. In this regard, he stressed
the fact that since this was not Petitioner’s first MMR vaccination, her prior vaccination would have
primed her immune system to a faster reaction to the vaccination than would be the case with a first
vaccination (which faster response he termed a “memory” response or an “anamnestic” response).
(E.g., Tr. 45-47, 72-74; see also the unnumbered report filed by Dr. Shoenfeld on July 6, 2009 as ECF
11.) But Dr. Shoenfeld did not coherently explain why or how an “anamnestic” response could result
in symptoms of Type 1 diabetes appearing without a year or more of preceding islet cell destruction.
Does a second MMR vaccination actually cause the body’s immune system to react more than a year
sooner than would be the case after a first MMR vaccination? Dr. Shoenfeld did not explain. And
Drs. Maclaren and Bercu were persuasive in their testimony that there is no reason to believe that the
mere fact of a second vaccination could cause symptoms of Type 1 diabetes without a year-long (or
longer) process of islet cell destruction. (E.g., Tr. 129, 131-32, 139-40, 168.)

        Further, Dr. Shoenfeld noted that certain blood tests done on Petitioner prior to her vaccination
appeared normal, and argued that these results meant that at that time of those tests Petitioner could not
have been undergoing an ongoing process of pancreas islet cell destruction, as Drs. Maclaren and
Bercu theorize. (E.g., Tr. 24.) However, Dr. Maclaren answered that the type of pre-vaccination blood
test results to which Dr. Shoenfeld points do not mean that Petitioner was not already experiencing islet
cell destruction at the time of the tests. Dr. Maclaren explained that those particular tests can yield
                                                   13
inaccurate results. (Tr. 124-25, 142-43.) Further, he stressed that the type of test which would have
been the best at identifying whether a cell destruction process was underway--i.e., a hemoglobin A1c
test (also described as “HbA1c” test--Ex. D, p. 2)--was not performed on Petitioner prior to her
vaccination. (Ex. D, p. 2; Tr. 125-29.) Further, when such test was actually performed after
Petitioner’s clinical diabetes symptoms appeared, the results of that hemoglobin A1c test were so high
that it indicated that the islet cell destruction must have been going for a long time, prior to the
vaccination in question. (Tr. 125-26, 129 lines 5-12. 11) Dr. Shoenfeld did not effectively refute this
testimony of Dr. Maclaren, the expert in Type 1 diabetes.

        In sum, the most important reason that I must reject Dr. Shoenfeld’s theory is his failure to get
around the problem that it is not credible that islet cell destruction in Petitioner’s pancreas could be
initiated by her MMR vaccination, then cause symptoms within a period of only one to two months.

                                                            VIII

              DR. SHOENFELD’S OPINION WAS POORLY EXPLAINED, FLAWED,
                          AND UNPERSUASIVE ON ITS FACE

        A second important reason for my conclusion is that Dr. Shoenfeld failed to explain his
causation theory well, and his attempted explanations simply left me unpersuaded. Unlike
respondent’s experts, he was often unable to cogently respond to questions about his causation theory.
He failed to cite any support in medical literature for many parts of his testimony. At times he seemed
to acknowledge that his theory in this case amounted to mere speculation. At other times, he seemed to
contradict himself, or to, in effect, offer more than one possible theory of causation, without explaining
which approach seemed persuasive to himself. Further, at times he seemed to suggest that any type of
vaccination can cause any type of autoimmune disease, with the time of onset at any interval after
vaccination being acceptable.

        I will start with Dr. Shoenfeld’s statements described in my previous sentence. For example, at
one time, he stated that any vaccination that contains an “adjuvant,” 12 which would seem to describe a
great many types of vaccinations, “can cause any autoimmune disease.” (Tr. 75, lines 16-17.) At
another time, he stated that “it’s very reasonable that * * * every vaccine can induce any autoimmune
disease.” (Tr. 85, lines 15-17, emphasis added.) These statements may well set up Dr. Shoenfeld to
act as a paid expert in any Vaccine Act case involving an autoimmune disease, but they do not inspire
confidence in me that he can reasonably say in any particular case that causation was “more probable
than not.”

       As another example of the general lack of persuasiveness of Dr. Shoenfeld’s testimony, at times
he acknowledged that his causation theory in this case amounts to mere speculation. When asked to
summarize his opinion, he acknowledged that his theory was “in the way of speculation.” (Tr. 54, lines
9-10.) He later said that he would “like to speculate” that Petitioner would not have developed
diabetes but for the vaccination. (Tr. 55, lines 1-6.) And after reading his reports and listening to his

11
         At p. 126, line 12 of the transcript, it appears that Dr. Maclaren’s mention of the “A1c” test was mistranscribed as
“A13.”
12
         See discussion of “adjuvants” at p. 22 below.
                                                             14
entire hearing testimony, it strikes me, as well, that Dr. Shoenfeld’s opinion amounts to no more than
mere “speculation.”

        Another example of the dubious overall nature of Dr. Shoenfeld’s presentation is his assertion
that “molecular mimicry” was the most likely mechanism 13 by which the vaccination instigated
Petitioner’s Type 1 diabetes. (E.g., Tr. 32, 48-49.) As noted above, in molecular mimicry, a body part
has a similar molecular structure to an invasive agent that the immune system has been programmed to
attack, so that the immune system, mistaking the body part for the invasive agent, mistakenly attacks
that body part. In Petitioner’s case, it is the Petitioner’s pancreas islet cells that have been attacked by
her immune system, and Dr. Shoenfeld speculates that there are molecular “similarities” between the
“viral particles” of the MMR vaccine and the “pancreatic structure,” thus prompting Petitioner’s
autoimmune system to mistakenly attack the islet cells. (Tr. 32, lines 21-24.)

        To be sure, the general concept of molecular mimicry, as an explanation for autoimmune
attacks, is a well-established concept. As Dr. Shoenfeld pointed out, there have been many articles
noting molecular mimicry as a potential cause of various autoimmune diseases. (Tr. 48-49.)
Respondent’s experts did not take issue with the general concept of molecular mimicry as a possible
explanation for autoimmune disease. (E.g., Tr. 168.)

        However, Dr. Shoenfeld never explained why there is good reason to point to molecular
mimicry in this case. That is, he never explained why he believes that there are molecular
“similarities” between Petitioner’s islet cells and any “particles” in the MMR vaccine. (See Tr. 32,
lines 21-24.) Dr. Shoenfeld indicated in a different autoimmune disease that he studied, he suspected a
process of molecular mimicry precisely because he had found in patients “the same sequence of amino
acids” in both the suspected invasive agent and in the attacked body parts. (Tr. 49, lines 11-14.) But
as to his allegation of potential similarities between MMR vaccine “particles” and Petitioner’s islet
cells, Dr. Shoenfeld did not point to any identical or similar sequences of amino acids.

        Dr. Maclaren, the Type 1 diabetes expert, on the other hand, testified that he was unaware of
any molecular similarities between the MMR vaccine parts and the islet cells that are actually attacked
by the immune system in Type 1 diabetes. (Tr. 139.) Dr. Bercu also noted that there is “absolutely no
evidence” that molecular mimicry plays a role in the particular autoimmune disease from which
Petitioner suffers, Type 1 diabetes. (Tr. 168-69.) Dr. Bercu opined that Dr. Shoenfeld’s assertion that
molecular mimicry can be the cause of Type 1 diabetes amounts to mere “speculation.” (Tr. 168, line
21.)

       In short, I found many flaws in Dr. Shoenfeld’s general presentation, too numerous to discuss
here. Some of those deficiencies have been described above, and some will be described below. In

13
           In his first written report, Dr. Shoenfeld admitted that he did not know the exact method by which the MMR
vaccine caused Petitioner’s diabetes, but indicated that it could be any one of four mechanisms. (Ex. 1, pp. 7-9.) Those
four mechanisms included “molecular mimicry,” plus “polyclonal activation,” “tissue damage,” and “bystander activation.”
(Id.) During his hearing testimony, however, Dr. Shoenfeld appeared to focus exclusively on “molecular mimicry,”
discussed above at p. 15 of this Decision, and did not present any detailed discussion concerning the other potential
mechanisms mentioned at page 8 of Ex. 1. I find that Dr. Shoenfeld did not make a persuasive presentation concerning any
of his proposed mechanisms. (Dr. Shoenfeld also suggested in passing that “the rubella can cause diabetes mellitus” (Tr.
32, lines 12-13), but the next two lines of his testimony demonstrate that he was referring to “congenital rubella syndrome,”
i.e., infection of a fetus by rubella in utero, a syndrome that of course did not happen in this case.)
                                                                 15
general, I simply did not find Dr. Shoenfeld’s presentation in this case to be persuasive, while I found
that the contrary arguments of Drs. Maclaren and Bercu were convincing.

                                                              IX

         THE EPIDEMIOLOGICAL STUDIES OFFER SUPPORT TO RESPONDENT’S
                  EXPERTS RATHER THAN PETITIONER’S EXPERT

       The Vaccine Act case law makes it clear that in order to show causation under the Act’s “more
probable than not” standard, a petitioner need not supply epidemiologic or other medical literature
supporting causation. (See, e.g., Capizzano v. HHS, 440 F.3d 1317, 1325 (Fed. Cir. 2006); Andreu v.
HHS, 569 F.3d 1367, 1378 (Fed. Cir. 2009).) However, when epidemiologic literature concerning the
vaccine in question is placed into the record of the case, the special master may give such literature
weight, as appropriate, if such literature either offers support for, or tends to contradict, the petitioner’s
causation theory. (See, e.g., Taylor v. HHS, 108 Fed. Cl. 807, 819-21 (Fed. Cl. 2013) (the special
master did not err in considering epidemiological evidence); Andreu v. HHS, 569 F.3d 1367, 1379
(Fed. Cir. 2009) (a special master may assess epidemiological evidence in “reaching an informed
judgment as to whether a particular vaccination likely caused a particular injury”).)

        In this case, a number of epidemiological studies have specifically looked at the issue of
whether vaccines, including the MMR vaccine, are associated 14 with Type 1 diabetes. The experts in
this case have discussed those studies, and medical articles describing such studies have been filed into
the record of this case. After carefully reviewing those medical articles and the expert testimony
relevant to them, I conclude that all of the large reliable studies have found no association between any
vaccine and Type 1 diabetes. I conclude that as a whole those studies offer support to the opinions of
respondent’s experts, not to the opinion of petitioner’s expert.

        First, Dr. Maclaren explained that a succession of very large studies conducted internationally
have all failed to find any association between vaccines and Type 1 diabetes. (Ex. D, p. 3; Tr. 113,
lines 23-25.) He stated that there have been at least 20 such studies that looked for, but failed to find,
an association between vaccines and Type 1 diabetes. (Tr. 132-33.) Dr. Maclaren in his expert report
cited several such studies, pointing to articles describing those studies by DeStefano (2001), Hviid
(2004 and 2006), and Hyoty (1993). 15 (Ex. G, pp. 4-5.)

       Dr. Bercu also reviewed the relevant medical literature and, like Dr. Maclaren, explained that
many large epidemiological studies have failed to find any association between any vaccine and Type 1
diabetes. (Ex. A, pp. 3-4; Tr. 163.) Dr. Bercu pointed to articles describing several different studies in


14
         Technically, epidemiological studies do not address the question of whether Factor A “causes” Condition B, but
instead whether the two are “associated.” Two factors are said to be “associated” if they occur together more often than
would be expected by chance. (Dorland’s Illustrated Medical Dictionary (32nd ed. 2012), p. 167.) If an “association” is
found, then medical experts will evaluate other factors to determine if that association is “causal.” But if no association is
found, then that result casts doubt on (though does not entirely disprove) the proposition that Factor A is a significant cause
of Condition B.
15
         See Exs. P, Q, R, and S, filed August 4, 2011.

                                                              16
this regard, including Blom 1991, Graves 1999, Halsey 1999, the EURODIAB study 2000, Hummel
2000, DeStefano 2001, Hviid 2004, and Zingg 2005. 16 (Ex. A, p. 4.)

        Further, Dr. Maclaren specifically discussed some of the studies in this regard. He pointed, for
example, to a large study performed by the U.S. Centers for Disease Control (“CDC”) that looked at
whether a number of different vaccinations are associated with Type 1 diabetes, and found no
association between any vaccine and Type 1 diabetes. (Tr. 112-13.) An article describing that study
by DeStefano and colleagues is filed into the record of this case as Ex. I. (Filed 8-21-09.) That article
indicates that one of the vaccines involved in that large CDC study was in fact the MMR vaccine, and
no association between the MMR vaccine and Type 1 diabetes was found. (Ex. I, p. 3.)

       Dr. Maclaren also described another huge study that followed more than 5.5 million doses of
MMR vaccine administered in Germany between 1978 and 1989. (Ex. 73, p. 1; Ex. G, p. 2.) That
study again found no association between MMR vaccination and Type 1 diabetes. (Ex. 73, pp. 7, 9;
Ex. G, p. 2.) Instead, the study found fewer cases of the onset of diabetes within 30 days after
vaccination than would be expected by chance alone. (Ex. G, p. 2.)

        Dr. Bercu further noted that the Hviid 2004 article described a huge study that followed all
children born in Denmark for the full decade of 1990-2000, a total of almost five million “person-
years” of follow-up, but found no increased risk of diabetes associated with any vaccination. (Ex. A, p.
4; Ex. S, filed August 21, 2009.)

        In this regard, there are three articles in the record authored by Dr. John B. Classen, who
suggested, after re-analyzing data from the studies of others, that diabetes can be caused by vaccines,
with symptoms usually appearing two to four years after vaccination. (Exs. E, F, and G, filed on
August 21, 2009.) But Dr. Bercu indicated that the evidence contradicting Dr. Classen’s causation
conclusion was much stronger. (Ex. A, pp. 3-4.) Moreover, petitioner’s own expert, Dr. Shoenfeld,
did not rely on the Classen articles to support his causation theory in this case. This is not surprising,
because Dr. Classen’s conclusion that vaccines can cause diabetes assumes that typically symptoms of
the patient’s diabetes would arise only two-to-four years after vaccination (Ex. E, p. 1), which
obviously contradicts Dr. Shoenfeld’s conclusion in this case that the MMR caused diabetes with
symptoms appearing only one to two months post-vaccination. 17

        To be sure, in response to the reliance of Drs. Maclaren and Bercu on the epidemiological
studies described above, Dr. Shoenfeld supplied an interesting argument. Dr. Shoenfeld noted that
there exists at least some evidence that the mumps virus in its “wild” (“natural”), non-vaccine form,
might cause, or at least trigger the onset of, Type 1 diabetes. 18 He suggested that the wild rubella virus
also might cause diabetes. And he acknowledged that the MMR vaccine, as is its purpose, does reduce

16
         See Exs. C, O, V, L, R, I, S and MM, filed on August 21, 2009.
17
         Petitioner’s counsel discusses Dr. Classsen’s work briefly in his opening post-hearing brief (Brief filed
8-31-11, pp. 36-37.) But counsel, as is typical in his briefs, failed to cite to any page numbers in the Classen articles. Nor
does counsel’s discussion claim that his own expert, Dr. Shoenfeld, relied upon or endorsed the Classen conclusions. In
short, counsel’s brief discussion of the Classen articles was not persuasive, or helpful to Petitioner’s case.
18
         The issue of whether environmental factors, including “wild” mumps infection, can cause Type 1 diabetes, will be
discussed in greater detail below. (See pp. 23-24.)
                                                            17
the incidence of subsequent “wild” mumps or rubella infections in the vaccinated population.
Therefore, he argues, the MMR vaccine’s undoubted protective effect against “wild” mumps and
rubella infection might, in the studies discussed above, be “masking,” or covering up, the actual
causation of Type 1 diabetes in a very few individuals by the MMR vaccine. In other words,
Dr. Shoenfeld does not take issue with the studies’ conclusion that overall, the MMR vaccination does
not raise the risk of Type 1 diabetes in the vaccinated population. He argues rather, that the MMR
vaccination might be causing Type 1 diabetes in a very small number of genetically susceptible
individuals, and yet, because the MMR vaccination does reduce the incidence of Type 1 diabetes in
most of the vaccinated population, by reducing subsequent mumps and rubella infections which might
in turn cause diabetes, the MMR-causation of a small number of cases of diabetes simply would not
show up in the studies. (Ex. 1, pp. 9-10; Tr. 83-84, 90, 100-01.)

       Dr. Shoenfeld’s argument in this one aspect is quite logical. He is likely correct that if the
MMR vaccine causes Type 1 diabetes in only a relatively few genetically-susceptible persons, then
such causation would likely not show up in the epidemiological studies on which the respondent’s
experts rely.

         However, Dr. Shoenfeld’s reasonable logic on that point offers no practical support toward
carrying the Petitioner’s burden in this case. It is, in fact, always true that epidemiological studies can
never prove definitively that Factor A never causes Condition B. Even when large studies fail to
identify an association between Factor A and Condition B, it is always theoretically possible that
Factor A causes Condition B in a very small number of cases, an effect too rare for the study to detect.
But it is not the Respondent’s burden in this case to prove that it is impossible that the MMR
vaccination can cause Type 1 diabetes. It is, rather, the Petitioner’s burden to show not only that the
MMR vaccine can cause Type 1 diabetes (Althen Prong 1, see p. 25 below), but also that her own
MMR vaccination did cause Petitioner’s Type 1 diabetes (Althen Prong 2, see p. 25 below). And,
therefore, the epidemiological studies cited in this case, including Dr. Classen’s articles, clearly do not
help Petitioner carry her burden. As Dr. Shoenfeld argues, the studies, like all epidemiological studies,
do not prove that the MMR vaccine can never cause Type 1 diabetes. But they offer no support at all
to Petitioner in carrying her burden of showing that the MMR vaccine can cause Type 1 diabetes. To
the contrary, because so many studies have looked for an association between vaccines (including
MMR vaccines) and Type 1 diabetes, and failed to find any association, then on an overall basis, the
existence of the many studies offers at least some support for the argument that it is unlikely that the
MMR vaccine causes Type 1 diabetes.

                                                    X

         THE IOM REPORTS ADD SUPPORT TO MY CONCLUSION IN THIS CASE

        The record of this case prior to the evidentiary hearing contained a report of a committee of the
Institute of Medicine (“IOM”), which addressed the issue of whether Type 1 diabetes can be caused by
vaccines in general. That IOM committee, in 2002, concluded that “the epidemiological literature
favors rejection of a causal relationship between multiple immunizations and [an increased risk of]
type 1 diabetes.” (Ex. U, filed 8-21-09, p. 110, emphasis added.) The conclusion of that committee of
the prestigious IOM was in the record of this case as of the time of the evidentiary hearing in this case
on March 30, 2011, and, of course, offers at least some support to the position of the Respondent in this
case.
                                                    18
       Respondent’s Post-Hearing Memorandum, filed on October 31, 2011, noted the publication of a
new report by the Institute of Medicine that was not available at the time of the hearing in this case.
(See Resp. Post-Hearing Memo, p. 11.) Respondent argued that this new IOM report should be
included in the record of this case because it examined the possibility of a causal relationship between
the MMR vaccine in particular and Type 1 diabetes. On January 31, 2012, respondent filed a motion to
introduce that IOM report, with a copy of the relevant portion attached, labeled as Ex. NNN. 19 On
February 13, 2012, petitioner filed an “Objection” to the inclusion of Exhibit NNN in the record. On
May 14, 2012, I filed an abbreviated Ruling, allowing Exhibit NNN to be considered as part of the
evidentiary record, and indicating that a detailed opinion explaining the reasons would follow. The
paragraphs below discuss the reasons why it is appropriate to consider the IOM report within the
context of this case.

        The Institute of Medicine is the medical arm of the National Academy of Sciences. The
National Academy of Sciences (“NAS”) was created by Congress in 1863 to be an advisor to the
federal government on scientific and technical matters (see An Act to Incorporate the National
Academy of Sciences, ch. 111, 12 Stat. 806 (1863)), and the Institute of Medicine is an offshoot of the
NAS established in 1970 to provide advice concerning medical issues. When it enacted the Vaccine
Act in 1986, Congress specifically directed that the IOM conduct studies concerning potential causal
relationships between vaccines and illnesses. See § 300aa–1 note.

        [T]he Vaccine Act establishes a broad program to study and reduce the risk of
        childhood vaccines. See, e.g., National Childhood Vaccine Injury Act of 1986, Pub.L.
        No. 99–660, §§ 312(a)-(d), 313(a), 1986 U.S.C.C.A.N. (100 Stat.) 3755, 3779–82
        (directing the Secretary to request that the Institute of Medicine of the National
        Academy of Sciences conduct studies exploring the link between childhood vaccines
        with certain illnesses). Congress clearly intended the Secretary to be guided by the
        findings from such studies when she decides to promulgate regulations to revise the
        injury table. See id. § 312(c)-(d), 100 Stat. at 3780; 42 U.S.C. § 300aa–14(d) (1994).

Terran v. HHS, 195 F.3d 1302, 1315 (Fed. Cir. 1999). Such studies have been used frequently to
guide the United States Department of Health and Human Services regarding the identification of
vaccine-related injuries in Vaccine Act regulations. See, e.g., Hanlon v. HHS, 191 F.3d 1344, 1348 n. 1
(Fed. Cir. 1999) (discussing substantive revisions of the Vaccine Injury Table that were based on
reports by the IOM); Loving v. HHS, 86 Fed. Cl. 135, 142 (Fed. Cl. 2009).

        During the 25-year history of the Vaccine Act, special masters have consistently relied upon the
reports of the Institute of Medicine, and reviewing judges have consistently indicated approval of such
reliance. E.g., Isaac v. HHS, 108 Fed. Cl. 743, 755 (2013), aff’d, 2013 WL 5952008 (Fed. Cir. Nov 8,
2013) (affirming the special master’s reliance on findings of the IOM); Porter v. HHS, 663 F.3d 1242,
1252 (Fed. Cir. 2011)(noting the special master’s comment that “IOM reports are favored, although not
dispositive, in the Vaccine Act Program,” then affirming the special master’s decision); Cedillo v.
HHS, No. 98-916V, 2010 WL 331968, at *94 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 89 Fed. Cl.
19
       Exhibit NNN: excerpts from Kathleen Stratton, et al., Institute of Medicine, Adverse Effects of Vaccines: Evidence
and Causality (National Academy Press, Prepublication ed. 2011). (The final edition of that report was published in 2012.)


                                                            19
158 (Fed. Cl. 2009) (affirming special master’s reliance on conclusions of IOM), aff’d, 617 F.3d 1328
(Fed. Cir. 2010); Rodriguez v. HHS, 67 Fed. Cl. 409, 410 (Fed. Cl. 2005) (relying on IOM report
regarding vaccine causation of an injury); Althen v. HHS, No. 00-170V, 2003 WL 21439669, *11, n.
28 (Fed. Cl. Spec. Mstr. 2003) (“Due to the IOM’s statutory charge, the scope of its review, and the
cross-section of experts making up the committee reviewing the adverse events associated with
vaccines, the court considers their determinations authoritative and subject to great deference.”), rev’d
on other grounds, 58 Fed. Cl. 270, 272-74 (Fed. Cl. 2003)(citing IOM reports frequently in support of
various scientific propositions), aff’d, 418 F.3d 1274 (Fed. Cir. 2005); Terran v. HHS, 41 Fed. Cl. 330,
337 (1998)(affirming special master's reliance on conclusions of IOM), aff'd, 195 F.3d 1302 (Fed.
Cir.1999), cert. denied, 531 U.S. 812 (2000); Cucuras v. HHS, 993 F.2d 1525, 1529 (Fed. Cir. 1993)
(noting that the special master had placed “a great deal of weight” on an IOM report in reaching a
decision, then affirming the special master’s decision); Stroud v. HHS, 113 F.3d 1258 (Fed.Cir.
1997)(unpublished)(special master may rely upon an IOM report that neither party filed as evidence);
Ultimo v. HHS, 28 Fed. Cl. 148, 152 (1993) (proper for a special master to rely on IOM report);
Manville v. HHS, 63 Fed. Cl. 482, 491 (2004) (same); Ryman v. HHS, 65 Fed. Cl. 35, 39 (2005)
(same); Capizzano v. HHS, No. 00–759V, 2004 WL 1399178 at *2, n. 6 (Fed. Cl. Spec. Mstr. June 8,
2004) (“Considering the IOM's statutory charge, the scope of its review, and the cross-section of
experts making up the committee, the special masters have consistently accorded great weight to the
IOM's findings.”), rev'd on other grounds, 440 F.3d 1317 (Fed. Cir. 2006); Larive v. HHS, No. 99-
429V, 2004 WL 1212142, *11 (Fed. Cl. Spec. Mstr. May 12, 2004); Falksen v. HHS, No. 01–317V,
2004 WL 785056 at *13 (Fed. Cl. Spec. Mstr. Mar. 30, 2004) (“[T]he Court gives great deference to
the findings of the Institute of Medicine on the issue of cause and effect between vaccines and discrete
injuries.”); King v. HHS, No. 03-584V, 2010 WL 892296 at *76 (Fed. Cl. Spec. Mstr. Mar. 12, 2010);
Kelley v. HHS, 68 Fed. Cl. 84, 91, n. 11 (Fed. Cl. 2005); Doe v. HHS, 2004 WL 3321302 at *24 (Fed.
Cl. Spec. Mstr. Oct. 5, 2004) (special masters frequently rely on IOM conclusions to answer questions
about plausibility and causation); Kuperas v. HHS, No. 01-60V, 2003 WL 2292885 at *9, n. 25 (Fed.
Cl. Spec. Mstr. Oct. 23, 2003); Malloy v. HHS, No. 99–193V, 2003 WL 22424968 at *15 (Fed. Cl.
Spec. Mstr. Aug. 6, 2003); Watson v. HHS, No. 96-639V, 2001 WL 1682537 at *5, n. 11 (Fed. Cl.
Spec. Mstr. Dec. 18, 2001); Hill v. HHS, No. 96–783, 2001 WL 166639 at *3, n. 2 (Fed. Cl. Spec.
Mstr. Jan. 29, 2001); Salmond v. HHS, No. 91-123V, 1999 WL 778528 at *5 (Fed. Cl. Spec. Mstr.
Sept. 16, 1999); Castillo v. HHS, No. 95–652V, 1999 WL 605690 at *11 (Fed. Cl. Spec. Mstr. July 19,
1999); Ashe Robinson v. HHS, No. 94–1096V, 1998 WL 994191 at *7, n. 8 (Fed. Cl. Spec. Mstr.
Dec. 22, 1998); Cohen v. HHS, No. 94–353V, 1998 WL 408784 at *8 (Fed. Cl. Spec. Mstr. July 1,
1998); Schell v. HHS, No. 90–3243V, 1994 WL 71254 at *5 (Fed. Cl. Spec. Mstr. Feb. 22, 1994);
Aldridge v. HHS, No. 90–2475V, 1992 WL 153770 at *2, n.12 (Cl. Ct. Spec. Mstr. June 11, 1992);
Woodcock v. HHS, No. 90–1030V, 1992 WL 92169 at *11, n. 50 (Cl. Ct. Spec. Mstr. Apr. 10, 1992).

        It is notable that the particular IOM report filed post-hearing in this case has been considered in
a previous case in which a special master relied on that report in concluding that the testimony of a
petitioner’s medical expert was unreliable. Upon review, the presiding judge, after specifically noting
such reliance, affirmed the special master’s decision, and that ruling was also affirmed. Isaac v. HHS,
108 Fed. Cl. 743, 779 (2013), aff’d, 540 Fed. App’x 999 (Fed. Cir. 2013).

        The admission of evidence during a Vaccine Act proceeding is governed by Vaccine Rule 8. 20
The critical factors to be considered are the relevance and reliability of the evidence in question. In

20
     Vaccine Rule 8 Taking Evidence; Hearing Argument
                                                        20
this case, Petitioner agrees that the contested IOM report is relevant, but argues that it is not dispositive
of the causation issue. (See Petitioner’s Objection, February 13, 2012, p. 2.) Since Exhibit NNN
contains an excerpt of the IOM report that addresses the possibility of a causal relationship between the
MMR vaccine in particular and Type 1 diabetes, that discussion is directly relevant to the issue in this
case. Based on the Congressional direction that the IOM provide reports for use in Vaccine Act cases,
as well as the history of Vaccine Act decisions in which special masters have relied on the findings of
IOM reports, I conclude that evidence from IOM reports should be considered when relevant.
Therefore, pursuant to Vaccine Rule 8, I have chosen to admit the contested IOM report into evidence
and consider it carefully, since the report is both relevant and reliable. Stroud v. HHS, 113 F.3d 1258
(Fed. Cir. 1997)(unpublished) (“The special master determines what constitutes the record, and there is
nothing to preclude the special master from including in the record evidence that is relevant and
reliable. In the proceedings before the Court of Federal Claims, that court concluded that petitioner
failed to discredit the IOM report or explain how it was misconstrued or misapplied. We find no error
in that determination.”)

         In reaching this conclusion, I note that in most circumstances, I would not permit the
Respondent to introduce new evidence after the evidentiary hearing in a case, although in a few cases I
have permitted a petitioner to do so. However, the circumstances here are unusual. As noted above,
Congress has specifically directed the IOM provide such reports, concerning whether vaccines can
cause injury. And here, an IOM committee had just issued a new report, after the hearing in this case,
concerning the exact causation issue pending before me in this case. I concluded that the best course
was to heed the direction of Congress, and consider the new IOM report in deciding the case. I
therefore gave the Petitioner’s expert the chance to file a new expert report addressing the new IOM
report, and gave Petitioner’s counsel the opportunity to address the report in the final brief filed in this
case, filed on April 18, 2013.

         I have considered the arguments concerning the new IOM report raised by Dr. Shoenfeld in his
post-hearing expert report (Ex. 84) and in Petitioner’s final brief (filed 4-8-13). Dr. Shoenfeld argued
that I should disregard the new IOM report because in his view IOM reports are typically “not based
upon science but [are issued] * * * largely due to political considerations.” (Ex. 84, p. 2.) Dr.
Shoenfeld also made the same point that I discussed above at pp. 17-18, relating to reasons for caution
in interpreting the epidemiological studies upon which the IOM committee relied. (Id., p. 3.)
Petitioner’s final brief then simply quoted Dr. Shoenfeld. (Brief filed 4-8-13, p. 2.)

        However, neither Dr. Shoenfeld nor Petitioner’s counsel has persuaded me to simply ignore the
IOM report’s conclusion. A committee of highly qualified experts has reviewed all of the available
evidence, and explicitly stated a firm negative conclusion on the exact “general causation” issue that I
face in this case, i.e., whether the MMR vaccination causes Type 1 diabetes. I would be remiss in my
duty if I chose to disregard this important item of evidence. I find that this new IOM report adds
another significant item of evidence that supports my decision to reject Petitioner’s causation claim in
this case.


  a) In General. The special master will determine the format for taking evidence and hearing argument based on
     the specific circumstances of each case and after consultation with the parties.
  b) Evidence.
      1) Rules. In receiving evidence , the special master will not be bound by common law or statutory rules of
        evidence but must consider all relevant and reliable evidence governed by principles of fairness to both parties.
                                                             21
       I do also stress, however, that the existence of this new IOM report was not a crucial item of
evidence in this case. For all of the reasons set forth in Sections VI, VII, VIII, IX, XI, and XII of this
Decision, my ruling would have been exactly the same even if no IOM report existed.

                                                          XI

                                          ADDITIONAL ANALYSIS

        There are a few additional points worthy of brief discussion.

A. Dr. Shoenfeld’s testimony concerning “adjuvants” and “ASIA Syndrome”

        Another factor that contributed to the unpersuasive nature of Dr. Shoenfeld’s presentation is the
fact that at various times in his presentation, he mentioned a number of points that he seemed to present
as support for his causation opinion in this case, but which he (1) never developed, (2) never explained,
(3) never offered evidence for, (4) never fit within his general causation theory, and/or (5) eventually
retracted.

        For example, at various times, Dr. Shoenfeld seemed to suggest that the MMR vaccine contains
one or more “adjuvants,” 21 and that such factor supports his theory that the MMR vaccination
instigated a very rapid autoimmune process of islet cell destruction in Petitioner. (Ex. 1, p. 9; Tr. 33-
36, 54, 82.) But Dr. Shoenfeld did not explain with any clarity how the supposed existence of
adjuvants in the MMR vaccine makes it likely that the vaccine instigated Petitioner’s diabetes.
Moreover, in his post-hearing expert report, which was supposed to address the post-hearing IOM
report, Dr. Shoenfeld finally admitted that there are no adjuvants in the MMR vaccine. (Ex. 84, p. 3.)

        And to add further confusion to this very confused portion of Dr. Shoenfeld’s presentation,
Petitioner’s counsel in his main post-hearing brief (filed on 8-31-11) refers to the alleged adjuvants in
the MMR vaccine as “adjuvinants” (pp. 16-17), and does not seem to have noticed that Dr. Shoenfeld
in his post-hearing expert report apparently retracted the “adjuvant” part of his theory, since
Dr. Shoenfeld there admitted that there are no adjuvants in the MMR vaccine. (Ex. 84, p. 3.)

       In any event, this part of Dr. Shoenfeld’s testimony, in which he pointed to alleged adjuvants in
the MMR vaccine as support for his theory, underlines the disjointed and confused nature of his overall
testimony, and adds yet more reason to doubt the validity of Dr. Shoenfeld’s testimony.

        Similarly, in his hearing testimony and in his post-hearing expert report, Dr. Shoenfeld referred
to an apparent theory of his about an alleged entity that he called “ASIA Syndrome”--he described
“ASIA” as an acronym for “autoimmune syndrome induced by adjuvants.” (Tr. 37, 83-84; Ex. 84, p.
1.) He seemed to offer his “ASIA Syndrome” theory in support of his causation opinion. But the
“ASIA syndrome” would seem to have no application to this case in light of his above-described post-
hearing acknowledgement that there are no adjuvants in the MMR vaccine. And once again,
Dr. Shoenfeld seemed to just haphazardly throw the references to “ASIA syndrome” into his


21
        An “adjuvant” is an extra ingredient added to some immunizations in order to prompt an enhanced reaction from
the immune system. (Tr. 33.)
                                                           22
presentation as an afterthought, without any coherent explanation of how the alleged syndrome fit into
his overall causation theory.

        There were a number of other instances in which Dr. Shoenfeld seemed to randomly throw
concepts, allegations, or ideas into his presentation, without explaining them clearly or fitting them into
his causation theory. These instances are too numerous to enumerate here, so I will just say that I
found no persuasive value in any of these references or suggestions.

B. Allegations that other environmental factors have instigated Type 1 diabetes

        Dr. Shoenfeld at many places in his report asserted that a number of other environmental
factors, such as infections, have caused cases of Type 1 diabetes. (E.g., Ex. 1, pp. 6-7, 10-11; Ex. 84,
pp. 1, 4; Tr. 45, 176-85.) For example, Dr. Shoenfeld asserted that the “wild,” natural form of the
mumps virus can cause Type 1 diabetes. (Ex. 84, p. 1; Tr. 45, 176-85.) (An intentionally weakened
(“attenuated”) form of the mumps virus is contained in the MMR vaccine.) (Ex. BB, filed 8-21-09, p.
1.)

        Petitioner also submitted articles in which single cases of Type 1 diabetes appeared after
infection by the wild mumps virus (Exs. 74 and 76), and infection by the cytomegalovirus (Ex. 71).
Dr. Shoenfeld seemed to suggest that because the wild mumps infection and other environmental
factors might cause Type 1 diabetes, then the weakened forms of the mumps, measles, and rubella
viruses contained in the MMR vaccine can cause Type 1 diabetes.

       However, this argument of Dr. Shoenfeld was not persuasive either. For one thing,
Dr. Shoenfeld admitted that he himself in 2002 published an article in which he stated that there was no
good evidence that vaccines cause environmental diseases. (Tr. 186-87.) Then, at the end of the
evidentiary record in this case, Dr. Shoenfeld admitted that the suspicion that the mumps wild virus can
cause Type 1 diabetes “has not been scientifically confirmed.” 22 (Ex. 84, p. 4.)

       Further, single case reports of Disease X occurring after Factor Y, such as Exs. 71, 74, and 76,
do not offer strong evidence that the temporal relationship is a causal one--the temporal relationship
could be pure random chance. 23 (See statement to that effect by Dr. Maclaren at Ex. G, bottom of
page. 2.)

       To be sure, there is some evidence that the wild mumps virus might be capable of instigating
Type1 diabetes, as Dr. Shoenfeld pointed out. But Dr. Bercu noted contrary evidence indicating that
while some viruses can destroy islet cells, the mumps virus has not been shown to do so. (Ex. A, p. 4.)
Moreover, even if there were strong proof that the wild mumps virus could instigate Type 1 diabetes,


22
         Dr. Maclaren also testified that it has not been scientifically established whether the wild mumps infection can
cause diabetes. (Tr. 159-60.)
23
         Petitioner also submitted Ex. 75, a single case report in which, as with Petitioner, symptoms of Type 1 diabetes
appeared soon after a mumps vaccination. But again, as Dr. Maclaren pointed out in response, the above-discussed
epidemiological studies strongly suggest that the occurrence of Type 1 diabetes after a mumps vaccination was likely mere
chance, coincidence. (Ex. G, bottom of p. 2.)

                                                             23
that would not automatically demonstrate that the MMR vaccine, which contains an intentionally
weakened form of the mumps virus, could cause Type 1 diabetes.

         Further, even when Dr. Shoenfeld pointed to evidence potentially linking the wild mumps virus
to Type 1 diabetes, Dr. Shoenfeld did not dispute that after the mumps infections the diabetes seemed
to occur two or more years later, a far cry from the one-to-two month time separation in this case. (Tr.
45.) In this regard, it is true that it is accepted that if an unborn child experiences infection by the
rubella virus while in utero--i.e., “congenital rubella,” Type 1 diabetes can be caused. (Ex. A, p. 7.)
However, Dr. Bercu pointed out that with congenital rubella, the Type 1 diabetes does not appear for
years. 24 (Id.) Dr. Bercu later noted again that after congenital rubella, Type 1 diabetes does not appear
for years, even decades. (Tr. 169.)

       Similarly, Dr. Maclaren acknowledged that he could not say that viral infections can never
cause Type 1 diabetes. He even acknowledged that a case of the wild mumps infection (not mumps
vaccine) might be capable of causing Type 1 diabetes. (Tr. 194-95.) He simply argued that there is no
good reason to believe that the MMR vaccine causes Type 1 diabetes at all, or that it did in Petitioner’s
case.

       In sum, I found that the evidence in this case concerning the possible causation of Type 1
diabetes by a few environmental factors did not add any significant weight to the allegations that the
MMR vaccine can cause Type 1 diabetes.

C. Allegation concerning “factor unrelated”

       In his first post-hearing brief, Petitioner’s counsel argued that “the respondent has not met its
burden of establishing the existence of a factor unrelated.” (Brief filed 8-31-11, p. 50.) Petitioner’s
counsel, however, misstates the applicable law.

        If a petitioner has established a prima facie case that the vaccine contributed to causing the
injury in question, then the burden shifts to the Respondent to show, by a preponderance of the
evidence, that the injury was caused by factors unrelated to the vaccine. 42 U.S.C. § 300aa-
13(a)(1)(B); Shalala v. Whitecotton, 514 U.S. 268, 270-71, 115 S. Ct. 1477, 131 L.Ed.2d 374 (1995)
(“The Secretary of Health and Human Services may rebut a prima facie case by proving that the injury
or death was in fact caused by factors unrelated to the administration of the vaccine* * *. If the
Secretary fails to rebut, the claimant is entitled to compensation” (citation & internal quotation marks
omitted)); De Bazan, 539 F.3d at 1352 (“Once the petitioner has established a prima facie case for
entitlement to compensation and thus met her burden to prove causation-in-fact, the burden shifts to the
government to prove ‘[by] a preponderance of the evidence that the [petitioner’s injury] is due to
factors unrelated to the administration of the vaccine described in the petition.’”) However, if, as in the
case here, a petitioner fails to establish a prima facie case, the burden does not shift. Bradley v. HHS,
991 F.2d 1570, 1575 (Fed. Cir. 1993).


24
          Dr. Bercu acknowledged that there is some evidence that the Coxsackie virus and the rubella wild virus (perhaps a
reference to in utero infection by the rubella wild virus) may also cause Type 1 diabetes. (Ex. A, p. 7.) But he added that
there is no evidentiary support for causation of diabetes by any of the three weakened viruses contained in the MMR
vaccine. (Id.)

                                                            24
        In this case, Petitioner did not come close to establishing a prima facie case, for the reasons set
forth above. Accordingly, the Respondent was not required to demonstrate that Petitioner’s condition
was caused by some specific non-vaccine factor.

                                                    XII

                        PETITIONER’S CASE FAILS THE ALTHEN TEST

       As noted above, in its ruling in Althen, the U.S. Court of Appeals for the Federal Circuit
discussed the Acausation-in-fact@ issue in Vaccine Act cases. The court stated 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. If Althen satisfies this
       burden, she is Aentitled 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 1274, 1278 (Fed. Cir. 2005) (citations omitted). In the pages above, of course, I have
already set forth in detail my analysis in rejecting Petitioner=s Acausation-in-fact@ theory in this case. In
this part of my Decision, then, I will briefly explain how that analysis fits specifically within the three
parts of the Althen test, enumerated in the first sentence of the Althen excerpt set forth above. The
short answer is that I find that Petitioner=s evidence in this case clearly does not satisfy any of the three
parts of the Althen test.

A. Application of Althen Prongs 1 and 2 to this case

        One interpretative issue with the Althen test concerns the relationship between the first two
elements of that test. The first two prongs of the Althen test, as noted above, are that a petitioner must
provide A(1) a medical theory causally connecting the vaccination and the injury,@ and A(2) a logical
sequence of cause and effect showing that the vaccination was the reason for the injury.@ Initially, it is
not absolutely clear how the two prongs differ from each other. That is, on their faces, each of the two
prongs seems to require a demonstration of a Acausal@ connection between Athe vaccination@ and Athe
injury.@ However, a number of Program opinions have concluded that these first two elements reflect
the analytical distinction that has been described as the Acan cause@ vs. Adid cause@ distinction. That is,
in many Program opinions issued prior to Althen involving Acausation-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, No. 01-60V, 2003 WL
22912885, at *8 (Fed. Cl. Spec. Mstr. Oct. 23, 2003); Helms v. HHS, No. 96-518V, 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 Acan cause@ requirement, and Prong 2
of Althen is the Adid 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,
                                                     25
2008). And, most importantly, the Federal Circuit itself confirmed that interpretation in Pafford,
ruling explicitly that the Acan 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 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 the particular
vaccination did cause the particular condition of the vaccinee in question.

        A few decisions of judges and special masters have discussed issues with respect to the precise
interpretation of Prongs 1 and 2 of Althen. E.g., Doe 11, 83 Fed. Cl. at 173-74; Scott v. HHS, 2006 WL
2559776, at *18 (Fed. Cl. Spec. Mstr. Aug. 21, 2006); Nussman v. HHS, 2008 WL 449656, at *12-13
(Fed. Cl. Spec. Mstr. Jan. 31, 2008), aff=d, 83 Fed. Cl. 111 (2008); Fields v. HHS, 2008 WL 2222141,
at *7 n.5 (Fed. Cl. Spec. Mstr. May 14, 2008). However, it is not necessary, in this case, to delve into
any such potential interpretative issues, since under any reasonable interpretation of Althen, the
Petitioner=s causation evidence put forward in this case could not satisfy either of the first two prongs
of the Althen test.

        That is, as set forth in detail above, I have concluded that Petitioner has fallen far short of
demonstrating either that the vaccine can contribute, in general, to the causation of Type 1 diabetes, or
that Petitioner’s own MMR vaccination did cause Petitioner’s own case of Type 1 diabetes. Thus,
Petitioner=s causation arguments in this case would fail under any interpretation of Althen=s Prongs 1
and 2.

        Moreover, there can be no doubt whatsoever that the Althen test ultimately requires that, as an
overall matter, a petitioner must demonstrate that it is Amore 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
Apreponderance of the evidence.@ ' 300aa-13(a)(1)(A). And, whatever is the precise meaning of
Prongs 1 and 2 of Althen, in this case the overall evidence falls far short of demonstrating that it is
Amore probable than not@ that the MMR vaccine contributed to the causation of Petitioner’s Type 1
diabetes.

B. Application of Prong 3 of the Althen test to this case

        Since I have concluded that Petitioner has failed to satisfy either of the first two prongs of
Althen, I need not determine whether Petitioner=s case satisfies the third prong. But in the interest of
completeness, I will add a brief discussion of Prong 3.

        To be sure, one striking aspect of this case is that Petitioner suffered the first symptoms of her
Type 1 diabetes about one-to-two months after her MMR vaccination in question; that temporal
relationship might naturally cause a lay person to consider whether a causal relationship exists.
However, for all of the reasons detailed above, the evidence in this case failed, by a large margin, to
provide any reason to believe that MMR vaccinations can cause a case of Type 1 diabetes in general,
or that Petitioner’s MMR vaccination did cause her own case of diabetes.

         Moreover, as explained above in Section VII of this Decision, the occurrence of Petitioner’s
first diabetes symptoms only about one to two months post-vaccine in fact militates strongly against
                                                      26
Petition on the timeliness issue, since the evidence strongly indicates that whatever caused the Type 1
diabetes, it would take a year or more for the islet cell destruction to proliferate to the point where
symptoms would develop.

C. This is not a close case

        As noted above, in Althen the Federal Circuit indicated that the Vaccine Act involves a Asystem
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. As
set forth in detail in the sections above, I find that the testimony of the Respondent’s experts was much
more persuasive than that of Petitioner’s expert Dr. Shoenfeld, concerning all of the issues raised by
Dr. Shoenfeld’s causation theory. Overall, I found the evidence in this case to be quite one-sided. 25

                                                        XIII

                                                 CONCLUSION

        The record of this case demonstrates plainly that Amy Crutchfield has been through a painful
medical ordeal. She is certainly deserving of great sympathy. Congress, however, designed the
Program to compensate only the individuals whose injuries 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. 26


                                                         /s/ George L. Hastings, Jr.
                                             ____________________________________
                                                         George L. Hastings, Jr.
                                                         Special Master
25
          While it does not constitute “evidence” in this case, it is still noteworthy that in several other Vaccine Act cases
special masters have rejected claims that vaccines caused Type 1 diabetes. Hennessey v. HHS, No. 01–190V, 2009 WL
1709053 (Fed. Cl. Spec. Mstr. May 29, 2009), aff’d 91 Fed. Cl. 126 (Fed. Cl. 2010) (rejecting Dr. Shoenfeld’s theory that
the hepatitis B vaccine caused Type 1 diabetes or aggravated an underlying pre-diabetic condition); Meyers v. HHS, No.
04-1771V, 2006 WL 1593947 (Fed. Cl. Spec. Mstr. May 22, 2006) (petitioner failed to establish a causal link between
DTaP vaccine and Type 1 diabetes); Baker v. HHS, No. 99-653V, 2003 WL 22416622 (Fed. Cl. Spec. Mstr. Sept. 26, 2003)
(rejecting claim that multiple vaccinations caused Type 1 diabetes).

         It is also noteworthy that in a number of other Vaccine Act cases, Dr. Shoenfeld’s theories have been rejected, and
sometimes strongly criticized. See, e.g., Lombardi v. HHS, 656 F.3d 1343, 1355 (Fed. Cir. 2011); Shapiro v. HHS, 105
Fed. Cl. 353, 359-60 (2012) (“Dr. Shoenfeld’s own published work contradicts his theory”); Hennessey v. HHS, 91 Fed. Cl.
126, 135-42 (2010); Hennessey v. HHS, No. 01-190V, 2009 WL 1709053, at *44, *52-*53, *56, * 59 (Fed. Cl. Spec. Mstr.
May 29, 2009) (Dr. Shoenfeld was “tailoring his opinion” and violated the “intellectual rigor” test--id. at *44); John
Doe 54 v. HHS, No. 99-454V, 2009 WL 5196160 (Fed. Cl. Spec. Mstr. Dec. 22, 2009) (Dr. Shoenfeld’s report described as
“misleading,” “unreliable,” and containing “errors”--id. at *22; his opinion was “unpersuasive”--id. at 21, 23); Doe 60 v.
HHS, 2010 WL 1506010 at *25-30 (Fed. Cl. Spec. Mstr. Jan. 29, 2010) (Dr. Shoenfeld took “inconsistent positions” (id. at
*28); was “not persuasive” (id. at 29); and did “stretch well beyond what the facts” indicate—id. at *30), aff’d, 94 Fed. Cl.
597, 618-19 (2010).
26
        In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter judgment
accordingly.
                                                            27
