Crutchfield v. Secretary of Health and Human Services

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. *

*

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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

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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.

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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).

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

accordingly.

27