# In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS No. 08

- 792 V ( T o be published)

* * * * * * * * * * * * * * * * * * * * * * * * * BRIAN LONG and KIMBERLY LONG, * as parents and natural guardians, on behalf * of their minor son, BCL
, *

* Petitioner s , * Filed: February 9, 2015

*

v. *

* SECRETARY OF HEALTH AND * Vaccine Act Entitlement; HUMAN SERVICES * Causation

- in

- fact; Influenza

* V accine/ 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 P etitioner s , 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.” 1I

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 sho wing 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 show n 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 In jury 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 availabl e 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 a t 1279; Hines , 940 F.2d at 1525. Under that standard, the petitioner must show that it is “more probable than not” that the vaccination cause d or aggravated the injury. Althen , 418 F.3d at 1279. The petitioner need not show that the vaccination was the s ole 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 ., eviden ce 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:

2Concis ely 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 evi dence, 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 ca usation 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 cons istent 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 const ruing 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 se cond 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 “pos sible.” 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.

3Another important aspect of the causation

- in

- fact case law under the Program concerns the factors that a special ma ster 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 th at 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 *** a llows certain petitioners to be compensated upon showing, among other thing s, that a person ‘sustained, or had significantly aggravated ’ a vaccine

- re lated ‘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

, 8 1 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 cl aim.” 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

- 3 3(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 significa nt 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 signifi cant 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”).

4II

BACKGROUND: THE OMNIBUS AUTISM PROCEEDING (“OAP”)

This case is one of more than 5, 4 00 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 proceedi ng 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, wa s 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 call ed the Petitioners’ Steering Committe e (“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 group s of attorneys to presen t 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 measle s, 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 directl y 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 fir st 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); Sny der 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. C l. 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 detai l 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 Snyd er did not appeal the decision of the U.S. Court of Federal Claims. 5solidly 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 sec ond 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 ei ther 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); He nderson 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 fo und 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 MM R 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.

6II I

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 allege d 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, Petiti oners further claim ed that BCL suffered the significant aggravation of his “pre

- existing vaccine injury” by an influenza vaccine administered on November 21, 2005. ( Id. ) Finally, Petitioners state d that they seek compensation not for the alleged initial injury by unspecified vaccinations , but for the significant aggravation allegedly caused by the 2005 f lu 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 Petit ioners’ 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 Novemb er 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 1 8, 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 Ju ne 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. )

7BCL ’s first “ sick visit ” to his pediatrician occurred on January 28, 1999, when he was treated for an upper respiratory infection and otitis med ia. ( Ex. 5, p. 20. ) Dur ing 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 cours e 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, p ediatric 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 t o have a “moderately severe articulation disorder

, ” and weekly therapy was recommended. ( Id

. , p. 50

. ) Although records dated A ugust 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 beca use 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 indica te d 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

- 1 7. ) Dr. Raskin concluded that BCL had probable Attention Deficit

- Hyperactivity Disorder (“ADHD”)

, and recommended medication. ( Id., p. 15. ) Over the course of the n ext year, BCL was treated with various doses of several medications

, including Ritalin, Adderall XR, Concerta, and Strattera. ( Ex. 5, p p . 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 ” ( i d

. ) , and that BCL be evaluated for the same at the Child Evaluation Center ( i d

. , p. 16 0 )

. On June 14, 2004, BCL u nderwent o ccupation al ther apy, s peech and l anguage, p sychological, and c omprehensive m edical evaluations at the Weisskopf Child Evaluation Center. ( Ex. 5, pp. 182

- 93. ) The experts indicate that BCL h ad made progress in some areas, but

s till 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,” bu t was otherwise normal. ( Ex. 5, p. 209. ) A medication management evaluation on Ap ril 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 la uded 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. )

8According 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. N ot paying attention.” ( Ex. 10, p. 11.)

O n 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 medication s w ere 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 1 7 , 2006, sta ted that she attributed his problems in school to “[A]nxiety depression and dealing with new environment and a l ot 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 development al disorder. ” ( Id

. , p. 2 1 .)

BCL visited Texas Children’s Hospital on September 5, 2006, for a new patient neurolo gy evaluation. (Ex. 13, p. 1 9.) Records from this evaluation indicate that BCL ’s “parents have no ted 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,
t he record indicates that BCL ’s parents first began to notice problems several months after thei r move to Texas. ( Id. )

BCL was treated at the Lawlis

- Peavey PsychoNeuroPlasticity Center beginnin g in March 2007. (Ex. 17, p. 5 .) Records i ndicate 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, conti nue s to suffer from autism and “intellectual d isability ” (formerly known as “ m entally r etar ded”)

, experiencing s evere 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.

9A. 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 B oston 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 Pediatri c and Adolescent Ability Center , where she specializes in the treatment of autistic individuals. ( Id.

, 2

- Tr. 175

- 77.) She has tre ated thousands of autistic patients ( 2

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

- Tr. 17 5 )

.
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 o f 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 MT HFR gene, in the C677T allele of that ge ne. (Ex. 24, p. 6; Ex. 24

- 1, p. 2; 2

- Tr. 215

- 216 .) She opined that t his 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. 10excessive oxidative stress can di sturb brain functio n, thus aggra vating autism (Ex. 24

- 1, p p . 2

- 3; 2

- Tr. 288 )

.
Dr. Megson further opined that BCL’s flu vaccination, o n November 21, 2005, by exposing BCL to 25 mic r ograms (“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 MT HFR 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

- 5 7 .)

B. Respondent’s expert s

1. Dr. Cede rbaum ’s qualifications

Dr. Stephen Cederbaum , M.D., attended Amherst College and graduated cum laude in 1959
, with an A.B. Honors in Chemistr y. (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 Amer ican Board of Medical Genetics. (Ex. D, p. 2.)

F rom 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 Divisio n 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

re viewed publications, plus 70 to 80 no n

- 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 sig nificance of the fact that BCL has a single C677T variant of his MT FHR gene. Dr. Cederbaum explained that

, in fact

, 35 to 40 percent of the entire populat ion 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, p p. 3

- 4 .) Dr. Cederbaum noted that the C677T

var iant of the MT FHR gene has been studied intensively ( 2

- Tr. 314), and that the strong medi cal consensus in the genetics specialty i s 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.)

11Dr. 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 Louisia na 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 f rom 1974

- 1978. ( Id., p. 2.) He addit ionally 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

- 7 5 , 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 lecture d 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 t o 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 suggest ed 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 tha t 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 “i ntellectually d isabled ” (formerly known as “ m entally r etarded ” ). (Ex. A, p. 15

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

Dr. Leventhal acknowledge d 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 disagree d 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

12city, 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 sch ool, 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 wea k 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 mor e 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

a

utism 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 demo nstrate that it is “more probabl e 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 nonexist ence.” In re Winship , 397 U.S. 358, 371 (1970)(Harlan, J., concurring). 13VII

I FOUND NO MERIT IN THE FI RST 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 w as far more persuasive than Dr. Megson concerning this point.

For one thing, concerning this point Dr. Cederbaum is far more qualified t han Dr. Megson. As noted above, Dr. Megson is a pediatrician. She has made no claim to any special training in gene tics. 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 Califor nia 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 4 0 percent of the entire population have that exact same genetic variant, without any apparent detriment al effects. (Ex. C, p. 3 ; Tr. 309, 314.) Dr. Cederbaum explained that the existence of t his variant has been extensively studied (Tr. 314), and that experts in the area have conclude d that the existence of such a variant does not make a person more susceptible to neurologic diso rder, 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 suscept ible to neurologic disorder, the n we would be pr actically 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 h ave reached a strong

cons ensus that the C677 T 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

- 4 3, 363). I have reviewed this testimony of both experts concerning this literature, as well as the literature itself. I find that Dr. Cederbaum’s discus sion 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 w ere also persuasive.

14To be su re, Dr. Cederbaum clarified in his testimony that the presence of a sin gle 5 C677T variant in the MTHFR , which BCL has

, i s 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 c linically 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 import ant 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 part icularly susceptible to brain injury. (2

- Tr. 3 08). He also found that there is no evidence for Dr. Megson’s theory that the flu vaccine, acting in c oncert with a single C677T variant, caused any harm to BCL. (2

- Tr. 323.)

Again, I find that t he discuss ion 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. Meg son’s theory, co mbined 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.

VI II

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 pl ainly 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 m ild 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 acknowledge d 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). 15severe 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 spectr um 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 a s 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, bo ard

- certified in both general psych iatry and adolescent psychiatry (2

- Tr. 372)

, has specialized in adolescent psychiatry (2

- Tr. 372, 374

- 75, 378

- 80). At the Universi ty of Chicago, he served for 25 years as Director of Child and A dolescent Psychiatry, and for10 years as Chief of the Departm ent 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 ab out autism around the world. (2

- Tr. 374, 376

- 78.) Dr. Leventhal has participated in devising the medica l 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

a utism , and Dr. Leventhal was f ar 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 testimo ny 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 l ittle 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 individu als who have been diagnosed by someone else with ASD. (2

- Tr. 17 8.) 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 .) 16To be sure, Dr. Megson did assert in her expert reports that BCL’s flu vaccination of November 21, 2005, exposed BCL to 25 micrograms (“m cg”) of mercury

, contained as a vaccine preservative known as “thimerosal,” suggesting that such mercury caused “oxidative stress” to his brain , there b y 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 specu lative 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 acknowledge d 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 ad missions, 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 influenz a vaccination during the period o f time in which he was havi ng academic troubles and a downturn in his behavior, during the 2005

- 2006 school year, she seems to have automatically jumped to the conclusion t hat 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 vaccin e, 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

- T r . 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 acknowledge d 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 disagree d 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 beh avior 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.)

1 7Further, Dr. Leventhal explained that with ASD it is common for behavi or 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. F or 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

- T r. 245

- 46.) Dr. Leventhal, however, testified persuasively that still photos cannot te ll 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 vaccinatio n. (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 wo uld be chronic brain inflammation, for which a physician could easily te s t, 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 acknowledge d 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

- N OS 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 “ Per vasive Developmental Disorder, N ot Otherwise S pecified.” (2

- Tr. 389.) 18(2

- Tr. 273, lines 13

- 16)

. She then seemed to acknowledge that BCL was on th e autism spectrum at that time, but on the “mi l d end” of that spectrum. (2

- Tr. 273, lines 17

- 19.)

Dr. Leventhal, on the other hand, indicated that while BCL w as 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 o ften confusing and scatt er shot 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 f or 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 sever al problems with this argument, however.

First as discussed at pp. 14

- 18 of this Decision, above, Dr. Megson was wholly

un persuasive 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 th a n not, the vaccination caused the downturn.

Moreover, a clos e 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 tha t 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.

19In this regard, I acknowledge that during the first evidentiary hearing in his case, BCL’s parents testified t hat the 2005

- 2006 deter ioration 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 l ate 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 diffe rent st ory 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 vaccin ation 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 specif ically 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. 6 7

- 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 vaccinatio n , but as starting after he experienced a “new envi ronment 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

- 20 06 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.

20IX

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 presente d in either Althen or Loving

. The U.S. Court of Appeals for the Federal Circuit declared in Althen that it is a
p etitioner’s burden:

to show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory causal ly 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 c ontributing 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 h is preexisting autism. However, in this ca se, 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 “significa nt 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 accompanie d by substantial deterioration of health.” §300 aa

- 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 C ourt of Appeals for the Federal Circuit acknowledged that “the Loving case provides the correct framework for evaluating off

- table significant aggravat ion claims,” in W.C. v. HHS , 704 F.3d 1352, 1357 (Fed. Cir. 2013). Thus, the Federal C ircuit C ourt 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 showin g:

21(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 aggravat ion’ 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 significa nt 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 ele ments 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 thr ee elements of the Loving test include the entirety of the Althen test, with in significant wording modifications, the analysis of those three elements would be the same using either standard.

One interpretive issue with the A l then 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 bee n 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 vaccin e e did cause the vaccinee ’s own injury. See
, e.g. , Kuperus v. HHS , 2003 WL 22912885, at *8 (Fed. Cl. Spec. Mstr. Oct. 23, 20 03); Helms v. HHS , 2002 WL 31441212, at *18 n.42 (Fed. Cl. Spec. M str. Aug. 8, 2002). T hus, 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. J uly 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 th e type of condition in question; and

22under Prong 2 of Althen , that petitioner must then demonstrate that the particular vaccination did cause or aggravate the particular condition of the vaccine e in question. If these conclusions are applied to the analog ous 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 d emonstrate 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 administrati on of the vaccine?

As explained above, all of the experts in this case agree that BCL was at le ast somewhat neurologically compromise d prior to the influenza vaccination of November 21, 2005. Dr. Megson argue d that his prior deficiency was minimal, while Dr. Leventhal more persuasively
argue d that BCL likely met the criteria for ASD, a nd also manif ested significant intellectual d isability.

2. What is BCL’s current condition?

My conclusion

, from s tudying the records of this case , is that BCL currently suffers from significant autism as well as significant i ntellectual d isability.

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 c ourse 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 hi s pre existing 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

.

23That is, as e xplained 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 t he 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. P etitioners 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 bo th 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 assum ption as to when his downturn began within the 2005

- 20 06 school year.

6. Petitioners have failed to establish Prong 6 of Loving/ Prong 3 of Althen in this cas e . Since I have explained why Petitioners have failed to satisfy the first and second prongs of Althen (4 th and 5 th Prongs of Loving )

, I need not discuss why Petitioners’ case also fails to satisfy the P rong 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

- 20 06 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 ultimate ly 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). 24X

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 i n the influenza vaccine could cause or aggravate autism. ( E.g. , Ex. 24, p p . 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

- 1 202V, 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 “ox idative stress” theory that was also soundly rejected in the same three test cases. (Ex. 24, p. 6, E x. 24

- 1, pp. 2

- 3; 2

- Tr. 288.) S he acknowledged that in this regard she was specifically relying upon the work of Dr. Richard Deth, who testified in the se cond 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 th an these previously

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

Therefore, I hereby put Vaccine Act attorneys (and pro se litigants ) on not ice 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,
t hat it will li kely 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 B CL 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 K in g 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 vaccine s would cause no more oxidative stress than drinking a four

- ounce glass of milk. 2010 WL 892296 at *56. 25medical 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 appa rent to me.

Nor do I doubt that BCL’s parents are sincere in their belief that BCL’s vaccin ation 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 vac cination 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 ou r 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 availa ble 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 eviden ce. 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. 26