Long v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 08-792V

(To be published)

*************************

BRIAN LONG and KIMBERLY LONG, *

as parents and natural guardians, on behalf *

of their minor son, BCL, *

*

Petitioners, * Filed: February 9, 2015

*

v. *

*

SECRETARY OF HEALTH AND * Vaccine Act Entitlement;

HUMAN SERVICES * Causation-in-fact; Influenza

* Vaccine/Aggravation of Autism

Respondent. *

*************************

Sheila Bjorklund, Lommen Abdo Law Firm, Minneapolis, MN, for Petitioners.

Justine Daigneault, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION

HASTINGS, Special Master

This is an action in which Petitioners, Brian and Kimberly Long, seek an award under the

National Vaccine Injury Compensation Program (hereinafter “the Program 1), on account of their

son BCL’s autism spectrum disorder (“ASD”), which they believe was significantly aggravated

by his receipt of the influenza (“flu”) vaccine. For the reasons set forth below, I conclude that

Petitioners are not entitled to an award.

1

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

Hereinafter, for ease of citation, all "§" references will be to 42 U.S.C. (2006 ed.). At this time, I may also refer to

the Act of Congress that created the Program or the “Vaccine Act.”

1

I

THE APPLICABLE STATUTORY SCHEME

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 showing that an

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

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

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

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

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

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

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

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

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

unless it is affirmatively shown that the injury was caused by some factor other than the

vaccination. § 300aa-13(a)(1)(A); § 300 aa-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)(B); § 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, or significantly aggravated, 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 1279; Hines, 940 F.2d at 1525. Under that

standard, the petitioner must show that it is “more probable than not” that the vaccination caused

or aggravated 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 or aggravating 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:

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 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 the 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 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 fact-finder 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 fact-finders 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), considered when a 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 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.

3

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 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.

In this case, the Petitioners do not assert that the influenza vaccination of November 21,

2005, initially caused BCL’s autism. Rather, they assert that the vaccination caused a significant

aggravation of BCL’s autism. According to W.C. v. HHS, 704 F.3d 1352 (Fed. Cir. 2013), “the

National Vaccine Injury Compensation Program***allows certain petitioners to be compensated

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

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

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

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

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

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

aggravation’ means any change for the worse in a preexisting condition which results in

markedly greater disability, pain or illness accompanied by substantial deterioration of health.”

§ 300aa-33(4).

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

86 Fed. Cl. 135, 144 (2009). There, the court combined the test from Althen, above, which

defines off-Table causation cases, with the test from Whitecotton v. HHS, 81 F.3d 1099, 1107

(Fed. Cir. 1996), which concerns on-Table significant aggravation cases. The resultant test has

six components, which are:

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

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

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

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

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

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

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

relationship between the vaccination and the significant aggravation.

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

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

aggravation claims”).

4

II

BACKGROUND: THE OMNIBUS AUTISM PROCEEDING (“OAP”)

This case is one of more than 5,400 cases filed under the Program in which petitioners

alleged that conditions known as “autism” or “autism spectrum disorders” (“ASD”) were caused

by one or more vaccinations. A special proceeding known as the Omnibus Autism Proceeding

(“OAP”) was developed to manage these cases within the Office of Special Masters (“OSM”). A

detailed history of the controversy regarding vaccines and autism, along with a history of the

development of the OAP, was set forth in the six entitlement decisions issued by three special

masters as “test cases” for two theories of causation litigated in the OAP (see cases cited below),

and will only be summarized here.

A group called the Petitioners’ Steering Committee (“PSC”) was formed in 2002 by the

many attorneys who represented Vaccine Act petitioners who raised autism-related claims.

About 180 attorneys participated in the PSC. Their responsibility was to develop any available

evidence indicating that vaccines could contribute to causing autism, and eventually present that

evidence in a series of “test cases,” exploring the issue of whether vaccines could cause autism,

and, if so, in what circumstances. Ultimately, the PSC selected groups of attorneys to present

evidence in two different sets of “test cases” during many weeks of trial in 2007 and 2008. In

the six test cases, the PSC presented two separate theories concerning the causation of ASDs.

The first theory alleged that the measles portion of the measles, mumps, rubella (“MMR”)

vaccine could cause ASDs. That theory was presented in three separate Program test cases

during several weeks of trial in 2007. The second theory alleged that the mercury contained in

thimerosal-containing vaccines could directly affect an infant’s brain, thereby substantially

contributing to the causation of ASD. That theory was presented in three additional test cases

during several weeks of trial in 2008.

Decisions in each of the three test cases pertaining to the PSC’s first theory rejected the

petitioners’ causation theories. Cedillo v. HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec.

Mstr. Feb. 12, 2009) aff’d, 89 Fed. Cl. 158 (2009), aff’d, 617 F.3d 1328 (Fed. Cir. 2010);

Hazlehurst v. HHS, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d

88 Fed. Cl. 473 (2009), aff’d, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. HHS, No. 01-162V,

2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009). 2 Decisions

in each of the three “test cases” pertaining to the PSC’s second theory also rejected the

petitioners’ causation theories, and the petitioners in each of those three cases chose not to

appeal. Dwyer v. HHS, No. 03-1202V, 2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010);

King v. HHS, No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar 12, 2010); Mead v.

HHS, No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12, 2010).

The “test case” decisions were comprehensive, analyzing in detail all of the evidence

presented on both sides. The three test case decisions concerning the PSC’s first theory

(concerning the MMR vaccine) totaled more than 600 pages of detailed analysis, and were

2

The petitioners in Snyder did not appeal the decision of the U.S. Court of Federal Claims.

5

solidly affirmed in many more pages of analysis in three different rulings by three different

judges of the United States Court of Federal Claims, and in two rulings by two separate panels of

the United States Court of Appeals for the Federal Circuit. The three special master decisions

concerning the PSC’s second theory (concerning vaccinations containing the preservative

“thimerosal”) were similarly comprehensive.

All told, the 11 lengthy written rulings by the special masters, the judges of the U.S.

Court of Federal Claims, and the panels of the U.S. Court of Appeals for the Federal Circuit

unanimously rejected the petitioners’ claims, finding no persuasive evidence that either the

MMR vaccine or thimerosal-containing vaccines could contribute in any way to the causation of

autism.

Thus, the proceedings in the six “test cases” concluded in 2010. Thereafter, the

Petitioners in this case, and the petitioners in other cases within the OAP, were instructed to

decide how to proceed with their own claims. The vast majority of those autism petitioners

elected either to withdraw their claims or, more commonly, to request that the special master

presiding over their case decide their case on the written record, uniformly resulting in a decision

rejecting the petitioner’s claim for lack of support. However, a small minority of the autism

petitioners have elected to continue to pursue their cases, seeking other causation theories and/or

other expert witnesses. A few such cases have gone to trial before a special master, and in the

cases of this type decided thus far, all have resulted in rejection of petitioners’ claims that

vaccines played a role in causing their child’s autism. See, e.g., Blake v. HHS, No. 03-31V, 2014

WL 2769979 (Fed. Cl. Spec. Mstr. Vowell May 21, 2014) (autism not caused by MMR

vaccination); Henderson v. HHS, No. 09-616V, 2012 WL 5194060 (Fed. Cl. Spec. Mstr. Vowell

Sept. 28, 2012) (autism not caused by pneumococcal vaccination); Franklin v. HHS, No. 99-

855V, 2013 WL 3755954 (Fed. Cl. Spec. Mstr. Hastings May 16, 2013) (MMR and other

vaccines found not to contribute to autism); Coombs v. HHS, No. 08-818V, 2014 WL 1677584

(Fed. Cl. Spec. Mstr. Hastings Apr. 8, 2014) (autism not caused by MMR or Varivax vaccines).

In addition, some causation autism claims have been rejected without trial, at times over the

petitioner’s objection, in light of the failure of the petitioner to file plausible proof of vaccine-

causation. See, e.g., Waddell v. HHS, No. 10-316V, 2012 WL 4829291 (Fed. Cl. Spec. Mstr.

Campbell-Smith Sept. 19, 2012) (autism not caused by MMR vaccination); Geppert v. HHS, No.

00-286V, 2012 WL 2500852 (Fed. Cl. Spec. Mstr. Vowell Sept. 6, 2012); Fesanco v. HHS, No.

02-1770, 2010 WL 4955721 (Fed. Cl. Spec. Mstr. Hastings Nov. 9, 2010); Fresco v. HHS, No.

06-469V, 2013 WL 364723 (Fed. Cl. Spec. Mstr. Vowell Jan. 7, 2013); Pietrucha v. HHS, No.

00-269V, 2014 WL 4338058 (Fed. Cl. Spec. Mstr. Hastings Aug. 22, 2014). Judges of this court

have affirmed the practice of dismissal without trial in such a case. E.g., Fesanco v. HHS, 2011

WL 1891701 (May 16, 2011) (Judge Braden).

In none of the rulings since the test cases has a special master or judge found any merit in

an allegation that any vaccine can contribute to causing autism.

6

III

PROCEDURAL HISTORY OF THIS CASE

On November 4, 2008, Brian and Kimberly Long (“Petitioners”) filed a “Petition for

Vaccine Compensation” on behalf of their son, BCL. Petitioners at that time alleged generally

that the “recommended childhood vaccinations” caused BCL “to develop pervasive

developmental disorder-not otherwise specified (“PDD-NOS”) and/or an autism spectrum

disorder (“ASD”).” (Petition (“Pet”) at 1.)

In their petition, Petitioners further claimed that BCL suffered the significant

aggravation of his “pre-existing vaccine injury” by an influenza vaccine administered on

November 21, 2005. (Id.) Finally, Petitioners stated that they seek compensation not for the

alleged initial injury by unspecified vaccinations, but for the significant aggravation allegedly

caused by the 2005 flu vaccination. (Id.) At the same time that the petition was filed, Petitioners

filed Exhibits 1-20, which are the medical records of BCL.

This case was originally assigned to Special Master Golkiewicz. (Notice, ECF No. 2.)

Additional medical records, medical articles, and other documents were filed by Petitioners at

various times thereafter, as Petitioners’ Exhibits 21 through 41. Respondent has also filed

Exhibits at various times, identified as Ex. A through Ex. G.

On February 5, 2009, Respondent filed a “Rule 4(c) Report” urging that compensation be

denied. (ECF No. 7.) On May 24, 2011, the case was reassigned to my docket. Petitioners

eventually filed two expert reports by Dr. Mary Megson, a pediatrician, on October 7, 2011 (Ex.

24), and November 13, 2012 (Ex. 24-1), supporting their causation allegation.

Respondent filed an expert report of Dr. Bennett L. Leventhal, a child psychiatrist (Ex.

A), on July 16, 2012, and an expert report of Dr. Stephen Cederbaum, a geneticist, on March 18,

2013 (Ex. C). Both parties also filed certain medical literature.

On September 25, 2013, a “fact hearing” took place in Richmond, Virginia, at which I

heard testimony from the Long family. (See Transcript of Proceedings “(1-Tr.)”, ECF No. 40.)

On February 10, 2014, I conducted a second hearing, to hear the expert testimony of Drs.

Megson, Leventhal, and Cederbaum. (See Transcript of Proceedings “2-Tr.”, ECF No. 51.) On

March 25, 2014, Petitioners’ counsel filed their post-hearing brief. On June 6, 2014,

Respondent’s counsel filed a responsive post-hearing brief. (Petitioners had the opportunity to

file a reply brief, but have not done so.)

IV

FACTUAL HISTORY

BCL was born on September 7, 1998. (Ex. 1, p. 1.) As a baby, BCL suffered from

“severe colic” and was therefore fed several different formulas. (Ex. 16, p. 23; Ex. 20, p. 30.)

7

BCL’s first “sick visit” to his pediatrician occurred on January 28, 1999, when he was treated for

an upper respiratory infection and otitis media. (Ex. 5, p. 20.) During his early childhood, BCL

was treated for several other episodes of otitis media. Further, BCL contracted croup and

bronchitis in February, 2003. (Id., pp. 60, 62.)

Throughout the course of his early pediatric care, BCL received numerous routine

pediatric vaccinations. Some of BCL’s early medical records indicate concern about BCL’s

development. For example, pediatric records dated January 11, 2002, indicate concerns about

BCL’s unclear and delayed speech. (Ex. 5, pp. 38-39.) At a speech evaluation on May 6, 2002,

he found to have a “moderately severe articulation disorder,” and weekly therapy was

recommended. (Id., p. 50.) Although records dated August 9, 2002, note that BCL was “making

progress [with] speech,” by February 2003, his mother thought that the therapy was not helping,

and that “something else is going on.” (Id., pp. 52, 61.)

On February 17, 2003, BCL was referred for further evaluation because of “Sensory

irregularities,” including “difficulty [with] fine motor language . . . . Is very easily distracted.”

(Ex. 5, p. 63.) BCL underwent an occupational therapy evaluation on March 3, 2003. (Ex. 8, pp.

2-5.) The report notes that BCL “does socially interact with children his own age and adults;

however, frequently prefers to be by himself playing.” (Id., p. 2.)

Notes from BCL’s pediatrician indicated a desire for BCL to undergo testing for

Attention Deficit Disorder (“ADD”). (Ex. 5, pp. 85-86.) Accordingly, BCL was assessed by

Larry Raskin, Ph.D., in late March to early April, 2003. (Ex. 6, pp. 15-17.) Dr. Raskin

concluded that BCL had probable Attention Deficit-Hyperactivity Disorder (“ADHD”), and

recommended medication. (Id., p. 15.) Over the course of the next year, BCL was treated with

various doses of several medications, including Ritalin, Adderall XR, Concerta, and Strattera.

(Ex. 5, pp. 91, 96-97, 110-11, 179.)

On March 9, 2004, BCL visited Louisville Neurology Associates. (Ex. 5, p. 159.) The

examining physician, Dr. Puri, concluded that BCL’s “findings are suggestive of mild PDD or an

autistic spectrum disorder possibly” (id.), and that BCL be evaluated for the same at the Child

Evaluation Center (id., p. 160).

On June 14, 2004, BCL underwent occupational therapy, speech and language,

psychological, and comprehensive medical evaluations at the Weisskopf Child Evaluation

Center. (Ex. 5, pp. 182-93.) The experts indicate that BCL had made progress in some areas, but

still had various difficulties, including attention problems and impulse control. (Id.) His full-

scale IQ score, at 60, was within the deficient range. (Ex. 5, pp. 189-90.)

A brain MRI conducted on September 8, 2004, revealed “mild prominence of the cerebral

sulci,” but was otherwise normal. (Ex. 5, p. 209.) A medication management evaluation on April

12, 2005, noted that BCL was making great progress and doing well in his kindergarten class at

Summit Academy. (Id., p. 234.) A year-end report from BCL’s teacher also lauded his progress

during the 2004-05 school year. (Ex. 7, p. 4.)

BCL’s family moved from Louisville, Kentucky, to Beaumont, Texas, during the summer

of 2005. (Ex. 12, p. 21.) That fall, BCL enrolled in St. Anne Catholic School. (Id., p. 3.)

8

According to his mother, BCL “had trouble adjusting at first” at the new school, but started to do

better until the family was evacuated for three weeks due to a hurricane, after which “things

progressively became worse.” (Id., p. 21.) A note from the office of Rosa Gonzalez, M.D.,

dated November 10, 2005, indicated that BCL’s teachers said that his behavior was “not like

him. Getting up—running out of classroom. Not paying attention.” (Ex. 10, p. 11.)

On November 21, 2005, BCL received an influenza vaccine. (Ex. 18, p. 2.) BCL’s

pediatric records from this time do not indicate any adverse reaction to this vaccination. (Ex. 10,

pp. 14-17.)

Throughout the rest of the 2005-2006 school year, BCL continued to have problems and

poor school performance. His medications were frequently altered. (Ex. 10, pp. 17-18, 20-21,

26, 39.) Notes from March 30, 2006, indicate that BCL was having “mild hallucinations” and

exhibiting high anxiety. (Id. at p. 29.) A special education form filled out by BCL’s mother on

May 17, 2006, stated that she attributed his problems in school to “[A]nxiety depression and

dealing with new environment and a lot of changes.” (Ex. 12, pp. 20-21.) On July 27, 2006,

BCL was evaluated at Texas Children’s Hospital. (Ex. 13, p. 19.) It was noted that BCL was

diagnosed with developmental delay and sensory integration issues at four years of age, but that

he had “regression in the last 6-9 months.” (Id.) The evaluating pediatric neurologist

commented that “it is possible” that this regression “is a normal manifestation of his pervasive

developmental disorder.” (Id., p. 21.)

BCL visited Texas Children’s Hospital on September 5, 2006, for a new patient

neurology evaluation. (Ex. 13, p. 19.) Records from this evaluation indicate that BCL’s “parents

have noted marked changes in the last few months, which are: decreased memory, decreased

socialization with them and others, decreased need for sleep, increased aggressiveness, more

frequent outbursts, increased hyperreactivity, and bladder control problems.” (Id.) Furthermore,

the record indicates that BCL’s parents first began to notice problems several months after their

move to Texas. (Id.)

BCL was treated at the Lawlis-Peavey PsychoNeuroPlasticity Center beginning in March

2007. (Ex. 17, p. 5.) Records indicate that BCL’s parents stated that he began to regress in

March 2006. (Id., p. 26.) However, an arrow points from this statement to a handwritten note

that reads, “Regression started in November or December of 2005.” (Id.)

The record of this case indicates that since 2007, BCL has experienced periods of

improvement mixed with periods of worsening. Now age 16, BCL, unfortunately, continues to

suffer from autism and “intellectual disability” (formerly known as “mentally retarded”),

experiencing severe defects in many areas of development.

V

SUMMARY OF EXPERT WITNESSES’ QUALIFICATIONS AND OPINIONS

In this case, Petitioners presented the expert report and testimony of one medical expert;

Respondent presented the expert report and testimony of two medical experts. At this point, I

will briefly summarize both the qualifications and the opinions of these expert witnesses.

9

A. Petitioners’ expert, Dr. Mary Megson

1. Qualifications

Dr. Mary Megson, M.D., graduated cum laude in 1974 from Hollins College with a

Bachelor in Science, and was designated as Phi Beta Kappa. (Ex. 41, p. 1.) She earned her M.D.

from The University of Virginia School of Medicine in 1978. (Id.) She interned and completed

her residency at the Boston Floating Hospital at Tufts Medical Center. (Id.) She continued to

complete a fellowship in Ambulatory Pediatrics at Boston Children’s Hospital, as well as a

fellowship in Child Development at the Medical College of Virginia. (Id.)

Dr. Megson is certified by the American Board of Pediatrics. (Id.) Currently, she is in

private practice, and acts as CEO of the Pediatric and Adolescent Ability Center, where she

specializes in the treatment of autistic individuals. (Id., 2-Tr. 175-77.) She has treated thousands

of autistic patients (2-Tr. 177), and currently about 85 to 92 % of her patients are autistic (2-Tr.

175).

2. Summary of Dr. Megson’s opinion

Summarizing Dr. Megson’s opinion in this case is not an easy task, she since often stated

her points vaguely or unclearly. However, by studying both her two written expert reports 3 and

her hearing testimony it would be fair to summarize her opinion as follows.

Dr. Megson acknowledges that BCL had some neurologic abnormalities prior to his

influenza vaccination of November 21, 2005. She acknowledges that he had ADHD. (E.g., Ex.

24, p. 1.) At times in her presentation she also acknowledged that BCL, prior to November 21,

2005, also had “previously-diagnosed PDD-NOS,” which is a form of autism spectrum disorder.

(Ex. 24, p. 1.)

Dr. Megson opined, however, that the flu vaccination significantly aggravated BCL’s

pre-existing neurologic problems, including his autism, making them far worse. (Ex. 24, p. 1;

Ex. 24-1, p. 1.)

Her theory of how the vaccination allegedly aggravated BCL’s disorder, as best I can

understand it, is as follows. Dr. Megson started with the fact that genetic testing has shown that

BCL has a variant or “mutation” of the MTHFR gene, in the C677T allele of that gene. (Ex. 24,

p. 6; Ex. 24-1, p. 2; 2-Tr. 215-216.) She opined that this genetic variant can disturb “the

metabolic pathways regulating oxidative stress in the brain” (Ex. 24, p. 6; 2-Tr. 218), and that

3

As noted above, Petitioners filed an expert report of Dr. Megson, identified as Ex. 24 on Oct. 7, 2011, on a

compact disc. On Nov. 13, 2012, Petitioners filed a supplemental expert report of Dr. Megson, electronically

identified as Ex. 24-1.

10

excessive oxidative stress can disturb brain function, thus aggravating autism (Ex. 24-1, pp. 2-3;

2-Tr. 288).

Dr. Megson further opined that BCL’s flu vaccination, on November 21, 2005, by

exposing BCL to 25 micrograms (“mcg”) of mercury contained as a preservative (known as

thimerosal) in that vaccination, caused considerable damage to BCL’s brain, because he was

particularly susceptible to such damage because of his MTHFR genetic variant. (Ex. 24, pp. 7,

9; 2-Tr. 229.)

Dr. Megson also relied on evidence that BCL’s autism symptoms took a major turn for

the worse in the period of several months after the flu vaccination in question. (E.g., Ex. 24, pp.

4-5; 2-Tr. 201-10; 254-57.)

B. Respondent’s experts

1. Dr. Cederbaum’s qualifications

Dr. Stephen Cederbaum, M.D., attended Amherst College and graduated cum laude in

1959, with an A.B. Honors in Chemistry. (Ex. D, p. 1.) Dr. Cederbaum additionally graduated

in 1964 from New York University with an M.D. Honors in Biochemistry. (Id.) Dr. Cederbaum

interned and did his residency at the Barnes Hospital in St. Louis, Missouri, from July 1964 to

June of 1966. (Id.)

Dr. Cederbaum is licensed by the American Board of Medical Examiners, the state of

California, and the American Board of Medical Genetics. (Ex. D, p. 2.)

From 1970 to 2010, Dr. Cederbaum served at the University of California, Los Angeles,

as an Assistant Professor, Associate Professor, or Professor, of Psychiatry, Pediatrics, or Human

Genetics. (Ex. D, p. 1.) From 1994 to 2003, he was Chief of the Division of Genetics,

Department of Pediatrics, at that institution. (Id.) Since 2010 he has served at that same

institution as a “Professor Emeritus--Recalled.” Dr. Cederbaum has published about 150 peer-

reviewed publications, plus 70 to 80 non-peer-reviewed publications. (2-Tr. 305.)

2. Summary of Dr. Cederbaum’s opinion

Testifying in the area of his medical specialty, Dr. Cederbaum disagreed with Dr.

Megson. Most importantly, Dr. Cederbaum disagreed strongly with Dr. Megson’s assertion

concerning the significance of the fact that BCL has a single C677T variant of his MTFHR gene.

Dr. Cederbaum explained that, in fact, 35 to 40 percent of the entire population has that exact

same variant. (Ex. C, p. 3; 2-Tr. 309, 314.) Dr. Cederbaum opined that the existence of such

variant in a person would not make that person more susceptible to neurologic disorder or to any

disorder or disease. (2-Tr. 318, 349; Ex. C, pp. 3-4.) Dr. Cederbaum noted that the C677T

variant of the MTFHR gene has been studied intensively (2-Tr. 314), and that the strong medical

consensus in the genetics specialty is that such variant is not associated with an increased rate for

any disease or disorder. (2-Tr. 330, 338-39, 342-43, 363; Ex. C, p. 4; Ex. E.)

11

Dr. Cederbaum opined that BCL’s autism was not influenced by the flu vaccine. (Ex. C,

p. 6.)

3. Dr. Leventhal’s qualifications

Dr. Bennett L. Leventhal, M.D., received a Bachelor of Science degree from Louisiana

State University in 1972. (Ex. B, p. 1, ECF No. 19.) Dr. Leventhal graduated from Louisiana

State University in 1974 with a degree in medicine. (Id.) Dr. Leventhal served as a resident in

Psychiatry at Duke University Medical Center from 1974-1978. (Id., p. 2.) He additionally

served as a Fellow in the Child and Adolescent Psychiatry Duke University Medical Center.

(Id.)

Dr. Leventhal is board-certified in both general psychiatry and adolescent psychiatry (2-

Tr. 372.) He has specialized in adolescent psychiatry (autism is considered a psychiatric as well

as a neurologic diagnosis). (2-Tr. 372, 374-75, 378-80, 482-83.) At the University of Chicago,

he served for 25 years as Director of Child and Adolescent Psychiatry, and for 10 years as Chief

of the Department of Psychiatry. (2-Tr. 372-73.) During his 40-year medical career, Dr.

Leventhal has treated many autistic children, and his practice is largely focused on autism. (2-

Tr. 374-75, 378-80, 433-36.) He has taught and lectured about autism around the world. (2-Tr.

374, 376-78.) Dr. Leventhal has participated in devising the medical tests for diagnosing autism

(2-Tr. 374-75), and he frequently diagnoses autism in his clinical practice (2-Tr. 380). Dr.

Leventhal has 152 peer-reviewed publications listed on his curriculum vitae, many of them

pertaining to autism. (Ex. B, pp. 13-28; 2-Tr. 382.)

4. Summary of Dr. Leventhal’s opinion

Dr. Leventhal, Respondent’s expert in diagnosing and treating autism, testified that he

found no merit in the second part of Dr. Megson’s theory, that an influenza vaccination can

aggravate a neurological disorder, and that it did significantly aggravate BCL’s disorder. (Ex. A,

pp. 16-18; 2-Tr. 387.)

While Dr. Megson suggested that BCL had only minimal neurological problems prior to

his influenza vaccination on November 21, 2005, Dr. Leventhal studied BCL’s medical records

and concluded that BCL clearly was significantly delayed prior to that vaccination. (Ex. A, pp.

14-15; 2-Tr. 392-413.) Dr. Leventhal opined that by the time BCL was five years old, in 2003,

he met the diagnostic criteria for autism, and also was clearly within the category of

“intellectually disabled” (formerly known as “mentally retarded”). (Ex. A, p. 15.) This was still

true when BCL received the flu vaccination at seven years of age. (Id.)

Dr. Leventhal acknowledged that the 2005-2006 school year went poorly for BCL, with

deterioration of his behavior both at school and at home. (Ex. A, p. 16.) But Dr. Leventhal

disagreed that the influenza vaccination had any adverse effect upon BCL. (Ex. A, p. 17; 2-Tr.

387.) Dr. Leventhal noted that in 2005 BCL experienced situations that could have explained the

worsening of his behavior and school achievement--specifically a move of his family to a new

12

city, a new school, and a three-week evacuation because of a hurricane. (Ex. A, p. 16; 2-Tr. 414-

15, 495-96.)

Further, he noted that with ASD it is common for behavior and developmental progress

to wax and wane--i.e., get better or worse--at various times, without any apparent reason. (2-Tr.

408, 422, 486.) He pointed out that the age of six or seven years, when a child is expected to

face significant new challenges in school, is a very common time at which a child with autism

takes a turn for the worse, in the ordinary course of autism. (2-Tr. 422, 486-88.) (BCL turned

seven as the 2005-2006 school year began.)

Finally, Dr. Leventhal testified that there is no plausible evidence that an influenza

vaccine, or any other vaccine, could aggravate autism, or did so in BCL. (Ex. A, p. 17; 2-Tr.

388.)

VI

SUMMARY OF MY OPINION

The shortest summary of my opinion is that I found Petitioners’ expert Dr. Megson to be

a very weak and unconvincing witness, while I found Respondent’s experts to be far more

qualified and far more persuasive.

In the first part of her theory, Dr. Megson based her reasoning on her view that a certain

variant in BCL’s genone made him substantially more susceptible to neurologic injury than the

average person. However, Dr. Cederbaum, a geneticist, is far better qualified to testify

concerning this issue than Dr. Megson, a pediatrician. His testimony, that such variant is not

harmful, was far more persuasive on this point.

Second, Dr. Megson testified that BCL’s influenza vaccination of November 21, 2005,

caused him to go from a mild neurologic disorder, including a form of autism that is not severe,

to a severe and debilitating form of autism. However, Dr. Megson never made a plausible case

that the influenza vaccine can aggravate or otherwise affect a person’s autism. Further, Dr.

Leventhal, as a child psychiatrist, has far better medical qualifications concerning the subject of

autism than does Dr. Megson, and Dr. Leventhal testified persuasively that there is no reason to

think that the influenza vaccine can aggravate autism, or that it did aggravate BCL’s autism in

this case.

Accordingly, Petitioners have wholly failed to demonstrate that it is “more probable than

not” that BCL’s flu vaccination of November 21, 2005, aggravated his autism. 4

4

Petitioners have the burden of demonstrating the facts necessary to show 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).

13

VII

I FOUND NO MERIT IN THE FIRST PART OF DR. MEGSON’S THEORY,

CONCERNING BCL’s GENETIC VARIANT

First, I will analyze Dr. Megson’s first principal point, her assertion that the fact that BCL

has a single variant of the C677T allele of the MTHFR gene made him especially susceptible to

neurological injury by a vaccination. I found that Dr. Cederbaum was far more persuasive than

Dr. Megson concerning this point.

For one thing, concerning this point Dr. Cederbaum is far more qualified than Dr.

Megson. As noted above, Dr. Megson is a pediatrician. She has made no claim to any special

training in genetics. Dr. Cederbaum, in contrast, has spent much of a 50-year medical career

specializing in human genetics. (Ex. D, p. 1; 2-Tr. 302-05.) From 1994 to 2003, he was Chief of

the Division of Genetics, Department of Pediatrics, at the University of California at Los

Angeles. (Ex. D, p. 1.) Clearly, on the issue of the potential effects of a genetic variant, Dr.

Cederbaum is much more qualified than Dr. Megson.

Moreover, Dr. Cederbaum’s testimony concerning this point was far more logical and

convincing than that of Dr. Megson. Dr. Cederbaum explained that in fact 35 to 40 percent of

the entire population have that exact same genetic variant, without any apparent detrimental

effects. (Ex. C, p. 3; Tr. 309, 314.) Dr. Cederbaum explained that the existence of this variant

has been extensively studied (Tr. 314), and that experts in the area have concluded that the

existence of such a variant does not make a person more susceptible to neurologic disorder, or to

any other disorder or disease. (2-Tr. 318, 330, 338-39, 342-43, 349, 363, 365; Ex. C, p. 4.) Dr.

Cederbaum added that if Dr. Megson were correct that a single C677T variant made a person

susceptible to neurologic disorder, then we would be practically prevented from vaccinating 35

to 40% of the entire population. (2-Tr. 361.)

In this regard, both parties submitted medical literature. Dr. Cederbaum relied on Ex. E,

which, he asserted, demonstrated that experts in the specialty of genetics have reached a strong

consensus that the C677T variant is not associated with increased risk of any disorder or disease.

(2-Tr. 320, 338-39, 342-43, 362; Ex. C, p. 4, Ex. E.)

Dr. Megson also submitted certain medical literature related to this point, and testified

briefly concerning that literature at the hearing. Dr. Cederbaum, on the other hand, presented

testimony concerning the literature submitted by Dr. Megson (2-Tr. 325-331, 352-55), and

concerning Ex. E that he submitted (2-Tr. 330, 338-39, 342-43, 363). I have reviewed this

testimony of both experts concerning this literature, as well as the literature itself. I find that Dr.

Cederbaum’s discussion was much more persuasive. Ex. E, I find, provides strong support for

Dr. Cederbaum’s analysis, while Dr. Cederbaum’s comments about the problems with the

literature filed by Dr. Megson were also persuasive.

14

To be sure, Dr. Cederbaum clarified in his testimony that the presence of a single 5 C677T

variant in the MTHFR, which BCL has, is not totally without meaning. He acknowledged that as

a result of a single C677T variant, the methylation capacity of such a person would be only about

75% of that of a person without any such variant. (2-Tr. 320-21; Ex. C, p. 4.) But Dr.

Cederbaum explains that this 25% reduction does not impair the person’s methylation function at

a clinically detectable or clinically significant level. (2-Tr. 313, 318, 365.) Dr. Cederbaum

explained that each human has about 50 to 100 abnormalities in his or her genome, but in most

cases when only one of two corresponding genes is abnormal, such an abnormality does not

result in any clinically detectable function reduction. (2-Tr. 321, 324-25.) He explained that a

single C677T variant in MTHFR would not reduce a person’s methylation function at a clinically

detectable or clinically significant level. (2-Tr. 313, 318, 322.)

In this regard, Dr. Megson testified that BCL’s allegedly impaired methylation due to the

C677T variant would result in reduced brain production of “glutathione,” an important brain

component. (E.g., 2-Tr. 292.) But Dr. Cederbaum explained that there is no evidence that the

C677T variant causes impaired production (“synthesis”) of glutathione. (2-Tr. 321.)

Dr. Cederbaum testified that the C677T variant did not make BCL particularly

susceptible to brain injury. (2-Tr. 308). He also found that there is no evidence for Dr.

Megson’s theory that the flu vaccine, acting in concert with a single C677T variant, caused any

harm to BCL. (2-Tr. 323.)

Again, I find that the discussion in Ex. E strongly supports Dr. Cederbaum’s testimony

concerning these points.

In short, I find that Dr. Cederbaum’s testimony, concerning this first part of Dr. Megson’s

theory, combined with Ex. E, was much more persuasive than Dr. Megson’s presentation

concerning this point. I find that Dr. Megson has wholly failed to establish the first part of her

theory.

VIII

I FOUND NO MERIT IN THE SECOND PART OF DR. MEGSON’s THEORY,

CONCERNING THE ALLEGED AGGRAVATION OF AUTISM

Since I have rejected the first part of Dr. Megson’s theory, as described in Section VII of

this Decision above, I could end my analysis here, since rejection of her first part plainly dooms

her overall causation theory. However, in the interest of completeness, I will also discuss why I

reject the second part of Dr. Megson’s theory, that the influenza vaccine damaged BCL’s brain,

thereby allegedly changing him from a child with mild neurologic problems to a child with a

5

In general, humans have in their genome two copies of every gene. (2-Tr. 312-13, 324.) In BCL’s case, one of

his two genes, not both, has the C677T variant. In one of her expert reports, Dr. Megson had stated that BCL had

the variant in both genes (Ex. 24-1, p. 2), but at the hearing she acknowledged that her report had been mistaken in

that regard, and that BCL has only a single C677T variant in an MTHFR gene (2-Tr. 291).

15

severe form of autism. This part of Dr. Megson’s theory must also be rejected, for many

reasons.

A. Relative qualifications of experts

First, the qualifications of Respondent’s expert concerning autism spectrum disorders,

Dr. Leventhal, are much superior to those of Dr. Megson in that subject matter area.

Dr. Megson is, to be sure, a board-certified pediatrician who, to her credit in this regard,

has spent much of her 37-year medical career engaged in treating children with autism spectrum

disorders. 6 (2-Tr. 175-77.) However, Dr. Leventhal has far superior academic credentials and

specialized medical training qualifications in the area of autism. Autism is considered a

psychiatric diagnosis as well as a neurological diagnosis. (E.g., 2-Tr. 482-83.) Dr. Leventhal

explained that child psychiatrists and pediatric neurologists are the most qualified experts to

diagnose and treat autism. (2-Tr. 483.) Dr. Leventhal, board-certified in both general psychiatry

and adolescent psychiatry (2-Tr. 372), has specialized in adolescent psychiatry (2-Tr. 372, 374-

75, 378-80). At the University of Chicago, he served for 25 years as Director of Child and

Adolescent Psychiatry, and for10 years as Chief of the Department of Psychiatry. (2-Tr. 372-

73.) Moreover, during his 40-year medical career, Dr. Leventhal has specialized in autism, and

has treated many autistic children. (2-Tr. 374-75, 378-80, 433-34.) He has taught and lectured

about autism around the world. (2-Tr. 374, 376-78.) Dr. Leventhal has participated in devising

the medical tests for diagnosing autism (2-Tr. 374-75), and he frequently diagnoses autism in his

clinical practice (2-Tr. 280). Dr. Leventhal has 152 peer-viewed publications listed on his

curriculum vitae, many of them pertaining to autism. (Ex. B, pp. 13-28.) He has received

important awards for his work in autism. (2-Tr. 376.)

Thus, in terms of specialized medical training relevant to autism, Dr. Leventhal has the

much superior resume.

B. Dr. Megson presented no plausible evidence that flu vaccine can cause or aggravate

autism, and Dr. Leventhal was far more persuasive.

Second, Dr. Megson simply failed to present any plausible evidence that an influenza

vaccine can aggravate autism or any neurological disorder, much less that it did aggravate BCL’s

neurological disorder. Dr. Megson spent the large majority of her testimony at the evidentiary

hearing testifying concerning her belief that BCL’s genetic variant allegedly made him

susceptible to brain damage. (I have rejected that part of the theory in Section VII of this

Decision above.) In contrast, she spent relatively little time attempting to explain how the

influenza vaccine could damage a child’s brain, thereby aggravating autism.

6

Dr. Megson is not board-certified in the sub-specialties within pediatrics—i.e., “developmental behavior

pediatrics” or “neurodevelopmental disabilities”—that would be most relevant to autism spectrum disorder. (2-Tr.

262.) Dr. Megson usually treats individuals who have been diagnosed by someone else with ASD. (2-Tr. 178.)

And if she sees a patient who has not been diagnosed, she often refers that patient to a specialist for a formal autism

diagnosis. (Id.)

16

To be sure, Dr. Megson did assert in her expert reports that BCL’s flu vaccination of

November 21, 2005, exposed BCL to 25 micrograms (“mcg”) of mercury, contained as a vaccine

preservative known as “thimerosal,” suggesting that such mercury caused “oxidative stress” to

his brain, thereby aggravating his autism. (Ex. 24, pp. 6, 7, 9; Ex. 24-1, pp. 2, 3.) But at the

evidentiary hearing she did not explain or elaborate in any significant detail on these assertions.

In no part of her reports or testimony did she point to any significant evidence that the influenza

vaccine can aggravate autism or otherwise damage the brain.

In this regard, while Dr. Megson’s basic theory of the case was that the small amount of

the mercury contained in the influenza vaccine caused “oxidative stress” sufficient to severely

damage BCL’s brain, she was forced on cross-examination to, in effect, admit how speculative

her causation theory is. She admitted that she cannot quantify the amount of oxidative stress

caused by a single flu vaccination. (2-Tr. 288.) She acknowledged that she can’t say how much

oxidative stress could cause a regression in a person’s autism. (2-Tr. 289.) She admitted that

there exists no data from the 2005-2006 period to measure the actual oxidative stress in BCL at

that time. (2-Tr. 290). These admissions, in effect, show that Dr. Megson’s theory amounts to

pure speculation.

After attending Dr. Megson’s testimony, I received the impression that she does truly

believe, for whatever reason, that vaccinations and metals can cause or aggravate autism. When

she found out that BCL received an influenza vaccination during the period of time in which he

was having academic troubles and a downturn in his behavior, during the 2005-2006 school year,

she seems to have automatically jumped to the conclusion that it was his influenza vaccine that

caused his troubles during that school year by aggravating his autism.

I find Dr. Leventhal, on the other hand, to be quite persuasive in his testimony that there

exists no plausible evidence that an influenza vaccine, or any other vaccine, can aggravate

autism, or did so in BCL’s case. (Ex. A, p. 17; 2-Tr. 388.) He opined, inter alia, that he has

never seen any scientific proof that “oxidative stress” can affect autism. (2-Tr. 388.)

While Dr. Megson argued that BCL had only minimal neurological problems prior to his

influenza vaccination on November 21, 2005, Dr. Leventhal studied BCL’s medical records and

concluded that BCL clearly was significantly delayed prior to that vaccination. (Ex. A, pp. 14-

15; 2-Tr. 390-413.) Dr. Leventhal opined that by the time BCL was five years old, in 2003, he

met the diagnostic criteria for autism, and also was clearly within the category of Intellectually

Disabled (formerly known as Mentally Retarded). (Ex. A, p. 15.) This was still true when BCL

received the flu vaccination at seven years of age. (Ex. A, p. 15.)

Dr. Leventhal acknowledged that the 2005-2006 school year went poorly for BCL, with

deterioration of his behavior both at school and at home. (Ex. A, p. 16.) But Dr. Leventhal

disagreed that the influenza vaccination had any adverse effect upon BCL. (Ex. A, p. 17; 2-Tr.

387.) Dr. Leventhal noted that in 2005 BCL experienced situations that could have explained the

worsening of his behavior and school achievement--specifically a move of his family to a new

city, a new school, and a three-week evacuation because of a hurricane. (Ex. A, p. 16; 2-Tr. 414-

15, 495-96.)

17

Further, Dr. Leventhal explained that with ASD it is common for behavior and

developmental progress to wax and wane--i.e., get better or worse--at various times, without any

apparent reason. (2-Tr. 388, 408, 422, 424-25, 486, 492; Ex. A, p. 15.) He pointed out that the

age of six or seven years, when a child is expected to face significant new challenges in school,

is a very common time at which a child with autism takes a turn for the worse, in the ordinary

course of autism. (2-Tr. 413-14, 422, 486-88.) (BCL turned seven as the 2005-2006 school year

began.) Thus, BCL’s downturn in behavior in 2005-06 may be explained simply by the ordinary

course of autism. (In this regard, note that one of BCL’s treating doctors at the time wrote

exactly that--that BCL’s 2005-06 downturn “may be a normal manifestation of his pervasive

developmental disorder”--Ex. 13, p. 2.)

C. Other individual points of Dr. Megson

Dr. Megson also added several additional observations about BCL’s case, often in a

disorganized fashion, in which it was impossible for me to tell how her different points fit within

her basic “mercury/oxidative stress” theory. But, in any event, Dr. Leventhal effectively refuted

Dr. Megson on many of these individual points. For example, Dr. Megson emphasized some

still photographs of BCL before and after the flu vaccination in question, and argued that she

could tell from these photos that there had been a significant worsening of his autism. (E.g., 2-

Tr. 245-46.) Dr. Leventhal, however, testified persuasively that still photos cannot tell us

anything about the course of BCL’s autism. (2-Tr. 430-31, 470-71, 481-82.)

Also, Dr. Megson, without significant elaboration, asserted that BCL’s autism is a result

of an ongoing autoimmune response by his immune system to the influenza vaccination. (2-Tr.

296-97.) Dr. Leventhal, however, testified that there was no evidence to support the contention

that BCL has an “immunologic” brain defect. (2-Tr. 429.) He noted that in the case of such an

immunologic cause for BCL’s brain disorder, there would be chronic brain inflammation, for

which a physician could easily test, but no such test has been done on BCL, and no evidence for

brain inflammation in BCL exists. (2-Tr. 429-30.)

Third, Dr. Megson seemed somewhat ambiguous throughout her reports and testimony

concerning whether BCL actually had an ASD prior to his flu vaccination of November 21,

2005. She clearly acknowledged that he had a neurological abnormality--ADHD, or Attention

Deficit-Hyperactivity Disorder. At times she also acknowledged that he had an ASD prior to the

vaccination. For example, in one report she wrote that he had a “previously diagnosed PDD-

NOS” 7 prior to the vaccination. (Ex. 24, p. 1.) But at the evidentiary hearing, Dr. Megson at

times seemed to assert that BCL did not have an actual ASD prior to the vaccination--for

example, she testified that at age six years, seven months (April of 2005), BCL did not meet the

criteria for an ASD. (2-Tr. 196.) Then, on cross-examination, she first admitted that he did have

PDD-NOS prior to the vaccination (2-Tr. 273, line 10), then immediately back-tracked in her

very next answer to say that BCL had only “features” of PDD-NOS, but not “full blown autism”

7

There are five categories of ASD, including “PDD-NOS”--which stands for “Pervasive Developmental Disorder,

Not Otherwise Specified.” (2-Tr. 389.)

18

(2-Tr. 273, lines 13-16). She then seemed to acknowledge that BCL was on the autism spectrum

at that time, but on the “mild end” of that spectrum. (2-Tr. 273, lines 17-19.)

Dr. Leventhal, on the other hand, indicated that while BCL was never adequately tested

for ASD prior to the vaccination, based upon the medical records it appears retrospectively that

he met the ASD criteria at age 5 and again at age 7 (the flu vaccination was administered at age 7

years and five months). (Ex. A, p. 15.) Further, Dr. Leventhal explained that he had never heard

the term “full blown autism” before, and that PDD-NOS is not considered a mild form of autism.

(2-Tr. 389.)

This exchange is not at all crucial to the outcome of this case, in which the overall

evidence is overwhelmingly in Respondent’s favor. But it simply again illustrates the often

confusing and scattershot nature of Dr. Megson’s testimony in this case.

D. It is common for no cause to be identified in autism.

In addition, Dr. Leventhal explained that is quite common in autism that, as in BCL’s

case, no definitive “cause” for the autism, or for changes in the autistic symptoms over time, is

ever identified. (2-Tr. 429-30, 489, 490-91.)

E. Dr. Megson’s reliance on timing

As part of their causation case, Petitioners and Dr. Megson also rely upon an assertion

that BCL took a severe turn for the worse in his autism symptoms immediately after his influenza

vaccination of November 21, 2005. They suggest that this alleged temporal relationship offers

support to their claim of a causal relationship. There are several problems with this argument,

however.

First as discussed at pp. 14-18 of this Decision, above, Dr. Megson was wholly

unpersuasive in her arguments that the flu vaccine can aggravate autism or neurological

disorders. Thus, even if petitioners were able to show a very stark temporal relationship between

a sudden downturn in BCL’s autism and his flu vaccination, the temporal relationship alone

would not be enough to show that, more probably than not, the vaccination caused the downturn.

Moreover, a close examination of the entire record of this case demonstrates that

Petitioners have not shown that BCL’s autism symptoms took a sharp turn for the worse

immediately after his vaccination, as they assert.

To be sure, as noted above, there is no doubt that during the 2005-2006 school year,

BCL’s behavior and his school performance deteriorated, as Dr. Leventhal did not dispute. But

did this deterioration begin immediately or soon after the flu vaccination on November 21, 2005,

as Petitioners now assert? An examination of the overall record makes this assertion seem

doubtful.

19

In this regard, I acknowledge that during the first evidentiary hearing in his case, BCL’s

parents testified that the 2005-2006 deterioration began soon after the vaccination in question.

(See Transcript, ECF No. 40.) I stress that I found BCL’s parents to be very fine people, good

parents, and admirably dedicated to BCL’s welfare. But they were testifying in late 2013, about

eight years after the events in question. Therefore, as to the timing of BCL’s symptoms, I find

that the medical records made at the time, or soon after, present a more reliable history of BCL’s

symptoms.

The medical records tell a different story than the scenario assumed by Dr. Megson. The

records indicate that BCL’s downturn during the 2005-06 school year began prior to his flu

vaccination of November 21, 2005.

First, a note from the office of Rosa Gonzalez, M.D., dated November 10, 2005, prior to

the vaccinations, indicates that BCL’s teachers said that his behavior was “not like him. Getting

up--running out of classroom. Not paying attention.” (Ex. 10, p. 11.) And a second note in Dr.

Gonzalez’s records indicates that the new behaviors were persisting on November 15, 2005,

again prior to the vaccination. (Ex. 10, p. 12.)

Second, in a questionnaire filled out by BCL’s mother on May 17, 2006, she was

specifically asked what she thinks caused BCL’s recent difficulties. And she did not mention the

vaccination at all; instead, she responded that the cause could be “dealing with new environment

and a lot of changes.” (Ex. 12, p. 21.) She added that “after the hurricane things got

progressively worse.” (Id.) (The hurricane occurred in September of 2005--see 1-Tr. 67-8.)

Thus, apparently, in the mind of BCL’s mother at that time, Mrs. Long was not remembering the

downturn as starting right after any vaccination, but as starting after he experienced a “new

environment and a lot of changes” (obviously, the family move and his entry into a new school),

and after the hurricane evacuation, events which predated the vaccination.

Third, BCL’s medical records do not show that BCL was taken to any physician soon

after the November 21, 2005, vaccination with a complaint of sudden change of behavior. His

pediatrician’s notes do not show any visit in late November of 2005, and the notes of two visits

in December of 2005 do not indicate any abrupt change of behavior (Ex. 10, pp. 16-17), but

instead indicate only a “little bit of progress” (id. at 17).

In short, the medical records in this case actually contradict Dr. Megson’s inference that

BCL suffered a downturn soon after his influenza vaccination in question. They show that the

beginning of his 2005-2006 downturn likely predated that vaccination.

F. Summary

In sum, for all the reasons stated above, I find no merit in the second part of Dr.

Megson’s theory, that an influenza vaccine can cause an aggravation of autism, or that it did

cause an aggravation of BCL’s autism.

20

IX

PETITIONERS’ CASE FAILS THE TESTS REQUIRED BY ALTHEN AND LOVING

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

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

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

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

petitioner’s burden:

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

by providing: (1) a medical theory causally connecting the vaccination and the

injury; (2) a logical sequence of cause and effect showing that the vaccination was

the reason for the injury; and (3) a showing of a proximate temporal relationship

between vaccination and injury.

Althen, 418 F.3d at 1278 (citations omitted). There can be no doubt whatsoever that the Althen

test ultimately requires that, as an overall matter, a petitioner must demonstrate that it is “more

probable than not” that the particular vaccine was a substantial contributing factor in causing or

aggravating the particular injury in question. That is clear from the statute itself, which states

that the elements of a petitioner’s case must be established by a “preponderance of the evidence.”

(§ 300aa-13(a)(1)(A).) The overall evidence here shows that the onset of BCL’s autism occurred

before the influenza vaccination in question, so it is clear that the influenza vaccine of November

21, 2005, was not the initial cause of his preexisting autism. However, in this case, Petitioners

do not assert that the influenza vaccinations initially caused BCL’s autism. Rather, the injury

alleged is that the influenza vaccination of November 21, 2005, caused a significant aggravation

of BCL’s autism.

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

The Vaccine Act states that “[t]the term ‘significant aggravation’ means any change for

the worse in a preexisting condition which results in markedly greater disability, pain or illness

accompanied by substantial deterioration of health.” §300aa-33(4).

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

HHS, 86 Fed. Cl. 135, 144 (2009). The United States Court of Appeals for the Federal Circuit

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

significant aggravation claims,” in W.C. v. HHS, 704 F.3d 1352, 1357 (Fed. Cir. 2013). Thus,

the Federal Circuit Court of Appeals, which sets binding precedent for decisions by the Office of

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

elaborated in Loving. A petitioner must prove by preponderant evidence that a vaccination

caused significant aggravation by showing:

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

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

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

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

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

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

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

relationship between the vaccination and the significant aggravation.

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

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

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

Loving test combines the first three Whitecotton factors, which establish significant

aggravation, with the Althen factors, which establish causation.”) Since the last three

elements of the Loving test include the entirety of the Althen test, with insignificant

wording modifications, the analysis of those three elements would be the same using

either standard.

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

first two elements of that test (that is, prongs 4 and 5 of the Loving test). Initially, it was

not absolutely clear how the two prongs differed from each other. That is, on their faces,

each of the two prongs seems to require a demonstration of a “causal” connection

between “the vaccination” and “the aggravation.” However, a number of Program

opinions concerning Althen have concluded that these first two elements reflect the

analytical distinction that has been described as the “can cause” vs. “did cause”

distinction. That is, in many Program opinions issued prior to Althen involving

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

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

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

cause the vaccinee’s own injury. See, e.g., Kuperus v. HHS, 2003 WL 22912885, at *8

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

(Fed. Cl. Spec. Mstr. Aug. 8, 2002). Thus, a number of judges and special masters of this

court have concluded that Prong 1 of Althen is the “can cause” requirement, and Prong 2

of Althen is the “did cause” requirement. See, e.g., Doe 11 v. HHS, 83 Fed. Cl. 157, 172-

73 (2008); Nussman v. HHS, 83 Fed. Cl. 111, 117 (2008); Banks v. HHS, 2007 WL

2296047, at *24 (Fed. Cl. Spec. Mstr. July 20, 2007); Zeller v. HHS, 2008 WL 3845155,

at *25 (Fed. Cl. Spec. Mstr. July 30, 2008).

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

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

equivalent to the first two prongs of the Althen test. (Pafford v. HHS, 451 F.3d at 1352,

1355-56 (Fed. Cir. 2006).) Thus interpreting the first two prongs of Althen as specified in

Pafford, under Prong 1 of Althen a petitioner must demonstrate that the type of

vaccination in question can cause or aggravate the type of condition in question; and

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under Prong 2 of Althen, that petitioner must then demonstrate that the particular

vaccination did cause or aggravate the particular condition of the vaccinee in question.

If these conclusions are applied to the analogous elements in the Loving test, then under

Prong 4 of Loving a petitioner must demonstrate that the type of vaccination in question

can cause the type of significant aggravation in question; while Prong 5 of Loving would

require that the Petitioner also demonstrate that the particular vaccination did cause the

particular aggravation in question.

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

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

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

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

As explained above, all of the experts in this case agree that BCL was at least somewhat

neurologically compromised prior to the influenza vaccination of November 21, 2005. Dr.

Megson argued that his prior deficiency was minimal, while Dr. Leventhal more persuasively

argued that BCL likely met the criteria for ASD, and also manifested significant intellectual

disability.

2. What is BCL’s current condition?

My conclusion, from studying the records of this case, is that BCL currently suffers from

significant autism as well as significant intellectual disability.

3. BCL’s current condition legally constitutes a “significant aggravation”

of his prior condition.

My further conclusion is that BCL’s current condition is, in fact, as Petitioners contend,

significantly worse than his condition prior to the vaccination (though the worsening seems

likely to have been the result of the normal course of autism, and was likely not caused by the

vaccination). Therefore, under Loving, BCL’s current condition likely does amount to a

“significant aggravation” of his preexisting ASD.

4. Petitioners have failed to establish Prong 4 of Loving/Prong 1 of Althen.

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

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

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

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

Petitioners have wholly failed to show that an influenza vaccination can aggravate a preexisting

ASD, or any type of neurological disorder.

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That is, as explained above, under Prong 4 of Loving/Prong 1 of Althen a petitioner must

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

type of condition in question. Petitioners’ theory is that BCL’s influenza vaccine significantly

aggravated BCL’s previously diagnosed PDD-NOS and ADHD. However, in this case I have

already explained in detail (see part VII of this Decision) how Dr. Cederbaum’s testimony

thoroughly refuted the first part of Dr. Megson’s theory as to how a vaccine could cause or

aggravate autism, and how Dr. Leventhal thoroughly refuted the second part of Dr. Megson’s

theory (see part VIII of this Decision). Accordingly, it is quite evident that Petitioners have

wholly failed to establish Prong 4 of Loving/Prong 1 of Althen in this case.

5. Petitioners have failed to establish Prong 5 of Loving/Prong 2

of Althen in this case.

Under Prong 5 of Loving/Prong 2 of Althen, the Petitioners need to show that it is “more

probable than not” that BCL’s influenza vaccination did aggravate BCL’s autism. But they have

failed to do so, for all the reasons detailed above. As discussed in both Sections VII and VIII

above, Dr. Megson’s theory as to how the vaccination allegedly aggravated BCL’s autism has

been shown to be without scientific merit. Further, as shown in Section VIII, Dr. Megson’s

theory about BCL was based upon a mistaken assumption as to when his downturn began within

the 2005-2006 school year.

6. Petitioners have failed to establish Prong 6 of Loving/Prong 3 of Althen

in this case.

Since I have explained why Petitioners have failed to satisfy the first and second prongs

of Althen (4th and 5th Prongs of Loving), I need not discuss why Petitioners’ case also fails to

satisfy the Prong 3 of Althen/Prong 6 of Loving. However, in the interest of completeness, I will

note again that the medical records show that BCL’s downturn during the 2005-2006 school year

actually predated his flu vaccination (see pp. 19-20). Thus, Petitioners have also failed to

establish Prong 6 of Loving/Prong 3 of Althen in this case.

C. This not a close case

As noted above, in Althen, the Federal Circuit indicated that the Vaccine Act involves

“system created by Congress, in which close calls regarding causation are resolved in favor of

injured claimants.” Althen, 418 F.3d at 1280. Accordingly, I note here that this case is

ultimately is not a close call. For all the reasons set forth above, I find that Dr. Megson’s theory

was not at all persuasive, while Respondent’s experts were far more persuasive. 8

8

It should be noted that in this case the Petitioners never came close to carrying their burden of making a “prima

facie” case showing that BCL suffered a vaccine-caused or vaccine-aggravated injury. Therefore, the burden never

shifted to Respondent to demonstrate that BCL’s condition was “due to factors unrelated to the administration of the

vaccine.” §300aa-13(a)(1)(B).

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X

NOTATION CONCERNING VIABILITY OF DR. MEGSON AS AN

EXPERT WITNESS IN FUTURE PROGRAM CASES

As I have stressed above, I found Dr. Megson, despite her apparent sincerity, to be a very

unpersuasive witness in this case. Dr. Megson, in effect, relied on the theory that the miniscule

amount of mercury in the thimerosal preservative in the influenza vaccine could cause or

aggravate autism. (E.g., Ex. 24, pp. 7, 9; Ex. 24-1, pp. 1, 3.) But that theory was thoroughly

examined and soundly rejected by three special masters in the “second theory” autism test cases.

Dwyer v. HHS, No. 03-1202V, 2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); King v.

HHS, No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead v. HHS, No.

03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12, 2010).

Further, Dr. Megson relied on the “oxidative stress” theory that was also soundly rejected

in the same three test cases. (Ex. 24, p. 6, Ex. 24-1, pp. 2-3; 2-Tr. 288.) She acknowledged that

in this regard she was specifically relying upon the work of Dr. Richard Deth, who testified in

the second theory test cases, and whose analysis was rejected and criticized in those cases. 9 (Ex.

24-1, p. 2; 2-Tr. 236.)

Nor did Dr. Megson even seem to present her causation theories as any different than

these previously-discredited theories, or offer any new evidence for these theories.

Therefore, I hereby put Vaccine Act attorneys (and pro se litigants) on notice that if Dr.

Megson’s opinion, relying on the same discredited theories devoid of any new and plausible

evidence, is offered in future Vaccine Act cases, I will not be likely to compensate such

petitioners for any work by Dr. Megson performed after the publication date of this Decision.

Further, I also stress to Vaccine Act attorneys and pro se litigants, as I have in the past,

that it will likely be fruitless to present once again, even with different experts, the same autism

causation theories that were rejected in the “test case” decisions and in the additional cases cited

on Section II of this Decision above.

XI

CONCLUSION

The record of this case demonstrates plainly that BCL and his family have been through a

tragic ordeal. I had the opportunity, in the courtroom during the first evidentiary hearing, to

meet and observe BCL and his parents. I have also studied the records describing BCL’s

9

One discussion rejecting the “oxidative stress” theory in the autism “test case” rulings is set forth in King v. HHS,

2010 WL 892296 at *55-*61. For example, one highly qualified expert explained that the cumulative oxidative

stress from a typical six-month course of childhood vaccines would cause no more oxidative stress than drinking a

four-ounce glass of milk. 2010 WL 892296 at *56.

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medical history, and the efforts of his family in caring for him. Based upon those experiences,

the great dedication of BCL’s family to his welfare is readily apparent to me.

Nor do I doubt that BCL’s parents are sincere in their belief that BCL’s vaccination

played a role in aggravating BCL’s autism. BCL’s parents have heard the opinion of Dr.

Megson, and perhaps other physicians, who profess to believe in a causal connection between

vaccines and autism. After studying the extensive evidence in this case, I am convinced that the

opinion provided by Petitioners’ expert in this case, advising the Long family that there is a

causal connection between the flu vaccination and an aggravation of BLC’s autism, was quite

wrong. Nevertheless, I can understand why BCL’s parents found such opinion to be believable

under the circumstances. I conclude that the Petitioners filed this petition in good faith.

Thus, I feel deep sympathy for the Long family. Further, I find it unfortunate that my

ruling in this case means the Program will not be able to provide funds to assist this family, in

caring for their child who suffers from a serious disorder. It is my view that our society does not

provide enough assistance to families of all autistic children, regardless of the cause of their

disorders. And it is certainly my hope that our society will find ways to ensure that in the future

much more generous assistance is available to all such children. Such families must cope every

day with tremendous challenges in caring for their autistic children, and all are deserving of

sympathy and admiration. However, I must decide this case not on sentiment, but by analyzing

the evidence. Congress designed the Program to compensate only the families of individual

whose injuries or deaths can be linked causally, either by Table Injury or presumption or by

preponderance of “causation-in-fact” evidence, to a listed vaccine. In this case, the evidence

advanced by Petitioners has fallen far short of demonstrating such a link. Accordingly, I

conclude that the Petitioners in this case are not entitled to a Program award on BCL’s behalf. 10

IT IS SO ORDERED.

/s/ George L. Hastings, Jr.

George L. Hastings, Jr.

Special Master

10

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

accordingly.

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